Marija Barbateskovic1, Thijs M Koster2, Ruben J Eck3, Mathias Maagaard4, Arash Afshari5, Fredrike Blokzijl6, Maria Cronhjort7, Willem Dieperink2, Maria L Fabritius8, Josh Feinberg9, Craig French10, Barzi Gareb11, Anja Geisler12, Anders Granholm13, Bart Hiemstra14, Ruixue Hu15, Georgina Imberger16, Bente T Jensen17, Andreas B Jonsson13, Oliver Karam18, De Zhao Kong19, Steven K Korang4, Geert Koster2, Baoyong Lai20, Ning Liang15, Lars H Lundstrøm21, Søren Marker22, Tine S Meyhoff22, Emil E Nielsen9, Anders K Nørskov4, Marie W Munch13, Emilie C Risom23, Sofie L Rygård13, Sanam Safi4, Naqash Sethi4, Fredrik Sjövall24, Susanne V Lauridsen25, Nico van Bakelen11, Meint Volbeda2, Iwan C C van der Horst26, Christian Gluud4, Anders Perner22, Morten H Møller22, Eric Keus2, Jørn Wetterslev27. 1. Copenhagen Trial Unit (CTU), Centre for Clinical Intervention Research, Capital Region of Denmark, Denmark; Centre for Research in Intensive Care (CRIC), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: marija.barbateskovic@ctu.dk. 2. Department of Critical Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 3. Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 4. Copenhagen Trial Unit (CTU), Centre for Clinical Intervention Research, Capital Region of Denmark, Denmark. 5. Department of Pediatric and Obstetric Anesthesia, University of Copenhagen, Rigshospitalet, Denmark. 6. Department of Cardiothoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 7. Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Section of Anaesthesia and Intensive Care, Stockholm, Sweden. 8. Department of Anaesthesiology, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 9. Department of Internal Medicine, Cardiology Section, Holbaek Hospital, Holbaek, Denmark. 10. Centre for Integrated Critical Care, The University of Melbourne, Melbourne, Australia. 11. Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 12. Department of Anaesthesiology, Zealand University Hospital, Koege, Denmark. 13. Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 14. Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 15. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. 16. Department of Anaesthesia and Pain Medicine, Western Health, Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia. 17. Department of Urology, Aarhus University Hospital, Denmark. 18. Division of Pediatric Critical Care Medicine, Children's Hospital of Richmond at VCU, Richmond, VA, USA. 19. Liaoning University of Traditional Chinese Medicine, Shenyang, China; Department of Science and Technology Management, The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China. 20. The Third Affiliated Hospital of Beijing, University of Chinese Medicine, Beijing, China. 21. Department of Anaesthesiology and Intensive Care, Nordsjællands Hospital, Hillerød, Denmark. 22. Centre for Research in Intensive Care (CRIC), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 23. Department of Cardiothoracic Anesthesiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. 24. Department for Intensive- and perioperative care, Skane University Hospital, Malmö, Sweden, Department for Clinical Sciences, Mitochondrial Medicine, Lund University, Lund, Sweden. 25. WHO-CC, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen Denmark; Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 26. Department of Intensive Care Medicine, Maastricht University Medical Center +, University Maastricht, Maastricht, The Netherlands. 27. Copenhagen Trial Unit (CTU), Centre for Clinical Intervention Research, Capital Region of Denmark, Denmark; Centre for Research in Intensive Care (CRIC), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Abstract
OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions. STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups. RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters. CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.
OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions. STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups. RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters. CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.
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