A methodological survey on reporting of pilot and feasibility trials for physiotherapy interventions: a study protocol

Autor(es)

Cadete Scola, Luiz Felicio ^{[1, 2, 3]} ; Moseley, Anne M. ^[4] ; Thabane, Lehana ^[5] ; Almeida, Matheus ^{[1, 2]} ; Menezes Costa, Luciola da Cunha ^{[1, 2]}

Afiliação do(s) autor(es)

^[1] Univ Cidade Sao Paulo, Masters Program Phys Therapy, Sao Paulo - Brazil

^[2] Univ Cidade Sao Paulo, Doctoral Program Phys Therapy, Sao Paulo - Brazil

^[3] Ctr Univ Anhanguera, Dept Phys Therapy, Sao Paulo - Brazil

^[4] Univ Sydney, Inst Musculoskeletal Hlth, Sch Publ Hlth, Sydney, NSW - Australia

^[5] McMaster Univ, Hlth Res Methods Evidence & Impact, Hamilton, ON - Canada

• Tipo de documento: Artigo Científico
• Fonte: BMJ OPEN; v. 9, n. 5 MAY 2019.
• Citações Web of Science: 0

Resumo

Introduction Pilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial. Pilot trials must be reported in a transparent, accurate and complete way. In this report, we present a protocol for a methodological survey with the following aims: (1) to determine the percentage of physiotherapy trial reports which claim to be pilot or feasibility trials that evaluate feasibility, (2) to determine the aspect of feasibility evaluated in the primary objectives of the pilot or feasibility trials, (3) to describe the completeness of reporting of abstracts and full articles of pilot or feasibility trials using the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials and (4) to investigate factors associated with completeness of reporting of pilot or feasibility trials. Methods and analysis Reports of randomised controlled trials indexed in the Physiotherapy Evidence Database (PEDro) that claim to be pilot or feasibility trials and published in 2011-2017 will be included. Two independent reviewers will confirm eligibility and classify the aspect of feasibility being evaluated in the objectives of the included pilot or feasibility trials. Completeness of reporting of both the abstract and the full article will be evaluated using the CONSORT extension to randomised pilot and feasibility trials. The primary analysis will be a descriptive analysis about the reporting quality of abstracts and full texts of pilot and feasibility trials. We will use generalised estimating equation analysis to explore factors associated with completeness of reporting. Ethics and dissemination The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. Ethical approval is not necessary for this study. (AU)

• Processo FAPESP: 19/00812-1 - Revisão metodológica da avaliac'ao da qualidade de descric'ao dos estudos pilotos e de viabilidade de intervenc'ao em fisioterapia: protocolo
• Beneficiário: Luciola da Cunha Menezes Costa
• Modalidade de apoio: Auxílio à Pesquisa - Publicações científicas - Artigo
• Processo FAPESP: 16/10317-0 - Influência da ocultação de alocação e análise por intenção de tratar nos efeitos de tratamento das intervenções fisioterapêuticas em ensaios clínicos para pacientes com dor lombar: um estudo meta-epidemiológico
• Beneficiário: Matheus Oliveira de Almeida
• Modalidade de apoio: Bolsas no Brasil - Pós-Doutorado