Eligible participants if Primary Secondary Outcome Clinical context Main clinical assumptions implemented outcomes outcomes Preventive care at Infants born at <30 weeks' Infants: Infants: Child Prior to the trial, there was Main impact is through maternal outcomes rather than those for infants. home leads to gestation with no major Cognitive, behaviour and little existing evidence for the Dysregulation will not be treated in clinical practice at this stage. Dysregulation Improved congenital brain anomalies language and emotional effectiveness for preventive may be predictive of longer term neurodevelopmental outcomes (e.g. autism), behavioural associated with poor motor regulation at care at home for newborns. It is however, it is not costed here as the predictive association is not part of this outcomes for infants, neurodevelopmental development at age 2. unlikely the trial results will be study. and reduces anxiety outcomes = 1.7% age 2. implemented due to the cost of Impairment for maternal anxiety and depression is for two years in parents of and depression for Mothers: and intervention. very preterm infants. primary caregivers. mental health of Live births = 307277, primary care-giver mothers = 304777 at same Infants, N = 5224, Mothers, N = 5181 Outcome Difference in N if Health Economic QALY impact Economic impact Total Economic Impact risk between implemented service Impact on health per person on QALYS if control and at 65% cost per service costs if implemented treatment person or implemented day Primary Cognitive, No statistically language and significant - - - - - - motor difference. development Secondary Anxiety -43% -326 -$2,000 -$0.7m -$60,979 -$20m -$21m (maternal) Depression -35% -1027 -$2,000 -$2m -$57,033 -$59m -$60m (maternal) Change in +$6m intervention costs Totals -$3m -$78m -$75m Columns may not sum due to rounding. Negative values are savings in the calculations.
Outcome Eligible participants if implemented Primary outcomes Secondary outcomes Clinical context Main clinical assumptions Preventive care at home leads to Improved behavioural outcomes for infants, and reduces anxiety and depression for primary caregivers. Infants born at <30 weeks' gestation with no major congenital brain anomalies associated with poor neurodevelopmental outcomes = 1.7% Infants: Cognitive, language and motor development at age 2. Mothers: and mental health of primary care-giver at same Infants: Child behaviour and emotional regulation at age 2. Prior to the trial, there was little existing evidence for the effectiveness for preventive care at home for newborns. It is unlikely the trial results will be implemented due to the cost of intervention. Main impact is through maternal outcomes rather than those for infants. Dysregulation will not be treated in clinical practice at this stage. Dysregulation may be predictive of longer term neurodevelopmental outcomes (e.g. autism), however, it is not costed here as the predictive association is not part of this study. Impairment for maternal anxiety and depression is for two years in parents of very preterm infants. Live births = 307277, mothers = 304777 Infants, N = 5224, Mothers, N = 5181 Outcome Difference in risk between control and treatment N if implemented at 65% Health service cost per person or day Economic Impact on health service costs if implemented QALY impact per person Economic impact on QALYS if implemented Total Economic Impact Primary Cognitive, language and motor development No statistically significant difference. - - - - - - Secondary Anxiety (maternal) -43% -326 -$2,000 -$0.7m -$60,979 -$20m -$21m Depression (maternal) -35% -1027 -$2,000 -$2m -$57,033 -$59m -$60m Change in intervention costs Totals +$6m -$3m -$78m -$75m Columns may not sum due to rounding. Negative values are savings in the calculations.
Supplementary-Appendix-B-Economic-evaluation-of-investigator-initiated-clinical-trials-conducted-by-networks.docx