A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus
Abstract
Background and objective To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatments (NPTs). Study design and setting The Delphi consensus method was used to select and reduce the number of items in the checklist. A total of 154 individuals were invited to participate: epidemiologists and statisticians involved in the field of methodology of RCTs (n = 55), members of the Cochrane Collaboration (n = 41), and clinicians involved in planning NPT clinical trials (n = 58). Participants ranked on a 10-point Likert scale whether an item should be included in the checklist. Results Fifty-five experts (36%) participated in the survey. They were experienced in systematic reviews (68% were involved in the Cochrane Collaboration) and in planning RCTs (76%). Three rounds of the Delphi method were conducted to achieve consensus. The final checklist contains 10 items and 5 subitems, with items related to the standardization of the intervention, care provider influence, and additional measures to minimize the potential bias from lack of blinding of participants, care providers, and outcome assessors. Conclusions This tool can be used to critically appraise the medical literature, design NPT studies, and assess the quality of trial reports included in systematic reviews.
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RCTs were assessed using a modified CLEAR-NPT checklist, and non-RCTs were assessed using the NHLBI-NIH quality assessment tool.
“RCTs were assessed using a modified form of the Boutron checklist to evaluate a report of a nonpharmacological trial (CLEAR-NPT; Appendix A.3) [51,62]. Non-RCTs were assessed using the National Heart, Lung, and Blood Institute of the National Institutes of Health (NHLBI-NIH) quality assessment tool for single-arm, pre-post, or non-randomized studies (Appendix A.4) [63].”
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- Authors
- BOUTRON, I., MOHER, D., TUGWELL, P., GIRAUDEAU, B., POIRAUDEAU, S., NIZARD, R., & RAVAUD, P.
- Affiliations
- Inserm (FR)
- University of Ottawa (CA)
- Hôpital Cochin (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Corresponding author
- BOUTRON, I
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2005-12
- Volume
- 58
- Issue
- 12
- Pages
- 1233-1240
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W1994065729
- Cited by
- 308
- References
- 8
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 6 · 2023: 6 · 2022: 7 · 2021: 4 · 2020: 10 · 2019: 11 · 2018: 4 · 2017: 14 · 2016: 16 · 2015: 27 · 2014: 18 · 2013: 32 · 2012: 37
- FWCI
- 21.07
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- non-pharmacological treatment, randomized controlled trials, reporting checklist, critical appraisal, blinding, intervention standardization, Delphi consensus
- MeSH terms
- Delphi Technique, Evaluation Studies as Topic, Humans, Research Design, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Consensus
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