Background

To describe the ethical issues and experiences of scientists conducting mixed methods health services research and to advance empirical and conceptual discussion on ethical integrity in mixed methods health research.

Methods

The study was conducted with 64 scholars, faculty and consultants from the NIH-funded Mixed Methods Research Training Program (MMRTP) for the Health Sciences. This was a cross-sectional study. Survey results were analyzed using descriptive statistics to characterize responses and open coding to summarize strategies about eight ethical mixed methods research issues. Respondents completed an online survey to elicit experiences related to eight ethical issues (informed consent, confidentiality, data management, burden, safety, equitable recruitment, communication, and dissemination) and strategies for addressing them.

Results

Only about one-third of respondents thought their research ethics training helped them plan, conduct, or report mixed methods research. The most frequently occurring ethical issues were participant burden, dissemination and equitable recruitment (> 70% endorsement). Despite occurring frequently, < 50% of respondents rated each ethical issue as challenging. The most challenging ethical issues were related to managing participant burden, communication, and dissemination. Strategies reported to address ethical issues were largely not specific or unique to mixed methods with the exception of strategies to mitigate participant burden and, to a lesser degree, to facilitate equitable recruitment and promote dissemination of project results.

Conclusions

Mixed methods health researchers reported encountering ethical issues often yet varying levels of difficulty and effectiveness in the strategies used to mitigate ethical issues. This study highlights some of the unique challenges faced by mixed methods researchers to plan for and appropriately respond to arising ethical issues such as managing participant burden and confidentiality across data sources and utilizing effective communication and dissemination strategies particularly when working with a multidisciplinary research team. As one of the first empirical studies to examine mixed methods research ethics, our findings highlight the need for greater attention to ethics in health services mixed methods research and training.

Background

In the context of prostate cancer (PCa) characterized by the multiple alternative treatment strategies, comparative effectiveness analysis is essential for informed decision-making. We analyzed the comparative effectiveness of PCa treatments through systematic review and meta-analysis with a focus on outcomes that matter most to newly diagnosed localized PCa patients.

Methods

We performed a systematic review of literature published in English from 1995 to October 2016. A search strategy was employed using terms "prostate cancer," "localized," "outcomes," "mortality," "health related quality of life," and "complications" to identify relevant randomized controlled trials (RCTs), prospective, and retrospective studies. For observational studies, only those adjusting for selection bias using propensity-score or instrumental-variables approaches were included. Multivariable adjusted hazard ratio was used to assess all-cause and disease-specific mortality. Funnel plots were used to assess the level of bias.

Results

Our search strategy yielded 58 articles, of which 29 were RCTs, 6 were prospective studies, and 23 were retrospective studies. The studies provided moderate data for the patient-centered outcome of mortality. Radical prostatectomy demonstrated mortality benefit compared to watchful waiting (all-cause HR = 0.63 CI = 0.45, 0.87; disease-specific HR = 0.48 CI = 0.40, 0.58), and radiation therapy (all-cause HR = 0.65 CI = 0.57, 0.74; disease-specific HR = 0.51 CI = 0.40, 0.65). However, we had minimal comparative information about tradeoffs between and within treatment for other patient-centered outcomes in the short and long-term.

Conclusion

Lack of patient-centered outcomes in comparative effectiveness research in localized PCa is a major hurdle to informed and shared decision-making. More rigorous studies that can integrate patient-centered and intermediate outcomes in addition to mortality are needed.