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  • Reporting of health‐related...
    St Germain, Diane; Denicoff, Andrea; Torres, Andrea; Kelaghan, Joseph; McCaskill‐Stevens, Worta; Mishkin, Grace; O’Mara, Ann; Minasian, Lori M.

    Cancer, June 1, 2020, 2020-06-01, 2020-06-00, 20200601, Letnik: 126, Številka: 11
    Journal Article

    Background The importance of capturing and reporting health‐related quality of life (HRQOL) in clinical trials has been increasingly recognized in the oncology field. As a result, the National Cancer Institute (NCI) began to provide support for correlative HRQOL studies in cancer treatment trials. The current study was conducted to assess the publication rate of HRQOL correlative studies in NCI‐supported treatment trials and to identify potential factors positively or negatively associated with publication rates. Methods The NCI conducted a retrospective review of existing NCI databases to identify cancer treatment trials that had obtained additional NCI funding for the assessment of HRQOL and to determine the extent to which funded HRQOL studies have been completed and published in a peer‐reviewed journal. Results Of the 108 included trials, 58 (54%) had a parent trial (PT) publication; of these, 36 trials (62%) had a published HRQOL result: 20 as an independent publication and 16 that were included and/or reported in the PT publication. The length of time between trial activation and closure, as well as the specific cancer, appeared to be associated with the publication rates. Conclusions The results of the current study demonstrated that approximately 45% of the PT publications were followed by a HRQOL publication within 1 year, to allow the knowledge to be used in patient treatment decision making. The authors believe the current analysis is an important first step toward a better understand of the challenges that researchers face when reporting HRQOL endpoints. Greater than 60% of the National Cancer Institute–funded health‐related quality of life (HRQOL) correlative studies embedded in cancer treatment trials are found to have an associated publication in a peer‐reviewed journal. HRQOL publication rates vary based on the length of time between trial activation and closure and type of cancer.