患者报告的结果(PRO)可以为医疗保健决策提供信息,监管决定,和医疗保健政策。它们还可用于审计/基准测试和监测症状,以根据个人需求提供及时的护理。然而,与PRO使用有关的几个道德问题已经被提出。
为了发展国际化,基于共识,临床研究的专业特定伦理准则。
PRO道德准则是根据“提高健康研究的质量和透明度”(EQUATOR)网络的准则制定框架制定的。这包括对临床研究中PRO的伦理意义的系统评价。数据库MEDLINE(Ovid),Embase,AMED,从一开始到2020年3月,都对和CINAHL进行了搜索。关键词患者报告结果*和伦理*用于搜索数据库。两名审稿人在全文筛选前独立进行标题和摘要筛选,以确定资格。该审查得到了SPIRIT-PRO延长试验方案建议的补充。随后,举行了两轮国际德尔菲进程(n=96名参与者;2021年5月和8月)和一次共识会议(n=25名国际参与者;2021年10月)。投票前,向共识会议参与者提供了Delphi过程结果的摘要以及有关项目是否与现有道德指南一致的信息。
在德尔菲程序的第一轮中考虑了23个项目:来自系统审查的6个相关候选项目和来自SPIRIT-PRO扩展的17个额外项目。96名国际与会者就每个项目纳入道德准则的相关重要性进行了投票,并建议将另外12个项目纳入德尔菲第2轮(共35个项目)。建议在协商一致会议上列入14个项目(n=25名与会者)。PRO道德准则的最终措辞由与会者协商一致同意,另有6人提出意见。包括侧重于与研究理由相关的PRO特定伦理问题的项目,目标,资格要求,PRO概念和域,PRO评估时间表,样本量,PRO数据监控,PRO完成的障碍,参与者的可接受性和负担,为无法自我报告PRO数据的参与者管理PRO问卷,患者合作伙伴或公众对PRO策略的输入,避免丢失数据,和传播计划。
PRO伦理指南为PRO临床研究中应解决的伦理问题提供了建议。解决PRO临床研究的伦理问题有可能确保高质量的PRO数据,同时最大限度地降低参与者的风险,负担,伤害和保护参与者和研究人员的福利。
Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.
To develop international,
consensus-based, PRO-specific ethical
guidelines for clinical research.
The PRO ethics
guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network\'s
guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.
Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the
consensus meeting (n = 25 participants). The final wording of the PRO ethical
guidelines was agreed on by
consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.
The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.