ArticleImplementation science : IS2021
Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool.
Article in Implementation science : IS, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 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.
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Who cites it
37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- How Pragmatic Are Sarcopenia Intervention Studies? A Systematic Review.Journal of cachexia, sarcopenia and muscle · 2026Pooled it
- Assessing the Pragmatic Nature of Mobile Health Interventions Promoting Physical Activity: Systematic Review and Meta-analysis.JMIR mHealth and uHealth · 2023Pooled it
- What works to recruit general practices to trials? A rapid review.HRB open research · 2023Pooled it
- Practice Variability in the SHARING Choices Pragmatic Trial of Primary Care Advance Care Planning.Journal of the American Geriatrics Society · 2026Trial
- Trial
- Trial
- A methodological review of pragmatic designs in acute stroke trials.International journal of stroke : official journal of the International Stroke Society · 2026Review
- Conduction of Pragmatic Clinical Trials in Routine Clinical Settings: Guidelines for Development of Protocol.Current therapeutic research, clinical and experimental · 2026Review
- Matters arising: a critique of "Nuancing the continuum from ideal to real-world implementation" by Eldh et al. 2025.Implementation science communications · 2026Article
- Could master protocols be adapted for effectiveness-implementation hybrid studies?BMC medical research methodology · 2025Article
- Community-Based Organizations' Approaches to Recruitment and Retention for a Digital HIV Prevention Intervention for Young Men Who Have Sex With Men: A Mixed Methods Study.Journal of medical Internet research · 2025Article
- Considerations for evaluating pragmatic design elements in digital health intervention trials: the case of Keep It Up! 3.0.Implementation science communications · 2025Article
- 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
- Pragmatic Evaluation of an Improvement Program for People Living With Modifiable High-Risk COPD Versus Usual Care: Protocols for the Cluster Randomized PREVAIL Trial.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2025Article
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- Pragmatic Clinical Trials: A Study Design for Real-World Evidence.The American journal of nursing · 2025Article
- Screening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual.Pain medicine (Malden, Mass.) · 2024Article
- Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.Journal of general internal medicine · 2024Article
- Implementation science for cancer control: One center's experience addressing context, adaptation, equity, and sustainment.Translational behavioral medicine · 2024Article
- Returning individual research results to participants: Values, preferences, and expectations.Journal of clinical and translational science · 2024Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundFirst articulated by Schwartz and Lellouch (1967), randomized controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to more pragmatic. The purpose and intent of the former is to test interventions under ideal contexts, and the purpose and intent of the latter is to test interventions in real-world contexts. The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) is a validated tool that helps researchers make decisions about the elements of the trial to match the overall purpose and intent of the trial along the continuum. The PRECIS-2 tool has guided the design of hundreds of RCTs. However, a few aspects of the tool would benefit from greater clarity, including its application to provider-focused implementation trials rather than patient-focused intervention trials. MAIN TEXT: We describe the newly developed PRECIS-2-Provider Strategies (PRECIS-2-PS) tool, an extension of the PRECIS-2 tool, which has been adapted for trials testing provider-focused strategies. We elaborate on nine domains that can make a provider-focused trial more explanatory or more pragmatic, including eligibility, recruitment, setting, implementation resources, flexibility of provider strategies, flexibility of intervention, data collection, primary outcome, and primary analysis. We detail the complementary roles that researchers and stakeholders play in the trial design phase, with implications for generalizability of trial results to the contexts in which they are intended to be applied.
conclusionsThe PRECIS-2-PS tool is designed to help research and practice teams plan for provider-focused trials that reflect the overall intent and purpose of the trial. The tool has potential to help advance the science of provider-focused strategies across a range of trials, with the ultimate goal of facilitating the adoption, integration, and sustainability of provider-focused strategies outside the context of 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.