Weston Sophie, Adhkari Bipin, Thriemer Kamala
Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
PLOS Glob Public Health. 2023 Sep 5;3(9):e0002062. doi: 10.1371/journal.pgph.0002062. eCollection 2023.
Results-sharing with participants or their communities after the completion of research is an essential element of ethical research. The main objective of this study was to identify and document current practice of trial result dissemination, to explore attitudes among trialists towards result dissemination and to better understand previous experiences and barriers to returning results to participants. This mixed-methods study used a sequential exploratory design with two phases: i) an initial qualitative phase to explore the topic and to inform the quantitative data collection, ii) a quantitative survey. Findings from the survey and interviews were triangulated and presented to a network of clinical malaria researchers for validation. A total of 11 semi-structured interviews (SSIs) were conducted using an interview guide. The quantitative survey had a response rate of 19.9% (42/211). Disseminating results to participants after clinical trials was deemed critical for ethical malaria related research, with 38.1% indicating it as extremely important and 45.2% rating it as mostly important. Most respondents referred to the dissemination of results to policymakers and wider stakeholders as important aspects of research translation. The practice of patient or community engagement was prioritized in the pre-trial period and during the trial for obvious instrumental goals of improving retention, coverage and adherence, but much less priority was given to the post-trial period. The main reason for poor dissemination practice was the notion that the time lag between study participation and the availability of results was too long (42.4%). Other reasons included the assumption that the community was not interested (36.4%), and financial restraints (9.1%). The rich qualitative data revealed detailed accounts of operational, cultural, educational and economic aspects that pose further barriers to results-sharing, including limited knowledge about best practice. Better planning which includes adequate financial resourcing is required for meaningful dissemination of results to study participants. Improved institutional guidance and more stringent requirements by funders could support researchers who are generally interested and willing to complete the process. Best practice methods to conduct such dissemination remains to be explored.
研究完成后与参与者或其社区分享研究结果是伦理研究的一个基本要素。本研究的主要目的是识别并记录当前试验结果传播的实践情况，探究试验者对结果传播的态度，并更好地了解以往向参与者反馈结果的经验和障碍。这项混合方法研究采用了两阶段的顺序探索性设计：i）初始定性阶段，以探索该主题并为定量数据收集提供信息；ii）定量调查。将调查和访谈的结果进行三角互证，并提交给临床疟疾研究人员网络进行验证。使用访谈指南共进行了11次半结构化访谈（SSI）。定量调查的回复率为19.9%（42/211）。临床试验后向参与者传播结果被认为是与疟疾相关伦理研究的关键，38.1%的人表示这极其重要，45.2%的人将其评为非常重要。大多数受访者认为向政策制定者和更广泛的利益相关者传播结果是研究转化的重要方面。在试验前和试验期间，为了提高保留率、覆盖率和依从性等明显的实用目标，患者或社区参与的实践得到了优先考虑，但在试验后阶段的优先级则低得多。传播实践不佳的主要原因是认为研究参与和结果可得之间的时间间隔太长（42.4%）。其他原因包括认为社区不感兴趣（36.4%）和资金限制（9.1%）。丰富的定性数据揭示了在操作、文化、教育和经济方面存在的详细情况，这些情况对结果分享构成了进一步的障碍，包括对最佳实践的了解有限。为了向研究参与者有意义地传播结果，需要进行更好的规划，包括充足的资金投入。改进机构指导以及资助者提出更严格的要求，可以支持那些总体上有兴趣并愿意完成这一过程的研究人员。进行此类传播的最佳实践方法仍有待探索。
