ArticleTrials2017
Publishing protocols for trials of complex interventions before trial completion - potential pitfalls, solutions and the need for public debate.
Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Work-break interventions for preventing musculoskeletal symptoms and disorders in healthy workers.The Cochrane database of systematic reviews · 2025Pooled it
- Work-break schedules for preventing musculoskeletal symptoms and disorders in healthy workers.The Cochrane database of systematic reviews · 2019Pooled it
- Trial
- Effectiveness of the Ready to Reduce Risk (3R) complex intervention for the primary prevention of cardiovascular disease: a pragmatic randomised controlled trial.BMC medicine · 2020Trial
- Feasibility trial of an early therapy in perinatal stroke (eTIPS).BMC neurology · 2018Trial
- Coproducing an Ecological Momentary Assessment Measurement Burst Mental Health Study With Young People: The MHIM Coproduction Protocol.Health expectations : an international journal of public participation in health care and health policy · 2025Article
- Article
- Publication of Results of Registered Trials With Published Study Protocols, 2011-2022.JAMA network open · 2024Article
- Assessing Open Science practices in physical activity behaviour change intervention evaluations.BMJ open sport & exercise medicine · 2022Article
- Implications for blinding in clinical trials with THC-containing cannabinoids based on the CANNA-TICS trial.Frontiers in neuroscience · 2022Article
- Article
- Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.BMC medical research methodology · 2020Article
- The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2018Article
- Article
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
Abstract
backgroundOpen Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed.
conclusionTriallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.
Indexed as
Identifiers
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.