Infectious Diseases and Amsterdam Institute for Infection and Immunology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
BMJ Open. 2023 Nov 27;13(11):e073758. doi: 10.1136/bmjopen-2023-073758.
Successful antiviral therapy has transformed HIV infection into a chronic condition, where optimising quality of life (QoL) has become essential for successful lifelong treatment. Patient-reported outcome measures (PROMs) can signal potential physical and mental health problems related to QoL. This study aims to determine whether PROMs in routine clinical care improve quality of care as experienced by people with HIV (PWH).
We report the protocol of a multicentre longitudinal cohort studying PWH at Amsterdam University Medical Centres in the Netherlands. PROMs are offered annually to patients via the patient portal of the electronic health record. Domains include anxiety, depression, fatigue, sleep disturbances, social isolation, physical functioning, stigma, post-traumatic stress disorder, adherence, drug and alcohol use and screening questions for sexual health and issues related to finances, housing and migration status. Our intervention comprises (1) patients' completion of PROMs, (2) discussion of PROMs scores during annual consultations and (3) documentation of follow-up actions in an individualised care plan, if indicated. The primary endpoint will be patient-experienced quality of care, measured by the Patient Assessment of Chronic Illness Care, Short Form (PACIC-S). Patients will provide measurements at baseline, year 1 and year 2. We will explore change over time in PACIC-S and PROMs scores and examine the sociodemographical and HIV-specific characteristics of subgroups of patients who participated in all or only part of the intervention to ascertain whether benefit has been achieved from our intervention in all subgroups.
Patients provide consent for the analysis of data collected as part of routine clinical care to the AIDS Therapy Evaluation in the Netherlands study (ATHENA) cohort through mechanisms described in Boender . Additional ethical approval for the analysis of these data is not required under the ATHENA cohort protocol. The results will be presented at national and international academic meetings and submitted to peer-reviewed journals for publication.
成功的抗病毒治疗将 HIV 感染转变为慢性疾病，优化生活质量（QoL）成为成功终身治疗的关键。患者报告的结果测量（PROMs）可以提示与 QoL 相关的潜在身心健康问题。本研究旨在确定常规临床护理中的 PROM 是否能改善 HIV 感染者（PWH）的护理质量。
我们报告了一项多中心纵向队列研究的方案，该研究在荷兰阿姆斯特丹大学医学中心对 PWH 进行研究。通过电子健康记录的患者门户，每年向患者提供 PROMs。各领域包括焦虑、抑郁、疲劳、睡眠障碍、社会隔离、身体功能、耻辱感、创伤后应激障碍、依从性、药物和酒精使用以及性健康和与财务、住房和移民状况相关的问题筛查问题。我们的干预措施包括（1）患者完成 PROMs，（2）在年度咨询期间讨论 PROMs 评分，（3）如有必要，在个体化护理计划中记录后续行动。主要终点是患者体验的护理质量，通过慢性疾病患者评估护理的简短形式（PACIC-S）来衡量。患者将在基线、第 1 年和第 2 年提供测量结果。我们将探索 PACIC-S 和 PROMs 评分随时间的变化，并检查参与全部或部分干预措施的患者亚组的社会人口学和 HIV 特定特征，以确定我们的干预措施是否在所有亚组中都取得了成效。
患者通过 Boender 中描述的机制同意分析作为荷兰艾滋病治疗评估（ATHENA）队列研究的一部分收集的数据，以用于分析。根据 ATHENA 队列方案，不需要额外的伦理批准即可分析这些数据。研究结果将在国家和国际学术会议上进行报告，并提交给同行评议期刊发表。
