Evidence map›Paper›PMID 29126437›Full record

ArticleTrials2017

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains.

Paula Darby Lipman, Kirsty Loudon, Leanora Dluzak, Rachael Moloney, Donna Messner, Catherine M Stoney

Abstract read
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In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Paula Darby LipmanWestat, 1600 Research Boulevard, Rockville, MD, 20850, USA. paulalipman@westat.com.ORCID http://orcid.org/0000-0002-2522-9691
Kirsty LoudonNMAHP Research Unit, Unit 13 Scion House, Stirling University Innovation Park, Stirling, FK9 4NF, UK.
Leanora DluzakWestat, 1600 Research Boulevard, Rockville, MD, 20850, USA.
Rachael MoloneyCenter for Medical Technology Policy, World Trade Center Baltimore, 401 East Pratt Street, Suite 631, Baltimore, MD, 21202, USA.
Donna MessnerCenter for Medical Technology Policy, World Trade Center Baltimore, 401 East Pratt Street, Suite 631, Baltimore, MD, 21202, USA.
Catherine M StoneyNational Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), RKL2, BG RM 10220, 6701 Rockledge Drive, Bethesda, MD, 20817, USA.

Funding

Evaluation and Administration Support for Pragmatic TrialsR01HL125114 · NHLBI · WESTAT, INC. · PI LIPMAN, PAULA DARBY · 2014 to 2018
$1.1M
National Heart, Lung, and Blood Institute 1R01HL125114-01NHLBI NIH HHS R01 HL125114
6 · The paper itself

Abstract

backgroundThere continues to be debate about what constitutes a pragmatic trial and how it is distinguished from more traditional explanatory trials. The NIH Pragmatic Trials Collaborative Project, which includes five trials and a coordinating unit, has adopted the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) instrument. The purpose of the study was to collect PRECIS-2 ratings at two points in time to assess whether the tool was sensitive to change in trial design, and to explore with investigators the rationale for rating shifts.

methodsA mixed-methods design included sequential collection and analysis of quantitative data (PRECIS-2 ratings) and qualitative data. Ratings were collected at two annual, in-person project meetings, and subsequent interviews conducted with investigators were recorded, transcribed, and coded using NVivo 11 Pro for Windows. Rating shifts were coded as either (1) actual change (reflects a change in procedure or protocol), (2) primarily a rating shift reflecting rater variability, or (3) themes that reflect important concepts about the tool and/or pragmatic trial design.

resultsBased on PRECIS-2 ratings, each trial was highly pragmatic at the planning phase and remained so 1 year later in the early phases of trial implementation. Over half of the 45 paired ratings for the nine PRECIS-2 domains indicated a rating change from Time 1 to Time 2 (N = 24, 53%). Of the 24 rating changes, only three represented a true change in the design of the trial. Analysis of rationales for rating shifts identified critical themes associated with the tool or pragmatic trial design more generally. Each trial contributed one or more relevant comments, with Eligibility, Flexibility of Adherence, and Follow-up each accounting for more than one.

conclusionsPRECIS-2 has proved useful for "framing the conversation" about trial design among members of the Pragmatic Trials Collaborative Project. Our findings suggest that design elements assessed by the PRECIS-2 tool may represent mostly stable decisions. Overall, there has been a positive response to using PRECIS-2 to guide conversations around trial design, and the project's focus on the use of the tool by this group of early adopters has provided valuable feedback to inform future trainings on the tool.

Indexed as

Research DesignTerminology as TopicEligibility DeterminationEndpoint DeterminationGuideline AdherenceHumansPatient SelectionPractice Guidelines as TopicPragmatic Clinical Trials as TopicTime FactorsEffectiveness trialsMixed methodsPragmatic trialsPRECIS-2 toolTrial design

Identifiers

PMID29126437
PMCPMC5681765

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Registered trials

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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.