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Rehabilitation medicine
Protocol
Pre-post changes in main outcomes of medical rehabilitation in Germany: protocol of a systematic review and meta-analysis of individual participant and aggregated data
  1. Michael Schuler1,2,
  2. Kathrin Murauer1,2,
  3. Stephanie Stangl2,
  4. Anna Grau2,
  5. Katharina Gabriel2,
  6. Lauren Podger3,
  7. Peter U Heuschmann2,4,
  8. Hermann Faller1
  1. 1 Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, Julius-Maximilians-Universität Würzburg, Würzburg, Bayern, Germany
  2. 2 Institute for Clinical Epidemiology and Biometry (ICE-B), Julius-Maximilians-Universität Würzburg, Würzburg, Bayern, Germany
  3. 3 ICON Plc, London, UK
  4. 4 Comprehensive Heart Failure Center Würzburg, Julius-Maximilians-Universität Würzburg, Würzburg, Bayern, Germany
  1. Correspondence to Dr Michael Schuler; m.schuler{at}uni-wuerzburg.de

Abstract

Introduction Multidisciplinary, complex rehabilitation interventions are an important part of the treatment of chronic diseases. However, little is known about the effectiveness of routine rehabilitation interventions within the German healthcare system. Due to the nature of the social insurance system in Germany, randomised controlled trials examining the effects of rehabilitation interventions are challenging to implement and scarcely accessible. Consequently, alternative pre-post designs can be employed to assess pre-post effects of medical rehabilitation programmes. We present a protocol of systematic review and meta-analysis methods to assess the pre-post effects of rehabilitation interventions in Germany.

Methods and analysis The respective study will be conducted within the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A systematic literature review will be conducted to identify studies reporting the pre-post effects (start of intervention vs end of intervention or later) in German healthcare. Studies investigating the following disease groups will be included: orthopaedics, rheumatology, oncology, pulmonology, cardiology, endocrinology, gastroenterology and psychosomatics. The primary outcomes of interest are physical/mental quality of life, physical functioning and social participation for all disease groups as well as pain (orthopaedic and rheumatologic patients only), blood pressure (cardiac patients only), asthma control (patients with asthma only), dyspnoea (patients with chronic obstructive pulmonary disease only) and depression/anxiety (psychosomatic patients only). We will invite the principal investigators of the identified studies to provide additional individual patient data. We aim to perform the meta-analyses using individual patient data as well as aggregate data. We will examine the effects of both study-level and patient-level moderators by using a meta-regression method.

Ethics and dissemination Only studies that have received institutional approval from an ethics committee and present anonymised individual patient data will be included in the meta-analysis. The results will be presented in a peer-reviewed publication and at research conferences. A declaration of no objection by the ethics committee of the University of Würzburg is available (number 20180411 01).

Trial registration number CRD42018080316.

  • rehabilitation
  • meta-analysis
  • individual patient data
  • pre-post effects
  • germany

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023826

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    Footnotes

    • Contributors MS is the guarantor. MS and HF developed the study design. MS, HF, PUH, SS, AG, KM and KG contributed to drafting the first version of the manuscript. LP has revised the entire manuscript linguistically. MS, HF and LP drafted the final version of the manuscript. All authors read and approved the final version of the manuscript for submission. All authors fulfill the authorship criteria of the International Committee of Medical Journal Editors.

    • Funding The study is funded by the German Statutory Pension Insurance (Deutsche Rentenversicherung Bund), Hohenzollerndamm 46/47, 10713 Berlin, Germany (grant number: 0423/40-64-50-59). Funding covers personnel, material and travelling expenses. This publication was funded by the German Research Foundation (DFG) and the University of Wuerzburg in the funding programme Open Access Publishing.

    • Competing interests None declared.

    • Ethics approval As this is a protocol for a systematic review, a formal ethics committee review is not required. A declaration of no objection by the ethics committee of the University of Würzburg is available (number 20180411 01).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Correction notice This article has been corrected since it was published online. Author name Stefanie Stangl has been updated to Stephanie Stangl.