Matthias Schwenkglenks

University of Basel / University of Zürich · Institute of Pharmaceutical Medicine (ECPM) / Epidemiology, Biostatistics and prevention Institute

Background Conducting high-quality randomized clinical trials (RCTs) is challenging, time consuming, and resource intense. Academic investigators usually depend on scarce financial resources; however, current literature lacks systematically collected empirical data on the detailed resource use and costs of investigator-initiated RCTs. Methods The...

Background Treatment decisions for persons with relapsing–remitting multiple sclerosis (RRMS) rely on clinical and radiological disease activity, the benefit-harm profile of drug therapy, and preferences of patients and physicians. However, there is limited evidence to support evidence-based personalized decision-making on how to adapt disease-modi...

Background: With the DSM-5 revision, Somatic Symptom Disorder (SSD) no longer necessitates the medical unexplainability of symptoms, focusing instead on psychobehavioral criteria. This study is part of the “SomPsyNet” project that targets patients from SOMatic acute hospitals and aims to prevent PSYchosocial distress consequences in their course of...

Purpose To explore the association between medication use-related factors and health-related quality of life (HRQoL) in older hospitalised multimorbid patients with polypharmacy. Methods This cross-sectional study used the intervention arm data of the OPERAM trial (hospitalised patients ≥ 70 years with polypharmacy). HRQoL was assessed using the v...

Previous observational studies have indicated that social influences, such as arising from herding-like behaviour, can contribute to medical errors. In this study, we experimentally examined whether general practitioners (GPs) would follow incorrect prescription recommendations from fellow GP or specialists. To investigate this, we conducted an onl...

Background: The revised classification of Somatic Symptom Disorder (SSD) according to DSM-5 no longer considers whether physical symptoms are medically unexplained. Instead, new psychobehavioral positive criteria are diagnostically relevant – irrespective of the etiology of the complaints. Our study, conducted within the "SomPsyNet" project, inves...

Background Treatment decisions for persons with relapsing-remitting multiple sclerosis (RRMS) rely on clinical and radiological disease activity, the benefit-harm profile of drug therapy, and preferences of patients and physicians. However, there is limited evidence to support evidence-based personalized decision-making on how to adapt disease modi...

Haemophilia B is a rare genetic disease that is caused by a deficiency of coagulation factor IX (FIX) in the blood and leads to internal and external bleeding. Under the current standard of care, haemophilia is treated either prophylactically or on-demand via intravenous infusions of FIX. These treatment strategies impose a high burden on patients...

Background Electronic clinical decision support systems (eCDSS), such as the ‘Systematic Tool to Reduce Inappropriate Prescribing’ Assistant (STRIPA), have become promising tools for assisting general practitioners (GPs) with conducting medication reviews in older adults. Little is known about how GPs perceive eCDSS-assisted recommendations for pha...

Assessment of Somatic Symptom Disorder in General Hospital Care (Abstract: Journal of Psychosomatic Medicine and Psychotherapy)

Introduction: Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph no...

Aims Direct-acting oral anticoagulants (DOACs) have, to a substantial degree, replaced vitamin K antagonists (VKA) as treatments for stroke prevention in atrial fibrillation (AF) patients. However, evidence on the real-world causal effects of switching patients from VKA to DOAC is lacking. We aimed to assess the empirical incremental cost-effective...

Introduction Approximately 30% of somatic hospital inpatients experience psychosocial distress, contributing to increased (re-)hospitalisation rates, treatment resistance, morbidity, and direct and indirect costs. However, such distress often remains unrecognised and unaddressed. We established ‘SomPsyNet’, a ‘stepped and collaborative care model’...

Background Optimizing health‐related quality of life (HRQoL) is an important aim of atrial fibrillation (AF) treatment. Little is known about patients' long‐term HRQoL trajectories and the impact of patient and disease characteristics. The aim of this study was to describe HRQoL trajectories in an observational AF study population and in clusters o...

Aims Atrial fibrillation (AF) costs are expected to be substantial, but cost comparisons with the general population are scarce. Using data from the prospective Swiss-AF cohort study and population-based controls, we estimated the impact of AF on direct healthcare costs from the Swiss statutory health insurance perspective. Methods Swiss-AF patien...

Abstract Introduction Dravet syndrome (DS) is a rare, lifelong epileptic encephalopathy characterised by frequent and severe seizures associated with premature mortality. Typically diagnosed in infancy, patients also experience progressive behavioural, motor-function and cognitive decline. Twenty percent of patients do not reach adulthood. Quality...

Background: An increased risk of intracranial hemorrhage (ICH) associated with statins has been reported; but data on the relationship between statin-use and cerebral microbleeds (CMBs) in patients with atrial fibrillation (AF), a population at high bleeding and cardiovascular risk are lacking. Aims: To explore the association between statin-use...

Objective To study the effects of a primary care medication review intervention centred around an electronic clinical decision support system (eCDSS) on appropriateness of medication and the number of prescribing omissions in older adults with multimorbidity and polypharmacy compared with a discussion about medication in line with usual care. Desi...

Background: Benzodiazepine receptor agonists (BZRAs) are commonly prescribed in older adults despite an unfavorable risk-benefit ratio. Hospitalizations may provide a unique opportunity to initiate BZRA cessation, yet little is known about cessation during and after hospitalization. We aimed to measure the prevalence of BZRA use before hospitaliza...

Objectives: We identified factors associated with healthcare costs and health-related quality of life (HRQoL) of multimorbid older adults with polypharmacy. Methods: Using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid older people) trial, we described the magnitude and composition of healthc...

Objective Evidence on long-term costs of atrial fibrillation (AF) and associated factors is scarce. As part of the Swiss-AF prospective cohort study, we aimed to characterise AF costs and their development over time, and to assess specific patient clusters and their cost trajectories. Methods Swiss-AF enrolled 2415 patients with variable duration...

Background In metastatic hormone-sensitive prostate cancer (mHSPC) treatment, survival benefits have been shown by adding docetaxel or recent androgen receptor axis-targeted therapies (ARATs) abiraterone, apalutamide, or enzalutamide to androgen deprivation therapy (ADT). However, the optimal treatment strategy in terms of costs and effects is uncl...

Importance Inappropriate prescribing and prescribing omissions are major drivers of healthcare-related harm. Medication review may help improve pharmacotherapy. Objective To study the effects of a primary care medication review intervention centered around an electronic clinical decision support system (eCDSS) on medication appropriateness and the...

Aims To determine the risk of subsequent adverse clinical outcomes in anticoagulated patients with atrial fibrillation (AF) who experienced a new bleeding event. Methods and results Anticoagulated AF patients were followed in two prospective cohort studies. Information on incident bleeding was systematically collected during yearly follow-up visit...

Objectives Dravet syndrome (DS) is a rare, lifelong epileptic encephalopathy characterised by frequent and severe seizures associated with premature mortality. Typically diagnosed in infancy, patients also experience progressive behavioural, motor-function and cognitive decline. Twenty percent of patients do not reach adulthood. Quality of life (Qo...

Background Patients with hormone receptor-positive, HER2-negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy (NACT) are at a high risk of relapse. PENELOPE-B was a double-blind, placebo-controlled, phase III trial that investigated adding palbociclib (PAL) for thirteen 28-day cycles to adjuvant endocrine therapy...

Objective We aimed to estimate the cost-effectiveness, burden of disease and budget impact of inclisiran added to standard-of-care lipid-lowering therapy in the real-world secondary cardiovascular prevention population in Switzerland.Methods An open-cohort Markov model captured event risks by sex, age and low-density lipoprotein cholesterol based...

Introduction Venetoclax in combination with rituximab (VEN + R) demonstrated prolonged overall survival (OS) and progression-free survival (PFS) for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) in comparison to standard chemoimmunotherapy [bendamustine + rituximab (BR)]. We conducted a cost-effectiveness and budget imp...

Objective We aimed to identify the most cost-effective of all prophylactic measures available in Switzerland for women not yet affected by breast and ovarian cancer who tested positive for a BRCA1/2 mutation. Methods Prophylactic bilateral mastectomy (PBM), salpingo-oophorectomy (PBSO), combined PBM&PBSO and chemoprevention (CP) initiated at age 4...

Objective We aimed to evaluate the cost-effectiveness of voretigene neparvovec (VN) compared with standard of care (SoC) for patients with inherited retinal disease (IRD) caused by a biallelic RPE65-mutation. VN is a live, non-replicating adeno-associated virus serotype 2 (AAV2). SoC is best supportive care provided to patients with visual impairme...

Objective: We aimed to estimate the cost-effectiveness, burden of disease and budget impact of inclisiran added to standard-of-care lipid-lowering therapy in the real-world secondary cardiovascular prevention population in Switzerland. Methods: An open-cohort Markov model captured event risks by sex, age and low-density lipoprotein cholesterol b...

Background Unwarranted variation in healthcare utilization can only partly be explained by variation in the health care needs of the population, yet it is frequently found globally. This is the first cross-sectional study that systematically assessed geographic variation in the adherence to clinical recommendations in Switzerland. Specifically, we...

Context Multiple treatments for metastatic, hormone-sensitive prostate cancer (mHSPC) are available, but their effects on health-related quality of life (HRQoL) and benefit-harm balance remain unclear. Objective To assess clinical effectiveness regarding survival and HRQoL, safety, and benefit-harm balance of mHSPC treatments. Evidence acquisitio...

Objectives Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols fr...

Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs c...

Background Patients with atrial fibrillation (AF) face an increased risk of adverse cardiovascular events. Evidence suggests that early rhythm control including AF ablation may reduce this risk. Methods To compare the risks for cardiovascular events in AF patients with and without pulmonary vein isolation (PVI), we analysed data from two prospecti...

Background Inappropriate polypharmacy has been linked with adverse outcomes in older, multimorbid adults. OPERAM is a European cluster-randomized trial aimed at testing the effect of a structured pharmacotherapy optimization intervention on preventable drug-related hospital admissions in multimorbid adults with polypharmacy aged 70 years or older....

Polypharmacy and inappropriate medication use are very common in multimorbid older patients. This population has unfortunately been excluded from most large, randomized studies. In a recent multicenter randomized study (OPERAM), we included over 2000 multimorbid patients. We found that 86% of the patients aged 70 years and more had inappropriate me...

Aims: We aimed to investigate the association of clinically overt and silent brain lesions with cognitive function in atrial fibrillation (AF) patients. Methods and results: We enrolled 1227 AF patients in a prospective, multicentre cohort study (Swiss-AF). Patients underwent standardized brain magnetic resonance imaging (MRI) at baseline and af...

Background: Patients in intensive care units (ICUs) are at high risk of developing physical, functional, cognitive, and mental impairments. Early mobilisation aims to improve patient outcomes and is increasingly considered the standard of care. This survey aimed to investigate the characteristics, current use and variations of early mobilisation a...

Purpose: Fenfluramine is a recently licensed add-on therapy to standard of care antiepileptic drugs to treat the frequent, severe seizures of DS. Although an alternative to cannabidiol, there are no comparative trials of these therapies. We assessed the comparative effectiveness of licensed fenfluramine (with/without concomitant stiripentol) to can...

Geografische Variabilität der Inanspruchnahme von Gesundheitsleistungen hat vielfältige Ursachen. Sie kann auf Qualitätsprobleme im Gesundheitswesen hinweisen. Über die Situation in der Schweiz war bisher wenig bekannt. Die Studie «Geographic variation in the utilisation of health care inter­ventions: what is the role of recommendations and other i...

Background: Indoor exposure to dry air during heating periods has been associated with dryness and irritation symptoms of the upper respiratory airways and the skin. The irritated or damaged mucous membrane poses an important entry port for pathogens causing respiratory infections. Objectives: To determine the effectiveness of interventions that...

Background This systematic review and meta-analysis aimed to determine the effectiveness of systematic early mobilization in improving muscle strength and physical function in mechanically ventilated intensive care unit (ICU) patients. Methods We conducted a two-stage systematic literature search in MEDLINE, EMBASE and the Cochrane Library until J...

Purpose Physical activity has been shown to improve survival and quality of life of cancer patients. Due to differences in patient populations, healthcare settings, and types of intervention, cost-effectiveness analyses of physical activity interventions in cancer survivors are difficult to compare. Available evidence from breast cancer survivor re...

Background Older adults with chronic conditions are at high risk of complications from influenza and pneumococcal infections. Evidence about factors associated with influenza and pneumococcal vaccination among older multimorbid persons in Europe is limited. The aim of this study was to investigate the prevalence and determinants of these vaccinatio...

Importance Clinical trial registries are important for gaining an overview of ongoing research efforts and for deterring and identifying publication bias and selective outcome reporting. The reliability of the information in trial registries is uncertain. Objective To assess the reliability of information across registries for trials with multiple...

This cross-sectional study compares randomized clinical trial protocols to assess the prevalence and reporting quality of planned subgroup analyses over time.

Purpose: Fenfluramine is a recently licensed add-on therapy to standard of care antiepileptic drugs to treat the frequent, often daily severe seizures of DS. It may be considered an alternative to cannabidiol; however, there are no head-to-head comparative trials of these therapies. We assessed the comparative effectiveness of licensed fenfluramine...

Introduction: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast...

Objective: To analyse utilisation patterns of lipid-lowering drugs and the related costs in Switzerland between the years 2013 and 2019. Methods: We conducted a retrospective descriptive study using administrative claims data of persons aged ≥18 years enrolled with the health insurance company Helsana. To enable statements at the Swiss populatio...

Purpose: Fenfluramine is a recently licensed add-on therapy to standard of care antiepileptic drugs to treat the frequent, severe seizures of DS. Although an alternative to cannabidiol, there are no comparative trials of these therapies. We assessed the comparative effectiveness of licensed fenfluramine (with/without concomitant stiripentol) to can...

Background: The incidence of influenza and influenza-like illnesses in Switzerland is generally high. Although related direct medical costs can be substantial, especially if hospitalisations occur, several studies suggested that indirect costs due to the loss of productivity may represent an even higher economic burden. The aim of this study was t...

Objective To examine the effect of optimising drug treatment on drug related hospital admissions in older adults with multimorbidity and polypharmacy admitted to hospital. Design Cluster randomised controlled trial. Setting 110 clusters of inpatient wards within university based hospitals in four European countries (Switzerland, Netherlands, Belg...

Objective We examined real-world effects of cantonal legislations to direct surgery patients from the inpatient to the outpatient setting in Switzerland. Methods Analyses were based on claims data of the Helsana Group, a leading Swiss health insurance. The study population consisted of 13’145 (in 2014), 12’455 (in 2016), and 12’875 (in 2018) insur...

Objectives Recruiting general practitioners (GPs) and their multimorbid older patients for trials is challenging for multiple reasons (e.g., high workload, limited mobility). The comparability of study participants is important for interpreting study findings. This manuscript describes the baseline characteristics of GPs and patients participating...

Objectives When research evidence is lacking, patient and provider preferences, expected to vary geographically, might have a stronger role in clinical decisions. We investigated whether the strength or the direction of recommendation is associated with the degree of geographic variation in utilisation. Design In this cross-sectional study, we sel...

Objectives: To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interv...

Objective The study aim was to evaluate the cost effectiveness and budget impact of siponimod compared to interferon beta-1a for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease, from a Swiss health insurance perspective.Methods We conducted an analysis using a Markov cohort model with a cycle length of 1 year...