癌症试验中患者报告结局问卷的管理：就试验协调员的角色、经验、挑战及培训情况进行的访谈
The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles, experiences, challenges and training.
作者信息
Mercieca-Bebber Rebecca, Calvert Melanie, Kyte Derek, Stockler Martin, King Madeleine T
机构信息
Central Clinical School, Sydney Medical School, University of Sydney, NSW 2006, Australia.
Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, NSW 2006, Australia.
出版信息
Contemp Clin Trials Commun. 2017 Nov 23;9:23-32. doi: 10.1016/j.conctc.2017.11.009. eCollection 2018 Mar.
AIMS
To explore cancer trial coordinators' roles and challenges in administering patient-reported outcome (PRO) questionnaires, and establish what PRO-specific training and guidance they received and needed.
METHODS
Eligible cancer trial coordinators experienced with PRO assessment from approved Australian sites participated in an audio-recorded, semi-structured interview (transcribed verbatim). Recruitment continued until data saturation. Transcripts underwent content analysis.
RESULTS
Twenty coordinators participated (professional training: nursing (n = 12), science/research (n = 4), both (n = 4)). PRO administration formed a minor component of most (85%) coordinators' roles. PRO administration challenges included managing 'English second language' participants, participants' companions who attempted to complete questionnaires, burdensome questionnaires, and balancing their duty of care against trial requirements. Coordinators reported inconsistencies in PRO administration, which appeared to arise as a result of confusion and inconsistent or contradictory PRO training. Inconsistencies concerned whether/when they explained the purpose of PRO assessment, which participants they approached to complete PROs, and whether they used PRO trial data to inform care.Coordinators received PRO training from various sources; most commonly study-specific start-up meetings (45%) or from colleagues (30%). Two received no PRO-specific training. Despite the challenges reported, many (55%) felt they did not need further PRO training.
CONCLUSION
Trial coordinators receive inconsistent PRO-specific training and are often unclear how to prioritise different aspects of data quality when faced with everyday challenges, leading to inconsistent methods, missing data, poor quality data, and even bias. Agreement on how coordinators should prioritise the requirements of PRO studies is a necessary pre-requisite for the development of much-needed, consensus-based PRO administration guidelines.
目的
探讨癌症试验协调员在管理患者报告结局（PRO）问卷方面的作用和挑战，并确定他们接受了哪些以及需要哪些特定于PRO的培训和指导。
方法
来自澳大利亚获批站点、有PRO评估经验的合格癌症试验协调员参加了一次录音的半结构化访谈（逐字转录）。招募工作持续进行直至数据饱和。对访谈记录进行内容分析。
结果
20名协调员参与（专业培训情况：护理专业12名，科学/研究专业4名，两者兼具4名）。PRO管理是大多数（85%）协调员工作的一个次要组成部分。PRO管理面临的挑战包括应对“英语非母语”参与者、试图代填问卷的参与者同伴、问卷繁琐，以及在其护理职责与试验要求之间取得平衡。协调员报告称PRO管理存在不一致的情况，这似乎是由于困惑以及PRO培训不一致或相互矛盾所致。不一致之处涉及他们是否/何时解释PRO评估的目的、找哪些参与者来完成PRO问卷，以及他们是否使用PRO试验数据来指导护理。协调员从各种来源接受PRO培训；最常见的是特定研究的启动会议（45%）或同事（30%）。两名协调员未接受任何特定于PRO的培训。尽管报告了这些挑战，但许多人（55%）觉得他们不需要进一步的PRO培训。
结论
试验协调员接受的PRO特定培训不一致，并且在面对日常挑战时，往往不清楚如何对数据质量的不同方面进行优先级排序，从而导致方法不一致、数据缺失、数据质量差，甚至产生偏差。就协调员应如何对PRO研究的要求进行优先级排序达成共识，是制定急需的、基于共识的PRO管理指南的必要前提。
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