Investigating Trends in the Quality of Reporting of Patient-Reported Outcomes in Oncology Over Time: Analysis of 631 Randomized Controlled Trials Published Between 2004 and 2019

Efficace, Fabio; Giesinger, Johannes; Cella, David; Cottone, Francesco; Sparano, Francesco; Vignetti, Marco; Aaronson, Neil K.

doi:10.1016/j.jval.2021.06.003

Cited by 7 publications

(19 citation statements)

References 21 publications

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“…Use of a PRO as a primary end point, compared with as a secondary end point, was frequently associated with better reporting. 11 , 13 , 14 , 23 Larger sample size was also described as factor associated with better reporting. 14 However, whether the reporting of PROs has improved in trials over time is not entirely clear based on the literature available so far.…”

Section: Discussionmentioning

confidence: 99%

“… 11 , 13 , 14 , 23 Larger sample size was also described as factor associated with better reporting. 14 However, whether the reporting of PROs has improved in trials over time is not entirely clear based on the literature available so far. 9 , 14 …”

Section: Discussionmentioning

confidence: 99%

“… 14 However, whether the reporting of PROs has improved in trials over time is not entirely clear based on the literature available so far. 9 , 14 …”

Section: Discussionmentioning

confidence: 99%

“…11,13,14,23 Larger sample size was also described as factor associated with better reporting. 14 However, whether the reporting of PROs has improved in trials over time is not entirely clear based on the literature available so far. 9,14 The extensive literature on reporting of PROs in different settings of cancer trials fits well with our results.…”

Section: Jama Network Open | Oncologymentioning

confidence: 99%

“…Since then, specific trial characteristics have been associated with favorable PRO reporting, such as PROs being the primary end point or a more recent date of publication. 13 , 14 …”

Section: Introductionmentioning

confidence: 99%

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Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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ImportanceApproximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications.ObjectiveTo investigate the use and reporting of PROs in clinical trials of palliative radiotherapy.Evidence ReviewThis preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines.FindingsAmong 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score.Conclusions and RelevanceIn this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“… 14 However, whether the reporting of PROs has improved in trials over time is not entirely clear based on the literature available so far. 9 , 14 …”

Section: Discussionmentioning

confidence: 99%

“…11,13,14,23 Larger sample size was also described as factor associated with better reporting. 14 However, whether the reporting of PROs has improved in trials over time is not entirely clear based on the literature available so far. 9,14 The extensive literature on reporting of PROs in different settings of cancer trials fits well with our results.…”

Section: Jama Network Open | Oncologymentioning

confidence: 99%

“…Since then, specific trial characteristics have been associated with favorable PRO reporting, such as PROs being the primary end point or a more recent date of publication. 13 , 14 …”

Section: Introductionmentioning

confidence: 99%

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Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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Clinical outcome assessment trends in clinical trials—Contrasting oncology and non‐oncology trials

et al. 2023

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BackgroundClinical outcome assessments (COAs) are key to patient‐centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their incorporation in trial outcomes have lagged that of traditional survival and tumor responses. To understand the trends of COA use in oncology and the impact of landmark efforts to promote COA use, we computationally surveyed oncology clinical trials in ClinicalTrials.gov comparing them to the rest of the clinical research landscape.MethodsOncology trials were identified using medical subject heading neoplasm terms. Trials were searched for COA instrument names obtained from PROQOLID. Regression analyses assessed chronological and design‐related trends.ResultsEighteen percent of oncology interventional trials initiated 1985–2020 (N = 35,415) reported using one or more of 655 COA instruments. Eighty‐four percent of the COA‐using trials utilized patient‐reported outcomes, with other COA categories used in 4–27% of these trials. Likelihood of COA use increased with progressing trial phase (OR = 1.30, p < 0.001), randomization (OR = 2.32, p < 0.001), use of data monitoring committees (OR = 1.26, p < 0.001), study of non‐FDA‐regulated interventions (OR = 1.23, p = 0.001), and in supportive care versus treatment‐focused trials (OR = 2.94, p < 0.001). Twenty‐six percent of non‐oncology trials initiated 1985–2020 (N = 244,440) reported COA use; they had similar COA‐use predictive factors as oncology trials. COA use increased linearly over time (R = 0.98, p < 0.001), with significant increases following several individual regulatory events.ConclusionWhile COA use across clinical research has increased over time, there remains a need to further promote COA use particularly in early phase and treatment‐focused oncology trials.

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The impact of current therapeutic options on the health-related quality of life of patients with relapse/refractory multiple myeloma: a systematic review of clinical studies

et al. 2023

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Investigating Trends in the Quality of Reporting of Patient-Reported Outcomes in Oncology Over Time: Analysis of 631 Randomized Controlled Trials Published Between 2004 and 2019

Cited by 7 publications

References 21 publications

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Clinical outcome assessment trends in clinical trials—Contrasting oncology and non‐oncology trials

The impact of current therapeutic options on the health-related quality of life of patients with relapse/refractory multiple myeloma: a systematic review of clinical studies

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