An analysis of published trials found that current use of pragmatic trial labels is uninformative
Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum In...
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| Veröffentlicht in: | Journal of clinical epidemiology 2022-11, Vol.151, p.113-121 |
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| container_title | Journal of clinical epidemiology |
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| creator | Taljaard, Monica Nicholls, Stuart G. Howie, Alison H. Nix, Hayden P. Carroll, Kelly Moon, Paxton M. Nightingale, Natalie M. Giraudeau, Bruno Hey, Spencer P. Eldridge, Sandra M. Weijer, Charles Zwarenstein, Merrick |
| description | Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains).
We reviewed primary trial reports published 2014–2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.
Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.
Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent. |
| doi_str_mv | 10.1016/j.jclinepi.2022.08.007 |
| format | Article |
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We reviewed primary trial reports published 2014–2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.
Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.
Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent.</description><identifier>ISSN: 0895-4356</identifier><identifier>ISSN: 1878-5921</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/j.jclinepi.2022.08.007</identifier><identifier>PMID: 35987403</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Clinical outcomes ; Clinical trials ; Design ; Domains ; Epidemiology ; Flexibility ; Humans ; Intervention ; Labels ; Life Sciences ; Medical ethics ; Patient-reported outcomes ; Pragmatism ; Randomization ; Randomized controlled trial ; Real-world trials ; Research Design ; Research ethics ; Routinely collected data ; Trial designs</subject><ispartof>Journal of clinical epidemiology, 2022-11, Vol.151, p.113-121</ispartof><rights>2022 Elsevier Inc.</rights><rights>Copyright © 2022 Elsevier Inc. All rights reserved.</rights><rights>2022. Elsevier Inc.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c534t-ec1d41cfe33d2ceecea3bf1af263b04f33aeb7fea96e00b7616ef2fca4ed00e13</citedby><cites>FETCH-LOGICAL-c534t-ec1d41cfe33d2ceecea3bf1af263b04f33aeb7fea96e00b7616ef2fca4ed00e13</cites><orcidid>0000-0002-4205-5857 ; 0000-0003-0162-7027 ; 0000-0003-0485-9069 ; 0000-0002-7367-0270 ; 0000-0002-3978-8961 ; 0000-0003-3031-8258 ; 0000-0002-5510-1074 ; 0000-0003-4444-8213</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0895435622001950$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35987403$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04674163$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Taljaard, Monica</creatorcontrib><creatorcontrib>Nicholls, Stuart G.</creatorcontrib><creatorcontrib>Howie, Alison H.</creatorcontrib><creatorcontrib>Nix, Hayden P.</creatorcontrib><creatorcontrib>Carroll, Kelly</creatorcontrib><creatorcontrib>Moon, Paxton M.</creatorcontrib><creatorcontrib>Nightingale, Natalie M.</creatorcontrib><creatorcontrib>Giraudeau, Bruno</creatorcontrib><creatorcontrib>Hey, Spencer P.</creatorcontrib><creatorcontrib>Eldridge, Sandra M.</creatorcontrib><creatorcontrib>Weijer, Charles</creatorcontrib><creatorcontrib>Zwarenstein, Merrick</creatorcontrib><title>An analysis of published trials found that current use of pragmatic trial labels is uninformative</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains).
We reviewed primary trial reports published 2014–2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.
Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.
Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent.</description><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Design</subject><subject>Domains</subject><subject>Epidemiology</subject><subject>Flexibility</subject><subject>Humans</subject><subject>Intervention</subject><subject>Labels</subject><subject>Life Sciences</subject><subject>Medical ethics</subject><subject>Patient-reported outcomes</subject><subject>Pragmatism</subject><subject>Randomization</subject><subject>Randomized controlled trial</subject><subject>Real-world trials</subject><subject>Research Design</subject><subject>Research ethics</subject><subject>Routinely collected data</subject><subject>Trial 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uninformative</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2022-11-01</date><risdate>2022</risdate><volume>151</volume><spage>113</spage><epage>121</epage><pages>113-121</pages><issn>0895-4356</issn><issn>1878-5921</issn><eissn>1878-5921</eissn><abstract>Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains).
We reviewed primary trial reports published 2014–2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.
Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.
Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>35987403</pmid><doi>10.1016/j.jclinepi.2022.08.007</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-4205-5857</orcidid><orcidid>https://orcid.org/0000-0003-0162-7027</orcidid><orcidid>https://orcid.org/0000-0003-0485-9069</orcidid><orcidid>https://orcid.org/0000-0002-7367-0270</orcidid><orcidid>https://orcid.org/0000-0002-3978-8961</orcidid><orcidid>https://orcid.org/0000-0003-3031-8258</orcidid><orcidid>https://orcid.org/0000-0002-5510-1074</orcidid><orcidid>https://orcid.org/0000-0003-4444-8213</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Clinical outcomes Clinical trials Design Domains Epidemiology Flexibility Humans Intervention Labels Life Sciences Medical ethics Patient-reported outcomes Pragmatism Randomization Randomized controlled trial Real-world trials Research Design Research ethics Routinely collected data Trial designs |
| title | An analysis of published trials found that current use of pragmatic trial labels is uninformative |
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