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Abstract Background Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews. Method We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers' Handbook, and the process was repeated. Results The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based a-priori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented. Conclusions There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies.

Abstract Background Reporting numbers needed to treat (NNT) improves interpretability of trial results. It is unusual that continuous outcomes are converted to numbers of individual responders to treatment (i.e., those who reach a particular threshold of change); and deteriorations prevented are only rarely considered. We consider how numbers needed to treat can be derived from continuous outcomes; illustrated with a worked example showing the methods and challenges. Methods We used data from the UK BEAM trial (n = 1, 334) of physical treatments for back pain; originally reported as showing, at best, small to moderate benefits. Participants were randomised to receive 'best care' in general practice, the comparator treatment, or one of three manual and/or exercise treatments: 'best care' plus manipulation, exercise, or manipulation followed by exercise. We used established consensus thresholds for improvement in Roland-Morris disability questionnaire scores at three and twelve months to derive NNTs for improvements and for benefits (improvements gained+deteriorations prevented). Results At three months, NNT estimates ranged from 5.1 (95% CI 3.4 to 10.7) to 9.0 (5.0 to 45.5) for exercise, 5.0 (3.4 to 9.8) to 5.4 (3.8 to 9.9) for manipulation, and 3.3 (2.5 to 4.9) to 4.8 (3.5 to 7.8) for manipulation followed by exercise. Corresponding between-group mean differences in the Roland-Morris disability questionnaire were 1.6 (0.8 to 2.3), 1.4 (0.6 to 2.1), and 1.9 (1.2 to 2.6) points. Conclusion In contrast to small mean differences originally reported, NNTs were small and could be attractive to clinicians, patients, and purchasers. NNTs can aid the interpretation of results of trials using continuous outcomes. Where possible, these should be reported alongside mean differences. Challenges remain in calculating NNTs for some continuous outcomes. Trial Registration UK BEAM trial registration: ISRCTN32683578.

Background: Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the feasibility of four key aspects of a planned, future evaluative trial of a new education and self-management intervention for people with chronic headache: 1) recruiting people with chronic headache from primary care; 2) a telephone interview for the classification of chronic headaches; 3) the education and self-management intervention itself; and 4) the most appropriate patient reported outcomes (PROMS).Methods: Participants were identified and recruited from general practices in the West Midlands of the UK. We developed a nurse-led chronic headache classification interview and assessed agreement with an interview with headache specialists. We developed and tested a group based education and self-management intervention to assess training and delivery receipt using observation, facilitator, and participant feedback. We explored the acceptability and relevance of PROMs using postal questionnaires, interviews and a smartphone app.Results: Fourteen practices took part in the study and participant recruitment equated to 1.0/1000 registered patients. Challenges to recruitment were identified. We did 107 paired headache classification interviews. The level of agreement between nurse and doctor interviews was very good. We piloted the intervention in four groups with 18 participants. Qualitative feedback from participants and facilitators helped refine the intervention including shortening the overall intervention and increasing the facilitator training time. Participants completed 131 baseline questionnaires, measurement data quality, reliability and validity for headache-specific and generic measures was acceptable.Conclusion: This study indicated that recruiting people with chronic headache from primary care is feasible but challenging, our headache classification interview is fit for purpose, our study intervention is viable, and that our choice of outcome measures is acceptable to participants in a future randomised controlled trial (RCT).Trial Registration: ISRCTN, ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100. [ABSTRACT FROM AUTHOR]