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

ObjectivesTo assess biostatistical quality of study protocols submitted to German medical ethics committees according to personal appraisal of their statistical members.DesignWe conducted a web-based survey among biostatisticians who have been active as members in German medical ethics committees du...

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Autores principales:	Ulrich Mansmann, Geraldine Rauch, Lorena Hafermann, Iris Pigeot
Formato:	article
Lenguaje:	EN
Publicado:	BMJ Publishing Group 2020
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/99e9d7df8fe64593a1ef671113332ebf
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spelling	oai:doaj.org-article:99e9d7df8fe64593a1ef671113332ebf2021-12-02T10:00:05ZComprehensive survey among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols10.1136/bmjopen-2019-0328642044-6055https://doaj.org/article/99e9d7df8fe64593a1ef671113332ebf2020-02-01T00:00:00Zhttps://bmjopen.bmj.com/content/10/2/e032864.fullhttps://doaj.org/toc/2044-6055ObjectivesTo assess biostatistical quality of study protocols submitted to German medical ethics committees according to personal appraisal of their statistical members.DesignWe conducted a web-based survey among biostatisticians who have been active as members in German medical ethics committees during the past 3 years.SettingThe study population was identified by a comprehensive web search on websites of German medical ethics committees.ParticipantsThe final list comprised 86 eligible persons. In total, 57 (66%) completed the survey.QuestionnaireThe 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 measuresThe 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.ResultsFor 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.ConclusionsBiostatisticians 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.Ulrich MansmannGeraldine RauchLorena HafermannIris PigeotBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 10, Iss 2 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Ulrich Mansmann Geraldine Rauch Lorena Hafermann Iris Pigeot 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
description	ObjectivesTo assess biostatistical quality of study protocols submitted to German medical ethics committees according to personal appraisal of their statistical members.DesignWe conducted a web-based survey among biostatisticians who have been active as members in German medical ethics committees during the past 3 years.SettingThe study population was identified by a comprehensive web search on websites of German medical ethics committees.ParticipantsThe final list comprised 86 eligible persons. In total, 57 (66%) completed the survey.QuestionnaireThe 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 measuresThe 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.ResultsFor 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.ConclusionsBiostatisticians 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.
format	article
author	Ulrich Mansmann Geraldine Rauch Lorena Hafermann Iris Pigeot
author_facet	Ulrich Mansmann Geraldine Rauch Lorena Hafermann Iris Pigeot
author_sort	Ulrich Mansmann
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMJ Publishing Group
publishDate	2020
url	https://doaj.org/article/99e9d7df8fe64593a1ef671113332ebf
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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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