Authors' objectives: This report aims to identify and summarise evidence that addresses the following question: What is the diagnostic accuracy, clinical effectiveness, and cost-effectiveness of pharyngolaryngeal biopsies with local anaesthetic in the outpatient setting (outpatient laryngeal biopsy (OLB)) for people with suspicious laryngeal or pharyngeal lesions compared to undergoing biopsy in an operating theatre (OTB) under general anaesthetic?

Authors' results and conclusions: The Scottish Health Technologies Group (SHTG) in 2018 identified two prospective observational studies and five retrospective studies. Health Technology Wales researchers have identified a further four observational studies. Relevant outcome measures include diagnostic accuracy (sensitivity, specificity, positive predictive values, and negative predictive values), time to biopsy procedure, diagnosis, and treatment, procedure success rate, and complication rates. Of the studies identified by SHTG (2018), sensitivity values ranged from 60% to 81.1% and the specificity values ranged from 87% to 100%. HTW identified a further study that reported the sensitivity value as 75.6% and the specificity value as 100%. From consultation to biopsy procedure, the mean number of days was 1.3 for OLB compared to 17.4 days under OTB (p < 0.0001). From consultation to diagnosis under OLB, the mean number of days was 7.5 compared to 23 days under OTB (p < 0.0001). The mean time from consultation to start of treatment in one study was 27 days for OLB compared to 41.5 days for OTB (p < 0.0001). Of the studies identified by SHTG (2018), the proportion of patients experiencing complications was low and ranged from 0 to 2.6%. Three out of four observational studies identified by HTW did not report any complications. Due to a lack of identified cost-effectiveness data, HTW developed a de-novo cost-utility analysis comparing OLB to OTB over a lifetime horizon. Inputs were sourced from the SHTG budget impact analysis, updated with values more relevant to a Welsh setting where possible. Sensitivity and specificity of OLB were sourced from SHTG, updated with the additional identified study by HTW, and OTB was assumed to have perfect diagnostic accuracy - 100% sensitivity and specificity. In a population with 2,183 at risk patients, OLB when compared to OTB was considered a cost-effective diagnostic strategy over a lifetime horizon. OLB was associated with less costs and fewer QALYs than OTB, corresponding to an incremental cost-effectiveness ratio (ICER) of £21,011 – a cost-effective result when costs and quality-adjusted life years (QALYs) are lower than the comparator. Scenario analyses demonstrated that the proportion of patients who go on to have treatment following a false positive diagnosis can mean that OLB is no longer cost-effective – this occurs when more than 42% of patients are undetected as false positive during conventional staging.

Authors' recommendations: The evidence supports the adoption of pharyngolaryngeal biopsy under local anaesthesia to confirm, but not to rule out, a diagnosis of head and neck cancer. This procedure can be done in an outpatient setting and avoids the need for inpatient care and general anaesthesia. A positive result has the potential to accelerate the initiation of treatment, but a negative result should be followed by a second biopsy in an operating theatre under general anaesthesia. Economic modelling estimates that there is the potential for cost saving through the use of pharyngolaryngeal biopsy under local anaesthesia rather than in a theatre environment under general anaesthesia and that this is a cost-effective procedure.

Authors' methods: The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this. SHTG conducted their literature search from 2008 until 22 February 2018, so our rapid review has included evidence that was published after this date.

Project Status: Completed

Year Published: 2022

URL for published report: https://healthtechnology.wales/reports-guidance/outpatient-laryngeal-biopsy/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk

Copyright: Health Technology Wales