Involving Stakeholders in a Systematic Review of Biosimilars in Oncology: Importance of Outcomes from the Patients’ Perspective

Session Type
Oral presentation
Patient or healthcare consumers involvement and shared decision making
Veçoso LVZ1, Livinalli A2, Lopes LC3, Barreto JOM4, Silva MT3, Galvão TF1
1University of Campinas, BR
2Ministry of Health, BR
3University of Sorocaba, BR
4Oswaldo Cruz Foundation, BR

Background: Involving patients in systematic reviews enables including their perspective in decision making.
Objectives: We aimed to rate the importance of outcomes from a Cochrane review about biosimilars in oncology taking the patients’ perspective and to identify how they thematise such outcomes.
Methods: This is a consensus study with nominal group technique and qualitative content analysis. Patients with cancer were selected by convenience sampling and invited for two mediated virtual meetings in February 2022. Twelve outcomes from the systematic review were explained in plain language to participants to be classified as critical (9-7), important (6-4) or not important (1-3) according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, by individual voting, discussion and consensus. To identify themes underpinning this classification, we employed Iramuteq software for lexical categorization (Reinert method) of the meeting transcripts. The study was approved by the University of Campinas Ethics Committee (opinion number 5.109.137/2021).
Results: Out of 22 persons invited, five women with cancer participated (3 had metastatic cancer, 1 non-metastatic, 1 recurrent). Six outcomes were classified as critical (rank): duration of response (9), progression-free survival (9), pathological complete response (8), overall survival (8), severe adverse events (7), quality of life (7); three as important: mortality (6), event-free survival (6), overall response rate (6); and three as non-important: neutralizing antidrug antibody (3), any adverse event (2), non-neutralizing antidrug antibody (1). Four outcomes (duration of response, pathological complete response, severe adverse events, quality of life) were considered as secondary in the review protocol (, but as critical by the patients. The main themes influencing the importance were related to the disease (progression and control) and treatment (recognition, expectation, communication, endeavor) and suggest that patients have the desire to control the disease and to live as long as possible with quality of life.
Conclusions: Patients rated most outcomes as critical or important, some of them regarded as secondary in the review protocol. Feelings about disease progression and treatment effect affected consumers’ judgment on outcomes’ relevance. Taking stakeholders’ perspective is likely to add value for health technology assessments.