Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
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- Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
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Background: Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings. Methods: The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation. Results: The first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity. Discussion: We present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 160 |
| Tidsskrift | BMC Medical Research Methodology |
| Vol/bind | 21 |
| Udgave nummer | 1 |
| ISSN | 1471-2288 |
| DOI | |
| Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
We thank the investigators and parents of participants globally for making this randomised clinical trial possible. Collaborators The SafeBoosC-III trial group consists of (listed in alphabetically order by forename) and should be defined as seen in ?Collaborator Names?-section in Authorship in MEDLINE (nih.gov) : Adelina Pellicer (Hospital La Paz, Spain); Agata Bargiel (Warsaw University of Medical Sciences, Warszawa, Poland); Andrew Hopper (Loma Linda University Children?s Hospital, USA); Anita Truttmann (Lausanne University Hospital, Switzerland); Anja Klamer (Odense Universitetshospital, Odense, Denmark); Anne Marie Heuchan (Royal Hospital for Children, Glasgow, United Kingdom); Asli Memisoglu (Marmara University Pendik Egitim ve Arastirma Hastanesi, Turkey); Barbara Krolak-Olejnik (Wroclaw Medical University, Wroc?aw, Poland); Beata Rzepecka (Medical Center UJASTEK, Krak?w, Poland); Bergona Loureiro (Hospital De Cruces, Spain); Chantal Lecart (Grand Hopital de Charleroi, Belgium); Cornelia Hagmann (University Hospital of Z?rich, Switzerland); Ebru Ergenekon (Gazi University hospital, Turkey); Eleftheria Hatzidaki (University Hospital of Heraklion, Greece); Emmanuele Mastretta (Presidio Ospedaliero S.Anna, Turin, Italy); Eugene Dempsey (University College Cork, Ireland); Evangelina Papathoma (Alexandra University and State Maternity Hospital, Athens, Greece); Fang Lou (The Children?s Hospital, Zhejiang University School of Medicine, Hangzhou, China); Gabriel Dimitriou (University of Patras General Hospital, Patras, Greece); Gerhard Pichler (University Hospital Graz, Austria); Giovanni Vento (Fondazione Policlinico Universitario A. Gemelli, Roma, Italy); Gitte Holst Hahn (Rigshospitalet, Copenhagen, Denmark); Gunnar Naulaers (University Hospital Leuven, Belgium); Guoqiang Cheng (Children?s Hospital affiliated to Fudan University, Shanghai, China); Hans Fuchs (University Medical Center Freiburg, Germany); Hilal Ozkan (Uludag University hospital, Turkey); Isabel De Las Cuevas (Hospital Universitario Marqu?s De Valdecilla, Spain); Iwona Sadowska-Krawczenko (Jan Biziel University Hospital, Bydgoszcz, Poland); Jakub Tkaczyk (Motol University Hospital, Prague, Czech Republic); Jan Sirc (The Institute for the Care of Mother and Child, Prague, Czech Republic); Jinhua Zhang (Guangzhou Women and Children?s Medical Center, Guangzhou, China); Jonathan Mintzer (Mountainside Medical Center, USA); Julie De Buyst (CHU Tivoli, Belgium); Karen McCall (Wishaw General Hospital, United Kingdom); Klaudiusz Bober (Specialist Hospital No. 2 in Bytom, Poland); Kosmas Sarafidis (Ippokrateion General Hospital of Thessaloniki, Greece); Lars Bender (Aalborg Universitetshospital, Denmark); Laura Serrano Lopez (Hospital Universitario Virgen De Las Nieves (Granada), Spain); Lina Chalak (UT Southwestern Medical Center, Dallas, USA); Ling Yang (Maternal and child health care hospital of hainan province, Haikou, China); Luc Cornette (AZ St. Jan University Hospital Brugge, Belgium); Luis Arruza (Complejo Hospitalario San Carlos, Spain); Mariana Baserga (University of Utah, Division of Neonatology, USA); Martin Stocker (Luzerner Kantonsspital, Switzerland); Massimo Agosti (Ospedalo Fillipo del Ponte, Varese, Italy); Merih Cetinkaya (Istanbul Basaksehir Cam and Sakura City Hospital, Turkey); Miguel Alsina (Hospital Clinic De Barcelona (Maternitat), Spain); Monica Fumagalli (Fondazione IRCCS C? Granda Ospedale Maggiore Policlinico, Milano, Italy); Olalla L?epez Suarez (C.H. Universitario De Santiago, Spain); Olalla Otero (H. Universitario Juan XXIII De Tarragona, Spain); Olivier Baud (University Hospital Geneva, Switzerland); Pamela Zafra (Hospital Unversitarie Puerta Del Mar (Cadiz), Spain); Peter Agergaard (Aarhus Universitetshospital, Denmark); Pierre Maton (Liege Rocourt, Belgium); Renaud Viellevoye (Liege Citadelle Hospital, Belgium); Ruth del Rio Florentino (Hospital De Sant Joan De Deu, Barcelona, Spain); Ryszard Lauterbach (Szpital Uniwersytecki, Krak?w, Poland); Salvador Piris Borregas (Hospital Universitario 12 De Octubre, Spain); Saudamini Nesargi (St Johns Medical College Hospital, Bangalore, India); Segundo Rite (Hospital Miguel Servet, Spain); Shashidhar Rao (St Johns Medical College Hospital, Bangalore, India); Shujuan Zeng (Longgang district Central Hospital of shenzhen, China); Silvia Pisoni (Fondazione IRCCS C? Granda Ospedale Maggiore Policlinico, Milano, Italy); Simon Hyttel-S?rensen (Rigshospitalet, Copenhagen, Denmark); Siv Fredly (Oslo University Hospital, Ullev?l, Norway); Suna Oguz (Bilkent Integrated Health Care Campus, Ankara City Hospital Maternity Hospital, Turkey); Tanja Karen (University Hospital of Z?rich, Switzerland); Tomasz Szczapa (Poznan University of Medical sciences, Pozna?, Poland); Xiaoyan Gao (Guangxi Maternal and Child Healthcare Hospital, Nanning, China); Xin Xu (Xiamen Children?s Hospital, China); and Zhaoqing Yin (The People?s Hospital of Dehong autonomous prefecture, China).
Publisher Copyright:
© 2021, The Author(s).
ID: 281167964