Core outcomes in neonatal encephalopathy: a qualitative study with parents

Quirke, Fiona; Ariff, Shabina; Battin, Malcolm; Bernard, Caitlin; Bloomfield, Frank H.; Daly, Mandy; Devane, Declan; Haas, David M.; Healy, Patricia; Hurley, Tim; Kibet, Vincent; Kirkham, Jamie J; Koskei, Sarah; Meher, Shireen; Molloy, Eleanor J.; Niaz, Maira; Bhraonáin, Elaine Ní; Okaronon, Christabell Omukagah; Tabassum, Farhana; Walker, Karen

doi:10.1136/bmjpo-2022-001550

Cited by 7 publications

(4 citation statements)

References 32 publications

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“…If RCTs continue to be conducted, it is crucial that they are high quality in both design and reporting; ideally, they should include long‐term follow‐up. Of note, a core outcome set for neonatal encephalopathy treatment (COHESION) is under development; if applied, it will facilitate the standardization of outcome measurement and reporting in the future 65, 66 …”

Section: Discussionmentioning

confidence: 99%

“…Of note, a core outcome set for neonatal encephalopathy treatment (COHESION) is under development; if applied, it will facilitate the standardization of outcome measurement and reporting in the future. 65,66 Of the RCTs comparing magnesium sulphate in combination with therapeutic hypothermia and therapeutic hypothermia alone, two were conducted in LMICs 29,47 and two included HICs (one was a multi-country study). 39,55 While the available data did not enable exploration of possible differences in effects according to setting (i.e.…”

Section: Outcome and Subgroupmentioning

confidence: 99%

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Neonatal magnesium sulphate for neuroprotection: A systematic review and meta‐analysis

Shepherd,

Karim,

McIntyre

et al. 2024

Develop Med Child Neuro

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AimTo review the evidence of the effects of neonatal magnesium sulphate for neuroprotection in perinatal asphyxia and hypoxic‐ischaemic encephalopathy (HIE).MethodThis was a systematic review of randomized controlled trials (RCTs) (with meta‐analysis) and non‐RCTs assessing magnesium sulphate for treating perinatal asphyxia and HIE at 35 weeks or more gestation (primary outcomes: neonatal death and death or long‐term major neurodevelopmental disability).ResultsTwenty‐five RCTs (2099 infants) and four non‐RCTs (871 infants) were included, 23 in low‐ and middle‐income countries (LMICs). In RCTs, reductions in neonatal death with magnesium sulphate versus placebo or no treatment (risk ratio [RR] = 0.68; 95% confidence interval [CI] = 0.53–0.86; 13 RCTs), and magnesium sulphate with melatonin versus melatonin alone (RR = 0.74; 95% CI = 0.58–0.95; one RCT) were observed. No difference in neonatal death was seen for magnesium sulphate with therapeutic hypothermia versus therapeutic hypothermia alone (RR = 0.66, 95% CI = 0.34–1.26; three RCTs), or magnesium sulphate versus phenobarbital (RR = 3.00; 95% CI = 0.86–10.46; one RCT). No reduction in death or long‐term neurodevelopmental disability (RR = 0.52; 95% CI = 0.14–1.89; one RCT) but reductions in several short‐term adverse outcomes were observed with magnesium sulphate. Evidence was low‐ to very‐low certainty because of risk of bias and imprecision.InterpretationGiven the uncertainty of the current evidence, further robust neonatal magnesium sulphate research is justified. This may include high‐quality studies to determine stand‐alone effects in LMICs and effects with and after therapeutic hypothermia in high‐income countries.

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Section: Discussionmentioning

confidence: 99%

Section: Outcome and Subgroupmentioning

confidence: 99%

Neonatal magnesium sulphate for neuroprotection: A systematic review and meta‐analysis

Shepherd,

Karim,

McIntyre

et al. 2024

Develop Med Child Neuro

View full text Add to dashboard Cite

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“…Previous qualitative studies in core outcome set development have used different analyses approaches, including thematic analysis, framework approach and approach informed by grounded theory [ 57 – 61 ]. Recent studies used interpretive evidence synthesis methods to transform participants’ experiences and views into measurable outcomes [ 62 , 63 ].…”

Section: Discussionmentioning

confidence: 99%

Key outcomes for reporting in studies of pregnant women with multiple long-term conditions: a qualitative study

Lee

Hanley

Vowles

et al. 2023

BMC Pregnancy Childbirth

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Background Maternal multiple long-term conditions are associated with adverse outcomes for mother and child. We conducted a qualitative study to inform a core outcome set for studies of pregnant women with multiple long-term conditions. Methods Women with two or more pre-existing long-term physical or mental health conditions, who had been pregnant in the last five years or planning a pregnancy, their partners and health care professionals were eligible. Recruitment was through social media, patients and health care professionals’ organisations and personal contacts. Participants who contacted the study team were purposively sampled for maximum variation. Three virtual focus groups were conducted from December 2021 to March 2022 in the United Kingdom: (i) health care professionals (n = 8), (ii) women with multiple long-term conditions (n = 6), and (iii) women with multiple long-term conditions (n = 6) and partners (n = 2). There was representation from women with 20 different physical health conditions and four mental health conditions; health care professionals from obstetrics, obstetric/maternal medicine, midwifery, neonatology, perinatal psychiatry, and general practice. Participants were asked what outcomes should be reported in all studies of pregnant women with multiple long-term conditions. Inductive thematic analysis was conducted. Outcomes identified in the focus groups were mapped to those identified in a systematic literature search in the core outcome set development. Results The focus groups identified 63 outcomes, including maternal (n = 43), children’s (n = 16) and health care utilisation (n = 4) outcomes. Twenty-eight outcomes were new when mapped to the systematic literature search. Outcomes considered important were generally similar across stakeholder groups. Women emphasised outcomes related to care processes, such as information sharing when transitioning between health care teams and stages of pregnancy (continuity of care). Both women and partners wanted to be involved in care decisions and to feel informed of the risks to the pregnancy and baby. Health care professionals additionally prioritised non-clinical outcomes, including quality of life and financial implications for the women; and longer-term outcomes, such as children’s developmental outcomes. Conclusions The findings will inform the design of a core outcome set. Participants’ experiences provided useful insights of how maternity care for pregnant women with multiple long-term conditions can be improved.

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“…The RTD survey presented 87 outcomes for rating. These outcomes were identified from a systematic review of randomised trials of interventions for the treatment of neonatal encephalopathy [ 14 ] and qualitative interviews with parents/caregivers from high-income countries (HiCs) and low- to middle-income countries (LMiCs) [ 15 ]. Five additional outcomes were added to the survey based on stakeholder feedback.…”

Section: Methodsmentioning

confidence: 99%

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial

Quirke

Battin

Bernard

et al. 2023

Trials

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Background Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether ‘feedback’, ‘iteration’, and ‘initial condition’ effects may occur in the two survey methods. Methods We recruited 269 participants (parents/caregivers, healthcare providers and researchers/academics) of which 222 were randomised to either the MRD or the RTD. We investigated the outcomes prioritised in each survey and the ‘feedback’, ‘iteration’, and ‘initial condition’ effects to identify differences between the two survey methods. Results In the RTD, n = 92 participants (83%) fully completed the survey. In the MRD, n = 60 participants (54%) completed all three rounds. Of the 92 outcomes presented, 26 (28%) were prioritised differently between the RTD and MRD. Significantly fewer participants amended their scores when shown stakeholder responses in the RTD compared to the MRD (‘feedback effect’). The ‘iteration effect’ analysis found most experts appeared satisfied with their initial ratings in the RTD and did not amend their scores following stakeholder response feedback. Where they did amend their scores, ratings were amended substantially, suggesting greater convergence. Variance in scores reduced with subsequent rounds of the MRD (‘iteration effect’). Whilst most participants did not change their initial scores in the RTD, of those that did, later recruits tended to align their final score more closely to the group mean final score than earlier recruits (an ‘initial condition’ effect). Conclusion The feedback effect differed between the two Delphi methods but the magnitude of this difference was small and likely due to the large number of observations rather than because of a meaningfully large difference. It did not appear to be advantageous to require participants to engage in three rounds of a survey due to the low change in scores. Larger drop-out through successive rounds in the MRD, together with a lesser convergence of scores and longer time to completion, indicate considerable benefits of the RTD approach. Trial registration NCT04471103. Registered on 14 July 2020.

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Core outcomes in neonatal encephalopathy: a qualitative study with parents

Cited by 7 publications

References 32 publications

Neonatal magnesium sulphate for neuroprotection: A systematic review and meta‐analysis

Neonatal magnesium sulphate for neuroprotection: A systematic review and meta‐analysis

Key outcomes for reporting in studies of pregnant women with multiple long-term conditions: a qualitative study

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial

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