The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness.

BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions. METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting. RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set. CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.

Redesigning a Web-Based Stakeholder Consensus Meeting About Core Outcomes for Clinical Trials: Formative Feedback Study.

BACKGROUND: Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes make it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended, comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study. OBJECTIVE: This study aims to evaluate the modifications made by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol. METHODS: The study team worked with health care users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving the key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experiences of the 22 participating members. Feedback covered premeeting preparation, the process of facilitated discussions and voting, ability to contribute, and perceived fairness of the outcome. RESULTS: Overall, 98% (53/54) of feedback responses agreed or strongly agreed with the statements given, indicating that the web-based meeting achieved its original goals of open discussion, debate, and voting to agree with a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and management of the unpredictability of tasks on the day. CONCLUSIONS: Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximize inclusiveness, enhance geographical access, and reduce research costs.

Talk to us! Communication is a key factor in improving the comfort of MRI research participants.

CONTEXT: Magnetic resonance imaging (MRI) is an invaluable diagnostic and research tool. Having an MRI scan is not always comfortable and may deter people from taking part in MRI research. Maximizing comfort during scanning will improve participants' experiences and image quality. OBJECTIVE: To define which factors improve comfort during an MRI scan for research by asking people who have participated in MRI research. SETTING AND PARTICIPANTS: People who had participated in MRI research during the past two years were invited, as 'public advisors' to discuss their experiences together and agree on which factors are most important in ensuring comfort while participating in MRI research. RESULTS: Public advisors ranked researcher-participant communication as the most important factor. In response, an example script to guide MRI researchers in communicating with participants was developed through close consultation between research staff, public advisors and the public. This outlines the often-missing information necessary to convey to participants, including explaining the reasons behind instructions, managing expectations, providing reassurance, encouragement and progress updates during scanning. CONCLUSIONS: Drawing upon personal experiences as MRI research participants, public advisors highlighted the importance of effective and on-going researcher communication throughout. The example script may be used as a training tool for researchers to help ensure participants' comfort during scanning. PATIENT AND PUBLIC CONTRIBUTION: All contributors had previously taken part in MRI research. The project was co-designed, co-delivered and co-authored with a public research partner. Public advisors agreed key factors of importance. External public reviewers and public advisors reviewed example script drafts.

Correction to: Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey.

Following the publication of our article [1], the authors have notified us of a typo in the third bullet point of the Consensus Criteria section.

Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey.

BACKGROUND: Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions. METHODS/DESIGN: The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked. DISCUSSION: The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.

The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults.

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.

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

PLAIN ENGLISH SUMMARY: Outcome domains are aspects of a condition that matter to patients and clinicians and can be measured to assess treatment effects. For tinnitus, examples include 'tinnitus loudness' and 'ability to concentrate'. This study focuses on the first stage of agreeing which outcome domains should be measured in all clinical trials of tinnitus. Crucially, it involves identifying outcome domains, prior to a voting process. This article describes how we effectively involved patients in that study design process, and reflects on the impact of their input.The study first compiled a long list of all possible outcome domains before asking interested parties, including patients, to vote which ones to include. Ensuring patients fully participate in this process holds unique challenges as it can be long, repetitive and its purpose far removed from their needs. These challenges may be addressed by involving patients in designing the research. There is evidence that other research teams are doing this, but its reporting is not detailed enough to guide others. Our paper seeks to address this.We describe how we involved patients (people living with tinnitus) in creating a long list of outcome domains that we included in our study. We also reflect on the benefits this brought. Two patients partnered with us in designing the survey. We also consulted an independent patient review panel. Involving patients reduced the list of domains included in the survey and made domain names and associated descriptions clearer. Our resulting survey performed well in recruiting and retaining patients as participants. ABSTRACT: 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.

Co-producing public involvement training with members of the public and research organisations in the East Midlands: creating, delivering and evaluating the lay assessor training programme.

PLAIN ENGLISH SUMMARY: Members of the public share their views with researchers to improve health and social care research. Lay assessing is one way of doing this. This is where people, drawing upon personal and general life experience, comment on material, such as grant applications and patient information, to highlight strengths and weaknesses and to suggest improvements. This paper reports on setting up a training programme for lay assessors. Meetings were held between interested public and staff from research organisations. People discussed what lay assessing is, why they want to do it, skills and support needed and if training was wanted. They were invited to form a group to develop the training together. Training was delivered in the East Midlands. People who attended gave their thoughts about it by completing questionnaires and joining a feedback event. The group developed the structure of the training programme together and it oversaw the development of the training content by individual members. People who attended training reported feeling more confident about lay assessing. This was particularly so for those who had not done lay assessing before. They indicated how valuable it was to talk with others at the training. Our findings support the National Institute for Health Research recommendations for improving learning and development for public involvement in research. This project has created a solid base for local research organisations to work together in public involvement training. Lay assessor training is now part of a wider programme of shared resources called the Sharebank. ABSTRACT: Background Involving members of the public in research can improve its quality and incorporate the needs and views of patients. One method for doing this is lay assessing, where members of the public are consulted to improve research materials. This paper documents the establishment of a pilot training programme for lay assessors. It describes a way of working that embodies a regional, cross-organisational approach to co-producing training with members of the public. Methods Open meetings, led by AH, were held for existing and aspiring lay assessors to define lay assessing, motivations for doing it, skills required, associated learning and development needs, and to gauge interest for training. Those who attended meetings, including members of the public and staff, were invited to form a working group to co-produce the training programme. Training was delivered in modules at two centres in the East Midlands and evaluated through participant feedback at the end of each module and at an evaluation event. Feedback was through a mix of Likert scale scoring, open text and verbal responses. Results Discussions from the open meetings informed the development of the training by the working group. Led by AH, the working group, as a whole, co-produced the structure and format of the training and oversaw training content development by individuals within the group. Training was well-received by participants. Feedback through Likert scoring (n = 14) indicated higher feelings of confidence in knowledge of relevant subject matter and in fulfilling the lay assessor role, particularly amongst those who had not done lay assessing before. Opportunities that the training afforded for interaction between participants - sharing of varied experiences and knowledge - and a 'learn by doing' approach was of particular value, as indicated by 10 responses to open-ended questions. Conclusions This project has created a solid foundation for collaboration between research organisations in the East Midlands in devising and delivering training in public involvement together. Our evaluation provides evidence in support of National Institute for Health Research (NIHR) recommendations on principles for learning and development for public involvement in research.

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 health care 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 is 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 (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative.

Going the extra mile - creating a co-operative model for supporting patient and public involvement in research.

PLAIN ENGLISH SUMMARY: In 2014, the Chief Medical Officer and Director General of Research and Development commissioned a review of patient and public involvement in the National Institute for Health Research. The report on this review, entitled 'Going the Extra Mile' was published in March, 2015. It described the bold goal of expecting all people using health and social care, and increasing numbers of the public, to be aware of and choosing to be involved in research. This requires more effort to build public awareness of research and better support for the public and researchers to do patient and public involvement in research. The author has created a new way of providing support for patient and public involvement based on co-operation between organisations. Termed 'share-banking', this model pools limited resources across organisations to deliver a regional programme of support activities for patient and public involvement over the long term. This includes helping organisations to share and learn from each other to avoid 're-inventing wheels' (where separate organisations each develop the same thing from the beginning). The 'Going the Extra Mile' report recommends that local organisations should work together to deliver public involvement activities across a region. 'Share-banking' should help fulfil this recommendation. ABSTRACT: The 'Going the Extra Mile' final report opened with the ambition to increase the public's awareness, participation and involvement in research. It stated the need for public and researchers to be better supported to do public involvement. A new co-operative model, termed 'share-banking', has been developed whereby organisations pool limited resources to create and sustain support for patient and public involvement in research. This should fulfil the 'Going the Extra Mile' report's recommendation to take a collaborative, cross-organisational and regional approach to public involvement.

Placing interprofessional learning at the heart of improving practice: the activities and achievements of CLAHRC in Leicestershire, Northamptonshire and Rutland.

BACKGROUND: The National Institute for Health Research initiative 'collaborations for leadership in applied health research and care' (CLAHRC) in Leicestershire Northamptonshire and Rutland (LNR) is a partnership between the University of Leicester and NHS trusts in LNR that aims to reduce the second gap in translation (the long delay between conducting research and it having an impact on clinical practice). METHOD: CLAHRC-LNR appointed specialist staff as boundary spanners and knowledge brokers to improve links between academia and the NHS, and to facilitate a range of activities designed to increase the implementation of research evidence. An interprofessional and interdisciplinary approach is used and incorporates a range of activities including: applied research, service evaluation and pilot projects, education and training events, knowledge dissemination activities and developing networks to increase the use of research in the NHS partners. RESULTS: CLAHRC-LNR's close collaboration with partner NHS trusts has aided the development of a programme of applied research that aims to develop interprofessional teamworking to improve healthcare systems and patient outcomes. Co-ordinators (boundary spanners) have been appointed in trusts and have been crucial in facilitating interprofessional working. Activities include a successful programme of training and education courses within the NHS partner trusts using the principles of interprofessional education. CLAHRC-LNR is developing the use of knowledge exchange events and workshops as well as establishing communities of practice to bring together professionals from across LNR NHS trusts and the University of Leicester to share their expertise and build interprofessional relationships. CLAHRC fellows (knowledge brokers) are being appointed to work with co-ordinators to facilitate the use of research evidence in decision making in the trusts and clinical commissioning groups (CCGs). CONCLUSION: Interprofessional working is integral to the approach adopted by CLAHRC-LNR, running through many of its activities, and is proving vital to addressing and helping to close the second gap in translation.

Promotion of human dermal fibroblast migration, matrix remodelling and modification of fibroblast morphology within a novel 3D model by Lucilia sericata larval secretions.

Lucilia sericata larvae, or green bottle fly maggots are applied to chronic wounds to aid healing. Previously, our laboratory has characterized the enzymatic activities present within maggot excretions/secretions (ES). Since then, we have related these to the degradation of extracellular matrix components, alteration of human, dermal fibroblast adhesion to surfaces and the stimulation of fibroblast migration within a two-dimensional in vitro assay. In this study, we developed a novel three-dimensional in vitro assay in which to observe fibroblast migration and morphology in response to maggot ES. Here, primary human foreskin fibroblasts were embedded within collagen gels containing fibronectin. Phase contrast and confocal microscopy were used in conjunction with image analysis software to examine and quantify aspects of fibroblast behavior. Our results showed that maggot ES stimulated fibroblast migration through the matrix and induced altered cell morphologies. Remodelling of the extracellular matrix located between individual fibroblasts was also induced, providing a mechanism by which cells may detect each other's presence over considerable distances. Thus, mechanisms by which maggots enhance tissue formation within wounds may be via the promotion of fibroblast motility, acceleration of extracellular matrix remodelling and coordination of cellular responses.

Maggots and wound healing: an investigation of the effects of secretions from Lucilia sericata larvae upon the migration of human dermal fibroblasts over a fibronectin-coated surface.

Lucilia sericata larvae, or greenbottle fly maggots, placed within chronic wounds have been observed to remove necrotic tissue and infection. They are also believed to actively promote granulation tissue formation. Interactions between fibroblasts and the surrounding extracellular matrix play a crucial role in tissue formation, influencing fibroblast proliferation, migration, and tissue remodeling. For example, the strength of cell adhesion to surfaces coated with extracellular matrix influences cell motility. L. sericata larval excretory/secretory products having previously been shown to modify fibroblast adhesion to collagen and particularly fibronectin, it was hypothesized that these products would alter fibroblast migration. This was investigated using a two-dimensional in vitro wound assay, time-lapse digital photography, enzyme class-specific substrates and inhibitors, and gel electrophoresis. Results showed that L. sericata excretory/secretory products promoted fibroblast migration upon a fibronectin-coated surface. This was related to the degradation of fibronectin by serine proteinases within maggot excretion/secretions. The presence of a metalloproteinase activity may also have played a role. Thus, a possible mechanism by which maggots enhance tissue formation within wounds may be via the promotion of fibroblast motility, providing for a wider distribution of viable fibroblasts.