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Strand B, Rapid Assessment of Other Health Technologies Such As Medical Devices, Surgical Interventions Or Diagnostics 333 EUnetHTA WP5 Joint Action 2 (2012-2015) Strand B, Rapid assessment of other health technologies such as medical devices, surgical interventions or diagnostics Pilot rapid assessment of other health technologies using the HTA Core Model® for Rapid Relative Effectiveness Assessment Balloon Eustachian tuboplasty for the treatment of Eustachian tube dysfunction Pilot ID: SB-13 Version 5.0, February, 2015 Final Version EUnetHTA JA2 Balloon Eustachian tuboplasty for the treatment of Eustachian tube dysfunction WP5B DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V1.0 26 August 2014 V1.0 = First draft V2.0 29 September 2014 Updated following review by dedicated reviewers V 3.0 13 November 2014 Updated version based on comments from external clinical experts, WP5 strand B members and manufacturers V 4.0 15 December 2014 Updated version based on the comments and corrections from medical editing V 5.0 3 February Updated version based on comments from LBI This assessment was produced by experts from the institutions listed below, and was reviewed by members of Work Package 5 (WP5) Joint Action 2 of the EUnetHTA network; the whole process was coordinated by the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA). Disclaimer The assessment represents a consolidated view of the EUnetHTA network members and is in no case the official opinion of the participating institutions or individuals. EUnetHTA Joint Action 2 is supported by a grant from the European Commission. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are re- sponsible for any use that may be made of the information contained therein. Pilot team Author THL, National Institute for Health and Sinikka Sihvo Welfare, Finohta Tapani Keränen Maija Saijonkari Co-Author HIQA, Health Information and Quality Michelle O’Neill Authority Patricia Harrington Ronan Glynn Reviewers HVB, Association of Austrian Social Bettina Maringer Security Institutions GYEMSZI, National Institute for Quality- Zoltan Hursti and Organizational Development in Jacinta Juhasz Healthcare and Medicines AHTAPol, Agency for Health Technology Aleksandra Pelczarska Assessment in Poland Urszula Cegłowska Michał Witkowski Kinga Grzywacz Anna Zawada External University of Helsinki, Head of Section Jussi Jero, MD, Docent Reviewers Otology and Skull Base Surgery, Department of Otorhinolaryngology OUH- Oslo University Hospital, Department Juha Silvola, MD, PhD of Otolaryngology Feb2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 2 EUnetHTA JA2 Balloon Eustachian tuboplasty for the treatment of Eustachian tube dysfunction WP5B Contact information Agency Name Contact details FinOHTA/THL Sinikka Sihvo [email protected] FinOHTA/THL Tapani Keränen [email protected] FinOHTA/THL Maija Saijonkari [email protected] HIQA Patricia Harrington [email protected] HIQA Michelle O’Neill [email protected] HIQA Ronan Glynn [email protected] Further contributors Public consultation – Project Plan Spiggle & Theis Medizintechnik GmbH Susanne Ferfers Acclarent, Inc., a part of the Johnson & Johnson family of companies Michael McCormack Mutualités Libres Onafhankelijke Ziekenfondsen (MLOZ) Philippe Van Wilder Pilot Rapid Assessment Strand B members AQuAS – Agència de Qualitat i Avaluació Sanitàries, Spain Cari Almazan IQWiG – Institute for Quality and Efficiency in Health Care, Germany Stefan Sauerland AGENAS – Agenzia Nazionale per i Servizi Sanitari Regionali, Italy Marina Cerbo AHTAPol – Agency for Health Technology Assessment, Poland Urszula Cegłowska Manufacturer(s) Acclarent, Inc., a part of the Johnson & Johnson family of companies Michael McCormack Spiggle & Theis Medizintechnik GmbH Susanne Ferfers Conflict of interest All authors and reviewers involved in the production of this pilot assessment have declared they have no conflicts of interest in relation to the technology assessed according to the EUnetHTA con- flicts of interest (COI) statement form or, respectively, the Declaration of Interest and Confidentiality Undertaking (DOICU) form. Feb2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 3 EUnetHTA JA2 Balloon Eustachian tuboplasty for the treatment of Eustachian tube dysfunction WP5B Table of contents LIST OF ABBREVIATIONS ............................................................................................................. 5 SUMMARY OF RELATIVE EFFECTIVENESS OF BALLOON EUSTACHIAN TUBOPLASTY .... 6 SCOPE ........................................................................................................................................................... 6 INTRODUCTION ............................................................................................................................................. 6 METHODS ..................................................................................................................................................... 9 RESULTS ....................................................................................................................................................... 9 1 SCOPE ................................................................................................................................... 13 2 HEALTH PROBLEM AND CURRENT USE OF THE TECHNOLOGY ................................. 14 2.1 METHODS ...................................................................................................................................... 14 2.2 RESULTS ........................................................................................................................................ 15 2.3 DISCUSSION ................................................................................................................................... 19 3 DESCRIPTION AND TECHNICAL CHARACTERISTICS OF TECHNOLOGY .................... 20 3.1 METHODS ...................................................................................................................................... 20 3.2 RESULTS ........................................................................................................................................ 21 3.3 DISCUSSION ................................................................................................................................... 25 4 CLINICAL EFFECTIVENESS ................................................................................................ 26 4.1 METHODS ...................................................................................................................................... 26 4.2 RESULTS ........................................................................................................................................ 27 4.3 DISCUSSION ................................................................................................................................... 35 5 SAFETY .................................................................................................................................. 37 5.1 METHODS ...................................................................................................................................... 37 5.2 RESULTS ........................................................................................................................................ 38 5.3 DISCUSSION ................................................................................................................................... 39 6 POTENTIAL ETHICAL, ORGANISATIONAL, SOCIAL AND LEGAL ASPECTS ................ 40 7 REFERENCES ....................................................................................................................... 41 APPENDIX 1: METHODS AND DESCRIPTION OF THE EVIDENCE USED .............................. 44 METHODS ................................................................................................................................................ 44 Overall description of methods ............................................................................................................. 44 Documentation of the search strategies ................................................................................................ 45 Flow chart of study selection ................................................................................................................. 50 DESCRIPTION OF THE EVIDENCE USED ........................................................................................... 51 Evidence tables of individual studies included for clinical effectiveness and safety ............................. 51 APPENDIX 2: CHECKLIST FOR POTENTIAL ETHICAL, ORGANISATIONAL, SOCIAL AND LEGAL ASPECTS .......................................................................................... 59 Feb2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 4 EUnetHTA JA2 Balloon Eustachian tuboplasty for the treatment of Eustachian tube dysfunction WP5B LIST OF TABLES Table 1: Summary of relative effectiveness of balloon Eustachian tuboplasty (BET) ................. 11 Table 2: Reimbursement status of balloon Eustachian tuboplasty (BET) in Europe ................... 24 Table 3: Clinical effectiveness of balloon Eustachian tuboplasty (BET) ...................................... 32 Table 4: Characteristics of relevant studies ................................................................................
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