Outcome Measurement in Adult Auditory Rehabilitation

Barker, Fiona; Mackenzie, Emma; Elliott, Lynette; Lusignan, Simon de

doi:10.1097/aud.0000000000000167

Cited by 25 publications

(17 citation statements)

References 37 publications

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“…Our review confirmed similar diversity (24 different tinnitus-related questionnaire instruments) and lack of consensus (14 used twice or more). In the second, Barker and et al [ 41 ] conducted a scoping review to document the range and nature of outcome measurement in the context of adult auditory rehabilitation. Like us, they included registered trials and published studies.…”

Section: Discussionmentioning

confidence: 99%

“…Again, the use of generic terms such as ‘handicap’ perpetuate the difficulty that many trialists experience in understanding what construct(s) are measured by a particular questionnaire instrument. The frequency of reporting adverse events was not given by Granberg et al [ 40 ], but Barker et al [ 41 ] stated that no studies reported on adverse events. Poor reporting of harms-related data is not restricted to clinical trials in the hearing sciences [ 42 ].…”

Section: Discussionmentioning

confidence: 99%

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Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

Hall

Haider²,

Szczepek

et al. 2016

Trials

148

145

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BackgroundThere is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus.MethodsRecords were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded.ResultsTwo hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used.ConclusionsOur findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments.PROSPERO registrationThe systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Registered on 12 March 2015 revised on 15 March 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1399-9) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

Hall

Haider²,

Szczepek

et al. 2016

Trials

148

145

View full text Add to dashboard Cite

show abstract

“…We know that studies using non-validated scales are prone to risk of bias [31]. In contrast, studies that use reliable, systematic and validated outcome measures give the possibility to compare different trials and perform a meta-analysis [32]. Another limitation is that the number of prospective randomized controlled trials in the field is low [22, 33–36].…”

Section: Introductionmentioning

confidence: 99%

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Calon

Hoof

Berge

et al. 2016

Trials

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BackgroundOver the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma.MethodsA multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression.The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.DiscussionThis is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement.Trial registrationRegistered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14. Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618. This trial is sponsored by Oticon Medical AB.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1662-0) contains supplementary material, which is available to authorized users.

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“…The frequency of usage of individual instruments is therefore low. This pattern of “many questionnaires in use, yet little consensus” (Granberg, Dahlstrom, et al., 2014) has been confirmed more recently by a scoping review (Barker, MacKenzie, Elliott, & de Lusignan, 2015). Some researchers have developed hearing loss assessment questionnaires that tap into specific domains, such as the social and emotional consequences of hearing loss that are in the HHIE.…”

Section: Introductionmentioning

confidence: 82%

A Data-Driven Synthesis of Research Evidence for Domains of Hearing Loss, as Reported by Adults With Hearing Loss and Their Communication Partners

2017

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A number of assessment tools exist to evaluate the impact of hearing loss, with little consensus among researchers as to either preference or psychometric adequacy. The item content of hearing loss assessment tools should seek to capture the impact of hearing loss on everyday life, but to date no one has synthesized the range of hearing loss complaints from the perspectives of the person with hearing loss and their communication partner. The current review aims to synthesize the evidence on person with hearing loss- and communication partner-reported complaints of hearing loss. Searches were conducted in Cos Conference Papers Index, the Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica Database, PubMed, Web of Science, and Google Scholar to identify publications from May 1982 to August 2015. A manual search of four relevant journals updated the search to May 2017. Of the 9,516 titles identified, 78 records (comprising 20,306 participants) met inclusion criteria and were taken through to data collection. Data were analyzed using meta-ethnography to form domains representing the person with hearing loss- and communication partner-reported complaints of hearing loss as reported in research. Domains and subdomains mutual to both perspectives are related to “Auditory” (listening, communicating, and speaking), “Social” (relationships, isolation, social life, occupational, and interventions), and “Self” (effort and fatigue, emotions, identity, and stigma). Our framework contributes fundamental new knowledge and a unique resource that enables researchers and clinicians to consider the broader impacts of hearing loss. Our findings can also be used to guide questions during diagnostic assessment and to evaluate existing measures of hearing loss.

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Outcome Measurement in Adult Auditory Rehabilitation

Cited by 25 publications

References 37 publications

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

A Data-Driven Synthesis of Research Evidence for Domains of Hearing Loss, as Reported by Adults With Hearing Loss and Their Communication Partners

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