Patient-reported outcomes in randomized controlled trials evaluating BRAF inhibitors in patients with cutaneous melanoma: a systematic scoping review of quality of reporting and trial results
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View abstract on PubMed
Summary
This summary is machine-generated.This review of BRAF inhibitor trials for advanced melanoma found patient-reported outcomes (PROs) were secondary endpoints, often using generic tools. Improved PRO reporting quality is needed for better treatment tolerability assessments.
Area Of Science
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background
- Advanced melanoma treatment often involves BRAF inhibitors.
- Patient-reported outcomes (PROs) are crucial for assessing treatment tolerability.
- Current practices in PRO assessment within BRAF inhibitor trials require evaluation.
Purpose Of The Study
- To overview current PRO assessment practices in advanced melanoma trials using BRAF inhibitors.
- To extract data on symptomatic adverse events (AEs) from clinician reports.
- To inform future PRO measurement strategies for clinical trials.
Main Methods
- Systematic scoping review of randomized controlled trials (RCTs) indexed on PubMed.
- Included RCTs evaluated BRAF inhibitors with PRO endpoints.
- Data extraction on RCT characteristics, clinical results, and PROs; quality assessment using CONSORT-PRO checklist.
Main Results
- Nine RCTs met inclusion criteria, with PROs as secondary or exploratory endpoints.
- The EORTC QLQ-C30 questionnaire was predominantly used for PRO measurement.
- PRO reporting quality varied, with frequent omissions in handling missing data and PRO hypotheses.
- Twenty-nine symptomatic AEs were identified as suitable for direct patient reporting.
Conclusions
- Findings can guide the PRO component of future BRAF inhibitor RCTs, focusing on comprehensive tolerability assessment.
- There is a need to enhance the quality of PRO reporting to maximize the impact of findings.
- Optimizing PRO measures requires careful selection of symptoms and AEs for patient reporting.
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