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Results for “Randomised Controlled Trial”

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PubMed1977

Randomised controlled trial of anti-smoking advice in pregnancy.

In a randomised controlled trial intensive individual anti-smoking advice given in parallel with hospital antenatal care did not influence the outcome of pregnancy. The belief that retardation of fetal growth caused by maternal smoking occurs in late pregnancy is not well based, and the advice may not have been given in time to be effective. Other possible interpretations of the results, that maternal smoking is merely an index of some other factor that retards growth or that those counselled did not reduce their smoking sufficiently to influence outcome, cannot be excluded.

Birth Weight↗

PubMed1998

Randomised controlled trial of compliance therapy. 18-month follow-up.

BACKGROUND: A randomised controlled trial was conducted in an acute treatment setting to examine the effectiveness of compliance therapy, a brief pragmatic intervention targeting treatment adherence in psychotic disorders, based on motivational interviewing and recent cognitive approaches to psychosis. METHOD: Seventy-four patients with psychotic disorders according to DSM-III-R criteria recruited from consecutive admissions to an acute in-patient unit, received 4-6 sessions of either compliance therapy or non-specific counselling, and were followed-up over 18 months. The principal outcome measures were observer-rated compliance, attitudes to treatment, insight and social functioning. RESULTS: Significant advantages were found for the compliance therapy group post-treatment on measures of insight, attitudes to treatment and observer-rated compliance which were retained over the follow-up period. Global social functioning improved relatively more over time in the compliance therapy group compared with the control group. Survival in the community prior to readmission was significantly longer in the compliance therapy group. CONCLUSIONS: The results support the effectiveness of compliance therapy in improving functioning and community tenure after an acute psychotic episode.

Acute Disease↗

PubMed1985

A prospective randomised controlled trial of mezlocillin versus netilmicin in biliary surgery.

A prospective randomised controlled trial of mezlocillin versus netilmicin in 133 patients undergoing biliary surgery at a district hospital is reported. Sixty-four patients received mezlocillin and 69 received netilmicin. The two groups of patients were comparable with regard to age, sex, underlying pathology and operative procedures performed. The incidence of infected bile at operation was 14.2% and both antibiotics were equally effective in reducing postoperative bacteraemia (0.75%) and wound infection (4.5%) to acceptable levels. It is concluded that netilmicin is a more cost-effective antibiotic in biliary surgery than mezlocillin.

Aged↗

PubMed2005

The reporting quality of abstracts of randomised controlled trials submitted to the ICS meeting in Heidelberg.

AIMS: The quality of randomised controlled trials (RCTs) is associated with bias. Thus, reports of RCTs must have enough detail of key elements of quality to enable them to be interpreted properly. This study examines the quality of abstracts of RCTs reported at the ICS meeting in Heidelberg in 2002, using the CONSORT statement as the gold standard. MATERIALS AND METHODS: All of the abstracts accepted for the meeting at Heidelberg were read to identify reports of RCTs. Copies of these were printed and examined to see whether they complied with the 22 items in the CONSORT statement. As these were all abstracts the first CONSORT item was changed so that to comply the title had to say it was a randomised trial. Each item was scored as not met, partially met, met. RESULTS: Fifty-three reports of RCTs were found. Five of these were podium presentations, 14 discussion posters, and 34 non-discussion posters. Most reports did not comply with many of the items in the CONSORT statement, lacking particularly in technical details of the methods (only one study clearly reported hidden allocation to groups), and how the results were presented (only two studies fully reported results). Only 2/53 of the abstracts complied fully with more than 10 of the items, and 30/53 did not comply at all with 10 or more. CONCLUSIONS: The quality of reporting of studies at ICS is so poor that it is difficult to interpret the results. Reporting was particularly poor on the details of the randomisation and the numeric results.

Abstracting and Indexing↗

PubMed2004

A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease.

OBJECTIVES: We developed a patient centred approach to chronic disease self management by providing information designed to promote patient choice. We then conducted a randomised controlled trial of the approach in inflammatory bowel disease (IBD) to assess whether it could alter clinical outcome and affect health service use. DESIGN: A multicentre cluster randomised controlled trial. SETTING: The trial was conducted in the outpatient departments of 19 hospitals with randomisation by treatment centre, 10 control sites, and nine intervention sites. For patients at intervention sites, an individual self management plan was negotiated and written information provided. PARTICIPANTS: A total of 700 patients with established inflammatory bowel disease were recruited. MAIN OUTCOME MEASURES: Main outcome measures recorded at one year were: quality of life, health service resource use, and patient satisfaction. Secondary outcomes included measures of enablement-confidence to cope with the condition. RESULTS: One year following the intervention, self managing patients had made fewer hospital visits (difference -1.04 (95% confidence interval (CI) -1.43 to -0.65); p<0.001) without increase in the number of primary care visits, and quality of life was maintained without evidence of anxiety about the programme. The two groups were similar with respect to satisfaction with consultations. Immediately after the initial consultation, those who had undergone self management training reported greater confidence in being able to cope with their condition (difference 0.90 (95% CI 0.12-1.68); p<0.03). CONCLUSIONS: Adoption of this approach for the management of chronic disease such as IBD in the NHS and other managed health care organisations would considerably reduce health provision costs and benefit disease control.

Adaptation, Psychological↗

PubMed2000

Health outcomes associated with calcium antagonists compared with other first-line antihypertensive therapies: a meta-analysis of randomised controlled trials.

BACKGROUND: Several observational studies and individual randomised trials in hypertension have suggested that, compared with other drugs, calcium antagonists may be associated with a higher risk of coronary events, despite similar blood-pressure control. The aim of this meta-analysis was to compare the effects of calcium antagonists and other antihypertensive drugs on major cardiovascular events. METHODS: We undertook a meta-analysis of trials in hypertension that assessed cardiovascular events and included at least 100 patients, who were randomly assigned intermediate-acting or long-acting calcium antagonists or other antihypertensive drugs and who were followed up for at least 2 years. FINDINGS: The nine eligible trials included 27,743 participants. Calcium antagonists and other drugs achieved similar control of both systolic and diastolic blood pressure. Compared with patients assigned diuretics, beta-blockers, angiotensin-converting-enzyme inhibitors, or clonidine (n=15,044), those assigned calcium antagonists (n=12,699) had a significantly higher risk of acute myocardial infarction (odds ratio 1.26 [95% CI 1.11-1.43], p=0.0003), congestive heart failure (1.25 [1.07-1.46], p=0.005), and major cardiovascular events (1.10 [1.02-1.18], p=0.018). The treatment differences were within the play of chance for the outcomes of stroke (0.90 [0.80-1.02], p=0.10) and all-cause mortality (1.03 [0.94-1.13], p=0.54). INTERPRETATION: In randomised controlled trials, the large available database suggests that calcium antagonists are inferior to other types of antihypertensive drugs as first-line agents in reducing the risks of several major complications of hypertension. On the basis of these data, the longer-acting calcium antagonists cannot be recommended as first-line therapy for hypertension.

Aged↗

PubMed2006

Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.

BACKGROUND: Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction METHODS: The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

Journal Article↗

PubMed2003

Validation of a home safety questionnaire used in a randomised controlled trial.

OBJECTIVE: To measure the validity of self reported safety practices from a questionnaire, completed by families participating in a home safety randomised controlled trial. METHODS: The postal questionnaire was used to measure secondary outcomes in a randomised controlled trial. The answers to 26 questions that could be assessed by observation were checked by a home visit. Families were invited to take part in a "home safety check"; they were not told that the visit was part of a validation study. At the time of the visit the researcher was blind to the self reports in the questionnaires. RESULTS: Sixty four questionnaires were validated by visits to 64 households. Percentage agreement ranged from 58% to 100%. Sensitivity was high (68% or above) for most safety practices. The positive predictive value was also high for most safety practices (78% or above for 15 of the 16 practices). CONCLUSIONS: This study found a fairly high degree of consistency between self reported data and actual observations. The findings from this relatively small study need confirmation from larger studies.

Accidents, Home↗

PubMed2005

Can we evaluate population screening strategies in UK general practice? A pilot randomised controlled trial comparing postal and opportunistic screening for genital chlamydial infection.

STUDY OBJECTIVE: To assess whether opportunistic and postal screening strategies for Chlamydia trachomatis can be compared with usual care in a randomised trial in general practice. DESIGN: Feasibility study for a randomised controlled trial. SETTING: Three West of Scotland general medical practices: one rural, one urban/deprived, and one urban/affluent. PARTICIPANTS: 600 women aged 16-30 years, 200 from each of three participating practices selected at random from a sample of West of Scotland practices that had expressed interest in the study. The women could opt out of the study. Those who did not were randomly assigned to one of three groups: postal screening, opportunistic screening, or usual care. RESULTS: 38% (85 of 221) of the approached practices expressed interest in the study. Data were collected successfully from the three participating practices. There were considerable workload implications for staff. Altogether 124 of the 600 women opted out of the study. During the four month study period, 55% (81 of 146) of the control group attended their practice but none was offered screening. Some 59% (80 of 136) women in the opportunistic group attended their practice of whom 55% (44 of 80) were offered screening. Of those, 64% (28 of 44) accepted, representing 21% of the opportunistic group. Forty eight per cent (59 of 124) of the postal group returned samples. CONCLUSION: A randomised controlled trial comparing postal and opportunistic screening for chlamydial infection in general practice is feasible, although resource intensive. There may be problems with generalizing from screening trials in which patients may opt out from the offer of screening.

Adolescent↗

PubMed2002

Conservative treatment options for carpal tunnel syndrome: a systematic review of randomised controlled trials.

Carpal tunnel syndrome (CTS) is a common disorder, for which various conservative treatment options are available. The objective of this study is to determine the efficacy of the various conservative treatment options for relieving the symptoms of CTS. Computer-aided searches of MEDLINE (1/1966 to 3/2000), EMBASE (1/1988 to 2/2000) and the Cochrane Controlled Trials Register (2000, issue 1) were conducted, together with reference checking. Included were randomised controlled trials evaluating the efficacy of conservative treatment options in a study population of CTS patients, with a full report published in English, German, French or Dutch. Two reviewers independently selected the studies. Fourteen randomised controlled trials were included in the review. Assessment of methodological quality and data-extraction was independently performed by two reviewers. A rating system, based on the number of studies and their methodological quality and findings, was used to determine the strength of the available evidence for the efficacy of the treatment. Diuretics, pyridoxine, non-steroidal anti-inflammatory drugs, yoga and laser-acupuncture seem to be ineffective in providing short-term symptom relief (varying levels of evidence) and steroid injections seem to be effective (limited evidence). There is conflicting evidence for the efficacy of ultrasound and oral steroids. For providing long-term relief from symptoms there is limited evidence that ultrasound is effective, and that splinting is less effective than surgery. In conclusion, there is still little known about the efficacy of most conservative treatment options for CTS. To establish stronger evidence more high quality trials are needed.

Adult↗

PubMed2005

Continuous versus intermittent intravenous administration of antibiotics: a meta-analysis of randomised controlled trials.

Intermittent intravenous administration of antibiotics is the first-line approach in the management of severe infections worldwide. However, the potential benefits of alternate modes of administration of antibiotics, including continuous intravenous infusion, deserve further evaluation. We did a meta-analysis of randomised controlled trials comparing continuous intravenous infusion with intermittent intravenous administration of the same antibiotic regimen. Nine randomised controlled trials studying beta-lactams, aminoglycosides, and vancomycin were included. Clinical failure was lower, although without statistical significance, in patients receiving continuous infusion of antibiotics (pooled OR 0.73, 95% CI 0.53-1.01); the difference was statistically significant in a subset of randomised controlled trials that used the same total daily antibiotic dose for both intervention arms (0.70, 0.50-0.98, fixed and random effects models). Regarding mortality and nephrotoxicity, no differences were found (mortality 0.89, 0.48-1.64; nephrotoxicity 0.91, 0.56-1.47). In conclusion, the data suggest that the administration of the same total antibiotic dose by continuous intravenous infusion may be more efficient, with regard to clinical effectiveness, compared with the intermittent mode. In an era of gradually increasing resistance among most pathogens, the potential advantages of continuous intravenous administration of antibiotics on several clinical outcomes should be further investigated.

Aminoglycosides↗

PubMed1999

Does hospital at home for palliative care facilitate death at home? Randomised controlled trial.

OBJECTIVE: To evaluate the impact on place of death of a hospital at home service for palliative care. DESIGN: Pragmatic randomised controlled trial. SETTING: Former Cambridge health district. PARTICIPANTS: 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. INTERVENTION: Hospital at home versus standard care. MAIN OUTCOME MEASURES: Place of death. RESULTS: Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. CONCLUSION: In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting.

Death↗

PubMed2004

A randomised controlled trial of a psycho-educational intervention to aid recovery in infectious mononucleosis.

OBJECTIVES: Glandular fever is associated with an approximate fivefold increase in fatigue at 6 months. Reduced levels of fitness and illness beliefs may be important predictors of fatigue following glandular fever. We therefore developed a brief psycho-educational intervention aimed at improving recovery from infectious mononucleosis, and piloted a randomised controlled trial to evaluate the intervention. METHODS: We performed a randomised-controlled trial in primary health care in Southeast London and Kent. Sixty-nine patients aged between 16 and 45 years who were diagnosed, serologically and clinically, with acute infectious mononucleosis between December 1999 and December 2000 were randomised. The control group received a standardised fact-sheet about infectious mononucleosis, which gave no advice on rehabilitation. Patients who were randomised to the intervention received an individual treatment session, two follow-up telephone calls, and an information booklet. Fatigue score 6 months after the onset of infectious mononucleosis was the main outcome measure. RESULTS: Sixty-nine out of 139 patients referred were recruited and randomised. Eighty-seven percent of those recruited completed the Fatigue Questionnaire at 6 months. The intervention was acceptable to all who received it. There were fewer fatigue cases in the intervention group than the control group at 6 months follow-up (odds ratio 0.31, 95% confidence interval 0.09-0.91). CONCLUSIONS: A brief intervention at the diagnosis of infectious mononucleosis is acceptable, and may help prevent the development of chronic fatigue. Definitive randomised controlled trials are required to test the intervention.

Adolescent↗

PubMed1995

Better efficacy of twice-monthly than monthly aerosolised pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with AIDS. An Italian multicentric randomised controlled trial. The Italian PCP Study Group.

The aim of this multicentric randomised controlled trial was to evaluate long-term efficacy and safety of once-monthly versus twice-monthly 300 mg aerosolized pentamidine (AP) as secondary prophylaxis of Pneumocystis carinii pneumonia (PCP). We randomised 205 patients with a previous confirmed episode of PCP (107 treated with 300 mg once-monthly AP, and 98 with 300 mg twice monthly AP); the median review period was 232 days. Kaplan-Meier method and Cox's hazard regression model were used for analysis. The main outcome assessments were PCP recurrence, survival and incidence of drug toxicity. The two groups were balanced for prognostic predictors. In the once-monthly AP group, 14 relapses of confirmed PCP were observed, while five occurred in the twice-monthly AP group; the crude relative risk (RR) was 2.69 (95% CI 1.002-7.236, P=0.0496) and the adjusted RR accounting for prognostic predictors was 2.62 (95% CI 0.92-7.5, P=0.071). Death occurred in 36 of 26 patients respectively (adjusted RR 1.32, 95% CI 0.8-2.18, P=0.28). Two patients interrupted the study because of intolerance to AP (one in each group), and severe coughing occurred in two patients (one in each group). At the end of the study, pulmonary function tests were not changed compared with baseline and were the same between the two groups. Our study suggests that 300 mg twice-monthly AP is more effective than 300 mg once-monthly AP as secondary prophylaxis of PCP.

Acquired Immunodeficiency Syndrome↗

PubMed2004

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials.

BACKGROUND: Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. METHODS: RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. RESULTS: The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. CONCLUSION: There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis.

Child↗

PubMedDate not supplied

Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial.

BACKGROUND: The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics and beta blockers. Our aim, therefore, was to compare the effect on non-fatal myocardial infarction and fatal CHD of combinations of atenolol with a thiazide versus amlodipine with perindopril. METHODS: We did a multicentre, prospective, randomised controlled trial in 19 257 patients with hypertension who were aged 40-79 years and had at least three other cardiovascular risk factors. Patients were assigned either amlodipine 5-10 mg adding perindopril 4-8 mg as required (amlodipine-based regimen; n=9639) or atenolol 50-100 mg adding bendroflumethiazide 1.25-2.5 mg and potassium as required (atenolol-based regimen; n=9618). Our primary endpoint was non-fatal myocardial infarction (including silent myocardial infarction) and fatal CHD. Analysis was by intention to treat. FINDINGS: The study was stopped prematurely after 5.5 years' median follow-up and accumulated in total 106 153 patient-years of observation. Though not significant, compared with the atenolol-based regimen, fewer individuals on the amlodipine-based regimen had a primary endpoint (429 vs 474; unadjusted HR 0.90, 95% CI 0.79-1.02, p=0.1052), fatal and non-fatal stroke (327 vs 422; 0.77, 0.66-0.89, p=0.0003), total cardiovascular events and procedures (1362 vs 1602; 0.84, 0.78-0.90, p<0.0001), and all-cause mortality (738 vs 820; 0.89, 0.81-0.99, p=0.025). The incidence of developing diabetes was less on the amlodipine-based regimen (567 vs 799; 0.70, 0.63-0.78, p<0.0001). INTERPRETATION: The amlodipine-based regimen prevented more major cardiovascular events and induced less diabetes than the atenolol-based regimen. On the basis of previous trial evidence, these effects might not be entirely explained by better control of blood pressure, and this issue is addressed in the accompanying article. Nevertheless, the results have implications with respect to optimum combinations of antihypertensive agents.

Adrenergic beta-Antagonists↗

PubMedDate not supplied

Attempting to set up a randomised controlled trial.

AIM: The aim of this article is to provide an account of an attempt to set up a randomised control trial (RCT) to evaluate the effects of programmes of continuing professional education on nursing practice. METHOD: The logistical and methodological challenges of the RCT are described, and an alternative quasi-experimental approach is outlined. RESULTS: It was not possible to obtain a sample of potential students due to the many constraints put on managers, mainly in relation to maintaining staff morale and providing a service while staff are away on courses. CONCLUSION: Few studies into the effects of education on nursing practice adopt a randomised control trial (RCT) methodology. Most continue to be process rather than outcome oriented, focusing on such things as teaching and learning strategies. This might be related to the methodological challenges posed by the RCT when applied in social settings.

Aged↗

PubMed2000

Psychological debriefing for road traffic accident victims. Three-year follow-up of a randomised controlled trial.

BACKGROUND: Psychological debriefing is widely used for trauma victims but there is uncertainty about its efficacy. We have previously reported a randomised controlled trial which concluded that at 4 months it was ineffective. AIMS: To evaluate the 3-year outcome in a randomised controlled trial of debriefing for consecutive subjects admitted to hospital following a road traffic accident. METHOD: Patients were assessed in hospital by the Impact of Event Scale (IES), Brief Symptom Inventory (BSI) and questionnaire and re-assessed at 3 months and 3 years. The intervention was psychological debriefing as recommended and described in the literature. RESULTS: The intervention group had a significantly worse outcome at 3 years in terms of general psychiatric symptoms (BSI), travel anxiety when being a passenger, pain, physical problems, overall level of functioning, and financial problems. Patients who initially had high intrusion and avoidance symptoms (IES) remained symptomatic if they had received the intervention, but recovered if they did not receive the intervention. CONCLUSIONS: Psychological debriefing is ineffective and has adverse long-term effects. It is not an appropriate treatment for trauma victims.

Accidents, Traffic↗