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

Background Voice 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 -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 -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.