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Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Mapping of potential evidence sources for the Prudent Healthcare Project: Effectiveness of interventions for hearing loss For further information please contact: Public Health Wales Observatory, 36 Orchard Street, Swansea SA1 5AQ Tel: 01792 607331 E mail: [email protected], [email protected] 1 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Introduction Evidence mapping is used to provide an understanding of the extent and distribution of available evidence, identify and sign-post to key evidence sources. Evidence maps do not provide a synthesis of available evidence but indicate the source and nature of relevant evidence and where there may be knowledge gaps. They provide a springboard for evidence review and synthesis for more focussed questions. The framework which has been used to map available evidence relating to the Prudent Healthcare project priority topics is based on that put forward by the Bevan Commission report1. Due to the tight time constraints for preparing the evidence maps the search conducted was restricted to secondary and tertiary level sources (systematic reviews and guidelines) and not primary research. It is important to note that as the included sources are all reviews of some type, they are not independent, meaning, they may have drawn on the same sets of primary studies. Evidence sources included in the map have not been subject to formal critical appraisal. The ‘Status of Source’ statements provide a guide as to the likely robustness (reliability) of the source given the methodology employed by the source authors. It is essential that the source is directly accessed and reliability fully assessed before use of the source findings/recommendations on effectiveness or efficiency to inform decision-making regarding possible elimination or substitution of any intervention. A protocol detailing the methodology followed for the evidence mapping process and full search details are available on request. Background documents Relevant Welsh documents 1. Health Foundation, 2012. Operational research modelling: transferring ENT/audiology services into a community setting- SHINE 2012 , Available at: http://www.health.org.uk/areas-of-work/programmes/shine-twelve/related-projects/cardiff-and-vale-university-health-board/ 2. Jader L, 2006. Access Project 2009 - Predicted Future Changes in General Surgery and ENT in Wales. Cardiff: NPHS. Available at: http://nww2.nphs.wales.nhs.uk:8080/HealthServiceQDTDocs.nsf/Public/C488D7043F9AD1128025722C004F63FE/$file/Horizon%20Scanning%20Report %20(Gen%20surgery%20%20ENT)%20for%20Project%202009%20(3).pdf?OpenElement 1 Simply Prudent Healthcare – achieving better care and value for money in Wales – discussion paper Mansel Aylward, Ceri Phillips, Helen Howson. December 2013. 2 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss 3. Public Health Wales Observatory, 2010. Drainage of middle ear and grommet insertion in Variation in Elective Surgery Procedures across Wales. Cardiff: Public Health Wales. Available at: http://nww2.nphs.wales.nhs.uk:8080/PubHObservatoryProjDocs.nsf/61c1e930f9121fd080256f2a004937ed/2ece58ea6212e8d3802577ea003cf6fe/$FIL E/Variation%20in%20elective%20procedures%20across%20Wales%20v1%2026112010.doc 4. Public Health Wales, 2014. Otitis Media with Effusion Grommets – INNU. Available at: http://howis.wales.nhs.uk/sitesplus/888/page/48748 5. Public Health Wales, 2014. Newborn hearing screening Wales , Available at: http://www.newbornhearingscreening.wales.nhs.uk/ 6. Webb M, 2008. Rapid review of the evidence on the effectiveness of combined approach tympanoplasty for cholesteatoma. Cardiff: NPHS. Available at: http://nww2.nphs.wales.nhs.uk:8080/HealthServiceQDTDocs.nsf/Public/72030DB3938E81598025764900394468/$file/CAT%20doc%20Final.doc?OpenE lement 7. Welsh Office. Direct referral to audiology clinics. Cardiff: WO; 1996. Available at: http://wales.gov.uk/docs/phhs/publications/wsacguidance/091015audiologyen.pdf 8. Welsh Assembly Government. Quality Standards for Paediatric Audiology (Wales). Cardiff: WAG; 2010. Available at: http://wales.gov.uk/docs/dhss/publications/100421qulaitystandardspaediatricaudiologyen.pdf 9. Welsh Health Specialised Services Committee. Cochlear Implants - INNU. 2006. Available at: http://howis.wales.nhs.uk/sitesplus/888/page/52483 Documents of general relevance 1. 2011 Annual Evidence update on Hearing disorders. 2011. NHS Evidence Available at: https://arms.evidence.nhs.uk/resources/hub/35907/attachment 2. Audiology Improvement Programme. Pushing the boundaries: Evidence to support the delivery of good practice in audiology. NHS Improvement; 2010. Available at: http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=2&cad=rja&uact=8&ved=0CDEQFjAB&url=http%3A%2F%2Fsystem.imp rovement.nhs.uk%2FImprovementSystem%2FViewDocument.aspx%3Fpath%3DAudiology%2FNational%2Fwebsite%2FPushing%2Bthe%2BBoundaries. pdf&ei=O-EdU8PUNdOQhQefv4CoAw&usg=AFQjCNGVeMu88kQqEEw1qEdE1UypOzAvzw 3 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss 3. Centers for Disease Control and Preventions, 2014. Hearing loss in children. Available at: http://www.cdc.gov/ncbddd/hearingloss/ 4. Centers for Disease Control and Preventions, 2014. Noise and hearing loss prevention. Available at: http://www.cdc.gov/niosh/topics/noise/ 5. ENT UK. ENT Services 2008 The Provision of Otorhinolaryngology and Head and Neck Surgery Services in England. London: RCS; 2008. Available at: https://entuk.org/docs/prof/publications/ent_services 6. Glasziou P. Helping commissioners, managers and GPs make more use of Cochrane reviews: an investigation focussed by ENT disorders [NIHR project]. Oxford: University of Oxford; 2012. Available at: http://www.nets.nihr.ac.uk/projects/sr/10400003 7. British Society of Audiology, 2007. Guidance on the use of real ear measurement to verify the fitting of digital signal processing hearing aids: BSA. Available at: http://www.thebsa.org.uk/docs/RecPro/REM.pdf 8. National Institute for Health and Clinical Excellence, 2013. Ear, nose and throat pathway: NICE. Available at: http://pathways.nice.org.uk/pathways/ear-nose-and-throat-conditions 9. Olusanya BO et al. The global burden of disabling hearing impairment: a call to action. Bulletin of the World Health Organization 2014 Available at: http://www.who.int/bulletin/online_first/BLT.13.128728.pdf 10. Royal College of Paediatrics and Child Health, Children's audiology services: a multi-professional review. London: RCPCH; 2005. Available at: http://www.rcpch.ac.uk/sites/default/files/asset_library/Publications/C/Audiology.pdf 11. Royal College of Surgeons, 2013. Commissioning guide: Otitis media with effusion. London: RCS. Available at: http://www.rcseng.ac.uk/healthcare-bodies/docs/published-guides/ome 12. World Health Organization, Multi-country assessment of national capacity to provide hearing care. Geneva: WHO; 2013.. Available at: http://www.who.int/pbd/publications/WHOReportHearingCare_Englishweb.pdf Relevant international guidelines 1. American College of Radiology, 2008. ACR appropriateness criteria: vertigo and hearing loss Available at: http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/HearingLossVertigo.pdf 4 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss 2. Moyer, V. A. & U.S.Preventive Services Task Force, 2012. Screening for hearing loss in older adults: U.S. Preventive Services Task Force recommendation statement.[Summary for patients in Ann Intern Med. 2012 Nov 6;157(9):I-38; PMID: 23405388]. Annals of Internal Medicine 157 (9) : 655-661. 3. Roland, P. S., Smith, T. L., Schwartz, S. R., Rosenfeld, R. M., Ballachanda, B., Earll, J. M., Fayad, J., Harlor, A. D., Jr., Hirsch, B. E., Jones, S. S., Krouse, H. J., Magit, A., Nelson, C., Stutz, D. R., & Wetmore, S., 2008. Clinical practice guideline: cerumen impaction. Otolaryngology - Head & Neck Surgery 139 (3:Suppl 2) : Suppl-S21. 4. Stachler RJ et al. 2012. Clinical practice guideline: sudden hearing loss. Otolaryngology - Head & Neck Surgery 146 (3:Suppl) : Suppl-35. Available at: https://www.entnet.org/Community/upload/Sudden-Hearing-Loss-Clinical-Practice-Guideline.pdf 5. US Preventive Services, 2008. Universal screening for hearing loss in newborns: US Preventive Services Task Force recommendation statement. [Review] [66 refs][Reprint in Am Fam Physician. 2010 Jan 15;81(2):185; PMID: 20082514]. Pediatrics 122 (1) : 143-148. 5 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Evidence Map: Hearing loss Contents Prevention - Workplace..........................................................................................................................................7 Prevention - Meningitis...........................................................................................................................................8 Prevention - Cancer treatment.................................................................................................................................9 Early Intervention - Paediatric Screening..................................................................................................................11 Management - Otitis Media.....................................................................................................................................13 Management - Hearing Aids....................................................................................................................................19 Management - Cochlear Implants............................................................................................................................22 Management - Brain Stem Implants.........................................................................................................................26 Management – Earwax...........................................................................................................................................27 Management - Idiopathic Sudden Sensorineural hearing loss (ISSHL)...........................................................................27 Management - Balloon Dilation of the Eustachian Tube...............................................................................................30 Management – Micropressure therapy for refractory Ménière's disease......................................................................... 31 Management - Inappropriate Referrals.....................................................................................................................32 NICE ‘Do not do’ interventions................................................................................................................................35 6 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Evidence Map Focus and main findings of source Status of source Reference The authors followed the standard Cochrane methodology. Verbeek J et al. (2012) Interventions to prevent occupational noise-induced hearing loss. Cochrane Database Syst Rev Issue 10. Art. No.: CD006396. DOI: 10.1002/14651858.CD006396.pu b3. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD006396.p ub3/abstract Prevention Prevention - Workplace Aim: To assess the effectiveness of non-pharmaceutical interventions for preventing occupational noise exposure or occupational hearing loss compared to no intervention or alternative interventions. Author’s Conclusions There is low quality evidence that implementation of stricter legislation can reduce noise levels in workplaces. Even though case studies show that substantial reductions in noise levels in the workplace can be achieved, there are no controlled studies of the effectiveness of such measures. The effectiveness of hearing protection devices depends on training and their proper use. There is very low quality evidence that the better use of hearing protection devices as part of Hearing Loss Prevention Programmes (HLPPs) reduces the risk of hearing loss, whereas for other programme components of HLPPs we did not find such an effect. Better implementation and reinforcement of HLPPs is needed. Better evaluations of technical interventions and longterm effects are needed. The review included 25 studies. No controlled studies on engineering controls for noise exposure were identified however one study found evaluated legislation to reduce noise exposure in a 12-year timeseries analysis. Eight studies with 3,430 participants evaluated immediate and long-term effects of personal hearing protection devices (HPDs) and sixteen studies with 82,794 participants evaluated short and long-term effects of hearing loss prevention programmes (HLPPs). [Cochrane Syst Rev] The overall quality of studies was 7 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference low to very low. Prevention - Meningitis Aim: To examine the effect of adjuvant corticosteroid therapy versus placebo on mortality, hearing loss and neurological sequelae in people of all ages with acute bacterial meningitis. The systematic review reports in its results that corticosteroids were associated with lower rates of severe hearing loss (RR 0.67, 95% CI 0.51 to 0.88) and any hearing loss (RR 0.74, 95% CI 0.63 to 0.87). It also notes that subgroup analyses for causative organisms showed that corticosteroids reduced severe hearing loss in children with H. influenzae meningitis (RR 0.34, 95% CI 0.20 to 0.59) but not in children with meningitis due to nonHaemophilus species. The authors however support the use of adjunctive corticosteroids in children in high-income countries with meningitis due to all micro-organisms; they base this comment on the lack of evidence of adverse events (in general and micro-organism specific) but acknowledge that administration of corticosteroids to children with meningitis due to bacteria other than H. influenzae remains controversial. Author’s conclusions: Corticosteroids significantly reduced hearing loss and neurological sequelae, but did not reduce overall mortality. Data support the use of corticosteroids in patients with bacterial meningitis in high-income countries. We found no 8 Date: 18/3/14 Version:1 The authors followed the standard Cochrane methodology. 25 randomised controlled trials involving 4121 participants were included. 19 studies had a double-blind design; six studies did not use blinding. Hearing loss was defined as severe when there was bilateral hearing loss greater than 60 dB or requiring bilateral hearing aids. Brouwer MC et al. (2013) Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev Issue 6. Art. No.: CD004405. DOI: 10.1002/14651858.CD004405.pu b4. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD004405.p ub4/abstract [Cochrane Syst Rev] Of the 25 randomised clinical trials included in the metaanalysis four were of high quality, 14 of medium quality and seven of low quality. Although the number of highquality studies was low, the number of participants in these studies accounted for 45% of participants included in the metaanalysis. Studies were mostly categorised as medium or low Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source beneficial effect in low-income countries. Implications for practice: Authors recommend a four day regimen of dexamethasone (0.6 mg/kg daily) given before or with the first dose of antibiotics. Further research required: The role of corticosteroids in neonatal meningitis is currently unclear due to the different spectrum of causative microorganisms and the lack of applicable RCT data. Additional RCTs in neonatal meningitis are needed. Reference quality due to a lack of addressing missing data or because no intention-to-treat analysis was performed. For the analysis on severe hearing loss, significant heterogeneity between trials of high, medium and low quality was found. As studies of high quality showed no effect the results of this meta-analysis should interpreted with caution. The sensitivity analysis showed that in a worst-case scenario dexamethasone would have no beneficial or harmful effect on hearing loss or neurological sequelae. However, this analysis was heavily influenced by a single study accounting for 46% of missing values. When this study was left out a trend towards benefit of dexamethasone on any hearing loss was found. Prevention - Cancer treatment Aim: The primary objective was to assess the efficacy of different otoprotective medical interventions in preventing 9 Date: 18/3/14 Version:1 The authors followed the standard Cochrane methodology. van-As, JW et al (2012) Medical interventions for the prevention Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source hearing loss in children with cancer treated with platinumbased therapy. Secondary objectives were to determine possible effects of these interventions on anti-tumour efficacy, toxicities other than hearing loss and quality of life. Author’s conclusions: At the moment there is no evidence from individual studies in children with osteosarcoma and hepatoblastoma treated with different platinum analogues and dosage schedules which underscores the use of amifostine as an otoprotective intervention as compared to no additional treatment. Since pooling of results was not possible and all studies had serious methodological limitations, no definitive conclusions can be made. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. Based on the currently available evidence, we are not able to give recommendations for clinical practice. For other possible otoprotective medical interventions and other types of malignancies no eligible studies were identified, so no conclusions can be made about their efficacy in preventing ototoxicity in children treated with platinum-based therapy. More high quality research is needed. The review included 149 participants from two randomized controlled trials and one controlled clinical trial evaluating the use of amifostine versus no additional treatment. Two studies included children with osteosarcoma, the other study included children with hepatoblastoma. All studies had methodological limitations. Reference of platinum-induced hearing loss in children with cancer. Cochrane Database Syst Rev Issue 5. Art. No.: CD009219. DOI:10.1002/14651858.CD0092 19.pub2. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD009219.p ub2/abstract [Cochrane Syst Rev] Note: There are current ongoing studies evaluating cisplatin chemotherapy with or without sodium thiosulfate in children with different types of tumours; among others, childhood liver cancer, germ cell tumor, medulloblastoma, neuroblastoma and osteosarcoma 10 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference Consensus guidelines formulated by the Newborn Hearing Screening Program (NHSP) clinical group. References included but no documented systematic search for literature. NHS Screening Programmes. Newborn hearing, 2012. Guidelines for surveillance and audiological referral of infants & children following the newborn hearing screen. London: Public Health England. Available at: http://hearing.screening.nhs.uk/ getdata.php?id=23226 Early Intervention Early Intervention – Paediatric Screening This document pertains to surveillance, referral and audiological monitoring following newborn hearing screening. It identifies which children should be followed up and monitored, how and when this should be done, and by whom. Refer to full-text for summary. [National Guideline] This document provides guidance on the early audiological assessment and management of babies referred from the newborn hearing screen. It describes some prerequisites for the provision of the service, issues related to the timing and organisation of the service and issues related to the choice, timing and order of test procedures. Refer to full-text for recommendations Consensus guidelines formulated by the Newborn Hearing Screening Program (NHSP) clinical group. References included but no documented systematic search for literature. NHS Screening Programmes. Newborn hearing, 2013. Guidelines for the early audiological assessment and management of babies referred from the Newborn Hearing Screening Programme. London: Public Health England. Available at: http://hearing.screening.nhs.uk/ getdata.php?id=23832 [National Guideline] 11 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference This document outlines the recommendations of the Newborn Hearing Screening Programme (NHSP) in England for the assessment, diagnosis and management of infants suspected of having Auditory Neuropathy Spectrum Disorder (ANSD) Consensus guidelines formulated by the Newborn Hearing Screening Program (NHSP) clinical group. References included but no documented systematic search for literature. NHS Screening Programmes. Newborn hearing, 2013. Guidelines for the assessment and management of auditory neuropathy spectrum disorder in young infants. London: Public Health England. Available at: http://hearing.screening.nhs.uk/ getdata.php?id=23846 Refer to full-text for recommendations The authors highlight that many controversies and areas of uncertainty remain in the diagnosis and management of ANSD. The aim of these guidelines is to provide an evidence based approach to medical evaluation of all children with bilateral permanent sensorineural, conductive or mixed hearing loss with average hearing level of 20‐69dB HL measured in the better hearing ear at 0.5, 1, 2, 4kHz. Refer to full-text for recommendations Clinical Guideline including graded recommendations based on categories of evidence defined according to research study methodology. Medline, Embase, and Cochrane searched by the NLH Specialist Library for ENT and Audiology with additional hand search of journals. [National Guideline] British Association of Audiovestibular Physicians, 2009. Aetiological investigation into bilateral mild to moderate permanent hearing loss in children. London: BAAP. Available at: http://www.baap.org.uk/docs/Mil d%20to%20Moderate%20Perma nent%20Hearing%20Loss%20in %20children%20Aetiological%20 Investigation%20BAAP%20BAPA %20Guideline%202009.pdf [Specialty guideline] The aim of these guidelines is to provide an evidence based 12 Date: 18/3/14 Version:1 Clinical Guideline including British Association of Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source approach to medical evaluation of all children with unilateral • Permanent sensorineural hearing loss of prelingual or late onset including fluctuating and progressive losses with two or more thresholds greater than 40dbHL. • Permanent conductive hearing loss Refer to full-text for recommendations Status of source Reference graded recommendations based on categories of evidence defined according to research study methodology. Medline, Embase, and Cochrane searched by the NLH Specialist Library for ENT and Audiology with additional hand search of journals. Audiovestibular Physicians, 2009. Medical evaluation of children with permanent unilateral hearing loss. London: BAAP. Available at: http://www.baap.org.uk/docs/Un ilateral%20Permanent%20Hearin g%20Loss%20in%20Children%2 0Medical%20Investigation%20BA AP%20BAPA%20Guideline%2020 09.pdf [Specialty guideline] Management Management - Otitis Media Aim: To assess the effectiveness of grommet insertion compared with myringotomy or non-surgical treatment in children with otitis media with effusion (OME). Author’s conclusions In children with OME the effect of grommets on hearing, as measured by standard tests, appears small and diminishes after six to nine months by which time natural resolution also leads to improved hearing in the non-surgically treated children. No effect was found on other child outcomes but data on these were sparse. No study has been performed in children with established speech, language, learning or developmental 13 Date: 18/3/14 Version:1 The authors followed the standard Cochrane methodology. The review included 10 trials comprised of 1728 participants. Some trials randomised children (grommets versus no grommets), others ears (grommet one ear only). The severity of OME in children varied between trials. Only one 'by child' study (MRC: TARGET) had Browning G et al. (2010) Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children . Cochrane Database Syst Rev Issue 10. Art. No.: CD001801. DOI:10.1002/14651858.CD0018 01.pub3. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD001801.p ub3/abstract Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source problems so no conclusions can be made regarding treatment of such children. Aim: To assess the effectiveness of autoinflation compared with no treatment in children and adults with otitis media with effusion. Author’s conclusions All of the studies were small, of limited treatment duration and had short follow-up. However, because of the low cost and absence of adverse effects it is reasonable to consider autoinflation whilst awaiting natural resolution of otitis media with effusion. Primary care could prove a beneficial place to evaluate such interventions and there is ongoing research in this area. Further research should also consider the duration of treatment, the long-term impact on developmental outcomes in children and additional quality of life outcome measures for children and families. Authors note in the discussion that the evidence for the use of autoinflation in the treatment of glue ear in children is conflicting but suggests that it may be of clinical benefit in the short term. Aim: To assess the effectiveness of adenoidectomy versus nonsurgical management or tympanostomy tubes in children with otitis media. Date: 18/3/14 Eight studies, with a total of 702 participants, met the inclusion criteria. None of the included studies were considered high quality. Only one study noted that the outcome assessors were blinded. Version:1 [Cochrane Syst Rev] Perera R et al. (2013) Autoinflation for hearing loss associated with otitis media with effusion. Cochrane Database Syst Rev Issue 11. Art. No.: CD005234. DOI: 10.1002/14651858.CD005234.pu b6. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD006285.p ub2/abstract [Cochrane Syst Rev] The authors followed the standard Cochrane methodology. Fourteen randomised controlled trials, including 2712 children, Author’s conclusions 14 particularly stringent audiometric entry criteria. No trial was identified that used long-term grommets. The authors followed the standard Cochrane methodology. Reference Van-den-Aardweg-Maaike-TA et al. (2010) Adenoidectomy for otitis media in children. Cochrane Database Syst Rev Issue 1. Art. No.: CD007810. DOI: Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference studying the effectiveness of adenoidectomy in children with otitis media were evaluated. Most of the trials were too heterogeneous to pool in a metaanalysis. Loss to follow up varied from 0% to 63% after two years 10.1002/14651858.CD007810.pu b2. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD007810.p ub2/abstract Aim: To assess the effects of antibiotics in children up to 18 years with OME. The authors followed the standard Cochrane methodology. Author’s conclusions The results of our review do not support the routine use of antibiotics for children up to 18 years with otitis media with effusion. The largest effects of antibiotics were seen in children treated continuously for four weeks and three months. Even when clear and relevant benefits of antibiotics have been demonstrated, these must be balanced against the potential adverse effects when making treatment decisions. Immediate adverse effects of antibiotics are common and the emergence of bacterial resistance has been causally linked to the widespread use of antibiotics for common conditions such as otitis media. This guideline provides recommendations for best practice in the management of acute otitis media and otitis media with 23 studies, including 3027 children, covering a range of antibiotics, participants, outcome measures and time points of evaluation were evaluated. The included studies were assessed as being at low risk of bias. van, ZA et al. (2012) Antibiotics for otitis media with effusion in children. Cochrane Database Syst Rev Issue 9. Art. No.: CD009163. DOI: 10.1002/14651858.CD009163.pu b2. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD009163.p ub2/abstract Our review shows a significant benefit of adenoidectomy as far as the resolution of middle ear effusion in children with OME is concerned. However, the benefit to hearing is small and the effects on changes in the tympanic membrane are unknown. The risks of operating should be weighed against these potential benefits. The absence of a significant benefit of adenoidectomy on AOM suggests that routine surgery for this indication is not warranted. 15 Date: 18/3/14 Version:1 [Cochrane Syst Rev] [Cochrane Syst Rev] SIGN guidelines are developed using an explicit methodology Scottish Intercollegiate Guidelines Network, 2003. Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source effusion. It provides evidence about detection, management, referral and follow up of children with these conditions. It excludes discussion of surgical management such as the insertion of grommets and does not address issues beyond childhood years. In addition, the needs of children with genetic or facial abnormalities are not considered. Refer to full text for the detail of the guideline. Status of source Reference based on three core principles: Development is carried out by multidisciplinary, nationally representative groups A systematic review is conducted to identify and critically appraise the evidence Recommendations are explicitly linked to the supporting evidence. Guideline 66: Diagnosis and management of childhood otitis media in primary care Guideline. Edinburgh: SIGN. Available at: http://www.sign.ac.uk/pdf/sign6 6.pdf [National Guideline] Readers should consider the publication date of this document and be mindful that there may be more recent evidence in some areas. The aim of the guideline was to outline appropriate criteria for referral, assessment and optimum surgical management of children younger than 12 years with a suspected diagnosis of OME and suspected hearing loss including: – children with all types of cleft palate – children with Down’s syndrome. Guideline developed by systematic review (SR) combined with expert opinion: one or more SRs conducted to address key questions and the Guideline Development Group (GDG) use SR findings to generate evidence Key recommendations statements and Formal assessment of a child with suspected OME should recommendations. Registered include: stakeholders are invited to Clinical history taking, focusing on: comment on the scope of the 16 Date: 18/3/14 Version:1 National Collaborating Centre for Women's and Children's Health, 2008. Surgical management of otitis media with effusion in children. London: NCC-WCH. Available at: http://www.nice.org.uk/nicemedi a/live/11928/39633/39633.pdf [National Guideline] Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source poor listening skills indistinct speech or delayed language development inattention and behaviour problems hearing fluctuation recurrent ear infections or upper respiratory tract infections balance problems and clumsiness poor educational progress Clinical examination, focusing on: • otoscopy • general upper respiratory health • general developmental status Hearing testing, which should be carried out by trained staff using tests suitable for the developmental stage of the child, and calibrated equipment. Reference guideline and on the draft guideline. The draft is also reviewed by an independent Guideline Review Panel (GRP). The comments made by the stakeholders, peer reviewers and the GRP are considered systematically by the GDG. 3 care pathways are included in the guideline, a general pathway and two tailored pathways for children with cleft palate and children with Down’s syndrome. Tympanometry. Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of 25– 30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) should be considered for surgical intervention. Once a decision has been taken to offer surgical intervention for OME in children, the insertion of ventilation tubes is recommended. Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory 17 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference tract symptoms. The following treatments are not recommended management of OME: • antibiotics • topical or systemic antihistamines • topical or systemic decongestants • topical or systemic steroids • homeopathy • cranial osteopathy • acupuncture • dietary modification, including probiotics • immunostimulants • massage. for the Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention where surgery is contraindicated or not acceptable. Hearing aids should normally be offered to children with Down’s syndrome and OME with hearing loss. Insertion of ventilation tubes at primary closure of the cleft palate should be performed only after careful otological and audiological assessment. Insertion of ventilation tubes should be offered as an alternative to hearing aids in children with cleft palate who have OME and persistent hearing loss. 18 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Management – Hearing Aids Aim: To summarise and critically appraise the evidence pertaining to the effectiveness of various types of digital hearing aids and assistive listening devices in managing adults with hearing loss. Author’s conclusions This systematic review concluded that adult patients with hearing loss may benefit from using various styles of digital hearing aids. In particular the authors found that satisfaction was gained from the use of various styles and fittings of digital hearing aids. For patients with high‐frequency hearing loss, open canal fittings were much more preferable than non‐open canal devices. For patients with asymmetric severe‐to‐profound hearing loss, contra‐lateral routing of signal digital hearing aids may improve satisfaction (as shown by better acceptance rates for the new hearing aids than the older models). This systematic review did not identify relevant evidence to support the routine use of the one‐to‐one communicator (assistive listening devices). 19 Date: 18/3/14 Version:1 Status of source Reference The systematic review included eight studies , one pseudo-randomised controlled trial with the remainder being non randomised and with various strengths and weaknesses. Ali, W, Suebwongpat, A, Weston, A. 2008 The effectiveness of digital hearing aids and assistive listening devices for adults with hearing loss: A systematic review of the literature. Christchurch: Health Services Assessment Collaboration (HSAC) Reviewers only searched for English language publications. The methodological quality of the included studies ranged from good to poor. The two good quality studies were limited by the small number of the patients included in one study and by the inclusion of patients with tinnitus but also have hearing loss in the other. http://onlinelibrary.wiley.com/o/ cochrane/clhta/articles/HTA32008100310/frame.html The studies showed considerable heterogeneity at all levels (participant, intervention, comparisons, and outcomes measured), in particular the interventions and comparisons conducted varied across all the studies. [Systematic review] http://www.healthsac.net/downlo ads/publications/HSAC03%20Hea ring%20Aids%20081008%20FIN AL.pdf Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Aim: To assess the clinical effectiveness and cost-effectiveness of bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf. The evaluation considered BAHAs compared with conventional hearing aids [air conduction hearing aid (ACHA) or bone conduction hearing aid (BCHA)], ear surgery and the unaided condition, and the use of unilateral or bilateral BAHAs. Many of the studies relied mainly on subjective measures (from the subjects’ personal perspective) rather than on objective measures. The systematic review included 12 studies of clinical effectiveness; seven cohort pre– post studies and five crosssectional audiological comparison studies. No studies with a control group were identified. Author’s Conclusions The findings suggest that hearing is improved with BAHAs compared with no hearing aid, and although there are audiological benefits of BAHAs when compared with conventional BCHAs, the audiological benefits of BAHAs when compared with ACHAs are less clear. Limited data suggest an improvement in QoL with BAHAs when compared with conventional aids, but there is an absence of evidence regarding other potential benefits, such as length of time the aid is able to be worn and improvement of discharging ears. The evidence suggests that there are some benefits of bilateral BAHAs compared with unilateral BAHAs. The results of our cost analysis demonstrate that BAHAs are significantly more costly than conventional BCHAs. The 20 Date: 18/3/14 Version:1 Seven studies compared BAHAs with conventional hearing aids, three of these and one additional study compared BAHAs with unaided hearing, and four studies compared unilateral and bilateral BAHAs. No prospective studies comparing BAHAs with ear surgery were identified. Reference Colquitt JL, Jones J, Harris P, Loveman E, Bird A, Clegg AJ, Baguley DM, Proops DW, Mitchell TE, Sheehan PZ, Welch K. Bone‐anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technology Assessment, 2011;1‐200. Available at: http://www.hta.ac.uk/1770 [Systematic review] The overall quality was rated as weak for all included studies and meta-analysis was not possible due to differences in outcome measures and patient Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source additional costs continue while individuals remain using their BAHA and are not restricted to the initial processes of surgical implantation and fitting of the BAHA sound processor. Our exploratory cost-effectiveness analysis of BAHAs versus BCHAs suggests that BAHAs are unlikely to be a cost-effective option where the benefits (in terms of hearing gain and probability of using of alternative aids) are similar for BAHAs and their comparators. The greater the benefit from aided hearing and, in particular, the greater the difference in the proportion of people using the hearing aid for ≥ 8 hours per day, the more likely BAHAs are to be a cost-effective option. The inclusion of other dimensions of QoL may also increase the likelihood of BAHAs being a cost-effective option. Aim: To systematically review the outcomes of bilateral versus unilateral bone-anchored hearing aids (BAHA) for individuals with bilateral permanent conductive hearing loss. Findings Bilateral BAHA provided audiologic benefit compared to unilateral BAHA (improved thresholds for tones [2 studies], speech in quiet [5 studies] and in noise [3 studies], and improved localization/lateralization [3 studies]) and patients' perceived subjective benefit from bilateral BAHA (3 studies). Disadvantages of bilateral BAHAs included listening in noise in some conditions (3 studies), presumed additional cost, and presumed increase in adverse event risk 21 Date: 18/3/14 Version:1 Reference populations. The authors note that the available evidence is methodologically weak and the results have a high risk of bias The systematic review included 11 observational studies and a total of 168 patients. In most studies, comparisons between unilateral and bilateral BAHA were intra-subject. Studies were small; eight of the studies had fewer than 13 subjects with bilateral BAHAs. Janssen, R. M., Hong, P., & Chadha, N. K., 2012. Bilateral bone-anchored hearing aids for bilateral permanent conductive hearing loss: a systematic review. [Review]. Otolaryngology - Head & Neck Surgery 147 (3) : 412-422. [Systematic review] Likely selection bias in earlier studies favouring bilateral BAHA implantation. Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference Meta-analysis was not possible due to heterogeneity of studies Management - Cochlear implants 1.1 Unilateral cochlear implantation is recommended as an option for people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids, as defined in 1.5. If different cochlear implant systems are considered to be equally appropriate, the least costly should be used. Assessment of cost should take into account acquisition costs, long-term reliability and the support package offered. 1.2 Simultaneous bilateral cochlear implantation is recommended as an option for the following groups of people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids, as defined in 1.5: • children • adults who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness. Acquisition of cochlear implant systems for bilateral implantation should be at the lowest cost and include currently available discounts on list prices equivalent to 40% or more for the second implant. 1.3 Sequential bilateral cochlear implantation is not recommended as an option for people with severe to profound deafness. 1.4 People who had a unilateral implant before publication of this guidance, and who fall into one of the categories described 22 Date: 18/3/14 Version:1 Technology Appraisal Guidance developed by systematic review (SR) and cost effectiveness analysis combined with expert opinion. One SR was conducted to address key questions and the appraisal committee used the SR findings to generate recommendations and evidence summary. Registered stakeholders, including manufacturers, specialist/professional and patient/carer groups were invited to comment on the scope of the assessment report and the appraisal consultation document (ACD). Selected professionals also provided expert opinion. The comments made by the stakeholders are considered systematically by the appraisal committee. National Institute for Health and Clinical Excellence, 2009. Cochlear implants for children and adults with severe to profound deafness. London: NICE. Available at: http://www.nice.org.uk/nicemedi a/live/12122/42854/42854.pdf [National Technology Appraisal] Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference in 1.2, should have the option of an additional contralateral implant only if this is considered to provide sufficient benefit by the responsible clinician after an informed discussion with the individual person and their carers. 1.5 For the purposes of this guidance, severe to profound deafness is defined as hearing only sounds that are louder than 90 dB HL at frequencies of 2 and 4 kHz without acoustic hearing aids. Adequate benefit from acoustic hearing aids is defined for this guidance as: • for adults, a score of 50% or greater on Bamford–Kowal– Bench (BKB) sentence testing at a sound intensity of 70 dB SPL • for children, speech, language and listening skills appropriate to age, developmental stage and cognitive ability. 1.6 Cochlear implantation should be considered for children and adults only after an assessment by a multidisciplinary team. As part of the assessment children and adults should also have had a valid trial of an acoustic hearing aid for at least 3 months (unless contraindicated or inappropriate). When considering the assessment of adequacy of acoustic hearing aids, the multidisciplinary team should be mindful of the need to ensure equality of access. Tests should take into account a person’s disabilities (such as physical and cognitive impairments), or linguistic or other communication difficulties, and may need to be adapted. If it is not possible to administer tests in a language in which a person is sufficiently fluent for the tests to be appropriate, other methods of assessment should be considered. Aim: The technology assessment evaluated the clinical effectiveness of unilateral cochlear implants and bilateral 23 Date: 18/3/14 Version:1 A systematic review of the literature largely following Agency for Healthcare Research and Quality (AHRQ), 2011. Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source cochlear implants in adult patients (≥ 18 years of age) with sensorineural hearing loss. It examined communication-related health outcomes as well as quality-of-life outcomes, and also preoperative characteristics associated with successful implantation. methods used for AHRQ comparative effectiveness reviews. Detail of the methodology is available at:http://www.effectivehealthcar e.ahrq.gov/index.cfm/search-forguides-reviews-andreports/?pageaction=displayprod uct&productid=318 Author’s conclusions In summary, unilateral cochlear implantation with or without additional use of hearing aids has been an effective method of hearing assistance. Published studies show improved speech perception and health-related quality-of-life in adults with sensorineural hearing loss. Bilateral cochlear implantation provides added improvements in speech perception outcomes in noisy environments over unilateral cochlear implantation. With future improvements in implant device technology and implant programming, the number of patients implanted bilaterally will continue to increase. Further studies with longer follow-up duration are needed to assess the additional benefits in terms of improved health-related quality-of-life and potential risks of bilateral cochlear implantation compared with unilateral implantation. Additionally, none of the studies have been able to quantify the sensation described by patients of fusion of bilateral sound into a stereo perception within one’s head. There is a need to develop better measures of performance and disease-specific quality-of –life instruments that may reflect the significance of these subjective benefits. Reference Effectiveness of cochlear implants in adults with sensorineural hearing loss. Available at: https://www.cms.gov/Medicare/C overage/DeterminationProcess/d ownloads/id80TA.pdf [Systematic Review] The strength of the evidence found for each key question is graded as high, moderate, low or insufficient Refer to full text for summaries relating to each of the key questions considered. 24 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source This document describes considerations prior to this intervention being considered appropriate in both children and adults. These include the duration of a trial of hearing aids, the degree of hearing loss and demonstrable speech and language difficulties. The position statement arose from consideration of published evidence in conjunction with clinical experience and outcome data shared with the British Cochlear Implant Group. No systematic review of clinical studies is documented. The technology appraisal guidance from NICE was published subsequent to this statement. Reference British Cochlear Implant Group, 2007. Proposed position statement on guidelines for paediatric cochlear implantation: BCIG. Available at: http://www.bcig.org.uk/downloa ds/pdfs/BCIG%20position%20sta tement%20%20Guidelines%20for%20Cochle ar%20Implantation%20APril%20 07.pdf [Position Statement] The same group have created a document specifies quality standards for various aspects of a cochlear implantation programme including Service Structure Accommodation Clinical Facilities Referral and Selection Criteria The Assessment Process Liaison with other services Pre-operative Information and Counselling The Cochlear Implant Device Surgery and In-patient Care 25 Date: 18/3/14 Version:1 Consensus document British Cochlear Implant Group & Royal National Institute for the Deaf, 2009. Quality standards for adult cochlear implantation: BCIG. Available at: http://www.bcig.org.uk/downloa ds/pdfs/BCIG%20Adult%20Qualit y%20Standards%202010.pdf [Best Practice guidance] Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Reference The Interventional Procedure guidance was based on a rapid review of published literature in conjunction with review of the procedure by a specialist advisor. National Institute for Health and Clinical Excellence, 2005. Auditory brain stem implants. London: NICE. Available at: http://www.nice.org.uk/nicemedi a/live/11086/30959/30959.pdf Post-operative Fitting and Programming of the Speech Processor Post-operative Rehabilitation and Assessments Follow-up and Long Term Maintenance Device Failure Audit and Service Monitoring Transfer of Care Patient and Other Feedback and Complaints Management – Brain stem implants Focus is the safety and efficacy of auditory brain stem implants for the indications of total deafness in both ears caused by damage to the vestibulocochlear nerve as a result of tumours or surgery. in people with vestibulocochlear nerve damage, hearing is not improved by hearing aids or cochlear implants. The interventional Procedure guidance notes “Current evidence on the safety and efficacy of auditory brain stem implants appears adequate to support the use of this procedure by surgical teams experienced in this technique, provided that normal arrangements are in place for consent, audit and clinical governance.” 26 Date: 18/3/14 Version:1 No systematic reviews or randomised controlled trials or non-randomised controlled studies were identified. Published literature comprised of 12 uncontrolled case-series all of which were small and unable to give a precise estimate of risks of complications. There may be overlap of patients amongst published case-series. [National Interventional Procedure Guidance] Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Management- Earwax Aim: To offer guidance to nursing staff with responsibility for various aspects of ear care. The Best Practice Statement includes sections on Educational preparation of healthcare staff undertaking ear care Ear care assessment Cerumen management Instrumentation Ear irrigation Use of microscope and microsuction Infection control Status of source Reference This is a best practice statement developed where variation in practice exists. The document was developed to promote a consistent, cohesive and achievable approach to care. A literature search was conducted but the breadth and detail of the search strategy is not documented. A reference group was used to consult on drafts of the document. NHS Quality Improvement Scotland, 2006. Ear Care. Best practice statement. Edinburgh: Health Care Improvement Scotland. Available at: http://www.healthcareimprovem entscotland.org/idoc.ashx?docid= 95aeda29-930d-4c88-a7a0e532c48d9f4c&version=-1 [Best Practice Statement] This evidence summary on earwax covers diagnosis and management of earwax and provides detailed information on how to irrigate the ear and when irrigation is contraindicated. NICE CKS summaries provide primary care practitioners with a synopsis of the current evidence base and practical guidance on best practice on a variety of topics. CKS, 2012. Earwax http://cks.nice.org.uk/earwax [Evidence summary] Management – Idiopathic Sudden Sensorineural hearing loss (ISSHL) Aim: To determine whether steroids in the treatment of idiopathic sudden sensorineural hearing loss (ISSHL) improves hearing (primary) and reduce tinnitus (secondary) and also to determine the incidence of significant side effects from the 27 Date: 18/3/14 Version:1 The authors followed the standard Cochrane methodology. The review included three trials, Wei-Benjamin PC et al. (2013) Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source medication. Author’s conclusions: The value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomised controlled trials is contradictory in outcome, in part because the studies are based upon too small a number of patients. Aim: To determine the effectiveness and adverse effects of vasodilators and other vasoactive substances in improving hearing in patients with ISSHL. Status of source Reference involving 267 participants. The included studies were of poor quality and contained relatively small numbers of participants. No meta-analysis conducted because of heterogeneity in definition of hearing improvement, differences in the formulations, duration and dosage of the steroid intervention, variations in the participants’ geographic background, differences in the means of assessing the outcomes and variations in the methodological quality of the studies. Issue 7. Art. No.: CD003998. DOI: 10.1002/14651858.CD003998.pu b3. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD003998.p ub3/abstract Design of research studies complicated by low incidence of ISSHL and the highly variable natural history of condition which includes early spontaneous resolution in some patients. The authors followed the standard Cochrane methodology. Three trials, involving 189 participants were identified, all of 28 Date: 18/3/14 Version:1 [Cochrane Syst Rev] Agarwal L & Pothier DD. (2009) Vasodilators and vasoactive substances for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Author’s conclusions The effectiveness of vasodilators in the treatment of ISSHL remains unproven. The included studies were of relatively poor quality and the number of patients included was small. Moreover, there were differences in the type, dosage and duration of vasodilator used in each study. Due to the degree of heterogeneity the results could not be combined to reach a conclusion. low quality. Meta-analysis was not possible due to heterogeneity of studies arising from differences in the type, dosage and duration of vasodilator treatment and in the definition of hearing improvement. Aim: To determine the effectiveness and side effect profile of antivirals in the treatment of ISSHL.” Design of research studies complicated by low incidence of ISSSHL and the highly variable natural history of condition which includes early spontaneous resolution in some patients. The authors followed the standard Cochrane methodology. Author’s conclusions There is currently no evidence to support the use of antiviral drugs in the treatment of ISSHL. The four trials included in this review were, however, small and with a low risk of bias. Further randomised controlled trials with larger patient populations, using standardised inclusion criteria, antiviral regimes and outcome measures, are needed in order for adequate metaanalysis to be performed to reach definitive conclusions. A uniform definition of ISSHL should also be established, together with what constitutes adequate recovery. The review included four randomised trials comprising of 257 participants. Three out of the four included studies were prospective, randomised, double-blinded, placebocontrolled trials with a low risk of bias. One study had high risk of bias, with unclear description of allocation, blinding and patient 29 Date: 18/3/14 Version:1 Reference Issue 4. Art. No.: CD003422. DOI: 10.1002/14651858.CD003422.pu b4. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD003422.p ub4/abstract [Cochrane Syst Rev] Awad Z et al. (2012) Antivirals for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev Issue 8. Art. No.: CD006987. DOI: 10.1002/14651858.CD006987.pu b2. Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD006987.p ub2/abstract Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Focus and main findings of source Evidence mapping: Prudent healthcare – Hearing Loss Status of source Reference exclusions. [Cochrane Syst Rev] Aim: To assess the benefits and harms of hyperbaric oxygen therapy (HBOT) for treating ISSHL and/or tinnitus. The authors followed the standard Cochrane methodology. Author’s conclusions For people with acute ISSHL, the application of HBOT significantly improved hearing, but the clinical significance remains unclear. We could not assess the effect of HBOT on tinnitus by pooled analysis. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously. An appropriately powered trial is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The review included Seven trials comprising 392 participants. The studies were small and of generally poor quality. Bennett MH et al. (2012) Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev Available at: http://onlinelibrary.wiley.com/doi /10.1002/14651858.CD004739.p ub4/abstract There is no evidence of a beneficial effect of HBOT on chronic ISSHL or tinnitus and we do not recommend the use of HBOT for this purpose. The authors note variability and poor reporting of entry criteria, variable nature and timing of outcomes, and poor reporting of both outcomes and methodology. Also noted is that given the high rate of spontaneous recovery from ISSHL, there is a possibility of bias due to different times to entry in these small trials, as well as from non-blinded management decisions in all trials. [Cochrane Syst Rev] Management– Balloon dilation of the Eustachian Tube The document examined the safety and efficacy of balloon dilatation of the Eustachian tube used for persistent blockage of the Eustachian tube. 30 Date: 18/3/14 Version:1 The Interventional Procedure guidance was based on a rapid review of published literature in National Institute for Health and Clinical Excellence, 2011. Balloon dilatation of the Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Guidance Current evidence on the efficacy and safety of balloon dilatation of the Eustachian tube is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research, which should address the efficacy of the procedure in the short and longer term, and also document safety outcomes. Research studies should clearly describe which parts of the Eustachian tube are being treated and report subjective measurements of symptom improvement and objective measurements of Eustachian tube function. Status of source Reference conjunction with review of the procedure by 3 specialist advisors. The review identified 1 small case series published as a full article and two further small case series were described in published conference abstracts. There is a lack of long-term data. Eustachian tube. Manchester: NICE. Available at: http://www.nice.org.uk/nicemedi a/live/13423/57219/57219.pdf Supporting overview document available at http://www.nice.org.uk/nicemedi a/live/13423/55152/55152.pdf [National Interventional Procedure Guidance] Management– Micropressure therapy for refractory Ménière's disease The document examined the safety and efficacy of micropressure therapy for refractory Ménière's disease Guidance Current evidence on the safety of micropressure therapy for refractory Ménière's disease is inadequate in quantity. There is some evidence of efficacy, but it is based on limited numbers of 31 Date: 18/3/14 Version:1 The Interventional Procedure guidance was based on a rapid review of published literature in conjunction with review of the procedure by 3 specialist advisors. National Institute for Health and Clinical Excellence, 2012. Micropressure therapy for refractory Ménière's disease. Manchester: NICE. Available at: http://www.nice.org.uk/nicemedi This overview is based on 240 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source patients. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. patients from 2 randomised controlled trials (RCTs), 1 comparative study and 3 case series. Quality of Included RCTs was questionable. In addition there was no long-term follow-up (longer than 2 years) and a lack of safety data. No mention of complications in 4 of the 6 studies reported. a/live/13440/58918/58918.pdf Consensus document British Academy of Audiology, 2009. Guidelines for referral to audiology of adults with hearing difficulty: BAA. Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence 1.2 Clinicians wishing to undertake micropressure therapy for refractory Ménière's disease should take the following actions. Inform the clinical governance leads in their Trusts. Ensure that patients understand the uncertainty about the procedure's efficacy and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended. Reference Supporting overview document available at: http://www.nice.org.uk/nicemedi a/live/13440/55575/55575.pdf [National Interventional Procedure Guidance] Audit and review clinical outcomes of all patients having micropressure therapy for refractory Ménière's disease (see section 3.1). 1.3 NICE encourages further research into micropressure therapy for refractory Ménière's disease. Research studies should report long-term outcomes, in particular the need for subsequent surgical treatment. Management - Inappropriate Referrals This document lists situations where adult patients should NOT be referred directly to audiology for hearing assessment and rehabilitative treatment from either primary care or other intrahospital consultant pathways. 32 Date: 18/3/14 Version:1 Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Available at: http://www.baaudiology.org/files /3513/5898/2984/BAA_Direct_Re ferral_Criteria_0909_amended1. pdf Contra-indications History: Reference Persistent pain affecting either ear (defined as earache lasting more than 7 days in the past 90 days before appointment) History of discharge other than wax from either ear within the last 90 days Sudden loss or sudden deterioration of hearing (sudden=within 1 week, in which case send to A&E or Urgent Care ENT clinic) Rapid loss or rapid deterioration of hearing (rapid=90 days or less) Fluctuating hearing loss, other than associated with colds Unilateral or asymmetrical, or pulsatile or distressing tinnitus lasting more than 5 minutes at a time Troublesome, tinnitus which may lead to sleep disturbance or be associated with symptoms of anxiety or depression Abnormal auditory perceptions (dysacuses) Vertigo Normal peripheral hearing but with abnormal difficulty hearing in noisy backgrounds; possibly having problems with sound localization, or difficulty following complex auditory directions. [Specialty Guidance] Ear examination: 33 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Focus and main findings of source Status of source Complete or partial obstruction of the external auditory canal preventing proper examination of the eardrum and/or proper taking of an aural impression. Abnormal appearance of the outer ear and/or the eardrum (e.g., inflammation of the external auditory canal, perforated eardrum, active discharge). Reference Audiometry: 34 Conductive hearing loss, defined as 25 dB or greater airbone gap present at two or more of the following frequencies: 500, 1000, 2000 or 4000 Hz. Unilateral or asymmetrical sensorineural hearing loss, defined as a difference between the left and right bone conduction thresholds of 20 dB or greater at two or more of the following frequencies: 500, 1000, 2000 or 4000 Hz. Evidence of deterioration of hearing by comparison with an audiogram taken in the last 24 months, defined as a deterioration of 15 dB or more in air conduction threshold readings at two or more of the following frequencies: 500, 1000, 2000 or 4000 Hz. Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence Public Health Wales – Health Intelligence/Observatory Evidence mapping: Prudent healthcare – Hearing Loss Guidance ID NICE 'do not do' recommendation Interventions CG60 Once a decision has been taken to offer surgical intervention for otitis media with effusion (OME) in children, insertion of ventilation tubes is recommended. Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms. adjuvant adenoidectomy CG60 Antibiotics are not recommended for the management of otitis media with effusion (OME). antibiotics CG60 Topical or systemic antihistamines are not recommended for the management of otitis media with effusion (OME). topical or systemic antihistamines CG60 Topical or systemic decongestants are not recommended for the management of otitis media with effusion (OME). topical or systemic decongestants CG60 Topical or systemic steroids are not recommended for the management of otitis media with effusion (OME). topical or systemic steroids CG60 Homeopathy is not recommended for the management of otitis media with effusion (OME). homeopathy CG60 Cranial osteopathy is not recommended for the management of otitis media with effusion (OME). cranial osteopathy CG60 Acupuncture is not recommended for the management of otitis media with effusion (OME). acupuncture CG60 Dietary modification, including probiotics is not recommended for the management of dietary modification, including otitis media with effusion (OME). probiotics CG60 Immunostimulants are not recommended for the management of Otitis media with effusion (OME). 35 Date: 18/3/14 Version:1 Dinah Roberts, Eleri Tyler: Evidence Service/Health Intelligence