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