Escudero-Vilaplana Vicente, Bernal Elsa, Casado Gema, Collado-Borrell Roberto, Diez-Fernández Raúl, Fernández Román Ana Beatriz, Folguera Carlos, González-Cortijo Lucía, Herrero-Fernández Marta, Marquina Gloria, Martínez Nieto Concepción, Rodríguez Miguel Angel, Rubio Ana Rosa, Sanmartin-Fenollera Patricia, Vazquez Castillo Maria José, Comellas Marta, Guerra Eva Maria
Hospital Pharmacy, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Front Oncol. 2022 May 18;12:885910. doi: 10.3389/fonc.2022.885910. eCollection 2022.
Advanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients' health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients' follow-up from patients' and healthcare professionals' (HCP) perspective.
The project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as 'relevant', 'appropriate', or 'feasible' (score 7-9).
A total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1 round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients' HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient's treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1-year of treatment; and later (4) every six months until treatment completion/change.
The consensus reached represents the first step towards including the patient's perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.
晚期卵巢癌（AOC）及其治疗会引发多种症状，并对患者的健康相关生活质量（HRQoL）产生影响。我们旨在从患者和医疗保健专业人员（HCP）的角度，就AOC患者随访期间最相关的患者报告结局（PROs）、相应的测量工具（PROMs）以及测量频率达成共识。
该项目包括五个步骤：1）文献综述；2）患者焦点小组；3）HCP名义小组；4）与患者和HCP进行两轮德尔菲咨询；5）与HCP召开最终会议。基于文献综述、焦点小组（5名患者）和名义小组（16名HCP）制定了德尔菲问卷。评估了每个PRO的相关性以及所提议的PROM的适宜性（A）和可行性（F）（李克特量表1 = 强烈同意；9 = 强烈不同意）。当至少75%的小组成员将其评为“相关”、“适宜”或“可行（得分7 - 9）时，达成共识。
共有56名HCP[51.8%为医院药剂师；41.1%为肿瘤学家；3.6%为护士；3.6%为心理肿瘤学家；专科平均工作时间12.5（8.0）年]和10名AOC患者[平均诊断时间5.4（3.0）年]参与了第一轮。除皮肤干燥（58.0%）外，所有PROs在相关性方面均达成共识。对于使用PRO-CTCAE评估疲劳（A：84.9%；F：75.8%）、神经病变（A：92.4%；F：77.3%）、腹泻（A：87.9%；F：88.7%）、便秘（A：86.4%；F：
