ArticleTrials2008
Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units.
Article in Trials, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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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
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Health economic evaluation of structured education programs for patients with diabetes: a systematic review.Frontiers in public health · 2024Pooled it
- Public health economics: a systematic review of guidance for the economic evaluation of public health interventions and discussion of key methodological issues.BMC public health · 2013Pooled it
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- Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial.BMC public health · 2013Trial
- The Depression in Visual Impairment Trial (DEPVIT): trial design and protocol.BMC psychiatry · 2012Trial
- FIRE (Facilitating Implementation of Research Evidence): a study protocol.Implementation science : IS · 2012Trial
- Enhancing ventilation in homes of children with asthma: cost-effectiveness study alongside randomised controlled trial.The British journal of general practice : the journal of the Royal College of General Practitioners · 2011Trial
- A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation.BMC public health · 2010Trial
- Protocol for the economic evaluation of the "Healthy for Two/Healthy for You" pragmatic lifestyle intervention in prenatal care to reduce gestational weight gain and gestational diabetes mellitus.Contemporary clinical trials · 2025Article
- Current UK Practices on Health Economics Analysis Plans (HEAPs): Are We Using Heaps of Them?PharmacoEconomics · 2018Article
- OARSI Clinical Trials Recommendations: Key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis.Osteoarthritis and cartilage · 2015Review
- Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.Trials · 2013Article
- Article
- Clinical trials in orthopaedics research. Part III. Overcoming operational challenges in the design and conduct of randomized clinical trials in orthopaedic surgery.The Journal of bone and joint surgery. American volume · 2012Article
- Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting.BMJ (Clinical research ed.) · 2011Article
- Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials.
methodsA collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis.
resultsOur recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP.
conclusionWe argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.
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.