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ORIGINAL ARTICLE  PROBLEMS WITH STATISTICS IN REHABILITATION FROM THE RCTRACK PROJECT Freefree

European Journal of Physical and Rehabilitation Medicine 2020 December;56(6):829-35

DOI: 10.23736/S1973-9087.20.06710-6

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Reporting of patients’ characteristics in rehabilitation trials: an analysis of publications of RCTs in major clinical rehabilitation journals

Thorsten MEYER , Christiane TILLY

Research Unit Rehabilitation Sciences, Health Services Research in Rehabilitation, School of Public Health, Bielefeld University, Bielefeld, Germany



BACKGROUND: The reporting of patients’ characteristics in randomized-controlled trials (RCTs) is one important dimension to improve the clinical replicability or transferability of study results into clinical practice.
AIM: Based on a previously developed framework for reporting on patient characteristics, the aim of this study was to determine whether and how patients’ characteristics are presented in RCTs of major rehabilitation journals.
DESIGN: A literature search in eight high-impact medical rehabilitation journals was conducted.
SETTING: Any setting.
POPULATION: A rehabilitation patient group.
METHODS: Papers were included if they presented results on a RCT on rehabilitation patients. We excluded pilot or feasibility studies. We extracted information related to the description of personal, clinical and diagnosis-specific characteristics, comorbidities, and functioning according to the ICF (body functions and structures, activities and participation and context personal/environmental factors).
RESULTS: From a total of 129 papers initially identified we finally included 100 papers. Patient groups were almost exclusively defined by clinical diagnostic groups. Age and gender were the most prominent persons’ characteristics (100% / 99% reported), followed by marital (22%), educational (15%) and occupational status (14%). Clinical characteristics usually relate to the respective diagnosis; general characteristics were reported on the duration of illness or symptoms (62%), to a lesser degree on BMI (45%) and/or weight (32%) and height (27%). One out of five papers report on comorbidities of the patients (20%). Information of body functions were present in almost every paper (98%), and nearly two third reported at least some aspect of activities and participation at baseline (63%).
CONCLUSIONS: The present analysis shows that there is a need to further the development of appropriate standards for the reporting of patient characteristics in rehabilitation trials.
CLINICAL REHABILITATION IMPACT: In future it should help rehabilitation practitioners to decide whether the patients in a study and their own patients share features similar enough to allow for transferability of results.


KEY WORDS: Randomized controlled trial; Rehabilitation; Clinical trials as topic

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