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Published online by Cambridge University Press: 23 December 2022
Since October 2020, Conitec has made public calls (PCs) to invite patients and family members to express perspectives during committee meetings. This study seeks to reflect about the impact of the newest patient and public involvement (PPI) Conitec strategy and how it can contribute to increase patient direct involvement and public confidence regarding Brazilian health decisions in medical devices.
We conducted a document analysis after searching for PCs addressed to medical devices in the section “Patient Perspectives” on Conitec´s website until Aug 31, 2021.
From 64 PCs, five were related to medical devices. Rotational thromboelastometry for transfusion controls: Ended upon applicant request. Transcatheter aortic valve implantation (TAVI): One patient gave his testimonial, explaining how it impacted his quality of life and daily activities, besides answering questions from the committee. The testimonial was not included in the recommendation report. After the public consultation, the initial recommendation changed from non-reimbursement to reimbursement. Botton™ probe for gastrotomy: Eleven people volunteered and a family member was selected. She expressed the importance of the device in her son’s quality of life, making ordinary activities more accessible, helping in the physiotherapy sessions, reducing hospitalizations, and supporting her son’s socialization. The initial recommendation was to reimburse it. iStent Inject Trabecular Micro-Bypass System™ (glaucoma treatment): No patients volunteered. The final recommendation report informed that Conitec received 55 comments through public consultation, including experiences and opinions about the technology. After the public consultation, there was a change from the initial to the final recommendation, from non-incorporation to incorporation. Non-invasive ventilation (cystic fibrosis treatment): There were five volunteers and a mother of twins, both with cystic fibrosis, gave her testimonial. She expressed the importance of this device in her kids’ quality of life, allowing them to sleep better, eat and study, control the symptoms, and reduce hospitalizations and antibiotic usage.
Aspects such as documenting this participation, communicating and offering support to the public and patients, analysis and transparency are essential for evaluating and improving this strategy.