Roles for knowledge-based computer systems: Case studies in maternity care

Harris, Maureen I.; Jagodzinski, A. P.; Greene, Kate

doi:10.1007/bf01206117

Cited by 2 publications

(2 citation statements)

References 13 publications

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“…The Guardian system consists of a medical-grade PC platform, which meets the MHRA standards for a class IIa device. The design has been informed by user-preference studies and ethnographic and audio-visual observations of clinical care and decision making [ 21 , 22 ]. It has a touch-screen user-interface www.K2ms.com and is connected to a conventional CTG recorder at the woman’s bedside.…”

Section: Introductionmentioning

confidence: 99%

A study of an intelligent system to support decision making in the management of labour using the cardiotocograph – the INFANT study protocol

Brocklehurst¹

2016

BMC Pregnancy Childbirth

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BackgroundContinuous electronic fetal heart rate monitoring in labour is widely used but its potential for improving fetal and neonatal outcomes has not been realised. The most likely reason is the difficulty of interpreting the fetal heart rate trace correctly during labour. Computerised interpretation of the fetal heart rate and intelligent decision-support has the potential to deliver this improvement in care.This trial will test whether the addition of decision support software to aid the interpretation of the cardiotocogram (CTG) during labour will reduce the number of ‘poor neonatal outcomes’ in those women judged to require continuous electronic fetal heart rate monitoring.Methods and designAn individually randomised controlled trial of 46,000 women who are judged to require continuous electronic fetal monitoring in labour.Eligibility criteria: Women admitted to a participating labour ward who are judged to require continuous electronic fetal monitoring, have a singleton or twin pregnancy, are ≥ 35 weeks’ gestation, have no known gross fetal abnormality and are ≥ 16 years of age.Exclusion criteria: Triplets or higher order pregnancy, elective caesarean section prior to the onset of labour, planned admission to NICU.Trial interventions: Computerised interpretation of the CTG with decision-support.Primary outcomes: Short term: A composite of ‘poor neonatal outcome’ including stillbirth after trial entry, early neonatal death except deaths due to congenital anomalies, significant morbidity: neonatal encephalopathy, admissions to the neonatal unit with 48 h for > 48 h with evidence of feeding difficulties, respiratory illness or encephalopathy where there is evidence of compromise at birth. Long term: Developmental assessment at the age of 2 years in a subset of 7000 surviving babies.Data Collection: For all participating women and babies, labour variables and outcomes will be stored automatically and contemporaneously onto the Guardian® system.DiscussionThe results of this trial will have importance for pregnant women and for health professionals who provide care for them.Trial registrationCurrent Controlled Trials ISRCTN98680152 assigned 30.09.2008

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Section: Introductionmentioning

confidence: 99%

A study of an intelligent system to support decision making in the management of labour using the cardiotocograph – the INFANT study protocol

Brocklehurst¹

2016

BMC Pregnancy Childbirth

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“…The design has been informed by user preference studies and ethnographic and audio-visual observations of clinical care and decision-making. 32,33 It has a touch-screen user interface ( Figure 3) and is connected to a conventional CTG recorder at the woman's bedside.…”

Section: Introductionmentioning

confidence: 99%

Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT)

Brocklehurst

Field

Greene

et al. 2018

Health Technol Assess

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BackgroundContinuous electronic fetal monitoring (EFM) in labour is widely used and computerised interpretation has the potential to increase its utility.ObjectivesThis trial aimed to find out whether or not the addition of decision support software to assist in the interpretation of the cardiotocograph (CTG) reduced the number of poor neonatal outcomes, and whether or not it was cost-effective.DesignTwo-arm individually randomised controlled trial. The allocations were computer generated using stratified block randomisation employing variable block sizes. The trial was not masked.SettingLabour wards in England, Scotland and the Republic of Ireland.ParticipantsWomen in labour having EFM, with a singleton or twin pregnancy, at ≥ 35 weeks’ gestation.InterventionsDecision support or no decision support.Main outcome measuresThe primary outcomes were (1) a composite of poor neonatal outcome {intrapartum stillbirth or early neonatal death (excluding lethal congenital anomalies), or neonatal morbidity [defined as neonatal encephalopathy (NNE)], or admission to a neonatal unit within 48 hours for ≥ 48 hours (with evidence of feeding difficulties, respiratory illness or NNE when there was evidence of compromise at birth)}; and (2) developmental assessment at the age of 2 years in a subset of surviving children.ResultsBetween 6 January 2010 and 31 August 2013, 47,062 women were randomised and 46,042 were included in the primary analysis (22,987 in the decision support group and 23,055 in the no decision support group). The short-term primary outcome event rate was higher than anticipated. There was no evidence of a difference in the incidence of poor neonatal outcome between the groups: 0.7% (n = 172) of babies in the decision support group compared with 0.7% (n = 171) of babies in the no decision support group [adjusted risk ratio 1.01, 95% confidence interval (CI) 0.82 to 1.25]. There was no evidence of a difference in the long-term primary outcome of the Parent Report of Children’s Abilities-Revised with a mean score of 98.0 points [standard deviation (SD) 33.8 points] in the decision support group and 97.2 points (SD 33.4 points) in the no decision support group (mean difference 0.63 points, 95% CI –0.98 to 2.25 points). No evidence of a difference was found for health resource use and total costs. There was evidence that decision support did change practice (with increased fetal blood sampling and a lower rate of repeated alerts).LimitationsStaff in the control group may learn from exposure to the decision support arm of the trial, resulting in improved outcomes in the control arm. This was identified in the planning stage and felt to be unlikely to have a significant effect on the results. As this was a pragmatic trial, the response to CTG alerts was left to the attending clinicians.ConclusionsThis trial does not support the hypothesis that the use of computerised interpretation of the CTG in women who have EFM in labour improves the clinical outcomes for mothers or babies.Future workThere continues to be an urgent need to improve knowledge and training about the appropriate response to CTG abnormalities, including timely intervention.Trial registrationCurrent Controlled Trials ISRCTN98680152.FundingThis project was funded by the National Institute for Health Research (NIHR) HTA programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 9. See the NIHR Journals Library website for further project information. Sara Kenyon was part funded by the NIHR Collaboration for Leadership in Applied Health Research and Care West Midlands.

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Roles for knowledge-based computer systems: Case studies in maternity care

Cited by 2 publications

References 13 publications

A study of an intelligent system to support decision making in the management of labour using the cardiotocograph – the INFANT study protocol

A study of an intelligent system to support decision making in the management of labour using the cardiotocograph – the INFANT study protocol

Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT)

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