Faculty of Health and Social Sciences, Western Norway University of Applied Sciences-Forde Campus, Forde, Norway
Department of Global Public Health and Primary Care, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.
BMJ Open. 2020 Jun 22;10(6):e037685. doi: 10.1136/bmjopen-2020-037685.
Consultations before and after bariatric surgery should include structured assessments of patients' health-related quality of life (HRQOL) and mental health. One way to conduct this assessment is to implement patient-reported outcome monitoring with a clinical feedback system (PRO/CFS).
We will explore patients' and healthcare professionals' experiences when a PRO/CFS is an integrated part of bariatric surgery care.
This is a design paper in which a PRO/CFS will be implemented in two bariatric outpatient clinics. All patients who have an appointment with a healthcare professional prior to, and 3 and 12 months after surgery, will be asked to complete six digital questionnaires measuring HRQOL, mental health, bowel symptoms and eating self-efficacy prior to each consultation. A digital summary report generated from the patient's responses will form the basis for the clinical consultation. A team of patient representatives, healthcare professionals and researchers will be involved in all phases of designing the PRO/CFS to ensure its relevance for clinical consultations. The patients' experiences will be explored with a generic 12-item questionnaire, developed for use in outpatient clinics, prior to and 12 months after bariatric surgery. We will conduct focus-group interviews with patients and healthcare professionals to explore their experiences when PRO/CFS is integrated into the consultations.
Written informed consent will be obtained for all participants in the study. The project is approved by the Norwegian Centre for Research Data, Department of Data Protection Services (ref. no. 282738). The project has also undergone Data Protection Impact Assessments, both at Førde Hospital Trust and at St. Olav Hospital (registration no. 2016/3912). Data from the qualitative and quantitative studies will be kept in de-identified form in a secured research database, and the findings will be published in international peer-reviewed journals and presented at scientific conferences.
减重手术前后的咨询应包括对患者健康相关生活质量（HRQOL）和心理健康的结构化评估。一种进行这种评估的方法是实施患者报告的结果监测和临床反馈系统（PRO/CFS）。
我们将探讨当 PRO/CFS 成为减重手术护理的一部分时，患者和医疗保健专业人员的体验。
这是一篇设计论文，其中将在两个减重门诊诊所实施 PRO/CFS。所有在手术前、术后 3 个月和 12 个月与医疗保健专业人员预约的患者，将被要求在每次就诊前完成六份数字问卷，测量 HRQOL、心理健康、肠道症状和饮食自我效能。患者反应生成的数字摘要报告将作为临床咨询的基础。一个由患者代表、医疗保健专业人员和研究人员组成的团队将参与设计 PRO/CFS 的所有阶段，以确保其与临床咨询相关。在减重手术前后，我们将使用一个通用的 12 项问卷来探索患者的体验，该问卷是为门诊诊所开发的。我们将对患者和医疗保健专业人员进行焦点小组访谈，以探讨当 PRO/CFS 融入咨询时他们的体验。
所有参与研究的参与者都将获得书面知情同意。该项目已获得挪威研究数据中心、数据保护服务部（编号 282738）的批准。该项目还进行了数据保护影响评估，分别在弗尔达医院信托基金和圣奥拉夫医院（注册编号 2016/3912）进行。定性和定量研究的数据将以去识别形式保存在安全的研究数据库中，研究结果将发表在国际同行评议期刊上，并在科学会议上展示。
