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• Journal article
  Webbe J, Grunton G, Ali S, Duffy JMN, Modi N, Gale CRKet al., 2017,

  Developing, implementing and disseminating a core outcome set for neonatal medicine

  , BMJ Paediatrics Open, Vol: 1, ISSN: 2399-9772

  Background In high resource settings, 1 in 10 newborn babies require admission to a neonatal unit. Research evaluating neonatal care involves recording and reporting many different outcomes and outcome measures. Such variation limits the usefulness of research as studies cannot be compared or combined. To address these limitations, we aim to develop, disseminate and implement a core outcome set for neonatal medicine.Methods A steering group that includes parents and former patients, healthcare professionals and researchers has been formed to guide the development of the core outcome set. We will review neonatal trials systematically to identify previously reported outcomes. Additionally, we will specifically identify outcomes of importance to parents, former patients and healthcare professionals through a systematic review of qualitative studies. Outcomes identified will be entered into an international, multi-perspective eDelphi survey. All key stakeholders will be invited to participate. The Delphi method will encourage individual and group stakeholder consensus to identify a core outcome set. The core outcome set will be mapped to existing, routinely recorded data where these exist.Discussion Use of a core set will ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research. Embedding the core outcome set within future clinical studies will extend the usefulness of research to inform practice, enhance patient care and ultimately improve outcomes. Using routinely recorded electronic data will facilitate implementation with minimal addition burden.Trial registration number Core Outcome Measures in Effectiveness Trials (COMET) database: 842 (www.comet-initiative.org/studies/details/842).

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• Journal article
  Webbe J, Sinha I, Gale C, 2017,

  Core outcome sets

  , Archives of Disease in Childhood-Education and Practice Edition, Vol: 103, Pages: 163-166, ISSN: 1743-0593
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• Journal article
  Duffy J, Hirsch M, Kawsar A, Gale C, Pealing L, Plana MN, Showell M, Williamson PR, Khan KS, Ziebland S, McManus RJ, iHOPE International Collaboration to Harmonise Outcomes in Pre-Eclampsiaet al., 2017,

  Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.

  , BJOG: An International Journal of Obstetrics and Gynaecology, Vol: 124, Pages: 1829-1839, ISSN: 1470-0328

  BACKGROUND: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. OBJECTIVES: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. SEARCH STRATEGY: Randomised trials were identified by searching bibliographical databases from inception to January 2016. SELECTION CRITERIA: Randomised controlled trials. DATA COLLECTION AND ANALYSIS: We systematically extracted and categorised outcome reporting. MAIN RESULTS: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. CONCLUSIONS: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues.

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• Conference paper
  Jawad S, Gray D, Modi N, Gale CRKet al., 2017,

  A systematic review identifying neonatal core data elements for clinical trials, and assessment of data completeness of identified data elements using the national neonatal research database (NNRD)

  , 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials, Publisher: BioMed Central, Pages: 102-103, ISSN: 1745-6215
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• Journal article
  Modi N, Battersby C, Longford N, 2017,

  Proposed Definition of Necrotizing Enterocolitis May Be of Limited Value Reply

  , JAMA Pediatrics, Vol: 171, Pages: 711-712, ISSN: 2168-6203
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• Journal article
  Battersby C, Michaelides S, Upton M, Rennie Jet al., 2017,

  Term admissions to neonatal units in England: a role for transitional care? A retrospective cohort study

  , BMJ Open, Vol: 7, ISSN: 2044-6055

  Objective To identify the primary reasons for term admissions to neonatal units in England, to determine risk factors for admissions for jaundice and to estimate the proportion who can be cared for in a transitional setting without separation of mother and baby.Design Retrospective observational study using neonatal unit admission data from the National Neonatal Research Database and data of live births in England from the Office for National Statistics.Setting All 163 neonatal units in England 2011–2013.Participants 133 691 term babies born ≥37 weeks gestational age and admitted to neonatal units in England.Primary and secondary outcomes Primary reasons for admission, term babies admitted for the primary reason of jaundice, patient characteristics, postnatal age at admission, total length of stay, phototherapy, intravenous fluids, exchange transfusion and kernicterus.Results Respiratory disease was the most common reason for admission overall, although jaundice was the most common reason for admission from home (22% home vs 5% hospital). Risk factors for admission for jaundice include male, born at 37 weeks gestation, Asian ethnicity and multiple birth. The majority of babies received only a brief period of phototherapy, and only a third received intravenous fluids, suggesting that some may be appropriately managed without separation of mother and baby. Admission from home was significantly later (3.9 days) compared with those admitted from elsewhere in the hospital (1.7 days) (p<0.001).Conclusion Around two-thirds of term admissions for jaundice may be appropriately managed in a transitional care setting, avoiding separation of mother and baby. Babies with risk factors may benefit from a community midwife postnatal visit around the third day of life to enable early referral if necessary. We recommend further work at the national level to examine provision and barriers to transitional care, referral pathways between primary and secondary care, an

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• Journal article
  Haumont D, NguyenBa C, Modi N, 2017,

  eNewborn: The Information Technology Revolution and Challenges for Neonatal Networks

  , NEONATOLOGY, Vol: 111, Pages: 388-397, ISSN: 1661-7800
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• Journal article
  Duffy JMN, Rolph R, Gale CRK, Hirsch M, Khan KS, Ziebland S, McManus RJet al., 2017,

  Core outcome sets in women's and newborn health: a systematic review

  , BJOG: An International Journal of Obstetrics and Gynaecology, Vol: 124, Pages: 1481-1489, ISSN: 1470-0328

  BackgroundVariation in outcome collection and reporting is a serious hindrance to progress in our specialty, over eighty journals have come together to support the development, dissemination, and implementation of core outcome sets.ObjectiveThis study systematically reviewed and characterised registered, progressing, or completed core outcome sets relevant to women's and newborn health.Search strategySystematic search using the Core Outcome Measures in Effectiveness Trial initiative and the Core Outcomes in Women's and Newborn Health initiative databases.Selection criteriaRegistry entries, protocols, systematic reviews, and core outcome sets.Data collection and analysisDescriptive statistics to describe characteristics and results.ResultsThere were 46 core outcome sets in maternal and newborn health, with the majority registered in 2015 (22; 48%) or 2016 (16; 35%). Benign gynaecology (5; 11%) and newborn health (3; 9%) is currently under-represented. Twenty-four (52%) core outcome sets were funded by international (1; 2%), national (18; 39%), and regional (4; 9%) bodies. Seven protocols were published. Twenty systematic reviews characterised the inconsistency in outcome reporting across a broad range of relevant healthcare conditions. Four core outcome sets were completed: reconstructive breast surgery (11 outcomes), preterm birth (13 outcomes), epilepsy in pregnancy (29 outcomes), and maternity care (48 outcomes). The quantitative, qualitative, and consensus methods used to develop core outcome sets have varied considerably.ConclusionsCore outcome sets are currently being developed across women's and newborn health, although coverage of topics is variable. Development of further infrastructure to develop, disseminate, and implement core outcome sets is urgently required.

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• Journal article
  Statnikov Y, Ibrahim B, Modi N, 2017,

  A systematic review of administrative and clinical databases of infants admitted to neonatal units

  , Archives of Disease in Childhood-Fetal and Neonatal Edition, Vol: 102, Pages: F270-F276, ISSN: 1468-2052

  Objectives:High quality information, increasingly captured in clinical databases, is a useful resource for evaluating and improving newborn care. We conducted a systematic review to identify neonatal databases, and define their characteristics. MethodsWe followed a preregistered protocol using MesH terms to search MEDLINE, EMBASE, CINAHL, Web of Science and OVID Maternity and Infant Care Databases for articles identifying patient level databases covering more than one neonatal unit. Full-text articles were reviewed and information extracted on geographic coverage, criteria for inclusion, data source, and maternal and infant characteristics. ResultsWe identified 82 databases from 2,037 publications. Of the country specific databases there were 39 regional and 39 national. Sixty databases restricted entries to neonatal unit admissions by birth characteristic or insurance cover; 22 had no restrictions. Data were captured specifically for 53 databases; 21 administrative sources; 8 clinical sources. Two clinical databases hold the largest range of data on patient characteristics, USA’s Pediatrix BabySteps Clinical Data Warehouse and UK’s National Neonatal Research Database.Conclusion A number of neonatal databases exist that have potential to contribute to evaluating neonatal care. The majority are created by entering data specifically for the database, duplicating information likely already captured in other administrative and clinical patient records. This repetitive data entry represents an unnecessary burden in an environment where electronic patient records are increasingly used. Standardisation of data items is necessary to facilitate linkage within and between countries.

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• Journal article
  Kelly LE, Shah PS, Hakansson S, Kusuda S, Adams M, Lee SK, Sjors G, Vento M, Rusconi F, Lehtonen L, Reichman B, Darlow BA, Lui K, Feliciano LS, Gagliardi L, Bassler D, Modi Net al., 2017,

  Perinatal health services organization for preterm births: a multinational comparison

  , JOURNAL OF PERINATOLOGY, Vol: 37, Pages: 762-768, ISSN: 0743-8346
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