关于物理治疗干预措施的试验和可行性试验报告方法的调查:研究方案。

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

机构信息

Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil.

Department of Physical Therapy, Centro Universitário Anhanguera, São Paulo, Brazil.

出版信息

BMJ Open. 2019 May 22;9(5):e020580. doi: 10.1136/bmjopen-2017-020580.

Abstract

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.

摘要

简介

  • 探索性试验和可行性试验旨在测试是否可以进行全面试验,或者是否需要对全面试验进行任何修改。

  • 探索性试验必须以透明、准确和完整的方式进行报告。

  • 在本报告中,我们提出了一项方法学调查方案,目的如下:

  • (1)确定声称是评估可行性的探索性或可行性试验的物理治疗试验报告的百分比;

  • (2)确定探索性或可行性试验的主要目标中评估的可行性方面;

  • (3)使用 CONSORT 延伸版评估随机探索性和可行性试验的摘要和全文,描述探索性或可行性试验报告的完整性;

  • (4)调查与探索性或可行性试验报告完整性相关的因素。

方法和分析

  • 将纳入 2011-2017 年发表的 Physiotherapy Evidence Database(PEDro)索引的声称是探索性或可行性试验的随机对照试验报告。

  • 两名独立的审查员将确认合格性,并对纳入的探索性或可行性试验的目标中评估的可行性方面进行分类。

  • 使用 CONSORT 延伸版评估随机探索性和可行性试验,评估摘要和全文的报告完整性。

  • 主要分析将是对探索性和可行性试验的摘要和全文的报告质量进行描述性分析。

  • 我们将使用广义估计方程分析探索与报告完整性相关的因素。

伦理和传播

  • 本研究的结果将通过会议报告进行传播,并将提交给同行评审期刊发表。本研究不需要伦理批准。
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf63/6538092/89803068cc38/bmjopen-2017-020580f01.jpg

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