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      Go Zika Go: A Feasibility Protocol of a Modified Ride-on Car Intervention for Children with Congenital Zika Syndrome in Brazil

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          Abstract

          Children with congenital Zika syndrome (CZS) present severe motor disability and can benefit from early powered mobility. The Go Zika Go project uses modified ride-on toy cars, which may advance the body functions, activities, and participation of children. This paper describes the study protocol aiming to assess the feasibility of a modified ride-on car intervention for children with CZS in Brazil. A mixed-methods design with a multiple 1-week baseline, 3-month intervention, and 1-month follow-up will be implemented. Modified ride-on car training sessions will be conducted three times a week at the participants’ home or in the clinic. The primary outcome will be a narrative description of study feasibility (photovoice method, focus groups, parent feasibility questionnaire and assessment of learning powered mobility). Secondary outcomes will be switch activation, driving sessions journal, social-cognitive interactions, mobility (pediatric evaluation of disability inventory computer adaptive test), goal attainment scaling (GAS), and participation (young children’s participation and environment measure). Go Zika Go is expected to be viable and to improve function, activity, and participation of children with CZS, providing a low-cost, evidence-based rehabilitation option that will be relevant to early child development in a global perspective.

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          Three approaches to qualitative content analysis.

          Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.
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            A tutorial on pilot studies: the what, why and how

            Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.
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              Photovoice: Concept, Methodology, and Use for Participatory Needs Assessment

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                Author and article information

                Journal
                Int J Environ Res Public Health
                Int J Environ Res Public Health
                ijerph
                International Journal of Environmental Research and Public Health
                MDPI
                1661-7827
                1660-4601
                21 September 2020
                September 2020
                : 17
                : 18
                : 6875
                Affiliations
                [1 ]Postgraduate Program in Rehabilitation Sciences and Postgraduate Program in Collective Health, Federal University of Rio Grande do Norte—Faculty of Health Sciences of Trairi (UFRN-FACISA), Santa Cruz 59200-000, Brazil; smkarolinne@ 123456gmail.com
                [2 ]Department of Physical Therapy, Federal University of São Carlos, São Carlos 13565-905, Brazil; accampos@ 123456ufscar.br (A.C.D.C.); carol.corsi7@ 123456gmail.com (C.C.)
                [3 ]Postgraduate Program in Rehabilitation Sciences, Federal University of Rio Grande do Norte—Faculty of Health Sciences of Trairi (UFRN-FACISA), Santa Cruz 59200-000, Brazil; amandaspinola@ 123456gmail.com (A.S.B.); dinaralaiana@ 123456hotmail.com (D.L.d.L.N.C.)
                [4 ]Postgraduate Program in Collective Health, Federal University of Rio Grande do Norte—Faculty of Health Sciences of Trairi (UFRN-FACISA), Santa Cruz 59200-000, Brazil; monique.masso@ 123456gmail.com
                [5 ]College of Public Health and Human Sciences, Oregon State University, Corvallis, OR 97331, USA; sam.logan@ 123456oregonstate.edu
                Author notes
                [* ]Correspondence: egmarlongo@ 123456yahoo.es ; Tel.: +55-8432912411
                Author information
                https://orcid.org/0000-0001-7267-4467
                https://orcid.org/0000-0003-2254-8723
                Article
                ijerph-17-06875
                10.3390/ijerph17186875
                7558945
                32967070
                ecb2e4c1-9228-4d4e-869e-ad25dd915ebc
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 15 August 2020
                : 10 September 2020
                Categories
                Protocol

                Public health
                congenital zika syndrome,user participation,mobility,intervention
                Public health
                congenital zika syndrome, user participation, mobility, intervention

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