Pre and Post-Operative Voice Therapy for Benign Vocal Fold Lesions: The PAPOV Feasibility Trial
Background
Patients undergoing phonosurgery for removal of benign vocal fold lesions (BVFLs) may have improved outcomes with the addition of pre and post- operative voice therapy. However, what constitutes pre and post-operative voice therapy is poorly described. To address the gap in the evidence base, we systematically co-created, and published a pre- and post-operative voice therapy intervention, termed the PAPOV intervention.
Aim
The aim of this non-randomised multicentre feasibility trial, with embedded process evaluation was to assess the feasibility and acceptability of delivering the PAPOV intervention to patients with BVFLs.
Methods
Patients with benign vocal fold lesions (n=41) from two sites were recruited to receive the PAPOV intervention. Patients received a prescribed protocol of voice therapy before and after their phonosurgery. Measures of feasibility, including recruitment, retention, and adherence were assessed. The feasibility of gathering clinical and cost effectiveness data was measured pre-treatment, then at 3 and 6 months post-operatively. An embedded process evaluation was undertaken to explain feasibility findings and consider the acceptability of the intervention to participants and clinicians.
Results
Between January and October 2023, 41 participants were recruited to the PAPOV feasibility trial. All feasibility objectives were met. Targets for recruitment and retention were met. 73% of those eligible were recruited against a target of 50% and attrition was 15%, against a target of 80%) for all clinical and health economic outcome measures. There was a statistically significant improvement in all patient reported outcomes, perceptual and acoustic measures of voice measures after treatment (p<0.005). There was no evidence of change in Maximum Phonation Time (MPT) and pitch range.
It was feasible to collect a range of health economics data pertaining to patient level costs and impact on quality of life. Both the disease specific (VR-QOL) and overall quality of life (EQ-5D-5L) scores improved after treatment (p<0.005). Interview data suggested that both clinicians and participants found the PAPOV intervention and trial processes acceptable.
Conclusions
The PAPOV intervention can be reliably and feasibly delivered by voice specialist speech and language therapists. Patients tolerated and competed the intervention and there was indication of benefit for voice and quality of life. Future work should consider clinical and cost-effectiveness research for this intervention.