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Background: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods: Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results: The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions: We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. [ABSTRACT FROM AUTHOR]

In order to fully understand and explore the effectiveness of any intervention for the management of multiple sclerosis (MS), it is important to have robust, valid, reliable, and universally applied measures. The recent article, ‘Disability outcome measures in multiple sclerosis clinical trials’ by Cohen, Reingold, Polman and Wolinsky (2012), explores this issue in regards to the effective measurement of MS-related disability, and the utilisation of patient-reported outcome measures, whilst highlighting the need for collaboration between the academic and clinical communities. Although it is important to examine disability measures, it is also equally important to recognise that physical function is only one aspect of a person’s experience; for example, quality of life and psychological well-being are also important aspects to assess. The application of e-health technologies and patient registers could be a useful method of gaining additional information, using patient-reported outcomes. This commentary explores these issues in relation to points raised by the Cohen et al. paper. [ABSTRACT FROM AUTHOR]