SynthesisPsychology & health2015
How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes.
Synthesis in Psychology & health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 5 of them syntheses that pooled it.
What it found
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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
22 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Selection and reporting of usual care comparators when designing primary care trials of complex health interventions: a systematic review.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025Pooled it
- Estimating the true effectiveness of smoking cessation interventions under variable comparator conditions: A systematic review and meta-regression.Addiction (Abingdon, England) · 2023Pooled it
- Variability and effectiveness of comparator group interventions in smoking cessation trials: a systematic review and meta-analysis.Addiction (Abingdon, England) · 2020Pooled it
- Systematic meta-review of supported self-management for asthma: a healthcare perspective.BMC medicine · 2017Pooled it
- Pooled it
- WISE-Therapy (What's Important: Schedule and Engage) and bouldering psychotherapy for depression: A randomized clinical trial.BMC medicine · 2026Trial
- Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT.Health technology assessment (Winchester, England) · 2024Trial
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- Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial.Trials · 2015Trial
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- The feasibility, acceptability and clinical impact of a guided self-help mobile intervention (INTERconNEcT-EDs) for individuals with eating disorders: protocol for two multicenter randomized controlled trials.Journal of eating disorders · 2025Article
- Key Considerations for Designing Clinical Studies to Evaluate Digital Health Solutions.Journal of medical Internet research · 2024Article
- Review
- Best practices for recruitment in veterinary clinical trials.Frontiers in veterinary science · 2024Review
- Review
- Pragmatic evaluation of methods for retrieving unpublished information on comparator interventions in a systematic review of smoking cessation trials.Psychology & health · 2022Article
- A review and definition of 'usual care' in genetic counseling trials to standardize use in research.Journal of genetic counseling · 2021Review
- Article
- Is your standard, my standard? Why control arm reporting matters in pediatric clinical trials.Pediatric research · 2020Article
- Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.Pediatric research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePoor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes.
designWe conducted systematic searches for articles published between 1999 and 2012. We extracted standard care descriptions and contacted trial authors to complete a checklist of standard care activities. The relationship between standard care quality and outcomes was examined via subgroup meta-analyses and meta-regression.
main outcome measuresStandard care descriptions, standard care quality, and relationships between standard care quality with medical and psychological outcomes.
resultsWe identified 20 RCTs described across 26 articles. Published descriptions of standard care were limited to service-level features. Author responses indicated standard care provision extended beyond published accounts. Subgroup analyses suggested control groups receiving higher standard care quality showed larger improvements in both medical and psychological outcomes, although standard care quality did not predict outcomes significantly.
conclusionThe quality of care delivered to control group participants can influence outcomes of RCTs. Inadequate reporting exacerbates this issue by masking variations between trials. We argue for increased clarity in reporting standard care in future trials.
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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.