Developing, implementing and disseminating a core outcome set for neonatal medicine
James Webbe,Ginny Brunton,Shohaib Ali,James Duffy,Neena Modi,Chris Gale +5 more
- Vol. 1, Iss: 1
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TLDR
A core outcome set for neonatal medicine is developed to ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research.Abstract:
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).read more
Citations
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Contemporary Outcomes for Infants with Necrotizing Enterocolitis-A Systematic Review.
TL;DR: A systematic review of recent large cohort studies reporting outcomes of infants who developed NEC to develop an accurate understanding of outcomes for necrotizing enterocolitis to inform parental counseling, clinical care, and research agendas and justify ongoing research efforts.
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Effects of family-centred care interventions on preterm infants and parents in neonatal intensive care units: A systematic review and meta-analysis of randomised controlled trials
TL;DR: FCC interventions can improve weight gain and readmission in preterm infants as well as parent satisfaction, knowledge, and skills, and possibly long-term anxiety, depression, and stress.
Journal ArticleDOI
Core outcomes in neonatology: Development of a core outcome set for neonatal research
James Webbe,James Duffy,Elsa Afonso,Iyad Al-Muzaffar,Ginny Brunton,Anne Greenough,Nigel J. Hall,Marian Knight,Jos M. Latour,Caroline Lee-Davey,Neil Marlow,Laura Noakes,Julie Nycyk,Angela Richard-Löndt,Ben Wills-Eve,Neena Modi,Chris Gale +16 more
TL;DR: A core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting has been identified to help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by Neonatal care.
Journal ArticleDOI
A core outcome set for pre‐eclampsia research : an international consensus development study
Jmn Duffy,Jmn Duffy,A. E. Cairns,D. Richards-Doran,J. van 't Hooft,C Gale,Mark Brown,Lucy C Chappell,William A. Grobman,Ray Fitzpatrick,SA Karumanchi,Asma Khalil,D. N. Lucas,Laura A. Magee,Ben W.J. Mol,Michael Stark,Shakila Thangaratinam,Matthew Wilson,P. von Dadelszen,Paula R Williamson,Sue Ziebland,Richard J McManus +21 more
TL;DR: To develop a core outcome set for pre‐eclampsia, a large number of patients with atypical or high‐risk pregnancies will be diagnosed with at least one of the following conditions: hyperexcitability, high blood pressure, or both.
Journal ArticleDOI
Developing a core outcome set for future infertility research: An international consensus development study
James Duffy,H. AlAhwany,Sohinee Bhattacharya,Barbara Collura,Cate Curtis,J.L.H. Evers,Roy G. Farquharson,S. Franik,Linda C. Giudice,Y. Khalaf,J.M.L. Knijnenburg,Brigitte Leeners,Richard S. Legro,Sarah Lensen,J C Vazquez-Niebla,Dimitrios Mavrelos,Ben W.J. Mol,Craig Niederberger,Ernest Hung Yu Ng,A.S. Otter,L. Puscasiu,S. Rautakallio-Hokkanen,Sjoerd Repping,I Sarris,Joe Leigh Simpson,Annika Strandell,C. Strawbridge,Helen L. Torrance,Andy Vail,M. van Wely,M. Vercoe,N L Vuong,Alex Y. Wang,Rui Wang,Jack Wilkinson,Mohamed A. Youssef,Cindy Farquhar,Core Outcome Measure for Infertility Trials (Commit) initiative +37 more
TL;DR: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials and systematic reviews evaluating potential treatments for infertility, which consists of viable intrauterine pregnancy confirmed by ultrasound, pregnancy loss, live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly.
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