Neurodevelopmental outcome descriptions in cohorts of extremely preterm children

Ding, Sharon; Mew, Emma; Chee-A-Tow, Alyssandra; Offringa, Martin; Butcher, Nancy J.; Moore, Gregory P.

doi:10.1136/archdischild-2019-318144

Cited by 13 publications

(15 citation statements)

References 42 publications

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“…For example, some studies have used a chart review of medical records, which probably is sufficient to make a decision on severe disabilities, but may not distinguish between milder impairments. Also, the composite outcomes should be defined and their completeness reported precisely when describing neurodevelopmental outcome in different study populations 24 . It could be noted that several variables, included in the definition of the composite outcome of NDI, were not available in all studies.…”

Section: Discussionmentioning

confidence: 99%

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Using different definitions affected the reported prevalence of neurodevelopmental impairment in children born very preterm

et al. 2020

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Aim We investigated the impact of varying definitions on the prevalence of neurodevelopmental impairment (NDI) in children born very preterm at 6.5 years of age. Methods Cognitive development and neurosensory impairments were assessed in 91 children (40/51 girls/boys) born <32 gestational weeks, in 2004‐2007 in Uppsala county, Sweden. The results were compared with data from a reference group of 67 children born full term. The prevalence of NDI in the present cohort was reported according to definitions used by seven contemporary studies of children born very or extremely preterm. Results The prevalence of severe NDI varied from 2% to 23% depending on the definition used. The prevalence of cognitive impairment varied from 2% (−3 SD according to test norms) to 16% (−2 SD according to control group), the prevalence of cerebral palsy from 0% (severe) to 9% (any) and the prevalence of severe visual impairment from 0% (blindness) to 1% (visual acuity < 0.3). There were no children with severe hearing impairment. Conclusion A high variability in definitions affects the reporting of the prevalence of NDI in long‐term follow‐up studies of very or extremely preterm born children. There is a need for a better consensus to enable comparisons across studies.

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Section: Discussionmentioning

confidence: 99%

“…Our results highlight that caution should be taken when comparing the prevalence of NDI across studies. In future follow‐up studies of children born very preterm, it would be important to reach consensus and use clearly described definitions of NDI when reporting outcomes 24,26 …”

Section: Discussionmentioning

confidence: 99%

Using different definitions affected the reported prevalence of neurodevelopmental impairment in children born very preterm

et al. 2020

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“…Owing to the reference sample selection bias, however, differences between preterm and term born groups are probably underestimated. Finally, assessors were not blinded to the gestational comparison with other studies Reporting outcomes for children born preterm is challenging not only because completeness of reporting is difficult to achieve, 39 but also because outcome measures have to be meaningful for both health professionals and policy makers and for children and parents. 13 Two recent international Delphi surveys have defined themes to be reported in follow-up studies of preterm born children in high income settings.…”

Section: Populationmentioning

confidence: 99%

Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study

Pierrat

Marchand-Martin

Marret

et al. 2021

BMJ

156

146

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Objectives To describe neurodevelopment at age 5 among children born preterm. Design Population based cohort study, EPIPAGE-2. Setting France, 2011. Participants 4441 children aged 5½ born at 24-26, 27-31, and 32-34 weeks Main outcome measures Severe/moderate neurodevelopmental disabilities, defined as severe/moderate cerebral palsy (Gross Motor Function Classification System (GMFCS) ≥2), or unilateral or bilateral blindness or deafness, or full scale intelligence quotient less than minus two standard deviations (Wechsler Preschool and Primary Scale of Intelligence, 4th edition). Mild neurodevelopmental disabilities, defined as mild cerebral palsy (GMFCS-1), or visual disability ≥3.2/10 and <5/10, or hearing loss <40 dB, or full scale intelligence quotient (minus two to minus one standard deviation) or developmental coordination disorders (Movement Assessment Battery for Children, 2nd edition, total score less than or equal to the fifth centile), or behavioural difficulties (strengths and difficulties questionnaire, total score greater than or equal to the 90th centile), school assistance (mainstream class with support or special school), complex developmental interventions, and parents’ concerns about development. The distributions of the scores in contemporary term born children were used as reference. Results are given after multiple imputation as percentages of outcome measures with exact binomial 95% confidence intervals. Results Among 4441 participants, 3083 (69.4%) children were assessed. Rates of severe/moderate neurodevelopmental disabilities were 28% (95% confidence interval 23.4% to 32.2%), 19% (16.8% to 20.7%), and 12% (9.2% to 14.0%) and of mild disabilities were 38.5% (33.7% to 43.4%), 36% (33.4% to 38.1%), and 34% (30.2% to 37.4%) at 24-26, 27-31, and 32-34 weeks, respectively. Assistance at school was used by 27% (22.9% to 31.7%), 14% (12.1% to 15.9%), and 7% (4.4% to 9.0%) of children at 24-26, 27-31, and 32-34 weeks, respectively. About half of the children born at 24-26 weeks (52% (46.4% to 57.3%)) received at least one developmental intervention which decreased to 26% (21.8% to 29.4%) for those born at 32-34 weeks. Behaviour was the concern most commonly reported by parents. Rates of neurodevelopment disabilities increased as gestational age decreased and were higher in families with low socioeconomic status. Conclusions In this large cohort of children born preterm, rates of severe/moderate neurodevelopmental disabilities remained high in each gestational age group. Proportions of children receiving school assistance or complex developmental interventions might have a significant impact on educational and health organisations. Parental concerns about behaviour warrant attention.

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“…The final version of CONSORT-Outcomes was developed after the conduct of this study and is in preparation for peerreviewed publication. The preliminary version of the extension used in this study is organized into 10 thematic categories: 1) What: Description of the outcome; 2) Why: Rationale for selecting the outcome; 3) How: The way the outcome is measured; 4) Who: Source of information of the outcome; 5) Where: Assessment location and setting of the outcome; 6) When: Timing of measurement of the outcome; 7) Outcome data management and analyses; 8) Missing outcome data; 9) Interpretation; and 10) Modifications [31][32][33].…”

Section: Outcome Reporting Assessmentmentioning

confidence: 99%

Primary outcome reporting in adolescent depression clinical trials needs standardization

Monsour

Mew

Patel

et al. 2020

BMC Med Res Methodol

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Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as "fully reported", "partially reported", or "not reported" for each checklist item, as applicable. Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6 to 17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed.

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Neurodevelopmental outcome descriptions in cohorts of extremely preterm children

Cited by 13 publications

References 42 publications

Using different definitions affected the reported prevalence of neurodevelopmental impairment in children born very preterm

Using different definitions affected the reported prevalence of neurodevelopmental impairment in children born very preterm

Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study

Primary outcome reporting in adolescent depression clinical trials needs standardization

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