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Main Title: Quality of sample size estimation in trials of medical devices: high-risk devices for neurological conditions as example
Author(s): Olberg, Britta
Perleth, Matthias
Felgenträger, Katja
Schulz, Sandra
Busse, Reinhard
Type: Article
Language Code: en
Abstract: Background: The aim of this study was to assess the quality of reporting sample size calculation and underlying design assumptions in pivotal trials of high-risk medical devices (MDs) for neurological conditions. Methods: Systematic review of research protocols for publicly registered randomized controlled trials (RCTs). In the absence of a published protocol, principal investigators were contacted for additional data. To be included, trials had to investigate a high-risk MD, registered between 2005 and 2015, with indications stroke, headache disorders, and epilepsy as case samples within central nervous system diseases. Extraction of key methodological parameters for sample size calculation was performed independently and peer-reviewed. Results: In a final sample of seventy-one eligible trials, we collected data from thirty-one trials. Eighteen protocols were obtained from the public domain or principal investigators. Data availability decreased during the extraction process, with almost all data available for stroke-related trials. Of the thirty-one trials with sample size information available, twenty-six reported a predefined calculation and underlying assumptions. Justification was given in twenty and evidence for parameter estimation in sixteen trials. Estimates were most often based on previous research, including RCTs and observational data. Observational data were predominantly represented by retrospective designs. Other references for parameter estimation indicated a lower level of evidence. Conclusions: Our systematic review of trials on high-risk MDs confirms previous research, which has documented deficiencies regarding data availability and a lack of reporting on sample size calculation. More effort is needed to ensure both relevant sources, that is, original research protocols, to be publicly available and reporting requirements to be standardized
Issue Date: 2017
Date Available: 11-Feb-2019
DDC Class: 610 Medizin und Gesundheit
Subject(s): medical devices
randomized controlled trials
sample size calculation
Journal Title: International Journal of Technology Assessment in Health Care
Publisher: Cambridge University Press
Volume: 33
Issue: 1
Publisher DOI: 10.1017/S0266462317000265
Page Start: 103
Page End: 110
EISSN: 1471-6348
ISSN: 0266-4623
Notes: Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.
Appears in Collections:FG Management im Gesundheitswesen » Publications

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