Title: Pre and post-operative voice therapy: Complex intervention development and feasibility of a voice therapy programme for adults undergoing phonosurgery for benign vocal fold lesions
Funder: Health Education England

Abstract: BackgroundVoice disorders affect one in three people during their lifetime. Consequential time off work alone costs the UK 200 million each year and direct healthcare costs in the US are calculated at 10-11billion per year, comparable with COPD and diabetes. Patients suffer considerable social, emotional and financial consequences. Benign vocal fold lesions (BVFLs) such as polyps and cysts account for up to 68% of those seeking help for voice disorders. Over 6500 surgical procedures are undertaken in England each year to remove BVFLs and emerging evidence suggests that the best outcomes occur when surgery is accompanied by voice therapy. Voice therapy intervention is likely to speed up recovery (facilitating return to work), reduce permanent disability and prevent reccurence. However, voice therapy is poorly described for patients with BVFLs. No management guidelines exist and clinical practice varies. Surgical preparation, wound healing and re-establishing vocal fold vibration pose additional complexities in voice therapy programmes. There is no robust evidence to determine the effectivessness of voice therapy in this patient group. Aim This proposal aims to refine and evaluate the feasibility and acceptability of a pre and post-operative voice therapy intervention study for patients with BVFLs, in preparation for future economic and clinical effectiveness research. Methods A mixed methods plan is proposed, comprising three sequential work packages: WP1:Update Systematic review -A previous systematic scoping review will be updated; identifying additional insights into components of a voice therapy intervention (0-5months) WP2:Delphi Study -h;A three-round international electronic Delphi study with expert voice therapists (n=40) will aim to reach consensus on key components of a best practice intervention. Findings will be used to finalise the intervention delivered in WP3 (6-15months) WP3:Feasibility Trial -h;A multi-centre mixed methods feasibility trial (n=40, 2 sites) will be conducted to a)explore feasibility elements including recruitment, retention, adherence and acceptability of clinicians and patients, b)gather clinical outcomes data at baseline, 3 and 6 months post-operatively and c)explore the feasibility of gathering data needed to complete a future economic evaluation (16-38months) Patient and Public Involvement (PPI) The topic area, methods and dissemination plan were developed and modified following regular discussions with a PPI group. PPI members have reviewed the application and confirmed their ongoing involvement to ensure that improved patient care remains the central focus. PPI will contribute to; Discussions on intervention acceptability (WP2&3) Study materials (patient information sheets and consent forms) (WP3) Analysis of interview data (WP3) Dissemination materials (WP1,2&3)Impact and dissemination Findings will be disseminated to patients, clinicians, commissioners and researchers via publications, social media, conference presentations and the development of two videos. This research will enable clinicians and commissioners to develop care pathways based on the best available evidence. Pre-operative voice therapy may prevent surgery in some individuals. For those still requiring surgery, adjunct voice therapy will improve knowledge, understanding and skill to manage their symptoms. This proposal aims to assess feasibility of delivering an intervention to direct future research; leading to a phase III definitive multi-centre RCT evaluating the clinical and cost effectiveness of the intervention.

Lay abstract: Aim To develop and test a voice therapy programme for adults having vocal fold surgery.Background We take our voice for granted but one in three of us will experience voice problems in our lifetime. These may arise because of cancerous or benign changes on the vocal folds. Polyps and cysts are examples of benign vocal fold lesions (BVFLs) which stop the vocal folds from closing fully or vibrating properly. This can cause hoarseness, voice loss and pain.Why does it matter? Voice is embedded into every aspect of our lives. Individuals with BVFLs have reduced participation at work, in hobbies, social situations and caring responsibilities. This can lead to social isolation, anxiety and depression. Surgical and therapy costs coupled with absenteeism and reduced productivity at work impacts patients and their families, society, the NHS and the UK economy. Treatment for BVFLs is inconsistent. Patients may receive surgery, voice therapy, or a combination of these. Emerging research suggests the best outcomes are achieved when patients receive voice therapy in addition to surgery.Unanswered questions It is not clear which elements of voice therapy are helpful and why, nor how or when exercises should be introduced. It may be that voice therapy exercises, effective for other types of voice disorders, are beneficial for patients with benign lesions. However, we suspect that different elements are needed to address the unique problems associated with wound healing and scar prevention after surgery. This substantial gap in the evidence for pre and post-operative voice therapy needs to be addressed in order to understand the effectiveness of pre and post-operative voice therapy. Methods This proposal involves three sequential studies: 1. The available evidence will be reviewed systematically and any new research will be identified and considered to inform subsequent studies 2. Delphi study An international expert panel of voice therapists (n=40) will reach agreement through a series of electronic questionnaires on the important components of best practice voice therapy. Findings will be compared to patients' views on the acceptability of an intervention. 3. Feasibility study The intervention finalised in the Delphi study will be tested for feasibility on 40 adult patients who are having vocal fold surgery at two hospitals in the UK. It will consider how many patients complete the intervention or drop-out and why, as well as how well therapists stick to the planned treatment. Interviews with patients and therapists will help to explore their views in detail, clarifying procedures for a future effectiveness trial. Patient and Public Involvement (PPI) The topic area, research question, methods and dissemination plan were developed following repeat discussions with six patients. PPI members have reviewed the application and agreed to provide ongoing input to the study. This will help ensure that the long term goal of improved patient care, remains at the centre of the research. PPI will contribute to: Discussions on acceptability of treatment (study 2,3) Study materials including patient information sheets and consent forms (study 3) Analysis of interview data (study 3) Dissemination materials (study 1,2,3)Dissemination Findings will be shared with patients, carers, members of the public, health professionals and service commissioners. A video explaining the research background and findings will be produced for members of the public and health professionals; shared using social media. Articles relating to each study will be submitted for publication in peer-reviewed journals. Findings will be presented at national and international clinical conferences, professional networking, groups and NHS meetings. Posters summarising findings, developed with PPI members will be displayed in clinical waiting areas and circulated nationally. A video, featuring PPI members, will be produced, to prepare patients for surgery.

Research activity codes: 6.7 PHYSICAL
Health categories: RESPIRATORY