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Barriers to patient recruitment in a poststroke neurorehabilitation multicenter trial in Brazil.

Taís Regina da SilvaGustavo José LuvizuttoLaís Geronutti MartinsRafael Dalle Molle da CostaJuli Thomaz De SouzaFernanda Cristina WincklerLorena Cristina Alvarez SartorGabriel Pinheiro ModoloNatalia Cristina FerreiraJ C S RodriguesR G KandaM O FogaroliGuilherme Ferreira BorgesG R S RizzattiPriscila Watson RibeiroDanielle Silveira PiresDiandra Bosi FavorettoL R AguiarSilméia Garcia Zanati BazanLuiz Eduardo Gomes Garcia BettingL C O AntunesHélio Rubens De Carvalho NunesVitor Mendes PereiraTaiza Elaine Grespan SantosOctavio Marques Pontes NetoAdriana Bastos ConfortoRodrigo Bazan
Published in: Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas (2023)
There is a high demand for stroke rehabilitation in the Brazilian public health system, but most studies that have addressed rehabilitation for unilateral spatial neglect (USN) after stroke have been performed in high-income countries. Therefore, the aim of this study was to analyze USN patient recruitment in a multicenter noninvasive brain stimulation clinical trial performed in Brazil and to provide study design recommendations for future studies. We evaluated the reasons for exclusion of patients from a multicenter, randomized, double-blinded clinical trial of rehabilitation of USN patients after stroke. Clinical and demographic variables were compared between the included and excluded patients. A descriptive statistical analysis was performed. Only 173 of the 1953 potential neglect patients (8.8%) passed the initial screening. After screening evaluation, 87/173 patients (50.3%) were excluded for clinical reasons. Cognitive impairment led to the exclusion of 21/87 patients (24.1%). Low socioeconomic status led to the exclusion of 37/173 patients (21.4%). Difficulty obtaining transportation to access treatment was the most common reason for their exclusion (16/37 patients, 43.3%). The analyzed Brazilian institutions have potential for conducting studies of USN. The recruitment of stroke survivors with USN was restricted by the study design and limited financial support. A history of cognitive impairment, intracranial stenting or craniectomy, and lack of transportation were the most common barriers to participating in a multicenter noninvasive brain stimulation trial among patients with USN after stroke.
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