Pre- and post-operative voice therapy (PaPOV): Development of an intervention for patients with benign vocal fold lesions.

backgroundPre- and post-operative voice therapy may improve voice and quality-of-life outcomes for patients undergoing phonosurgery to remove benign vocal fold lesions (BVFLs). However, what constitutes voice therapy in this population is poorly described, resulting in a poor evidence base, lack of clinical guidelines and unwarranted variation in management. In order to develop the evidence base, a robust, iterative process of intervention development work should precede feasibility testing and effectiveness studies. METHODS & PROCEDURES: Guidance for developing complex interventions, drawing on evidence, theory and modelling, was used to inform the development of a pre- and post-operative voice therapy intervention entitled 'PaPOV'. Data from four sources of evidence were synthesized using a published triangulation protocol. Data from a systematic review, national survey of current practice, expert interview study, and patient and public involvement conversations were used to populate a triangulation matrix, outlining components of a PaPOV. Data were coded to reflect areas of agreement, dissonance and silence with each component of the intervention. Based on this evidence, an assessment of convergence for each intervention component could be made. OUTCOMES &

resultsIn total, 61 components of the PaPOV intervention were explored. Of these, 27 were categorized as having stability of consensus according to a priori criteria. A total of 34 failed to meet the criteria. This was more frequently due to silence (27) rather than dissonance (seven) in the data. By evidencing areas of agreement and stability of consensus across data sources, the validity of individual findings has been enhanced. Furthermore, the study has exposed specific areas of the intervention that lack consensus and require exploration through further intervention development studies. CONCLUSIONS & IMPLICATIONS: This systematic triangulation process has contributed to the development of a PaPOV intervention for patients with BVFLs. Exploration of specific components relating to the intervention will allow outstanding questions to be answered in preparation for feasibility testing. WHAT THIS PAPER ADDS: What is already known on the subject BVFLs cause dysphonia by preventing vocal fold closure, impacting on vibratory characteristics and increasing compensatory muscle tension. Management for these patients is variable with them being offered phonosurgery, voice therapy, pharmacological management or a combined approach. Pre- and post-operative voice therapy may improve both voice and quality-of-life outcomes. This patient group has unique complexities when considering voice therapy, including surgical preparation, wound healing and epithelial mobilization. What this paper adds to existing knowledge This study uses a robust triangulation process to synthesize current evidence and patient experiences in order to inform the development of a PaPOV. It outlines some of the key components and considerations when delivering pre- and post-operative voice therapy to adults with BVFLs. Furthermore, it serves as a methodological example for intervention development in complex interventions, highlighting key guidance and recommended processes for developing and evaluating complex interventions. What are the potential or actual clinical implications of this work? The 61 components discussed as potential 'ingredients' for a PaPOV enable clinicians to reflect on key considerations when planning and delivering voice therapy to adults with BVFLs. This study highlights the pitfalls both clinically and in research of failing to describe interventions adequately and the benefits of using accurate, specific and agreed terminology in clinical practice, such as that outlined in the Rehabilitation Treatment Specification System (TRSS).