ArticleBMC health services research2021
Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.
Article in BMC health services research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03590041 (Invested in Diabetes), which is not on this map. Cited by 5 papers.
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.
Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)
Who cites it
5 citing papers in PubMed.
- Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.Journal of general internal medicine · 2024Trial
- Matters arising: a critique of "Nuancing the continuum from ideal to real-world implementation" by Eldh et al. 2025.Implementation science communications · 2026Article
- What works in implementing shared medical appointments for patients with diabetes in primary care to enhance reach: a qualitative comparative analysis from the Invested in Diabetes study.Implementation science communications · 2024Article
- A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.Clinical diabetes : a publication of the American Diabetes Association · 2023Article
- Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.Critical care explorations · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations.
methodsWe report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics.
resultsIn general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings.
conclusionsWe discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research.
trial registrationClinicaltrials.gov Registration ID: NCT03590041 .
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