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How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial.

ABSTRACT: Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study.We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published 'Pragmatic-Explanatory Continuum Indicatory Summary (PRECIS)' tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains.After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism.This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.

SUBMITTER: Selby P

PROVIDER: S-EPMC3477062 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial.

Selby Peter P Brosky Gerald G Oh Paul I PI Raymond Vincent V Ranger Suzanne S

BMC medical research methodology 20120723

<h4>Background</h4>Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic es ...[more]

PMID: 22824225

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Project description: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 .

Project description:BACKGROUND:PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) can assess how clinical trial design decisions (along the explanatory-pragmatic continuum) influence the applicability of trial results to intended stakeholders. The tool has been used to assess features of trials during the trial design phase and also upon completion. The ongoing PRagmatic trial Of Video Education in Nursing homes (PROVEN), which is evaluating the effectiveness of a suite of videos to improve advance care planning, is one of the first large pragmatic, cluster randomized trials within nursing home health care systems. While certain features of pragmatic trials remain static once designed (e.g., recruitment, outcomes), successful implementation of a system-wide program requires on-going evaluation and adaptation. This report's objectives were to apply PRECIS-2 in a novel manner during the actual conduct of the PROVEN trial to assess how dynamic adaptations shifted implementation to either a more explanatory or a more pragmatic approach. METHODS:We assessed PROVEN's protocol as initially designed according to the three PRECIS-2 domains pertinent to implementation: (1) Organization, (2) Flexibility-Delivery, and (3) Flexibility-Adherence. We then applied this framework to conduct a formative evaluation of decisions made while the trial was ongoing to adapt the implementation approach along the pragmatic versus the explanatory continuum in response to emergent challenges. RESULTS:Based on the PRECIS-2 rubric, the initial design of the PROVEN implementation approach reflected a hybrid of pragmatic and explanatory features. Most notably, within the Flexibility-Delivery, the trial had a relatively pragmatic approach to protocol delivery by front-line nursing home providers, balanced with a more explanatory approach to protocol monitoring enabled by the analytic capabilities of the research team. This more intensive monitoring proved critical in revealing implementation problems once the study began. Dynamic adaptations made in response to these challenges generally reflected shifts to more explanatory approaches within the Flexibility-Delivery and Flexibility-Adherence domains including ever more intensive compliance monitoring, as well as detailed coaching of front-line providers delivering the intervention by the research team. CONCLUSIONS:Pragmatic trials conducted in the nursing home setting may benefit from a more dynamic approach to implementation. Allowing fluidity between pragmatic and explanatory features may still preserve the trial's applicability to intended stakeholders' needs. PRECIS-2 provides a useful formative evaluation tool to assess these adaptations in "real-time." TRIAL REGISTRATION:US National Library of Medicine, ClinicalTrials.gov, ID: NCT02612688 . Registered on 19 November 2015.

Project description:IntroductionThe pragmatic design has received much attention in the field of acupuncture clinical trials because of insufficient information about the specific effects of acupuncture. However, pragmatism in pragmatic acupuncture trials has not been comprehensively investigated. The PRECIS-2 tool was developed and has been gradually used to design pragmatic trials; therefore, we will apply the PRECIS-2 tool to investigate the pragmatism of pragmatic acupuncture trials in this study.Methods and analysisIn this systematic review, self-declared 'pragmatic' randomised clinical trials (RCTs) or protocols of self-declared 'pragmatic' RCTs investigating acupuncture will be searched and included to be reviewed. MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov for registered trials will be electronically searched from inception to March 2022. Protocols of published RCTs or secondary analysis of RCTs will be excluded. Additionally, no language restriction will be applied. Two authors will independently extract descriptive information and assess the pragmatism of pragmatic acupuncture trials using nine domains of the PRECIS-2 tool and one additional domain-control. Descriptive statistics will be reported for each domain and the overall score, and a one-sample t-test will be used to statistically analyse whether the score is greater than 3 (equally pragmatic and explanatory). The wheel diagrams of the nine domains of the PRECIS-2 tool will be used to demonstrate the pragmatism of the included studies.Ethics and disseminationEthical approval is not warranted as this study will obtain data from previously reported articles. The results will be disseminated through peer-reviewed journals and conferences.Prospero registration numberCRD42021236975.

Project description:Background and aimsWithin the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits.DesignCluster-randomized clinical trial.SettingTwenty-two primary care clinics in South Carolina, USA.ParticipantsAdult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics).MeasurementsThe primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline.FindingsSeven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7).ConclusionProviding smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.

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How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial.

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How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial.

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