Randall Winnette1, Victor Zárate2, Gerardo Machnicki3, Carla DeMuro4, Mary Gawlicki5, Ari Gnanasakthy6. 1. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: randall.winnette@gmail.com. 2. Universidad de los Andes, Santiago, Chile. 3. RTI Health Solutions, Durham, NC, USA. 4. Novartis Pharmaceuticals Corporation, Buenos Aires, Argentina. 5. Corporate Translations, Hartford, CT, USA. 6. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Abstract
BACKGROUND: Patient-reported outcomes (PROs) are increasingly used to demonstrate the value of interventions and support health technology assessment (HTA). OBJECTIVE: The objective of this work was to analyze trends regarding PROs in Latin America (LatAm), highlight challenges in the application of PROs in this region, and suggest solutions. METHODS: A team of researchers with expertise in PROs conducted a nonsystematic PubMed literature search pertaining to the use of PROs in LatAm. The experts also drew on their experience working with PROs to assess the application of PROs in LatAm. RESULTS: The literature search yielded more than 4000 publications, with an increasing publication rate in recent years. PROs are being used in LatAm in various study types: instrument validation, phase III international clinical trials, health service research. A large Inter-American Development Bank study demonstrates the growing importance of PROs in the region. The growth in local value sets for the EuroQol five-dimensional questionnaire in LatAm reflects the regional emergence of HTA systems. Operational challenges relate to ensuring the use of good-quality questionnaires that, at a minimum, have undergone appropriate cultural adaptation and ideally have established psychometric properties. CONCLUSIONS: PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm.
BACKGROUND:Patient-reported outcomes (PROs) are increasingly used to demonstrate the value of interventions and support health technology assessment (HTA). OBJECTIVE: The objective of this work was to analyze trends regarding PROs in Latin America (LatAm), highlight challenges in the application of PROs in this region, and suggest solutions. METHODS: A team of researchers with expertise in PROs conducted a nonsystematic PubMed literature search pertaining to the use of PROs in LatAm. The experts also drew on their experience working with PROs to assess the application of PROs in LatAm. RESULTS: The literature search yielded more than 4000 publications, with an increasing publication rate in recent years. PROs are being used in LatAm in various study types: instrument validation, phase III international clinical trials, health service research. A large Inter-American Development Bank study demonstrates the growing importance of PROs in the region. The growth in local value sets for the EuroQol five-dimensional questionnaire in LatAm reflects the regional emergence of HTA systems. Operational challenges relate to ensuring the use of good-quality questionnaires that, at a minimum, have undergone appropriate cultural adaptation and ideally have established psychometric properties. CONCLUSIONS: PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm.
Keywords:
Clinical trials as topic; Latin America; Patients; Quality of Life; Questionnaires; drug industry; multicenter studies as topic; outcome assessment (health care); self-report
Authors: Nishita Sinha; Andrew Yang; Amrose Pradeep; R Bhuvaneswari; Nagalingeswaran Kumarasamy; Conall O'Cleirigh; Kenneth H Mayer; Brian T Chan Journal: AIDS Care Date: 2019-09-18