Is well-becoming important for children and young people? Evidence from in-depth interviews with children and young people and their parents.

PURPOSE: This study explores how important well-becoming factors appear to be to children during childhood. We define well-becoming as the indicators which predict children and young people's future wellbeing and opportunities. The priority for this work was to explore whether well-becoming might be an important factor to include in outcome measures for children and young people. The inclusion of well-becoming indicators could ensure that opportunities to invest in promoting wellbeing in children's futures are not missed. METHODS: In-depth, qualitative interviews (N = 70) were undertaken with children and young people aged 6-15 years and their parents. Analysis used constant comparison and framework methods to investigate whether well-becoming factors were considered important by informants to children and young people's current wellbeing. RESULTS: The findings of the interviews suggested that children and young people and their parents are concerned with future well-becoming now, as factors such as future achievement, financial security, health, independence, identity, and relationships were identified as key to future quality of life. Informants suggested that they considered it important during childhood to aspire towards positive outcomes in children and young people's futures. CONCLUSION: The study findings, taken alongside relevant literature, have generated evidence to support the notion that future well-becoming is important to current wellbeing. We have drawn on our own work in capability wellbeing measure development to demonstrate how we have incorporated a well-becoming attribute into our measures. The inclusion of well-becoming indicators in measures could aid investment in interventions which more directly improve well-becoming outcomes for children and young people.

Development of a brief, generic, modular resource-use measure (ModRUM): piloting with patients.

BACKGROUND: Bespoke self-report resource-use measures (RUMs) are commonly developed or adapted for each new randomised controlled trial. Consequently, RUMs lack standardisation and validation is rarely conducted. A new generic RUM, ModRUM, has been developed using a rigorous process, including consultation with health economists and patients. ModRUM includes a concise core healthcare module, designed to be included in all trials, and depth-adding questions, which can replace or be added to core questions as needed. Modules covering other sectors are under development. The aim of this study was to test the acceptability, feasibility, and criterion and construct validity of the healthcare module of ModRUM. METHODS: Patients who had a recent appointment at their GP practice were invited to complete ModRUM (core module or core module with depth questions), a characteristics form and the EQ-5D-5L. Acceptability was assessed via response rates and questionnaire completion time. Feasibility was assessed by reviewing issues observed in participants' responses and question completion rates. Construct validity was tested via hypothesis testing and known-group analyses, using Wilcoxon rank-sum and Kruskal-Wallis tests, and a generalised linear model. Criterion validity was tested by comparing ModRUM results with primary care medical records. Sensitivity, specificity, and agreement using Lin's concordance correlation coefficient (pc) were estimated. RESULTS: One hundred patients participated from five GP practices in the South-West of England. Acceptability was higher for the core module (20% versus 10% response rate). Question completion rates were high across both versions (> 90%). Some support was observed for construct validity, with results suggesting that healthcare costs differ dependent on the number of long-term conditions (p < 0.05) and are negatively associated with health-related quality of life (p < 0.01). Sensitivity was high for all questions (> 0.83), while specificity varied (0.33-0.88). There was a good level of agreement for GP contacts and costs, and prescribed medication costs (pc > 0.6). CONCLUSION: This study provided preliminary evidence of the acceptability, feasibility, and criterion and construct validity of ModRUM. Further testing is required within trials and with groups that were less well represented in this study.

Challenges in developing capability measures for children and young people for use in the economic evaluation of health and care interventions.

Methods for measuring outcomes suitable for economic evaluations of health and care interventions have primarily focused on adults. The validity of such methods for children and young people is questionable in areas including the outcome domains measured and how they are measured and valued, with most existing measures narrowly focusing on health. Novel methods for assessing benefits beyond health by focusing on a person's capability have also concentrated on adults to date. This paper aims to set out the rationale for capability measures in children and young people. It argues for the need to expand the evaluative space beyond health functioning towards broader capabilities, with children and young people playing an integral role in capability measure development. Drawing from existing literature, specific challenges related to the identification, measurement, and valuation of capabilities in children and young people are also discussed. Finally, the practical implications for conducting economic evaluation when measuring and valuing capabilities at different stages across the life-course are illustrated. We develop an alternative framework based on conceiving capabilities as evolving across the life-course. This framework may also be helpful in thinking about how to model health outcomes across the life-course.

Measuring capability wellbeing in adults at different stages of life for use in economic evaluation of health and care interventions: a qualitative investigation in people requiring kidney care.

PURPOSE: Capability wellbeing measures, such as the ICECAP measures, have been proposed for use in economic evaluations to capture broader outcomes of health and care interventions. The ICECAP measures have been developed to reflect capabilities at different stages of life. Some patient groups include patients of different ages and at different stages of life, so it is not always apparent which ICECAP measure is most relevant. This study explores the impact of age and life stage on completion, where both ICECAP-A and ICECAP-O were completed by the same patient. METHODS: A think-aloud study, and an associated semi-structured interview were conducted with people receiving kidney care as a renal outpatient, kidney transplant outpatient, or through receiving facility-based haemodialysis. Qualitative analysis focused on (1) differences in responses across measures by individuals, where attributes had conceptual overlap, (2) key factors in self-reported capability levels, and (3) measure preference. RESULTS: Thirty participants were included in the study, with a mix of older and younger adults. Attributes with similar wording across measures produced similar responses compared to attributes where wording differed. Age and health were key factors for self-reported capability levels. ICECAP-A was slightly preferred overall, including by older adults. CONCLUSION: This study suggests use of ICECAP-A in patients with certain chronic health conditions that include a mix of adults across the life course. This study highlights the importance of considering the stage of life when using capability measures and in economic evaluations of health and care interventions more generally.

Development of a brief, generic, modular resource-use measure (ModRUM): cognitive interviews with patients.

BACKGROUND: Self-report resource-use measures (RUMs) are often used to collect healthcare use data from participants in healthcare studies. However, RUMs are typically adapted from existing measures on a study-by-study basis, resulting in a lack of standardisation which limits comparability across studies. Psychometric testing of RUMs is rarely conducted. This paper reports on cognitive interviews with patients to test the content validity and acceptability of a new RUM (ModRUM). ModRUM is a brief, generic RUM with a core module on healthcare use and questions/modules to increase depth and breadth. METHODS: A purposeful sampling strategy with maximum variation was used to recruit patients from primary care to participate in "think-aloud" interviews with retrospective probing. Participants verbalised their thought processes as they completed ModRUM, which allowed errors (issues with completion) to be identified. The interviewer asked follow-up and probing questions to investigate errors, clarity and acceptability. Interviews were audio-recorded and transcribed verbatim. Research team members independently scored transcripts to identify errors in comprehension, recall, judgement and response. Members met to agree on final scores. Interview transcripts were analysed qualitatively using techniques of constant comparison, to identify common themes and ideas for improvement. Data collection and analysis were performed concurrently and in rounds. RESULTS: Twenty participants were interviewed between December 2019 and March 2020. Interviews were conducted in three rounds, with revisions made iteratively and in response to interview findings. Seven participants completed the core module and 13 completed the core module plus depth questions. Of 71 issues, 28 were in comprehension, 14 in retrieval, 10 in judgement, 18 in response and 1 uncategorised. Most issues (21 issues by 2 participants) were due to participants including family healthcare use. Other issues included using incorrect recall periods (5 issues) and overlooking questions leading to missing responses (9 issues). Common participant suggestions included highlighting important details and providing additional definition or examples for some terms. The length, content and layout were acceptable to most participants. CONCLUSIONS: A generic RUM is needed to increase study comparability. RUM development requires thorough testing to demonstrate and enhance validity. Cognitive interviewing has demonstrated the acceptability and content validity of ModRUM.

Key Insights into Developing Qualitative Concept Elicitation Work for Outcome Measures with Children and Young People.

Qualitative concept elicitation can develop meaningful patient-reported outcome measures for children and young people; however, the methods used for concept elicitation are often underreported for this population. This paper provides in-depth insight into the methods used for concept elicitation with children and young people, with a focus on key stages of concept elicitation that are challenging or unique to doing this research with children. Drawing on our experiences of developing wellbeing measures for children and young people aged 6-15 years, we detail the processes followed in our qualitative concept elicitation work, covering issues related to sampling and recruitment, encouraging informed assent and freedom over children and young people's involvement in concept elicitation, and the use of creative and participatory methods to develop measure items. We provide reflections on the approaches taken to navigate challenging aspects of concept elicitation with children and young people. Our reflections suggest that using existing links and online recruitment methods can help to navigate organisational gatekeepers, and using appropriate processes to develop study information and obtain informed assent can ensure that research is inclusive and that children have the freedom to decide whether to be involved. Our adaptation of a creative and participatory activity to generate concepts for measure items suggests that such approaches can be engaging and may help to give children greater control over their participation. In detailing our methods, we hope to have developed a useful resource for other researchers, while highlighting the value of transparent reporting in this area.

Identification and prioritisation of items for a draft participant-reported questionnaire to measure use of social care, informal care, aids and adaptations.

BACKGROUND: Resource-use measurement is integral for assessing cost-effectiveness within trial-based economic evaluations. Methods for gathering resource-use data from participants are not well developed, with questionnaires typically produced for each trial and rarely validated. The healthcare module of a generic, modular resource-use measure, designed for collecting self-report resource-utilisation data, has recently been developed in the UK. The objective of this research is to identify and prioritise items for new, bolt-on modules, covering informal care, social care and personal expenses incurred due to health and care needs. METHODS: Identification and prioritisation, conducted between April and December 2021, involved a rapid review of questionnaires included in the Database of Instruments for Resource Use Measurement and economic evaluations published from 2011 to 2021 to identify candidate items, an online survey of UK-based social care professionals to identify omitted social care items and focus groups with UK-based health economists and UK-based people who access social care services either for themselves or as carers to prioritise items. RESULTS: The review identified 203 items. Over half of the 24 survey respondents reported no missing items. Five academic health economists and four people who access social care services participated in focus groups. Feedback shaped the social and informal care modules and indicated that no specific personal expenses were essential to collect in all trials. Aids/adaptations were highlighted as costly personal expenses when relevant; therefore, the personal expenses module was narrowed to aids/adaptations only. CONCLUSION: Draft informal care, social care and aids/adaptations modules were developed, ready for further testing.

Estimating loss in capability wellbeing in the first year of the COVID-19 pandemic: a cross-sectional study of the general adult population in the UK, Australia and the Netherlands.

OBJECTIVES: To estimate capability wellbeing lost from the general adult populations in the UK, Australia and the Netherlands in the first year of the COVID-19 pandemic and the associated social restrictions, including lockdowns. DESIGN: Cross-sectional with recalled timepoints. SETTING: Online panels in the UK, Australia and the Netherlands conducted in February 2021 (data collected 26 January-2 March 2021). PARTICIPANTS: Representative general adult (≥ 18 years old) population samples in the UK (n = 1,017), Australia (n = 1,011) and the Netherlands (n = 1,017) MAIN OUTCOME MEASURE: Participants completed the ICECAP-A capability wellbeing measure in February 2021, and for two recalled timepoints during the initial lockdowns in April 2020 and in February 2020 (prior to COVID-19 restrictions in all three countries). ICECAP-A scores on a 0-1 no capability-full capability scale were calculated for each timepoint. Societal willingness to pay estimates for a year of full capability (YFC) was used to place a monetary value associated with change in capability per person and per country. Paired t tests were used to compare changes in ICECAP-A and YFC from pre- to post-COVID-19-related restrictions in each country. RESULTS: Mean (standard deviation) loss of capability wellbeing during the initial lockdown was 0.100 (0.17) in the UK, 0.074 (0.17) in Australia and 0.049 (0.12) in the Netherlands. In February 2021, losses compared to pre-lockdown were 0.043 (0.14) in the UK, 0.022 (0.13) in Australia and 0.006 (0.11) in the Netherlands. In monetary terms, these losses were equivalent to £14.8 billion, AUD$8.6 billion and €2.1 billion lost per month in April 2020 and £6.4 billion, A$2.6 billion and €260 million per month in February 2021 for the UK, Australia and the Netherlands, respectively. CONCLUSIONS: There were substantial losses in capability wellbeing in the first year of the COVID-19 pandemic. Future research is required to understand the specific impact of particular COVID-19 restrictions on people's capabilities.

A Systematic Review of the Use and Quality of Qualitative Methods in Concept Elicitation for Measures with Children and Young People.

BACKGROUND: Qualitative research is recommended in concept elicitation for patient-reported outcome measures to ensure item content validity, and those developing measures are encouraged to report qualitative methods in detail. However, in measure development for children and young people, direct research can be challenging due to problems with engagement and communication. OBJECTIVES: The aim of this systematic review was to (i) explore the qualitative and adapted data collection techniques that research teams have used with children and young people to generate items in existing measures and (ii) assess the quality of qualitative reporting. METHODS: Three electronic databases were searched with forward citation and reference list searching of key papers. Papers included in the review were empirical studies documenting qualitative concept elicitation with children and young people. Data on qualitative methods were extracted, and all studies were checked against a qualitative reporting checklist. RESULTS: A total of 37 studies were included. The quality of reporting of qualitative approaches for item generation was low, with information missing on sampling, data analysis and the research team, all of which are key to facilitating judgements around measure content validity. Few papers reported adapting methods to be more suitable for children and young people, potentially missing opportunities to more meaningfully engage children in concept elicitation work. CONCLUSIONS: Research teams should ensure that they are documenting detailed and transparent processes for concept elicitation. Guidelines are currently lacking in the development and reporting of item generation for children, with this being an important area for future research.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI).

BACKGROUND: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention-the QuinteT Recruitment Intervention (QRI)-to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren's contracture (the HAND-1 study). METHODS: The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges. RESULTS: Two key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target. CONCLUSIONS: Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a "head start" in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in "real-time" as recruitment proceeds.

Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care.

BACKGROUND: Recruitment to randomised controlled trials (RCTs) is challenging. Pre-trial qualitative research provides insights into the feasibility and acceptability of proposed trial designs and delivery; however, this is rarely conducted. This paper reports on work undertaken in advance of the Prepare for Kidney Care trial (formerly PrepareME), which compares preparing for dialysis with preparing for conservative care for patients with chronic kidney disease. The paper describes how the findings refined plans for the forthcoming trial. METHODS: Semi-structured interviews were undertaken with health-care professionals involved in delivering or recruiting to the trial. Interview findings were considered in relation to observations of a patient advisory group workshop and introductory site visits, which were set up to present the trial to professionals involved in the internal pilot phase of the RCT. The use of findings and input from multiple sources was intended to support suggested refinements to the forthcoming trial. The findings were fed back to the trial management group and other expert stakeholders. RESULTS: Sixteen health-care professionals were interviewed, and one patient advisory group workshop and six introductory visits to sites involved in the internal pilot were observed. The professionals interviewed included renal consultants, nurses and renal social workers. Key themes identified from the interviews, supported by the observations, were concerns around the eligibility criteria, the feasibility of the trial intervention, imbalances in the presentation of the trial arms, and anticipated recruitment issues arising from patients' and clinicians' preferences for one arm or the other. Changes to the design were made in response, including to the content of the intervention, the presentation of the trial arms and the name of the RCT. CONCLUSIONS: This study highlights the value of carrying out pre-trial work with health-care professionals to identify issues with delivering the proposed trial. This work can be particularly valuable in trials of new interventions, for which the barriers to their integration into routine care are unknown. This work has important implications for facilitating the identification of further obstacles in the main RCT. We suggest that pre-trial qualitative work is undertaken to address design issues early on, in addition to ongoing qualitative research to monitor the emergence of obstacles affecting recruitment.

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation.

OBJECTIVE: To evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements "QRI actions" to address these as recruitment proceeds. STUDY DESIGN AND SETTING: A mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators. RESULTS: Five UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. CONCLUSION: There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

Understanding and Identifying Key Issues with the Involvement of Clinicians in the Development of Decision-Analytic Model Structures: A Qualitative Study.

INTRODUCTION: Decision-analytic models play an essential role in informing healthcare resource allocation decisions; however, their value to decision makers will depend on model structures being clinically valid to determine cost-effectiveness recommendations. Clinician involvement can help modellers to develop clinically valid but straightforward structures; however, there is little guidance available on methods for clinician input to model structure. This study aims to provide an in-depth exploration of clinician involvement in structural development, highlighting key issues and generating recommendations to optimise practices. METHODS: A qualitative study was undertaken with a range of modellers and clinicians working in different modelling contexts. In-depth interviews and case studies using observations were carried out to understand how clinicians are involved in model structural development and to identify problems and optimal approaches from informants' perspectives. RESULTS: Twenty-four interviews and two case studies were undertaken with modellers and modelling teams. Key issues included the number and diversity of clinicians contributing to structural development, potentially impacting the generalisability of structures, and problems with clinician understanding of important information to contribute to model pathways. Modellers and clinicians suggested that clinician training in modelling could enhance structural processes. CONCLUSIONS: Recommendations to optimise current practices include recruiting clinicians from a variety of backgrounds and using discussions between experts to develop valid and generalisable structures. Future research should focus on developing training materials for clinicians and finding ways to help modellers recruit clinicians from different settings.

Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention.

OBJECTIVES: The objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. STUDY DESIGN AND SETTING: One of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments. RESULTS: Sixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1-6.9 and after 6.9-8.2 (scale 0-10, all 95% confidence intervals are above 0 and all P-values <0.05)]. Awareness of hidden challenges of recruitment following training was high-surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0-10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made "a lot" of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences. CONCLUSION: Surgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent.

How Qualitative Methods Can be Used to Inform Model Development.

Decision-analytic models play a key role in informing healthcare resource allocation decisions. However, there are ongoing concerns with the credibility of models. Modelling methods guidance can encourage good practice within model development, but its value is dependent on its ability to address the areas that modellers find most challenging. Further, it is important that modelling methods and related guidance are continually updated in light of any new approaches that could potentially enhance model credibility. The objective of this article was to highlight the ways in which qualitative methods have been used and recommended to inform decision-analytic model development and enhance modelling practices. With reference to the literature, the article discusses two key ways in which qualitative methods can be, and have been, applied. The first approach involves using qualitative methods to understand and inform general and future processes of model development, and the second, using qualitative techniques to directly inform the development of individual models. The literature suggests that qualitative methods can improve the validity and credibility of modelling processes by providing a means to understand existing modelling approaches that identifies where problems are occurring and further guidance is needed. It can also be applied within model development to facilitate the input of experts to structural development. We recommend that current and future model development would benefit from the greater integration of qualitative methods, specifically by studying 'real' modelling processes, and by developing recommendations around how qualitative methods can be adopted within everyday modelling practice.

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

CONTEXT: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. OBJECTIVE: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. EVIDENCE ACQUISITION: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. EVIDENCE SYNTHESIS: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. CONCLUSIONS: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. PATIENT SUMMARY: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

Does laryngeal reinnervation or type I thyroplasty give better voice results for patients with unilateral vocal fold paralysis (VOCALIST): study protocol for a feasibility randomised controlled trial.

INTRODUCTION: A functioning voice is essential for normal human communication. A good voice requires two moving vocal folds; if one fold is paralysed (unilateral vocal fold paralysis (UVFP)) people suffer from a breathy, weak voice that tires easily and is unable to function normally. UVFP can also result in choking and breathlessness. Current treatment for adults with UVFP is speech therapy to stimulate recovery of vocal fold (VF) motion or function and/or injection of the paralysed VF with a material to move it into a more favourable position for the functioning VF to close against. When these therapies are unsuccessful, or only provide temporary relief, surgery is offered. Two available surgical techniques are: (1) surgical medialisation; placing an implant near the paralysed VF to move it to the middle (thyroplasty) and/or repositioning the cartilage (arytenoid adduction) or (2) restoring the nerve supply to the VF (laryngeal reinnervation). Currently there is limited evidence to determine which surgery should be offered to adults with UVFP. METHODS AND ANALYSIS: A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life. ETHICS AND DISSEMINATION: Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial. TRIAL REGISTRATION NUMBER: ISRCTN90201732; 16 December 2015.