| Added by | mollevi |
|---|---|
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review |
| Creator | Charton et al. |
| Author | E. Charton |
| Author | B. Cuer |
| Author | F. Cottone |
| Author | F. Efficace |
| Author | C. Touraine |
| Author | Z. Hamidou |
| Author | F. Fiteni |
| Author | F. Bonnetain |
| Author | M.-C. Woronoff-Lemsi |
| Author | C. Bascoul-Mollevi |
| Author | A. Anota |
| Abstract | 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. |
| Publication | Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation |
| Date | Nov 27, 2019 |
| Journal Abbr | Qual Life Res |
| Language | eng |
| DOI | 10.1007/s11136-019-02367-7 |
| ISSN | 1573-2649 |
| Short Title | Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data |
| Library Catalog | PubMed |
| Extra | 00000 PMID: 31776827 |
| Tags | Clinical Deterioration, Humans, Neoplasms, Patient Reported Outcome Measures, Patient-reported outcomes, Quality of Life, Randomized clinical trials, Randomized Controlled Trials as Topic, Systematic review, Time to deterioration |
| Date Added | 2019/12/10 - 17:03:47 |
| Date Modified | 2020/07/24 - 16:15:07 |
| Notes and Attachments | PubMed entry (Attachment) PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
