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Results for “Randomised Controlled Trial”

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PubMed2000

Distribution of randomised controlled trials of drugs for post-operative nausea and vomiting.

PURPOSE: Randomised controlled trials (RCTs) guide therapeutic decisions. But which RCTs are done; which omitted; and which should be done? This study illustrates a method to explore these questions applied to drugs for post-operative nausea and vomiting (PONV). METHODS: Review articles listed 18 drugs for PONV. All RCTs of these drugs for PONV were sought. The first drug mentioned in an RCT was counted and tabulated against others in all the arms of the RCT (against itself in a dose-ranging RCT). Additional drugs mentioned in these RCTs were added to the study, for a total of 40 drugs. RESULTS: Drugs involved in the most RCTs were: ondansetron 131 RCTs; propofol 118; droperidol 74; metoclopramide 67; granisetron 52; scopolamine 22; tropisetron 16. Drugs involved in the fewest RCTs: two drugs with 2 RCTs; twelve drugs with one; three with none. Probability that this distribution occurred by chance: P < 0.00001; that the distribution of dose-ranging RCTs occurred by chance: P < 0.001. Regression of RCT numbers on cost: R = 0.86, P < 0.0001; on year of drug introduction: R = 0.14. Of 1600 possible comparisons of drugs for PONV, (including dose-ranging) 97.8% have never been published. CONCLUSION: Although some antiemetic drugs for PONV have been studied in large numbers of RCTs, many have not been adequately evaluated. Finding relevant RCTs and tabulating their comparison arms is useful for directing future research, and is applicable to any symptom or disorder.

Antiemetics↗

PubMed2001

Orthopaedic fractures: trends in randomised controlled trials.

AIM: To ascertain and describe the number and epidemiology of randomised controlled trials (RCTs) focused on orthopaedic fractures. METHODS: A sensitive literature search was carried out for the period 1966-May 1999. Labels were applied to each identified RCT to indicate the fracture type, and the main type of intervention. RESULTS: 648 RCTs related to surgery of which 123 focused on adjuvant therapies and 88 related mainly to anaesthesia, analgesia, and radiography. The number of trials have increased exponentially with time so that the present decade has seen more RCTs published than all the other years added together. CONCLUSION: There is clearly an encouraging trend in the number of RCTs published. However there is a need to ensure that trials are on fracture types where there is most need for guidance. This growing evidence base should fuel systematic reviews and clinical guidelines within orthopaedics.

Evidence-Based Medicine↗

PubMed1978

Randomised controlled trial of early discharge for inguinal hernia and varicose veins.

A randomised controlled trial has been conducted into the effects of discharging patients from hospital either 48 hours or six to seven days after operations for inguinal hernia and varicose veins. There was no statistically significant difference in major postoperative complications between the two lengths of stay for either of the two conditions. Similarly there was no difference between the two groups of hernia patients in relation to eventual recurrences. There was no significant difference in length of convalescence between long-stay and short-stay patients in full-time occupations. The savings to the statutory services of discharging patients early were estimated at 25.72 pounds per patient. Patients appeared to approve of the type of care they experienced, regardless of length of stay. However, the families of short-stay patients were significantly less enthusiastic in their attitudes towards the policy of early discharge than the families of long-stay patients.

Adolescent↗

PubMed1986

Effect of a lactation nurse on the success of breast-feeding: a randomised controlled trial.

An evaluation of a lactation nurse by means of a randomised controlled trial is described. The lactation nurse was employed to assist, support, and encourage mothers during the early weeks after parturition in hospital and at home. All mothers who breast-fed at least once were entered into the trial. Altogether 649 mothers were interviewed 12 months later to establish the duration of breast-feeding and to enquire after practices of and attitudes towards infant feeding. The lactation nurse significantly extended the duration of breast-feeding, particularly during the first four weeks and among women of lower social class. Although she did not reduce problems or change practices significantly, all the trends were consistently in the right direction. Mothers in the experimental group were more satisfied with the help they received than were mothers in the control group. It seems likely that the lactation nurse by consistent advice, assistance, support, and encouragement enabled mothers to cope more successfully with difficulties and that this led to significantly fewer ending breast-feeding prematurely.

Birth Order↗

PubMed1996

Randomised controlled trial of anti-smoking advice in pregnancy. 1977.

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.

Female↗

PubMed1997

Corticosteroids in acute traumatic brain injury: systematic review of randomised controlled trials.

OBJECTIVE: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. DESIGN: Systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury. Summary odds ratios were estimated as an inverse variance weighted average of the odds ratios for each study. SETTING: Randomised trials available by March 1996. SUBJECTS: The included trials with outcome data comprised 2073 randomised participants. RESULTS: The effect of corticosteroids on the risk of death was reported in 13 included trials. The pooled odds ratio for the 13 trials was 0.91 (95% confidence interval 0.74 to 1.12). Pooled absolute risk reduction was 1.8% (-2.5% to 5.7%). For the 10 trials that reported death or disability the pooled odds ratio was 0.90 (0.72 to 1.11). For infections of any type the pooled odds ratio was 0.92 (0.69 to 1.23) and for the seven trials reporting gastrointestinal bleeding it was 1.05 (0.44 to 2.52). With only those trials with the best quality of concealment of allocation, the pooled odds ratio estimates for death and death or disability became closer to unity. CONCLUSIONS: This systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury shows that there remains considerable uncertainty over their effects. Neither moderate benefits nor moderate harmful effects can be excluded. The widely practicable nature of the drugs and the importance of the health problem suggest that large simple trials are feasible and worth while to establish whether there are any benefits from use of corticosteroids in this setting.

Acute Disease↗

PubMed2006

Robust randomised control trials needed for drug treatments for trigeminal neuralgia.

DATA SOURCES: Searches for appropriate studies were made using the following: Cochrane Neuromuscular Disease Group Register, Medline, Embase and LILACS (Latin American and Caribbean Literature on the Health Sciences) together the Chinese Biomedical Retrieval System, the database of the Chinese Cochrane Centre, conference paper databases and checked bibliographies. 10 Chinese journals were searched by hand. STUDY SELECTION: Randomised controlled trials (RCT) or quasi-randomised controlled trials were included. DATA EXTRACTION AND SYNTHESIS: Two authors decided which trials fitted the inclusion criteria and graded methodological quality independently. RESULTS: Nine trials of different non-antiepileptic drugs involving 223 participants were included. Each trial investigated one non-antiepileptic drug. Two trials tested baclofen. In one, more people achieved 50% reduction from baseline than with placebo [relative risk (RR), 15.00; 95% confidence interval (CI), 0.97-231.84; P 0.05]. In the other, slightly more participants who took baclofen showed a 75% reduction in attacks on the tenth day compared with carbamazepine (RR, 2.38; 95% CI, 0.83-6.85; P 0.11). One trial showed no significant difference in reduction in average daily frequency of attacks with Baclofen compared with Racemic Baclofen. Tizanidine was investigated in two trials. In one, the proportion of people with a reduction in the mean number of paroxysms per day increased with tizanidine compared with placebo (RR, 8.00; 95% CI, 1.21-52.69; P 0.03). In the other, one of five participants improved their visual analogue scale score with tizanidine and four of six did so having taken carbamazepine (RR, 0.30; 95% CI, 0.05-1.89; P 0.20). One study showed that the improvement in mean values of pain scores with tocainide was similar to that of carbamazepine. In a further trial, more participants improved during the pimozide than the carbamazepine period (RR, 1.78; 95% CI, 1.39-2.28). In another, a 0.5% instillation of proparacaine hydrochloride into the eyes did not produce significantly different results from placebo (RR, 1.06; 95% CI, 0.37-2.99; P 0.92). Finally, there was moderate or marked improvement in a study in seven of nine participants who took clomipramine and three of nine who took amitriptyline during a 12-week treatment (RR, 2.33; 95% CI, 0.87-6.27). CONCLUSIONS: Trials of non-antiepileptic drugs for treating trigeminal neuralgia have all been limited by poor methodological quality or poor reporting. There is insufficient evidence from randomised clinical trials to show significant benefit from non-antiepileptic drugs for trigeminal neuralgia.

Comment↗

PubMedDate not supplied

Accidents in elderly care: a randomised controlled trial (Part 1).

This paper reports the data on accidents from a randomised controlled trial evaluating health authority-funded nursing home and long stay care of the elderly ward care in one inner London health district. Respondents randomised to NHS nursing homes experienced a higher accident rate than respondents randomised to conventional long stay hospital wards for elderly people. Respondents in the homes also experienced an earlier decline in functional and mental ability than those in hospital. These disadvantages have to be balanced against the previously published observational data from the evaluation, which clearly indicated that quality of life in the homes was superior to that in the wards. The conclusion from this study is that earlier decline in functional and mental ability and increased accident risk in the more flexible environments of the nursing homes have to be balanced against an inferior quality of life in the large hospital long stay wards.

Accidental Falls↗

PubMedDate not supplied

Accidents in elderly care: a randomised controlled trial (Part 2).

Accidental Falls↗

PubMedDate not supplied

Accidents in elderly care: a randomised controlled trial (part 3).

Accidental Falls↗

PubMed2000

Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. I: clinical effectiveness.

OBJECTIVE: To compare the clinical effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients. DESIGN: Prospective, controlled trial with randomised and patient preference allocation arms. SETTING: General practices in London and greater Manchester. PARTICIPANTS: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion. INTERVENTIONS: Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists. MAIN OUTCOME MEASURES: Beck depression inventory scores, other psychiatric symptoms, social functioning, and satisfaction with treatment measured at baseline and at 4 and 12 months. RESULTS: 197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. All groups improved significantly over time. At four months, patients randomised to non-directive counselling or cognitive-behaviour therapy improved more in terms of the Beck depression inventory (mean (SD) scores 12.9 (9.3) and 14.3 (10.8) respectively) than those randomised to usual general practitioner care (18.3 (12.4)). However, there was no significant difference between the two therapies. There were no significant differences between the three treatment groups at 12 months (Beck depression scores 11.8 (9.6), 11.4 (10.8), and 12.1 (10.3) for non-directive counselling, cognitive-behaviour therapy, and general practitioner care). CONCLUSIONS: Psychological therapy was a more effective treatment for depression than usual general practitioner care in the short term, but after one year there was no difference in outcome.

Adult↗

PubMed2003

Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA): a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population [ISRCTN89345269].

BACKGROUND: Atrial fibrillation (AF) is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly. The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting. STUDY DESIGN: A randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire.1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa). The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular), hospital admissions (all cause, vascular), cognition, quality of life, disability and compliance with study medication.

Aged↗

PubMed2000

Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. II: cost effectiveness.

OBJECTIVE: To compare the cost effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients. DESIGN: Prospective, controlled trial with randomised and patient preference allocation arms. SETTING: General practices in London and greater Manchester. PARTICIPANTS: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion. INTERVENTIONS: Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists. MAIN OUTCOME MEASURES: Beck depression inventory scores, EuroQol measure of health related quality of life, direct treatment and non-treatment costs, and cost of lost production. RESULTS: 197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. At four months, both non-directive counselling and cognitive-behaviour therapy reduced depressive symptoms to a significantly greater extent than usual general practitioner care. There was no significant difference in outcome between treatments at 12 months. There were no significant differences in direct costs, production losses, or societal costs between the three treatments at either four or 12 months. Sensitivity analyses did not suggest that the results depended on particular assumptions in the statistical analysis. CONCLUSIONS: Within the constraints of available power, the data suggest that both brief psychological therapies may be significantly more cost effective than usual care in the short term, as benefit was gained with no significant difference in cost. There are no significant differences between treatments in either outcomes or costs at 12 months.

Adult↗

PubMed2001

Randomised controlled trial of structured personal care of type 2 diabetes mellitus.

OBJECTIVE: To assess the effect of a multifaceted intervention directed at general practitioners on six year mortality, morbidity, and risk factors of patients with newly diagnosed type 2 diabetes. DESIGN: Pragmatic, open, controlled trial with randomisation of practices to structured personal care or routine care; analysis after 6 years. SETTING: 311 Danish practices with 474 general practitioners (243 in intervention group and 231 in comparison group). PARTICIPANTS: 874 (90.1%) of 970 patients aged >/=40 years who had diabetes diagnosed in 1989-91 and survived until six year follow up. INTERVENTION: Regular follow up and individualised goal setting supported by prompting of doctors, clinical guidelines, feedback, and continuing medical education. MAIN OUTCOME MEASURES: Predefined clinical non-fatal outcomes, overall mortality, risk factors, and weight. RESULTS: Predefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower for intervention patients than for comparison patients (median values): fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24% (110/459) v 15% (61/415)). Intervention doctors arranged more follow up consultations, referred fewer patients to diabetes clinics, and set more optimistic goals. CONCLUSIONS: In primary care, individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain.

Age Factors↗

PubMed2004

Detecting diminutive colorectal lesions at colonoscopy: a randomised controlled trial of pan-colonic versus targeted chromoscopy.

BACKGROUND: Diminutive and flat colorectal lesions can be difficult to detect using conventional colonoscopic techniques. Previous data have suggested that pan-chromoscopy may improve detection rates. No randomised control trial has been performed examining detection rates of such lesions while controlling for extubation time and lavage effect. AIM: We conducted a randomised controlled trial of pan-colonic chromoscopic colonoscopy for the detection of diminutive and flat colorectal lesions while controlling for extubation time and lavage effect. METHODS: Consecutive patients attending for routine colonoscopy were randomised to either pan-chromoscopy using 0.5% indigo carmine (IC) or targeted chromoscopy (control group). A minimum diagnostic extubation time was set at eight minutes with controls undergoing a matched volume of saline wash. RESULTS: A total of 260 patients were randomised; 132 controls and 128 to pan-colonic chromoscopy. Extubation times did not differ significantly between the control (median 15 minutes (range 8-41)) and chromoscopy (median 17 minutes (range 8-39)) groups. The volume of IC used in the pan-chromoscopy group (median 68 ml (range 65-90)) and normal saline used in the control group (69 ml (range 60-93)) did not differ significantly. There was a statistically significant difference between the groups regarding the total number of adenomas detected (p<0.05) with significantly more diminutive (<4 mm) adenomas detected in the pan-chromoscopy group (p = 0.03). Pan-chromoscopy diagnosed more diminutive and flat lesions in the right colon compared with controls (p<0.05), with more patients with multiple adenomas (>3) detected using pan-chromoscopy (p<0.01). Hyperplastic lesions were more commonly detected in the pan-chromoscopy group compared with controls (p<0.001). More hyperplastic polyps were detected in the left colon (86% rectosigmoid) using chromoscopy compared with controls. CONCLUSION: Chromoscopy improves the total number of adenomas detected and enhances the detection of diminutive and flat lesions. Importantly, eight diminutive lesions had foci of high grade dysplasia. Chromoscopy may benefit patients, assuming a high risk of colorectal cancer, and help in risk stratification and planning follow up colonoscopy intervals.

Adenoma↗

PubMed2004

Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes.

BACKGROUND: Adherence difficulties and psychological problems are associated with poor glycaemic control in diabetes. We undertook a systematic review and meta-analysis of psychological therapies to assess their effectiveness in improving glycaemic control in type 2 diabetes. METHODS: We searched MEDLINE, PsychINFO, EMBASE, and the Cochrane Central Register of Controlled Trials up to January, 2003. Eligible studies were randomised controlled trials that involved people with type 2 diabetes and evaluated a psychological therapy (counselling, cognitive behaviour therapy, or psychodynamic therapy) to improve diabetes control. We extracted the number of participants, their age, duration of diabetes, glycaemic control, type of psychological therapy, its mode of delivery, and type of intervention in the control group. The main outcome was long-term glycaemic control measured by percentage of glycated haemoglobin. Blood glucose concentration, weight, and psychological distress were also measured. Pooled standardised effect sizes were calculated. FINDINGS: 25 trials were eligible for the review. In 12 trials, the mean percentage glycated haemoglobin was lower in people assigned a psychological intervention than in the control group (usual care, education, waiting list, or attention control); the pooled mean difference was -0.32 (95% CI -0.57 to -0.07) equivalent to an absolute difference of -0.76%. There were non-significant differences in blood glucose concentration (eight trials; -0.11 [-0.65 to 0.42]) and weight gain (nine trials; 0.37 [-0.18 to 0.93]). Psychological distress was significantly lower in the intervention groups (five trials; -0.58 [-0.95 to -0.20]). INTERPRETATION: In type 2 diabetes, there are improvements in long-term glycaemic control and psychological distress but not in weight control or blood glucose concentration in people who receive psychological therapies.

Blood Glucose↗

PubMed2006

Progressive coronary calcification despite intensive lipid-lowering treatment: a randomised controlled trial.

OBJECTIVES: To evaluate the effect of intensive lipid-lowering treatment on coronary artery calcification in a substudy of a trial recruiting patients with calcific aortic stenosis. METHODS: In a double blind randomised controlled trial, 102 patients with calcific aortic stenosis and coronary artery calcification were randomly assigned by the minimisation technique to atorvastatin 80 mg daily or matched placebo. Coronary artery calcification was assessed annually by helical computed tomography. RESULTS: 48 patients were randomly assigned to atorvastatin and 54 to placebo with a median follow up of 24 months (interquartile range 24-30). Baseline characteristics and coronary artery calcium scores were similar in both groups. Atorvastatin reduced serum low density lipoprotein cholesterol (-53%, p < 0.001) and C reactive protein (-49%, p < 0.001) concentrations whereas there was no change with placebo (-7% and 17%, p > 0.95 for both). The rate of change in coronary artery calcification was 26%/year (0.234 (SE 0.037) log arbitrary units (AU)/year; n = 39) in the atorvastatin group and 18%/year (0.167 (SE 0.034) log AU/year; n = 49) in the placebo group, with a geometric mean difference of 7%/year (95% confidence interval -3% to 18%, p = 0.18). Serum low density lipoprotein concentrations were not correlated with the rate of progression of coronary calcification (r = 0.05, p = 0.62). CONCLUSION: In contrast to previous observational studies, this randomised controlled trial has shown that, despite reducing systemic inflammation and halving serum low density lipoprotein cholesterol concentrations, statin treatment does not have a major effect on the rate of progression of coronary artery calcification.

Adult↗

PubMed2005

Lay public's understanding of equipoise and randomisation in randomised controlled trials.

OBJECTIVES: To research the lay public's understanding of equipoise and randomisation in randomised controlled trials (RCTs) and to look at why information on this may not be not taken in or remembered, as well as the effects of providing information designed to overcome barriers. DESIGN: Investigations were informed by an update of systematic review on patients' understanding of consent information in clinical trials, and by relevant theory and evidence from experimental psychology. Nine investigations were conducted with nine participants. SETTING: Access (return to education), leisure and vocational courses at Further Education Colleges in the Midlands, UK. PARTICIPANTS: Healthy adults with a wide range of educational backgrounds and ages. INVESTIGATIONS: Participants read hypothetical scenarios and wrote brief answers to subsequent questions. Sub-samples of participants were interviewed individually to elaborate on their written answers. Participants' background assumptions concerning equipoise and randomisation were examined and ways of helping participants recognise the scientific benefits of randomisation were explored. MAIN OUTCOME MEASURES: Judgments on allocation methods; treatment preferences; the acceptability of random allocation; whether or not individual doctors could be completely unsure about the best treatment; whether or not doctors should reveal treatment preferences under conditions of collective equipoise; and how sure experts would be about the best treatment following random allocation vs doctor/patient choice. Assessments of understanding hypothetical trial information. RESULTS: Recent literature continues to report trial participants' failure to understand or remember information about randomisation and equipoise, despite the provision of clear and readable trial information leaflets. In current best practice, written trial information describes what will happen without offering accessible explanations. As a consequence, patients may create their own incorrect interpretations and consent or refusal may be inadequately informed. In six investigations, most participants identified which methods of allocation were random, but judged the random allocation methods to be unacceptable in a trial context; the mere description of a treatment as new was insufficient to engender a preference for it over a standard treatment; around half of the participants denied that a doctor could be completely unsure about the best treatment. A majority of participants judged it unacceptable for a doctor to suggest letting chance decide when uncertain of the best treatment, and, in the absence of a justification for random allocation, participants did not recognise scientific benefits of random allocation over normal treatment allocation methods. The pattern of results across three intervention studies suggests that merely supplementing written trial information with an explanation is unlikely to be helpful. However, when people manage to focus on the trial's aim of increasing knowledge (as opposed to making treatment decisions about individuals), and process an explanation actively, they may be helped to understand the scientific reasons for random allocation. CONCLUSIONS: This research was not carried out in real healthcare settings. However, participants who could correctly identify random allocation methods, yet judged random allocation unacceptable, doubted the possibility of individual equipoise and saw no scientific benefits of random allocation over doctor/patient choice, are unlikely to draw upon contrasting views if invited to enter a real clinical trial. This suggests that many potential trial participants may have difficulty understanding and remembering trial information that conforms to current best practice in its descriptions of randomisation and equipoise. Given the extent of the disparity between the assumptions underlying trial design and the assumptions held by the lay public, the solution is unlikely to be simple. Nevertheless, the results suggest that including an accessible explanation of the scientific benefits of randomisation may be beneficial provided potential participants are also enabled to reflect on the trial's aim of advancing knowledge, and to think actively about the information presented. Further areas for consideration include: the identification of effective combinations of written and oral information; helping participants to reflect on the aim of advancing knowledge; and an evidence-based approach to leaflet construction.

Adolescent↗