Development of the impact of tinnitus in children questionnaire (iTICQ)

Introduction: Tinnitus is a common disorder of the auditory system. Questionnaires are essential tools for clinical assessment and research. Whilst many questionnaires are available to measure different aspects of tinnitus complaint in adults, there is currently no self-report questionnaire measure of tinnitus that has been developed for or is suitable for use with children. This study describes the development of the first self-report measure of tinnitus impact for children aged 8–16 years old. Methods: Two phases of questionnaire development were conducted. In Phase 1 children's tinnitus-related problems were elicited from interviews with children with tinnitus (n = 11; aged 9–16 years old), parents (n = 5), and clinicians (n = 8). Interview transcripts were analyzed using qualitative content analysis. Findings were combined with problems identified by the clinical co-authors, researchers, and clinicians in a conference workshop, and those previously reported in service evaluation of UK National Health Service pediatric tinnitus services and in a scoping review. From this, a conceptual framework of tinnitus impact on health-related quality of life in children was developed. Based on the conceptual framework, a 38-item pilot questionnaire was drafted. In Phase 2, content validity of the pilot questionnaire was assessed in cognitive interviews with six children who had tinnitus (aged 8–15 years old) and an online survey with clinicians working in pediatric tinnitus services (n = 8 services and 28 clinicians). Finally, readability assessments were conducted. Feedback led to iterative revisions to the questionnaire. The final questionnaire was named the Impact of Tinnitus in Children Questionnaire (iTICQ). Results: The iTICQ contains three scene setting (non-scoring) items, and 33 scoring items covering six domains of tinnitus impact: Sleep and Feeling Tired, Learning, Emotional Health, Hearing and Listening, Taking Part, and Relationships. Conclusions: The iTICQ is a new self-report measure of tinnitus impact that can be self-completed by children aged 8–16 years old. It shows good content validity and can be used to measure problem severity across the domains of core relevance to children with tinnitus. Further validation studies and translations of the iTICQ are indicated to determine its psychometric properties in different child populations and to make it widely accessible

A systematic review of techniques and effects of self-help interventions for tinnitus: application of taxonomies from health psychology

Objective: Self-help interventions are followed by people independently with minimal or no therapist contact. This review aims to assess the effectiveness of self-help interventions for adults with chronic tinnitus and systematically identify the self-help techniques used. Design: Systematic review and application of health psychology taxonomies. Electronic database searches were conducted, supplemented by citation searching and hand-searching of key journals. Prospective controlled trials, which used measures of tinnitus distress, functional management, anxiety, depression, and quality of life, were included. Michie et al’s behaviour change techniques (BCTs) taxonomy and Taylor et al’s PRISMS taxonomy of self-management components were applied to describe interventions. Study sample: Five studies were included, providing low-to-moderate levels of evidence. Results: Randomized controlled trial studies were too few and heterogeneous for meta-analysis to be performed. Studies comparing self-help interventions to therapist-guided interventions and assessing non tinnitus-specific psychosocial outcomes and functional management were lacking. Fifteen BCTs and eight self-management components were identified across interventions. Conclusions: A lack of high-quality and homogeneous studies meant that confident conclusions could not be drawn regarding the efficacy of self-help interventions for tinnitus. Better reporting and categorization of intervention techniques is needed for replication in research and practice and to facilitate understanding of intervention mechanisms

Core outcome domains for early-phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus

Background: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is therefore to develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods: The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed methods approach that incorporates input from healthcare users at the pre-Delphi stage, a modified three round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following core outcome set publication. Discussion: The COMIT’ID study aims to develop a Core Outcome Domain Set that are agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the core outcome set in the long term. Trial registration: This project has been registered in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative

Applying multi-phase DES approach for modelling the patient journey through accident and emergency departments

Accident and Emergency departments (A&ED) are in charge of providing access to patients requiring urgent acute care. A&ED are difficult to model due to the presence of interactions, different pathways and the multiple outcomes that patients may undertake depending on their health status. In addition, public concern has focused on the presence of overcrowding, long waiting times, patient dissatisfaction and cost overruns associated with A&ED. There is then a need for tackling these problems through developing integrated and explicit models supporting healthcare planning. However, the studies directly concentrating on modelling the A&EDs are largely limited. Therefore, this paper presents the use of a multi-phase DES framework for modelling the A&ED and facilitating the assessment of potential improvement strategies. Initially, the main components, critical variables and different states of the A&ED are identified to correctly model the entire patient journey. In this step, it is also necessary to characterize the demand in order to categorize the patients into pipelines. After this, a discrete-event simulation (DES) model is developed. Then, validation is conducted through the 2-sample t test to demonstrate whether the model is statistically comparable with the real-world A&ED department. This is followed by the use of Markov phase-type models for calculating the total costs of the whole system. Finally, various scenarios are explored to assess their potential impact on multiple outcomes of interest. A case study of a mixed-patient environment in a private A&E department is provided to validate the effectiveness of the multi-phase DES approach

Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains

Background Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology (‘Delphi’ survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains. Methods Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform. Results Insights gained from the workshops and survey feedback prompted substantial, unforeseen modifications to the long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment exceeded the target by 171%, there were equivalent numbers of patient and professional participants (n=358 and n=312, respectively), feedback was mostly positive, and retention was high (87%). Conclusions Patient involvement was an integral and transformative step of the study design process. Patient involvement was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were many comments about a positive participatory experience. Seven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers

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

BACKGROUND: There 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. METHODS: Records 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. RESULTS: Two 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. CONCLUSIONS: Our 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 REGISTRATION: The 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 MATERIAL: The online version of this article (doi:10.1186/s13063-016-1399-9) contains supplementary material, which is available to authorized users

New simulants for martian regolith: Controlling iron variability

Existing martian simulants are predominantly based on the chemistry of the average ‘global’ martian regolith as defined by data on chemical and mineralogical variability detected by orbiting spacecraft, surface rovers and landers. We have therefore developed new martian simulants based on the known composition of regolith from four different martian surface environments: an early basaltic terrain, a sulfur-rich regolith, a haematite-rich regolith and a contemporary Mars regolith. Simulants have been developed so that the Fe2+/Fe3+ ratios can be adjusted, if necessary, leading to the development of four standard simulants and four Fe-modified simulants. Characterisation of the simulants confirm that all but two (both sulfur-rich) are within 5 wt% of the martian chemistries that they were based on and, unlike previous simulants, they have Fe2+/Fe3+ ratios comparable to those found on Mars. Here we outline the design, production and characterisation of these new martian regolith simulants. These are to be used initially in experiments to study the potential habitability of martian environments in which Fe may be a key energy source