Advanced fibrosis associated with non-alcoholic steatohepatitis (NASH) in Spain: results of a Delphi study. / Fibrosis avanzada asociada a esteatohepatitis no alcohólica (NASH) en España: resultados de un estudio Delphi.

OBJECTIVE: To describe in detail the epidemiology, diagnosis, clinical management, treatment options, impact on quality of life and unmet needs of patients with advanced liver fibrosis (F3-F4) associated with non-alcoholic steatohepatitis (NASH) in Spain. METHODOLOGY: Delphi study of two rounds of consultation rounds with 41 expert hepatologists from 16 autonomous communities to collect their experience in clinical practice. RESULTS: The estimated prevalence of adult patients diagnosed with F3-F4 fibrosis associated with NASH in Spain is 0.019% (95% confidence interval [CI]: 0.019-0.020%). Approximately 7,588 adults with this condition are currently diagnosed and managed in the Digestive System Services of Spanish hospitals, and around 1,881 new patients are diagnosed each year. Management is multidisciplinary and includes the specialties of Digestive System, Endocrinology and Internal Medicine, considering the frequently associated metabolic comorbidities (obesity, type 2 diabetes mellitus or dysmetabolic iron overload). Despite a clear impact on quality of life, this it is not routinely evaluated in clinical practice. The most widely used non-invasive diagnostic techniques are transitional elastography and liver fibrosis index 4 (FIB-4). The absence of effective and safe treatments appears as the main unmet need for the management of these patients. CONCLUSIONS: This study provides a representation of the current situation of patients diagnosed with F3-F4 fibrosis associated with NASH in Spain, increasing the evidence available and contributing to informed decision-making by professionals and the health system.

Determining What Represents Value in the Treatment of Refractory or Unexplained Chronic Cough from the Perspective of Key Stakeholders in Spain Using Multi-Criteria Decision Analysis.

BACKGROUND AND OBJECTIVE: Chronic cough is defined as cough lasting for more than 8 weeks. It can be described as refractory when persisting despite thorough clinical assessment and treatment of any cough-related underlying condition, or unexplained when no underlying cough-related condition can be identified. Refractory or unexplained chronic cough (RCC|UCC) greatly affects patient health-related quality of life (HRQoL). Although around 10% of the population suffer from chronic cough (with 40-60% of these patients suffering from RCC|UCC), there is limited information available in the literature about the condition and the assessment of treatment success. This study aimed to determine what represents value in the treatment of RCC|UCC from the perspective of key stakeholders in Spain using Multi-Criteria Decision Analysis (MCDA) methodology. METHODS: A literature review was conducted to adapt the MCDA framework to the specific context of RCC|UCC. A total of 24 participants were involved, representing three key stakeholder groups (7 patients, 9 physicians and 8 hospital pharmacists). The study was structured in two phases. In Phase 1, participants validated the adapted MCDA framework and assigned relative weights (100-point allocation) to the framework's value criteria/sub-criteria during three individual stakeholder meetings, one per each stakeholder group. In Phase 2, participants were brought together in a multi-stakeholder meeting to review findings of each stakeholder group, after which stakeholders repeated the weighting exercise as a collective group. All meetings included reflective discussion by participants of each value criteria/sub-criteria included within the adapted MCDA framework, where stakeholders shared their perspectives and opinions on what represents value in RCC|UCC. RESULTS: Refractory or unexplained chronic cough is regarded as a chronic medical condition, with variable severity across patients and the potential to heavily impact their HRQoL (including physical, psychological and social/work productivity domains). Current treatments used by healthcare professionals, which have not been specifically developed and are not approved for RCC|UCC, show limited clinical effectiveness and associated safety and tolerability issues, which result in frequent treatment discontinuations. The reduction of the average cough frequency over a 24-h period is regarded as the primary goal of treatment by stakeholders, with the aim of improving HRQoL. Improvement of other cough symptoms, such as intensity, is also considered important. Minor adverse events and a slower onset of treatment effect would be acceptable to stakeholders if accompanied by strong efficacy and improvement in HRQoL. Given the inability to measure cough frequency in clinical practice, Patient-Reported Outcomes (PROs) could be considered a proxy of treatment effectiveness. A multidisciplinary approach to the condition is regarded as key for treatment success. CONCLUSIONS: Refractory or unexplained chronic cough is a medical condition that seriously impacts patients' HRQoL. The primary goal of treatment is to improve patients' HRQoL by reducing the frequency and intensity of cough.