Economic evaluation of strategies for managing crying and sleeping problems Morris S, St James-Roberts I, Sleep J, Gillham P

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1 Economic evaluation of strategies for managing crying and sleeping problems Morris S, St James-Roberts I, Sleep J, Gillham P Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The use of two strategies for the treatment of infant crying and sleeping problems in the first 12 weeks of age. The two strategies were behavioural intervention and educational intervention. These were compared with existing services. Type of intervention Treatment. Economic study type Cost-effectiveness analysis. Study population The study population comprised infants in the first 12 weeks of age. Setting The setting was primary care. The economic analysis was carried out in West Berkshire, UK. Dates to which data relate For the cost-effectiveness analysis, the outcome and resource use data were obtained from a study conducted between March 1997 and February The cost burden analysis used the number of live births in The price year was not reported. Source of effectiveness data The effectiveness data were derived from a single randomised controlled trial, which has been submitted for publication. Link between effectiveness and cost data The resource use data were collected prospectively from the same patient sample as that used in the effectiveness study. This was supplemented by the resource use and cost data from three surveys of health care professionals, which were conducted during the study. Study sample No power calculations were used to determine the sample size for the study. The authors did not report the method of sample selection, or the inclusion or exclusion criteria. In addition, they did not provide details of the mothers who refused to participate, or who were excluded from the study. The trial was described in another paper, which has been submitted for publication. The authors stated that the entry criteria might have led to high-risk babies being excluded from the trial. Page: 1 / 5

2 In total, 610 mothers were enrolled in the study. These were allocated to either the behavioural intervention (n=205), the educational intervention (n=202) or the control group (n=203). Study design The study was a prospective randomised controlled trial. The duration of follow-up was 12 weeks. Complete follow-up data were available for 150 (73%) babies in the behavioural group, 159 (79%) babies in the education group, and 132 (65%) babies in the control group. The authors did not report the methods used to mask the outcomes assessed or the number of centres in the trial. Analysis of effectiveness The authors did not report whether the analysis of effectiveness was performed on an intention to treat basis, or on treatment completers only. The effectiveness data were only reported for those mothers with complete follow-up data. The primary outcome measure was the mean number of interruption-free nights per baby over the 12-week period. The authors did not report whether the groups were comparable at baseline. Effectiveness results The mean number of interruption-free nights per baby was (standard deviation, SD=20.25) for the behavioural intervention, (SD=22.06) for the educational intervention, and (SD=21.83) for the control group. The mean number of interruption-free nights gained was 3.20 (95% confidence interval, CI: ) for the behavioural intervention versus control, and 2.02 (95% CI: ) for the educational intervention versus control. The authors reported that the differences between the behavioural intervention and control groups were statistically significant at 11 and 12 weeks of age. However, they did not report the statistical test used or the p-value. Clinical conclusions The authors concluded that, compared with usual care, the behavioural intervention provided a small but significant additional benefit whereas the educational intervention did not. Measure of benefits used in the economic analysis The measure of benefits used was the number of interruption-free nights gained from the behavioural and educational interventions, relative to the control group. An interruption-free night was defined as a night in which the parents reported their baby was asleep continuously for at least 5 hours between 10 pm and 6 am. Direct costs The following direct costs were reported as the mean cost per baby for each intervention. The mother visits the health visitor at a clinic or surgery: the costs were 8.37 (behavioural), 9.81 (educational) and 6.93 (control). The health visitor or midwife visits the mother at home: the costs were (behavioural), (educational) and (control). The mother telephones the health visitor or midwife: the costs were 4.41 (behavioural), 4.77 (educational) and 4.48 (control). The mother visits the GP at the surgery: the costs were (behavioural), (educational) and 9.24 (control). The GP visits the mother at home: the costs were 8.75 (behavioural), 7.70 (educational) and (control). Page: 2 / 5

3 The total mean cost per baby for contact with the NHS was, therefore, for the behavioural intervention, for the educational intervention, and for the control. The costs were estimated from the actual resource use data collected from mothers in the trial, and also from additional surveys of health care professionals. The cost per hour for the health care professionals was derived using the national estimates of staff costs in the NHS. These included the following costs: wages and salaries; the employers' national insurance and superannuation contributions; pre and post-registration initial training; ongoing training and qualifications; clerical and administration costs; direct supervision and uniforms; indirect support services; and capital overheads and travel. The intervention costs comprised the mean time spent by the health visitors in explaining the interventions, and the cost of supplying the information pack. The authors reported the resource use and prices (unit costs) separately. Only the direct costs to the NHS were included, which was appropriate for the perspective chosen. The costs were not discounted due to the short timeframe of the study. Statistical analysis of costs The authors reported the SDs of the mean costs per group, and the 95% CIs of the mean differences in costs per group. No statistical tests of differences between the costs were reported. Indirect Costs The indirect costs of the interventions were not reported. Currency UK pounds sterling () and US dollars ($). The individual costs were only reported in UK pounds sterling (). The conversion rate and price year used were not reported. Sensitivity analysis A cost-acceptability analysis was used to estimate the probability that the behavioural and intervention groups were costeffective relative to the control group. This was conducted as a function of the critical cost-effectiveness ratios. Estimated benefits used in the economic analysis Over a 12-week period, the mean number of interruption-free nights gained per baby was 3.20 for the behavioural intervention versus control, and 2.02 for the educational intervention versus control. The authors did not report any adverse events. Cost results The mean cost per baby was for the behavioural intervention, for the educational intervention and for the control group. The mean incremental costs per baby were, therefore, 1.81 for the behavioural intervention versus the control group, and 8.32 for the educational intervention versus the control group. Synthesis of costs and benefits The incremental cost per interruption-free night gained was 0.56 for the behavioural intervention versus the control group, and 4.13 for the educational intervention versus the control group. A cost-acceptability curve was presented. This indicated that approximately 80% of the incremental cost-effectiveness ratios estimated for the behavioural intervention were less than 10, compared with approximately 60% of the incremental cost-effectiveness ratios for the Page: 3 / 5

4 educational intervention. The authors reported that the probability of the cost per interruption-free night being less than 0.56 for the behavioural intervention was Authors' conclusions The annual total cost to the NHS of infant crying and sleeping problems was substantial. In the cost-effectiveness analysis, the behavioural intervention incurred a small additional cost, and produced a small significant benefit at 11 and 12 weeks of age. The educational intervention incurred a small additional cost without producing a significant benefit. CRD COMMENTARY - Selection of comparators The authors compared both the behavioural and educational intervention strategies to existing services, which represented current practice within the UK NHS. You should decide if this is a widely used health technology in your own setting. Validity of estimate of measure of effectiveness The measures of effectiveness were estimated from a single randomised controlled trial. The authors reported that there was a 20 to 35% loss to follow-up between the groups. The authors did not provide sufficient detail on the comparability of the patient groups at baseline and the design of the trial. In addition, they did not report whether the statistical power of the trial sample size was sufficient to detect statistically significant differences. The methods used to assess the validity and robustness of the outcome results were also not described. It was not possible to assess whether the outcomes of the educational intervention and control groups were equivalent or not. There was insufficient detail to assess whether the initial study sample, or those with complete follow-up, was representative of the study population. The outcome data were collected by mothers completing prospective logs of the number of interruption-free nights per week. A sample of mothers (n=12) was asked to complete diaries of their babies nightly sleeping habits over 3 days. The diary and log data were consistent. However, the authors did not report whether the sample of diary data collected was sufficient to assess the accuracy, completeness and consistency of the log data. Validity of estimate of measure of benefit The benefits were estimated directly from the effectiveness analysis. The authors reported that the outcome measure of benefit focused on instances where the parents detected their babies waking at night, as it is parents who seek NHS help. There was insufficient information to assess the validity of the effectiveness data. The authors did not report whether there were any other adverse events associated with the interventions evaluated, or whether these were included in the measure of benefit. The measure of health benefit chosen did not include an assessment of the impact of the intervention on the health status, or health related quality of life, of the mother or baby. Validity of estimate of costs All the categories of cost relevant to the perspective adopted were included in the analysis. The costs and prices were reported separately. The authors did not report whether the costs of any adverse events were included. Other issues The authors were unable to make appropriate comparisons of their findings with those from other studies. This is because of the lack of research on the cost of infant crying and sleeping problems, and the cost-effectiveness of strategies for treating these problems. The issue of generalisability to other settings was not addressed. The study enrolled infants in the first 12 weeks of age and this was reflected in the authors' conclusion. Implications of the study The authors concluded that health care decision-makers need to decide whether the extra benefits of the interventions Page: 4 / 5

5 Powered by TCPDF ( are worth the additional costs. Source of funding Funded by the Department of Health, reference MCH Bibliographic details Morris S, St James-Roberts I, Sleep J, Gillham P. Economic evaluation of strategies for managing crying and sleeping problems. Archives of Disease in Childhood 2001; 84(1): PubMedID Indexing Status Subject indexing assigned by NLM MeSH Behavior Therapy /economics; Crying; Follow-Up Studies; Great Britain; Health Care Costs; Health Education /economics; Humans; Infant; Infant, Newborn; Prospective Studies; Sleep Wake Disorders /economics /therapy; State Medicine /economics; Treatment Outcome AccessionNumber Date bibliographic record published 31/05/2002 Date abstract record published 31/05/2002 Page: 5 / 5