Objective Inconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection.
Design A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted; randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted.
Results Seventy-six trials involving 43 126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty-three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection.
Conclusions Inconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.
- outcomes research
- patient perspective
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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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