Little is known about how to systematically integrate complex qualitative studies within the context of randomized controlled\r\ntrials. A two-phase sequential explanatory mixed methods study was conducted in Canada to understand how women decide\r\nto disclose intimate partner violence in emergency department settings. Mixing a RCT (with a subanalysis of data) with a\r\ngrounded theory approach required methodological modifications to maintain the overall rigour of this mixed methods study.\r\nModifications were made to the following areas of the grounded theory approach to support the overall integrity of the mixed\r\nmethods study design: recruitment of participants, maximum variation and negative case sampling, data collection, and analysis\r\nmethods. Recommendations for future studies include: (1) planning at the outset to incorporate a qualitative approach with a RCT\r\nand to determine logical points during the RCT to integrate the qualitative component and (2) consideration for the time needed\r\nto carry out a RCT and a grounded theory approach, especially to support recruitment, data collection, and analysis. Data mixing\r\nstrategies should be considered during early stages of the study, so that appropriatemeasures can be developed and used in the RCT\r\nto support initial coding structures and data analysis needs of the grounded theory phase.
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