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A Core Outcome Set (COS) is an agreed list of outcomes that are measured and reported in all clinical trials for a particular health condition. An 'e-Delphi' is an increasingly popular method for developing a COS whereby stakeholders are consulted via a multi-round online survey to reach agreement regarding the most important outcomes. Many COS studies seek diverse, international input that includes professionals and healthcare users. However, the recruitment and retention of participants can be deterred by various factors (e.g. language barriers and iterative, time-consuming rounds). This report evaluates the effectiveness of recruitment and retention methods used in the Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study using participant feedback from healthcare users, healthcare practitioners, researchers, commercial representatives and funders. A range of methods were applied to recruit participants to the study and maintain engagement over the three rounds. Feedback on recruitment and retention methods was collected using a twenty-item online questionnaire, with free text comments. A personalised email invitation was the most frequent recruitment route, and 719 professionals and healthcare users consented to take part. Retention of each stakeholder group ranged from 76 to 91% completing all three e-Delphi rounds. Feedback was given by 379 respondents. A majority of respondents were satisfied with the study methods that were implemented to promote retention. Over 55% indicated that their overall experience closely matched their expectations at the start of the study, and over 90% felt that their contribution was appreciated. This report highlights study methods that worked well with respect to recruitment and retention, and those that did not. Findings provide a unique contribution to the growing evidence base of good practice in COS development by demonstrating the relative effectiveness of recruitment and retention methods for an e-Delphi survey. This project was registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The protocol is published in Trials (doi:10.1186/s13063-017-2123-0).

Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints (“outcome domains”) are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. “Tinnitus intrusiveness” was voted in for all three interventions. For sound-based interventions, the minimum set included “ability to ignore,” “concentration,” “quality of sleep,” and “sense of control.” For psychology-based interventions, the minimum set included “acceptance of tinnitus,” “mood,” “negative thoughts and beliefs,” and “sense of control.” For pharmacology-based interventions, “tinnitus loudness” was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.

The need to reform the way in which research is undertaken is clear, with reducing research bureaucracy and waste at the forefront of this issue for the UK government, funding organisations, higher education institutions and wider research community. The aim of this study was to describe researchers’ experiences of the time, effort and burden involved in funding processes–namely applying for research funding and fulfilling reporting requirements. This was an in-depth qualitative study using semi-structured interviews with researchers who had experience applying for funding and/or completing reporting requirements for a UK health and social care research funder between January 2018 and June 2021. Following thematic analysis, five key themes were identified describing researcher experiences of key issues around time, efforts and burden associated with funding processes. These themes encompassed (1) issues with the current funding model for health and social care research, (2) time and effort involved in funding processes, (3) the need for a streamlined end-to-end process, (4) implications for work-life balance, and (5) addressing the need for better support and communication. The findings from this study describe researcher experiences of tasks in the research pathway that currently take considerable time and effort. It was clear that whilst some of this time and effort is considered necessary, some is exacerbated by inefficient and ineffective processes, such as perceived under-funding of research or lack of clarity with regards to funder expectations. This in turn contributes to unnecessary researcher burden, research waste and negative research culture. Better investment in health and social care research and in the researchers themselves who design and deliver the research, alongside improvements in transparency, streamlining and research support could ensure a more positive research culture, and improve the quality of funded research.

ObjectiveTo explore the experiences, current approaches, opinions and awareness of healthcare professionals (HCPs) caring for adults with traumatic brain injury (TBI) regarding the audio-vestibular consequences.Design/settingCross-sectional online survey study.ParticipantsHCPs with experience of caring for adults with TBI, who were not ENT (ear nose throat) specialists or audiologists.MethodsThe study was conducted from May 2022 to December 2022. The online survey consisted of 16 closed and open-text questions in English and Turkish about clinical experience, current approaches and awareness of audio-vestibular consequences following TBI. Frequencies of responses to closed questions and associations between variables were analysed using SPSS V.28. Open-text responses were summarised in Microsoft Excel.ResultsSeventy HCPs participated from 17 professions and 14 countries, with the majority from the UK (42.9%). HCPs stated that ‘some’ to ‘all’ of their patients had auditory problems such as ‘inability to understand speech-in-noise’ (66%), ‘tinnitus’ (64%), ‘hyperacusis’ (57%) and balance problems such as ‘dizziness’ (79%) and ‘vertigo’ (67%). Usually, HCPs asked about the balance status of patients at appointments and when they observed dizziness and/or balance disorder they used screening tests, most commonly finger-to-nose (53%). For auditory impairments, HCPs preferred referring patients with TBI to audiology/ENT services. However, 6% of HCPs felt that audio-vestibular conditions could be ignored on referral because patients with TBI struggled with many impairments. Additionally, 44% would suggest hearing aids to patients with TBI with hearing loss ‘if they would like to use’ rather than ‘definitely’.ConclusionsMany audio-vestibular impairments are observed by HCPs caring for patients with TBI. The assessment and intervention opinions and awareness of HCPs for these impairments vary. However, non-expert HCPs may not be aware of negative consequences of untreated audio-vestibular impairments following TBI. Therefore, developing a simple framework for screening and indications of audio-vestibular impairments for referral may be helpful for non-audiological specialists regularly seeing these patients.

Background There are a large number of assessment tools for tinnitus, with little consensus on what it is important to measure and no preference for a minimum reporting standard. The item content of tinnitus assessment tools should seek to capture relevant impacts of tinnitus on everyday life, but no-one has yet synthesised information about the range of tinnitus complaints. This review is thus the first comprehensive and authoritative collection and synthesis of what adults with tinnitus and their significant others report as problems in their everyday lives caused by tinnitus. Methods Electronic searches were conducted in PubMed, Embase, CINAHL, as well as grey literature sources to identify publications from January 1980 to June 2015 in which participants were enrolled because tinnitus was their primary complaint. A manual search of seven relevant journals updated the search to December 2017. Of the 3699 titles identified overall, 84 records (reporting 86 studies) met our inclusion criteria and were taken through to data collection. Coders collated generic and tinnitus-specific complaints reported by people with tinnitus. All relevant data items were then analyzed using an iterative approach to narrative synthesis to form domain groupings representing complaints of tinnitus, which were compared patients and significant others. Results From the 86 studies analyzed using data collected from 16,381 patients, 42 discrete complaints were identified spanning physical and psychological health, quality of life and negative attributes of the tinnitus sound. This diversity was not captured by any individual study alone. There was good convergence between complaints collected using open- and closed-format questions, with the exception of general moods and perceptual attributes of tinnitus (location, loudness, pitch and unpleasantness); reported only using closed questions. Just two studies addressed data from the perspective of significant others ( n  = 79), but there was substantial correspondence with the patient framework, especially regarding relationships and social life. Conclusions Our findings contribute fundamental new knowledge and a unique resource that enables investigators to appreciate the broad impacts of tinnitus on an individual. Our findings can also be used to guide questions during diagnostic assessment, to evaluate existing tinnitus-specific HR-QoL questionnaires and develop new ones, where necessary. Trial Registration PROSPERO registration number: CRD42015020629 . Protocol published in BMJ Open. 2016;6e009171.

Background Hyperacusis is a chronic condition commonly defined as a lowered tolerance or increased sensitivity to everyday environmental sounds. It has been viewed as a paediatric disorder which can cause significant impairment to a child’s normal functioning. Although clinical guidance highlights the importance of identifying whether the child has intolerance to loud sounds and managing this appropriately, there are currently no assessment or treatment methods that have been designed and tested for use with children with hyperacusis. A review is therefore indicated to consider the profile of children with hyperacusis as a basis for future research into their assessment and treatment. Method A scoping review methodology was followed with literature searches conducted in Embase, PsychINFO, PubMed CENTRAL, Scopus, Web of Science and Google Scholar. Research articles were included if they reported on research studies describing children diagnosed with hyperacusis, providing clinical profile information, and/or reporting on an assessment or management method for children with a primary complaint of hyperacusis. Data were charted on Excel and verified by a second researcher. Twenty-one research articles were included. Results Children with hyperacusis are typically described in terms of age at presentation, troublesome sounds, physical sensation, behavioural reactions, coping strategies, comorbid conditions and impact on daily life. Methods of assessing the children include semi-structured interviews, questionnaires, neurological assessment, observation and uncomfortable loudness levels. Management methods include psychological therapy, sound therapy, tinnitus retraining therapy, medication and neuro-rehabilitation. Conclusion The information we catalogued on various elements of clinical profile, assessment and management can serve as a stepping stone in future research developing questionnaires for clinical measurement of the impact of hyperacusis on children, and the measurement of treatment related change in clinic and in trials. Positive outcomes were noted by the authors following all of the above treatments; future research must compare these and specify the parameters for optimal results.

Introduction: Reporting is a mechanism for funding organisations to monitor and manage the progress, outputs, outcomes, and impacts of the research they fund. Inconsistent approaches to reporting and post-award management, and a growing demand for research information, can lead to perception of unnecessary administrative effort that impacts on decision-making and research activity. Identifying this effort, and what stakeholders see as unmet need for improvement, is crucial if funders and Higher Education Institutions (HEIs) are to streamline their practices and provide better support with reporting activities. In this review, we summarise the processes in post-award management, compare current practices, and explore the purpose of collecting information on funded research. We also identify areas where unnecessary effort is perceived and improvement is needed, using previously reported solutions to inform recommendations for funders and HEIs. Methods: We conducted a scoping review of the relevant research and grey literature. Electronic searches of databases, and manual searches of journals and funder websites, resulted in inclusion of 52 records and 11 websites. Information on HEI and funder post-award management processes was extracted, catalogued, and summarised to inform discussion. Results: Post-award management is a complex process that serves many purposes but requires considerable effort, particularly in the set up and reporting of research. Perceptions of unnecessary effort stem from inefficiencies in compliance, data management and reporting approaches, and there is evidence of needed improvement in mechanisms of administrative support, research impact assessment, monitoring, and evaluation. Solutions should focus on integrating digital systems to reduce duplication, streamlining reporting methods, and improving administrative resources in HEIs. Conclusions: Funders and HEIs should work together to support a more efficient post-award management process. The value of research information, and how it is collected and used, can be improved by aligning practices and addressing the specific issues highlighted in this review.

ObjectiveTo explore researchers’ experiences of funding processes, the effort and burden involved in applying for funding, obtaining funding and/or fulfilling reporting requirements with a UK health and social care research funder.Design/SettingA cross-sectional online survey study with open (free-text) and closed questions (August to November 2021).ParticipantsResearchers with experience of applying for/obtaining funding and/or experience of fulfilling reporting requirements for UK health and social care research funded between January 2018 and June 2021.ResultsThe survey was completed by 182 researchers, of which 176 had experience with applying for/obtaining funding, and 143 had experience with fulfilling reporting requirements during the timeframe. The majority of the 176 respondents (58%) completed between 7 and 13 key processes in order to submit an application and 69% felt that it was critically important to undertake these key processes. Respondents (n=143) reported submitting an average of 17 reports as part of research monitoring to a range of organisations (eg, funders, Higher Education Institutions). However, only 33% of respondents felt it was critically important to provide the requested reporting information to the different organisations. Thematic analysis of free-text questions on application and reporting identified themes relating to process inefficiencies including streamlining and alignment of systems, lack of understanding of processes including a need for improved communication and feedback from organisations with clear explanations about what information is needed, when and why, the support required by respondents and the time, effort and impact on workload and well-being.ConclusionsThrough this study, we were able to identify funding processes that are considered by some to be effortful, but necessary, as well as those that were perceived as unnecessary, complex and repetitive, and may waste some researchers time and effort and impact on well-being. Possible solutions to increase efficiency and enhance value in these processes were identified.

Tinnitus is a prevalent complaint, and people with bothersome tinnitus can report any number of associated problems. Yet, to date, only a few studies, with different populations and relatively modest sample sizes, have qualitatively evaluated what those problems are. Our primary objective was to determine domains of tinnitus problem according to a large clinical data set. This was a retrospective analysis of anonymized clinical data from patients who attended a U.K. Tinnitus Treatment Center between 1989 and 2014. Content analysis was used to code and collate the responses of 678 patients to the clinical interview question “Why is tinnitus a problem?” into categories of problems (domains). We identified 18 distinct domains of tinnitus-associated problems. Reduced quality of life, tinnitus-related fear, and constant awareness were notably common problems. Clinicians need to be mindful of the numerous problem domains that might affect their tinnitus patients. Current questionnaires, as well as being measures of severity, are useful clinical tools for identifying problem domains that need further discussion and possibly measurement with additional questionnaires. The domains identified in this work should inform clinical assessment and the development of future clinical tinnitus questionnaire.

Tinnitus is the awareness of sound in the ear or head in the absence of an external source. It affects around 10%–15% of people, and current treatment options are limited. Experimental treatments include various forms of electrical stimulation of the brain. Currently, there is no consensus on the outcomes that should be measured when investigating the efficacy of this type of intervention for tinnitus.ObjectiveThis study sought to address this issue by establishing a core domain set: a common standard of what specific tinnitus-related complaints are critically important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus.DesignA two-round Delphi survey was conducted, followed by a stakeholder consensus meeting to identify a core domain set. Setting All data collection took place onlineParticipantsParticipants represented one of two stakeholder groups: patients with lived experience of tinnitus and professionals with relevant clinical, commercial or research experience.ResultsStakeholders achieved consensus on the inclusion of ability to ignore, concentration, treatment satisfaction, helplessness (lack of control) and tinnitus intrusiveness in the core domain set, in addition to adverse effects.ConclusionThis study established a core domain set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. This core domain set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.