1. Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.
- Author
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Escudero-Vilaplana V, Bernal E, Casado G, Collado-Borrell R, Diez-Fernández R, Fernández Román AB, Folguera C, González-Cortijo L, Herrero-Fernández M, Marquina G, Martínez Nieto C, Rodríguez MA, Rubio AR, Sanmartin-Fenollera P, Vazquez Castillo MJ, Comellas M, and Guerra EM
- Abstract
Purpose: 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., Methods: 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)., Results: 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
st 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 1st -year of treatment; and later (4) every six months until treatment completion/change., Conclusions: 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., Competing Interests: VE-V received support to continuing education/advisory fees from Astellas, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, Novartis, Roche, and Sanofi. RC-B has received support to continuing education/advisory fees: Boehringer-Ingelheim, Janssen, Merck Sharp & Dohme, Hoffmann-La Roche, Amgen Inc, GlaxoSmithKline, and Pfizer. EG has received advisory/consultancy honorarium from AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; has received speaker bureau/expert testimony honorarium from AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis; and has received travel/accommodation/expenses from Roche, GSK-Tesaro and Baxter. MV works for an independent research entity that received funding from GlaxoSmithKline to coordinate and conduct the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Escudero-Vilaplana, Bernal, Casado, Collado-Borrell, Diez-Fernández, Fernández Román, Folguera, González-Cortijo, Herrero-Fernández, Marquina, Martínez Nieto, Rodríguez, Rubio, Sanmartin-Fenollera, Vazquez Castillo, Comellas and Guerra.)- Published
- 2022
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