The PRECIS-2 tool: designing trials that are fit for purpose

Loudon, Kirsty; Treweek, Shaun; Sullivan, Frank; Donnan, Peter T.; Thorpe, Kevin E.; Zwarenstein, Merrick

doi:10.1136/bmj.h2147

Cited by 1,330 publications

(1,399 citation statements)

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“…flexibility of delivery, flexibility of adherence, participant follow-up, primary analysis, and relevance of primary outcome [32]. The details of the PRECIS-2 rating scale, including pragmatic and explanatory extremes of each domain, have been described extensively elsewhere [32].…”

Section: Systematic Reviewsmentioning

confidence: 99%

“…The details of the PRECIS-2 rating scale, including pragmatic and explanatory extremes of each domain, have been described extensively elsewhere [32]. We adapted an existing rating tool that was used to assess PRE-CIS domains in a prior review article [33].…”

Section: Systematic Reviewsmentioning

confidence: 99%

“…We identified important practical feasibility factors derived from the RE-AIM framework that are not represented in the PRECIS-2 domains. These practical feasibility factors that we identified include reports of participant engagement, adaptation/change of intervention, program sustainability, unintended effects of intervention, and monetary costs of intervention [32][33][34]. We adapted an existing RE-AIM rating tool that was used to assess these practical feasibility factors in a prior review article [33].…”

Section: Systematic Reviewsmentioning

confidence: 99%

“…This measurement tool was named the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) model. In 2015, >80 international trialists, clinicians, and policy-makers revised and validated an updated version: the PRECIS-2 model [32]. The PRECIS-2 model may serve two purposes-to inform future trial design and to allow researchers to assess the Breal-world applicability^of published studies [33].…”

Section: Introductionmentioning

confidence: 99%

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How can clinical practices pragmatically increase physical activity for patients with type 2 diabetes? A systematic review

Luoma

Leavitt

Marrs

et al. 2017

Behav. Med. Pract. Policy Res.

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Although regular physical activity (PA) is a cornerstone of treatment for type 2 diabetes (T2D), most adults with T2D are sedentary. Randomized controlled trials (RCTs) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare settings. We sought to identify PA interventions that are effective and practical to implement in clinical practice settings. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to assess the potential for future implementation of PA interventions in clinical practice settings. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores. We searched PubMed MED-LINE from January 1980 through May 2015 for RCTs of behavioral PA interventions coordinated by clinical practices for patients with T2D. Dual investigators assessed pragmatism by PRECIS-2 scores, and study effectiveness was extracted from original RCT publications. The PRECIS-2 scores of the 46 behavioral interventions (n = 13,575 participants) ranged from 3.0 to 4.8, where 5 is the most pragmatic score. In the most pragmatic tertile of interventions (n = 16) by PRECIS-2 scores, 30.8 and 31.3% of interventions improved PA outcomes and hemoglobin A1c, respectively. A minority of published evidence-based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation. These should be tested for dissemination using implementation trial designs.

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Section: Systematic Reviewsmentioning

confidence: 99%

Section: Systematic Reviewsmentioning

confidence: 99%

Section: Systematic Reviewsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

How can clinical practices pragmatically increase physical activity for patients with type 2 diabetes? A systematic review

Luoma

Leavitt

Marrs

et al. 2017

Behav. Med. Pract. Policy Res.

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“…37 The aim of this trial was to examine the effectiveness of preloading in everyday clinical practice. In the UK, this was in the context of the NHS Stop Smoking Service.…”

Section: Design Features Classified By Precis-2mentioning

confidence: 99%

Nicotine preloading for smoking cessation: the Preloading RCT

Aveyard

Lindson

Tearne

et al. 2018

Health Technol Assess

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BackgroundNicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data.ObjectivesTo assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading.DesignOpen-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis.SettingNHS smoking cessation clinics.ParticipantsPeople seeking help to stop smoking.InterventionsNicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators.Main outcome measuresThe primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix®; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model.ResultsIn total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) –0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62;p = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73;p = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI –£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving.LimitationsThe open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified.ConclusionsUse of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication.Trial registrationCurrent Controlled Trials ISRCTN33031001.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.

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