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ISPO Recommendation for Defining Participants in Prosthetics Research

作者:管理员 本网 2014-08-21

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 ISPO Scientific Committee

Recommendation for Defining Participants in Prosthetics Research

Edward Lemaire, Man‐sang Wong – June 18, 2013

Introduction

An understanding of research participant characteristics is essential for interpreting results in the scientific and consumer literature. In the field of prosthetics, these characteristics are often underreported, or inconsistently presented, leaving the reader to make assumptions on the study design and clinical application of the results. Prosthetic studies require not only typical personal information, such as height, weight, and gender, but descriptions of the prosthetic components and other assistive devices.

For the researcher, the decision on participant information data collection is made during the study design phase, and is typically difficult or impossible to obtain after data collection is complete and the results are being disseminated. A participant information minimum data set would be used when planning prosthetic studies, to collect appropriate participant data during the participant encounters, and assist study reviewers by providing a set of criteria that could be adopted for publication assessment.

 This document is a recommendation for an ISPOsanctioned data set for reporting participant characteristics in prosthetic research and development publications. While this recommendation will have direct benefits for typical scientific publications, such as Prosthetics and Orthotics International, the data set can also improve how technical and clinical reports are designed and reported to the prosthetic community.

The data set includes a comprehensive list of items, descriptions, and formats for all possible descriptors. Researchers would typically not use the complete data set to describe study participants. A minimum data set is also presented and includes prosthetic descriptors that should be included in all publications.

Overall Considerations

Characteristics that apply to all participants should be mentioned in the manuscript text (e.g., all subjects were males with transtibial amputations, all prostheses used a PTB design withsupracondylar suspension, etc.).

The appropriate professional that reviewed the prosthesis and/or stump prior to inclusion in the study should be noted in the manuscript text (i.e., prosthetist [ISPO Category or certification], medical doctor, physical therapist, occupational therapist, prosthetic technician)

A table with each participant’s unique characteristics should be included

For group data, report mean and standard deviation for quantitative measures

Product year or version number can be included for prosthetic components to help define iterative product updates that can affect function

      http://www.ispoint.org/sites/default/files/ispo_recommendation_on_research_participant_description.pdf