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Results for “Randomised Controlled Trial”

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PubMed2006

Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.

BACKGROUND: Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. AIM: To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. DESIGN OF STUDY: Randomised controlled trial. SETTING: General practices in Reading, UK. METHOD: Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. RESULTS: Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. CONCLUSIONS: This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication.

Aged↗

PubMed2007

Protocol for the smoking, nicotine and pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy.

BACKGROUND: Smoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA)-funded smoking, nicotine and pregnancy (SNAP) trial will investigate whether or not nicotine replacement therapy (NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women. METHODS/DESIGN: Over two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within two weeks of this) and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups. DISCUSSION: This trial is designed to ascertain whether or not standard doses of NRT (as transdermal patches) are effective and safe when used for smoking cessation during pregnancy.

Adolescent↗

PubMedDate not supplied

Effects of antenatal multiple micronutrient supplementation on birthweight and gestational duration in Nepal: double-blind, randomised controlled trial.

BACKGROUND: Neonatal mortality is the biggest contributor to global mortality of children younger than 5 years, and low birthweight is a crucial underlying factor. We tested the hypotheses that antenatal multiple micronutrient supplementation would increase infant birthweight and gestational duration. METHODS: We did a double-blind, randomised controlled trial in Dhanusha district, Nepal. Women attending for antenatal care with singleton pregnancies at up to 20 weeks' gestation were invited to participate. Participants were randomly allocated either routine iron and folic acid supplements (control; n=600) or a multiple micronutrient supplement providing a recommended daily allowance of 15 vitamins and minerals (intervention; n=600). Supplementation began at a minimum of 12 weeks' gestation and continued until delivery. Primary outcome measures were birthweight and gestational duration. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN88625934. FINDINGS: Birthweight was available for 523/600 infants in the control group and 529/600 in the intervention group. Mean birthweight was 2733 g (SD 422) in the control group and 2810 g (453) in the intervention group, representing a mean difference of 77 g (95% CI 24-130; p=0.004) and a relative fall in the proportion of low birthweight by 25%. No difference was recorded in the duration of gestation (0.2 weeks [-0.1 to 0.4]; p=0.12), infant length (0.3 cm [-0.1 to 0.6]; p=0.16), or head circumference (0.2 cm [-0.1 to 0.4]; p=0.18). INTERPRETATION: In a poor community in Nepal, consumption of a daily supplement containing a recommended daily allowance of 15 micronutrients in the second and third trimesters of pregnancy was associated with increased birthweight when compared with a standard iron and folic acid preparation. The effects on perinatal morbidity and mortality need further comparisons between studies. Published online March 3, 2005 http://image.thelancet.com/extras/04art11045web.pdf.

Birth Weight↗

PubMed1998

Analysis and interpretation of cost data in randomised controlled trials: review of published studies.

OBJECTIVE: To review critically the statistical methods used for health economic evaluations in randomised controlled trials where an estimate of cost is available for each patient in the study. DESIGN: Survey of published randomised trials including an economic evaluation with cost values suitable for statistical analysis; 45 such trials published in 1995 were identified from Medline. MAIN OUTCOME MEASURES: The use of statistical methods for cost data was assessed in terms of the descriptive statistics reported, use of statistical inference, and whether the reported conclusions were justified. RESULTS: Although all 45 trials reviewed apparently had cost data for each patient, only 9 (20%) reported adequate measures of variability for these data and only 25 (56%) gave results of statistical tests or a measure of precision for the comparison of costs between the randomised groups. Only 16 (36%) of the articles gave conclusions which were justified on the basis of results presented in the paper. No paper reported sample size calculations for costs. CONCLUSIONS: The analysis and interpretation of cost data from published trials reveal a lack of statistical awareness. Strong and potentially misleading conclusions about the relative costs of alternative therapies have often been reported in the absence of supporting statistical evidence. Improvements in the analysis and reporting of health economic assessments are urgently required. Health economic guidelines need to be revised to incorporate more detailed statistical advice.

Cost-Benefit Analysis↗

PubMed2006

Psychological interventions for post-traumatic reactions in children and young people: a review of randomised controlled trials.

Children exposed to a wide range of traumatic events suffer significant post-traumatic reactions. Randomised controlled trials assessing the effectiveness of interventions with traumatised children are described, the limitations of the current literature base identified and issues regarding the applicability of these findings and interventions to everyday clinical practice discussed. Methodological issues, variations in interventions, parental involvement, theoretical underpinning and outcomes will be discussed and implications for future studies highlighted.

Adolescent↗

PubMed2003

The randomised controlled trial design: unrecognized opportunities for health sciences librarianship.

OBJECTIVE: to describe the essential components of the Randomised Controlled Trial (RCT) and its major variations; to describe less conventional applications of the RCT design found in the health sciences literature with potential relevance to health sciences librarianship; to discuss the limited number of RCTs within health sciences librarianship. METHODS: narrative review supported to a limited extent with PubMed and Library Literature database searches consistent with specific search parameters. In addition, more systematic methods, including handsearching of specific journals, to identify health sciences librarianship RCTs. RESULTS: While many RCTs within the health sciences follow more conventional patterns, some RCTs assume certain unique features. Selected examples illustrate the adaptations of this experimental design to answering questions of possible relevance to health sciences librarians. The author offers several strategies for controlling bias in library and informatics applications of the RCT and acknowledges the potential of the electronic era in providing many opportunities to utilize the blinding aspects of RCTs. RCTs within health sciences librarianship inhabit a limited number of subject domains such as education. This limited scope offers both advantages and disadvantages for making Evidence-Based Librarianship (EBL) a reality. CONCLUSIONS: The RCT design offers the potential to answer far more EBL questions than have been addressed by the design to date. Librarians need only extend their horizons through use of the versatile RCT design into new subject domains to facilitate making EBL a reality.

Evidence-Based Medicine↗

PubMed2005

Comparison of directed and self-directed learning in evidence-based medicine: a randomised controlled trial.

OBJECTIVES: To compare 2 educational programmes for teaching evidence-based medicine (EBM). DESIGN: Prospective randomised controlled trial accompanied by a qualitative evaluation. SETTING: University of Oslo, Norway, 2002-03. PARTICIPANTS: A total of 175 students entered the study. All tenth semester medical students from 3 semesters were eligible for inclusion if they completed baseline assessment and consent forms and either attended teaching on the first day of the semester or gave reasons for their absence on the first day in advance. Interventions One intervention was based on computer-assisted, self-directed learning (self-directed intervention), whilst the other was organised as workshops based on social learning theory (directed intervention). Both educational interventions consisted of 5 half-day sessions. MAIN OUTCOME MEASURES: The primary outcomes were knowledge about EBM and skills in critical appraisal. A secondary outcome measured attitudes to EBM. Outcomes were compared on an intention-to-treat basis using a stratified Wilcoxon rank-sum test. RESULTS: There were no differences in outcomes for the 2 study groups in terms of EBM knowledge (mean deviation 0.0 [95% confidence interval - 1.0, 1.0], P = 0.8), critical appraisal skills (MD 0.1 [95% CI - 0.9, 1.1], P = 0.5), or attitudes to EBM (MD - 0.3 [95% CI - 1.4, 0.8], P = 0.5). Follow-up rates were 96%, 97% and 63%, respectively. CONCLUSIONS: This trial and its accompanying qualitative evaluation suggest that self-directed, computer-assisted learning may be an alternative format for teaching EBM. However, further research is needed to confirm this and investigate alternative educational models.

Adult↗

PubMed1985

Randomised controlled trial of adenine arabinoside 5'-monophosphate (ARA-AMP) in chronic hepatitis B virus infection.

A randomised controlled trial was conducted in 29 HBV carriers who had been HBs and HBe antigen positive for more than six months. Fifteen patients were treated with ARA-AMP 10 mg/kg/day given as intramuscular injections 12 hours apart for five days followed by 5 mg/kg/day for 23 days. The 14 controls received no treatment. Serum HBV-DNA polymerase, and HBV-DNA decreased in all patients during therapy. Six treated patients lost serum HBV-DNA polymerase, HBV-DNA and HBeAg, HBsAg concentrations decreased, and five developed anti-HBe. One of these six patients lost HBsAg and developed anti-HBs. No such changes were observed in the control group over a similar 18 month period of observation. A four week course of ARA-AMP inhibits HBV replication and in a significant minority of patients this is long lasting and is associated with a reduced level of inflammatory activity in the liver.

Adult↗

PubMed2006

Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To determine whether psychological interventions have any effect on glycaemic control in people with type 1 diabetes. DESIGN: Systematic review and meta-analysis of psychological therapies to assess their effectiveness in improving glycaemic control in type 1 diabetes. DATA SOURCES: Medline, PsycINFO, Embase, and Cochrane central register of controlled trials searched to September 2004. REVIEW METHODS: All included studies were randomised controlled trials in children (including adolescents) or adults with type 1 diabetes that evaluated the effect of a psychological therapy (counselling, cognitive behaviour therapy, family systems therapy, and psychodynamic therapy) on control of diabetes. Data were extracted on sample size, age, duration of diabetes, type of psychological therapy, its mode of delivery, and type of intervention in control group. MAIN OUTCOME MEASURES: Glycaemic control measured by percentage of glycated haemoglobin and psychological distress. Pooled standardised effect sizes were calculated. RESULTS: 29 trials were eligible for the systematic review and 21 trials for the meta-analysis. In the 10 studies of children and adolescents included in the meta-analysis, the mean percentage of glycated haemoglobin was significantly reduced in those who had received a psychological intervention compared with those in the control group (pooled standardised mean difference -0.35 (95% confidence interval -0.66 to -0.04), equivalent to a 0.48% (0.05% to 0.91%) absolute reduction in glycated haemoglobin. In the 11 studies in adults the pooled standardised mean difference was -0.17 (-0.45 to 0.10), equivalent to 0.22% (-0.13% to 0.56%) absolute reduction in glycated haemoglobin. Psychological distress was significantly lower in the intervention groups in children and adolescents (pooled standardised effect size -0.46, -0.83 to -0.10) but not in adults (-0.25, -0.51 to 0.01). CONCLUSION: Psychological treatments can slightly improve glycaemic control in children and adolescents with diabetes but have no effect in adults.

Adult↗

PubMed2005

Interventions for preventing or treating alcohol hangover: systematic review of randomised controlled trials.

OBJECTIVE: To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover. DATA SOURCES: Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted. STUDY SELECTION AND DATA EXTRACTION: All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality. RESULTS: Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, gamma linolenic acid from B officinalis, and a yeast based preparation. CONCLUSION: No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation.

Alcoholic Intoxication↗

PubMed2006

A cost-effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomised controlled trial (the FOREMOST trial).

OBJECTIVE: To report an economic analysis of the Australian intrapartum fetal pulse oximetry (FPO) multicentre randomised controlled trial (the FOREMOST trial), which examined whether adding FPO to conventional cardiotocographic (CTG) monitoring (intervention group) was cost-effective in reducing operative delivery rates for non-reassuring fetal status compared with the use of CTG alone (control group). DESIGN: Cost-effectiveness analysis of the FOREMOST trial. SETTING: Four Australian maternity hospitals, each with more than 4000 births/year. POPULATION: Women in labour at > or =36 weeks of gestation, with a non-reassuring CTG. METHODS: Costs were for treatment-related expenses, incorporating diagnosis-related grouping costs and direct costs (including fetal monitoring). Incremental cost-effectiveness ratio (ICER) and cost-effectiveness plane were calculated, and sensitivity analysis was conducted. The primary outcome was that of the clinical trial: operative delivery for non-reassuring fetal status avoided in the intervention group relative to that in the control group. MAIN OUTCOME MEASURES: The ICER. RESULTS: The ICER demonstrated a saving of $A813 for each operative birth for non-reassuring fetal status averted by the addition of FPO to CTG monitoring compared with the use of CTG monitoring alone. CONCLUSION: The addition of FPO to CTG monitoring represented a less costly and more effective use of resources to reduce operative delivery rates for non-reassuring fetal status than the use of conventional CTG monitoring alone.

Adult↗

PubMed2005

A prospective, randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results.

The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials comparing TCs to femoral ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24-75 months). Five patients were excluded on the basis of technical infringements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p<0.05) other than for the vitality domain of the SF-36. For patients who received the FRA, mean VAS (back pain) improved by 2.0 points (p<0.01), mean ODI improved by 15 points (p=<0.01) and mean SF-36 scores improved by >11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.

Adult↗

PubMedDate not supplied

External validity of randomised controlled trials: "to whom do the results of this trial apply?".

In making treatment decisions, doctors and patients must take into account relevant randomised controlled trials (RCTs) and systematic reviews. Relevance depends on external validity (or generalisability)--ie, whether the results can be reasonably applied to a definable group of patients in a particular clinical setting in routine practice. There is concern among clinicians that external validity is often poor, particularly for some pharmaceutical industry trials, a perception that has led to underuse of treatments that are effective. Yet researchers, funding agencies, ethics committees, the pharmaceutical industry, medical journals, and governmental regulators alike all neglect external validity, leaving clinicians to make judgments. However, reporting of the determinants of external validity in trial publications and systematic reviews is usually inadequate. This review discusses those determinants, presents a checklist for clinicians, and makes recommendations for greater consideration of external validity in the design and reporting of RCTs.

Data Interpretation, Statistical↗

PubMed2001

Perineal massage in labour and prevention of perineal trauma: randomised controlled trial.

OBJECTIVE: To determine the effects of perineal massage in the second stage of labour on perineal outcomes. DESIGN: Randomised controlled trial. PARTICIPANTS: At 36 weeks' gestation, women expecting normal birth of a singleton were asked to join the study. Women became eligible to be randomised in labour if they progressed to full dilatation of the cervix or 8 cm or more if nulliparous or 5 cm or more if multiparous. 1340 were randomised into the trial. INTERVENTION: Massage and stretching of the perineum during the second stage of labour with a water soluble lubricant. MAIN OUTCOME MEASURES PRIMARY OUTCOMES: rates of intact perineum, episiotomies, and first, second, third, and fourth degree tears. SECONDARY OUTCOMES: pain at three and 10 days postpartum and pain, dyspareunia, resumption of sexual intercourse, and urinary and faecal incontinence and urgency three months postpartum. RESULTS: Rates of intact perineums, first and second degree tears, and episiotomies were similar in the massage and the control groups. There were fewer third degree tears in the massage group (12 (1.7%) v 23 (3.6%); absolute risk 2.11, relative risk 0.45; 95% confidence interval 0.23 to 0.93, P<0.04), though the trial was underpowered to measure this rarer outcome. Groups did not differ in any of the secondary outcomes at the three assessment points. CONCLUSIONS: The practice of perineal massage in labour does not increase the likelihood of an intact perineum or reduce the risk of pain, dyspareunia, or urinary and faecal problems.

Adult↗

PubMed2001

A comparison of acupuncture with advice and exercises on the symptomatic treatment of osteoarthritis of the hip--a randomised controlled trial.

Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.

Acupuncture Therapy↗

PubMed2005

The effect of educational intervention on intercultural communication: results of a randomised controlled trial.

BACKGROUND: Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. AIMS: To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. DESIGN OF STUDY: A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. SETTING: General practice in Rotterdam. METHOD: Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the 'Western' and 'non-Western' patients, and for patients with different cultural backgrounds separately. RESULTS: An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with 'non-Western' patients. CONCLUSIONS: A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between 'Western' and 'non-Western' patients.

Adolescent↗

PubMed2003

Estimating the marginal value of 'better' research output: 'designed' versus 'routine' data in randomised controlled trials.

We recently completed a study which demonstrated that the costs of health technology assessment (HTA) by randomised controlled trial (RCT) can be reduced by substituting routine datasets for data designed and collected specifically for a trial. This cost reduction, however, had the effect of reducing the quality of the research output. In the present study we attempted to tease out the values attached to the 'better' information provided by designed data RCTs using a mock grants committee. Two valuation techniques, implied values and willingness to pay, were used. Ex ante valuations were determined by comparing alternative research proposals - a more costly version using designed data and a cheaper version using routine data. Ex post valuations were determined by comparing results of both versions. The exercise was performed on four exemplar studies. Overall, the committee expressed a general lack of trust towards routine data both ex ante and ex post and placed high values on the better information from the designed data studies - particularly information on preferences. This suggests that currently available routine datasets are not perceived to be able to provide efficient alternatives to designed data for RCTs.

Blood Transfusion, Autologous↗

PubMed2005

Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention.

OBJECTIVE: To explore participants' understandings regarding treatment decisions, made within an efficacy randomised controlled trial (RCT) of decision-support tools. METHODS: Qualitative study: interviews (audio-recorded) with participants. Participants were interviewed 3-5 days after using a decision-support tool (n=30) and again at 3 months (n=26). Transcripts were analysed using a constant comparative approach. RESULTS: Participants' understandings were shaped by the ways in which they made sense of their participation. Participants made attributions about their trial identity that fell on a continuum. At one end we found participants who identified as 'experienced medical volunteers', and at the other those who identified as 'real patients'. In the participants' accounts, a trial identity of 'patient' accompanied an expectation that the decision-support tools offered a means of making treatment decisions. 'Volunteers', however, saw the interventions as tasks to be completed for the purposes of the trial team. CONCLUSION: In our study, trial identity shaped participants' understandings regarding treatment decisions and all other aspects of the trial. PRACTICE IMPLICATIONS: Different understandings regarding the appropriate response to trial tasks may affect behaviour and therefore outcomes in some trials. Further research is required to unravel the relationship between trial identities, understanding and behaviour.

Altruism↗