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Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.
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- المؤلفون: Charton E;Charton E;Charton E; Cuer B; Cuer B; Cuer B; Cottone F; Cottone F; Efficace F; Efficace F; Touraine C; Touraine C; Hamidou Z; Hamidou Z; Hamidou Z; Fiteni F; Fiteni F; Fiteni F; Bonnetain F; Bonnetain F; Bonnetain F; Bonnetain F; Woronoff-Lemsi MC; Woronoff-Lemsi MC; Woronoff-Lemsi MC; Bascoul-Mollevi C; Bascoul-Mollevi C; Bascoul-Mollevi C; Bascoul-Mollevi C; Anota A; Anota A; Anota A; Anota A
- المصدر:
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2020 Apr; Vol. 29 (4), pp. 867-878. Date of Electronic Publication: 2019 Nov 27.- نوع النشر :
Journal Article; Systematic Review- اللغة:
English - المصدر:
- معلومة اضافية
- المصدر: Publisher: Springer Netherlands Country of Publication: Netherlands NLM ID: 9210257 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2649 (Electronic) Linking ISSN: 09629343 NLM ISO Abbreviation: Qual Life Res Subsets: MEDLINE
- بيانات النشر: Publication: 2005- : Netherlands : Springer Netherlands
Original Publication: Oxford, UK : Rapid Communications of Oxford, Ltd, c1992- - الموضوع:
- نبذة مختصرة : Purpose: The time to deterioration (TTD) approach has been proposed as a modality of longitudinal analysis of patient-reported outcomes (PROs) in cancer randomized clinical trials (RCTs). The objective of this study was to perform a systematic review of how the TTD approach has been used in phase III RCTs to analyze longitudinal PRO data.
Methods: A systematic literature search was conducted in PubMed/MEDLINE, the Cochrane Library and through manual search to identify studies published between January 2014 and June 2018. All phase III cancer RCTs including a PRO endpoint using the TTD approach were considered. We collected general information about the study, PRO assessment and the TTD approach, such as the event definition, the choice of reference score and whether the deterioration was definitive or not.
Results: A total of 1549 articles were screened, and 39 studies were finally identified as relevant according to predefined criteria. Among these 39 studies, 36 (92.3%) were in advanced and/or metastatic cancer. Several different deterioration definitions were used in RCTs, 10 studies (25.6%) defined the deterioration as "definitive", corresponding to a deterioration maintained over time until the last PRO assessment available for each patient. The baseline score was explicitly stated as the reference score to qualify the deterioration for most studies (n = 31, 79.5%).
Conclusion: This review highlights the lack of standardization of the TTD approach for the analysis of PRO data in RCTs. Special attention should be paid to the definition of "deterioration", and this should be based on the specific cancer setting. - References: Efficace, F., Fayers, P., Pusic, A., Cemal, Y., Yanagawa, J., Jacobs, M., et al. (2015). Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials. Cancer,121(18), 3335–3342. https://doi.org/10.1002/cncr.29489 . (PMID: 10.1002/cncr.29489260791974755292)
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- Contributed Indexing: Keywords: Patient-reported outcomes; Randomized clinical trials; Systematic review; Time to deterioration
- الموضوع: Date Created: 20191129 Date Completed: 20200629 Latest Revision: 20210321
- الموضوع: 20221213
- الرقم المعرف: 10.1007/s11136-019-02367-7
- الرقم المعرف: 31776827
- المصدر:
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