Jmn Duffy1, M Hirsch2,3, A Kawsar3, C Gale4, L Pealing1, M N Plana5, M Showell6, P R Williamson7, K S Khan2, S Ziebland1, R J McManus1. 1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. 2. Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, London, UK. 3. Royal Free London NHS Trust, London, UK. 4. Neonatal Medicine, Faculty of Medicine, Imperial College London, London, UK. 5. Clinical Biostatistics Unit, Ramon y Cajal Institute of Research and Centro de Investigación Biomédica en Red Epidemiology and Public Health, Madrid, Spain. 6. Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand. 7. MRC North West Hub for Trials Methodology Research, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
Abstract
BACKGROUND: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. OBJECTIVES: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. SEARCH STRATEGY: Randomised trials were identified by searching bibliographical databases from inception to January 2016. SELECTION CRITERIA: Randomised controlled trials. DATA COLLECTION AND ANALYSIS: We systematically extracted and categorised outcome reporting. MAIN RESULTS: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. CONCLUSIONS: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. TWEETABLE ABSTRACT: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.
BACKGROUND: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. OBJECTIVES: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. SEARCH STRATEGY: Randomised trials were identified by searching bibliographical databases from inception to January 2016. SELECTION CRITERIA: Randomised controlled trials. DATA COLLECTION AND ANALYSIS: We systematically extracted and categorised outcome reporting. MAIN RESULTS: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. CONCLUSIONS: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. TWEETABLE ABSTRACT: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.
Authors: J M N Duffy; S Bhattacharya; C Curtis; J L H Evers; R G Farquharson; S Franik; Y Khalaf; R S Legro; S Lensen; B W Mol; C Niederberger; E H Y Ng; S Repping; A Strandell; H L Torrance; A Vail; M van Wely; N L Vuong; A Y Wang; R Wang; J Wilkinson; M A Youssef; C M Farquhar Journal: Hum Reprod Open Date: 2018-06-15
Authors: Simen Vergote; Felix De Bie; Jan Bosteels; Holly Hedrick; James Duffy; Beverley Power; Alexandra Benachi; Paolo De Coppi; Caraciolo Fernandes; Kevin Lally; Irwin Reiss; Jan Deprest Journal: Trials Date: 2021-02-23 Impact factor: 2.279
Authors: Constantin M Durnea; Vasilios Pergialiotis; James M N Duffy; Lina Bergstrom; Abdullatif Elfituri; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2018-10-22 Impact factor: 2.894