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  • Comprehensive survey among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols

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Research methods
Original research
Comprehensive survey among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols
  1. Geraldine Rauch1,2,
  2. Lorena Hafermann1,2,
  3. Ulrich Mansmann3,
  4. Iris Pigeot4,5
  1. 1Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
  2. 2Berlin Institute of Health, Berlin, Germany
  3. 3Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig-Maximilians-Universitat Munich, Munich, Germany
  4. 4Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
  5. 5University of Bremen, Institute of Statistics, Bremen, Germany
  1. Correspondence to Professor Geraldine Rauch; geraldine.rauch{at}charite.de

Abstract

Objectives To assess biostatistical quality of study protocols submitted to German medical ethics committees according to personal appraisal of their statistical members.

Design We conducted a web-based survey among biostatisticians who have been active as members in German medical ethics committees during the past 3 years.

Setting The study population was identified by a comprehensive web search on websites of German medical ethics committees.

Participants The final list comprised 86 eligible persons. In total, 57 (66%) completed the survey.

Questionnaire The first item checked whether the inclusion criterion was met. The last item assessed satisfaction with the survey. Four items aimed to characterise the medical ethics committee in terms of type and location, one item asked for the urgency of biostatistical training addressed to the medical investigators. The main 2×12 items reported an individual assessment of the quality of biostatistical aspects in the submitted study protocols, while distinguishing studies according to the German Medicines Act (AMG)/German Act on Medical Devices (MPG) and studies non-regulated by these laws.

Primary and secondary outcome measures The individual assessment of the quality of biostatistical aspects corresponds to the primary objective. Thus, participants were asked to complete the sentence ‘In x% of the submitted study protocols, the following problem occurs’, where 12 different statistical problems were formulated. All other items assess secondary endpoints.

Results For all biostatistical aspects, 45 of 49 (91.8%) participants judged the quality of AMG/MPG study protocols much better than that of ‘non-regulated’ studies. The latter are in median affected 20%–60% more often by statistical problems. The highest need for training was reported for sample size calculation, missing values and multiple comparison procedures.

Conclusions Biostatisticians being active in German medical ethics committees classify the biostatistical quality of study protocols as low for ‘non-regulated’ studies, whereas quality is much better for AMG/MPG studies.

  • medical ethics
  • statistics & research methods
  • epidemiology

Data availability statement

Data are available in a public, open access repository. The original dataset of the survey is available from the Dryad repository, https://datadryad.org/stash/dataset/doi:10.5061/dryad.4tmpg4f5f.

http://creativecommons.org/licenses/by-nc/4.0/

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/.

http://dx.doi.org/10.1136/bmjopen-2019-032864

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    Data availability statement

    Data are available in a public, open access repository. The original dataset of the survey is available from the Dryad repository, https://datadryad.org/stash/dataset/doi:10.5061/dryad.4tmpg4f5f.

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    Footnotes

    • Presented at This paper was written on behalf of a recently established joint working group 'Biometry in ethics committees' of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS) e. V. and the German Region of the International Biometric Society. (https://gmds.de/aktivitaeten/medizinischebiometrie/arbeitsgruppenseiten/projektgruppen/biometrie-in-der-ethikkommission/, accessed September 2019).

    • Correction notice This article has been corrected since it first published. Dataset in dryad link have been updated.

    • Contributors GR developed the research idea, designed the survey and wrote the manuscript. LH implemented the online survey, performed the analyses and reviewed the manuscript. UM helped to develop the research idea, reviewed the survey, reviewed the manuscript. IP helped to develop the research idea, reviewed the survey, reviewed the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

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