全膝关节置换术循证知情同意书的开发、试点及评估（EvAb-Pilot）：一项混合方法研究方案
Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study.
作者信息
Weise Alina, Lühnen Julia, Bühn Stefanie, Steffen Felicia, Zacher Sandro, Lauberger Julia, Ates Deha Murat, Böhmer Andreas, Rosenau Henning, Steckelberg Anke, Mathes Tim
机构信息
Institute for Research in Operative Medicine, Faculty of Health-School of Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.
出版信息
Pilot Feasibility Stud. 2021 May 13;7(1):107. doi: 10.1186/s40814-021-00843-x.
BACKGROUND
Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients' anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements.
METHODS
The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact.
DISCUSSION
The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients' competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners' acceptance of evidence-based informed consent forms meeting legal requirements could be increased.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04669483 . Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571 . Registered 15 December 2020.
背景
从业者经常使用知情同意书来支持医患沟通和知情同意过程。由于治疗失误的高责任风险，手术知情同意通常侧重于以风险为中心的信息。这可能会影响患者对不良事件的焦虑以及安慰剂效应。本研究的重点是优化术前关于风险和并发症的信息，同时使这些信息符合法律要求。
方法
全膝关节置换术（TKA）及相关麻醉程序的循证知情同意书的开发、试点和评估将遵循英国医学研究委员会（MRC）关于开发和评估复杂干预措施的框架。通过开展不同的子研究，我们将：（I）定性探索信息获取和决策过程；（II）以TKA及相关麻醉程序为例，开发并试点测试循证知情同意书；（III）进行单中心中断时间序列（ITS）试点研究，以评估循证知情同意书与标准同意书相比的效果；（IV）进行过程评估，以确定干预实施的障碍和促进因素，并分析影响机制。
讨论
在知情同意书中以循证且易懂的方式呈现风险，旨在避免对风险的歪曲描述，并增强患者正确评估手术风险的能力。这可能会减少对不良事件的负面预期和焦虑，进而可能减少安慰剂效应。同时，可以提高从业者对符合法律要求的循证知情同意书的接受度。
试验注册
ClinicalTrials.gov，NCT04669483。于2020年12月15日注册。德国临床试验注册中心，DRKS00022571。于2020年12月15日注册。
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