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Results for “Randomised Controlled Trial”

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PubMed1998

A randomised controlled trial of two pressure-reducing surfaces.

This randomised controlled trial of two dry-flotation pressure-reducing surfaces evaluates pressure sore incidence, patient comfort and the appropriate use of equipment in 100 orthopaedic patients. The trial involved five full Roho mattresses, five Sofflex mattresses and 10 Roho Quatro cushions to be used to complement the beds. Given the low rate of pressure sore incidence in this high-risk group it is not possible to determine whether there is any difference in effectiveness between the two mattresses. Both appear to provide similar levels of comfort, with the majority of patients finding them either comfortable or very comfortable. The initial setting of the equipment was, however, unsatisfactory.

Activities of Daily Living↗

PubMed2006

Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial.

BACKGROUND: The efficacy of screening by mammography has been shown in randomised controlled trials in women aged 50 years and older, but is less clear in younger women. A meta-analysis of all previous trials showed a 15% mortality reduction in invited women aged 40-49 years at study entry, but this finding could be due in part to screening of women after age 50 years. The Age trial was designed to study the effect on mortality of inviting women for annual mammography from age 40 years. METHODS: 160,921 women aged 39-41 years were randomly assigned in the ratio 1:2 to an intervention group of annual mammography to age 48 years or to a control group of usual medical care. The trial was undertaken in 23 NHS breast-screening units in England, Wales, and Scotland. The primary analysis was based on the intention-to-treat principle and compared mortality rates in the two groups at 10 years' follow-up. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN24647151. FINDINGS: At a mean follow-up of 10.7 years there was a reduction in breast-cancer mortality in the intervention group, in relative and absolute terms, which did not reach statistical significance (relative risk 0.83 [95% CI 0.66-1.04], p=0.11; absolute risk reduction 0.40 per 1000 women invited to screening [95% CI -0.07 to 0.87]). Mortality reduction adjusted for non-compliance in women actually screened was estimated as 24% (RR 0.76, 95% CI 0.51-1.01). INTERPRETATION: Although the reduction in breast-cancer mortality observed in this trial is not significant, it is consistent with results of other trials of mammography alone in this age-group. Future decisions on screening policy should be informed by further follow-up from this trial and should take account of possible costs and harms as well as benefits.

Adult↗

PubMed1998

Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis: systematic review of randomised controlled trials.

OBJECTIVE: To determine whether intranasal corticosteroids are superior to oral H1 receptor antagonists (antihistamines) in the treatment of allergic rhinitis. DESIGN: Meta-analysis of randomised controlled trials comparing intranasal corticosteroids with oral antihistamines. SETTING: Randomised controlled trials conducted worldwide and published between 1966 and 1997. SUBJECTS: 2267 subjects with allergic rhinitis in 16 randomised controlled trials. MAIN OUTCOME MEASURES: Nasal blockage, nasal discharge, sneezing, nasal itch, postnasal drip, nasal discomfort, total nasal symptoms, nasal resistance, and eye symptoms and global ratings. Outcomes measured on different scales were combined to determine pooled odds ratios (categorical outcomes) or standardised mean differences (continuous outcomes). Assessment of heterogeneity between studies, and subgroup analyses of eye symptoms, were undertaken. RESULTS: Intranasal corticosteroids produced significantly greater relief than oral antihistamines of nasal blockage (standardised mean difference 0.63, 95% confidence interval - 0.73 to - 0.53), nasal discharge (-0.5, - 0.6 to - 0.4), sneezing (- 0.49, - 0.59 to - 0.39), nasal itch (- 0.38,- 0.49 to - 0.21), postnasal drip (- 0.24,- 0.42 to - 0.06), and total nasal symptoms (- 0.42,- 0.53 to - 0.32), and global ratings gave an odds ratio for deterioration of symptoms of 0.26 (0.08 to 0.8). There were no significant differences between treatments for nasal discomfort, nasal resistance, or eye symptoms. The effects on sneezing, total nasal symptoms, and eye symptoms were significantly heterogeneous between studies. Other combined outcomes were homogeneous between studies. Subgroup analysis of the outcome of eye symptoms suggested that the duration of assessment (averaged mean score over the study period versus mean score at end of study period) might have accounted for the heterogeneity. CONCLUSION: The results of this systematic review, together with data on safety and cost effectiveness, support the use of intranasal corticosteroids over oral antihistamines as first line treatment for allergic rhinitis.

Administration, Intranasal↗

PubMed2003

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials.

OBJECTIVES: To determine whether parachutes are effective in preventing major trauma related to gravitational challenge. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists. STUDY SELECTION: Studies showing the effects of using a parachute during free fall. MAIN OUTCOME MEASURE: Death or major trauma, defined as an injury severity score > 15. RESULTS: We were unable to identify any randomised controlled trials of parachute intervention. CONCLUSIONS: As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.

Accidents, Aviation↗

PubMedDate not supplied

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials.

OBJECTIVES: To determine whether parachutes are effective in preventing major trauma related to gravitational challenge. Design Systematic review of randomised controlled trials. DATA SOURCES: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists. STUDY SELECTION: Studies showing the effects of using a parachute during free fall. MAIN OUTCOME MEASURE: Death or major trauma, defined as an injury severity score > 15. RESULTS: We were unable to identify any randomised controlled trials of parachute intervention. CONCLUSIONS: As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.

Journal Article↗

PubMed1999

What is meant by intention to treat analysis? Survey of published randomised controlled trials.

OBJECTIVES: To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals. DESIGN: Survey of all reports of randomised controlled trials published in 1997 in the BMJ, Lancet, JAMA, and New England Journal of Medicine. MAIN OUTCOME MEASURES: Methods of dealing with deviations from random allocation and missing data. RESULTS: 119 (48%) of the reports mentioned intention to treat analysis. Of these, 12 excluded any patients who did not start the allocated intervention and three did not analyse all randomised subjects as allocated. Five reports explicitly stated that there were no deviations from random allocation. The remaining 99 reports seemed to analyse according to random allocation, but only 34 of these explicitly stated this. 89 (75%) trials had some missing data on the primary outcome variable. The methods used to deal with this were generally inadequate, potentially leading to a biased treatment effect. 29 (24%) trials had more than 10% of responses missing for the primary outcome, the methods of handling the missing responses were similar in this subset. CONCLUSIONS: The intention to treat approach is often inadequately described and inadequately applied. Authors should explicitly describe the handling of deviations from randomised allocation and missing responses and discuss the potential effect of any missing response. Readers should critically assess the validity of reported intention to treat analyses.

Data Collection↗

PubMed1999

Randomised controlled trials addressing Australian aboriginal health needs: a systematic review of the literature.

OBJECTIVE: To describe the frequency and design of controlled clinical trials specifically addressing the health needs of Aboriginal Australians. METHODOLOGY: Electronic searching of Medline, the Australasian Medical Index, the Aboriginal and Torres Strait Islander health bibliographic database, and handsearching of Aboriginal Health: an annotated bibliography. Studies that met the following selection criteria were included: i) addressed an Aboriginal health problem, ii) had a formal description of methods and results, and iii) compared the health effects of an intervention with a concurrent control group. All summary data were extracted by a single author. RESULTS: Only 13 studies were identified. Nine were randomised controlled trials and four were controlled trials but not randomised. Only one of these involved adults, which is unexpected. Although important Aboriginal child health issues were addressed in 12 of the 13 studies, most were undertaken many years ago and may not be familiar to Australian paediatricians. The majority appeared to be designed appropriately. Interestingly, the two studies not published in the medical literature had the largest sample size. There is no evidence that the number of published clinical trials involving Aboriginal Australians is increasing, or that long-term applied clinical research programmes have been established. CONCLUSION: There is a profound lack of well-designed studies assessing medical interventions. This is further evidence that Australia has failed to develop a research infrastructure able to inform health care in Aboriginal communities. Adults appear especially disadvantaged.

Adolescent↗

PubMed2005

Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group.

OBJECTIVES: To assess how often new treatments for childhood cancer assessed in phase III randomised trials are superior or inferior to standard treatments and whether the pattern of successes and failures in new treatments is consistent with uncertainty being the ethical basis for enrolling patients in such trials. DESIGN: Observational study. SETTING: Phase III randomised controlled trials carried out under the aegis of the Children's Oncology Group between 1955 and 1997, regardless of whether they were published. MAIN OUTCOME MEASURES: Overall survival, event free survival, and treatment related mortality. RESULTS: 126 trials were included, involving 152 comparisons and 36,567 patients. The odds ratio for overall survival with experimental treatments was 0.96 (99% confidence interval 0.89 to 1.03), indicating that new treatments are as likely to be inferior as they are to be superior to standard treatments. This result was not affected by publication bias, methodological quality, treatment type, disease, or comparator. CONCLUSIONS: New treatments in childhood cancer tested in randomised controlled trials are, on average, as likely to be inferior as they are to be superior to standard treatments, confirming that the uncertainty principle has been operating.

Child↗

PubMed1998

Human albumin administration in critically ill patients: systematic review of randomised controlled trials.

OBJECTIVE: To quantify effect on mortality of administering human albumin or plasma protein fraction during management of critically ill patients. DESIGN: Systematic review of randomised controlled trials comparing administration of albumin or plasma protein fraction with no administration or with administration of crystalloid solution in critically ill patients with hypovolaemia, burns, or hypoalbuminaemia. SUBJECTS: 30 randomised controlled trials including 1419 randomised patients. MAIN OUTCOME MEASURE: Mortality from all causes at end of follow up for each trial. RESULTS: For each patient category the risk of death in the albumin treated group was higher than in the comparison group. For hypovolaemia the relative risk of death after albumin administration was 1.46 (95% confidence interval 0.97 to 2.22), for burns the relative risk was 2.40 (1.11 to 5.19), and for hypoalbuminaemia it was 1.69 (1.07 to 2.67). Pooled relative risk of death with albumin administration was 1.68 (1.26 to 2.23). Pooled difference in the risk of death with albumin was 6% (95% confidence interval 3% to 9%) with a fixed effects model. These data suggest that for every 17 critically ill patients treated with albumin there is one additional death. CONCLUSIONS: There is no evidence that albumin administration reduces mortality in critically ill patients with hypovolaemia, burns, or hypoalbuminaemia and a strong suggestion that it may increase mortality. These data suggest that use of human albumin in critically ill patients should be urgently reviewed and that it should not be used outside the context of rigorously conducted, randomised controlled trials.

Albumins↗

PubMed1999

Evaluation of general practice computer templates. Lessons from a pilot randomised controlled trial.

We conducted a pilot randomised trial of computerised templates for the management of asthma and diabetes in general practice in six general practices in North London. Uptake of the guidelines by general practitioners and practice nurses was assessed using qualitative (semi-structured interviews designed to assess the users' views) and quantitative (change in use of the template during the study period) outcome measures. The practice nurses used the templates frequently but general practitioners rarely used them. Several reasons were offered for non-use of the templates, such as the length of the template and non-involvement in the care of asthma or diabetes. Despite this, however, health professionals were favourably disposed to the use of templates for general clinical care. Pilot investigations of computerised templates are best achieved by observational or quasi-experimental methods rather than a randomised controlled trial. The use of both qualitative and quantitative methods in this study allowed exploration of the barriers to use of computers.

Asthma↗

PubMed2003

Intensive support to improve clinical decision making in cardiovascular care: a randomised controlled trial in general practice.

OBJECTIVE: To evaluate the effects of feedback reports combined with outreach visits from trained non-physicians on the clinical decision making of general practitioners (GPs) in cardiovascular care. DESIGN: Pragmatic cluster controlled trial with randomisation of practices to support (intervention group) or no special attention (control group); analysis after 2 years. SETTING: 124 general practices in The Netherlands. PARTICIPANTS: 185 GPs. MAIN OUTCOME MEASURES: Compliance rates for 12 evidence-based indicators for the management of patients with hypertension, hypercholesterolaemia, angina pectoris, or heart failure. The evaluation relied on the prospective recording of patient encounters by the participating GPs. RESULTS: The GPs reported 30 101 clinical decisions at baseline and 22 454 decisions after the intervention. A significant improvement was seen for five of the 12 indicators: assessment of risk factors in patients with hypercholesterolaemia (odds ratio 2.04; 95% CI 1.44 to 2.88) or angina pectoris (3.07; 1.08 to 8.79), provision of information and advice to patients with hypercholesterolaemia (1.58, 1.17 to 2.13) or hypertension (1.55, 1.35 to 1.77), and checking for clinical signs of deterioration in patients with heart failure (4.11, 2.17 to 7.77). Single handed practices, non-training practices, and practices with older GPs gained particular benefit from the intervention. CONCLUSIONS: Intensive support from trained non-physicians can alter certain aspects of the clinical decision making of GPs in cardiovascular care. The effect is small and the strategy needs further development.

Adult↗

PubMed2002

The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team.

A randomised controlled trial was undertaken to assess the effectiveness of a hospital Palliative Care Team (PCT) on physical symptoms and health-related quality of life (HRQoL); patient, family carer and primary care professional reported satisfaction with care; and health service resource use. The full package of advice and support provided by a multidisciplinary specialist PCT ('full-PCT') was compared with limited telephone advice ('telephone-PCT', the control group) in the setting of a teaching hospital trust in the SW of England. The trial recruited 261 out of 684 new inpatient referrals; 175 were allocated to 'full-PCT', 86 to 'telephone-PCT' (2 : 1 randomisation); with 191 (73%) being assessed at 1 week. There were highly significant improvements in symptoms, HRQoL, mood and 'emotional bother' in 'full-PCT' at 1 week, maintained over the 4-week follow-up. A smaller effect was seen in 'telephone-PCT'; there were no significant differences between the groups. Satisfaction with care in both groups was high and there was no significant difference between them. These data reflect a high standard of care of patients dying of cancer and other chronic diseases in an acute hospital environment, but do not demonstrate a difference between the two models of service delivery of specialist palliative care.

Activities of Daily Living↗

PubMedDate not supplied

Effects of repeated prenatal ultrasound examinations on childhood outcome up to 8 years of age: follow-up of a randomised controlled trial.

BACKGROUND: Despite the widespread use of prenatal ultrasound studies, there are no published data from randomised controlled trials describing childhood outcomes that might be influenced by repeated ultrasound exposures. We previously undertook a randomised controlled trial to assess the effects of multiple studies on pregnancy and childhood outcomes and reported that those pregnancies allocated to receive multiple examinations had an unexplained and significant increase in the proportion of growth restricted newborns. Our aim was to investigate the possible effects of multiple prenatal ultrasound scans on growth and development in childhood. Here, we provide follow-up data of the childrens' development. METHODS: Physical and developmental assessments were done on children whose pregnant mothers had been allocated at random to a protocol of five studies of ultrasound imaging and umbilical artery Doppler flow velocity waveform between 18 and 38 weeks' gestation (intensive group n=1490) or a single imaging study at 18 weeks' gestation (regular group n=1477). We used generalised logistic and linear regression models to assess the group differences in developmental and growth outcomes over time. Primary data analysis was done by intention-to-treat. FINDINGS: Examinations were done at 1, 2, 3, 5, and 8 years of age on children born without congenital abnormalities and from singleton pregnancies (intensive group n=1362, regular group n=1352). The follow-up rate at 1 year was 85% (2310/2714) and at 8 years was 75% (2042/2714). By 1 year of age and thereafter, physical sizes were similar in the two groups. There were no significant differences indicating deleterious effects of multiple ultrasound studies at any age as measured by standard tests of childhood speech, language, behaviour, and neurological development. INTERPRETATION: Exposure to multiple prenatal ultrasound examinations from 18 weeks' gestation onwards might be associated with a small effect on fetal growth but is followed in childhood by growth and measures of developmental outcome similar to those in children who had received a single prenatal scan.

Blood Flow Velocity↗

PubMed2002

Quality of reporting of randomised controlled trials in the intensive care literature. A systematic analysis of papers published in Intensive Care Medicine over 26 years.

OBJECTIVE: To assess the number and quality of the reporting of randomised controlled trials (RCTs) published in Intensive Care Medicine. DESIGN: Systematic revision. SETTING: Randomised controlled trials published in Intensive Care Medicine. STUDY SELECTION: All RCTs published in this journal from its birth to December 2000 identified by MEDLINE and our own research. MEASUREMENTS AND RESULTS: The Jadad scale and the individual assessment of key methodological components, namely the randomisation process, blinding and reporting and handling of loss to follow-up, were used to evaluate the quality of reporting. Other information was extracted regarding the design characteristics and the analytical approach. 173 RCTs, 63% of which were from European countries, were analysed. Adequately reported RCTs according to a Jadad scale score of more than 2 were 44 (25.4%). Analysis of individual methodological components revealed a variable percentage of adequate reporting ranging from 3.5% for randomisation to 10.4% for blinding and to 49.1% for loss to follow-up. Sample sizes were small with a median of 30 patients and rationale for its estimation was reported in 7.5%. Despite this, 81.5% of RCTs reported statistically significant results, suggesting that the treatment effects were strong or that a publication bias existed or that the uncertainty principle was not fulfilled. CONCLUSIONS: Randomised controlled trials offer the best evidence of the efficacy of medical interventions, provided that high standards of transparent reporting are used. More resolute attention to the methodological quality of reporting and adherence to recently published guidelines (CONSORT II) may help to achieve this result.

Bibliometrics↗

PubMed2006

Cognitive-behaviour therapy for chronic fatigue syndrome: comparison of outcomes within and outside the confines of a randomised controlled trial.

Outcomes for cognitive-behaviour therapy (CBT) in randomised controlled trials (RCTs) have rarely been compared to those in routine clinical practice. Taking the case of CBT for chronic fatigue syndrome (CFS), we evaluated the results of a successful RCT against those of the same treatment given in the same setting as part of routine practice. Fatigue and social adjustment scores were compared for patients who received CBT for CFS as part of a RCT (N=30) and patients who received CBT as part of everyday clinical practice (N=384). The results in the RCT were superior to those in routine clinical practice. Between pre-treatment and 6-month follow-up, the RCT showed a larger reduction in fatigue and greater improvement in social adjustment than those in routine treatment. The changes in fatigue scores were similar for both groups during treatment but were greater in the RCT between post-treatment and follow-up. Potential reasons for the superior results of the RCT include patient selection, therapist factors and the use of a manualised treatment protocol. Practitioners need to pay particular attention to relapse prevention and ensuring adequate follow-up in addition to encouraging patients to continue with cognitive-behavioural strategies once treatment has ended.

Adaptation, Psychological↗

PubMed1988

Quality of life on angina therapy: a randomised controlled trial of transdermal glyceryl trinitrate against placebo.

In a randomised controlled trial in 427 men with chronic stable angina continuous use of 5 mg transdermal glyceryl trinitrate (GTN) showed no advantage over placebo in terms of efficacy (anginal attack rates and sublingual GTN consumption) or quality of life (as measured with the sickness impact profile and a health index of disability). Patients on the active drug reported headaches more frequently than patients on placebo, and a higher proportion of them withdrew from the trial because of headache. Quality-of-life measurements showed a significant adverse effect of active treatment, principally in the social interaction dimension of the sickness impact profile. A similar effect was observed in placebo patients when crossed to active treatment in a 4-week single-blind period. The results suggest no benefit in the relief of chest pain from 5 mg transdermal GTN when used continuously.

Administration, Cutaneous↗

PubMed1986

Cataract surgery: interim results and complications of a randomised controlled trial. Oxford Cataract Treatment and Evaluation Team (OCTET).

A randomised controlled trial in progress for more than five years, with no loss to follow-up (except death), assessed 333 eyes treated by three methods of cataract surgery. They were (A) intracapsular extraction and contact lens usage, (B) intracapsular extraction and implantation of an iris supported lens (Federov I), and (C) extracapsular extraction and implantation of an iridocapsular lens (Binkhorst 2-loop). The purpose of the paper is to report interim visual results, complications, and corneal endothelial cell loss. More eyes in groups A (contact lens) and C (extracapsular + implant) achieved better visual acuity than in group B (intracapsular + Federov lens), which also had more postoperative complications. Both implant groups lost more endothelial cells than the non-implant group, which did not differ significantly from group B before one year.

Aged↗

PubMed1996

Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted over two years with confirmed myocardial infarction and discharged home within 28 days. INTERVENTIONS: Rehabilitation programmes comprising psychological therapy, counselling, relaxation training, and stress management training over seven weekly group outpatient sessions for patients and spouses. MAIN OUTCOME MEASURES: Anxiety, depression, quality of life, morbidity, use of medication, and mortality. RESULTS: At six months there were no significant differences between rehabilitation patients and controls in reported anxiety (prevalence 33%) or depression (19%). Rehabilitation patients reported a lower frequency of angina (median three versus four episodes a week), medication, and physical activity. At 12 months there were no differences in clinical complications, clinical sequelae, or mortality. CONCLUSIONS: Rehabilitation programmes based on psychological therapy, counselling, relaxation training, and stress management seem to offer little objective benefit to patients who have experienced myocardial infarction compared with previous reports of smaller trials.

Angina Pectoris↗