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Patients' perspectives on the relevance of biosimilars' outcomes in oncology: qualitative study with nominal group
Luisa von Zuben Vecoso1, Marcus Tolentino Silva2, Annemeri Livinalli1
1Universidade Estadual de Campinas, Campinas, Brazil.
Purpose:
We aimed to rate the importance of outcomes from a systematic review about biosimilars in oncology from patients' perspective.
Methods:
This is a qualitative research with nominal group technique. Patients with cancer were selected by convenience sampling and invited for two mediated virtual meetings in 2022. Twelve outcomes from a systematic review on biosimilars for oncology developed following a protocol were explained in plain language to participants who classified them as critical, important, or not important according to the Grading of Recommendations Assessment, Development and Evaluation approach. We employed Iramuteq software for lexical categorization of the meeting transcripts, and content analysis for interpretation.
Results:
Five women participated (three had metastatic cancer, one non-metastatic, one recurrent). Six outcomes were classified as critical: duration of response, progression-free survival, pathological complete response, overall survival, severe adverse events, and quality of life; three as important: mortality, event-free survival, and objective response; and three as non-important: neutralizing anti-drug antibody, any adverse event, and non-neutralizing anti-drug antibody. Duration of response, pathological complete response, severe adverse events, and quality of life were considered secondary in the review protocol, but critical by the patients. The main themes influencing the importance classification were related to the disease (progression and control) and treatment (recognition and healthcare setting).
Conclusion:
Patients rated most outcomes as critical or important, some of them previously regarded as secondary by the researchers, which reinforces the need to include stakeholders' perspectives in oncology research. Aspects of the disease progression and treatment effects influenced participants' judgment on outcomes' relevance.
Insights
Patients prioritize cancer outcomes like survival and quality of life, even those deemed secondary by researchers. Their perspectives are crucial for oncology research relevance.
Area of Science:
- Oncology
- Patient-Reported Outcomes
- Health Services Research
Background:
- Systematic reviews on oncology biosimilars often lack patient input on outcome importance.
- Understanding patient priorities is essential for aligning research with real-world impact.
Approach:
- Qualitative study using nominal group technique with cancer patients.
- Patients rated 12 outcomes from a systematic review using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
- Lexical analysis of transcripts identified key themes influencing outcome prioritization.
Key Points:
- Patients deemed duration of response, progression-free survival, pathological complete response, overall survival, severe adverse events, and quality of life as critical outcomes.
- Outcomes like neutralizing anti-drug antibodies were considered non-important by patients.
- Patient priorities sometimes diverged from those identified in the original systematic review protocol.
Conclusions:
- Patient perspectives significantly shape the perceived importance of oncology outcomes.
- Incorporating patient-reported outcomes is vital for patient-centered oncology research.
- Disease progression and treatment effects were major drivers of patient outcome valuation.
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