1.3 Bases conceptuales
1.3.5 Medios de Rehidratación
Main findings
This is the first economic evaluation of silk therapeutic garment use in children with moderate to severe eczema. The economic analysis extends the clinical analysis to show that silk garments in addition to standard care are unlikely to represent value for money for the NHS. In terms of the costs, the additional costs of providing silk garments to intervention participants were not recouped through cost savings from lower use of wider health-care resource items nor from families in terms of reduced out-of-pocket costs or from employers in terms of reduced time off work by parents caring for their child with eczema. In terms of outcomes (when looking at patient-assessed health-related quality of life), although the ADQoL showed a very small, non-significant, positive benefit in terms of QALYs in favour of silk garments, this was not
0 200 400 Cost (£) 600 800 –0.01 0.00 0.01 0.02
Incremental QALYs (EQ-5D-3L) FIGURE 17 Incremental cost-effectiveness plane (main carer EQ-5D-3L).
0 250 500 750 Cost (£) 1000 1250 1500 –0.03 –0.02 –0.01 0.00 0.01
Incremental QALYs (CHU-9D) FIGURE 18 Incremental cost-effectiveness plane (CHU-9D).
sufficient to outweigh the higher costs of providing silk garments. The CHU-9D showed a very small non-significant decrease in QALYs (suggesting worse health) in the intervention arm. When coupled with the higher costs, this suggests that silk garments do not represent value for money for the NHS. The small, non-statistically significant, differences found when estimating QALYs (using the different instruments) suggest that the difference between intervention and usual care groups is negligible and may have been due to chance.
The result of this within-trial cost-effectiveness study also provides an indication of the cost of treating moderate to severe eczema to the NHS. Over a 6-month period, health-care costs were in the region of £345 (SD £647.40) per child (using 2014/15 costs and excluding the cost of silk garments). In addition, the reported personal costs and time lost from work/school as a result of eczema were considerable and, provide important data to inform studies on the societal impact of this condition.
Strengths and weaknesses
Given the clinical result, it could have been argued that an economic evaluation was unnecessary.
However, resource use and quality-of-life data were collected alongside the trial, and these results provide useful data to inform future studies and decisions regarding health commissioning.
The study did not explicitly ask families to record how much time they spent applying treatments for their child’s eczema. Were a treatment to be effective at reducing disease severity, it could conceivably reduce the amount of time a parent or child spends applying/taking medications and it might be important to capture this effect from a family perspective in future studies.
The study attempted to measure QALYs for the main carer in addition to the child. Our approach had limitations because children may have also lived with another parent or carer in addition to siblings, and we did not seek to capture the health-related quality-of-life effects of these extended family members. It is unclear how best to capture the wider impacts of eczema within a family in an economic evaluation. Further research looking at whose QALYs to capture, how to aggregate QALYs estimated for patients, carers and siblings, and how to present such results is needed.64However, given that this study found no
difference in effect between treatment arms, the results are unlikely to be sensitive to the assumptions made in relation to such‘beyond the patient’effects.64
Conclusion
This economic evaluation shows that in children with moderate to severe eczema, silk garments do not offer value for money to the NHS.
Chapter 5
Nested qualitative study
T
he value of using mixed qualitative and quantitative research methods in trials is increasingly being acknowledged,70particularly when investigating complex health-related topics.71In the CLOTHES trialwe have been mindful that the qualitative work is more than an adjunct to the main trial; it has been used to elucidate a deep understanding of the‘what’,‘why’and‘how come’of participants’beliefs and behaviours.72This nested qualitative study was conducted by colleagues at the University of Hull, who
were not aware of the treatment allocation of the children involved. The results of this nested qualitative study were collected and analysed separately. The results were not revealed to the rest of the trial team until the data collection and analysis of the main trial results were complete, at which point the results of the qualitative study were used to inform interpretation of the trial findings.
It is now widely accepted that when children are the likely end users of a product under investigation, researchers should consult them directly, rather than depending on second-hand reports from adults.73
In this chapter we have used the term eczema rather than AE in order to reflect the language used by the parents and children.
The purpose of the qualitative component of the CLOTHES trial was to:
1. qualitatively examine participants’experiences of using silk garments for the treatment of eczema 2. examine barriers and motivators to prescribing silk garments from the perspectives of clinicians
and commissioners. Specific objectives were to:
1. explore factors that might influence the use of silk garments in everyday life
2. examine parent and child views on the feasibility and acceptability of using silk garments 3. explore parent and child experiences of using silk garments
4. examine barriers and motivators to prescribing silk garments from the perspectives of clinicians and commissioners.
This report is divided into three sections: 1. children’s focus groups and interviews 2. parent interviews and focus groups 3. clinician and commissioner interviews.
For each of the three elements, a generic qualitative research method was used.74The research team
comprised three nurse researchers, all of whom were aware of their own potential impact on the study. To ensure rigour, the following steps were taken: preconceived beliefs were acknowledged prior to data collection; each researcher used a reflective log to record their own thoughts; researcher understandings were checked with participants at the end of each episode of data collection; and analysis was conducted independently and then as a team.
The study was approved by Nottingham Health Research Authority East Midlands–Nottingham 1 Research Ethics Committee (13/EM/0255). Ethical guidelines on research with children were followed.75All
participants gave written or verbal consent or assent depending on their age and on whether the data collection was in person or over the telephone.