Cost-effectiveness of use of 20-valent pneumococcal conjugate vaccine among adults in Germany.

OBJECTIVES: Despite national recommendations for use of pneumococcal vaccines, rates of community-acquired pneumonia (CAP) and invasive pneumococcal disease (IPD) remain high in Germany. New pneumococcal conjugate vaccines (PCVs) with expanded coverage have the potential to reduce the pneumococcal disease burden among adults. METHODS: Using a Markov model, we evaluated the lifetime outcomes/costs comparing 20-valent PCV (PCV20) with standard of care (SC) vaccinations for prevention of CAP and IPD among adults aged ≥60 years and at-risk adults aged 18-59 years in Germany. PCV20 also was compared with sequential vaccination with 15-valent PCV (PCV15) followed by PPSV23 in a scenario analysis. RESULTS: Over the course of a lifetime (82 years), use of PCV20vs. SC would prevent 54,333 hospitalizations, 26368 outpatient CAP cases, 10946 disease-related deaths yield 74,694 additional life-years (LYs), while lowering total medical costs by 363.2 M €. PCV20 remained cost saving (i.e. dominant) versus SC even in numerous sensitivity analyses, including a sensitivity analysis assuming moderate effectiveness of the SC pneumococcal polysaccharide vaccine against noninvasive pneumococcal CAP. In several scenario analyses and a probabilistic sensitivity analysis, PCV20 was also cost-saving compared toPCV15 PPSV23 vaccination. CONCLUSIONS: One dose of PCV20 among adults aged ≥60 years and adults aged 18-59 years with moderate- and high-risk conditions wouldsubstantially reduce pneumococcal disease, save lives, and be cost saving compared with SC.

The association between the risk of developing type 2 diabetes mellitus and health-related quality of life: baseline results from the Dimini lifestyle intervention.

PURPOSE: The aim of the study was to analyse health-related quality of life (HRQoL) and its determinants in individuals with an increased risk of developing type 2 diabetes mellitus (T2D). METHODS: We used pseudonymized baseline data collected between 2018 and 2020 as part of the Dimini project in Hesse and Schleswig-Holstein. HRQoL was measured by the mental and the physical component score of the validated instrument Short Form 12 and descriptively analysed followed by multiple linear regression analysis. RESULTS: The Dimini population (n = 662) showed an average physical component score of 42.12 (SD 10.56) and a mental component score of 47.12 (SD 11.13). While men demonstrated both significantly higher physical and mental component scores than women, differences based on migration background were not observed. Younger age was associated with a higher level of the physical component score, whereas mental component scores linearly increased with age. Regarding indicators of T2D-risk, a significant influence of HbA1c on HRQoL was not confirmed. However, physical component scores are negatively related to Findrisk scores and BMI. Finally, study participants living alone and those with a handicap reported lower levels of HRQoL. CONCLUSION: Compared with a representative sample of the general German population (DEGS1), Dimini participants were characterized by a lower average HRQoL. The analysis showed a higher vulnerability to an impaired HRQoL within certain subgroups of the population and among participants with relatively higher levels of T2D-risk. As a result, tailored healthcare interventions are required to reach these target groups. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID NCT03482674.

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF.

BACKGROUND: The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies. METHODS: This is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms. DISCUSSION: This study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF. TRIAL REGISTRATION: This study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024642 ).