Article type
Year
Abstract
Background: Assessing the quality of reports of randomized clinical trials (RCTs) is necessary as study characteristics can influence treatment estimates. Existing validated tools used to assess quality do not take into account specific methodological issues in assessing nonpharmacological treatment (NPT; ie, difficulties in blinding, difficulties in standardizing the intervention and care providers' influence).
Objective: To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatment.
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 providersÂ’ 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.
Objective: To develop a checklist of items measuring the quality of reports of randomized clinical trials (RCTs) assessing nonpharmacological treatment.
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 providersÂ’ 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.