A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus.
OBJECTIVE
To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatments (NPTs).


METHODS
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.
Boutron
Isabelle
I
INSERM U738, Paris, France. isabelle.boutron@bch.ap-hop-paris.fr
Moher
David
D
Tugwell
Peter
P
Giraudeau
Bruno
B
Poiraudeau
Serge
S
Nizard
Remy
R
Ravaud
Philippe
P
D032921:Consensus; D003697:Delphi Technique; D005069:Evaluation Studies as Topic; D006801:Humans; D015201:Meta-Analysis as Topic; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design