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

Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice: Study design and methods for a multi-centre longitudinal observational study.

BACKGROUND: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance. METHOD: The study was designed based on a combination of a literature search, two clinician focus groups and expert review.A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise. CONCLUSION: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications

Identifying the most important outcomes for systematic reviews of interventions for rhinosinusitis in adults: working with Patients, Public and Practitioners

Introduction Promoting the assessment of health interventions using outcomes that matter to patients and practitioners is a key principle of Cochrane. Cochrane UK therefore commissioned the OMIPP project: Outcomes that are Most Important for Patients, Public and Practitioners to identify the outcomes they felt most important and should be evaluated in Cochrane reviews of health interventions for Chronic Rhinosinusitis (CRS). Methodology Using direct emailing, social media and printed cards, an online survey was distributed to a wide range of people involved in the care of patients with CRS. Patients and practitioners were asked to list the 3 outcomes from treatments most important to them. Responses were analysed through development of a thematic framework based on the data. Results Two hundred and thirty-five people completed the survey; 155 practitioners and 80 patients. Respondents provided 653 suggestions of important outcomes. 73% concerned symptoms of CRS, (nasal discharge or drip, facial pain, nasal blockage, headache, impaired sense of smell, congestion and breathing difficulties); 9% concerned quality of life, 4% reducing the need for further treatment and 4% side effects of treatment. Objective measurements of disease formed only 3% of responses. There was high level of agreement between patients and practitioners. Of 10 current Cochrane reviews on CRS, 9 include symptomatic outcomes identified by our survey as most important to patients and healthcare practitioners. Discussion We have identified outcomes that both patients and their doctors consider should be included in reviews evaluating treatments of rhinosinusitis. We recommend that primary outcomes in future reviews focus on symptom-based outcomes. The ability to extract these data from relevant trials is dependant upon their inclusion in trials, and so it is important that building on this work a core outcome set for rhinosinusitis research is developed