Evidence map›Paper›PMID 33771197›Full record

ReviewTrials2021

Understanding implementability in clinical trials: a pragmatic review and concept map.

Miranda S Cumpston, Steven A Webb, Philippa Middleton, Greg Sharplin, Sally Green, Australian Clinical Trials Alliance Reference Group on Impact and Implementation of CTN Trials

Abstract readReview
In one paragraph

Review in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
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.

Miranda S CumpstonSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, Melbourne, VIC, 3004, Australia. miranda.cumpston@monash.edu.ORCID http://orcid.org/0000-0001-6564-8615
Steven A WebbSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, Melbourne, VIC, 3004, Australia.
Philippa MiddletonSouth Australian Health & Medical Research Institute, PO BOX 11060, Adelaide, SA, 5001, Australia.
Greg SharplinRosemary Bryant AO Research Centre, Clinical and Health Sciences Unit, University of South Australia, City East Campus, Playford Building P4-27F, North Terrace, Adelaide, SA, 5000, Australia.
Sally GreenSchool of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, Melbourne, VIC, 3004, Australia.
Australian Clinical Trials Alliance Reference Group on Impact and Implementation of CTN Trials

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability.

methodsDocuments were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019.

resultsSixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map.

conclusionsThe concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.

trial registrationThis review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.

Indexed as

PublicationsResearch PersonnelAustraliaHumansApplicabilityClinical trialsImplementabilityImplementationKnowledge translationLate-phase trialsPragmatic trials

Identifiers

PMID33771197
PMCPMC7995762

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.