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D Elbourne

Publications and source records attributed to D Elbourne.

At least 37 records · Page 2Linked to original sources
PubMed1998

A comparison of two methods of follow-up in a trial of prophylactic volume expansion in preterm babies.

The outcome at age 2 years of preterm babies recruited into a three-arm randomised controlled trial of prophylactic volume expansion was ascertained in two ways: from a neurodevelopmental assessment performed by a paediatrician and from responses on a brief questionnaire completed by the child's personal health visitor. Of 776 babies recruited into the trial, 604 survived to the age of 2 years and the findings of a paediatric assessment were available for all survivors. Questionnaires were sent to the health visitors of 601 of the survivors; 513 (85.4%) were returned. There was sufficient information on the returned questionnaires to categorise 449 of the children as normal, impaired, moderately disabled or severely disabled. We were unable to detect a response bias by severity of disability. Agreement on individual questions ranged between 86.3% and 98.4%. There was some mismatch in the reporting of vision (weighted kappa = 0.71) and hearing (weighted kappa = 0.73), with differences in perception of level of severity of sensory loss. Health visitors tended to underestimate the child's functional level compared with the paediatrician. However, of 56 children classified as severely disabled by the paediatrician, 48 were classified similarly and eight as moderately disabled on the basis of the questionnaire. The end point of the trial was death or severe disability at 2 years of age. There was close similarity in the trial results whether based on the paediatric assessment or on the questionnaire. Further refinement of the questionnaire is needed, but this methodology may be useful in ascertaining the frequency of severe disability in large cohorts of babies.

Chi-Square Distribution↗
PubMed1998

Project Charlie.

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Health Education↗
PubMed1998

A randomised controlled trial of care of the perineum during second stage of normal labour.

OBJECTIVE: To compare the effect of two methods of perineal management used during spontaneous vaginal delivery on the prevalence of perineal pain reported at 10 days after birth. DESIGN: Randomised controlled trial. SETTING: Two English maternity care units. SAMPLE: 5471 women who gave birth between December 1994 and December 1996. METHODS: At the end of the second stage of labour women were allocated to either the 'hands on' method, in which the midwife's hands put pressure on the baby's head and support ('guard') the perineum; lateral flexion is then used to facilitate delivery of the shoulders, or the 'hands poised' method, in which the midwife keeps her hands poised, not touching the head or perineum, allowing spontaneous delivery of the shoulders. MAIN OUTCOME MEASURE: Perineal pain in the previous 24 hours reported by women in self-administered questionnaire 10 days after birth. RESULTS: Questionnaires were completed by 97% of women at 10 days after birth. 910 (34.1%) women in the 'hands poised' group reported pain in the previous 24 hours compared with 823 (31.1%) in the 'hands on' group (RR 1.10, 95% CI 1.01 to 1.18: absolute difference 3%, 0.5% to 5%, P = 0.02). The rate of episiotomy was significantly lower in the 'hands poised' group (RR 0.79, 99% CI 0.65 to 0.96, P = 0.008) but the rate of manual removal of placenta was significantly higher (RR 1.69, 99% CI 1.02 to 2.78; P = 0.008). There were no other statistically significant differences detected between the two methods. CONCLUSION: The reduction in pain observed in the 'hands on' group was statistically significant and the difference detected potentially affects a substantial number of women. These results provide evidence to enable individual women and health professionals to decide which perineal management is preferable.

Adult↗
PubMed1997

Opioids in labour.

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Analgesia, Epidural↗
PubMed1997

Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial.

Randomized controlled trials (RCTs) are widely accepted by the scientific community as the most rigorous way of evaluating interventions in health care. Although their central feature, random allocation of treatment, is generally seen as methodologically appropriate, its application has caused much debate amongst health professionals and ethicists. This paper describes the views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial. In-depth interviews were used to determine their response to the trial and randomization. The nature of the trial was often poorly understood. The random basis of the allocation of treatment and the rationale behind this approach were also problematic issues. Some parents did not perceive a random element in the process at all. These findings advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs. Greater understanding of participants' views provides the potential to improve the management of future trials and so the experience of those agreeing to take part.

Adult↗
PubMed1997

Comparing two methods of follow up in a multicentre randomised trial.

AIMS: To evaluate a parental questionnaire as a means of providing outcome measures for a multicentre randomised controlled trial of treatment for post-haemorrhagic ventricular dilatation. METHODS: The parents of 88 survivors were sent a questionnaire before a paediatric assessment at the age of 30 months. The parents' responses to individual questions taken mainly from the Griffiths' mental development scales and their perception of the child's ability to see and hear were compared with the paediatric findings. A model, based on the parents' responses to particular questions, allowed the categorisation of the children as normal, impaired, moderately or severely disabled; this was compared with similar categorisation based on the full paediatric assessment. RESULTS: Agreement on items concerning gross motor function ranged between 81 and 99%, concerning dressing between 77 and 80%, concerning feeding between 91 and 99%, and concerning language between 85 and 93%. Similar proportions of children were identified as disabled by the parents (60%) and by the paediatrician (66%). Of 29 children who had developmental quotients less than 70, parents identified 28 as disabled, 18 of them as severely disabled. They were not so good at identifying children with impairments without functional loss. CONCLUSIONS: Further work is required but there is sufficient encouragement from the results to pursue this methodology further for use in comparing groups in randomised trials.

Cerebrospinal Fluid Shunts↗
PubMed1996

Thyrotropin releasing hormone and corticosteroids prior to preterm labour: a survey of current practice in nine European countries. European Union Antenatal TRH Network Steering Committee.

There is considerable variation in the use of cortisosteroids within Europe before possible preterm delivery. Thyrotropin releasing hormone is rarely used as synergistic treatment in most, but not all, European countries-presumably reflecting uncertainty about the effectiveness and safety of this agent.

Adrenal Cortex Hormones↗
PubMed1996

A cost-effectiveness analysis of neonatal ECMO using existing evidence.

A cost-effectiveness analysis is part of the U.K. ECMO Trial. In preparation for this analysis, existing evidence on the costs and effectiveness of neonatal ECMO was evaluated. ECMO appears to be more costly but may be more or less effective than conventional treatment. No case can be made for introducing ECMO before trial results are available.

Cost-Benefit Analysis↗
PubMed1995

Controlled trial of dexamethasone in neonatal chronic lung disease: a 3-year follow-up.

OBJECTIVE: We compared the effects of a policy of neonatal steroid administration versus placebo for babies chronically dependent on supplemental oxygen in terms of long-term health and development, judged at 3 years of age. DESIGN: Double-blind randomized controlled trial. SETTING: Thirty-one centers in the United Kingdom, Ireland, Belgium, Germany, Canada, and the United States. PATIENTS: Babies who were chronically dependent on supplemental oxygen between 2 and 12 weeks of age were recruited to the trial between 1986 and 1989. Sixty-two children were known to have died, 23 before discharge from the hospital and 10 afterward in the active group, compared with 25 and 4, respectively, in the placebo group. Information was available for 209 of the 212 eligible for follow-up (99%). INTERVENTIONS: A 1-week course of active dexamethasone phosphate 0.6 mg/kg/d (dexamethasone base 0.5 mg/kg/d) or saline placebo was given intravenously (or orally, if no intravenous line). There was an option to give a second tapering 9-day course if relapse occurred after initial improvement. OUTCOME MEASURES: Information about respiratory problems, growth, neurodevelopment and disability, infection, and health service use when the children were 3 years old was ascertained from questionnaires to general practitioners, health visitors, and parents (and occasionally pediatricians). RESULTS: About half the children in both groups had been admitted to the hospital for respiratory problems, with more in the active than the placebo group having at least five outpatient consultations for these problems over the 3 years. Overall, the children were below average in height, weight, and head circumference. About one fifth had cerebral palsy, 8% some visual loss, and 16% hearing loss; 18% needed or were anticipated to need special schooling. There were no clear differences between the randomized groups. These overall conclusions were not altered by any of the prespecified secondary analyses. CONCLUSIONS: Despite early benefits, there were no clear effects at 3 years of age. As 40% of the placebo group eventually received open steroids, even a trial of this size has limited statistical power to detect a moderate effect of the policy. Regardless of random allocation, overall morbidity was high, confirming that babies with protracted dependence on supplemental oxygen are at high risk of childhood disability and poor health.

Chronic Disease↗