Capturing what matters: updating NICE methods guidance on measuring and valuing health.

In July 2019, the National Institute for Health and Care Excellence (NICE) initiated a major review of its health technology evaluation methods to update its methods guide. This update has recently concluded with the publication of its health technology evaluation manual in January 2022. This paper reports the methods and findings of the review in relation to the recommended approach to use for the measurement and valuation of health-related quality of life (HRQoL) in submissions to NICE. Issues related to (i) the methods to use when NICE's preferred measure (EQ-5D) is not appropriate or not available; (ii) adjusting health state utility values over time to account for age; (iii) measuring and valuing HRQoL in children and young people; and (iv) including carers' QoL in economic evaluations were included in this review. This commentary summarises the methods used to undertake the review, its findings, and the changes to NICE methods that were proposed based on these findings. It also outlines topics where further research is needed before definitive methods guidance can be issued. The broad proposals described here were subject to a public consultation in 2020 and a further consultation on the updated methods guidance was completed in October 2021 before the publication of the manual in January 2022.

The effect of early auditory experience on the spatial listening skills of children with bilateral cochlear implants.

OBJECTIVES: Both electrophysiological and behavioural studies suggest that auditory deprivation during the first months and years of life can impair listening skills. Electrophysiological studies indicate that 3½ years may be a critical age for the development of symmetrical cortical responses in children using bilateral cochlear implants. This study aimed to examine the effect of auditory experience during the first 3½ years of life on the behavioural spatial listening abilities of children using bilateral cochlear implants, with reference to normally hearing children. Data collected during research and routine clinical testing were pooled to compare the listening skills of children with bilateral cochlear implants and different periods of auditory deprivation. METHODS: Children aged 4-17 years with bilateral cochlear implants were classified into three groups. Children born profoundly deaf were in the congenital early bilateral group (received bilateral cochlear implants aged ≤3½ years, n=28) or congenital late bilateral group (received first implant aged ≤3½ years and second aged >3½ years, n=38). Children with some bilateral acoustic hearing until the age of 3½ years, who subsequently became profoundly deaf and received bilateral cochlear implants, were in the acquired/progressive group (n=16). There were 32 children in the normally hearing group. Children completed tests of sound-source localization and spatial release from masking (a measure of the ability to use both ears to understand speech in noise). RESULTS: The acquired/progressive group localized more accurately than both groups of congenitally deaf children (p<0.05). All three groups of children with cochlear implants showed similar spatial release from masking. The normally hearing group localized more accurately than all groups with bilateral cochlear implants and displayed more spatial release from masking than the congenitally deaf groups on average (p<0.05). CONCLUSION: Children with bilateral cochlear implants and early experience of acoustic hearing showed more accurate localization skills, on average, than children born profoundly deaf.

Estimates of the cost-effectiveness of pediatric bilateral cochlear implantation.

OBJECTIVES: Objectives were, first, to estimate the additional number of quality-adjusted life years (QALYs) gained by deaf children from bilateral compared with unilateral implantation (DeltaQ); second, to estimate the additional cost to the healthcare system in the United Kingdom for providing bilateral compared with unilateral implantation (DeltaC); and, third, to compare the values of incremental net benefit (INB), rDeltaQ - DeltaC, with criteria used by policy makers in deciding whether to adopt health technologies. In England and Wales, the healthcare policy-making body must be satisfied that the INB is positive for a maximum value of r of pound30,000 (the "net-benefit" criterion). Policy makers may also require the likelihood that the technology is cost-effective to exceed 0.8 (the "likelihood" criterion). DESIGN: An opportunity sample of 180 informants, composed of clinicians/researchers, students, and parents, valued the quality of life of a hypothetical child born profoundly deaf. The child was described in written vignettes as achieving typical outcomes with no implant, a unilateral implant, a unilateral implant with benefit from a contralateral acoustic hearing aid, or bilateral implants. Valuations were made using the time trade-off (TTO) and a visual analog scale (VAS). A decision model was constructed to describe events related to implantation that could occur over a child's lifetime after the decision to implant. A cost and a probability were associated with each event. Monte Carlo simulations modeled the management of cohorts of 3000 children and estimated a value of DeltaC for each child. An increment in quality of life was sampled with replacement from the appropriate distribution of informants' valuations to estimate a value of DeltaQ for each child. The minimum value of r for which the average INB was positive was calculated to test the net-benefit criterion. The proportion of simulations for which the INB was positive when r was pound30,000 was calculated to test the likelihood criterion. RESULTS: Estimates of the cost-effectiveness of unilateral implantation aligned closely with published estimates, giving credibility to analyses of bilateral implantation. Based on TTO data (VAS data in parentheses), bilateral implantation was associated with an increment in quality of life of +0.063 (+0.076), yielding 1.57 (1.87) additional QALYs at a cost of pound34,000. Net benefit was positive, provided that pound21,768 ( pound18,173) could be spent to gain a QALY. If pound30,000 could be spent, the probability that bilateral implantation is cost-effective was 0.480 (0.539). Thus, the net-benefit criterion, but not the likelihood criterion, was met in both analyses. The net-benefit criterion was also met in analyses based on data from the three groups of informants individually. CONCLUSIONS: Groups of adults varying widely in age and life experience perceived sufficient additional quality of life from giving children two implants rather than one to mean that bilateral cochlear implantation is possibly a cost-effective use of healthcare resources in the UK. Wide variation in valuations within the groups of informants means that considerable uncertainty surrounds that conclusion. Further data on the costs and benefits of bilateral implantation are needed to resolve the uncertainty.