Marcus Warnes Chief Operating Officer North Staffordshire CCG Morston House, The Midway Newcastle-under-Lyme Staffordshire ST5 1QG --- 31st July 2014 Dear Mr Warnes, Re: Proposed decommissioning of hearing aids services for people with mild and moderate hearing loss by North Staffordshire CCG The BSA is the pre-eminent learned Audiological Society in the UK. Its membership works in the full range of disciplines in the field of Audiology, predominantly in professional clinical practice, clinical and scientific research, but also in higher education. Its aims are to advance audiological research, learning, practice and clinical impact. The BSA has an important role in providing expert independent, evidence-based advice and is influential at a national level. We therefore believe that the BSA is well placed to advise clinical commissioning groups on the evidence base for the provision of hearing aids. Please find below the response from the BSA relating to this proposal. Comments have been provided against each to the factors where there is contention over scoring. For convenience we have indicated the score that the CCG has currently attributed to each of the scorecard factors, the maximum score and primary question from each factor. We have primarily referred to version 2.0 of the CCG’s Prioritisation Framework; at the technical meeting on 23rd July, CCG representatives stated that this was the version of the policy that is being used for consideration of this intervention. However, we have referred to the ‘notes on criteria and interpretation’ from version 2.1 as this material is only provided in the latter version. This response reflects our participation in an engagement event at Leek, email communications with the CCG, and a more recent technical discussion on 23rd July. The BSA has taken the opportunity to draw on expert knowledge from our membership to inform this response. 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] Factor 1. Magnitude of health improvement (CCG score = 12/40) To what extent does this intervention increase the health or life expectancy of users i.e. adding ‘life to years’ or ‘years to life’ --- We believe that the score of 12/40 is a gross underscore of the health gain to an individual with a mild or moderate hearing loss through this intervention. A UK Health Technology Assessment (1) found a significant improvement on the generic quality of life indicator the Health Utilities Index (HUI) of 0.075 (95% CI 0.038 to 0.112) for individuals fitted with hearing aids from mild losses onwards. Other studies (2,3,4) have reported HUI-3 improvements from hearing aids are 0.06, 0.12, and 0.08, respectively. There are also well established impacts of hearing aid use on condition specific measures (5, 6). Referring to the CCG’s notes on criteria and interpretation (page 14, document Ver 2.1), the question is asked ‘Are there appropriate measures relevant to the particular condition or patient group? Clearly this is the case for the intervention in question but this is not reflected in the scoring and is at odds with the CCG’s scoring guidance. One of the key issues in audiology is that the wider effects of a hearing loss, especially the loss in communication ability or social confidence, are not well represented in the primary generic questionnaires of health utility. For instance, none of the five questions in the EQ-5D relate to communication: one can be totally deaf and score exactly the same as someone with perfect hearing. Given the life-changing nature of many clinical interventions for hearing loss (such as a cochlear implant) we argue that the low score on these scales is due to an insensitivity of the scale rather than a low importance to people. The issue of generic and condition specific measures arose when NICE considered evidence to determine criteria for candidacy for cochlear implantation. Following an extensive review process, NICE was not dissuaded from providing national guidelines (7) that has rightly seen adult cochlear implantation supported by commissioners. We note that the incremental cost effectiveness ratios (ICERs) for cochlear implantation are less attractive compared to the intervention considered here, yet it is still recommended by NICE and funded throughout the UK Factor 2. Strength and quality of evidence (CCG score = 10/40) Is the evidence base robust and does it translate into a plausible effect for our local population? Our view is that there is a robust evidence base demonstrating benefit which is not reflected in the current score of 10/40. Referring to the CCG’s notes on criteria and interpretation (page 13), the NICE hierarchy of evidence is provided. The CCG’s current scoring of the intervention for this factor equates to level III/IV evidence (i.e., at the very lowest end of scoring evidence from experimental descriptive studies). This 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] appears greatly at odds with positive evidence from the quoted systematic review, RCTs and other trials. It is important to recognise that hearing aid technology and customising its use to meet the needs of individual patients has progressed significantly since the primary quoted review (5) was conducted in 2004. Many of these improvements have been prompted by service quality specifications/standards, and will feed through to progressive improvement to use, benefit and satisfaction attained by this intervention. --- Most RCTs of hearing aids compare their features or fittings (8). There are few RCTs investigating the effectiveness of hearing aids per se. This is because their benefits are long recognized and demonstrated, and in today’s research funding climate we doubt that any grant funder would fund a RCT to show the benefit of hearing aids. In many ways a hearing aid is the ‘best-proven’ intervention for mild/moderate hearing loss which in a UK context provides difficulties in performing an ethical RCT study. However, two available RCTs have demonstrated clear benefits of hearing aids to hearing-related quality of life (9, 10). Aside from the research evidence base, we believe that it also important for the CCG to consider practice-based evidence. Audiology has been at the forefront in the use of patient reported outcomes measures (PROMS) within service delivery. Extensive use of research validated PROMS is used to manage individual patients and monitor impact of interventions across cohorts of patients. Data such as from the Glasgow Hearing Aid Benefit Profile (11) will be available from the local services. For an established rather than a proposed service, we believe that the prioritisation scorecard should attach substantial value to practice-based and local evidence. Indeed, it is the routine engagement with patients and their reporting on their successful use of hearing aids and the consideration of empirical PROMs data that convinces Audiologists that fitting hearing aids to people with mild and moderate hearing loss is very effective. Moreover, patients are convinced too. Factor 5. Prevention of future illness (CCG score =0/40) Does this service prevent the occurrence of a particular health or health related conditions (e.g. lifestyle intervention? To score this factor as 0/40 is entirely inappropriate given the impact of delayed amplification on hearing impairment and impact of hearing on cognitive ability. It is well recognised that providing hearing aids to someone early is more beneficial than waiting. The UK Health Technology Assessment (1) reported that ‘those identified early had greater benefit than those of the same age and hearing impairment who were fitted with hearing aids later’ (p. 145). This reflects in part age-related co-morbidities (eg reduced manual dexterity) impacting on use, satisfaction and benefit from hearing aids, but also likely neuro-degenerative effects associated with under use of the auditory pathway. Therefore, continued auditory stimulation and familiarization with 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] hearing aids for those with mild and moderate losses can be regarded as preventing more disabling hearing impairment if hearing aids were provided many years later – as would be the case if the proposal were implemented. There is a clear secondary impact too: the proposed withdrawal of hearing aid fitting to those with mild and moderate hearing loss would impact adversely on those ultimately presenting for first hearing aid fitting later in life with severe losses. --- There is increasing evidence of an independent association between hearing loss, declining cognitive function (12) and dementia (13). There is also evidence of the benefit of hearing aids on communication (see above). Consequently, a reasonable hypothesis is that hearing aids will slow the rate of cognitive decline that would ordinarily lead to a diagnosis of dementia. This is having an important influence on the research field: it has catalyzed it into a ‘hot topic’, and many groups are now studying hearing loss and cognition. A Cochrane review is underway at the University of Manchester to formally assess the evidence. Given the scale of impact and burden of dementia on individuals, their carers and society, as well as its current prominence in on the health-care planning agenda, it would be quite imprudent at this time for the CCG to withdraw an intervention that has a positive impact on communication ability in the elderly. Factor 6. Supports people with existing health problems (CCG score = 13/40) Does this service improve health measures in people with long-term conditions? The score of 13/40 fails to acknowledge the impact of amplification for people with existing health conditions such as depression (9) and dementia (14). This is because the score card does not represent the tertiary preventative effect of hearing aid use: if people can hear and understand better then they can manage their other morbidities so much better, as well as reduce the disability and handicap they might develop in the future. It also reduces barriers to communications with their doctors or other healthcare providers: indeed, one could argue that good communication is fundamental to all health care. Referring to the Prioritisation Scorecard completed by the CCG in Feb 2014, we note a list of patient groups that can be given urgent priority (page 1). We presume that such patients with mild/moderate hearing loss would be fitted with hearing aids. In particular, we note one group is ‘individuals resident on in-patient wards where ability to communicate is adversely affecting the implementation of care plans and discharge’. This highlights the impact of hearing loss on other elements of healthcare delivery. It also illustrates a misunderstanding of the practicalities of hearing aid provision and the pitfalls of defining specific rationing criteria – in this case attempting to react to the adverse consequences of hearing loss on other health interventions rather than being pro-active, providing improved communication ability before the event. Hearing aids should be available to support all with mild/moderate hearing loss to i) mitigate the impact of other health problems (eg, depression) and ii) optimise outcomes of other healthcare interventions. 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] Factor 7. Addresses health inequality (CCG score = 0/20) Does this service reduce/narrow identified inequalities or inequities in the local population? --- A score of 0/20 does not reflect the disproportionate impact on the local population, as the impact of hearing loss is not randomly spread; it predominates in the elderly, those who have had more noisy work associated with lower paid occupations (15) and those from lower socio-economic groups (16). As a group they may be expected to predominate in areas of deprivation. This provides for an underlying health inequality associated with hearing loss. At a local level, the mix of people accessing free NHS hearing aid services is further weighted towards those who would be unable to purchase private hearing aids. Withdrawal of NHS hearing aids would leave individuals faced with the option of unmanaged hearing loss with adverse impact on their communication, health and well-being, or payment for a private hearing aid. Withdrawal of NHS free hearing aids services would increase inequalities and also lead to inequity in health. Lifetime noise exposure at work has been established for decades as a primary factor in hearing loss (17). Given the rich industrial heritage of the potteries in the North Staffs area, we would expect that there could be a relatively high proportion of hearingimpaired people in the area. We do not know of any detailed surveys of the prevalence of hearing loss at a local level, so estimates here can only be based upon national figures such as the Census (18). Ensuring an adequate provision of hearing aids for these people will be of great assistance to the local population. Factor 8. Delivers national and or local requirements/targets 0/40 Does this service or intervention support the PCT (CCG) in delivering the national and local ‘must dos’? A score of 0 for this factor is inappropriate given the relevance of mild and moderate hearing loss to national and local plans and policies. Hearing impairment is within the top 20 health conditions identified in the WHO Global Burden of Disease initiative (19). In view of the release of the Dept of Health and Public Health England Action Plan on Hearing Loss in the near future (anticipated September 2014), we believe that it would be imprudent for the CCG to proceed with this proposal – the CCG would likely find it position at odds with the direction of travel set by a key national guidance document. There are a number of local policies/initiatives that this proposal would compromise. One example is the Staffordshire Strategic Partnership’s goal to ‘positively support the ageing population’ (20). The Staffordshire Health and Wellbeing Board’s five year plan, 2013-2018, states ‘By helping people live independently and be in control of their lives, we can support older people to be healthy and well’ (Page 16). Hearing aid provision is a proven intervention technology that does support older people. At the recent technical discussion meeting CCG representatives indicated that a range of health interventions 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] could be construed as impacting on these initiatives. We concur, but we see this is a reason to acknowledge such in scoring rather than for the CCG to ignore on the basis of generality. What is the value of a local policy objective if it is not acknowledged or enabled by linking with the healthcare prioritisation process? Use of the Modified Portsmouth Scorecard and Process of Prioritisation --- Aside from the above comments relating to the scoring of the intervention against the available evidence for individual factors, we also have more general concerns at the use of the Portsmouth Scorecard for decommissioning by the CCG, and specifically, its adaptation, interpretation and threshold setting. Has the scoring and threshold setting been calibrated against other existing health interventions? In justifying scoring of individual criteria the CCG representatives have referred to a need for consistency of approach when appraising other health interventions. The CCG’s policy on prioritisation refers to a systematic review of commissioned services to produce a ranked list. We would like to see evidence that this is the case, in order to gauge consistency of approach. We ask that the CCG provides comparative scores for a range of other health interventions with equivalent analysis to that offered for this intervention. It is our concern that the process of disinvestment is being learnt/adapted by the CCG as it considers this proposal on a piecemeal basis, rather than through a coherent comparative process across a range of health interventions. Summary The evidence supporting the effectiveness of hearing aids for people with mild and moderate hearing loss is overwhelming. This intervention is in the best interests of the health of people in North Staffordshire. The BSA firmly believes that the proposal should be withdrawn. Failing that, a re-scoring should be performed, adequately reflecting the additional information supplied by the BSA, (and other organisations), the latest national guidelines and as part of a comparative, open systematic review of commissioned services. A response to this letter is requested. The BSA remains keen to engage further with the CCG, maintaining a dialogue to ensure a well informed outcome in the best interests of hearing impaired people in North Staffordshire. Your sincerely John Day BSA Trustee, on behalf of BSA Council. 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] Appendix: Key References 1. Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. 2007. Acceptability, benefit and cost of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007; 11(42) 2. Barton GR, Bankart J, Davis AC, Summerfield QA. Comparing utility scores before and after hearing-aid provision : results according to the EQ-5D, HUI3 and SF-6D. Appl Health Econ Health Policy. 2004;3(2):103-5. --- 3. Grutters J P, Joore M A, van der Horst F, Verschuure H, Dreschler W A, Anteunis L J. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007; 16:1439–1449. 4. Swan IR, Guy FH, Akeroyd MA. Health-related quality of life before and after management in adults referred to otolaryngology: rospective national study. Clin Otolaryngol. Feb 2012; 37(1): 35-43 5.Chisolm TH et al. A systematic review of health-related quality of life and hearing aids: final report of the American Academy of Audiology Task Force on the health-related quality of life benefits of amplification in adults. J. Am. Acad. Audiol. 2007; 18:151-83 6. Bainbridge K and Wallhagen M. Hearing Loss in an Aging American Population: Extent, Impact, and Management. Annu Rev Public Health. 2014; 35:139–52 7. UK Cochlear Implant Study Group. Criteria of candidacy for unilateral cochlear implantation in postlingually deafened adults. I: Theory and measures of effectiveness. Ear Hear 2004; 25:310-35 8. Metselaar M, et al. Self-reported disability and handicap after hearing-aid fitting and benefit of hearing aids: comparison of fitting procedures, degree of hearing loss, experience with hearing aids and uni- and bilateral fittings. Eur Arch Otorhinolaryngol. 2009; 266:907–917 9. Mulrow C D et al. Quality-of-Life Changes and Hearing Impairment: A Randomized Trial. Ann Intern Med. 1990;113(3):188-194. 10. Yueh B et al. Randomized Trial of Amplification Strategies001 – Arch Otol Head and Neck Surgery, vol 127. 11. Gatehouse, S. A self-report outcome measure for the evaluation of hearing-aid fittings and services, Health Bulletin, 1999; 57:424-436 12. Lin F, et al. Hearing Loss and Cognitive Decline in Older Adults. JAMA Intern. Med. 2013; 173: 293-99 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected] 13. Lin F, et al. Hearing loss and incident dementia. Archives of Neurology, 2011; 68(2):214-220 14. Palmer, C. V., Adams, S. W., Bourgeois, M., Durrant, J., & Rossi, M., 1999. Reduction in caregiver-identified problem behaviors in patients with Alzheimer disease posthearing-aid fitting. J Speech Lang Hear Res, 42, 312-328 15. Lutman, ME & Spencer H S, Occupational noise and demographic factors in hearing. Acta Otolryngol Suppl, 476, 74-84. --- 16. Ecob R, et al. Is the relationship of social class to change in hearing threshold levels from childhood to middle age explained by noise, smoking, and drinking behaviour? International Journal of Audiology. 2008. 47: 100-108 17. Taylor W, Pearson J, Mair A, Burns W. Study of noise and hearing in jute weaving. J Acoust Soc Am. 1965;38:113-20. 18. Foreman K , Akeroyd M A, Holman J A. Updated calculations of the number of adults in England, Scotland and Wales with a hearing loss MRC. 2013. Institute of Hearing Research, Scottish Section poster presentation at BSA Conference. 19. Murray CJ, et al. UK health performance: findings of the Global Burden of Disease Study The Lancet. 2013. Published on line March 5. http//dx.doi.org/10.1016/S01406736(13)60355-4 20. http://www.staffordshirepartnership.org.uk/About-us/Priorities.aspx 80 Brighton Road, Reading, RG6 1PS Tel: 0118 966 0622 Fax: 0118 935 1915 www.thebsa.org.uk [email protected]
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