Academic Journal
Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals
| العنوان: | Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals |
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| المؤلفون: | Boeker, Martin, Zöller, Daniela, Blasini, Romina, Macho, Philipp, Helfer, Sven, Behrens, Max, Prokosch, Hans-Ulrich, Gulden, Christian |
| المصدر: | Trials. - 25, 1 (2024) , 125, ISSN: 1745-6215 |
| سنة النشر: | 2024 |
| المجموعة: | University of Freiburg: FreiDok |
| الوصف: | Background As part of the German Medical Informatics Initiative, the MIRACUM project establishes data integration centers across ten German university hospitals. The embedded MIRACUM Use Case “Alerting in Care - IT Support for Patient Recruitment”, aims to support the recruitment into clinical trials by automatically querying the repositories for patients satisfying eligibility criteria and presenting them as screening candidates. The objective of this study is to investigate whether the developed recruitment tool has a positive effect on study recruitment within a multi-center environment by increasing the number of participants. Its secondary objective is the measurement of organizational burden and user satisfaction of the provided IT solution. Methods The study uses an Interrupted Time Series Design with a duration of 15 months. All trials start in the control phase of randomized length with regular recruitment and change to the intervention phase with additional IT support. The intervention consists of the application of a recruitment-support system which uses patient data collected in general care for screening according to specific criteria. The inclusion and exclusion criteria of all selected trials are translated into a machine-readable format using the OHDSI ATLAS tool. All patient data from the data integration centers is regularly checked against these criteria. The primary outcome is the number of participants recruited per trial and week standardized by the targeted number of participants per week and the expected recruitment duration of the specific trial. Secondary outcomes are usability, usefulness, and efficacy of the recruitment support. Sample size calculation based on simple parallel group assumption can demonstrate an effect size of d=0.57 on a significance level of 5% and a power of 80% with a total number of 100 trials (10 per site). Data describing the included trials and the recruitment process is collected at each site. The primary analysis will be conducted using linear mixed models ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | |
| اللغة: | English |
| Relation: | https://freidok.uni-freiburg.de/data/244237 |
| DOI: | 10.1186/s13063-024-07918-z |
| الاتاحة: | https://freidok.uni-freiburg.de/data/244237 https://nbn-resolving.org/urn:nbn:de:bsz:25-freidok-2442377 https://doi.org/10.1186/s13063-024-07918-z https://freidok.uni-freiburg.de/dnb/download/244237 |
| Rights: | free |
| رقم الانضمام: | edsbas.23F0757E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-024-07918-z |
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