Proactive assessment of patient reported outcomes in ovarian cancer studies: a systematic review and call for action in future studies.

This systematic review aims to evaluate the proactive or real-time assessment of patient reported outcomes in studies involving patients with ovarian cancer undergoing systemic therapy. PubMed, Embase, and Cochrane databases were searched (from database inception until February 2022), and prospective ovarian cancer studies (experimental or observational) that incorporated patient reported outcomes, including quality of life, were included. The primary objective was to assess the ratio of studies incorporating real-time use of patient reported outcomes among those studies performing patient reported outcomes. A secondary objective was to describe the patient reported outcome reporting. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 checklist was followed. Descriptive statistics were used. 3071 articles were screened, with 117 included in the final analysis. Studies were published between 1990 and 2022, and consisted of 35 735 patients (median 140 patients per study; interquartile range 58-415). Median time from patient enrollment initiation to study publication was 7 years (range 1-15). Most studies were experimental/clinical trials (n=93, 79%) followed by observational (n=23, 20%). Therapeutic strategies were assessed in 98% (91/93) of experimental studies, most frequently chemotherapy (n=53, 58%), followed by antiangiogenics or poly-ADP ribose polymerase (PARP) inhibitors (n=8, 9%, each). Patient reported outcomes were the primary endpoint in 7.5% (7/93) and 83% (19/23) of experimental and observational studies, respectively. The ratio of real-time patient reported outcomes assessment/evaluation was 0.9% (1/117). Completion of patient reported outcome questionnaires involves time and effort for patients with ovarian cancer. Responses to these questionnaires were only assessed in real time in <1% of analyzed studies. Efforts should be made to incorporate proactive assessment of patient reported outcomes to optimize patient care and safety.

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Competing interests: AM received honoraria from AstraZeneca, Clovis, GSK, MSD, PharmaMar. SL is principal investigator or co-investigator of different clinical trials with agents from AstraZeneca, Merck, Roche, GSK, Regeneron, Repare Therapeutics, Clovis. LK received honoraria from Eisai, Novartis, GSK. PT reports a consulting or advisory role with AstraZeneca, Daiichi-Sankyo, Adamed, Novartis and Seagen. Speakers’ bureaus for Pfizer, Novartis, Lilly, AstraZeneca, Daiichi-Sankyo, Esteve, Gilead, Reveal Genomics and Seagen. Travel grants from Pfizer, Novartis, AstraZeneca and Gilead. DV received honoraria from Abbie, Agios, Amgen, Astellas, BMS/Celgene, Gebro, Grifols, Janssen, Jazz Pharmaceuticals, Kite/Gilead, MSD, Novartis, Pfizer, Sanofi, Servier, Sobi and Takeda. AMO declared uncompensated consulting or advisory role in AstraZeneca and GSK. He has uncompensated relationships with AstraZeneca and Clovis and research funding from AstraZeneca, GSK. SL declared consulting fees from AstraZeneca, GSK, Merck, Eisai, Shattuck laboratories, Repare and Seagen. The remaining authors declare no other competing interests.