Proposals to NICE for revised eligibility criteria

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Presentation transcript:

Proposals to NICE for revised eligibility criteria Debi Vickers UCL Speech, Hearing and Phonetic Sciences Carl Verschuur Southampton Auditory Implant Programme Padraig Kitterick Nottingham Biomedical Research Unit National Cochlear Implant Users Association, 2018

Members of British Cochlear Implant Group (BCIG) said that candidacy issues are the most important factor that BCIG council should work on

Established BCIG candidacy working group Aim: to acquire and evaluate evidence on implant candidacy Members: Debi Vickers, Padraig Kitterick, Carl Verschuur, Carolina Leal, Louise Jenkinson Compile evidence on the BCIG website: http://www.bcig.org.uk/candidacy-action/ Update BCIG council Work with the Adult Cochlear Implant Alliance, providing evidence to support candidacy campaign

NICE guidance NICE guidance (2009) based on work published in 2004 Data from adults received implants between 1988 and 2000 Adults had poor hearing (PTA = 115 dB HL in better ear!) No data from children Patients implanted after NICE guidance likely to have: Larger and healthier population of nerve cells Greater access to hearing in non-implanted ear UKCISG (2004) Ear Hear, 25, 310-335

Justification for work NICE may update one of the recommendations in TAG166 Evidence suggests that eligibility criteria in section 1.5 no longer reflect clinical practice and should be updated As 1.5 is not linked to 1.1 to 1.4, we propose an update without the need for a Multiple Technology Appraisal Instead, the update of recommendation 1.5 would take place via consultation with relevant stakeholders Technology appraisal guidance

Goals of work To determine appropriate audiometric thresholds for future cochlear implant (CI) candidacy criteria in UK To determine most appropriate frequencies to include To prepare recommendations for feedback to NICE To determine the best speech test to use The criteria are intended as a guide to clinicians, and do not remove the need for assessment by a MDT prior to implantation.

Sources of Evidence Findings ‘Longitudinal comparison of outcomes for children with bilateral hearing aids (HAs) or bilateral CIs’ CII supplement on ‘Issues in CI candidacy’ Adults service evaluation Consensus meeting on appropriate candidacy criteria Literature review on important speech frequencies

Rosie Lovett, Quentin Summerfield & Deborah Vickers EVIDENCE SOURCE 1 Longitudinal comparison of outcomes for children with bilateral hearing aids (HAs) or bilateral CIs Rosie Lovett, Quentin Summerfield & Deborah Vickers For the past three years, I’ve been coordinating a research project that was run by UCL, in collaboration with NHS hospitals and the University of York. Your department kindly helped to recruit participants into the study. Today, I’m going to describe the background to the study and explain our results.

Threshold criteria Mild hearing impairment Profound hearing impairment In this talk, I’ll be using the phrase ‘criteria of candidacy for cochlear implantation’. I thought I’d start by defining what that means! So the horizontal blue line represents the spectrum of HI.

Threshold criteria Hearing aids Cochlear implants Mild hearing impairment Profound hearing impairment Intuitively, one would expect that children with mild to moderate hearing impairment should be provided with HA, and those with profound HI with CI.

Criterion of candidacy Threshold criteria Hearing aids Cochlear implants Mild hearing impairment Profound hearing impairment The criteria of candidacy can be represented by the vertical red line- children whose hearing is worse than the criteria are offered cochlear implants, and children with hearing better than the criteria are offered hearing aids. Specified by unaided PTA. Criterion of candidacy

Research design 43 children with bilateral hearing aids Mild to profound hearing impairment 28 children with bilateral cochlear implants Severe to profound hearing impairment

Research design 43 children with bilateral hearing aids Mild to profound hearing impairment 28 children with bilateral cochlear implants Severe to profound hearing impairment Assessment one Children aged 3 to 6 years Assessment two Children aged 4 to 7 years

Outcome measures Speech perception in quiet Speech perception in noise Speech perception in babble Language skills Sound-source localisation Health-related quality of life Chear Auditory Perception Test Courtesy of Dr Josephine Marriage

Outcome measures Speech perception in quiet Speech perception in noise Speech perception in babble Language skills Sound-source localisation Health-related quality of life

Two-frequency audiogram Summary Outcome measure Two-frequency audiogram Speech perception in quiet 79-83 Speech perception in noise 88-92 Speech perception in babble 78-80  Unaided two-frequency audiogram ≥ 80 dB HL bilaterally Lovett, Vickers, Summerfield (2015) Ear Hear

EVIDENCE SOURCE 2 http://www.tandfonline.com/toc/ycii20/17/sup1

Residual hearing Need to consider fitting hearing aids for contralateral ear With improved techniques for preserving hearing, this is a critical area of consideration Candidacy needs to be appropriate for Electroacoustic stimulation candidates Assymetric losses and unusual configurations Fielden, 2016; Kitterick and Lucas 2016; Sadadcharam, 2016; Verschuur, 2016; Wilson, 2016;

Audiometric criteria too restrictive Hearing aids Cochlear implants Mild hearing impairment Profound hearing impairment The criteria of candidacy can be represented by the vertical red line- children whose hearing is worse than the criteria are offered cochlear implants, and children with hearing better than the criteria are offered hearing aids. Specified by unaided PTA. Criterion of candidacy Hanvey et al, 2016; Wilson et al., 2016; Leal et al., 2016

Audiometric criteria too restrictive Hearing aids Cochlear implants Lower cut-off to 80 dB HL Need to consider unusual audiograms Mild hearing impairment Profound hearing impairment The criteria of candidacy can be represented by the vertical red line- children whose hearing is worse than the criteria are offered cochlear implants, and children with hearing better than the criteria are offered hearing aids. Specified by unaided PTA. Criterion of candidacy Hanvey et al, 2016; Wilson et al., 2016; Leal et al., 2016

Compare to other countries

Use of guidelines Greater flexibility in using criteria when CIs are privately or locally funded National guidelines associated with National funding

Audiometry A range audiometric criteria (bilaterally): Australia - mean thresholds > 70 dB HL above 1.5 kHz Sweden - 4FA (0.5, 1, 2 and 4 kHz) ≥70 dBHL (best ear) Finland – 3FA (0.5, 1 and 2 kHz) ≥ 75 dB HL Belgium - mean thresholds > 85 dB HL at .5, 1.0, and 2.0 kHz UK – thresholds > 90 dB HL at both 2 and 4 kHz Typical pattern - mean thresholds > 70–80 dB HL above 1 kHz

Speech testing 85% countries have adult speech-based criteria 76% use word tests in assessment

EVIDENCE SOURCE 3: Adult Service Evaluation Set up adult service evaluation to : Has current day performance improved since criteria derived Are word or sentence tests best pre-operative assessment

UK Adult Service Evaluation BCIG service evaluation with 10 UK centres Assessments in adult CI users at: pre-implant, 3 months post switch on 9-12 months switch on Collecting: Word scores (ABs); scored by word and phoneme BKB sentences; scored by key word correct

UK Adult Service Evaluation Determine whether current day performance has improved Mean scores at both 3 and 9-12 months higher than 55%

UK Adult Service Evaluation Determine whether word or sentence tests are best pre-operative assessment

UK Adult Service Evaluation Strong relationship between BKB sentences and AB scores (both word and phoneme) A BKB score of 50% is equivalent to an AB word score of 19% and an AB phoneme score of 35% If moved BKB criteria to 70% the approximate AB word score would be 27% and AB phoneme score of 50% Current criteria Suggested change

Candidacy consensus EVIDENCE SOURCE 4 https://www.cicandidacy.co.uk/ 160 stakeholders provided opinions on the candidacy criteria in the UK 41 Individuals from 30 stakeholder organisations completed questionnaires and voted on candidacy statements https://www.cicandidacy.co.uk/

Appropriateness analysis Respondents reviewed clinical scenarios (600) to determine if appropriate for implantation and also if necessary Appropriate (benefits outweigh any harms) Necessary (improper care not to provide implantation) ≥ 70 dB HL ≥ 80 dB HL > 90 dB HL Type of scenarios captured by criteria: Appropriate and necessary 96% Appropriate but unnecessary 4% Inappropriate 0% 80dB HL captures an additional scenarios where it is appropriate but not necessary

Appropriateness analysis Respondents reviewed clinical scenarios (600) to determine if appropriate for implantation and also if necessary Appropriate (benefits outweigh any harms) Necessary (improper care not to provide implantation) ≥ 70 dB HL ≥ 80 dB HL > 90 dB HL Type of scenarios captured by criteria: Appropriate and necessary 97% 96% Appropriate but unnecessary 3% 4% Inappropriate 0% 80dB HL captures an additional scenarios where it is appropriate but not necessary

Appropriateness analysis Respondents reviewed clinical scenarios (600) to determine if appropriate for implantation and also if necessary Appropriate (benefits outweigh any harms) Necessary (improper care not to provide implantation) ≥ 70 dB HL ≥ 80 dB HL > 90 dB HL Type of scenarios captured by criteria: Appropriate and necessary 76% 97% 96% Appropriate but unnecessary 12% 3% 4% Inappropriate 0% 80dB HL captures an additional scenarios where it is appropriate but not necessary

Literature on Important Speech Frequencies EVIDENCE SOURCE 5 Literature on Important Speech Frequencies All configurations of losses should be catered for Retain two-frequency rule but selected from a range Low frequency dead regions have devastating impact on speech understanding Crucial speech frequencies between 750-3000 Hz Transmit vowel formants Slightly lower for sentences and running speech Majority of other countries consider lower frequencies Vinay et al. (2008); Kates 2013

Recommendations to NICE Amend hearing threshold criteria to ≥80dBHL at two or more frequencies from 500Hz, 1000Hz, 2000Hz, 3000Hz and 4000Hz bilaterally without acoustic hearing aids. Amend speech criteria for adults to a phoneme score of <50% on the Arthur Boothroyd (AB) monosyllabic word test For children retain the rule that, speech, language and listening skills less than expected for age and cognitive ability For all candidates, the multidisciplinary clinical team should consider that cochlear implantation is likely to provide additional benefit beyond conventional hearing aids.

Thank you d.vickers@ucl.ac.uk