------------------- bmj15665005.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
Does home based medication review keep older people out of hospital? The HOMER randomised controlled trial.
Holland R Lenaghan E Harvey I Smith R Shepstone L Lipp A Christou M Evans D Hand C.
School of Medicine, Health Policy and Practice, University of East Anglia, Norwich NR4 7TJ.
r.holland@uea.ac.uk
OBJECTIVE
To determine whether home based medication review by pharmacists affects [hospital readmission rates] among older people.
DESIGN
Randomised controlled trial.
SETTING
Home based medication review after discharge from acute or community hospitals in Norfolk and Suffolk.
PARTICIPANTS
872 patients aged over 80 recruited during an emergency admission (any cause) if returning to own home or warden controlled accommodation and taking two or more drugs daily on discharge.
INTERVENTION
Two home visits by a pharmacist within two weeks and eight weeks of discharge to educate patients and carers about their drugs, remove out of date drugs, inform general practitioners of drug reactions or interactions, and inform the local pharmacist if a compliance aid is needed. Control arm received usual care .
MAIN OUTCOME MEASURE
Total [emergency readmissions to hospital] at six months . Secondary outcomes included [death] and {[quality of life] measured with the EQ-5D} .
RESULTS
By six months 178 [readmissions] had occurred in the control group and 234 in the intervention group (rate ratio = 1.30, 95% confidence interval 1.07 to 1.58; P = 0.009, Poisson model). 49 [deaths] occurred in the intervention group compared with 63 in the control group (hazard ratio = 0.75, 0.52 to 1.10; P = 0.14). [EQ-5D scores] decreased (worsened) by a mean of 0.14 in the control group and 0.13 in the intervention group (difference = 0.01, -0.05 to 0.06; P = 0.84, t test).
CONCLUSIONS
The intervention was associated with [a significantly higher rate of hospital admissions] and did not significantly improve [quality of life] or reduce [deaths] . Further research is needed to explain this counterintuitive finding and to identify more effective methods of medication review .
------------------- bmj15699058.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
Exercises to prevent [lower limb injuries] in youth sports: cluster randomised controlled trial.
Olsen OE Myklebust G Engebretsen L Holme I Bahr R.
Oslo Sports Trauma Research Center, Norwegian University of Sport and Physical Education, 0806 Oslo, Norway.
odd-egil.olsen@nih.no
OBJECTIVE
To investigate the effect of a structured warm-up programme designed to reduce the incidence of [knee and ankle injuries] in young people participating in sports.
DESIGN
Cluster randomised controlled trial with clubs as the unit of randomisation.
SETTING
120 team handball clubs from central and eastern Norway (61 clubs in the intervention group , 59 in the control group ) followed for one league season ( eight months ).
PARTICIPANTS
1837 players aged 15-17 years; 958 players (808 female and 150 male) in the intervention group ; 879 players (778 female and 101 male) in the control group .
INTERVENTION
A structured warm-up programme to improve running, cutting, and landing technique as well as neuromuscular control, balance, and strength.
MAIN OUTCOME MEASURE
The rate of [acute injuries to the knee or ankle] .
RESULTS
During the season, 129 [acute knee or ankle injuries] occurred, 81 [injuries] in the control group (0.9 (SE 0.09) [injuries] per 1000 player hours; 0.3 (SE 0.17) in training v 5.3 (SE 0.06) during matches) and 48 [injuries] in the intervention group (0.5 (SE 0.11) [injuries] per 1000 player hours; 0.2 (SE 0.18) in training v 2.5 (SE 0.06) during matches). Fewer [injured players] were in the intervention group than in the control group (46 (4.8%) v (76 (8.6%); relative risk intervention group v control group 0.53, 95% confidence interval 0.35 to 0.81).
CONCLUSION
A structured programme of warm-up exercises can prevent [knee and ankle injuries] in young people playing sports. Preventive training should therefore be introduced as an integral part of youth sports programmes.
------------------- bmj15705690.xml ---------------------------
Clinical Trial Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Feb 12;330(7487):317-8.
Rectal artemether versus intravenous quinine for the treatment of cerebral malaria in children in Uganda: randomised clinical trial.
Aceng JR Byarugaba JS Tumwine JK.
Department of Paediatrics and Child Health, Makerere Medical School, PO Box 7072, Kampala, Uganda.
OBJECTIVE
To compare the efficacy and safety of rectal artemether with intravenous quinine in the treatment of cerebral malaria in children.
DESIGN
Randomised, single blind, clinical trial.
SETTING
Acute care unit at Mulago Hospital, Uganda's national referral and teaching hospital in Kampala.
PARTICIPANTS
103 children aged 6 months to 5 years with cerebral malaria.
INTERVENTION
Patients were randomised to either intravenous quinine or rectal artemether for seven days .
MAIN OUTCOME MEASURES
[Time to clearance of parasites and fever] ; [time to regaining consciousness] , [starting oral intake] , and [sitting unaided] ; and [adverse effects] .
RESULTS
The difference in parasitological and clinical outcomes between rectal artemether and intravenous quinine did not reach significance ( [parasite clearance time] 54.2 (SD 33.6) hours v 55.0 (SD 24.3) hours, P = 0.90; [fever clearance time] 33.2 (SD 21.9) hours v 24.1(SD 18.9 hours, P = 0.08; [time to regaining consciousness] 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.10; [time to starting oral intake] 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14). [Mortality] was higher in the quinine group than in the artemether group (10/52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01). No [serious immediate adverse effects] occurred.
CONCLUSION
Rectal artemether is effective and well tolerated and could be used as treatment for cerebral malaria.
------------------- bmj15708844.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Apr 2;330(7494):759. dosage error in text.
Evid Based Ment Health. 2005 Nov;8(4):107.
Acute treatment of moderate to severe depression with hypericum extract WS 5570 ( St John's wort ) : randomised controlled double blind non-inferiority trial versus paroxetine .
Szegedi A Kohnen R Dienel A Kieser M.
Charit-Universittsmedizin Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy, Eschenallee 3, 14050 Berlin, Germany.
OBJECTIVE
To investigate the efficacy of hypericum extract WS 5570 ( St John's wort ) compared with paroxetine in patients with moderate to severe major depression.
DESIGN
Randomised double blind, double dummy, reference controlled, multicentre non-inferiority trial.
SETTING
21 psychiatric primary care practices in Germany.
PARTICIPANTS
251 adult outpatients with acute major depression with total score > or = 22 on the 17 item Hamilton depression scale.
INTERVENTIONS
900 mg/day hypericum extract WS 5570 three times a day or 20 mg paroxetine once a day for six weeks . In initial non-responders doses were increased to 1800 mg/day hypericum or 40 mg/day paroxetine after two weeks .
MAIN OUTCOME MEASURES
{Change in score on [Hamilton depression scale] from baseline to day 42} (primary outcome). Secondary measures were change in scores on [Montgomery-Asberg depression rating scale] , [clinical global impressions] , and [Beck depression inventory] .
RESULTS
[The Hamilton depression total score] decreased by mean 14.4 (SD 8.8) points, corresponding to 56.6% (SD 34.3%) of the baseline value, in the hypericum group and by 11.4 (SD 8.6) points (44.8% (SD 33.5%) of baseline value) in the paroxetine group (intention to treat analysis; similar results were observed in the per protocol analysis). The intention to treat analysis (lower one sided 97.5% confidence limit 1.5 points for the difference hypericum minus paroxetine ) and the per protocol analysis (lower confidence limit 0.7 points) showed non-inferiority of hypericum and statistical superiority over paroxetine . The lower limits in both cases exceeded the pre-specified non-inferiority margin of -2.5 points and the superiority margin of 0. The incidence of [adverse events] was 0.035 and 0.060 events per day of exposure for hypericum and paroxetine , respectively.
CONCLUSIONS
In the treatment of moderate to severe major depression, hypericum extract WS 5570 is at least as effective as paroxetine and is better tolerated.
------------------- bmj15716289.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Mar 26;330(7493):682-3. Evid Based Cardiovasc Med. 2005 Sep;9(3):230-3.
Cost effectiveness of nurse led secondary prevention clinics for coronary heart disease in primary care: follow up of a randomised controlled trial.
Raftery JP Yao GL Murchie P Campbell NC Ritchie LD.
Health Economics Facility, Health Services Management Centre, University of Birmingham, Birmingham B15 2RT.
j.p.raftery@bham.ac.uk
OBJECTIVE
To establish the cost effectiveness of nurse led secondary prevention clinics for coronary heart disease based on four years' follow up of a randomised controlled trial.
DESIGN
Cost effectiveness analysis.
SETTING
19 general practices in north east Scotland.
PARTICIPANTS
1343 patients (673 in intervention group and 670 in control group , as originally randomised) aged under 80 years with a diagnosis of coronary heart disease but without terminal illness or dementia and not housebound.
INTERVENTION
Nurse led clinics to promote medical and lifestyle components of secondary prevention.
MAIN OUTCOME MEASURES
[Costs of clinics] ; [overall costs to health service] ; and [cost per life year] and [per quality adjusted life year (QALY) gained] , expressed as incremental gain in intervention group compared with control group .
RESULTS
{[The cost of the intervention] ( clinics and drugs )} was 136 pounds sterling (254 dollars; 195 euros) per patient higher (1998-9 prices) in the intervention group , but the difference in other NHS costs, although lower for the intervention group , was not statistically significant. Overall, 28 fewer [deaths] occurred in the intervention group leading to a gain in [mean life years per patient] of 0.110 and of 0.124 QALYs. [The incremental cost per life year saved] was 1236 pounds sterling and that [per QALY] was 1097 pounds sterling.
CONCLUSION
Nurse led clinics for the secondary prevention of coronary heart disease in primary care seem to be cost effective compared with most interventions in health care , with the main gains in [life years saved] .
------------------- bmj15722369.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Apr 16;330(7496):857-8.
Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial.
Ballard C Margallo-Lana M Juszczak E Douglas S Swann A Thomas A O'Brien J Everratt A Sadler S Maddison C Lee L Bannister C Elvish R Jacoby R.
Institute of Psychiatry, King's College, London SE5 8AF.
OBJECTIVES
To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to {change in [cognitive performance]} .
DESIGN
Randomised double blind (clinician, patient, outcomes assessor) placebo controlled trial.
SETTING
Care facilities in the north east of England.
PARTICIPANTS
93 patients with Alzheimer's disease, dementia, and clinically significant agitation.
INTERVENTION
Atypical antipsychotic ( quetiapine ) , cholinesterase inhibitor ( rivastigmine ) , or placebo ( double dummy ) .
MAIN OUTCOME MEASURES
{[Agitation] ( [Cohen-Mansfield agitation inventory] )} and {[cognition] ( [severe impairment battery] )} at baseline and at six weeks and 26 weeks . The primary outcome was {[agitation inventory]} at six weeks .
RESULTS
31 patients were randomised to each group, and 80 (86%) started treatment (25 rivastigmine , 26 quetiapine , 29 placebo ), of whom 71 (89%) tolerated the maximum protocol dose (22 rivastigmine , 23 quetiapine , 26 placebo ). Compared with placebo , neither group showed significant differences in improvement on [the agitation inventory] either at six weeks or 26 weeks . Fifty six patients scored > 10 on [the severe impairment battery] at baseline , 46 (82%) of whom were included in the analysis at six week follow up (14 rivastigmine , 14 quetiapine , 18 placebo ). For quetiapine the change in [severe impairment battery score] from baseline was estimated as an average of -14.6 points (95% confidence interval -25.3 to -4.0) lower (that is, worse) than in the placebo group at six weeks (P = 0.009) and -15.4 points (-27.0 to -3.8) lower at 26 weeks (P = 0.01). [The corresponding changes] with rivastigmine were -3.5 points (-13.1 to 6.2) lower at six weeks (P = 0.5) and -7.5 points (-21.0 to 6.0) lower at 26 weeks (P = 0.3).
CONCLUSIONS
Neither quetiapine nor rivastigmine are effective in the treatment of [agitation] in people with dementia in institutional care. Compared with placebo , quetiapine is associated with [significantly greater cognitive decline] .
------------------- bmj15746106.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
Incidence and risk factors for [non-alcoholic steatohepatitis] : prospective study of 5408 women enrolled in Italian tamoxifen chemoprevention trial.
Bruno S Maisonneuve P Castellana P Rotmensz N Rossi S Maggioni M Persico M Colombo A Monasterolo F Casadei-Giunchi D Desiderio F Stroffolini T Sacchini V Decensi A Veronesi U.
Liver Unit, Azienda Ospedaliera Fatebenefratelli e Oftalmico, Corso di Porta Nuova 23, 20121 Milan, Italy.
savino.bruno@fbf.milano.it
OBJECTIVE
To assess the incidence, cofactors, and excess risk of development of [non-alcoholic fatty liver disease] , including [non-alcoholic steatohepatitis] , attributable to tamoxifen in women.
DESIGN
Prospective, randomised, double blind, placebo controlled trial.
SETTING AND PARTICIPANTS
5408 healthy women who had had hysterectomies, recruited into the Italian tamoxifen chemoprevention trial from 58 centres in Italy.
INTERVENTION
Women were randomly assigned to receive tamoxifen (20 mg daily) or placebo for five years .
MAIN OUTCOME MEASURE
Development of [non-alcoholic fatty liver disease] in all women with normal baseline liver function who showed at least two elevations of alanine aminotransferase (> or = 1.5 times upper limit of normal) over a six month period .
RESULTS
During follow up, 64 women met the predefined criteria: 12 tested positive for hepatitis C virus, and the remaining 52 were suspected of having developed [non-alcoholic fatty liver disease] (34 tamoxifen , 18 placebo )--hazard ratio = 2.0 (95% confidence interval 1.1 to 3.5; P = 0.04). In all 52 women ultrasonography confirmed the presence of [fatty liver] . Other factors associated with the development of [non-alcoholic fatty liver disease] included overweight (2.4, 1.2 to 4.8), obesity (3.6, 1.7 to 7.6), hypercholesterolaemia (3.4, 1.4 to 7.8), and arterial hypertension (2.0, 1.0 to 3.8). Twenty women had liver biopsies: 15 were diagnosed as having [mild to moderate steatohepatitis] (12 tamoxifen , 3 placebo ), and five had [fatty liver alone] (1 tamoxifen , 4 placebo ). No clinical, biochemical, ultrasonic, or histological signs suggestive of progression to cirrhosis were observed after a median follow up of 8.7 years.
CONCLUSIONS
Tamoxifen was associated with higher risk of development of [non-alcoholic steatohepatitis] only in overweight and obese women with features of metabolic syndrome, but the disease, in both the tamoxifen and the placebo group , after 10 years of follow up seems to be indolent.
------------------- bmj15757960.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Oct 15;331(7521):876.
ACP J Club. 2005 Sep-Oct;143(2):39.
Screening for abdominal aortic aneurysms : single centre randomised controlled trial.
Lindholt JS Juul S Fasting H Henneberg EW.
Vascular Research Unit, Department of Vascular Surgery, Sygehus Viborg, DK-8800 Viborg, Denmark.
jes.s.lindholt@sygehusviborg.dk
OBJECTIVE
To determine whether screening Danish men aged 65 or more for abdominal aortic aneurysms reduces [mortality] .
DESIGN
Single centre randomised controlled trial.
SETTING
All five hospitals in Viborg County, Denmark.
PARTICIPANTS
All 12,639 men born during 1921-33 and living in Viborg County. In 1994 we included men born 1921-9 (64-73 years). We also included men who became 65 during 1995-8.
INTERVENTIONS
Men were randomised to the intervention group ( screening by abdominal ultrasonography ) or control group . Participants with an abdominal aortic aneurysm > 5 cm were referred for surgical evaluation, and those with smaller aneurysms were offered annual scans.
OUTCOME MEASURES
{[Specific mortality] due to abdominal aortic aneurysm} , [overall mortality] , and {[number of planned and emergency operations] for abdominal aortic aneurysms} .
RESULTS
4860 of 6333 men were screened (attendance rate 76.6%). 191 (4.0% of those screened) had abdominal aortic aneurysms. The mean follow-up time was 52 months . The screened group underwent 75% (95% confidence interval 51% to 91%) [fewer emergency operations] than the control group . {[Deaths] due to abdominal aortic aneurysms} occurred in nine patients in the screened group and 27 in the control group . The number needed to screen to save one life was 352. [Specific mortality] was significantly reduced by 67% (29% to 84%). {Mortality due to non-abdominal aortic aneurysms} was non-significantly reduced by 8%. The benefits of screening may increase with time.
CONCLUSION
Mass screening for abdominal aortic aneurysms in Danish men aged 65 or more reduces [mortality] .
------------------- bmj15778231.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Jul 30;331(7511):249-50.
Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial.
Elden H Ladfors L Olsen MF Ostgaard HC Hagberg H.
Perinatal Center, Department of Obstetrics and Gynecology, Institute for the Health of Women and Children, Sahlgrenska Academy, East Hospital, 41685 Gothenburg, Sweden.
helen.elden@vgregion.se
OBJECTIVES
To compare the efficacy of standard treatment , standard treatment plus acupuncture , and standard treatment plus stabilising exercises for {[pelvic girdle pain] during pregnancy} .
DESIGN
Randomised single blind controlled trial. Settings East Hospital, Gothenburg, and 27 maternity care centres in Sweden.
PARTICIPANTS
386 pregnant women with pelvic girdle pain.
INTERVENTIONS
Treatment for six weeks with standard treatment (n = 130), standard treatment plus acupuncture (n = 125), or standard treatment plus stabilising exercises (n = 131).
MAIN OUTCOME MEASURES
Primary outcome measure was [pain] (visual analogue scale); secondary outcome measure was {assessment of [severity of pelvic girdle pain] by an independent examiner} before and after treatment.
RESULTS
After treatment the stabilising exercise group had [less pain] than the standard group in the morning (median difference = 9, 95% confidence interval 1.7 to 12.8; P = 0.0312) and in the evening (13, 2.7 to 17.5; P = 0.0245). The acupuncture group , in turn, had [less pain] in the evening than the stabilising exercise group (-14, -18.1 to -3.3; P = 0.0130). Furthermore, the acupuncture group had [less pain] than the standard treatment group in the morning (12, 5.9 to 17.3; P < 0.001) and in the evening (27, 13.3 to 29.5; P < 0.001). {[Attenuation of pelvic girdle pain] as assessed by the independent examiner} was greatest in the acupuncture group .
CONCLUSION
Acupuncture and stabilising exercises constitute efficient complements to standard treatment for {the management of [pelvic girdle pain] during pregnancy} . Acupuncture was superior to stabilising exercises in this study.
------------------- bmj15851401.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S.
BMJ. 2005 May 14;330(7500):1095-6.
Antioxidant supplementation for the prevention of [kwashiorkor] in Malawian children: randomised, double blind, placebo controlled trial.
Ciliberto H Ciliberto M Briend A Ashorn P Bier D Manary M.
Department of Pediatrics, Washington University School of Medicine, St Louis Children's Hospital, One Children's Place, St Louis, MO 63110, USA.
OBJECTIVE
To evaluate the efficacy of antioxidant supplementation in preventing [kwashiorkor] in a population of Malawian children at high risk of developing [kwashiorkor] .
DESIGN
Prospective, double blind, placebo controlled trial randomised by household.
SETTING
8 villages in rural southern Malawi.
PARTICIPANTS
2372 children in 2156 households aged 1-4 years were enrolled; 2332 completed the trial.
INTERVENTION
Daily supplementation with an antioxidant powder containing riboflavin, vitamin E, selenium, and N-acetylcysteine in a dose that provided about three times the recommended dietary allowance of each nutrient or placebo for 20 weeks .
MAIN OUTCOME MEASURES
The primary outcome was [the incidence of oedema] . Secondary outcomes were [the rates of change for weight and length] and [the number of days of infectious symptoms] .
RESULTS
62 children developed [kwashiorkor] (defined by [the presence of oedema] ); 39/1184 (3.3%) were in the antioxidant group and 23/1188 (1.9%) were in the placebo group (relative risk 1.70, 95% confidence interval 0.98 to 2.42). The two groups did not differ in [rates of weight or height gain] . Children who received antioxidant supplementation did not experience [less fever, cough, or diarrhoea] .
CONCLUSIONS
Antioxidant supplementation at the dose provided did not prevent [the onset of kwashiorkor] . This finding does not support the hypothesis that depletion of vitamin E, selenium, cysteine, or riboflavin has a role in [the development of kwashiorkor] .
------------------- bmj15860827.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
ACP J Club. 2005 Nov-Dec;143(3):72-4. Age Ageing. 2005 Nov;34(6):542-4. BMJ. 2005 Jul 9;331(7508):108-9; author reply 109. BMJ. 2005 Jul 9;331(7508):108; author reply 109. BMJ. 2005 Jul 9;331(7508):108; author reply 109.
Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for [prevention of fractures] in primary care.
Porthouse J Cockayne S King C Saxon L Steele E Aspray T Baverstock M Birks Y Dumville J Francis R Iglesias C Puffer S Sutcliffe A Watt I Torgerson DJ.
York Trials Unit, Department of Health Sciences, University of York, York YO10 5DD.
OBJECTIVE
To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces [the risk of fracture] in women with one or more risk factors for fracture of the hip.
DESIGN
Pragmatic open randomised controlled trial.
SETTING
Practice nurse led clinics in primary care.
PARTICIPANTS
3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health.
INTERVENTION
Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls , or leaflet only ( control group ).
MAIN OUTCOME MEASURES
Primary outcome measure was [all clinical fractures] and secondary outcome measures were [adherence to treatment] , [falls] , and [quality of life] (measured with the SF-12).
RESULTS
69% of the women who completed the follow-up questionnaire at 24 months were [still taking supplements] (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), [clinical fracture rates] were lower than expected in both groups but did not significantly differ for [all clinical fractures] (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for [hip fracture] was 0.75 (0.31 to 1.78). The odds of a woman having [a fall] at six and 12 months was 0.99 and 0.98, respectively. [Quality of life] did not significantly differ between the groups.
CONCLUSION
We found no evidence that calcium and vitamin D supplementation reduces [the risk of clinical fractures] in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.
------------------- bmj15911536.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial.
Rivero-Arias O Campbell H Gray A Fairbank J Frost H Wilson-MacDonald J.
Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford OX3 7LF.
OBJECTIVE
To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain.
DESIGN
Economic evaluation alongside a pragmatic randomised controlled trial.
SETTING
Secondary care.
PARTICIPANTS
349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002.
MAIN OUTCOME MEASURES
[Costs related to back pain and incurred by the NHS and patients] up to 24 months after randomisation. [Return to paid employment] and [total hours worked] . {[Patient utility] as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate [quality adjusted life years] ( [QALYs] )} . [Cost effectiveness] was expressed as [an incremental cost per QALY] .
RESULTS
At two years , 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. [The mean total cost per patient] was estimated to be 7830 pounds sterling (SD 5202 pounds sterling) in the surgery group and 4526 pounds sterling (SD 4155 pounds sterling) in the intensive rehabilitation arm , a significant difference of 3304 pounds sterling (95% confidence interval 2317 pounds sterling to 4291 pounds sterling). [Mean QALYs] over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group , giving a non-significant difference of 0.068 (-0.020 to 0.156). [The incremental cost effectiveness ratio] was estimated to be 48,588 pounds sterling per QALY gained (- 279,883 pounds sterling to 372,406 pounds sterling).
CONCLUSION
Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change-for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.
------------------- bmj15911537.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Jun 25;330(7506):1485.
BMJ. 2005 May 28;330(7502):1220-1. J Fam Pract. 2005 Sep;54(9):752.
Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial.
Fairbank J Frost H Wilson-MacDonald J Yu LM Barker K Collins R; Spine Stabilisation Trial Group.
Nuffield Orthopaedic Centre, Oxford OX3 7LD.
jeremy.fairbank@ndos.ox.ac.uk
OBJECTIVES
To assess the clinical effectiveness of surgical stabilisation ( spinal fusion ) compared with intensive rehabilitation for patients with chronic low back pain.
DESIGN
Multicentre randomised controlled trial.
SETTING
15 secondary care orthopaedic and rehabilitation centres across the United Kingdom.
PARTICIPANTS
349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion.
INTERVENTION
Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy .
MAIN OUTCOME MEASURE
The primary outcomes were [the Oswestry disability index] and [the shuttle walking test] measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure.
RESULTS
176 participants were assigned to surgery and 173 to rehabilitation . 284 (81%) provided follow-up data at 24 months . [The mean Oswestry disability index] changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group . The estimated mean difference between the groups was -4.1 (95% confidence interval -8.1 to -0.1, P = 0.045) in favour of surgery . No significant differences between the treatment groups were observed in [the shuttle walking test] or any of [the other outcome measures] .
CONCLUSIONS
Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation .
------------------- bmj15951310.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
Treatment of head louse infestation with 4% dimeticone lotion : randomised controlled equivalence trial.
Burgess IF Brown CM Lee PN.
Insect Research and Development, Shepreth, Royston SG8 6QZ.
ian@insectresearch.com
OBJECTIVE
To evaluate the efficacy and safety of 4% dimeticone lotion for treatment of head louse infestation.
DESIGN
Randomised controlled equivalence trial.
SETTING
Community, with home visits.
PARTICIPANTS
214 young people aged 4 to 18 years and 39 adults with active head louse infestation.
INTERVENTIONS
Two applications seven days apart of either 4.0% dimeticone lotion , applied for eight hours or overnight , or 0.5% phenothrin liquid , applied for 12 hours or overnight .
OUTCOME MEASURES
{[Cure of infestation] ( [no evidence of head lice after second treatment] )} or [reinfestation after cure] .
RESULTS
[Cure] or [reinfestation after cure] occurred in 89 of 127 (70%) participants treated with dimeticone and 94 of 125 (75%) treated with phenothrin (difference -5%, 95% confidence interval -16% to 6%). Per protocol analysis showed that 84 of 121 (69%) participants were [cured] with dimeticone and 90 of 116 (78%) were [cured] with phenothrin . [Irritant reactions] occurred significantly less with dimeticone (3/127, 2%) than with phenothrin (11/125, 9%; difference -6%, -12% to -1%). [Per protocol] this was 3 of 121 (3%) participants treated with dimeticone and 10 of 116 (9%) treated with phenothrin (difference -6%, -12% to -0.3%).
CONCLUSION
Dimeticone lotion cures head louse infestation. Dimeticone seems less irritant than existing treatments and has a physical action on lice that should not be affected by resistance to neurotoxic insecticides.
------------------- bmj15967762.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Jul 9;331(7508):88.
Should treatment of (sub)acute low back pain be aimed at psychosocial prognostic factors? Cluster randomised clinical trial in general practice.
Jellema P van der Windt DA van der Horst HE Twisk JW Stalman WA Bouter LM.
Department of General Practice, Institute for Research in Extramural Medicine, VU University Medical Center, Van der Boechorststraat 7, 1081 BT Amsterdam, Netherlands.
OBJECTIVE
To compare the effects of a minimal intervention strategy aimed at assessment and modification of psychosocial prognostic factors and usual care for treatment of (sub)acute low back pain in general practice.
DESIGN
Cluster randomised clinical trial.
SETTING
60 general practitioners in 41 general practices.
PARTICIPANTS
314 patients with non-specific low back pain of less than 12 weeks' duration, recruited by their general practitioner.
INTERVENTIONS
In the minimal intervention strategy group the general practitioner explored the presence of psychosocial prognostic factors, discussed these factors, set specific goals for reactivation, and provided an educational booklet. The consultation took about 20 minutes. Usual care was not standardised.
MAIN OUTCOME MEASURES
[Functional disability] (Roland-Morris disability questionnaire), [perceived recovery] , and [sick leave because of low back pain] assessed at baseline and after 6 , 13 , 26 , and 52 weeks .
RESULTS
The dropout rate was 8% in the minimal intervention strategy group and 9% in the usual care group . Multilevel analyses showed no significant differences between the groups on [any outcome measure] during 12 months of follow-up in the whole group or in relevant subgroups (patients with high scores on psychosocial measures at baseline or a history of frequent or prolonged low back pain).
CONCLUSION
This study provides no evidence that (Dutch) general practitioners should adopt our new treatment strategy aimed at psychosocial prognostic factors in patients with (sub)acute low back pain. Further research should examine why our new strategy was not more effective than usual care.
------------------- bmj15972728.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
ACP J Club. 2006 Jan-Feb;144(1):1. Evid Based Med. 2006 Feb;11(1):19. Evid Based Nurs. 2006 Jan;9(1):17. J Fam Pract. 2005 Oct;54(10):844.
Response to antibiotics of women with symptoms of urinary tract infection but negative dipstick urine test results: double blind randomised controlled trial.
Richards D Toop L Chambers S Fletcher L.
Department of Public Health and General Practice, Christchurch School of Medicine and Health Sciences, PO Box 4345, Christchurch, New Zealand.
derelie.richards@chmeds.ac.nz
OBJECTIVE
To assess the effectiveness of antibiotic treatment of women with symptoms of urinary tract infection but negative urine dipstick testing.
DESIGN
Prospective, double blind, randomised, placebo controlled trial.
SETTING
Primary care, among a randomly selected group of general practitioners in Christchurch, New Zealand.
PARTICIPANTS
59 women aged 16-50 years presenting with a history of dysuria and frequency in whom a dipstick test of midstream urine was negative for both nitrites and leucocytes. Participants with complicated urinary tract infection were excluded.
INTERVENTION
Trimethoprim 300 mg daily for three days or placebo .
MAIN OUTCOME MEASURES
Self reported diary of symptoms for seven days , recording the presence or absence of individual symptoms each day, followed by a structured telephone questionnaire after seven days . The main clinical outcome was [resolution of dysuria] at three and seven days and median time to resolution. Secondary outcomes were [resolution of other symptoms] .
RESULTS
The median time for [resolution of dysuria] was three days for trimethoprim compared with five days for placebo (P = 0.002). At day 3 , five (24%) of patients in the treatment group had [ongoing dysuria] compared with 20 (74%) in the placebo group (P = 0.005). This difference persisted until day 7 : two patients (10%) in the treatment group v 11 (41%) in the placebo group ; P = 0.02). The number needed to treat was 4. The median duration of {[constitutional symptoms] (feverishness, shivers)} was reduced by four days.
CONCLUSIONS
Although a negative dipstick test for leucocytes and nitrites accurately predicted absence of infection when standard microbiological definitions were used (negative predictive value 92%), it did not predict response to antibiotic treatment. Three days' treatment with trimethoprim significantly reduced dysuria in women whose urine dipstick test was negative. These results support the practice of empirical antibiotic use guided by symptoms. Balancing the competing interests of symptom relief and the minimisation of antibiotic use remains a dilemma-further research is needed to determine clinical predictors of response to antibiotics.
------------------- bmj15994660.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Aug 6;331(7512):320.
Effects of locality based community hospital care on independence in older people needing rehabilitation: randomised controlled trial.
Green J Young J Forster A Mallinder K Bogle S Lowson K Small N.
Department of Health Care for the Elderly, St Luke's Hospital, Bradford BD5 0NA.
becarrd.1@bradfordhospitals.nhs.uk
OBJECTIVE
To determine the effects on independence in older people needing rehabilitation in a locality based community hospital compared with care on a ward for elderly people in a district general hospital.
DESIGN
Randomised controlled trial.
SETTING
Care in a community hospital and district general hospital in Bradford, England.
PARTICIPANTS
220 patients needing rehabilitation after an acute illness that required hospital admission.
INTERVENTIONS
Patients were randomly allocated to a locality based community hospital or to remain within a department for the care of elderly people in a district general hospital .
MAIN OUTCOME MEASURES
Primary outcomes were [Nottingham extended activities of daily living scale] and [general health questionnaire 28] (carer). Secondary outcomes were {[activities of daily living] ( [Barthel index] )} , [Nottingham health profil] , [hospital anxiety and depression scale] , [mortality] , [destination after discharge] , [satisfaction with services] , [carer strain index] , and [carer's satisfaction with services] .
RESULTS
[The median length of stay] was 15 days for both the community hospital and the district general hospital groups (interquartile range: community hospital 9-25 days; district general hospital 9-24 days). [Independence] at six months was greater in the community hospital group (adjusted mean difference 5.30, 95% confidence interval 0.64 to 9.96). Results for [the secondary outcome measures] , including [care satisfaction] and [measures of carer burden] , were similar for both groups.
CONCLUSIONS
Care in a locality based community hospital is associated with greater independence for older people than care in wards for elderly people in a district general hospital .
------------------- bmj16046440.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Sep 3;331(7515):468-9.
Household based treatment of drinking water with flocculant-disinfectan for preventing diarrhoea in areas with turbid source water in rural western Kenya: cluster randomised controlled trial.
Crump JA Otieno PO Slutsker L Keswick BH Rosen DH Hoekstra RM Vulule JM Luby SP.
Foodborne and Diarrhoeal Diseases Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, MS A-38, Atlanta, Georgia 30333, USA.
jcrump@cdc.gov
OBJECTIVE
To compare the effect on prevalence of diarrhoea and mortality of household based treatment of drinking water with flocculant-disinfectant , sodium hypochlorite , and standard practices in areas with turbid water source in Africa.
DESIGN
Cluster randomised controlled trial over 20 weeks.
SETTING
Family compounds, each containing several houses, in rural western Kenya.
PARTICIPANTS
6650 people in 605 family compounds.
INTERVENTION
Water treatment: flocculant-disinfectant , sodium hypochlorite , and usual practice (control) .
MAIN OUTCOME MEASURES
[Prevalence of diarrhoea] and [all cause mortality] . [Escherichia coli concentration] , [free residual chlorine concentration] , and [turbidity in household drinking water] as surrogates for effectiveness of water treatment.
RESULTS
In children < 2 years old , compared with those in the control compounds , [the absolute difference in prevalence of diarrhoea] was -25% in the flocculant-disinfectant arm (95% confidence interval -40 to -5) and -17% in the sodium hypochlorite arm (-34 to 4). In all age groups compared with control , [the absolute difference in prevalence] was -19% in the flocculant-disinfectant arm (-34 to -2) and -26% in the sodium hypochlorite arm (-39 to -9). There were [significantly fewer deaths] in the intervention compounds than in the control compounds (relative risk of death 0.58, P = 0.036). Fourteen per cent of water samples from control compounds had [E coli concentrations] < 1 CFU/100 ml compared with 82% in flocculant-disinfectant and 78% in sodium hypochlorite compounds . [The mean turbidity of drinking water] was 8 nephelometric turbidity units (NTU) in flocculant-disinfectant households , compared with 55 NTU in the two other compounds (P < 0.001).
CONCLUSIONS
In areas of turbid water, flocculant-disinfectant was associated with [a significant reduction in diarrhoea] among children < 2 years. This health benefit, combined with [a significant reduction in turbidity] , suggests that the flocculant-disinfectant is well suited to areas with highly contaminated and turbid water.
------------------- bmj16055451.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Acupuncture in patients with tension-type headache: randomised controlled trial.
Melchart D Streng A Hoppe A Brinkhaus B Witt C Wagenpfeil S Pfaffenrath V Hammes M Hummelsberger J Irnich D Weidenhammer W Willich SN Linde K.
Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universitat Munchen, Kaiserstr 9, 80801 Munich, Germany.
OBJECTIVE
To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache.
DESIGN
Three armed randomised controlled multicentre trial.
SETTING
28 outpatient centres in Germany.
PARTICIPANTS
270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache.
INTERVENTIONS
Acupuncture , minimal acupuncture (superficial needling at non-acupuncture points) , or waiting list control . Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks.
MAIN OUTCOME MEASURE
[Difference in numbers of days with headache] between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries.
RESULTS
[The number of days with headache] decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group ( [difference] : acupuncture v minimal acupuncture , 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list , 5.7 days, 3.9 to 7.5 days, P < 0.001). [The proportion of responders] (at least 50% reduction in [days with headache] ) was 46% in the acupuncture group , 35% in the minimal acupuncture group , and 4% in the waiting list group .
CONCLUSIONS
The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache.
TRIAL REGISTRATION NUMBER
ISRCTN9737659.
------------------- bmj16061499.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Evid Based Med. 2006 Apr;11(2):50. Evid Based Nurs. 2006 Apr;9(2):55.
Randomised trial of telephone intervention in chronic heart failure: DIAL trial.
GESICA Investigators.
OBJECTIVE
To determine whether a centralised telephone intervention reduces the incidence of death or admission for worsening heart failure in outpatients with chronic heart failure.
DESIGN
Multicentre randomised controlled trial.
SETTING
51 centres in Argentina (public and private hospitals and ambulatory settings).
PARTICIPANTS
1518 outpatients with stable chronic heart failure and optimal drug treatment randomised, stratified by attending cardiologist, to telephone intervention or usual care.
INTERVENTION
Education, counselling, and monitoring by nurses through frequent telephone follow-up in addition to usual care , delivered from a single centre .
MAIN OUTCOME MEASURE
[All cause mortality] or [admission to hospital for worsening heart failure] .
RESULTS
Complete follow-up was available in 99.5% of patients. The 758 patients in the usual care group were more likely to be [admitted for worsening heart failure or to die] (235 events, 31%) than the 760 patients who received the telephone intervention (200 events, 26.3%) (relative risk reduction = 20%, 95% confidence interval 3 to 34, P = 0.026). This benefit was mostly due to [a significant reduction in admissions for heart failure] (relative risk reduction = 29%, P = 0.005). [Mortality] was similar in both groups. At the end of the study the intervention group had [a better quality of life] than the usual care group (mean total score on Minnesota living with heart failure questionnaire 30.6 v 35, P = 0.001).
CONCLUSIONS
This simple, centralised heart failure programme was effective in reducing the primary end point through [a significant reduction in admissions to hospital for heart failure] .
------------------- bmj16081445.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Aug 6;331(7512):304-5. Evid Based Nurs. 2006 Jan;9(1):25.
Effect of multivitamin and multimineral supplements on morbidity from infections in older people (MAVIS trial): pragmatic, randomised, double blind, placebo controlled trial.
Avenell A Campbell MK Cook JA Hannaford PC Kilonzo MM McNeill G Milne AC Ramsay CR Seymour DG Stephen AI Vale LD.
Health Services Research Unit, School of Medicine, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD.
a.avenell@abdn.ac.uk
OBJECTIVE
To examine whether supplementation with multivitamins and multiminerals influences [self reported days of infection] , [use of health services] , and [quality of life] in people aged 65 or over.
DESIGN
Randomised, placebo controlled trial, with blinding of participants, outcome assessors, and investigators.
SETTING
Communities associated with six general practices in Grampian, Scotland.
PARTICIPANTS
910 men and women aged 65 or over who did not take vitamins or minerals.
INTERVENTIONS
Daily multivitamin and multimineral supplementation or placebo for one year .
MAIN OUTCOME MEASURES
Primary outcomes were [contacts with primary care for infections] , [self reported days of infection] , and [quality of life] . Secondary outcomes included [antibiotic prescriptions] , [hospital admissions] , [adverse events] , and [compliance] .
RESULTS
Supplementation did not significantly affect [contacts with primary care] and [days of infection per person] (incidence rate ratio 0.96, 95% confidence interval 0.78 to 1.19 and 1.07, 0.90 to 1.27). [Quality of life] was not affected by supplementation . No statistically significant findings were found for [secondary outcomes] or subgroups.
CONCLUSION
Routine multivitamin and multimineral supplementation of older people living at home does not affect [self reported infection related morbidity] .
TRIAL REGISTRATION
ISRCTN: 66376460.
------------------- bmj16085658.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Arch Dermatol. 2006 Dec;142(12):1635-7. BMJ. 2005 Aug 13;331(7513):362-3. Evid Based Med. 2006 Feb;11(1):17.
Single blind, randomised, comparative study of the Bug Buster kit and over the counter pediculicide treatments against head lice in the United Kingdom.
Hill N Moor G Cameron MM Butlin A Preston S Williamson MS Bass C.
Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London WC1E 7HT.
nigel.hill@lshtm.ac.uk
OBJECTIVE
To compare the effectiveness of the Bug Buster kit with a single treatment of over the counter pediculicides for [eliminating head lice] .
DESIGN
Single blind, multicentre, randomised, comparative clinical study.
SETTING
Four counties in England and one county in Scotland.
PARTICIPANTS
133 young people aged 2-15 years with head louse infestation: 56 were allocated to the Bug Buster kit and 70 to pediculicide treatment.
INTERVENTIONS
Home use of proprietary pediculicides (organophosphate or pyrethroid) or the Bug Buster kit .
MAIN OUTCOME MEASURE
{[Presence of head lice] 2-4 days after end of treatment} : day 5 for the pediculicides and day 15 for the Bug Buster kit .
RESULTS
[The cure rate] using the Bug Buster kit was significantly greater than that for the pediculicides (57% v 13%; relative risk 4.4, 95% confidence interval 2.3 to 8.5). Number needed to treat for the Bug Buster kit compared with the pediculicides was 2.26.
CONCLUSION
The Bug Buster kit was the most effective over the counter treatment for head louse infestation in the community when compared with pediculicides .
------------------- bmj16093252.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Cognitive behaviour therapy in addition to antispasmodic treatment for irritable bowel syndrome in primary care: randomised controlled trial.
Kennedy T Jones R Darnley S Seed P Wessely S Chalder T.
Department of General Practice and Primary Care, Guy's, King's, and St Thomas' School of Medicine, King's College, London SE11 6SP.
OBJECTIVE
To assess the efficacy of cognitive behaviour therapy delivered in primary care for treating irritable bowel syndrome.
DESIGN
Randomised controlled trial.
SETTING
10 general practices in London.
PARTICIPANTS
149 patients with moderate or severe irritable bowel syndrome resistant to the antispasmodic mebeverine.
INTERVENTIONS
Cognitive behaviour therapy delivered by trained primary care nurses plus 270 mg mebeverine taken thrice daily compared with mebeverine treatment alone .
MAIN OUTCOME MEASURES
Primary measures were [patients' scores on the irritable bowel syndrome symptom severity scale] . Secondary measures were [scores on the work and social adjustment scale] and [the hospital anxiety and depression scale] .
RESULTS
Of 334 referred patients, 72 were randomised to mebeverine plus cognitive behaviour therapy and 77 to mebeverine alone . Cognitive behaviour therapy had considerable initial benefit on [symptom severity] compared with mebeverine alone , with a mean reduction in score of 68 points (95% confidence interval 103 to 33), with the benefit persisting at three months and six months after therapy (mean reductions 71 points (109 to 32) and 11 points (20 to 3)) but not later. Cognitive behaviour therapy also showed significant benefit on [the work and social adjustment scale] that was still present 12 months after therapy (mean reduction 2.8 points (5.2 to 0.4)), but had an inconsistent effect on [the hospital anxiety and depression scale] .
CONCLUSION
Cognitive behaviour therapy delivered by primary care nurses offered additional benefit over mebeverine alone up to six months , although the effect had waned by 12 months . Such therapy may be useful for certain patients with irritable bowel syndrome in primary care.
------------------- bmj16096286.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial
Randomised controlled trial of the Lidcombe programme of early stuttering intervention .
Jones M Onslow M Packman A Williams S Ormond T Schwarz I Gebski V.
Queensland Clinical Trials Centre, University of Queensland, Princess Alexandra Hospital, Woollongabba, Queensland 4102, Australia.
OBJECTIVES
To evaluate the efficacy of the Lidcombe programme of early stuttering intervention by comparison to a control group .
DESIGN
A pragmatic, open plan, parallel group, randomised controlled trial with blinded outcome assessment.
SETTING
Two public speech clinics in New Zealand.
PARTICIPANTS
Stuttering preschool children who presented to the speech clinics for treatment. Inclusion criteria were age 3-6 years and frequency of stuttering of at least 2% syllables stuttered. Exclusion criteria were onset of stuttering during the six months before recruitment and treatment for stuttering during the previous 12 months. 54 participants were randomised: 29 to the Lidcombe programme arm and 25 to the control arm . 12 of the participants were girls.
INTERVENTION
Lidcombe programme of early stuttering intervention .
MAIN OUTCOME MEASURES
[Frequency of stuttering] was measured as [the proportion of syllables stuttered] , from audiotaped recordings of participants' conversational speech outside the clinic. Parents in both arms of the trial collected speech samples in three different speaking situations before randomisation and at three, six, and nine months after randomisation.
RESULTS
Analysis showed a highly significant difference (P = 0.003) at nine months after randomisation . [The mean proportion of syllables stuttered] at nine months after randomisation was 1.5% (SD 1.4) for the treatment arm and 3.9% (SD 3.5) for the control arm , giving an effect size of 2.3% of syllables stuttered (95% confidence interval 0.8 to 3.9). This effect size was more than double the minimum clinically worthwhile difference specified in the trial protocol.
CONCLUSIONS
The results provide evidence from a randomised controlled trial to support early intervention for stuttering. The Lidcombe programme is an efficacious treatment for stuttering in children of preschool age.
------------------- bmj16096304.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Randomised controlled trial of home based motivational interviewing by midwives to help pregnant smokers quit or cut down.
Tappin DM Lumsden MA Gilmour WH Crawford F McIntyre D Stone DH Webber R MacIndoe S Mohammed E.
Paediatric Epidemiology and Community Health Unit, Department of Child Health, Division of Developmental Medicine, University of Glasgow, Yorkhill, Glasgow G3 8SJ.
goda11@udcf.gla.ac.uk
OBJECTIVE
To determine whether motivational interviewing --a behavioural therapy for addictions-provided at home by specially trained midwives helps pregnant smokers to quit.
DESIGN
Randomised controlled non-blinded trial analysed by intention to treat.
SETTING
Clinics attached to two maternity hospitals in Glasgow.
PARTICIPANTS
762/1684 pregnant women who were regular smokers at antenatal booking: 351 in intervention group and 411 in control group .
INTERVENTIONS
All women received standard health promotion information. Women in the intervention group were offered motivational interviewing at home . All interviews were recorded.
MAIN OUTCOME MEASURES
{[Self reported smoking cessation] verified by plasma or salivary cotinine concentration} .
RESULTS
17/351 (4.8%) women in the intervention group [stopped smoking] (according to self report and serum cotinine concentration < 13.7 ng/ml) compared with 19/411(4.6%) in the control group . Fifteen (4.2%) women in the intervention group [cut down] (self report and cotinine concentration less than half that at booking) compared with 26 (6.3%) in the control group . Fewer women in the intervention group reported [smoking more] (18 (5.1%) v 44 (10.7%); relative risk 0.48, 95% confidence interval 0.28 to 0.81). [Birth weight] did not differ significantly (mean 3078 g v 3048 g).
CONCLUSION
Good quality motivational interviewing did not [significantly increase smoking cessation] among pregnant women.
------------------- bmj16103032.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Sep 17;331(7517):586-7.
Randomised controlled trial of acute mental health care by a crisis resolution team : the north Islington crisis study.
Johnson S Nolan F Pilling S Sandor A Hoult J McKenzie N White IR Thompson M Bebbington P.
Department of Mental Health Sciences, Royal Free and University College Medical Schools, University College London, London W1W 7EY.
s.johnson@ucl.ac.uk
OBJECTIVE
To evaluate the effectiveness of a crisis resolution team .
DESIGN
Randomised controlled trial.
PARTICIPANTS
260 residents of the inner London Borough of Islington who were experiencing crises severe enough for hospital admission to be considered.
INTERVENTIONS
Acute care including a 24 hour crisis resolution team ( experimental group ), compared with standard care from inpatient services and community mental health teams ( control group ).
MAIN OUTCOME MEASURES
[Hospital admission] and [patients' satisfaction] .
RESULTS
Patients in the experimental group were less likely to be [admitted to hospital] in the eight weeks after the crisis (odds ratio 0.19, 95% confidence interval 0.11 to 0.32), though [compulsory admission] was not significantly reduced. A difference of 1.6 points in [the mean score on the client satisfaction questionnaire (CSQ-8)] was not quite significant (P = 0.07), although it became so after adjustment for baseline characteristics (P = 0.002).
CONCLUSION
Crisis resolution teams can reduce [hospital admissions] in mental health crises. They may also [increase satisfaction] in patients, but this was an equivocal finding.
------------------- bmj16115830.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Sep 3;331(7515):466-7. Evid Based Cardiovasc Med. 2006 Mar;10(1):15-6; author reply 17.
Targets and self monitoring in hypertension: randomised controlled trial and cost effectiveness analysis.
McManus RJ Mant J Roalfe A Oakes RA Bryan S Pattison HM Hobbs FD.
Department of Primary Care and General Practice, University of Birmingham, Birmingham B15 2TT.
r.j.mcmanus@bham.ac.uk
OBJECTIVES
To assess whether blood pressure control in primary care could be improved with the use of patient held targets and self monitoring in a practice setting , and to assess the impact of these on [health behaviours] , [anxiety] , [prescribed antihypertensive drugs] , [patients' preferences] , and [costs] .
DESIGN
Randomised controlled trial.
SETTING
Eight general practices in south Birmingham.
PARTICIPANTS
441 people receiving treatment in primary care for hypertension but not controlled below the target of < 140/85 mm Hg.
INTERVENTIONS
Patients in the intervention group received treatment targets along with facilities to measure their own blood pressure at their general practice ; they were also asked to visit their general practitioner or practice nurse if their blood pressure was repeatedly above the target level. Patients in the control group received usual care ( blood pressure monitoring by their practice ) .
MAIN OUTCOME MEASURES
Primary outcome: [change in systolic blood pressure] at six months and one year in both intervention and control groups . Secondary outcomes: [change in health behaviours] , [anxiety] , [prescribed antihypertensive drugs] , [patients' preferences of method of blood pressure monitoring] , and [costs] .
RESULTS
400 (91%) patients attended follow up at one year . [Systolic blood pressure] in the intervention group had significantly reduced after six months (mean difference 4.3 mm Hg (95% confidence interval 0.8 mm Hg to 7.9 mm Hg)) but not after one year (mean difference 2.7 mm Hg (- 1.2 mm Hg to 6.6 mm Hg)). No overall difference was found in [diastolic blood pressure] , [anxiety] , [health behaviours] , or [number of prescribed drugs] . Patients who self monitored [lost more weight] than controls (as evidenced by [a drop in body mass index] ), [rated self monitoring above monitoring by a doctor or nurse] , and [consulted less often] . Overall, self monitoring did not [cost significantly more] than usual care (251 pounds sterling (437 dollars; 364 euros) (95% confidence interval 233 pounds sterling to 275 pounds sterling) versus 240 pounds sterling (217 pounds sterling to 263 pounds sterling).
CONCLUSIONS
Practice based self monitoring resulted in [small but significant improvements of blood pressure] at six months , which were not sustained after a year . Self monitoring was well received by patients, [anxiety] did not increase, and there was no [appreciable additional cost] . Practice based self monitoring is feasible and results in [blood pressure control] that is similar to that in usual care .
------------------- bmj16115831.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Sep 24;331(7518):645-6.
Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial.
Stutchfield P Whitaker R Russell I; Antenatal Steroids for Term Elective Caesarean Section (ASTECS) Research Team.
Conwy and Denbighshire NHS Trust, Glan Clwyd Hospital, Rhyl, Denbighshire LL18 5UJ.
DrPeter.Stutchfield@cd-tr.wales.nhs.uk
OBJECTIVE
To test whether steroids reduce respiratory distress in babies born by elective caesarean section at term.
DESIGN
Multicentre pragmatic randomised trial.
SETTING
10 maternity units.
PARTICIPANTS
998 consenting women randomised at decision to deliver by elective caesarean section; 503 randomised to treatment group.
INTERVENTIONS
The treatment group received two intramuscular doses of 12 mg betamethasone in the 48 hours before delivery . The control group received treatment as usual .
OUTCOME MEASURES
The primary outcome was [admission to special care baby unit with respiratory distress] . Secondary outcomes were [severity of respiratory distress] and [level of care in response] .
RESULTS
Sex, birth weight, and gestation were not different between the two groups. Of the 35 babies admitted to special baby units with respiratory distress, 24 were in the control group and 11 in the intervention group (P = 0.02). [The incidence of admission with respiratory distress] was 0.051 in the control group and 0.024 in the treatment group (relative risk 0.46, 95% confidence interval 0.23 to 0.93). [The incidence of transient tachypnoea of the newborn] was 0.040 in the control group and 0.021 in the treatment group (0.54, 0.26 to 1.12). [The incidence of respiratory distress syndrome] was 0.011 in the control group and 0.002 in the treatment group (0.21, 0.03 to 1.32).
CONCLUSIONS
Antenatal betamethasone and delaying delivery until 39 weeks both reduce [admissions to special care baby units with respiratory distress] after elective caesarean section at term.
------------------- bmj16141449.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Nov 5;331(7524):1065.
BMJ. 2005 Sep 17;331(7517):586-7.
A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness.
Petersen L Jeppesen P Thorup A Abel MB Ohlenschlaeger J Christensen T Krarup G Jorgensen P Nordentoft M.
Bispebjerg Hospital, Department of Psychiatry, Bispebjerg Bakke 23, DK-2400 Copenhagen NV, Denmark.
OBJECTIVES
To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness.
DESIGN
Randomised clinical trial.
SETTING
Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark.
PARTICIPANTS
547 patients with first episode of schizophrenia spectrum disorder.
INTERVENTIONS
Integrated treatment and standard treatment . The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training . Standard treatment offered contact with a community mental health centre.
MAIN OUTCOME MEASURES
[Psychotic] and [negative symptoms] (each scored from 0 to a maximum of 5) at one and two years' follow-up .
RESULTS
At one year's follow-up , [psychotic symptoms] changed favourably to a mean of 1.09 (standard deviation 1.27) with an estimated mean difference between groups of -0.31 (95% confidence interval -0.55 to -0.07, P = 0.02) in favour of integrated treatment . [Negative symptoms] changed favourably with an estimated difference between groups of -0.36 (-0.54 to -0.17, P < 0.001) in favour of integrated treatment . At two years' follow-up the estimated mean difference between groups in [psychotic symptoms] was -0.32 (-0.58 to -0.06, P = 0.02) and in [negative symptoms] was -0.45 (-0.67 to -0.22, P < 0.001), both in favour of integrated treatment . Patients who received integrated treatment had [significantly less comorbid substance misuse] , [better adherence to treatment] , and [more satisfaction with treatment] .
CONCLUSION
Integrated treatment improved [clinical outcome] and [adherence to treatment] . [The improvement in clinical outcome] was consistent at one year and two year follow-ups .
------------------- bmj16150741.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Evid Based Nurs. 2006 Apr;9(2):59.
Effect of a multifaceted intervention on [number of antimicrobial prescriptions for suspected urinary tract infections] in residents of nursing homes: cluster randomised controlled trial.
Loeb M Brazil K Lohfeld L McGeer A Simor A Stevenson K Zoutman D Smith S Liu X Walter SD.
Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
loebm@mcmaster.ca
OBJECTIVE
To assess whether a multifaceted intervention can reduce [the number of prescriptions for antimicrobials for suspected urinary tract infections] in residents of nursing homes.
DESIGN
Cluster randomised controlled trial.
SETTING
24 nursing homes in Ontario, Canada, and Idaho, United States.
PARTICIPANTS
12 nursing homes allocated to a multifaceted intervention and 12 allocated to usual care. Outcomes were measured in 4217 residents.
INTERVENTIONS
Diagnostic and treatment algorithm for urinary tract infections implemented at the nursing home level using a multifaceted approach --small group interactive sessions for nurses, videotapes, written material, outreach visits, and one on one interviews with physicians .
MAIN OUTCOME MEASURES
[Number of antimicrobials prescribed for suspected urinary tract infections] , [total use of antimicrobials] , [admissions to hospital] , and [deaths] .
RESULTS
[Fewer courses of antimicrobials for suspected urinary tract infections] per 1000 resident days were prescribed in the intervention nursing homes than in the usual care homes (1.17 v 1.59 courses; weighted mean difference -0.49, 95% confidence intervals -0.93 to -0.06). [Antimicrobials for suspected urinary tract infection] represented 28.4% of all courses of drugs prescribed in the intervention nursing homes compared with 38.6% prescribed in the usual care homes (weighted mean difference -9.6%, -16.9% to -2.4%). The difference in [total antimicrobial use] per 1000 resident days between intervention and usual care groups was not significantly different (3.52 v 3.93; weighted mean difference -0.37, -1.17 to 0.44). No significant difference was found in [admissions to hospital] or [mortality] between the study arms.
CONCLUSION
A multifaceted intervention using algorithms can reduce [the number of antimicrobial prescriptions for suspected urinary tract infections] in residents of nursing homes.
------------------- bmj16150764.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Sep 10;331(7516):527-8.
Effectiveness of treatment for alcohol problems: findings of the randomised UK alcohol treatment trial (UKATT).
UKATT Research Team.
OBJECTIVE
To compare the effectiveness of social behaviour and network therapy , a new treatment for alcohol problems, with that of the proved motivational enhancement therapy .
DESIGN
Pragmatic randomised trial.
SETTING
Seven treatment sites around Birmingham, Cardiff, and Leeds.
PARTICIPANTS
742 clients with alcohol problems; 689 (93.0%) were interviewed at three months and 617 (83.2%) at 12 months .
INTERVENTIONS
Social behaviour and network therapy and motivational enhancement therapy .
MAIN OUTCOME MEASURES
[Changes in alcohol consumption] , [alcohol dependence] , and [alcohol related problems] over 12 months.
RESULTS
Both groups reported [substantial reductions in alcohol consumption] , [dependence] , and [problems] , and [better mental health related quality of life] over 12 months. Between groups we found only one significant difference in outcome, probably due to chance: the social network group showed [significantly better physical health] at three months . Non-significant differences at 12 months in the motivational group relative to the social network group included: [the number of drinks consumed per drinking day] had decreased by an extra 1.1 (95% confidence interval -1.0 to 3.2); [scores on the Leeds dependence questionnaire] had improved by an extra 0.6 (-0.7 to 2.0); [scores on the alcohol problems questionnaire] had improved by an extra 0.5 (-0.4 to 1.4); but [the number of days abstinent from drinking] had increased by 1.2% less (-4.5% to 6.9%).
CONCLUSION
The novel social behaviour and network therapy for alcohol problems did not differ significantly in effectiveness from the proved motivational enhancement therapy .
------------------- bmj16150765.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Sep 10;331(7516):527-8.
Cost effectiveness of treatment for alcohol problems: findings of the randomised UK alcohol treatment trial (UKATT).
UKATT Research Team.
OBJECTIVE
To compare the cost effectiveness of social behaviour and network therapy , a new treatment for alcohol problems >, with that of the proved motivational enhancement therapy .
DESIGN
Cost effectiveness analysis alongside a pragmatic randomised trial.
SETTING
Seven treatment sites around Birmingham, Cardiff, and Leeds.
PARTICIPANTS
742 clients with alcohol problems; 617 (83.2%) were interviewed at 12 months and full economic data were obtained on 608 (98.5% of 617). Main economic measures {[Quality adjusted life years] ( [QALYs] )} , [costs of trial treatments] , and {[consequences for public sector resources] ( [health care] , [other alcohol treatment] , [social services] , and [criminal justice services] )} .
RESULTS
Both therapies saved about five times as much in [expenditure on health] , [social] , and [criminal justice services] as they cost. Neither [net savings] nor [cost effectiveness] differed significantly between the therapies, despite [the average cost] of social behaviour and network therapy (221 pounds sterling; 385 dollars; 320 euros) being significantly more than that of motivational enhancement therapy (129 pounds sterling). If [a QALY] were worth 30,000 pounds sterling, then the motivational therapy would have 58% chance of being more cost effective than the social therapy , and the social therapy would have 42% chance of being more cost effective than the motivational therapy .
CONCLUSION
Participants reported [highly significant reductions in drinking] and [associated problems] and [costs] . The novel social behaviour and network therapy did not differ significantly in [cost effectiveness] from the proved motivational enhancement therapy .
------------------- bmj16157604.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Nov 5;331(7524):1082-3.
Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies.
Junghans C Feder G Hemingway H Timmis A Jones M.
Department of Epidemiology and Public Health, Royal Free and UCL Medical School, London WC1E 7HD.
C.Junghans@ucl.ac.uk
OBJECTIVE
To evaluate the effect of opt-in compared with opt-out recruitment strategies on response rate and selection bias.
DESIGN
Double blind randomised controlled trial.
SETTING
Two general practices in England.
PARTICIPANTS
510 patients with angina.
INTERVENTION
Patients were randomly allocated to an opt-in (asked to actively signal willingness to participate in research) or opt-out (contacted repeatedly unless they signalled unwillingness to participate) approach for recruitment to an observational prognostic study of patients with angina.
MAIN OUTCOME MEASURES
[Recruitment rate] and [clinical characteristics of patients] .
RESULTS
{[The recruitment rate] , defined by clinic attendance,} was 38% (96/252) in the opt-in arm and 50% (128/258) in the opt-out arm (P = 0.014). Once an appointment had been made, non-attendance at the clinic was similar (20% opt-in arm v 17% opt-out arm; P = 0.86). Patients in the opt-in arm had [fewer risk factors] (44% v 60%; P = 0.053), [less treatment for angina] (69% v 82%; P = 0.010), and [less functional impairment] (9% v 20%; P = 0.023) than patients in the opt-out arm .
CONCLUSIONS
The opt-in approach to participant recruitment , increasingly required by ethics committees, resulted in [lower response rates] and [a biased sample] . We propose that the opt-out approach should be the default recruitment strategy for studies with low risk to participants.
------------------- bmj16183652.xml ---------------------------
Clinical Trial Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Randomised controlled trial of prevention of falls in people aged > or =75 with severe visual impairment: the VIP trial.
Campbell AJ Robertson MC La Grow SJ Kerse NM Sanderson GF Jacobs RJ Sharp DM Hale LA.
Department of Medical and Surgical Sciences, Otago Medical School, Dunedin, New Zealand.
john.campbell@stonebow.otago.ac.nz
OBJECTIVES
To assess the efficacy and cost effectiveness of a home safety programme and a home exercise programme to reduce [falls] and [injuries] in older people with low vision.
DESIGN
Randomised controlled trial.
SETTING
Dunedin and Auckland, New Zealand.
PARTICIPANTS
391 women and men aged > or =75 with visual acuity of 6/24 or worse who were living in the community; 92% (361 of 391) completed one year of follow-up .
INTERVENTIONS
Participants received a home safety assessment and modification programme delivered by an occupational therapist (n = 100), an exercise programme prescribed at home by a physiotherapist plus vitamin D supplementation (n = 97), both interventions (n = 98), or social visits (n = 96).
MAIN OUTCOME MEASURES
[Numbers of falls] and [injuries resulting from falls] , [costs of implementing the home safety programme] .
RESULTS
[Fewer falls] occurred in the group randomised to the home safety programme but not in the exercise programme (incidence rate ratios 0.59 (95% confidence interval 0.42 to 0.83) and 1.15 (0.82 to 1.61), respectively). However, within the exercise programme , stricter adherence was associated with [fewer falls] (P = 0.001). A conservative analysis showed neither intervention was effective in reducing [injuries from falls] . Delivering the home safety programme [cost] NZ650 dollars (234 pounds sterling, 344 euros, US432 dollars) (at 2004 prices) [per fall prevented] .
CONCLUSION
The home safety programme reduced [falls] and was [more cost effective] than an exercise programme in this group of elderly people with poor vision. The Otago exercise programme with vitamin D supplementation was not effective in [reducing falls] or [injuries] in this group, possibly due to low levels of adherence. Trial registration number ISRCTN15342873.
------------------- bmj16183654.xml ---------------------------
Clinical Trial Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Oct 22;331(7522):966. BMJ. 2005 Oct 22;331(7522):966. BMJ. 2005 Oct 8;331(7520):788-9.
Postcards from the EDge project : randomised controlled trial of an intervention using postcards to reduce [repetition of hospital treated deliberate self poisoning] .
Carter GL Clover K Whyte IM Dawson AH D'Este C.
Suicide Prevention Research Unit, Centre for Mental Health Studies, Faculty of Health, University of Newcastle, Newcastle, Australia.
gregory.carter@newcastle.edu.au
OBJECTIVE
To determine whether an intervention using postcards (postcards from the EDge project) reduces [repetitions of hospital treated deliberate self poisoning] .
DESIGN
Randomised controlled trial.
SETTING
Regional referral service for general hospital treated deliberate self poisoning in Newcastle, Australia.
PARTICIPANTS
772 patients aged over 16 years with deliberate self poisoning.
INTERVENTION
Non-obligatory intervention using eight postcards over 12 months along with standard treatment compared with standard treatment alone .
MAIN OUTCOME MEASURES
[Proportion of patients with one or more repeat episodes of deliberate self poisoning] and [the number of repeat episodes for deliberate self poisoning per person in 12 months] .
RESULTS
[The proportion of repeaters with deliberate self poisoning] in the intervention group did not differ significantly from that in the control group (57/378, 15.1%, 95% confidence interval 11.5% to 18.7% v 68/394, 17.3%, 13.5% to 21.0%: difference between groups -2%, -7% to 3%). In unadjusted analysis [the number of repetitions] were significantly reduced (incidence risk ratio 0.55, 0.35 to 0.87).
CONCLUSION
A postcard intervention reduced [repetitions of deliberate self poisoning] , although it did not significantly reduce [the proportion of individual repeaters] .
------------------- bmj16195287.xml ---------------------------
Clinical Trial Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Effect of sublingual misoprostol on [severe postpartum haemorrhage] in a primary health centre in Guinea-Bissau: randomised double blind clinical trial.
Hoj L Cardoso P Nielsen BB Hvidman L Nielsen J Aaby P.
Department of Obstetrics and Gynaecology, Aarhus University Hospital, 8200 Aarhus N, Denmark.
lars.hoj@dadlnet.dk
OBJECTIVE
To evaluate whether routine administration of sublingual misoprostol 600 microg after delivery reduces [postpartum haemorrhage] .
DESIGN
Randomised double blind placebo controlled trial.
SETTING
Primary health centre in Bissau, Guinea-Bissau, West Africa.
PARTICIPANTS
661 women undergoing vaginal delivery.
INTERVENTION
Misoprostol 600 mug or placebo administered sublingually immediately after delivery.
MAIN OUTCOME MEASURES
{[Postpartum haemorrhage] , defined as a loss of > or = 500 ml} and [decrease in haemoglobin concentration after delivery] .
RESULTS
[The incidence of postpartum haemorrhage] was not significantly different between the two groups, the relative risk being 0.89 (95% confidence interval 0.76 to 1.04) in the misoprostol group compared with the placebo group . [Mean blood loss] was 10.5% (-0.5% to 20.4%) lower in the misoprostol group than in the control group . {[Severe postpartum haemorrhage] of > or = 1000 ml or > or = 1500 ml} occurred in 17% (56) and 8% (25) in the placebo group and 11% (37) and 2% (7) in the misoprostol group . Significantly fewer women in the misoprostol group experienced {[a loss] of > or = 1000 ml (0.66, 0.45 to 0.98) or > or = 1500 ml (0.28, 0.12 to 0.64)} . [The decrease in haemoglobin concentration] tended to be less in the misoprostol group , the mean difference between the two groups being 0.16 mmol/l (-0.01 mmol/l to 0.32 mmol/l).
CONCLUSION
Sublingual misoprostol reduces [the frequency of severe postpartum haemorrhage] .
------------------- bmj16195288.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana.
Chandramohan D Owusu-Agyei S Carneiro I Awine T Amponsa-Achiano K Mensah N Jaffar S Baiden R Hodgson A Binka F Greenwood B.
London School of Hygiene and Tropical Medicine, London WC1E 7HT.
daniel.chandramohan@lshtm.ac.uk
OBJECTIVE
To evaluate the effects of intermittent preventive treatment for malaria in infants ( IPTi ) with sulfadoxine-pyrimethamine in an area of intense, seasonal transmission.
DESIGN
Cluster randomised placebo controlled trial, with 96 clusters allocated randomly to sulfadoxine-pyrimethamine or placebo in blocks of eight.
INTERVENTIONS
Children received sulfadoxine-pyrimethamine or placebo and one month of iron supplementation when they received DPT-2, DPT-3, or measles vaccinations and at 12 months of age.
MAIN OUTCOME MEASURES
[Incidence of malaria] and of [anaemia] determined through passive case detection.
RESULTS
89% (1103/1242) of children in the placebo group and 88% (1088/1243) in the IPTi group completed follow-up to 24 months of age. The protective efficacy of IPTi against [all episodes of malaria] was 24.8% (95% confidence interval 14.3% to 34.0%) up to 15 months of age. IPTi had no protective effect against [malaria] between 16 and 24 months of age (protective efficacy -4.9%, -21.3% to 9.3%). [The incidence of high parasite density malaria] (> or = 5000 parasites/mul) was higher in the IPTi group than in the placebo group between 16 and 24 months of age (protective efficacy -19.5%, -39.8% to -2.2%). IPTi reduced [hospital admissions with anaemia] by 35.1% (10.5% to 52.9%) up to 15 months of age. IPTi had no significant effect on [anaemia] between 16 and 24 months of age (protective efficacy -6.4%, -76.8% to 35.9%). [The relative risk of death] up to 15 months of age in the IPTi group was 1.26 (95% confidence interval 0.81 to 1.96; P = 0.31), and from 16 to 24 months it was 1.28 (0.77 to 2.14; P = 0.35).
CONCLUSIONS
Intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine can reduce [malaria] and [anaemia] in infants even in seasonal, high transmission areas, but concern exists about possible rebound in [the incidence of malaria] in the second year of life.
------------------- bmj16195293.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Nov 12;331(7525):1120. Myers, Pat [corrected to Mayers, Pat].
Evid Based Nurs. 2006 Apr;9(2):58.
Effect of educational outreach to nurses on [tuberculosis case detection] and [primary care of respiratory illness] : pragmatic cluster randomised controlled trial.
Fairall LR Zwarenstein M Bateman ED Bachmann M Lombard C Majara BP Joubert G English RG Bheekie A van Rensburg D Mayers P Peters AC Chapman RD.
Knowledge Translation Unit, University of Cape Town Lung Institute, University of Cape Town, Groote Schuur, South Africa.
OBJECTIVES
To develop and implement an educational outreach programme for the integrated case management of priority respiratory diseases (practical approach to lung health in South Africa; PALSA) and to evaluate its effects on [respiratory care] and [detection of tuberculosis] among adults attending primary care clinics.
DESIGN
Pragmatic cluster randomised controlled trial, with clinics as the unit of randomisation.
SETTING
40 primary care clinics, staffed by nurse practitioners, in the Free State province, South Africa.
PARTICIPANTS
1999 patients aged 15 or over with cough or difficult breathing (1000 in intervention clinics, 999 in control clinics).
INTERVENTION
Between two and six educational outreach sessions delivered to nurse practitioners by usual trainers from the health department. The emphasis was on key messages drawn from the customised clinical practice guideline for the outreach programme, with illustrative support materials.
MAIN OUTCOME MEASURES
[Sputum screening for tuberculosis] , [tuberculosis case detection] , [inhaled corticosteroid prescriptions for obstructive lung disease] , and [antibiotic prescriptions for respiratory tract infections] .
RESULTS
All clinics and almost all patients (92.8%, 1856/1999) completed the trial. Although [sputum testing for tuberculosis] was similar between the groups (22.6% in outreach group v 19.3% in control group ; odds ratio 1.22, 95% confidence interval 0.83 to 1.80), [the case detection of tuberculosis] was higher in the outreach group (6.4% v 3.8%; 1.72, 1.04 to 2.85). [Prescriptions for inhaled corticosteroids] were also higher (13.7% v 7.7%; 1.90, 1.14 to 3.18) but [the number of antibiotic prescriptions] was similar (39.7% v 39.4%; 1.01, 0.74 to 1.38).
CONCLUSIONS
Combining educational outreach with integrated case management provides a promising model for improving [quality of care] and [control of priority respiratory diseases] , without extra staff, in resource poor settings.
TRIAL REGISTRATION
Current controlled trials ISRCTN13438073.
------------------- bmj16210250.xml ---------------------------
Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Oct 29;331(7523):979-80.
Effect of incorporating a 10 minute point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme: randomised controlled trial.
Barnfather KD Cope GF Chapple IL.
General Practice, 6 Harcourt House, London W1G 0PN.
OBJECTIVE
To investigate the effect of immediate feedback from a point of care test for salivary nicotine metabolites in promoting [smoking cessation] and [reduction in tobacco use] .
DESIGN
Prospective, operator blinded, randomised controlled trial.
SETTING
General dental practice, London.
PARTICIPANTS
100 adult smokers.
INTERVENTIONS
Participants completed a questionnaire on smoking, undertook a clinical examination, and received counselling in smoking cessation. Saliva samples were analysed at presentation and at eight weeks for [salivary nicotine metabolites] using a 10 minute semiquantitative point of care test .
MAIN OUTCOME MEASURES
[Smoking cessation] measured by [salivary nicotine metabolite values] (scale 0-6), [patient feedback on the perceived value] of the test (visual analogue scale) in quitting, and [reduction in tobacco use] .
RESULTS
[A higher smoking quit rate] was achieved with the point of care test (23% cases v 7% controls; P < 0.039), and [overall tobacco use] also decreased (68% cases v 28% controls; P < 0.001). Baseline values for [salivary nicotine metabolites] did not differ between the groups (cases, mean 4.1, SD 1.3 and 4.3, 1.4; P = 0.51). 87 participants reattended at eight weeks (44 cases, 43 controls). [Mean nicotine metabolite values] at eight weeks were 2.58 (2.0) for cases and 4.29 (1.8) for controls (P < 0.001).
CONCLUSION
Incorporation of individualised personal feedback using a point of care test for [salivary nicotine metabolites] into a general practice based smoking cessation programme increased [quit rates] by 17% at eight weeks and [reduced tobacco use] .
------------------- bmj16216821.xml ---------------------------
Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Dec 3;331(7528):1330.
Self management of oral anticoagulation : randomised trial.
Fitzmaurice DA Murray ET McCahon D Holder R Raftery JP Hussain S Sandhar H Hobbs FD.
Department of Primary Care, University of Birmingham, Birmingham.
d.a.fitzmaurice@bham.ac.uk
OBJECTIVE
To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants.
DESIGN
Multicentre open randomised controlled trial.
SETTING
Midlands region of the UK.
PARTICIPANTS
617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention.
INTERVENTION
Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin .
MAIN OUTCOME MEASURE
[Percentage of time spent within the therapeutic range of international normalised ratio] .
RESULTS
No significant differences were found in [percentage of time in the therapeutic range] between self management and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group . Nine patients (2.8/100 patient years) had [serious adverse events] in the self managed group , compared with seven (2.7/100 patient years) in the routine care arm (chi2(df = 1) = 0.02, P = 0.89).
CONCLUSION
With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve [the time spent the therapeutic range] for patients with initially poor control. Trial registration ISRCTN 19313375.
------------------- bmj16267077.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Nov 26;331(7527):1271. BMJ. 2005 Nov 26;331(7527):1271. Evid Based Nurs. 2006 Jul;9(3):90.
Transitional care facility for elderly people in hospital awaiting a long term care bed: randomised controlled trial.
Crotty M Whitehead CH Wundke R Giles LC Ben-Tovim D Phillips PA.
Department of Rehabilitation and Aged Care, Flinders University, Repatriation General Hospital, Daw Park SA 5041, Australia.
maria.crotty@flinders.edu.au
OBJECTIVE
To assess the effectiveness of moving patients who are waiting in hospital for a long term care bed to an off-site transitional care facility .
DESIGN
Randomised controlled trial.
SETTING
Three public hospitals in Southern Adelaide.
PARTICIPANTS
320 elderly patients (mean age 83 years) in acute hospital beds (212 randomised to intervention , 108 to control).
INTERVENTIONS
A transitional care facility where all patients received a single assessment from a specialist elder care team and appropriate ongoing therapy.
MAIN OUTCOME MEASURES
[Length of stay in hospital] , [rates of readmission] , [deaths] , and {[patient's functional level] ( [modified Barthel index] )} , {[quality of life] ( [assessment of quality of life] )} , and {[care needs] ( [residential care scale] )} at four months .
RESULTS
From admission, those in the intervention group [stayed a median of 32.5 days] (95% confidence interval 29 to 36 days) in hospital. In the control group [the median length of stay] was 43.5 days (41 to 51 days) (95% confidence interval for difference 6 to 16 days). Patients in the intervention group took a median of 21 days (6 to 27 days) longer to be [admitted to permanent care] than those in the control group . In both groups few patients [went home] (14 (7%) in the intervention group v 9 (9%) in the control group ). There were no significant differences in [death rates] (28% v 27%) or [rates of transfer back to hospital] (28% v 25%).
CONCLUSIONS
For frail elderly patients who are awaiting a residential care bed transfer out of hospital to an off-site transitional care unit with focus on aged care "unblocks beds" without adverse effects.
------------------- bmj16306060.xml ---------------------------
Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Randomised study of effect of different doses of vitamin A on [childhood morbidity] and [mortality] .
Benn CS Martins C Rodrigues A Jensen H Lisse IM Aaby P.
Danish Epidemiology Science Centre, Statens Serum Institut, Copenhagen, Denmark.
cb@ssi.dk
OBJECTIVES
To determine whether the dose of vitamin A currently recommended by the World Health Organization or half this dose gives better protection against [childhood morbidity] and [mortality] .
DESIGN
Randomised study.
SETTING
A combined oral polio vaccine and vitamin A supplementation campaign in Guinea-Bissau, Africa.
PARTICIPANTS
4983 children aged 6 months to 5 years.
INTERVENTIONS
One of two doses of vitamin A ( recommended and half ); oral polio vaccine .
MAIN OUTCOME MEASURES
[Mortality] and [morbidity] at six and nine months .
RESULTS
[Mortality] was lower in the children who took half the recommended dose of vitamin A compared with the full dose at both six months (mortality rate ratio 0.69, 95% confidence interval 0.36 to 1.35) and nine months (0.62, 0.36 to 1.06) of follow-up. There was [a significant interaction between sex and dose] , the lower dose being associated with [significantly reduced mortality] in girls (0.19, 0.06 to 0.66) but not in boys (1.98, 0.74 to 5.29). The lower dose of vitamin A was consistently associated with [lower hospital case fatality] in girls (0.19, 0.02 to 1.45). Paradoxically, in children aged 6-18 months, the low dose was associated with [slightly higher morbidity] .
CONCLUSIONS
Half the dose of vitamin A currently recommended by WHO may provide equally good or better protection against [mortality] but not against [morbidity] .
------------------- bmj16308382.xml ---------------------------
Randomized Controlled Trial
BMJ. 2005 Dec 10;331(7529):1407; author reply 1407; discussion 1408.
Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression.
Antonioli C Reveley MA.
Department of Health Sciences, Division of Clinical Psychiatry, University of Leicester Medical School, Leicester General Hospital, Leicester LE5 4PW.
OBJECTIVE
To evaluate the effectiveness of animal facilitated therapy with dolphins , controlling for the influence of the natural setting , in the treatment of mild to moderate depression and in the context of the biophilia hypothesis.
SETTING
The study was carried out in Honduras, and recruitment took place in the United States and Honduras.
DESIGN
Single blind, randomised, controlled trial.
PARTICIPANTS
Outpatients, recruited through announcements on the internet, radio, newspapers, and hospitals.
RESULTS
Of the 30 patients randomly assigned to the two groups of treatment, two dropped out of the treatment group after the first week and three withdrew their consent in the control group after they had been randomly allocated. For the participants who completed the study, [the mean severity of the depressive symptoms] was more reduced in the treatment group than in the control group ( [Hamilton rating scale for depression] , P = 0.002; [Beck depression inventory] , P = 0.006). For the sample analysed by modified intention to treat and last observation carried forward, the mean differences for [the Hamilton] and [Beck scores] between the two groups was highly significant (P = 0.007 and P = 0.012, respectively).
CONCLUSIONS
The therapy was effective in alleviating symptoms of depression after two weeks of treatment. Animal facilitated therapy with dolphins is an effective treatment for mild to moderate depression, which is based on a holistic approach, through interaction with animals in nature .
------------------- bmj16332728.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Dec 17;331(7530):1448-9. BMJ. 2006 Jan 7;332(7532):53-4. BMJ. 2006 Jan 7;332(7532):54. BMJ. 2006 Jan 7;332(7532):54. BMJ. 2006 Jan 7;332(7532):54.
Evaluation of a general practitioner with special interest service for dermatology : randomised controlled trial.
Salisbury C Noble A Horrocks S Crosby Z Harrison V Coast J de Berker D Peters T.
Academic Unit of Primary Health Care, Department of Community Based Medicine, University of Bristol, Bristol BS6 6JL.
c.salisbury@bristol.ac.uk
OBJECTIVE
To assess [the effectiveness] , [accessibility] , and [acceptability] of a general practitioner with special interest service for skin problems compared with a hospital dermatology clinic .
DESIGN
Randomised controlled trial.
SETTING
General practitioner with special interest dermatology service and hospital dermatology clinic .
PARTICIPANTS
Adults referred to a hospital dermatology clinic and assessed by a consultant or the general practitioner with special interest service,. Suitable patients had non-urgent skin problems and had been identified from the referral letter as suitable for management by a general practitioner with special interest.
INTERVENTIONS
Participants were randomised in 2:1 ratio to receive management by a general practitioner with special interest or usual hospital outpatient care .
MAIN OUTCOME MEASURES
Primary outcomes were {[disease related quality of life] ( [dermatology life quality index] )} and [improvement in patients' perception of access to services] , assessed nine months after randomisation. Secondary outcomes were [patient satisfaction] , [preference for site of care] , [proportion of failed appointments] , and [waiting times to first appointment] .
RESULTS
49% of the participants were judged suitable for care by the general practitioner with special interest service . Of 768 patients eligible, 556 (72.4%) were randomised (354 to general practitioner with special interest , 202 to hospital outpatient care ). After nine months , 422 (76%) were followed up. No noticeable differences were found between the groups in [clinical outcome] ( [median dermatology life quality index score] = 1 both arms, ratio of geometric means 0.99, 95% confidence interval 0.85 to 1.15). The general practitioner with special interest service was [more accessible] (difference between means on [access scale] 14, 11 to 19) and waited a mean of 40 (35 to 46) days less. Patients expressed [slightly greater satisfaction] with consultations with a general practitioner with special interest (difference in [mean satisfaction score] 4, 1 to 7), and at baseline and after nine months 61% said they preferred care at the service .
CONCLUSIONS
The general practitioner with special interest service for dermatology was [more accessible] and [preferred by patients] than hospital outpatient care , achieving similar clinical outcomes. Trial registration ISRCTN31962758.
------------------- bmj16339217.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2005 Dec 17;331(7530):1448-9. BMJ. 2006 Jan 7;332(7532):54. BMJ. 2006 Jan 7;332(7532):54.
Economic evaluation of a general practitioner with special interests led dermatology service in primary care.
Coast J Noble S Noble A Horrocks S Asim O Peters TJ Salisbury C.
Department of Social Medicine, University of Bristol, Bristol BS8 2PR.
j.coast@bham.ac.uk
OBJECTIVE
To carry out an economic evaluation of a general practitioner with special interest service for non-urgent skin problems compared with hospital outpatient care .
DESIGN
Cost effectiveness analysis and cost consequences analysis alongside a randomised controlled trial.
SETTING
General practitioner with special interest dermatology service covering 29 general practices in Bristol.
PARTICIPANTS
Adults referred to a hospital dermatology clinic who were potentially suitable for management by a general practitioner with special interest .
INTERVENTIONS
Participants were randomised 2:1 to receive either care by general practitioner with special interest service or usual hospital outpatient care .
MAIN OUTCOME MEASURES
[Costs to NHS] , [patients] , and [companions] , and [costs of lost production] . [Cost effectiveness] , using the two primary outcomes of [dermatology life quality index scores] and [improved patient perceived access] , was assessed by [incremental cost effectiveness ratios] and [cost effectiveness acceptability curves] . Cost consequences are presented in relation to all costs and both primary and secondary outcomes from the trial.
RESULTS
[Costs to the NHS] for patients attending the general practitioner with special interest service were 208 pounds sterling (361 dollars; 308 euro) compared with 118 pounds sterling for hospital outpatient care . Based on analysis with imputation of missing data, [costs to patients] and [companions] were 48 pounds sterling and 51 pounds sterling, respectively; [costs of lost production] were 27 pounds sterling and 34 pounds sterling, respectively. [The incremental cost effectiveness ratios] for general practitioner with special interest care over outpatient care were 540 pounds sterling per one point gain in [the dermatology life quality index] and 66 pounds sterling per 10 point change in [the access scale] .
CONCLUSIONS
The general practitioner with special interest service for dermatology is more costly than hospital outpatient care , but this additional cost needs to be weighed against [improved access] and [broadly similar health outcomes] .
------------------- bmj16339220.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jan 21;332(7534):151.
Evid Based Cardiovasc Med. 2006 Jun;10(2):147-8.
Ugeskr Laeger. 2007 Feb 5;169(6):497-9.
Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial.
Jespersen CM Als-Nielsen B Damgaard M Hansen JF Hansen S Helo OH Hildebrandt P Hilden J Jensen GB Kastrup J Kolmos HJ Kjoller E Lind I Nielsen H Petersen L Gluud C; CLARICOR Trial Group.
Bispebjerg Hospital, Copenhagen University Hospital, Department of Cardiology Y, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark.
cmj01@bbh.hosp.dk
OBJECTIVE
To determine if the macrolide clarithromycin affects [mortality] and [cardiovascular morbidity] in patients with stable coronary heart disease.
DESIGN
Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat.
SETTING
Five Copenhagen University cardiology departments and a coordinating centre.
PARTICIPANTS
13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised.
INTERVENTIONS
Two weeks' treatment with clarithromycin 500 mg/day or matching placebo .
MAIN OUTCOME MEASURES
Primary outcome: {composite of [all cause mortality] , [myocardial infarction] , or [unstable angina pectoris]} during three years' follow-up . Secondary outcome: {composite of [cardiovascular mortality] , [myocardial infarction] , or [unstable angina pectoris]} . The outcomes were obtained from Danish registers and were blindly assessed by the event committee.
RESULTS
2172 participants were randomised to clarithromycin and 2201 to placebo . We found no significant effects of clarithromycin on [the primary outcome] (hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or [secondary outcome] (1.17, 0.98 to 1.40). [Mortality] was significantly higher in the clarithromycin arm (1.27, 1.03 to 1.54; P = 0.03) as a result of [significantly higher cardiovascular mortality] (1.45, 1.09 to 1.92; P = 0.01).
CONCLUSIONS
Short term clarithromycin in patients with stable coronary heart disease may cause [significantly higher cardiovascular mortality] . The long term safety of clarithromycin in patients with stable ischaemic heart disease should be examined. Trial registration ClinicalTrials.gov NCT00121550.
------------------- bmj16356945.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Partner notification of chlamydia infection in primary care: randomised controlled trial and analysis of resource use.
Low N McCarthy A Roberts TE Huengsberg M Sanford E Sterne JA Macleod J Salisbury C Pye K Holloway A Morcom A Patel R Robinson SM Horner P Barton PM Egger M.
Department of Social Medicine, University of Bristol, Bristol BS8 2PR.
low@ispm.unibe.ch
OBJECTIVE
To evaluate the effectiveness of a practice nurse led strategy to improve the notification and treatment of partners of people with chlamydia infection.
DESIGN
Randomised controlled trial.
SETTING
27 general practices in the Bristol and Birmingham areas.
PARTICIPANTS
140 men and women with chlamydia (index cases) diagnosed by screening of a home collected urine sample or vulval swab specimen.
INTERVENTIONS
Partner notification at the general practice immediately after diagnosis by trained practice nurses, with telephone follow up by a health adviser ; or referral to a specialist health adviser at a genitourinary medicine clinic .
MAIN OUTCOME MEASURES
Primary outcome was {the proportion of index cases with [at least one treated sexual partner]} . Specified secondary outcomes included [the number of sexual contacts elicited during a sexual history] , [positive test result for chlamydia] six weeks after treatment, and {[the cost of each strategy] in 2003 sterling prices} .
RESULTS
65.3% (47/72) of participants receiving practice nurse led partner notification had [at least one partner treated] compared with 52.9% (39/68) of those referred to a genitourinary medicine clinic (risk difference 12.4%, 95% confidence interval -1.8% to 26.5%). Of 68 participants referred to the clinic , 21 (31%) did not attend. [The costs per index case] were 32.55 pounds sterling for the practice nurse led strategy and 32.62 pounds sterling for the specialist referral strategy .
CONCLUSION
Practice based partner notification by trained nurses with telephone follow up by health advisers is at least as effective as referral to a specialist health adviser at a genitourinary medicine clinic , and [costs the same] . Trial registration Clinical trials: NCT00112255.
------------------- bmj16377643.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial.
Puhan MA Suarez A Lo Cascio C Zahn A Heitz M Braendli O.
Horten Centre, University of Zurich, 8091 Zurich, Switzerland.
OBJECTIVE
To assess the effects of didgeridoo playing on [daytime sleepiness] and [other outcomes related to sleep] by reducing collapsibility of the upper airways in patients with moderate obstructive sleep apnoea syndrome and snoring.
DESIGN
Randomised controlled trial.
SETTING
Private practice of a didgeridoo instructor and a single centre for sleep medicine.
PARTICIPANTS
25 patients aged > 18 years with an apnoea-hypopnoea index between 15 and 30 and who complained about snoring.
INTERVENTIONS
Didgeridoo lessons and daily practice at home with standardised instruments for four months . Participants in the control group remained on the waiting list for lessons .
MAIN OUTCOME MEASURE
[Daytime sleepiness] ( [Epworth scale] from 0 (no daytime sleepiness) to 24), [sleep quality] ( [Pittsburgh quality of sleep index] from 0 (excellent sleep quality) to 21), [partner rating of sleep disturbance] ( [visual analogue scale] from 0 (not disturbed) to 10), [apnoea-hypopnoea index] , and [health related quality of life] (SF-36).
RESULTS
Participants in the didgeridoo group practised an average of 5.9 days a week (SD 0.86) for 25.3 minutes (SD 3.4). Compared with the control group in the didgeridoo group [daytime sleepiness] (difference -3.0, 95% confidence interval -5.7 to -0.3, P = 0.03) and [apnoea-hypopnoea index] (difference -6.2, -12.3 to -0.1, P = 0.05) improved significantly and [partners reported less sleep disturbance] (difference -2.8, -4.7 to -0.9, P < 0.01). There was no effect on [the quality of sleep] (difference -0.7, -2.1 to 0.6, P = 0.27). The combined analysis of [sleep related outcomes] showed a moderate to large effect of didgeridoo playing (difference between summary z scores -0.78 SD units, -1.27 to -0.28, P < 0.01). Changes in [health related quality of life] did not differ between groups.
CONCLUSION
Regular didgeridoo playing is an effective treatment alternative well accepted by patients with moderate obstructive sleep apnoea syndrome.
N ISRCTN
31571714.
------------------- bmj16428249.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jan 28;332(7535):187-8.
Impact of Helicobacter pylori eradication on [dyspepsia] , [health resource use] , and [quality of life] in the Bristol helicobacter project: randomised controlled trial.
Lane JA Murray LJ Noble S Egger M Harvey IM Donovan JL Nair P Harvey RF.
Department of Social Medicine, University of Bristol, Bristol BS8 2PR.
Athene.lane@bristol.ac.uk
OBJECTIVE
To determine the impact of a community based Helicobacter pylori screening and eradication programme on [the incidence of dyspepsia] , [resource use] , and [quality of life] , including [a cost consequences analysis] .
DESIGN
H pylori screening programme followed by randomised placebo controlled trial of eradication.
SETTING
Seven general practices in southwest England.
PARTICIPANTS
10,537 unselected people aged 20-59 years were screened for H pylori infection (13C urea breath test); 1558 of the 1636 participants who tested positive were randomised to H pylori eradication treatment or placebo , and 1539 (99%) were followed up for two years .
INTERVENTION
Ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily for two weeks or placebo .
MAIN OUTCOME MEASURES
[Primary care consultation rates for dyspepsia] (defined as epigastric pain) two years after randomisation, with secondary outcomes of [dyspepsia symptoms] , [resource use] , [NHS costs] , and [quality of life] .
RESULTS
In the eradication group , 35% fewer participants [consulted for dyspepsia] over two years compared with the placebo group (55/787 v 78/771; odds ratio 0.65, 95% confidence interval 0.46 to 0.94; P = 0.021; number needed to treat 30) and 29% fewer participants had [regular symptoms] (odds ratio 0.71, 0.56 to 0.90; P = 0.05). [NHS costs] were 84.70 pounds sterling (74.90 pounds sterling to 93.91 pounds sterling) greater per participant in the eradication group over two years , of which 83.40 pounds sterling (146 dollars; 121 euro) was [the cost of eradication treatment] . No difference in [quality of life] existed between the two groups.
CONCLUSIONS
Community screening and eradication of H pylori is feasible in the general population and led to significant reductions in [the number of people who consulted for dyspepsia] and had [symptoms] two years after treatment. These benefits have to be balanced against [the costs of eradication treatment] , so a targeted eradication strategy in dyspeptic patients may be preferable.
------------------- bmj16428253.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Feb 4;332(7536):249-50. Evid Based Ment Health. 2006 Aug;9(3):76.
Long term outcomes from the IMPACT randomised trial for depressed elderly patients in primary care.
Hunkeler EM Katon W Tang L Williams JW Jr Kroenke K Lin EH Harpole LH Arean P Levine S Grypma LM Hargreaves WA Unutzer J.
Kaiser Permanente, Division of Research, 2000 Broadway, 2nd Floor, Oakland, CA 94612, USA.
emh@dor.kaiser.org
OBJECTIVE
To determine the long term effectiveness of collaborative care management for depression in late life .
DESIGN
Two arm, randomised, clinical trial; intervention one year and follow-up two years .
SETTING
18 primary care clinics in eight US healthcare organisations. Patients 1801 primary care patients aged 60 and older with major depression, dysthymia, or both.
INTERVENTION
Patients were randomly assigned to a 12 month collaborative care intervention ( IMPACT ) or usual care for depression . Teams including a depression care manager, primary care doctor, and psychiatrist offered education, behavioural activation, antidepressants, a brief, behaviour based psychotherapy (problem solving treatment), and relapse prevention geared to each patient's needs and preferences.
MAIN OUTCOME MEASURES
Interviewers, blinded to treatment assignment, conducted interviews in person at baseline and by telephone at each subsequent follow up. They measured {[depression] ( [SCL-20] )} , [overall functional impairment] and {[quality of life] ( [SF-12] )} , {[physical functioning] ( [PCS-12] )} , [depression treatment] , and [satisfaction with care] .
RESULTS
IMPACT patients fared significantly (P < 0.05) better than controls regarding [continuation of antidepressant treatment] , [depressive symptoms] , [remission of depression] , [physical functioning] , [quality of life] , [self efficacy] , and [satisfaction with care] at 18 and 24 months . One year after IMPACT resources were withdrawn, a significant difference in [SCL-20 scores] (0.23, P < 0.0001) favouring IMPACT patients remained.
CONCLUSIONS
Tailored collaborative care actively engages older adults in treatment for depression and delivers substantial and persistent long term benefits. Benefits include [less depression] , [better physical functioning] , and [an enhanced quality of life] . The IMPACT model may show the way to less depression and healthier lives for older adults.
------------------- bmj16439370.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2007 Jun 2;334(7604):1127. Nat Clin Pract Cardiovasc Med. 2006 Jul;3(7):358-9.
Efficacy and safety of fondaparinux for [the prevention of venous thromboembolism] in older acute medical patients: randomised placebo controlled trial.
Cohen AT Davidson BL Gallus AS Lassen MR Prins MH Tomkowski W Turpie AG Egberts JF Lensing AW; ARTEMIS Investigators.
Department of Surgery, Guy's, King's, and St Thomas's School of Medicine, London SE5 9PJ.
alexander.cohen@kcl.ac.uk
OBJECTIVE
To determine the efficacy and safety of the anticoagulant fondaparinux in older acute medical inpatients at moderate to high risk of venous thromboembolism.
DESIGN
Double blind randomised placebo controlled trial.
SETTING
35 centres in eight countries.
PARTICIPANTS
849 medical patients aged 60 or more admitted to hospital for congestive heart failure, acute respiratory illness in the presence of chronic lung disease, or acute infectious or inflammatory disease and expected to remain in bed for at least four days.
INTERVENTIONS
2.5 mg fondaparinux or placebo subcutaneously once daily for six to 14 days.
OUTCOME MEASURE
The primary efficacy outcome was {[venous thromboembolism] detected by routine bilateral venography along with [symptomatic venous thromboembolism] up to day 15} . Secondary outcomes were [bleeding] and [death] . Patients were followed up at one month .
RESULTS
425 patients in the fondaparinux group and 414 patients in the placebo group were evaluable for safety analysis (10 were not treated). 644 patients (75.9%) were available for [the primary efficacy analysis] . [Venous thrombembolism] was detected in 5.6% (18/321) of patients treated with fondaparinux and 10.5% (34/323) of patients given placebo , a relative risk reduction of 46.7% (95% confidence interval 7.7% to 69.3%). [Symptomatic venous thromboembolism] occurred in five patients in the placebo group and none in the fondaparinux group (P = 0.029). [Major bleeding] occurred in one patient (0.2%) in each group. At the end of follow-up, 14 patients in the fondaparinux group (3.3%) and 25 in the placebo group (6.0%) had [died] .
CONCLUSION
Fondaparinux is effective in the prevention of [asymptomatic] and [symptomatic venous thromboembolic] events in older acute medical patients. The frequency of [major bleeding] was similar for both fondaparinux and placebo treated patients .
------------------- bmj16452103.xml ---------------------------
Comparative Study Randomized Controlled Trial Research Support, N.I.H., Extramural
Sham device v inert pill : randomised controlled trial of two placebo treatments.
Kaptchuk TJ Stason WB Davis RB Legedza AR Schnyer RN Kerr CE Stone DA Nam BH Kirsch I Goldman RH.
Osher Institute, Harvard Medical School, Boston, MA, 02215 USA.
ted_kaptchuk@hms.harvard.edu
OBJECTIVE
To investigate whether a sham device ( a validated sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain.
DESIGN
A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study .
SETTING
Academic medical centre.
PARTICIPANTS
270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored > or =3 on a 10 point pain scale.
INTERVENTIONS
Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks .
MAIN OUTCOME MEASURES
[Arm pain] measured on a 10 point pain scale. Secondary outcomes were [symptoms measured by the Levine symptom severity scale] , [function measured by Pransky's upper extremity function scale] , and [grip strength] .
RESULTS
[Pain] decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups (-0.14, 95% confidence interval -0.52 to 0.25, P = 0.49). Changes in severity scores for [arm symptoms] and [grip strength] were similar between groups, but [arm function] improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point [arm pain scale] in the sham device group than in the placebo pill group (-0.33 (-0.40 to -0.26) v -0.15 (-0.21 to -0.09), P = 0.0001) and on [the symptom severity scale] (-0.07 (-0.09 to -0.05) v -0.05 (-0.06 to -0.03), P = 0.02). Differences were not significant, however, on [the function scale] or for [grip strength] . [Reported adverse effects] were different in the two groups.
CONCLUSIONS
The sham device had greater effects than the placebo pill on [self reported pain] and [severity of symptoms] over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals.
------------------- bmj16455695.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Oral misoprostol for [induction of labour at term] : randomised controlled trial.
Dodd JM Crowther CA Robinson JS.
Department of Obstetrics and Gynaecology, University of Adelaide, Women's and Children's Hospital, North Adelaide, SA 5006, Australia.
jodie.dodd@adelaide.edu.au
OBJECTIVE
To compare oral misoprostol solution with vaginal prostaglandin gel ( dinoprostone ) for [induction of labour at term] to determine whether misoprostol is superior.
DESIGN
Randomised double blind placebo controlled trial.
SETTING
Maternity departments in three hospitals in Australia. Population Pregnant women with a singleton cephalic presentation at > or = 36+6 weeks' gestation, with an indication for prostaglandin induction of labour.
INTERVENTIONS
20 mug oral misoprostol solution at ourly intervals and placebo vaginal gel or vaginal dinoprostone gel at six hourly intervals and placebo oral solution .
MAIN OUTCOME MEASURES
[Vaginal birth within 24 hours] ; [uterine hyperstimulation with associated changes in fetal heart rate] ; [caesarean section (all)] ; and [caesarean section for fetal distress] .
RESULTS
741 women were randomised, 365 to the misoprostol group and 376 to the vaginal dinoprostone group . There were no significant differences between the two treatment groups in [the primary outcomes] : [vaginal birth not achieved in 24 hours] ( misoprostol 168/365 (46.0%) v dinoprostone 155/376 (41.2%); relative risk 1.12, 95% confidence interval 0.95 to 1.32; P = 0.134), [caesarean section] (83/365 (22.7%) v 100/376 (26.6%); 0.82, 0.64 to 1.06; P = 0.127), [caesarean section for fetal distress] (32/365 (8.8%) v 35/376 (9.3%); 0.91, 0.57 to 1.44; P = 0.679), or [uterine hyperstimulation with changes in fetal heart rate] (3/365 (0.8%) v 6/376 (1.6%); 0.55, 0.14 to 2.21; P = 0.401). Although there were differences in the process of labour induction, there were no significant differences in [adverse maternal] or [neonatal outcomes] .
CONCLUSIONS
This trial shows no evidence that oral misoprostol is superior to vaginal dinoprostone for [induction of labour] . However, it does not lead to poorer health outcomes for women or their infants, and oral treatment is preferred by women.
TRIAL REGISTRATION
National Health and Medical Research Council, Perinatal Trials, PT0361.
------------------- bmj16467348.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Mar 18;332(7542):618-9.
Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial.
Poustie VJ Russell JE Watling RM Ashby D Smyth RL; CALICO Trial Collaborative Group.
University of Liverpool Division of Child Health, Royal Liverpool Children's Hospital, Liverpool L12 2AP.
OBJECTIVE
To determine whether oral protein energy supplements , used long term in children with cystic fibrosis who are moderately malnourished, improve [nutritional] and [other outcomes] .
DESIGN
Multicentre randomised controlled trial.
SETTING
Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics.
PARTICIPANTS
102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished.
INTERVENTIONS
Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone , for 12 months .
MAIN OUTCOME MEASURE
[Change in body mass index centile] over one year .
RESULTS
Use of supplements was not associated with [a change in body mass index centile] (mean difference 2.99 centile points, 95% confidence interval -2.70 to 8.68) or [other nutritional] and [spirometric outcomes] in this group of children.
CONCLUSIONS
Long term use of oral protein energy supplements did not result in an improvement in [nutritional status] or [other clinical outcomes] in children with cystic fibrosis who were moderately malnourished. Oral protein energy supplements should not be regarded as an essential part of the management of this group of children.
TRIAL REGISTRATION
ISRCTN: 95744468.
------------------- bmj16488895.xml ---------------------------
Randomized Controlled Trial
BMJ. 2006 Mar 25;332(7543):680-1.
Treatment of low back pain by acupressure and physical therapy : randomised controlled trial.
Hsieh LL Kuo CH Lee LH Yen AM Chien KL Chen TH.
Institute of Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
OBJECTIVE
To evaluate the effectiveness of acupressure in terms of [disability] , [pain scores] , and [functional status] .
DESIGN
Randomised controlled trial.
SETTING
Orthopaedic clinic in Kaohsiung, Taiwan.
PARTICIPANTS
129 patients with chronic low back pain.
INTERVENTION
Acupressure or physical therapy for one month .
MAIN OUTCOME MEASURES
Self administered Chinese versions of [standard outcome measures for low back pain] (primary outcome: [Roland and Morris disability questionnaire] ) at baseline , after treatment , and at six month follow-up .
RESULTS
[The mean total Roland and Morris disability questionnaire score] after treatment was significantly lower in the acupressure group than in the physical therapy group regardless of the difference in absolute score (- 3.8, 95% confidence interval - 5.7 to - 1.9) or mean change from the baseline (- 4.64, - 6.39 to - 2.89). Acupressure conferred an 89% (95% confidence interval 61% to 97%) reduction in [significant disability] compared with physical therapy . The improvement in [disability score] in the acupressure group compared with the physical group remained at six month follow-up . Statistically significant differences also occurred between the two groups for [all six domains of the core outcome] , [pain visual scale] , and [modified Oswestry disability questionnaire] after treatment and at six month follow-up .
CONCLUSIONS
Acupressure was effective in reducing low back pain in terms of [disability] , [pain scores] , and [functional status] . The benefit was sustained for six months.
------------------- bmj16520326.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Apr 15;332(7546):864-5.
Are some people sensitive to mobile phone signals? Within participants double blind randomised provocation study.
Rubin GJ Hahn G Everitt BS Cleare AJ Wessely S.
King's College London, Institute of Psychiatry, Department of Psychological Medicine, Section of General Hospital Psychiatry, Weston Education Centre (PO62), London SE5 9RJ.
g.rubin@iop.kcl.ac.uk
OBJECTIVE
To test whether people who report being sensitive to mobile phone signals have more symptoms when exposed to a pulsing mobile signal than when exposed to a sham signal or a non-pulsing signal .
DESIGN
Double blind, randomised, within participants provocation study.
SETTING
Dedicated suite of offices at King's College London, between September 2003 and June 2005.
PARTICIPANTS
60 "sensitive" people who reported often getting headache-like symptoms within 20 minutes of using a global system for mobile communication (GSM) mobile phone and 60 "control" participants who did not report any such symptoms.
INTERVENTION
Participants were exposed to three conditions: a 900 MHz GSM mobile phone signal , a non-pulsing carrier wave signal , and a sham condition with no signal present . Each exposure lasted for 50 minutes.
MAIN OUTCOME MEASURES
The principal outcome measure was [headache severity assessed] with a 0-100 visual analogue scale. Other outcomes included [six other subjective symptoms] and [participants' ability to judge whether a signal was present] .
RESULTS
[Headache severity] increased during exposure and decreased immediately afterwards . However, no strong evidence was found of any difference between the conditions in terms of [symptom severity] . Nor did evidence of any differential effect of condition between the two groups exist. [The proportion of sensitive participants who believed a signal was present] during GSM exposure (60%) was similar to [the proportion who believed one was present] during sham exposure (63%).
CONCLUSIONS
No evidence was found to indicate that people with self reported sensitivity to mobile phone signals are able to detect such signals or that they react to them with increased symptom severity. As sham exposure was sufficient to trigger [severe symptoms] in some participants, psychological factors may have an important role in causing this condition.
TRIAL REGISTRATION
ISRCTN81432775.
------------------- bmj16543297.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Apr 1;332(7544):61.
BMJ. 2006 Apr 1;332(7544):741. Evid Based Ment Health. 2006 Nov;9(4):103. Evid Based Nurs. 2006 Oct;9(4):122.
Effect of enhanced psychosocial care on [antipsychotic use] in nursing home residents with severe dementia: cluster randomised trial.
Fossey J Ballard C Juszczak E James I Alder N Jacoby R Howard R.
Oxford University and Oxford Mental Healthcare Trust, Oxford.
OBJECTIVE
To evaluate the effectiveness of a training and support intervention for nursing home staff in reducing the proportion of residents with dementia who are prescribed neuroleptics.
DESIGN
Cluster randomised controlled trial with blinded assessment of outcome.
SETTING
12 specialist nursing homes for people with dementia in London, Newcastle, and Oxford.
PARTICIPANTS
Residents of the 12 nursing homes; numbers varied during the study period.
INTERVENTION
Training and support intervention delivered to nursing home staff over 10 months, focusing on alternatives to drugs for the management of agitated behaviour in dementia.
MAIN OUTCOME MEASURES
[Proportion of residents in each home who were prescribed neuroleptics] and {[mean levels of agitated and disruptive behaviour] ( [Cohen-Mansfield agitation inventory] )} in each home at 12 months .
RESULTS
At 12 months [the proportion of residents taking neuroleptics] in the intervention homes (23.0%) was significantly lower than that in the control homes (42.1%): [average reduction in neuroleptic use] 19.1% (95% confidence interval 0.5% to 37.7%). No significant differences were found in [the levels of agitated or disruptive behaviour] between intervention and control homes .
CONCLUSIONS
Promotion of person centred care and good practice in the management of patients with dementia with behavioural symptoms provides an effective alternative to neuroleptics.
------------------- bmj16543298.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
The REACT study: randomised evaluation of assertive community treatment in north London.
Killaspy H Bebbington P Blizard R Johnson S Nolan F Pilling S King M.
Department of Mental Health Sciences, University College London, London NW3 2PF.
h.killaspy@medsch.ucl.ac.uk
OBJECTIVE
To compare outcomes of care from assertive community treatment teams with care by community mental health teams for people with serious mental illnesses.
DESIGN
Non-blind randomised controlled trial.
SETTING
Two inner London boroughs.
PARTICIPANTS
251 men and women under the care of adult secondary mental health services with recent high use of inpatient care and difficulties engaging with community services.
INTERVENTIONS
Treatment from assertive community treatment team (127 participants) or continuation of care from community mental health team (124 participants).
MAIN OUTCOME MEASURES
Primary outcome was {[inpatient bed use] 18 months after randomisation} . Secondary outcomes included [symptoms] , [social function] , [client satisfaction] , and [engagement with services] .
RESULTS
No significant differences were found in [inpatient bed use] (median difference 1, 95% confidence interval -16 to 38) or in [clinical] or [social outcomes] for the two treatment groups. Clients who received care from the assertive community treatment team seemed [better engaged] ( [adapted homeless engagement acceptance schedule] : difference in means 1.1, 1.0 to 1.9), and those who agreed to be interviewed were [more satisfied with service] ( [adapted client satisfaction questionnaire] : difference in means 7.14, 0.9 to 13.4).
CONCLUSIONS
Community mental health teams are able to support people with serious mental illnesses as effectively as assertive community treatment teams, but assertive community treatment may be better at [engaging clients] and may lead to [greater satisfaction with services] .
------------------- bmj16565124.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Apr 15;332(7546):916. BMJ. 2006 Mar 25;332(7543):681-2. Evid Based Ment Health. 2006 Nov;9(4):102.
Effectiveness of educational interventions in improving [detection] and [management of dementia] in primary care: cluster randomised controlled study.
Downs M Turner S Bryans M Wilcock J Keady J Levin E O'Carroll R Howie K Iliffe S.
Bradford Dementia Group, Division of Dementia Studies, School of Health Studies, University of Bradford, Bradford BD5 0BB.
m.downs@bradford.ac.uk
OBJECTIVE
To test the effectiveness of educational interventions in improving [detection rates] and [management of dementia] in primary care.
DESIGN
Unblinded, cluster randomised, before and after controlled study.
SETTING
General practices in the United Kingdom (central Scotland and London) between 1999 and 2002.
INTERVENTIONS
Three educational interventions: an electronic tutorial carried on a CD Rom ; decision support software built into the electronic medical record ; and practice based workshops .
PARTICIPANTS
36 practices participated in the study. Eight practices were randomly assigned to the electronic tutorial ; eight to decision support software ; 10 to practice based workshops ; and 10 to control . Electronic and manual searches yielded 450 valid and usable medical records.
MAIN OUTCOME MEASURES
[Rates of detection of dementia] and the extent to which medical records showed evidence of [improved concordance with guidelines regarding diagnosis and management] .
RESULTS
Decision support software (P = 0.01) and practice based workshops (P = 0.01) both significantly improved [rates of detection] compared with control . There were no significant differences by intervention in [the measures of concordance with guidelines] .
CONCLUSIONS
Decision support systems and practice based workshops are effective educational approaches in improving [detection rates in dementia] .
------------------- bmj16597660.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
Effect of different forms of information produced for cancer patients on their [use of the information] , [social support] , and [anxiety] : randomised trial.
Jones RB Pearson J Cawsey AJ Bental D Barrett A White J White CA Gilmour WH.
Faculty of Health and Social Work, University of Plymouth, Drake Circus, Plymouth PL4 8AA.
ray.jones@plymouth.ac.uk
OBJECTIVE
To explore the hypothesis that different methods of selecting and printing information for cancer patients could improve [emotional support] by affecting interaction with others, and so lead to [improved psychological wellbeing] .
DESIGN
Randomised trial with eight groups (three factors, 2x2x2). Data collected at recruitment and three month follow-up .
PARTICIPANTS
400 patients starting radiotherapy, of whom 325 with breast or prostate cancer and complete anxiety and depression data were included in the analysis.
INTERVENTIONS
Printed booklets: half had only general information from CancerBACUP about each patient's cancer and half had personalised information from the patient's medical record plus selected general information ; half were composed of information chosen interactively by the patient and half were produced automatically with a larger volume of material ; and half had additional advice on anxiety management and half did not.
MAIN OUTCOME MEASURES
[Patients' views of the information] , [use of their booklets with others] ; [change in reported social support] ; [change in anxiety] and [depression] .
RESULTS
The larger booklets produced automatically were [more likely to be found useful] and [to tell patients something new] and [less likely to be seen as too limited] than the booklets produced interactively , but they were also [more likely to overwhelm some patients] . Personalised booklets were more likely than general booklets [to tell patients something new] . There was no difference in [patients' perceived understanding of their cancer] by any of the intervention factors. Patients with personalised information were [more likely to show their booklets to others] and [to think it helped in discussing their cancer or its treatment] . There were no major differences in [social support] , [anxiety] , or [depression] by any intervention factors.
CONCLUSIONS
Patients were [more likely to show personalised information to their confidants] than general information . Further research is needed into the effects of sharing information on [patients' social support] and [anxiety] . Trial registration US Government Clinical Trials Database NCT00127465.
------------------- bmj16627509.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Apr 22;332(7547):923-4. BMJ. 2006 Apr 22;332(7547):936. J Pediatr. 2007 Jan;150(1):116.
Age related, structured educational programmes for the management of atopic dermatitis in children and adolescents: multicentre, randomised controlled trial.
Staab D Diepgen TL Fartasch M Kupfer J Lob-Corzilius T Ring J Scheewe S Scheidt R Schmid-Ott G Schnopp C Szczepanski R Werfel T Wittenmeier M Wahn U Gieler U.
Department of Paediatric Pulmonology and Immunology, Charite, Humboldt University, Berlin.
OBJECTIVE
To determine the effects of age related, structured educational programmes on the management of moderate to severe atopic dermatitis in childhood and adolescence.
DESIGN
Multicentre, randomised controlled trial.
SETTING
Seven hospitals in Germany.
PARTICIPANTS
Parents of children with atopic dermatitis aged 3 months to 7 years (n = 274) and 8-12 years (n = 102), adolescents with atopic dermatitis aged 13-18 years (n = 70), and controls (n = 244, n = 83, and n = 50, respectively).
INTERVENTIONS
Group sessions of standardised intervention programmes for atopic dermatitis once weekly for six weeks or no education ( control group ).
MAIN OUTCOME MEASURES
[Severity of eczema] (scoring of atopic dermatitis scale), [subjective severity] (standardised questionnaires), and {[quality of life] for parents of affected children aged less than 13 years} , over 12 months .
RESULTS
Significant improvements in [severity of eczema] and [subjective severity] were seen in all intervention groups compared with control groups (total score for severity: age 3 months to 7 years - 17.5, 95% confidence intervals - 19.6 to - 15.3 v - 12.2, - 14.3 to - 10.1; age 8-12 years - 16.0, - 20.0 to - 12.0 v - 7.8, - 11.4; - 4.3; and age 13-18 years - 19.7, - 23.7 to - 15.7 v - 5.2, - 10.5 to 0.1). Parents of affected children aged less than 7 years experienced significantly better improvement in [all five quality of life subscales] , whereas parents of affected children aged 8-12 years experienced significantly better improvement in [three of five quality of life subscales] .
CONCLUSION
Age related educational programmes for the control of atopic dermatitis in children and adolescents are effective in the long term management of the disease.
------------------- bmj16636023.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Evid Based Nurs. 2006 Oct;9(4):115.
Can sutures get wet? Prospective randomised controlled trial of wound management in general practice.
Heal C Buettner P Raasch B Browning S Graham D Bidgood R Campbell M Cruikshank R.
James Cook University, Queensland, Australia.
clarshel@hotmail.com
OBJECTIVE
To compare standard management of keeping wounds dry and covered with allowing wounds to be uncovered and wet in the first 48 hours after minor skin excision .
DESIGN
Prospective, randomised controlled, multicentre trial testing for equivalence of infection rates.
SETTING
Primary care in regional centre, Queensland, Australia.
PARTICIPANTS
857 patients randomised to either keep their wound dry and covered (n = 442) or remove the dressing and wet the wound (n = 415).
RESULTS
[The incidence of infection] in the intervention group (8.4%) was not inferior to [the incidence] in the control group (8.9%) (P < 0.05). The one sided 95% confidence interval for the difference of infection rates was infinity to 0.028.
CONCLUSION
These results indicate that wounds can be uncovered and allowed to get wet in the first 48 hours after minor skin excision without increasing [the incidence of infection] .
------------------- bmj16675812.xml ---------------------------
Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 May 20;332(7551):1216; author reply 1216.
Safety and efficacy of rectal compared with intramuscular quinine for the early treatment of moderately severe malaria in children: randomised clinical trial.
Barennes H Balima-Koussoube T Nagot N Charpentier JC Pussard E.
Centre MURAZ, 01BP390 Bobo-Dioulasso, Burkina Faso.
hubert.barennes@auf.org
OBJECTIVE
To compare the safety and efficacy of quinine given by the rectal route with quinine given by the intramuscular route in children with moderately severe Plasmodium falciparum malaria.
DESIGN
Randomised, open, clinical trial.
SETTING
Health centre in Burkina Faso.
PARTICIPANTS
898 children with moderately severe P falciparum malaria who were unable to take oral treatment.
INTERVENTION
Rectal quinine (20 mg/kg diluted to 30 mg/ml in water solution) or intramuscular quinine (12.5 mg/kg) every 12 hours until oral quinine could be taken .
MAIN OUTCOME MEASURES
Primary safety outcome was [the presence of blood in stools] and secondary safety outcome was [diarrhoea] . Primary efficacy outcome was [early treatment failure] and secondary efficacy outcomes were [late clinical] and [parasitological failures] , [fever clearance time] , and [time to oral intake] .
RESULTS
[Blood in stools] and [diarrhoea] were more common in children given quinine by the rectal route than by the intramuscular route ( [blood in stools] : 5% v 1%, absolute difference 3.9%, 95% confidence interval 1.8% to 6.1%; [diarrhoea] : 5% v 1%, 3.5%, 1.3% to 5.7%). On anoscopy, inflammatory lesions (9/248, 3%) were associated with [bloody striations in stools] . Side effects of rectal quinine were rare and transitory. [Local pain] (90%), [inflammation] (79%), and [transient impairment of mobility] (15%) were observed with intramuscular quinine . [Early treatment failure] was higher in the rectal group (6% v 3%, absolute difference 3.0%, 95% confidence interval 0.2% to 5.9%). All except two children in each group had [negative blood slide results] at day 5 . [Fever recurrence] at day 7 was higher in the intramuscular group (37/375 v 18/395, absolute difference 5.3%, 1.6% to 8.9%). Other efficacy outcomes ( [late clinical failure] , [late parasitological failure] , [fever clearance time] , [time to starting oral intake] and [rate of deterioration to severe malaria] ) did not differ.
CONCLUSION
Quinine given by the rectal route has an acceptable safety profile and could be used in the early management of moderately severe malaria in children in sub-Saharan Africa, halting progression to severe disease.
------------------- bmj16679331.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jun 3;332(7553):1334. BMJ. 2006 Jun 3;332(7553):1334-5. BMJ. 2006 May 20;332(7551):1165-6.
Effect of family style mealtimes on [quality of life] , [physical performance] , and [body weight] of nursing home residents: cluster randomised controlled trial.
Nijs KA de Graaf C Kok FJ van Staveren WA.
Wageningen University, Division of Human Nutrition, PO Box 8129, 6700 EV Wageningen, Netherlands.
Kristel.Nijs@wur.nl
OBJECTIVE
To assess the effect of family style mealtimes on [quality of life] , [physical performance] , and [body weight] of nursing home residents without dementia.
DESIGN
Cluster randomised trial.
SETTING
Five Dutch nursing homes.
PARTICIPANTS
178 residents (mean age 77 years). Two wards in each home were randomised to intervention (95 participants) or control groups (83).
INTERVENTION
During six months the intervention group took their meals family style and the control group received the usual individual pre-plated service .
MAIN OUTCOME MEASURES
{[Quality of life] (perceived safety; autonomy; and sensory, physical, and psychosocial functioning)} , [gross and fine motor function] , and [body weight] .
RESULTS
The difference in change between the groups was significant for [overall quality of life] (6.1 units, 95% confidence interval 2.1 to 10.3), [fine motor function] (1.8 units, 0.6 to 3.0), and [body weight] (1.5 kg, 0.6 to 2.4).
CONCLUSION
Family style mealtimes maintain [quality of life] , [physical performance] , and [body weight] of nursing home residents without dementia.
TRIAL REGISTRATION
Clinical trials NCT00114582.
------------------- bmj16682420.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
HIV prevention in Mexican schools: prospective randomised evaluation of intervention .
Walker D Gutierrez JP Torres P Bertozzi SM.
Division of Reproductive Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico.
OBJECTIVE
To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception.
DESIGN
Cluster randomised controlled trial.
SETTING
40 public high schools in the state of Morelos, Mexico.
PARTICIPANTS
10 954 first year high school students.
INTERVENTION
Schools were randomised to one of three arms: an HIV prevention course that promoted condom use , the same course with emergency contraception as back-up , or the existing sex education course . Self administered anonymous questionnaires were completed at baseline , four months , and 16 months . Students at intervention schools received a 30 hour course (over 15 weeks) on HIV prevention and life skills , designed in accordance with guidelines of the joint United Nations programme on HIV/AIDS. Two extra hours of education on emergency contraception were given to students in the condom promotion with contraception arm .
MAIN OUTCOME MEASURES
Primary outcome measure was [reported condom use] . Other outcomes were [reported sexual activity] ; [knowledge and attitudes about HIV] and [emergency contraception] ; and [attitudes and confidence about condom use] .
RESULTS
Intervention did not affect [reported condom use] . [Knowledge of HIV] improved in both intervention arms and [knowledge of emergency contraception] improved in the condom promotion with contraception arm . [Reported sexual behaviour] was similar in the intervention arms and the control group .
CONCLUSION
A rigorously designed, implemented, and evaluated HIV education course based in public high schools did not reduce [risk behaviour] , so such courses need to be redesigned and evaluated. Addition of emergency contraception did not decrease [reported condom use] or increase [risky sexual behaviour] but did increase [reported use of emergency contraception] .
------------------- bmj16707508.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jun 17;332(7555):1418.
BMJ. 2006 May 27;332(7552):1225-6.
Effect of patient completed agenda forms and doctors' education about the agenda on [the outcome of consultations] : randomised controlled trial.
Middleton JF McKinley RK Gillies CL.
Leics, Northants and Rutland Deanery, University of Leicester.
OBJECTIVE
To assess the effect of patient completed agenda forms for the consultation and doctors' education on identifying patients' agendas on [the outcome of consultations] .
DESIGN
Randomised controlled trial.
SETTING
General practices in Leicestershire and Nottinghamshire, United Kingdom.
PARTICIPANTS
46 general practitioners and 976 patients.
INTERVENTIONS
Education for general practitioners , with an embedded clustered randomised controlled trial of a patient agenda form .
MAIN OUTCOME MEASURES
[Number of problems identified] , [time required to manage each problem] , [duration of consultations] , {[number of problems raised] after the doctor considered the consultation finishe ("by the way" questions)} , and [patient satisfaction] .
RESULTS
Data were available from 45 doctors (98%) and 857 patients (88%). [The number of problems identified in each consultation] increased by 0.2 (95% confidence interval 0.1 to 0.4) with the agenda form , by 0.3 (0.1 to 0.6) with education , and by 0.5 (0.3 to 0.7) with both interventions . [The time required to manage each problem] was not affected. [The duration of consultations] with the agenda form was increased by 0.9 minutes (0.3 to 1.5 minutes) and with the combined intervention by 1.9 minutes (1.0 to 2.8 minutes). [Patient satisfaction with the depth of the doctor-patient relationship] was increased with the agenda form . [The occurrence of "by the way" presentations] did not change.
CONCLUSION
A patient completed agenda form before the consultation or general practitioner education about the agenda form , or both , enabled [the identification of more problems in consultations] even though consultations were longer.
------------------- bmj16707509.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jun 17;332(7555):1454. BMJ. 2006 May 27;332(7552):1223-4.
Management of miscarriage: expectant , medical , or surgical ? Results of randomised controlled trial (miscarriage treatment (MIST) trial).
Trinder J Brocklehurst P Porter R Read M Vyas S Smith L.
Southmead Hospital, Westbury-on-Trym, Bristol BS10 5NB.
jo.trinder@bristol.ac.uk
OBJECTIVE
To ascertain whether a clinically important difference exists in [the incidence of gynaecological infection] between surgical management and expectant or medical management of miscarriage .
DESIGN
Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage.
SETTING
Early pregnancy assessment units of seven hospitals in the United Kingdom.
PARTICIPANTS
Women of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage.
INTERVENTIONS
Expectant management ( no specific intervention ) ; medical management ( vaginal dose of misoprostol preceded, for women with early fetal demise, by oral mifepristone 24-48 hours earlier ) ; surgical management ( surgical evacuation ) .
MAIN OUTCOME MEASURES
[Confirmed gynaecological infection] at 14 days and eight weeks ; [need for unplanned admission] or [surgical intervention] .
RESULTS
1200 women were recruited: 399 to expectant management , 398 to medical management , and 403 to surgical management . No differences were found in [the incidence of confirmed infection] within 14 days between the expectant group (3%) and the surgical group (3%) (risk difference 0.2%, 95% confidence interval - 2.2% to 2.7%) or between the medical group (2%) and the surgical group (0.7%, - 1.6% to 3.1%). Compared with the surgical group , [the number of unplanned hospital admissions] was significantly higher in both the expectant group (risk difference - 41%, - 47% to - 36%) and the medical group (- 10%, - 15% to - 6%). Similarly, when compared with the surgical group , [the number of women who had an unplanned surgical curettage] was significantly higher in the expectant group (risk difference - 39%, - 44% to - 34%) and the medical group (- 30%, - 35% to - 25%).
CONCLUSIONS
[The incidence of gynaecological infection] after surgical , expectant , and medical management of first trimester miscarriage is low (2-3%), and no evidence exists of a difference by the method of management. However, [significantly more unplanned admissions] and [unplanned surgical curettage] occurred after expectant management and medical management than after surgical management .
TRIAL REGISTRATION NATIONAL RESEARCH REGISTER
N0467011677/N0467073587.
------------------- bmj16720619.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jun 17;332(7555):1418.
BMJ. 2006 Jun 3;332(7553):1284-5. Nat Clin Pract Endocrinol Metab. 2006 Dec;2(12):658-9.
Randomised controlled trial of four commercial weight loss programmes in the UK: initial findings from the BBC "diet trials".
Truby H Baic S deLooy A Fox KR Livingstone MB Logan CM Macdonald IA Morgan LM Taylor MA Millward DJ.
School of Biomedical and Molecular Sciences, Centre for Nutrition, Dietetics and Food, University of Surrey, Guildford GU2 7XH.
h.truby@surrey.ac.uk
OBJECTIVE
To compare the effectiveness of four commercial weight loss diets available to adults in the United Kingdom.
DESIGN
Six month multicentre randomised unblinded controlled trial.
SETTING
Community based sample of otherwise healthy overweight and obese adults.
INTERVENTIONS
Dr Atkins' new diet revolution , Slim-Fast plan , Weight Watchers pure points programme , and Rosemary Conley's eat yourself slim diet and fitness plan .
MAIN OUTCOME MEASURES
[Weight] and [body fat changes] over six months .
RESULTS
All diets resulted in [significant loss of body fat] and [weight] over six months . Groups did not differ significantly but [loss of body fat] and [weight] was greater in all groups compared with the control group . In an intention to treat analysis, [average weight loss] was 5.9 kg and [average fat loss] was 4.4 kg over six months. The Atkins diet resulted in [significantly higher weight loss] during the first four weeks , but by the end was no more or less effective than the other diets.
CONCLUSIONS
[Clinically useful weight loss] and [fat loss] can be achieved in adults who are motivated to follow commercial diets for a substantial period. Given the limited resources for weight management in the NHS, healthcare practitioners should discuss with their patients programmes known to be effective.
TRIAL REGISTRATION
Clinical trials NCT00327821.
------------------- bmj16735333.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Evid Based Ment Health. 2007 Feb;10(1):19.
Effect of telephone contact on [further suicide attempts] in patients discharged from an emergency department: randomised controlled study.
Vaiva G Vaiva G Ducrocq F Meyer P Mathieu D Philippe A Libersa C Goudemand M.
University Hospital of Lille, School of Medicine, France.
gvaiva@chru-lille.fr
OBJECTIVE
To determine the effects over one year of contacting patients by telephone one month or three months after being discharged from an emergency department for deliberate self poisoning compared with usual treatment .
DESIGN
Multicentre, randomised controlled trial.
SETTING
13 emergency departments in the north of France.
PARTICIPANTS
605 people discharged from an emergency department after attempted suicide by deliberate self poisoning.
INTERVENTION
The intervention consisted of contacting patients by telephone at one month or three months after discharge from an emergency department for attempted suicide to evaluate the success of recommended treatment or to adjust treatment. Control patients received treatment as usual , in most cases referral back to their general practitioner .
MAIN OUTCOME MEASURES
The primary outcome measures were [proportion of participants who reattempted suicide] , [number of deaths by suicide] , and [losses to follow-up] at 13 months' follow-up . Secondary outcome measures were [types and number of contacts with health care] .
RESULTS
On an intention to treat basis, the three groups did not differ significantly for [further suicide attempts] , [deaths by suicide] , or [losses to follow-up] : contact at one month ( intervention 23% (34/147) v controls 30% (93/312), difference 7%, 95% confidence interval - 2% to 15%), three months (25% (36/146) v 30%, difference 5%, - 4% to 14%). Participants contacted at one month were less likely at follow-up to report [having reattempted suicide] (12% v 22% in control group , difference 10%, 2% to 18%).
CONCLUSION
Contacting people by telephone one month after being discharged from an emergency department for deliberate self poisoning may help [reduce the number of reattempted suicides] over one year.
------------------- bmj16735334.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Effective control of dengue vectors with curtains and water container covers treated with insecticide in Mexico and Venezuela: cluster randomised trials.
Kroeger A Lenhart A Ochoa M Villegas E Levy M Alexander N McCall PJ.
Special Programme for Research and Training in Tropical Medicine (TDR/WHO), World Health Organization, Geneva, Switzerland.
kroegera@who.int
OBJECTIVES
To measure the impact on the dengue vector population (Aedes aegypti) and disease transmission of window curtains and water container covers treated with insecticide.
DESIGN
Cluster randomised controlled trial based on entomological surveys and, for Trujillo only, serological survey. In addition, each site had a non-randomised external control.
SETTING
18 urban sectors in Veracruz (Mexico) and 18 in Trujillo (Venezuela).
PARTICIPANTS
4743 inhabitants (1095 houses) in Veracruz and 5306 inhabitants (1122 houses) in Trujillo.
INTERVENTION
Sectors were paired according to entomological indices, and one sector in each pair was randomly allocated to receive treatment. In Veracruz, the intervention comprised curtains treated with lambdacyhalothrin and water treatment with pyriproxyfen chips (an insect growth regulation) . In Trujillo, the intervention comprised curtains treated with longlasting deltamethrin ( PermaNet ) plus water jar covers of the same material . Follow-up surveys were conducted at intervals, with the final survey after 12 months in Veracruz and nine months in Trujillo.
MAIN OUTCOME MEASURES
[Reduction in entomological indices] , specifically [the Breteau] and [house indices] .
RESULTS
In both study sites, indices at the end of the trial were significantly lower than those at baseline , though with no significant differences between control and intervention arms. [The mean Breteau index] dropped from 60% (intervention clusters) and 113% ( control ) to 7% ( intervention ) and 12% ( control ) in Veracruz and from 38% to 11% ( intervention ) and from 34% to 17% ( control ) in Trujillo. [The pupae per person] and [container indices] showed similar patterns. In contrast, in nearby communities not in the trial [the entomological indices] followed the rainfall pattern. The intervention reduced [mosquito populations] in neighbouring control clusters (spill-over effect); and houses closer to treated houses were less likely to have infestations than those further away. This created a community effect whereby [mosquito numbers] were reduced throughout the study site. The observed effects were probably associated with the use of materials treated with insecticide at both sites because in Veracruz, people did not accept and use the pyriproxyfen chips .
CONCLUSION
Window curtains and domestic water container covers treated with insecticide can reduce [densities of dengue vectors] to low levels and potentially affect dengue transmission.
------------------- bmj16740528.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Aug 12;333(7563):339.
BMJ. 2006 Jun 17;332(7555):1401-2. Evid Based Nurs. 2007 Jan;10(1):23.
Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis.
Iglesias C Nixon J Cranny G Nelson EA Hawkins K Phillips A Torgerson D Mason S Cullum N; PRESSURE Trial Group.
Department of Health Sciences, University of York, York YO10 5DD.
OBJECTIVE
To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital.
DESIGN
Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial.
SETTING
11 hospitals in six UK NHS trusts.
PARTICIPANTS
Intention to treat population comprising 1971 participants.
MAIN OUTCOME MEASURES
Kaplan Meier estimates of [restricted mean time to development of pressure ulcers] and [total costs for treatment in hospital] .
RESULTS
Alternating pressure mattresses were associated with [lower overall costs] (283.6 pounds sterling per patient on average, 95% confidence interval--377.59 pounds sterling to 976.79 pounds sterling) mainly due to [reduced length of stay in hospital] , and [greater benefits] ( [a delay in time to ulceration] of 10.64 days on average,--24.40 to 3.09). The differences in [health benefits] and [total costs] for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, [a cost effectiveness acceptability curve] indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with an 80% probability of being cost saving.
CONCLUSION
Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays .
------------------- bmj16740529.xml ---------------------------
Comparative Study Randomized Controlled Trial
Effect of off-pump coronary artery bypass surgery on [clinical] , [angiographic] , [neurocognitive] , and [quality of life outcomes] : randomised controlled trial.
Al-Ruzzeh S George S Bustami M Wray J Ilsley C Athanasiou T Amrani M.
National Heart and Lung Institute, Imperial College of Science, Technology, and Medicine, Harefield Hospital, Middlesex UB9 6JH.
OBJECTIVE
To compare the [clinical] , [angiographic] , [neurocognitive] , and [quality of life outcomes] of off-pump coronary artery bypass surgery with conventional coronary artery bypass grafting surgery using cardiopulmonary bypass .
DESIGN
Randomised controlled clinical trial.
SETTING
Tertiary cardiothoracic centre in Middlesex, England.
PARTICIPANTS
168 patients (27 women) requiring primary isolated coronary artery bypass grafting surgery.
INTERVENTIONS
Patients were randomised to conventional coronary artery bypass grafting surgery using cardiopulmonary bypass (n = 84) or off-pump coronary artery bypass surgery (n = 84), carried out by one surgeon . Angiographic examination was carried out at three months postoperatively. Neurocognitive tests were carried out at baseline and at six weeks and six months postoperatively.
MAIN OUTCOME MEASURES
[Clinical outcome] , [graft patency] at three months , [neurocognitive function] at six weeks and six months , and [health related quality of life] .
RESULTS
[Graft patency] was evaluated by angiography in 151 (89.9%) patients and was similar between the cardiopulmonary bypass and off-pump groups (risk difference - 1%, 95% confidence interval - 5% to 4%), with the off-pump group considered the treatment group . Patients in the off-pump group required [fewer blood transfusions] (1.7 units v 1.0 unit, P = 0.02), [shorter duration of mechanical ventilation] (7.7 hours v 3.9 hours, P = 0.03), and [shorter hospital stay] (10.8 days v 8.9 days). Scores for [neurocognitive function] showed a significant difference in three memory subtests at six weeks and two memory subtests at six months in favour of the off-pump group .
CONCLUSIONS
Patients who underwent off-pump coronary artery bypass surgery showed [similar patency of grafts] , [better clinical outcome] , [shorter hospital stay] , and [better neurocognitive function] than patients who underwent conventional coronary artery bypass grafting surgery using cardiopulmonary bypass .
------------------- bmj16740530.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jul 1;333(7557):30.
BMJ. 2006 Jun 17;332(7555):1401-2. Evid Based Nurs. 2007 Jan;10(1):22.
Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial.
Nixon J Cranny G Iglesias C Nelson EA Hawkins K Phillips A Torgerson D Mason S Cullum N.
Clinical Trials Research Unit, University of Leeds.
OBJECTIVE
To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in [the development of new pressure ulcers] , [healing of existing pressure ulcers] , and [patient acceptability] .
DESIGN
Pragmatic, open, multicentre, randomised controlled trial.
SETTING
11 hospitals in six NHS trusts.
PARTICIPANTS
1972 people admitted to hospital as acute or elective patients.
INTERVENTIONS
Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990).
MAIN OUTCOME MEASURES
[The proportion of participants developing a new pressure ulcer of grade 2 or worse] ; [time to development of new pressure ulcers] ; [proportions of participants developing a new ulcer within 30 days] ; [healing of existing pressure ulcers] ; and [patient acceptability] .
RESULTS
Intention to treat analysis found no difference in [the proportions of participants developing a new pressure ulcer of grade 2 or worse] (10.7% overlay patients , 10.3% mattress patients ; difference 0.4%, 95% confidence interval--2.3% to 3.1%, P = 0.75). More overlay patients [requested change] owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02).
CONCLUSION
No difference was found between alternating pressure mattresses and alternating pressure overlays in [the proportion of people who develop a pressure ulcer] .
TRIAL REGISTRATION
ISRCTN 78646179.
------------------- bmj16763247.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jun 10;332(7554):1358.
Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study.
el Moussaoui R de Borgie CA van den Broek P Hustinx WN Bresser P van den Berk GE Poley JW van den Berg B Krouwels FH Bonten MJ Weenink C Bossuyt PM Speelman P Opmeer BC Prins JM.
Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, Netherlands.
OBJECTIVE
To compare the effectiveness of discontinuing treatment with amoxicillin after three days or eight days in adults admitted to hospital with mild to moderate-severe community acquired pneumonia who substantially improved after an initial three days' treatment.
DESIGN
Randomised, double blind, placebo controlled non-inferiority trial.
SETTING
Nine secondary and tertiary care hospitals in the Netherlands.
PARTICIPANTS
Adults with mild to moderate-severe community acquired pneumonia (pneumonia severity index score < or = 110).
INTERVENTIONS
Patients who had substantially improved after three days' treatment with intravenous amoxicillin were randomly assigned to oral amoxicillin (n = 63) or placebo (n = 56) three times daily for five days .
MAIN OUTCOME MEASURES
The primary outcome measure was [the clinical success rate] at day 10 . Secondary outcome measures were [the clinical success rate] at day 28 , [symptom resolution] , [radiological success rates] at days 10 and 28 , and [adverse events] .
RESULTS
Baseline characteristics were comparable, with the exception of symptom severity, which was worse in the three day treatment group . In the three day and eight day treatment groups [the clinical success rate] at day 10 was 93% for both (difference 0.1%, 95% confidence interval--9% to 10%) and at day 28 was 90% compared with 88% (difference 2.0%,--9% to 15%). Both groups had [similar resolution of symptoms] . [Radiological success rates] were 86% compared with 83% at day 10 (difference 3%,--10% to 16%) and 86% compared with 79% at day 28 (difference 6%,--7% to 20%). Six patients (11%) in the placebo group and 13 patients (21%) in the active treatment group reported [adverse events] (P = 0.1).
CONCLUSIONS
Discontinuing amoxicillin treatment after three days is not inferior to discontinuing it after eight days in adults admitted to hospital with mild to moderate-severe community acquired pneumonia who substantially improved after an initial three days' treatment.
------------------- bmj16769748.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial
BMJ. 2006 Jun 24;332(7556):1461-2.
Effect of clomifene citrate plus metformin and clomifene citrate plus placebo on [induction of ovulation] in women with newly diagnosed polycystic ovary syndrome: randomised double blind clinical trial.
Moll E Bossuyt PM Korevaar JC Lambalk CB van der Veen F.
Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Academic Medical Centre, PO Box 22700, 1100 DE, Amsterdam, Netherlands.
e.moll@amc.uva.nl
OBJECTIVE
To compare the effectiveness of clomifene citrate plus metformin and clomifene citrate plus placebo in women with newly diagnosed polycystic ovary syndrome.
DESIGN
Randomised clinical trial.
SETTING
Multicentre trial in 20 Dutch hospitals.
PARTICIPANTS
228 women with polycystic ovary syndrome.
INTERVENTIONS
Clomifene citrate plus metformin or clomifene citrate plus placebo .
MAIN OUTCOME MEASURE
The primary outcome measure was [ovulation] . Secondary outcome measures were [ongoing pregnancy] , [spontaneous abortion] , and [clomifene resistance] .
RESULTS
111 women were allocated to clomifene citrate plus metformin ( metformin group ) and 114 women were allocated to clomifene citrate plus placebo ( placebo group ). [The ovulation rate] in the metformin group was 64% compared with 72% in the placebo group , a non-significant difference (risk difference - 8%, 95% confidence interval - 20% to 4%). There were no significant differences in either [rate of ongoing pregnancy] (40% v 46%; - 6%, - 20% to 7%) or [rate of spontaneous abortion] (12% v 11%; 1%, - 7% to 10%). A significantly larger proportion of women in the metformin group [discontinued treatment] because of side effects (16% v 5%; 11%, 5% to 16%).
CONCLUSION
Metformin is not an effective addition to clomifene citrate as the primary method of inducing ovulation in women with polycystic ovary syndrome.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN55906981 [controlled-trials.com].
------------------- bmj16777857.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jun 24;332(7556):1463-4.
Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial.
Atroshi I Larsson GU Ornstein E Hofer M Johnsson R Ranstam J.
Department of Orthopaedics, Hassleholm and Kristianstad Hospitals, SE-281 25 Hassleholm, Sweden.
Isam.Atroshi@skane.se
OBJECTIVES
To compare endoscopic and open carpal tunnel release surgery among employed patients with carpal tunnel syndrome.
DESIGN AND SETTING
Randomised controlled trial at a single orthopaedic department.
PARTICIPANTS
128 employed patients aged 25-60 years with clinically diagnosed and electrophysiologically confirmed idiopathic carpal tunnel syndrome.
MAIN OUTCOME MEASURES
The primary outcome was {[severity of postoperative pain] in the scar or proximal palm} and [the degree to which pain or tenderness limits activities] , each rated on a 4 point scale, transformed into a combined score of 0 (none) to 100 ( [severe pain] or [tenderness causing severe activity limitation] ). The secondary outcomes were [length of postoperative work absence] , [severity of symptoms of carpal tunnel syndrome] and [functional status scores] , [SF-12 quality of life score] , and [hand sensation] and [strength] (blinded examiner); follow-up at three and six weeks and three and 12 months .
RESULTS
63 patients were allocated to endoscopic surgery and 65 patients to open surgery , with no withdrawals or dropouts. {[Pain in the scar] or [proximal palm]} was less prevalent or severe after endoscopic surgery than after open surgery but the differences were generally small. At three months , [pain in the scar or palm] was reported by 33 patients (52%) in the endoscopic group and 53 patients (82%) in the open group (number needed to treat 3.4, 95% confidence interval 2.3 to 7.7) and the mean score difference for [severity of pain in scar or palm] and [limitation of activity] was 13.3 (5.3 to 21.3). No differences between the groups were found in [the other outcomes] . [The median length of work absence after surgery] was 28 days in both groups. [Quality of life measures] improved substantially.
CONCLUSIONS
In carpal tunnel syndrome, endoscopic surgery was associated with [less postoperative pain] than open surgery , but the small size of the benefit and similarity in [other outcomes] make its cost effectiveness uncertain.
------------------- bmj16790460.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jul 15;333(7559):105.
Effect on [weight gain] of routinely giving albendazole to preschool children during child health days in Uganda: cluster randomised controlled trial.
Alderman H Konde-Lule J Sebuliba I Bundy D Hall A.
World Bank, Washington, DC 20433, USA.
halderman@worldbank.org
OBJECTIVE
To estimate the effectiveness of delivering an anthelmintic through a community child health programme on [the weight gain] of preschool children in Uganda.
DESIGN
Cluster randomised controlled trial.
SETTING
Eastern Uganda.
PARTICIPANTS
48 parishes participating in a new programme for child health: 24 offered children an additional service of anthelmintic treatment. The outcome is based on measurements from 27,995 children.
INTERVENTION
Treatment of children aged between 1 and 7 years with 400 mg albendazole added to standard services offered during child health days over a three year period.
MAIN OUTCOME MEASURE
[Weight gain] .
RESULTS
The provision of periodic anthelmintic treatment as a part of child health services in Uganda resulted in an increase in [weight gain] of about 10% (166 g per child per year, 95% confidence interval 16 to 316) above expected weight gain when treatments were given twice a year, and an increase of 5% when the treatment was given annually.
CONCLUSION
Deworming of preschool children in Uganda as part of regularly scheduled health services seems practical and associated with [increased weight gain] .
------------------- bmj16793810.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial.
Juul AB Wetterslev J Gluud C Kofoed-Enevoldsen A Jensen G Callesen T Norgaard P Fruergaard K Bestle M Vedelsdal R Miran A Jacobsen J Roed J Mortensen MB Jorgensen L Jorgensen J Rovsing ML Petersen PL Pott F Haas M Albret R Nielsen LL Johansson G Stjernholm P Molgaard Y Foss NB Elkjaer J Dehlie B Boysen K Zaric D Munksgaard A Madsen JB Oberg B Khanykin B Blemmer T Yndgaard S Perko G Wang LP Winkel P Hilden J Jensen P Salas N; DIPOM Trial Group.
Copenhagen Trial Unit, Centre for Clinical Intervention Research, H:S Rigshospitalet, Copenhagen University Hospital, Denmark.
anne.j@ctu.rh.dk
OBJECTIVES
To evaluate the long term effects of perioperative beta blockade on [mortality] and [cardiac morbidity] in patients with diabetes undergoing major non-cardiac surgery.
DESIGN
Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat.
SETTING
University anaesthesia and surgical centres and one coordinating centre.
PARTICIPANTS
921 patients aged > 39 scheduled for major non-cardiac surgery.
INTERVENTIONS
100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days.
MAIN OUTCOME MEASURES
The composite primary outcome measure was {[time to all cause mortality] , [acute myocardial infarction] , [unstable angina] , or [congestive heart failure]} . Secondary outcome measures were [time to all cause mortality] , [cardiac mortality] , and [non-fatal cardiac morbidity] .
RESULTS
[Mean duration of intervention] was 4.6 days in the metoprolol group and 4.9 days in the placebo group . Metoprolol significantly reduced [the mean heart rate] by 11% (95% confidence interval 9% to 13%) and [mean blood pressure] by 3% (1% to 5%). [The primary outcome] occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459 patients in the placebo group (20%) (hazard ratio 1.06, 0.80 to 1.41) during a median follow-up of 18 months (range 6-30). [All cause mortality] was 16% (74/462) in the metoprolol group and 16% (72/459) in the placebo group (1.03, 0.74 to 1.42). The difference in risk for the proportion of patients with [serious adverse events] was 2.4% (- 0.8% to 5.6%).
CONCLUSIONS
Perioperative metoprolol did not significantly affect [mortality] and [cardiac morbidity] in these patients with diabetes. Confidence intervals, however, were wide, and the issue needs reassessment.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN58485613.
------------------- bmj16803941.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Aug 5;333(7562):304-5. BMJ. 2006 Aug 5;333(7562):305. BMJ. 2006 Jul 22;333(7560):158-9. BMJ. 2006 Jul 22;333(7560):173-4.
Improving women's experience during speculum examinations at routine gynaecological visits: randomised clinical trial.
Seehusen DA Johnson DR Earwood JS Sethuraman SN Cornali J Gillespie K Doria M Farnell E 4th Lanham J.
Department of Family and Community Medicine, Eisenhower Army Medical Center, Fort Gordon, GA 30905, USA.
dseehusen@msn.com
OBJECTIVES
To determine if a standardised method of leg positioning without stirrups reduces [the physical discomfort] and [sense of vulnerability] and increases [the sense of control] among women undergoing speculum examination as part of a routine gynaecological examination.
DESIGN
Randomised clinical trial.
SETTING
Family medicine outpatient clinic.
PATIENTS
197 adult women undergoing routine gynaecological examination and cervical smear.
INTERVENTION
Examination with or without stirrups .
MAIN OUTCOME MEASURES
{Women's perceived levels of [physical discomfort]} , [sense of vulnerability] , and [sense of control during the examination] , measured on 100 mm visual analogue scales.
RESULTS
Women undergoing examination without stirrups had a reduction in [mean sense of vulnerability] from 23.6 to 13.1 (95% confidence interval of the difference - 16.6 to - 4.4). [Mean physical discomfort] was reduced from 30.4 to 17.2 (- 19.7 to - 6.8). There was no significant reduction in [sense of loss of control] .
CONCLUSION
Women should be able to have gynaecological examinations without using stirrups to reduce [the stress associated with speculum examinations] .
TRIAL REGISTRATION
US Army Central Investigation Regulatory Office. Trial No DDEAMC 05-11.
------------------- bmj16807257.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jul 15;333(7559):108-9.
Effectiveness and acceptability of lidocaine spray in reducing [perineal pain during spontaneous vaginal delivery] : randomised controlled trial.
Sanders J Campbell R Peters TJ.
Department of Social Medicine, University of Bristol, Bristol BS8 2PR.
julia.sanders@cardiffandvale.wales.nhs.uk
OBJECTIVES
To evaluate the effectiveness and acceptability of a lidocaine spray in reducing [perineal pain during spontaneous vaginal delivery] .
DESIGN
Randomised controlled trial.
SETTING
Consultant led obstetric unit.
PARTICIPANTS
185 women who had a spontaneous vaginal delivery without epidural analgesia.
INTERVENTIONS
Topically applied local anaesthetic spray (93 women) and placebo spray (92 women).
MAIN OUTCOME MEASURE
Primary outcome measure was [pain during delivery] (0-100 scale). The 16 secondary outcome measures included [second degree perineal trauma during delivery] , [trauma of the genital tract] , and [dyspareunia by two months] .
RESULTS
Lidocaine spray did not reduce [pain during spontaneous vaginal delivery] : mean 77 and 72 on a scale of 0-100 in the lidocaine and placebo groups, respectively (difference between means 4.8, 95% confidence interval -1.7 to 11.2). Lidocaine spray may reduce [genital tract trauma during delivery] , in particular [second degree perineal trauma] . The intervention was highly acceptable to the women and midwives.
CONCLUSIONS
Although lidocaine spray applied to the perineum during spontaneous vaginal delivery did not reduce [perineal pain] , it was acceptable to both the women and the midwives.
TRIAL REGISTRATION
Current controlled trials ISRCTN99732966 [controlled-trials.com].
------------------- bmj16847013.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 2;333(7566):468.
BMJ. 2006 Aug 12;333(7563):311-2. BMJ. 2006 Aug 26;333(7565):446. BMJ. 2006 Aug 26;333(7565):446-7. Evid Based Nurs. 2007 Jan;10(1):10. J Fam Pract. 2006 Dec;55(12):1031. J Pediatr. 2007 Jan;150(1):114-5.
A randomised controlled trial of management strategies for acute infective conjunctivitis in general practice.
Everitt HA Little PS Smith PW.
Primary Medical Care, University of Southampton, Aldermoor Health Centre, Southampton SO16 5ST.
hae1@soton.ac.uk
OBJECTIVE
To assess different management strategies for acute infective conjunctivitis.
DESIGN
Open, factorial, randomised controlled trial.
SETTING
30 general practices in southern England.
PARTICIPANTS
307 adults and children with acute infective conjunctivitis.
INTERVENTION
One of three antibiotic prescribing strategies- immediate antibiotics ( chloramphenicol eye drops ; n = 104) , no antibiotics ( controls ; n = 94) , or delayed antibiotics (n = 109); a patient information leaflet or not ; and an eye swab or not .
MAIN OUTCOME MEASURES
[Severity of symptoms on days 1-3 after consultation] , [duration of symptoms] , and [belief in the effectiveness of antibiotics for eye infections] .
RESULTS
Prescribing strategies did not affect [the severity of symptoms] but [duration of moderate symptoms] was less with antibiotics : no antibiotics ( controls ) 4.8 days, immediate antibiotics 3.3 days (risk ratio 0.7, 95% confidence interval 0.6 to 0.8), delayed antibiotics 3.9 days (0.8, 0.7 to 0.9). Compared with no initial offer of antibiotics , [antibiotic use] was higher in the immediate antibiotic group : controls 30%, immediate antibiotics 99% (odds ratio 185.4, 23.9 to 1439.2), delayed antibiotics 53% (2.9, 1.4 to 5.7), as was [belief in the effectiveness of antibiotics] : controls 47%, immediate antibiotics 67% (odds ratio 2.4, 1.1 to 5.0), delayed antibiotics 55% (1.4, 0.7 to 3.0), and [intention to reattend for eye infections] : controls 40%, immediate antibiotics 68% (3.2, 1.6 to 6.4), delayed antibiotics 41% (1.0, 0.5 to 2.0). A patient information leaflet or eye swab had no effect on [the main outcomes] . [Reattendance within two weeks] was less in the delayed compared with immediate antibiotic group : 0.3 (0.1 to 1.0) v 0.7 (0.3 to 1.6).
CONCLUSIONS
Delayed prescribing of antibiotics is probably the most appropriate strategy for managing acute conjunctivitis in primary care. It reduces [antibiotic use] , shows no evidence of medicalisation, provides similar [duration] and [severity of symptoms] to immediate prescribing , and reduces [reattendance for eye infections] .
TRIAL REGISTRATION
Current Controlled Trials ISRCTN32956955 [controlled-trials.com].
------------------- bmj16847014.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Jul 29;333(7561):209-10. Nat Clin Pract Urol. 2007 Apr;4(4):186-7.
Ned Tijdschr Geneeskd. 2007 Jun 16;151(24):1352-60.
Comparison of laparoscopic and mini incision open donor nephrectomy : single blind, randomised controlled clinical trial.
Kok NF Lind MY Hansson BM Pilzecker D Mertens zur Borg IR Knipscheer BC Hazebroek EJ Dooper IM Weimar W Hop WC Adang EM van der Wilt GJ Bonjer HJ van der Vliet JA IJzermans JN.
Department of Surgery, Erasmus MC, PO Box 2040, 3000 CA Rotterdam, Netherlands.
OBJECTIVES
To determine the best approach for live donor nephrectomy to minimise [discomfort to the donor] and to provide [good graft function] .
DESIGN
Single blind, randomised controlled trial.
SETTING
Two university medical centres, the Netherlands.
PARTICIPANTS
100 living kidney donors.
INTERVENTIONS
Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy .
MAIN OUTCOME MEASURES
The primary outcome was {[physical fatigue] using the multidimensional fatigue inventory 20 (MFI-20)} . Secondary outcomes were {[physical function] using the SF-36} , [hospital stay after surgery] , [pain] , [operating times] , [recipient graft function] , and [graft survival] .
RESULTS
Conversions did not occur. Compared with mini incision open donor nephrectomy , laparoscopic donor nephrectomy resulted in [longer skin to skin time] (median 221 v 164 minutes, P < 0.001), [longer warm ischaemia time] (6 v 3 minutes, P < 0.001), [less blood loss] (100 v 240 ml, P < 0.001), and [a similar number of complications] (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy , donors required [less morphine] (16 v 25 mg, P = 0.005) and [shorter hospital stay] (3 v 4 days, P = 0.003). During one year's follow-up [mean physical fatigue] was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and [physical function] was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy . [Function of the graft] and [graft survival rate of the recipient] at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy ).
CONCLUSIONS
Laparoscopic donor nephrectomy results in [a better quality of life] compared with mini incision open donor nephrectomy but equal [safety] and [graft function] .
------------------- bmj16861254.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
A cost effectiveness analysis within a randomised controlled trial of post-acute care of older people in a community hospital .
O'Reilly J Lowson K Young J Forster A Green J Small N.
York Health Economics Consortium, University of York, Heslington, York YO10 5NH.
OBJECTIVE
To assess [the cost effectiveness] of post-acute care for older people in a locality based community hospital compared with a department for care of elderly people in a district general hospital , which admits patients aged over 76 years with acute medical conditions.
DESIGN
Cost effectiveness analysis within a randomised controlled trial.
SETTING
Community hospital and district general hospital in Yorkshire, England.
PARTICIPANTS
220 patients needing rehabilitation after an acute illness for which they required admission to hospital.
INTERVENTIONS
Multidisciplinary care in the district general hospital or prompt transfer to the community hospital .
MAIN OUTCOME MEASURES
[EuroQol EQ-5D scores] transformed into {[quality adjusted life years] ( [QALYs] )} , and [health and social service costs over six months from randomisation] .
RESULTS
[The mean QALY score] for the community hospital group was marginally non-significantly higher than that for the district general hospital group (0.38 v 0.35) at six months after recruitment . The mean (standard deviation) [costs per patient of the health and social services resources] used were similar for both groups: community hospital group 7233 pounds sterling (euros 10,567; 13,341 dollars) (5031 pounds sterling), district general hospital group 7351 pounds sterling(6229 pounds sterling), and these findings were robust to several sensitivity analyses. [The incremental cost effectiveness ratio] for community hospital care dominated. [A cost effectiveness acceptability curve] , based on bootstrapped simulations, suggests that at [a willingness to pay threshold] of 10,000 pounds sterling per QALY, 51% of community hospital cases will be cost effective, which rises to 53% of cases when the threshold is 30,000 pounds sterling per QALY.
CONCLUSION
Post-acute care for older people in a locality based community hospital is of similar [cost effectiveness] to that of an elderly care department in a district general hospital .
------------------- bmj16861255.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Aug 12;333(7563):313-4. BMJ. 2006 Aug 26;333(7565):448.
Prevention of [postoperative nausea and vomiting] by metoclopramide combined with dexamethasone : randomised double blind multicentre trial.
Wallenborn J Gelbrich G Bulst D Behrends K Wallenborn H Rohrbach A Krause U Kuhnast T Wiegel M Olthoff D.
Department of Anaesthesiology and Intensive Care Medicine, University of Leipzig, D-04103 Leipzig, Germany.
OBJECTIVES
To determine whether 10 mg , 25 mg , or 50 mg metoclopramide combined with 8 mg dexamethasone , given intraoperatively, is more effective in preventing [postoperative nausea and vomiting] than 8 mg dexamethasone alone , and to assess benefit in relation to [adverse drug reactions] .
DESIGN
Four-armed, parallel group, double blind, randomised controlled clinical trial.
SETTING
Four clinics of a university hospital and four district hospitals in Germany.
PARTICIPANTS
3140 patients who received balanced or regional anaesthesia during surgery.
MAIN OUTCOME MEASURES
{[Postoperative nausea and vomiting] within 24 hours of surgery} (primary end point); [occurrence of adverse reactions] .
RESULTS
{Cumulative incidences (95% confidence intervals) of [postoperative nausea and vomiting]} were 23.1% (20.2% to 26.0%), 20.6% (17.8% to 23.4%), 17.2% (14.6% to 19.8%), and 14.5% (12.0% to 17.0%) for 0 mg , 10 mg , 25 mg , and 50 mg metoclopramide . In the secondary analysis, 25 mg and 50 mg metoclopramide were equally effective at [preventing early nausea] (0-12 hours), but only 50 mg reduced [late nausea and vomiting] (> 12 hours). The most frequent adverse drug reactions were [hypotension] and [tachycardia] , with cumulative incidences of 8.8% (6.8% to 10.8%), 11.2% (9.0% to 13.4%), 12.9% (10.5% to 15.3%), and 17.9% (15.2% to 20.6%) for 0 mg , 10 mg , 25 mg , and 50 mg metoclopramide .
CONCLUSION
The addition of 50 mg metoclopramide to 8 mg dexamethasone (given intraoperatively) is an effective, safe, and cheap way to prevent [postoperative nausea and vomiting] . A reduced dose of 25 mg metoclopramide intraoperatively , with additional postoperative prophylaxis in high risk patients, may be equally effective and cause [fewer adverse drug reactions] .
TRIAL REGISTRATION
Current Controlled Trials ISRCTN31625370 [controlled-trials.com].
------------------- bmj16877454.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 2;333(7566):460.
Effects of psychosocial stimulation and dietary supplementation in early childhood on {[psychosocial functioning] in late adolescence} : follow-up of randomised controlled trial.
Walker SP Chang SM Powell CA Simonoff E Grantham-McGregor SM.
Epidemiology Research Unit, Tropical Medicine Research Institute, University of the West Indies, Mona, Kingston 7, Jamaica.
susan.walker@uwimona.edu.jm
OBJECTIVE
To determine whether dietary supplementation or psychosocial stimulation given to growth retarded (stunted) children age 9-24 months has long term benefits for their {[psychosocial functioning] in late adolescence} .
DESIGN
Sixteen year follow-up study of a randomised controlled trial.
SETTING
Poor neighbourhoods in Kingston, Jamaica.
PARTICIPANTS
Of 129 stunted children identified at age 9-24 months, 103 adolescents aged 17-18 were followed up.
INTERVENTION
Supplementation with 1 kg milk based formula each week or psychosocial stimulation ( weekly play sessions with mother and child ) , or both , for two years.
MAIN OUTCOME MEASURES
[Anxiety] , [depression] , [self esteem] , and {[antisocial behaviour] assessed by questionnaires administered by interviewers} ; [attention deficit] , [hyperactivity] , and {[oppositional behaviour] assessed by interviews with parents} .
RESULTS
Primary analysis indicated that participants who received stimulation had significantly different [overall scores] from those who did not (F = 2.047, P = 0.049). Supplementation had no significant effect (F = 1.505, P = 0.17). Participants who received stimulation reported [less anxiety] (mean difference - 2.81, 95% confidence interval - 5.02 to - 0.61), [less depression] (- 0.43, - 0.78 to - 0.07), and [higher self esteem] (1.55, 0.08 to 3.02) and parents reported [fewer attention problems] (- 3.34, - 6.48 to - 0.19). These differences are equivalent to effect sizes of 0.40-0.49 standard deviations.
CONCLUSIONS
Stimulation in early childhood has sustained benefits to stunted children's [emotional outcomes] and [attention] .
------------------- bmj16885182.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 9;333(7567):507-8. Evid Based Nurs. 2007 Apr;10(2):57.
Safety and efficacy of routine postoperative ibuprofen for pain and disability related to [ectopic bone formation] after hip replacement surgery (HIPAID): randomised controlled trial.
Fransen M Anderson C Douglas J MacMahon S Neal B Norton R Woodward M Cameron ID Crawford R Lo SK Tregonning G Windolf M; HIPAID Collaborative Group.
The George Institute for International Health, University of Sydney, Australia.
mfransen@george.org.au
OBJECTIVES
To determine the benefits and risks of a non-steroidal anti-inflammatory drug ( NSAID ) as prophylaxis for [ectopic bone formation] in patients undergoing total hip replacement (or revision) surgery.
DESIGN
Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
SETTING
20 orthopaedic surgery centres in Australia and New Zealand.
PARTICIPANTS
902 patients undergoing elective primary or revision total hip replacement surgery.
INTERVENTION
14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
MAIN OUTCOME MEASURES
[Changes in self reported hip pain] and {[physical function] 6 to 12 months after surgery} (Western Ontario and McMaster University Arthritis index).
RESULTS
There were no significant differences between the groups for [improvements in hip pain] (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or [physical function] (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of [ectopic bone formation] (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen . There was a significantly increased risk of [major bleeding complication] s in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
CONCLUSIONS
These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
TRIAL REGISTRATION
NCT00145730.
------------------- bmj16891328.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 16;333(7568):563-4. Evid Based Med. 2007 Apr;12(2):41. Evid Based Nurs. 2007 Apr;10(2):43.
Effect of needle size on [immunogenicity] and [reactogenicity] of vaccines in infants: randomised controlled trial.
Diggle L Deeks JJ Pollard AJ.
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Department of Paediatrics, University of Oxford, Churchill Hospital, Oxford OX3 7LJ.
linda.diggle@paediatrics.ox.ac.uk
OBJECTIVES
To assess the immunogenicity of vaccines for infants and to investigate whether the incidence of [reactogenicity] is reduced after each immunisation dose using needles of varying lengths and gauges.
DESIGN
Randomised controlled trial.
SETTING
18 general practices within two UK primary care trusts.
PARTICIPANTS
696 healthy infants vaccinated at 2, 3, and 4 months of age, with follow-up to 5 months of age .
INTERVENTIONS
Combined diphtheria, tetanus, whole cell pertussis, and Haemophilus influenzae type b vaccine and a serogroup C meningococcal glycoconjugate vaccine administered using either a wide, long needle (23 gauge/0.6 mm diameter, 25 mm) , a narrow, short needle (25 gauge/0.5 mm diameter, 16 mm) , or a narrow, long needle (25 gauge, 25 mm) .
MAIN OUTCOME MEASURES
{[Local and general reactions] recorded by parents for three days after each dose} ; and [diphtheria] , [tetanus] , and [H influenzae type b antibody concentrations] and {functional antibody against serogroup C Neisseria meningitidis 28-42 days after the third dose} .
RESULTS
{[Local reactions] to diphtheria, tetanus, whole cell pertussis, H influenzae type b vaccinations} decreased significantly with wide, long needles compared with narrow, short needles . At all three doses one less infant experienced [local reactions] at days 1, 2, or 3 for every six to eight vaccinated. Significantly fewer infants vaccinated with the long needle experienced [severe local reactions] . [Non-inferiority of the immune response] was shown using a wide, long needle rather than a narrow, short needle for serogroup C meningococcal glycoconjugate vaccine and for diphtheria but not for H influenzae type b or tetanus, although no evidence was found of a decrease. Little difference was found between needles of the same length but different gauges in [local reaction] or [immune response] .
CONCLUSIONS
Long (25 mm) needles for infant immunisations can significantly reduce {[vaccine reactogenicity] at each dose} while achieving comparable [immunogenicity] to that of short (16 mm) needles. Trial registration Current Controlled Trials ISRCTN62032215 [controlled-trials.com].
------------------- bmj16895944.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 2;333(7566):455-6. Clin J Sport Med. 2007 Jul;17(4):332-3. J Pediatr. 2007 Mar;150(3):321.
Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial.
af Geijerstam JL Oredsson S Britton M; OCTOPUS Study Investigators.
Department of Medicine, Clinical Epidemiology Unit, Karolinska University Hospital, 171 76 Stockholm, Sweden.
jean-luc.af.geijerstam@ki.se
OBJECTIVE
To compare immediate computed tomography during triage for admission with observation in hospital in patients with mild head injury.
DESIGN
Multicentre, pragmatic, non-inferiority randomised trial.
SETTING
39 acute hospitals in Sweden.
PARTICIPANTS
2602 patients (aged > or = 6) with mild head injury.
INTERVENTIONS
Immediate computed tomography or admission for observation .
MAIN OUTCOME MEASURE
[Dichotomised extended Glasgow outcome scale] (1-7 v 8). The non-inferiority margin was 5 percentage points.
RESULTS
At three months , 275 patients (21.4%) in the computed tomography group had [not recovered completely] compared with 300 (24.2%) admitted for observation . The difference was - 2.8 percentage points, non-significantly in favour of computed tomography (95% confidence interval - 6.1% to 0.6%). [The worst outcomes] ( [mortality] and [more severe loss of function] ) were similar between the groups. In the patients admitted for observation , there was [a considerable delay in time to treatment] in those who required surgery. None of the patients with normal findings on immediate computed tomography had [complications later] . [Patients' satisfaction] with the two strategies was similar.
CONCLUSIONS
The use of computed tomography in the management of patients with mild head injury is feasible and leads to [similar clinical outcomes] compared with observation in hospital .
TRIAL REGISTRATION
ISRCTN81464462.
------------------- bmj16895945.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 2;333(7566):455-6.
Immediate computed tomography or admission for observation after mild head injury: cost comparison in randomised controlled trial.
Norlund A Marke LA af Geijerstam JL Oredsson S Britton M; OCTOPUS Study.
Department of Medicine, Clinical Epidemiology Unit, Karolinska University Hospital, 171 76 Stockholm, Sweden.
OBJECTIVE
To compare the costs of immediate computed tomography during triage for admission with those of observation in hospital in patients with mild head injury.
DESIGN
Prospective cost effectiveness analysis within a multicentre, pragmatic randomised trial.
SETTING
39 acute hospitals in Sweden PARTICIPANTS: 2602 patients (aged > or = 6) with mild head injury.
INTERVENTIONS
Immediate computed tomography or admission for observation .
MAIN OUTCOME MEASURES
{[Direct and indirect costs] related to the mild head injury during the acute and three month follow-up period} .
RESULTS
Outcome after three months was similar for both strategies (non-significantly in favour of computed tomography ). For the acute stage and complications, [the cost] was 461 euros (314 pounds sterling, 582 dollars) per patient in the computed tomography group and 677 euros (462 pounds sterling, 854 dollars) in the observation group ; an average of 32% less in the computed tomography group (216 euros, 95% confidence interval -272 to -164; P < 0.001). [Sensitivity analysis] showed that computed tomography was [the most cost effective strategy] under a broad range of assumptions. After three months , [total costs] were 718 euros and 914 euros per patient-that is, 196 euros less in the computed tomography group (- 281 to - 114; P < 0.001). The lower cost of the computed tomography strategy at the acute stage thus remained unchanged during follow-up.
CONCLUSION
Patients with mild head injury attending an emergency department can be managed more cost effectively with computed tomography rather than admission for observation in hospital .
TRIAL REGISTRATION
ISRCTN81464462.
------------------- bmj16914458.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Joint crisis plans for people with psychosis: economic evaluation of a randomised controlled trial.
Flood C Byford S Henderson C Leese M Thornicroft G Sutherby K Szmukler G.
Department of Mental Health and Learning Disability, City University, London E1 2EA.
OBJECTIVE
To investigate the cost effectiveness of joint crisis plans , a form of advance agreement for people with severe mental illness.
DESIGN
Single blind randomised controlled trial.
SETTING
Eight community mental health teams in southern England.
PARTICIPANTS
160 people with a diagnosis of psychotic illness or non-psychotic bipolar disorder who had been admitted to hospital at least once within the previous two years.
INTERVENTION
Joint crisis plan formulated by the patient, care coordinator, psychiatrist, and project worker containing contact information, details of illnesses, treatments, relapse indicators, and advance statements of preferences for care for future relapses . Control group was standardised service information .
MAIN OUTCOME MEASURES
[Admission to hospital] ; [service use over 15 months] .
RESULTS
Use of a joint crisis plan was associated with [less service use] and [lower costs] on average than in the standardised service information group , but differences were not significant. [Total costs] during follow-up were 7264 pounds sterling (10,616 euros, 13,560 dollars) for each participant with a joint crisis plan and 8359 pounds sterling (12,217 euros, 15,609 dollars) for each participant with standardised service information (mean difference 1095 pounds sterling; 95% confidence interval -2814 to 5004). Cost effectiveness acceptability curves, used to explore uncertainty in estimates of costs and effects, suggest there is a greater than 78% probability that joint crisis plans are [more cost effective] than standardised service information in reducing [the proportion of patients admitted to hospital] .
CONCLUSION
Joint crisis plans produced a non-significant decrease in [admissions] and [total costs] . Though the cost estimates had wide confidence intervals, the associated uncertainty suggests there is a relatively high probability of the plans being [more cost effective] than standardised service information for people with psychotic disorders.
------------------- bmj16916809.xml ---------------------------
Randomized Controlled Trial Research Support, Non-U.S. Gov't
ACP J Club. 2007 Jan-Feb;146(1):9. Evid Based Med. 2007 Feb;12(1):22.
Effectiveness of telephone counselling by a pharmacist in reducing [mortality] in patients receiving polypharmacy: randomised controlled trial.
Wu JY Leung WY Chang S Lee B Zee B Tong PC Chan JC.
Department of Medicine and Therapeutics, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR.
OBJECTIVE
To investigate the effects of compliance and periodic telephone counselling by a pharmacist on [mortality] in patients receiving polypharmacy.
DESIGN
Two year randomised controlled trial.
SETTING
Hospital medical clinic.
PARTICIPANTS
502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for randomisation to either the telephone counselling group (n = 219) or control group (n = 223) at enrollment 12-16 weeks later.
MAIN OUTCOME MEASURES
Primary outcome was [all cause mortality] in randomised patients. Associations between [compliance] and [mortality] in the entire cohort of 1011 patients were also examined. Patients were defined as compliant with a drug if they took 80-120% of the prescribed daily dose. To calculate {[a compliance score] for the whole treatment regimen} , the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage. Only patients who complied with all recommended drugs were considered compliant (100% score).
RESULTS
60 of the 502 eligible patients defaulted and only 442 patients were randomised. After two years , 31 (52%) of the defaulters had [died] , 38 (17%) of the control group had [died] , and 25 (11%) of the intervention group had [died] . After adjustment for confounders, telephone counselling was associated with a 41% reduction in [the risk of death] (relative risk 0.59, 95% confidence interval 0.35 to 0.97; P = 0.039). [The number needed to treat to prevent one death] at two years was 16. Other predictors included [old age] , [living alone] , [rate of admission to hospital] , [compliance score] , [number of drugs for chronic disease] , and {[non-treatment] with lipid lowering drugs at screening visit} . In the cohort of 1011 patients, [the adjusted relative risk for death] was 1.61 (1.05 to 2.48; P = 0.029) and 2.87 (1.80 to 2.57; P < 0.001) in patients with [compliance scores] of 34-66% and 0-33%, respectively, compared with those who had [a compliance score] of 67% or more.
CONCLUSION
In patients receiving polypharmacy, poor compliance was associated with [increased mortality] . Periodic telephone counselling by a pharmacist improved [compliance] and [reduced mortality] .
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number Register: SRCTN48076318.
------------------- bmj16935946.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Telephone administered cognitive behaviour therapy for treatment of obsessive compulsive disorder: randomised controlled non-inferiority trial.
Lovell K Cox D Haddock G Jones C Raines D Garvey R Roberts C Hadley S.
Department of Nursing, Midwifery, and Social Work, University of Manchester, Manchester M13 9PL.
Karina.Lovell@manchester.ac.uk
OBJECTIVES
To compare the effectiveness of cognitive behaviour therapy delivered by telephone with the same therapy given face to face in the treatment of obsessive compulsive disorder.
DESIGN
Randomised controlled non-inferiority trial.
SETTING
Two psychology outpatient departments in the United Kingdom.
PARTICIPANTS
72 patients with obsessive compulsive disorder.
INTERVENTION
10 weekly sessions of exposure therapy and response prevention delivered by telephone or face to face .
MAIN OUTCOME MEASURES
[Yale Brown obsessive compulsive disorder scale] , [Beck depression inventory] , and [client satisfaction questionnaire] .
RESULTS
Difference in [the Yale Brown obsessive compulsive disorder checklist score] between the two treatments at six months was -0.55 (95% confidence interval -4.26 to 3.15). [Patient satisfaction] was high for both forms of treatment.
CONCLUSION
The clinical outcome of cognitive behaviour therapy delivered by telephone was equivalent to treatment delivered face to face and similar levels of [satisfaction] were reported.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN500103984 [controlled-trials.com].
------------------- bmj16980315.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 23;333(7569):611-2.
A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis.
Ratcliffe J Thomas KJ MacPherson H Brazier J.
School of Health and Related Research, University of Sheffield.
j.ratcliffe@sheffield.ac.uk
OBJECTIVE
To evaluate the cost effectiveness of acupuncture in the management of persistent non-specific low back pain.
DESIGN
Cost effectiveness analysis of a randomised controlled trial.
SETTING
Three private acupuncture clinics and 18 general practices in York, England.
PARTICIPANTS
241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration.
INTERVENTIONS
Ten individualised acupuncture treatments over three months from acupuncturists trained in traditional Chinese medicine (n = 160) or usual care only (n = 81).
MAIN OUTCOME MEASURE
{[Incremental cost per quality adjusted life year] ( [QALY] ) gained over two years} .
RESULTS
[Total costs] to the United Kingdom's health service during the two year study period were higher on average for the acupuncture group (460 pounds sterling; 673 euros; 859 dollars) than for the usual care group (345 pounds sterling) because of the costs associated with initial treatment . [The mean incremental health gain] from acupuncture at 12 months was 0.012 QALYs (95% confidence interval -0.033 to 0.058) and at 24 months was 0.027 QALYs (-0.056 to 0.110), leading to a base case estimate of 4241 pounds sterling per QALY gained. This result was robust to [sensitivity analysis] . [The probabilistic sensitivity analysis] showed acupuncture to have a more than 90% chance of being cost effective at a pound20 000 cost per QALY threshold.
CONCLUSION
A short course of traditional acupuncture for persistent non-specific low back pain in primary care confers [a modest health benefit] for [minor extra cost] to the NHS compared with usual care . Acupuncture care for low back pain seems to be cost effective in the longer term.
TRIAL REGISTRATION
ISRCTN80764175 [controlled-trials.com].
------------------- bmj16980316.xml ---------------------------
Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Sep 23;333(7569):611-2.
Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain.
Thomas KJ MacPherson H Thorpe L Brazier J Fitter M Campbell MJ Roman M Walters SJ Nicholl J.
School of Health and Related Research, University of Sheffield.
OBJECTIVE
To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care.
DESIGN
Pragmatic, open, randomised controlled trial.
SETTING
Three private acupuncture clinics and 18 general practices in York, England.
PARTICIPANTS
241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration.
INTERVENTIONS
10 individualised acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients).
MAIN OUTCOME MEASURES
The primary outcome was [SF-36 bodily pain] , measured at 12 and 24 months . Other outcomes included [reported use of analgesics] , [scores on the Oswestry pain disability index] , [safety] , and [patient satisfaction] .
RESULTS
39 general practitioners referred 289 patients of whom 241 were randomised. At 12 months [average SF-36 pain scores] increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group . Adjusting for baseline score and for any clustering by acupuncturist, [the estimated intervention effect] was 5.6 points (95% confidence interval -0.2 to 11.4) at 12 months (n = 213) and 8.0 points (2.8 to 13.2) at 24 months (n = 182). The magnitude of the difference between the groups was about 10%-15% of the final pain score in the control group . [Functional disability] was not improved. [No serious or life threatening events] were reported.
CONCLUSIONS
Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months , but stronger evidence of a small benefit at 24 months . Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain.
TRIAL REGISTRATION
ISRCTN80764175 [controlled-trials.com].
------------------- bmj17012266.xml ---------------------------
Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
Aust J Physiother. 2007;53(1):61. BMJ. 2006 Nov 4;333(7575):927-8. Evid Based Med. 2007 Apr;12(2):39. J Fam Pract. 2007 Feb;56(2):98.
Mobilisation with movement and exercise , corticosteroid injection , or wait and see for tennis elbow: randomised trial.
Bisset L Beller E Jull G Brooks P Darnell R Vicenzino B.
School of Health and Rehabilitation Sciences, University of Queensland, St Lucia, QLD, Australia 4072.
OBJECTIVE
To investigate the efficacy of physiotherapy compared with a wait and see approach or corticosteroid injections over 52 weeks in tennis elbow.
DESIGN
Single blind randomised controlled trial.
SETTING
Community setting, Brisbane, Australia.
PARTICIPANTS
198 participants aged 18 to 65 years with a clinical diagnosis of tennis elbow of a minimum six weeks' duration, who had not received any other active treatment by a health practitioner in the previous six months.
INTERVENTIONS
Eight sessions of physiotherapy ; corticosteroid injections ; or wait and see .
MAIN OUTCOME MEASURES
[Global improvement] , [grip force] , and [assessor's rating of severity] measured at baseline , six weeks , and 52 weeks .
RESULTS
Corticosteroid injection showed significantly better effects at six weeks but with [high recurrence rates] thereafter (47/65 of successes subsequently regressed) and significantly poorer outcomes in the long term compared with physiotherapy . Physiotherapy was superior to wait and see in the short term; no difference was seen at 52 weeks , when most participants in both groups reported a successful outcome. Participants who had physiotherapy sought [less additional treatment] , such as non-steroidal anti-inflammatory drugs, than did participants who had wait and see or injections .
CONCLUSION
Physiotherapy combining elbow manipulation and exercise has a superior benefit to wait and see in the first six weeks and to corticosteroid injections after six weeks , providing a reasonable alternative to injections in the mid to long term. The significant short term benefits of corticosteroid injection are paradoxically reversed after six weeks , with [high recurrence rates] , implying that this treatment should be used with caution in the management of tennis elbow.
------------------- bmj17023435.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Nov 4;333(7575):932.
Effect of beta radiation on [success of glaucoma drainage surgery] in South Africa: randomised controlled trial.
Kirwan JF Cousens S Venter L Cook C Stulting A Roux P Murdoch I.
Department of Epidemiology and International Eye Health, Institute of Ophthalmology, University College London, London EC1V 9EL.
OBJECTIVE
To evaluate whether beta radiation may offer a practical method of improving [surgical success for glaucoma drainage surgery] in South Africa.
DESIGN
Double blind, randomised controlled trial.
SETTING
Three public hospitals in South Africa.
PARTICIPANTS
450 black Africans with primary glaucoma.
INTERVENTIONS
Trabeculectomy with 1000 cGy beta radiation or standard trabeculectomy without beta radiation ( placebo ) .
MAIN OUTCOME MEASURES
Primary outcome measure was {[surgical failure within 12 months] (intraocular pressure > 21 mm Hg while receiving no treatment for ocular hypotension)} . Secondary outcomes were [visual acuity] , [surgical reintervention for cataract] , and [intraoperative and postoperative complications] .
RESULTS
320 people were recruited. beta radiation was given to 164; 20 (6%) were not seen again after surgery. One year after surgery [the estimated risk of surgical failure] was 30% (95% confidence interval 22% to 38%) in the placebo arm compared with 5% (2% to 10%) in the radiation arm . The radiation group experienced [a higher incidence of operable cataract] (18 participants) than the placebo group (five participants; P = 0.01). At two years [the estimated risks] with placebo and beta radiation were, respectively, 2.8% (0.9% to 8.3%) and 16.7% (10.0% to 27.3%).
CONCLUSION
beta radiation substantially reduced [the risk of surgical failure after glaucoma surgery] . Some evidence was, however, found of [an increased risk for cataract surgery] (a known complication of trabeculectomy) in the beta radiation arm during the two years after surgery .
TRIAL REGISTRATION
ISRCTN62430622 [controlled-trials.com].
------------------- bmj17028105.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Dec 2;333(7579):1171; author reply 1171-2. BMJ. 2006 Dec 2;333(7579):1171; author reply 1171-2. BMJ. 2006 Dec 2;333(7579):1171; author reply 1171-2. BMJ. 2006 Nov 18;333(7577):1031-2. J Pediatr. 2007 May;150(5):561.
Physical activity to prevent obesity in young children: cluster randomised controlled trial.
Reilly JJ Kelly L Montgomery C Williamson A Fisher A McColl JH Lo Conte R Paton JY Grant S.
Division of Developmental Medicine, University of Glasgow, Yorkhill Hospitals, Glasgow G3 8SJ.
jjr2y@clinmed.gla.ac.uk
OBJECTIVE
To assess whether a physical activity intervention reduces [body mass index] in young children.
DESIGN
Cluster randomised controlled single blinded trial over 12 months.
SETTING
Thirty six nurseries in Glasgow, Scotland.
PARTICIPANTS
545 children in their preschool year, mean age 4.2 years (SD 0.2) at baseline .
INTERVENTION
Enhanced physical activity programme in nursery ( three 30 minute sessions a week over 24 weeks ) plus home based health education aimed at increasing [physical activity] through play and reducing [sedentary behaviour] .
MAIN OUTCOME MEASURE
[Body mass index] , expressed as a standard deviation score relative to UK 1990 reference data. Secondary measures were [objectively measured physical activity] and [sedentary behaviour] ; [fundamental movement skills] ; and [evaluation of the process] .
RESULTS
Group allocation had no significant effect on [the primary outcome measure] at six and 12 months or on [measures of physical activity] and [sedentary behaviour by accelerometry] . Children in the intervention group had significantly higher performance in [movement skills tests] than control children at six month follow-up (P=0.0027; 95% confidence interval 0.3 to 1.3) after adjustment for sex and baseline performance.
CONCLUSIONS
Physical activity can significantly improve [motor skills] but did not reduce [body mass index] in young children in this trial.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN36363490.
------------------- bmj17040924.xml ---------------------------
Randomized Controlled Trial Research Support, N.I.H., Extramural
BMJ. 2006 Nov 25;333(7578):1082-3.
Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma (Gypsy) men in Bulgaria: randomised controlled trial.
Kelly JA Amirkhanian YA Kabakchieva E Vassileva S Vassilev B McAuliffe TL DiFranceisco WJ Antonova R Petrova E Khoursine RA Dimitrov B.
Center for AIDS Intervention Research (CAIR), Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin, 2071 North Summit Avenue, Milwaukee, Wisconsin 53202, USA.
kdemming@mcw.edu
OBJECTIVE
To determine the effects of a behavioural intervention for [prevention of HIV and sexually transmitted diseases] that identified, trained, and engaged leaders of Roma (Gypsy) men's social networks to counsel their own network members.
DESIGN
A two arm randomised controlled trial.
SETTING
A disadvantaged, impoverished Roma settlement in Bulgaria.
PARTICIPANTS
286 Roma men from 52 social networks recruited in the community.
INTERVENTION
At baseline all participants were assessed for HIV risk behaviour, tested and treated for sexually transmitted diseases, counselled in risk reduction, and randomised to intervention or control groups . Network leaders learnt how to counsel their social network members on risk prevention. Networks were followed up three and 12 months after the intervention to determine evidence of risk reduction.
MAIN OUTCOME MEASURE
{[Occurrence of unprotected intercourse] during the three months before each assessment} .
RESULTS
Reported prevalence of [unprotected intercourse] in the intervention group fell more than in control group (from 81% and 80%, respectively, at baseline to 65% and 75% at three months and 71% and 86% at 12 months ). Changes were more pronounced among men with casual partners. Effects remained strong at long term follow-up , consistent with changes in risk reduction norms in the social network. Other measures of risk reduction corroborated the intervention's effects.
CONCLUSIONS
Endorsement and advice on HIV prevention from the leader of a social network produces well maintained change in [the reported sexual practices] in members of that network. This model has particular relevance for health interventions in populations such as Roma who may be distrustful of outsiders.
TRIAL REGISTRATION
Clinical Trials NCT00310973.
------------------- bmj17040925.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Nov 18;333(7577):1029-30.
Effect of baseline serum albumin concentration on outcome of resuscitation with albumin or saline in patients in intensive care units: analysis of data from the saline versus albumin fluid evaluation (SAFE) study.
SAFE Study Investigators Finfer S Bellomo R McEvoy S Lo SK Myburgh J Neal B Norton R.
Australian and New Zealand Intensive Care Society Clinical Trials Group, Carlton, Vic 3053, Australia.
sfinfer@george.org.au
OBJECTIVE
To determine whether outcomes of resuscitation with albumin or saline in the intensive care unit depend on patients' baseline serum albumin concentration.
DESIGN
Analysis of data from a double blind, randomised controlled trial.
SETTING
Intensive care units of 16 hospitals in Australia and New Zealand.
PARTICIPANTS
6045 participants in the saline versus albumin fluid evaluation (SAFE) study.
INTERVENTIONS
Fluid resuscitation with 4% albumin or saline in patients with a baseline serum albumin concentration of 25 g/l or less or more than 25 g/l.
MAIN OUTCOME MEASURES
Primary outcome was [all cause mortality] at 28 days . Secondary outcomes were [length of stay in the intensive care unit] , [length of stay in hospital] , [duration of renal replacement therapy] , and [duration of mechanical ventilation] .
MAIN RESULTS
The odds ratios for [death] for albumin compared with saline for patients with a baseline serum albumin concentration of 25 g/l or less and more than 25 g/l were 0.87 and 1.09, respectively (ratio of odds ratios 0.80, 95% confidence interval 0.63 to 1.02); P=0.08 for heterogeneity. No significant interaction was found between baseline serum albumin concentration as a continuous variable and the effect of albumin and saline on [mortality] . No consistent interaction was found between baseline serum albumin concentration and treatment effects on [length of stay in the intensive care unit] , [length of hospital stay] , [duration of renal replacement therapy] , or [duration of mechanical ventilation] .
CONCLUSION
The outcomes of resuscitation with albumin and saline are similar irrespective of patients' baseline serum albumin concentration.
TRIAL REGISTRATION
ISRCTN76588266.
------------------- bmj17040926.xml ---------------------------
Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't
BMJ. 2006 Oct 28;333(7574):867-8.
Self management of arthritis in primary care: randomised controlled trial.
Buszewicz M Rait G Griffin M Nazareth I Patel A Atkinson A Barlow J Haines A.
Department of Primary Care and Population Sciences, Royal Free and University College Medical School, London N19 5LW.
m.buszewicz@pcps.ucl.ac.uk
OBJECTIVE
To evaluate clinical effectiveness of a self management programme for arthritis in patients in primary care with osteoarthritis.
DESIGN
Randomised controlled trial.
SETTING
74 general practices in the United Kingdom.
PARTICIPANTS
812 patients aged 50 and over with osteoarthritis of hips or knees (or both) and pain or disability (or both).
INTERVENTION
Participants were randomised to six sessions of self management of arthritis and an education booklet ( intervention group ) or the education booklet alone ( control group ).
MAIN OUTCOME MEASURES
Primary outcome was {[quality of life] , as assessed by [the short form health survey] ( [SF-36] )} . [Several other physical and psychosocial secondary outcomes] were assessed. Data were collected at baseline , four months , and 12 months .
RESULTS
Response rates were 80% and 76% at four and 12 months . The two groups showed significant differences at 12 months on [the anxiety subscore of the hospital anxiety and depression scale] (mean difference -0.62, 95% confidence interval -1.08 to -0.16), [arthritis self efficacy scale for pain] (0.98, 0.07 to 1.89), and [self efficacy for other aspects of management] (1.58, 0.25 to 2.90). Results were similar for [intention to treat] and [per protocol analyses] . No significant difference was seen in [number of visits to the general practitioner] at [12 months] .
CONCLUSIONS
The self management of arthritis programme reduced [anxiety] and improved [participants' perceived self efficacy to manage symptoms] , but it had no significant effect on [pain] , [physical functioning] , or [contact with primary care] .
TRIAL REGISTRATION
Current Controlled Trials ISRCTN79115352 [controlled-trials.com].
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