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Outcome Reporting in Neonatal Clinical Trials: a Systematic Review

Presented at the Neonatal Society 2017 Spring Meeting.

Ali S1, Webbe J1, Duffy JMN2, Modi N1, Gale C1

1 Section of Neonatal Medicine, Imperial College London, Chelsea and Westminster campus, London, UK
2 Balliol College, University of Oxford, Oxford, OX2 6GG, UK

Background: Inconsistent outcome reporting in clinical trials is wasteful, limiting comparability and evidence synthesis (1). In preterm infants, clinical trial interventions have the potential to affect other organ systems in addition to the therapeutic target organ (2); preterm neonatal clinical trial outcomes should reflect this. We hypothesised: a. Trials reported a consistent set of outcomes b. That outcomes reported span the major organ systems We also examined whether trials reported parent or patient involvement in outcomes selection. This work will aid the development of a core outcome set for neonatology.

Methods: Design: Systematic review of randomised trials and cluster randomised trials. Data sources: We searched major bibliographic databases from their June 2011 to June 2016. Study selection and data extraction: All trials including preterm (<37 gestational weeks at birth) neonates (0-28 days) requiring admission to a neonatal intensive care unit or special care baby unit. We systematically extracted and categorised primary and secondary outcomes and outcome measures. Funding: SA was funded through a UROP Fellowship.

Results: We included 119 randomised trials involving 21,824 infants, reported 161 different primary outcomes and 1,210 different secondary outcomes. No studies reported parental involvement in outcome selection. Mortality was reported in 72 (61%) trials.

Major outcome domains were reported as follows: respiratory outcomes in 74 trials (62%), gastrointestinal in 73 trials (60%), cardiovascular in 62 trials (52%), infection in 50 trials (42%), genitourinary in 12 trials (10%) and psychosocial in 12 trials (10%).

Commonly reported secondary outcomes included: chronic lung disease (CLD) in 55 trials (45%), necrotising enterocolitis in 54 trials (45%), intraventricular haemorrhage in 46 trials (39%), sepsis in 46 trials (39%), patent ductus arteriosus in 44 trials (36%) and retinopathy of prematurity in 44 trials (37%). Among these common secondary outcomes there was variation in outcome measures used: CLD was reported using 7 different outcome measures. Neurodevelopmental outcomes after discharge were reported by 21 trials (18%); 17 different tools were used.

Conclusion: Outcome reporting in preterm neonatal trials is inconsistent. Trials do not consistently report outcomes across key organ systems and only a minority report development after discharge. Where outcomes are commonly reported, there is inconsistency outcome measures. There is no evidence of parent involvement in outcome selection. Developing and implementing a neonatal core outcome set will address these issues.

Corresponding author: shohaib.ali14@imperial.ac.uk

1. Glasziou P, et al., Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014 January 8;383(9913):267-76
2. Doyle LW, Et al., Early (<8 days) postnatal corticosteroids for preventing chronic lung disease in preterm infants. Cochrane Database Sys Rev. 2014 May 13;(5)

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