ArticleJournal of the Royal Society of Medicine1997
Are randomized controlled trials controlled? Patient preferences and unblind trials.
Article in Journal of the Royal Society of Medicine, 1997. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Yoga for chronic non-specific low back pain.The Cochrane database of systematic reviews · 2022Pooled it
- Yoga treatment for chronic non-specific low back pain.The Cochrane database of systematic reviews · 2017Pooled it
- Patients' preferences within randomised trials: systematic review and patient level meta-analysis.BMJ (Clinical research ed.) · 2008Pooled it
- Nonsurgical treatment outcomes for surgical candidates with lumbar disc herniation: a comprehensive cohort study.Scientific reports · 2021Trial
- Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial.Social psychiatry and psychiatric epidemiology · 2014Trial
- Design and methods of "diaBEAT-it!": a hybrid preference/randomized control trial design using the RE-AIM framework.Contemporary clinical trials · 2014Trial
- Trial
- No clear influence of preference bias on satisfaction and early functional outcome in resurfacing hip arthroplasty.Acta orthopaedica · 2011Trial
- Trial
- Checking for interviewer bias in outcome assessment: a method for strengthening the design of prospective, randomised trials in surgery.Langenbeck's archives of surgery · 2004Trial
- What influences participants' treatment preference and can it influence outcome? Results from a primary care-based randomised trial for shoulder pain.The British journal of general practice : the journal of the Royal College of General Practitioners · 2004Trial
- Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences.BMJ (Clinical research ed.) · 1999Trial
- Design and analysis of partially randomized preference trials with propensity score stratification.Statistical methods in medical research · 2022Article
- Factors associated with edentulous patients' willingness about implant-supported complete denture: a multivariate analysis.Clinical oral investigations · 2022Article
- Treatment expectations but not preference affect outcome in a trial of CBT and exercise for pain.Canadian journal of pain = Revue canadienne de la douleur · 2017Article
- Factors associated with interest in receiving prison-based methadone maintenance therapy in Malaysia.Drug and alcohol dependence · 2016Article
- The Future of Opioid Agonist Therapies in Ukraine: A Qualitative Assessment of Multilevel Barriers and Ways Forward to Promote Retention in Treatment.Journal of substance abuse treatment · 2016Article
- An exploratory qualitative assessment of self-reported treatment outcomes and satisfaction among patients accessing an innovative voluntary drug treatment centre in Malaysia.The International journal on drug policy · 2015Article
- Preference and Expectation for Treatment Assignment in a Randomized Controlled Trial of Once- vs Twice-weekly Yoga for Chronic Low Back Pain.Global advances in health and medicine · 2015Article
- Understanding patient values and the manifestations in clinical research with traditional chinese medicine-with practical suggestions for trial design and implementation.Evidence-based complementary and alternative medicine : eCAM · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions--for example, between treatment preferences and treatment effects--is generally subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments through poorly understood (psychological) pathways, then RCTs, particularly when unblinded, may wrongly attribute effects solely to a treatment's physiological/pharmacological properties. To interpret the RCT evidence base it is important to know whether any preference effects exist and, if so, by how much they affect outcome. Reliable measurement of these effects is difficult and will require new approaches to the conduct of trials. In view of the fanciful image with which such effects are portrayed and the uncertainties about their true nature and biological mechanisms, existing evidence is unlikely to provide sufficient justification for investment in trials. This is a Catch 22. Until an escape is found we might never know, even approximately, how much of modern medicine is attributable to psychological processes.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.