Improving Patient-Centered Outcomes in Bone Conduction Hearing Implants James Tysome PhD, FRCS (ORL-HNS) ENT Surgeon, Cambridge University Hospitals Ad Snik PhD Radbound University, Nijmegen

The Challenge

Most evidence case-control or case series Outcome measures – Diverse – Clinician-centred

Outcome measures 137 questionnaires to assess hearing Are these all useful? How can we decide which are best?

Patient-centred?

Holger’s score  clinician-centred Extra trips to hospital for infected skin  patient-centred

CORE SET

Core Outcome Measures in Effectiveness Trials

World Health Organisation International Classification of functioning, disability and health

A new standardized format for reporting hearing outcome in clinical trials Gurgel et al Otolaryngol. Head. Neck Surg 2012 International Outcome Inventory for hearing aids Danermarkl et al Int. J. Audiol 2011

How have others addressed this? Developed methodology to evaluate outcome measures Core sets of patient-centred outcome measures

OMERACT filter to outcome measures – Truth: Does it measure what it is supposed to? – Discrimination: Is it reliable and sensitive to change? – Feasible: Is it easily applied (time and cost)?

James Tysome, UK Peter Monksfield, UK Martin Johansson, Sweden Brian McKinnon, USA Ad Snik, Nijmegen Penny Feltham, Manchester Bill Hodgetts, Canada Ravi Sockalingham, USA Supported by Oticon Foundation

Improve outcomes of patients with hearing loss Develop core sets of patient-centred outcome measures that can – Guide individual practice – Act as a standard of reporting in clinical trials

Framework for identifying, assessing and reporting patient-centred outcome measures Plan to achieve and disseminate this 2015

The process Identify the area of hearing loss to be assess Conductive hearing loss

The process Identify stakeholders – Patients – Audiologists – ENT surgeons – Specialist nurses – Speech pathologists – Teachers of the deaf – Research methodologists – Industry – Clinical psychologists – Health economists

HearingPhysical PsychosocialEconomic Conductive hearing loss

Ask patients Physical

Will I have a long recovery from surgery? How long will my BAHA last? Will I get problems with my BAHA? Will I need further surgery in the future? Physical

Will I have a long recovery from surgery? – Technique How long will my BAHA last? – Implant loss Will I get problems with my BAHA? – Skin response Will I need further surgery in the future? – Revision of implant, abutment or skin Physical Domains

Will I need further surgery in the future? – Revision of implant, abutment or skin Physical Domains

Systematic review of outcome measures: implant loss Rate of implant loss Time to implant revision

Rate of implant loss – Commonly reported Time to implant revision – Rarely reported Systematic review of outcome measures: implant loss

OMERACT filter Rate of implant loss – Truth – Discrimination – Feasability

Review domains Consensus on outcome measures to be included Where no outcome measure, strategy to develop a new instrument

Method Identify – area of hearing loss to assess – stakeholders (including patients) – domains in each core area Systematic review of outcome measures OMERACT filter Recommend outcome measures Where not available, develop

Future Assess outcomes for conductive/mixed hearing loss – Hearing – Physical – Economic – Psychosocial Other types of hearing loss