Medical Faculty, Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.
Medical Faculty, Institute of General Practice and Family Medicine, Martin-Luther-University Halle, Magdeburger Straße 8, 06112, Halle (Saale), Germany.
BMC Health Serv Res. 2023 Sep 11;23(1):978. doi: 10.1186/s12913-023-09993-5.
Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients' information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.
We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.
We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.
We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.
全膝关节置换术(TKA)是治疗膝关节骨关节炎(OA)的一种选择。患者对手术的实际效果有很高的期望。患者可以就 TKA 的适应证寻求第二意见。在一项研究中,建议进行 TKA 的病例中,不到一半得到了第二意见的确认,而且保守治疗也没有得到充分利用。德国使用的知情同意书通常不符合支持知情决策的要求。我们的目的是描述从膝关节 OA 的诊断到 TKA 的决策过程再到知情同意过程的流程,并了解何时、如何以及由谁做出决策。此外,我们还想描述患者对膝关节 OA 及其治疗(包括 TKA)的信息需求和偏好,并了解提供了哪些信息。我们还想了解哪些信息对决策很重要,并确定在实践中优化使用基于证据的知情同意书的障碍和促进因素。
我们选择了定性方法,对即将接受、已经接受或拒绝接受 TKA 的患者以及在诊所获得知情同意的全科医生(GP)、门诊骨科医生和麻醉师进行了半结构化访谈。访谈进行了录音,转录后使用定性内容分析进行了分析。
我们对 13 名患者、3 名全科医生、4 名门诊骨科医生和 7 名获得知情同意的诊所医生进行了访谈。信息需求是基于主观疾病理论和医生传达的信息来建模的。该样本中的患者主要在没有获得足够信息的情况下做出决策。在该样本中,对医生的信任和经验似乎比基于事实的信息更为重要。门诊(全科医生、骨科医生)和诊所的骨科医生对其提供信息的角色和期望有不同的理解。
我们能够确定阻碍基于证据的知情同意书实施的结构性障碍和假设。