Eboni G Price-Haywood1,2, Jewel Harden-Barrios3, Christopher Carr4, Laya Reddy5, Lydia A Bazzano4, Mieke L van Driel6. 1. Center for Applied Health Services Research, Ochsner Health System, Academic Building - 2nd Floor, 1514 Jefferson Highway, New Orleans, LA, 70121, USA. eboni.pricehaywood@ochsner.org. 2. Ochsner Clinical School, University of Queensland, New Orleans, LA, USA. eboni.pricehaywood@ochsner.org. 3. Center for Applied Health Services Research, Ochsner Health System, Academic Building - 2nd Floor, 1514 Jefferson Highway, New Orleans, LA, 70121, USA. 4. Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA. 5. Ochsner Clinical School, University of Queensland, New Orleans, LA, USA. 6. Primary Care Clinical Unit, Faculty of Medicine, University of Queensland, Brisbane, Australia.
Abstract
OBJECTIVE: Given the global and economic burden of stroke as a major cause of long-term disability, patient-reported outcomes (PRO) data from clinical trials can elucidate differential benefits/harms of interventions from patients' perspectives and influence clinical decision making in stroke care management. METHODS: This systematic review examines stroke-related randomized controlled trials (RCT) published in 12 high-impact journals between 2002 and 2016 for (1) associations between trial characteristics and the reporting of PRO measures; and (2) psychometric properties of PRO instruments used in these studies. The study combines clinical trials identified in a prior review with trials identified with an updated literature search. RESULTS: Only 34 of 159 stroke-related RCTs reported PRO measures. Among the 34 trials, most were published in rehabilitation and general medical journals, were conducted in the United States or Europe, were funded by government/non-industry sponsors, and focused on post-stroke care. Thirty-one PRO instruments were employed in these studies. Only 5 instruments were stroke-specific measures, whereas the remaining 26 instruments were generic measures. Eight instruments assessed functional status, 9 measured quality of life, and 14 assessed symptoms. The most common health domains measured were emotional status and physical function. CONCLUSIONS: This study highlights the paucity of information from patients' perspective in stroke-related RCTs. This trend may change over time as researchers increase adherence to reporting guidelines for clinical trial protocols.
OBJECTIVE: Given the global and economic burden of stroke as a major cause of long-term disability, patient-reported outcomes (PRO) data from clinical trials can elucidate differential benefits/harms of interventions from patients' perspectives and influence clinical decision making in stroke care management. METHODS: This systematic review examines stroke-related randomized controlled trials (RCT) published in 12 high-impact journals between 2002 and 2016 for (1) associations between trial characteristics and the reporting of PRO measures; and (2) psychometric properties of PRO instruments used in these studies. The study combines clinical trials identified in a prior review with trials identified with an updated literature search. RESULTS: Only 34 of 159 stroke-related RCTs reported PRO measures. Among the 34 trials, most were published in rehabilitation and general medical journals, were conducted in the United States or Europe, were funded by government/non-industry sponsors, and focused on post-stroke care. Thirty-one PRO instruments were employed in these studies. Only 5 instruments were stroke-specific measures, whereas the remaining 26 instruments were generic measures. Eight instruments assessed functional status, 9 measured quality of life, and 14 assessed symptoms. The most common health domains measured were emotional status and physical function. CONCLUSIONS: This study highlights the paucity of information from patients' perspective in stroke-related RCTs. This trend may change over time as researchers increase adherence to reporting guidelines for clinical trial protocols.
Authors: Sheila Cristina Ouriques Martins; Wyllians Vendramini Borelli; Thais Leite Secchi; Gabriel Paulo Mantovani; Arthur Pille; Daissy Liliana Mora Cuervo; Leonardo Augusto Carbonera; Ana Claudia de Souza; Magda Carla Ouriques Martins; Rosane Brondani; Andrea Garcia de Almeida; Angélica Dal Pizzol; Franciele Pereira Dos Santos; Ana Claudia Alves; Nathalia Soares Meier; Guilherme Pamplona Bueno Andrade; Pedro Angst Maciel; Alexandre Weber; Gustavo Dariva Machado; Mohamed Parrini; Luiz Antonio Nasi Journal: Front Neurol Date: 2022-05-06 Impact factor: 4.086
Authors: Concepción Soto-Vidal; Soraya Pacheco-da-Costa; Victoria Calvo-Fuente; Sara Fernández-Guinea; Carlos González-Alted; Tomás Gallego-Izquierdo Journal: Int J Environ Res Public Health Date: 2020-06-14 Impact factor: 3.390