Dr. med. Maria Bösing

Ziel dieser Studie ist es, ein besseres Verständnis von Risikofaktoren, protektiven Faktoren, Komplikationen, therapeutischem Nutzen verschiedener Behandlungsstrategien, sowie dem generellen Verlauf von COVID-19 von am KSBL hospitalisierten Patienten zu erlangen. Zu diesem Zweck möchten wir eine umfassende Datenbank mit Daten von Patienten, die am Kantonsspital Baselland (KSBL) während der Pandemie aufgrund von COVID-19 hospitalisiert waren anlegen. Diese Datenbank soll als Grundlage für die explorative retrospektive Untersuchung der o.g. Fragestellungen dienen.

Diese Studie ist eine retrospektive single-center Kohortenstudie. Die Studienpopulation wird definiert durch alle aufgrund von COVID-19 am KSBL hospitalisierten Patienten zwischen Januar 2020 und August 2022. Es sollen keine genetischen Daten oder zusätzliches biologisches Material untersucht werden. Diese Daten sollen zunächst deskriptiv zusammengefasst und dann explorativ analysiert werden.

Background: The recent increasing complexity in internal medicine and the concurrent demand for improving quality while cutting down resources represent a major challenge for healthcare providers. Disease-specific clinical guidelines for diagnostic and therapeutic management provide support in this demanding situation. However, according to previous studies, guideline adherence is often poor in clinical practice. Clinical audits are a powerful instrument in the evaluation of guideline adherence and can ultimately improve quality of hospital care.

Objectives: With the QUA-DIT project we seek to identify disease-specific areas of in-hospital management where diagnostic and/or therapeutic guideline-adherence is poor. Furthermore, we plan to investigate the effect of guideline-adherence on patient outcome related quality indicators. By establishing a sustainable quality control program addressing these areas, we intend to lay the foundation for the overall improvement of hospital care.

Methods: The QUA-DIT project consists of seven clinically driven audits in typical acute diagnoses in the department of internal medicine at the Cantonal Hospital Baselland. Recent clinical routine data concerning diagnostic workup, treatment, and other measures of care will be collected and descriptively compared to the established national and international disease-specific guidelines. Ultimately, association of guideline-adherence with quality indicators mortality, length of hospital stay, and rehospitalization will be assessed by multivariable regression models. We expect to include data of 2410 patients into our analyses.

Relevance: Establishing a series of clinical audits with the same methodology and the aim to improve quality in different fields of internal medicine is an innovative approach. Based on the audit findings, we plan to implement several measures to achieve improvement in the evidence-based management of our patients. Being transparent about the results with the intention of publication is a way of creating awareness in the internal medicine community and may serve as a motivation for other hospitals to follow the example. The QUA-DIT project represents a significant step for improvement of the overall healthcare system, and ultimately for the health of the population.

Reduction of corticosteroid use in outpatient treatment of exacerbated COPD – a randomized, double-blind, placebo-controlled, non-inferiority study in an outpatient setting, performed in Northwestern and Central Switzerland and Austria

Background: Chronic obstructive pulmonary disease (COPD) is a major public health issue affecting approximately five to seven percent of the Swiss population. According to current guidelines for the inpatient setting, systemic corticosteroids are most important in the treatment of acute COPD exacerbations and should be given for five to seven days. Several studies suggest that corticosteroids accelerate the recovery of the FEV1 (forced expiratory volume in one second), enhance oxygenation, decrease duration of hospitalization and improve clinical outcome. However, the additional therapeutic benefit on FEV1 recovery appears to be most distinctive in the first three to five days. No data are available on the minimal necessary corticosteroid dose and treatment duration in primary care patients with acutely exacerbated COPD. Given the fact that many patients are treated in an outpatient setting, there is an urgent need to improve evidence about COPD management in this setting. Methods: The proposed study is a prospective, double-blind, randomized controlled trial that is conducted in a primary care setting including an anticipated 470 patients with acutely exacerbated COPD. Participants receive systemic corticosteroid treatment equivalent of 40 mg prednisone daily for either five days (conventional arm, n = 235), or for three days, followed by two days of placebo (experimental arm, n = 235). Antibiotic treatment for seven days is given to all patients with CRP ≥ 50 mg/l, known diagnosis of bronchiectasis, or presenting with Anthonisen Type-I exacerbation. Additional treatment after inclusion are left at the discretion of the treating general pracititioner. Follow-up visits are performed on days three and seven by the treating general practitioners, followed by telephone interviews on das 30, 90 and 180 after inclusion into the study. Primary endpoint is the time to next exacerbation during index exacerbation, or during a six-months follow-up period, whichever occurs first. Discussion: This study is designed to assess whether a three-day course of corticosteroid treatment is not inferior to the current conventional five-day treatment course in outpatients with exacerbated COPD. Depending on the results, this trial might lead to a further reduction of cumulative corticosteroid dose in COPD patients.

This study seeks to investigate if the introduction of guidelines introduced in 2015 supporting a shortened OCS course during acute exacerbation of COPD (AECOPD) altered the treatment efficacy and safety. The study population of interest will consist of patients with AECOPD treated with OCS in general practices in the United Kingdom that form part of the CPRD (Clinical Practice Research Datalink). The primary exposure is treatment with OCS before and after the introduction of the guidelines recommending only five days of treatment. The primary outcome is the time to next exacerbation during the 12 months after the index exacerbation. Secondary outcomes will be the number of exacerbations during the 12 months after the index exacerbation; duration of OCS therapy (if available), treatment safety, notably, the number of patients with new onset diabetes during twelve months after AECOPD.