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Inconsistent outcome reporting in large neonatal trials: a systematic review
  1. James William Harrison Webbe1,
  2. Shohaib Ali2,
  3. Susanna Sakonidou1,
  4. Thomas Webbe3,
  5. James M N Duffy4,
  6. Ginny Brunton5,
  7. Neena Modi1,
  8. Chris Gale1
  9. On behalf of the COIN Project Steering Committee
    1. 1 Section of Neonatal Medicine, Imperial College London, London, UK
    2. 2 School of Medicine, Imperial College London, London, London, UK
    3. 3 University of Bristol, Bristol, UK
    4. 4 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
    5. 5 UCL Institute of Education, University College London, London, UK
    1. Correspondence to Dr James William Harrison Webbe, Academic Neonatal Medicine, Imperial College London, London SW7 2AZ, UK; j.webbe{at}imperial.ac.uk

    Footnotes

    • Contributors SA, JWHW and CG conceived this systematic review. This protocol was created by SA, GB, JMND and CG. Searches were performed by JWHW. All search results were reviewed by JWHW, SA and SS assessed by the eligibility criteria above. Coding was completed by JWHW, SA and SS. Data analysis was completed by TW and JWHW. The first draft of the manuscript was written by SA and JWHW; CG, JMND and NM edited and reviewed the manuscript. It was approved by JWHW, SA, SS, TW, GB, JMND, CG, NM and the COIN Steering Group.

    • Funding This research is sponsored by Imperial College London and supported by an MRC Clinician Scientist Fellowship award to CG (MR/N008405/1) and salary support for JWHW from the Portland Hospital. Imperial College London, the MRC and the Portland Hospital had no involvement in the research or this publication.

    • Competing interests CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years, he had been the investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, and Westminster Medical School Research Trust and Chiesi Pharmaceuticals; JW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No unpublished data are available for this study.

    • Collaborators Steering Group Chair: Marian Knight (Professor of Maternal and Child Population Health. National Perinatal Epidemiology Unit, Oxford). Project Management Team: Chris GaleClinical (Senior Lecturer in Neonatal Medicine. Imperial College, London) James Webbe (Clinical Research Fellow. Imperial College, London). Steering Group: Elsa Afonso (Neonatal Staff Nurse. Cambridge University Hospitals NHS Foundation Trust, Cambridge); Iyad Al-Muzaffar (Consultant Neonatologist and Parent of preterm baby. Cwm Taf University Health Board, Wales); Ginny Brunton (Midwife and qualitative methodologist. UCL Institute of Education, London); James Duffy (Doctoral Research Fellow in Obstetrics and Gynaecology. Nuffield Department of Primary Health Sciences, Oxford); Anne Greenough (Professor of Neonatology and Clinical Respiratory Physiology. King’s College, London); Nigel Hall (Associate Professor of Paediatric Surgery, University of Southampton Jos Latour Professor of Clinical Nursing. Plymouth University, Plymouth); Neil Marlow (Professor of Neonatal Medicine. University College, London); Neena Modi (Professor of Neonatal Medicine. Imperial College, London. Laura Noakes Parent of neonatal patient). Julie Nycyk (Consultant Neonatologist, Sandwell and West Birmingham Hospitals NHS Trust Mehali Patel Research Engagement Officer Bliss, London). Angela Richard-Londt (Parent of neonatal patients). Ben Wills-Eve (Ex-neonatal patient).

    • Patient consent for publication Not required.

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    Footnotes

    • Contributors SA, JWHW and CG conceived this systematic review. This protocol was created by SA, GB, JMND and CG. Searches were performed by JWHW. All search results were reviewed by JWHW, SA and SS assessed by the eligibility criteria above. Coding was completed by JWHW, SA and SS. Data analysis was completed by TW and JWHW. The first draft of the manuscript was written by SA and JWHW; CG, JMND and NM edited and reviewed the manuscript. It was approved by JWHW, SA, SS, TW, GB, JMND, CG, NM and the COIN Steering Group.

    • Funding This research is sponsored by Imperial College London and supported by an MRC Clinician Scientist Fellowship award to CG (MR/N008405/1) and salary support for JWHW from the Portland Hospital. Imperial College London, the MRC and the Portland Hospital had no involvement in the research or this publication.

    • Competing interests CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years, he had been the investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, and Westminster Medical School Research Trust and Chiesi Pharmaceuticals; JW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No unpublished data are available for this study.

    • Collaborators Steering Group Chair: Marian Knight (Professor of Maternal and Child Population Health. National Perinatal Epidemiology Unit, Oxford). Project Management Team: Chris GaleClinical (Senior Lecturer in Neonatal Medicine. Imperial College, London) James Webbe (Clinical Research Fellow. Imperial College, London). Steering Group: Elsa Afonso (Neonatal Staff Nurse. Cambridge University Hospitals NHS Foundation Trust, Cambridge); Iyad Al-Muzaffar (Consultant Neonatologist and Parent of preterm baby. Cwm Taf University Health Board, Wales); Ginny Brunton (Midwife and qualitative methodologist. UCL Institute of Education, London); James Duffy (Doctoral Research Fellow in Obstetrics and Gynaecology. Nuffield Department of Primary Health Sciences, Oxford); Anne Greenough (Professor of Neonatology and Clinical Respiratory Physiology. King’s College, London); Nigel Hall (Associate Professor of Paediatric Surgery, University of Southampton Jos Latour Professor of Clinical Nursing. Plymouth University, Plymouth); Neil Marlow (Professor of Neonatal Medicine. University College, London); Neena Modi (Professor of Neonatal Medicine. Imperial College, London. Laura Noakes Parent of neonatal patient). Julie Nycyk (Consultant Neonatologist, Sandwell and West Birmingham Hospitals NHS Trust Mehali Patel Research Engagement Officer Bliss, London). Angela Richard-Londt (Parent of neonatal patients). Ben Wills-Eve (Ex-neonatal patient).

    • Patient consent for publication Not required.

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