Neonatal encephalopathy: a systematic review of reported treatment outcomes

Fiona Quirke; Linda Biesty; Malcolm Battin; Frank Bloomfield; Mandy Daly; Elaine  Finucane; Patricia Healy; Tim Hurley; Jamie Kirkham; Eleanor Molloy; David M  Haas; Shireen  Meher; Elaine Ní  Bhraonáin; Karen  Walker; James  Webbe; Declan  Devane

doi:10.1136/bmjpo-2024-002510

Neonatal encephalopathy: a systematic review of reported treatment outcomes

Fiona Quirke, Linda Biesty, Malcolm Battin, Frank Bloomfield, Mandy Daly, Elaine Finucane, Patricia Healy, Tim Hurley, Jamie Kirkham, Eleanor Molloy, David M Haas, Shireen Meher, Elaine Ní Bhraonáin, Karen Walker, James Webbe, Declan Devane

Division of Population Health, Health Services Research & Primary Care (L5)

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Abstract

Background Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of outcomes to be measured and reported in all studies for a condition, address this problem. This paper aimed to identify outcomes reported (primary, secondary, adverse events and other reported outcomes) in (1) randomised trials and (2) systematic reviews of randomised trials of interventions for the treatment of NE in the process of developing a COS for interventions for the treatment of NE.

Methods We completed a systematic search for outcomes used to evaluate treatments for NE using MEDLINE, Embase, Cochrane CENTRAL, the Cochrane Database of Systematic Reviews and the WHO International Clinical Trials Registry Platform. Two reviewers screened all included articles independently. Outcomes were extracted verbatim, similar outcomes were grouped and outcome domains were developed.

Results 386 outcomes were reported in 116 papers, from 85 studies. Outcomes were categorised into 18 domains. No outcome was reported by all studies, a single study reported 11 outcomes and it was not explicitly stated that outcomes had input from parents.

Discussion Heterogeneity in reported outcomes means that synthesis of studies evaluating new treatments for NE remains difficult. A COS, that includes parental/family input, is needed to ensure consistency in measuring and reporting outcomes, and to enable comparison of randomised trials.

Original language	English
Article number	e002510
Number of pages	9
Journal	BMJ Paediatrics open
Volume	8
Issue number	1
DOIs	https://doi.org/10.1136/bmjpo-2024-002510
Publication status	Published - 25 Sept 2024

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Quirke, F., Biesty, L., Battin, M., Bloomfield, F., Daly, M., Finucane, E., Healy, P., Hurley, T., Kirkham, J., Molloy, E., Haas, D. M., Meher, S., Bhraonáin, E. N., Walker, K., Webbe, J., & Devane, D. (2024). Neonatal encephalopathy: a systematic review of reported treatment outcomes. BMJ Paediatrics open, 8(1), Article e002510. https://doi.org/10.1136/bmjpo-2024-002510

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abstract = "Background Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of outcomes to be measured and reported in all studies for a condition, address this problem. This paper aimed to identify outcomes reported (primary, secondary, adverse events and other reported outcomes) in (1) randomised trials and (2) systematic reviews of randomised trials of interventions for the treatment of NE in the process of developing a COS for interventions for the treatment of NE.Methods We completed a systematic search for outcomes used to evaluate treatments for NE using MEDLINE, Embase, Cochrane CENTRAL, the Cochrane Database of Systematic Reviews and the WHO International Clinical Trials Registry Platform. Two reviewers screened all included articles independently. Outcomes were extracted verbatim, similar outcomes were grouped and outcome domains were developed.Results 386 outcomes were reported in 116 papers, from 85 studies. Outcomes were categorised into 18 domains. No outcome was reported by all studies, a single study reported 11 outcomes and it was not explicitly stated that outcomes had input from parents.Discussion Heterogeneity in reported outcomes means that synthesis of studies evaluating new treatments for NE remains difficult. A COS, that includes parental/family input, is needed to ensure consistency in measuring and reporting outcomes, and to enable comparison of randomised trials.",

author = "Fiona Quirke and Linda Biesty and Malcolm Battin and Frank Bloomfield and Mandy Daly and Elaine Finucane and Patricia Healy and Tim Hurley and Jamie Kirkham and Eleanor Molloy and Haas, {David M} and Shireen Meher and Bhraon{\'a}in, {Elaine N{\'i}} and Karen Walker and James Webbe and Declan Devane",

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AU - Battin, Malcolm

AU - Bloomfield, Frank

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AU - Finucane, Elaine

AU - Healy, Patricia

AU - Hurley, Tim

AU - Kirkham, Jamie

AU - Molloy, Eleanor

AU - Haas, David M

AU - Meher, Shireen

AU - Bhraonáin, Elaine Ní

AU - Walker, Karen

AU - Webbe, James

AU - Devane, Declan

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N2 - Background Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of outcomes to be measured and reported in all studies for a condition, address this problem. This paper aimed to identify outcomes reported (primary, secondary, adverse events and other reported outcomes) in (1) randomised trials and (2) systematic reviews of randomised trials of interventions for the treatment of NE in the process of developing a COS for interventions for the treatment of NE.Methods We completed a systematic search for outcomes used to evaluate treatments for NE using MEDLINE, Embase, Cochrane CENTRAL, the Cochrane Database of Systematic Reviews and the WHO International Clinical Trials Registry Platform. Two reviewers screened all included articles independently. Outcomes were extracted verbatim, similar outcomes were grouped and outcome domains were developed.Results 386 outcomes were reported in 116 papers, from 85 studies. Outcomes were categorised into 18 domains. No outcome was reported by all studies, a single study reported 11 outcomes and it was not explicitly stated that outcomes had input from parents.Discussion Heterogeneity in reported outcomes means that synthesis of studies evaluating new treatments for NE remains difficult. A COS, that includes parental/family input, is needed to ensure consistency in measuring and reporting outcomes, and to enable comparison of randomised trials.

AB - Background Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of outcomes to be measured and reported in all studies for a condition, address this problem. This paper aimed to identify outcomes reported (primary, secondary, adverse events and other reported outcomes) in (1) randomised trials and (2) systematic reviews of randomised trials of interventions for the treatment of NE in the process of developing a COS for interventions for the treatment of NE.Methods We completed a systematic search for outcomes used to evaluate treatments for NE using MEDLINE, Embase, Cochrane CENTRAL, the Cochrane Database of Systematic Reviews and the WHO International Clinical Trials Registry Platform. Two reviewers screened all included articles independently. Outcomes were extracted verbatim, similar outcomes were grouped and outcome domains were developed.Results 386 outcomes were reported in 116 papers, from 85 studies. Outcomes were categorised into 18 domains. No outcome was reported by all studies, a single study reported 11 outcomes and it was not explicitly stated that outcomes had input from parents.Discussion Heterogeneity in reported outcomes means that synthesis of studies evaluating new treatments for NE remains difficult. A COS, that includes parental/family input, is needed to ensure consistency in measuring and reporting outcomes, and to enable comparison of randomised trials.

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Neonatal encephalopathy: a systematic review of reported treatment outcomes

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