SynthesisQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2020
Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.
Synthesis in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed.
- Time to deterioration of patient-reported outcome endpoints in cancer clinical trials: targeted literature review and best practice recommendations.Journal of patient-reported outcomes · 2024Review
- Patient-reported outcomes in metastatic renal cell carcinoma trials using combinations versus sunitinib as first-line treatment.Nature reviews. Urology · 2023Review
- Minimally important changes do not always reflect minimally important change; moreover, there is no need for them.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Cardiovascular Reasons for Access to a Tertiary Oncological Emergency Service: The CARILLON Study.Journal of clinical medicine · 2023Article
- Improvement of postoperative quality of life in patients with esophageal squamous cell carcinoma: does tea consumption have a role?BMC public health · 2022Article
- Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Article
- Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Article
- Effect of Regorafenib in Delaying Definitive Deterioration in Health-Related Quality of Life in Patients with Advanced Cancer of Three Different Tumor Types.Cancer management and research · 2021Article
- Longitudinal analysis of health-related quality of life in cancer clinical trials: methods and interpretation of results.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021Article
- Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
purposeThe 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.
methodsA 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.
resultsA 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%).
conclusionThis 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.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.