The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified.

Systematic review has developed as a specific methodology for searching for, appraising and synthesizing findings of primary studies, and has rapidly become a cornerstone of the evidence-based practice and policy movement. Qualitative research has traditionally been excluded from systematic reviews, and much effort is now being invested in resolving the daunting methodological and epistemological challenges associated with trying to move towards more inclusive forms of review. We describe our experiences, as a very diverse multidisciplinary group, in attempting to incorporate qualitative research in a systematic review of support for breastfeeding. We show how every stage of the review process, from asking the review question through to searching for and sampling the evidence, appraising the evidence and producing a synthesis, provoked profound questions about whether a review that includes qualitative research can remain consistent with the frame offered by current systematic review methodology. We conclude that more debate and dialogue between the different communities that wish to develop review methodology is needed, and that attempts to impose dominant views about the appropriate means of conducting reviews of qualitative research should be resisted so that innovation can be fostered.

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Objective: Qualitative research is increasingly valued as part of the evidence for policy and practice, but how it should be appraised is contested. Various appraisal methods, including checklists and other structured approaches, have been proposed but rarely evaluated. We aimed to compare three methods for appraising qualitative research papers that were candidates for inclusion in a systematic review of evidence on support for breast-feeding. Method: A sample of 12 research papers on support for breast-feeding was appraised by six qualitative reviewers using three appraisal methods: unprompted judgement, based on expert opinion; a UK Cabinet Office quality framework; and CASP, a Critical Appraisal Skills Programme tool. Papers were assigned, following appraisals, to 1 of 5 categories, which were dichotomized to indicate whether or not papers should be included in a systematic review. Patterns of agreement in categorization of papers were assessed quantitatively using κ statistics, and qualitatively using cross-case analysis. Results: Agreement in categorizing papers across the three methods was slight ( κ =0.13; 95% CI 0.06–0.24). Structured approaches did not appear to yield higher agreement than that by unprompted judgement. Qualitative analysis revealed reviewers' dilemmas in deciding between the potential impact of findings and the quality of the research execution or reporting practice. Structured instruments appeared to make reviewers more explicit about the reasons for their judgements. Conclusions: Structured approaches may not produce greater consistency of judgements about whether to include qualitative papers in a systematic review. Future research should address how appraisals of qualitative research should be incorporated in systematic reviews.

Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions. In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions. Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives. Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.