Inconsistent outcome reporting in large neonatal trials: a systematic review
dc.contributor.author | Webbe, JWH | |
dc.contributor.author | Ali, S | |
dc.contributor.author | Sakonidou, S | |
dc.contributor.author | Webbe, T | |
dc.contributor.author | Duffy, JMN | |
dc.contributor.author | Brunton, G | |
dc.contributor.author | Modi, N | |
dc.contributor.author | Gale, C | |
dc.date.accessioned | 2021-08-09T17:31:47Z | |
dc.date.issued | 2020-01 | |
dc.identifier.issn | 1359-2998 | |
dc.identifier.issn | 1468-2052 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/17529 | |
dc.description.abstract |
<jats:sec><jats:title>Objective</jats:title><jats:p>Inconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted; randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Seventy-six trials involving 43 126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty-three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Inconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.</jats:p></jats:sec> | |
dc.format.extent | 69-75 | |
dc.format.medium | Print-Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | BMJ | |
dc.subject | neonatology | |
dc.subject | outcomes research | |
dc.subject | patient perspective | |
dc.subject | Humans | |
dc.subject | Infant, Newborn | |
dc.subject | Infant, Newborn, Diseases | |
dc.subject | Outcome and Process Assessment, Health Care | |
dc.subject | Randomized Controlled Trials as Topic | |
dc.title | Inconsistent outcome reporting in large neonatal trials: a systematic review | |
dc.type | journal-article | |
dc.type | Journal Article | |
dc.type | Systematic Review | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000507328800015&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 1 | |
plymouth.volume | 105 | |
plymouth.publication-status | Published | |
plymouth.journal | Archives of Disease in Childhood - Fetal and Neonatal Edition | |
dc.identifier.doi | 10.1136/archdischild-2019-316823 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/School of Nursing and Midwifery | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Health and Community | |
plymouth.organisational-group | /Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2019-04-24 | |
dc.rights.embargodate | 2021-8-25 | |
dc.identifier.eissn | 1468-2052 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1136/archdischild-2019-316823 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.type | Journal Article/Review |