Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants
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Extremely preterm infants have a high mortality and morbidity. Here, we present a statistical analysis plan for secondary Bayesian analyses of the pragmatic, sufficiently powered multinational, trial—SafeBoosC III—evaluating the benefits and harms of cerebral oximetry monitoring plus a treatment guideline versus usual care for such infants.
Methods
The SafeBoosC-III trial is an investigator-initiated, open-label, randomised, multinational, pragmatic, phase III clinical trial with a parallel-group design. The trial randomised 1601 infants, and the frequentist analyses were published in April 2023. The primary outcome is a dichotomous composite outcome of death or severe brain injury. The exploratory outcomes are major neonatal morbidities associated with neurodevelopmental impairment later in life: (1) bronchopulmonary dysplasia; (2) retinopathy of prematurity; (3) late-onset sepsis; (4) necrotising enterocolitis; and (5) number of major neonatal morbidities (count of bronchopulmonary dysplasia, retinopathy of prematurity, and severe brain injury). The primary Bayesian analyses will use non-informed priors including all plausible effects. The models will use a Hamiltonian Monte Carlo sampler with 1 chain, a sampling of 10,000, and at least 25,000 iterations for the burn-in period. In Bayesian statistics, such analyses are referred to as ‘posteriors’ and will be presented as point estimates with 95% credibility intervals (CrIs), encompassing the most probable results based on the data, model, and priors selected. The results will be presented as probability of any benefit or any harm, Bayes factor, and the probability of clinical important benefit or harm. Two statisticians will analyse the blinded data independently following this protocol.
Discussion
This statistical analysis plan presents a secondary Bayesian analysis of the SafeBoosC-III trial. The analysis and the final manuscript will be carried out and written after we publicise the primary frequentist trial report. Thus, we can interpret the findings from both the frequentists and Bayesian perspective. This approach should provide a better foundation for interpreting of our finding
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 737 |
| Tidsskrift | Trials |
| Vol/bind | 24 |
| Udgave nummer | 1 |
| Antal sider | 8 |
| ISSN | 1745-6215 |
| DOI | |
| Status | Udgivet - 2023 |
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 (La Paz University Hospital, Madrid, Spain); Afif El-Kuffash (The Rotunda Hospital, Dublin, Ireland); Agata Bargiel (Warsaw University of Medical Sciences, Warszawa, Poland); Ana Alarcon (Hospital Sant Joan de Deu, Barcelona, Spain); Andrew Hopper (Loma Linda University Children’s Hospital, Los Angeles, United States); Anita Truttmann (University Hospital Center of Lausanne, Lausanne, Switzerland); Anja Hergenhan (Children's Hospital Lucerne, Lucerne, Switzerland); Anja Klamer (Odense University Hospital, Odense, Denmark); Anna Curley (National Maternity Hospital, Holles Street, Dublin, Ireland); Anne Marie Heuchan (Royal Hospital for Children, Glasgow, United Kingdom); Anne Smits (University Hospitals Leuven, Leuven, Belgium); Asli Cinar Memisoglu (Marmara University Research and Educational Hospital, Istanbul, Turkey); Barbara Krolak-Olejnik (Wroclaw Medical University, Wrocław, Poland); Beata Rzepecka (Centrum Medycne “Ujastek” Sp. z.o.o, Kraków, Poland); Begona Loureiro Gonzales (University Hospital Cruces, Barakaldo, Spain); Beril Yasa (Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey); Berndt Urlesberger (University Hospital Graz, Graz, Austria); Catalina Morales-Betancourt (12 de Octubre University Hospital, Madrid, Spain); Chantal Lecart (Grand Hopital de Charleroi, Belgium); Claudia Knöepfli (University Hospital Zurich, Switzerland); Cornelia Hagmann (University Hospital Zürich, Switzerland); David Healy (University College Cork, Cork, Ireland); Ebru Ergenekon (Gazi University hospital, Turkey); Eleftheria Hatzidaki (University Hospital of Heraklion, Greece); Elena Bergon-Sendin (12 de Octubre University Hospital, Madrid, Spain); Eleni Skylogianni (University of Patras General Hospital, Patras, Greece); Elzbieta Rafinska-Wazny (Centrum Medyczne "Ujastek" Sp. z o.o., Krakow, Poland); Emmanuele Mastretta (Ospedale S.Anna – Cita della Salute e della Scienza di Torino, Turin, Italy); Eugene Dempsey (University College Cork, Cork, Ireland); Eva Valverde (La Paz University Hospital, Madrid, Spain); Evangelina Papathoma (“Alexandra” University and State Maternity Hospital, Athens, Greece); Fabio Mosca (Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy); Gabriel Dimitriou (University of Patras General Hospital, Patras, Greece); Gerhard Pichler (University Hospital Graz, Graz, Austria); Giovanni Vento (Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy); Gitte Holst Hahn (Copenhagen University Hospital, Copenhagen, Denmark); Gunnar Naulaers (University Hospitals Leuven, Leuven, Belgium); Guoqiang Cheng (Children's Hospital of Fudan University, Shanghai, China); Hans Fuchs (Medical Center, University of Freiburg, Freiburg, Germany); Hilal Ozkan (Bursa Uludag University Hospital, Bursa, Turkey); Isabel De Las Cuevas (Marqués De Valdecilla University Hospital, Santander, Spain); Itziar Serrano-Vinuales (Miguel Servet University Hospital, Zaragoza, Spain); Iwona Sadowska-Krawczenko (Collegium Medicum in Bydgoszcz Nicolaus Cupernicus University in Torun, Bydgoszcz, Poland); Jachym Kucera (The Institute for the Care of Mother and Child, Prague, Czech Republic); Jakub Tkaczyk (University Hospital Motol, Prague, Czech Republic); Jan Miletin (Coombe Women and Infant University Hospital, Dublin, Ireland); Jan Sirc (The Institute for the Care of Mother and Child, Prague, Czech Republic);Jana Baumgartner (Medical Center, University of Freiburg, Freiburg, Germany); Jonathan Mintzer (Mountainside Medical Center, Montclair, United States); Julie De Buyst (Tivoli Hospital, La Louviere, Belgium); Karen McCall (University Hospital Wishaw, Wishaw, United Kingdom); Konstantina Tsoni (Ippokrateion General Hospital of Thessaloniki, Thessaloniki, Greece); Kosmas Sarafidis (Ippokrateion General Hospital of Thessaloniki, Thessaloniki, Greece); Lars Bender (Aalborg University Hospital, Aalborg, Denmark); Laura Serrano Lopez (Virgen De Las Nieves University Hospital, Granada, Spain); Le Wang (Children’s Hospital of Fudan University, Shanghai, China); Liesbeth Thewissen (University Hospitals Leuven, Leuven, Belgium); Lin Huijia (Children's Hospital of Zheijang, Hangzhou, China); Lina Chalak (UT Southwestern Medical Center, Dallas, United States); Ling Yang (Hainan Women and Children’s Medical Center, Hainan, China); Luc Cornette (AZ St. Jan Bruges, Bruges, Belgium); Luis Arruza (Hospital Clinico San Carlos, Madrid, Spain); Maria Wilinska (Centre of Postgraduate Medical Education, Warsaw, Poland); Mariana Baserga (University of Utah Hospital, Salt Lake City, United States); Marie Isabel Skov Rasmussen (Copenhagen University Hospital, Copenhagen, Denmark); Marta Mencia Ybarra (La Paz University Hospital, Madrid, Spain); Marta Teresa Palacio (Hospital Clínic Barcelona, Barcelona, Spain); Martin Stocker (Children’s Hospital Lucerne, Lucerne, Switzerland); Massimo Agosti (“Fillipo del Ponte” Hospital, Varese, Italy); Merih Cetinkaya (Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey); Miguel Alsina (Hospital Clinic Barcelona, Barcelona, Spain); Monica Fumagalli (Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy); Munaf M. Kadri (Loma Linda University Children's Hospital, Los Angeles, United States); Mustafa Senol Akin (Ankara City Hospital, Ankara, Turkey). Münevver Baş (Gazi University Hospital, Ankara, Turkey); Nilgun Koksal (Bursa Uludag University Hospital, Bursa, Turkey); Olalla Otero Vaccarello (Hospital Universitario De Tarragona Juan XXIII, Tarragona, Spain); Olivier Baud (Children’s University Hospital of Geneva, Geneva, Switzerland); Pamela Zafra (Puerta Del Mar University Hospital, Cadiz, Spain); Peter Agergaard (Aarhus University Hospital, Aarhus, Denmark); Peter Korcek (The Institute for the Care of Mother and Child, Prague, Czech Republic); Pierre Maton (Clinique CHC Montlegia, Liege, Belgium); Rebeca Sanchez-Salmador (La Paz University Hospital, Madrid, Spain); Ruth del Rio Florentino (Hospital De Sant Joan De Deu, Barcelona, Spain); Ryszard Lauterbach (Jagiellonian University Hospital, Kraków, Poland); Salvador Piris Borregas (12 De Octubre University Hospital, Madrid, Spain); Saudamini Nesargi (St Johns Medical College Hospital, Karnataka, India); Serife Suna (Ankara City Hospital, Ankara, Turkey). Shashidhar Appaji Rao (St Johns Medical College Hospital, Karnataka, India); Shujuan Zeng (Longgang district Central Hospital, Shenzhen, China); Silvia Pisoni (Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy); Simon Hyttel-Sørensen (Copenhagen University Hospital, Copenhagen, Denmark); Sinem Gulcan Kersin (Marmara University Research and Education Hospital, Istanbul, Turkey); Siv Fredly (Oslo University Hospital, Oslo, Norway); Suna Oguz (Ankara City Hospital, Ankara, Turkey); Sylwia Marciniak (Specialist Hospital No.2, Bytom, Poland). Tanja Karen (University Hospital Zürich, Zürich, Switzerland); Tomasz Szczapa (Poznan University of Medical Sciences, Poznan, Poland); Tone Nordvik (Oslo University Hospital, Oslo, Norway); Veronika Karadyova (University Hospital Motol, Prague, Czech Republic); Xiaoyan Gao (Maternal and Child Health Hospital of Zhuang Autonomous Region, Guangxi, China); Xin Xu (Xiamen Children's Hospital, Xiamen, China); Zachary Vesoulis (St. Louis Children’s Hospital, St. Louis, United States); Zhang Peng (Children’s Hospital of Fudan University, Shanghai, China); and Zhaoqing Yin (The People's Hospital of Dehong, Dehong, China).
Publisher Copyright:
© 2023, The Author(s).
ID: 378127611