Patient Safety and the COVID-19 Pandemic in Germany: A Repeated Population-Based Cross-Sectional Survey.

The coronavirus (COVID-19) has presented Germany with major challenges and has led to concerns about patient safety. We conducted an observational, population-based, nationwide, repeated cross-sectional survey on patient safety in Germany in 2019, 2020, and 2021. Each of the three samples consisted of 1000 randomly recruited adults. Self-reported data via computer-assisted telephone interviews were taken from TK Monitor of Patient Safety. Perceptions, experience, and knowledge relating to patient safety were assessed. The majority of respondents considered medical treatment to involve risks to patient safety. This proportion decreased during the pandemic. The majority also had a high degree of self-efficacy regarding the prevention of medical errors, whereby the percentage that felt well informed with regard to patient safety rose throughout the pandemic. The proportion of persons that suspected they had in the past experienced an error in their treatment remained steady at one third as well as the reported errors. In 2020, 65% of respondents thought health communication with service providers (e.g., extent and comprehensibility of information) remained unchanged during the pandemic, while 35% reported that medical appointments had been cancelled or postponed. This study is the first to assess patient safety from a general population perspective during the coronavirus pandemic in Germany. COVID-19 had a positive impact on perceived patient safety but no impact on suspected and reported errors. Self-efficacy with regard to medical error prevention steadily increased in the general population, and people considered themselves well informed

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis

Background: Radiotherapy for patients suffering from malignant neoplasms has developed greatly during the past decades. Stereotactic radiosurgery (SRS) is one important radiotherapeutic option which is defined by a single and highly focussed application of radiation during a specified time interval. One of its important indications is the treatment of brain metastases. Objectives: The objective of this HTA is to summarise the current literature concerning the treatment of brain metastasis and to compare SRS as a single or additional treatment option to alternative treatment options with regard to their medical effectiveness/efficacy, safety and cost-effectiveness as well as their ethical, social and legal implications. Methods: A structured search and hand search of identified literature are performed from January 2002 through August 2007 to identify relevant publications published in English or German. Studies targeting patients with single or multiple brain metastases are included. The methodological quality of included studies is assessed according to quality criteria, based on the criteria of evidence based medicine. Results: Of 1,495 publications 15 medical studies meet the inclusion criteria. Overall study quality is limited and with the exception of two randomized controlleed trials (RCT) and two meta-analyses only historical cohort studies are identified. Reported outcome measures are highly variable between studies. Studies with high methodological quality provide evidence, that whole-brain radiotherapy (WBRT) in addition to SRS and SRS in addition to WBRT is associated with improved local tumour control rates and neurological function. However, only in patients with single brain metastasis, RPA-class 1 (RPA = Recursive partitioning analysis) and certain primary tumour entities, this combination of SRS and WBRT is associated with superior survival compared to WBRT alone. Studies report no significant differences in adverse events between treatment groups. Methodologically less rigorous studies provide no conclusive evidence with regard to medical effectiveness and safety, comparing SRS to WBRT, neurosurgery (NS) or hypofractionated radiotherapy (HCSRT). The quality of life is not investigated in any of the studies. Within the searched databases a total of 320 economic publications are identified. Five publications are eligible for this report. The five reports have a quiet variable quality. Concerning the economic efficiency of alternative equipment, while assuming equal effectiveness, the calculations show, that economic efficiency depends to a large extend on the number of patients treated. In case the two alternative equipments are used solely for SRS, the Gamma Knife might be more cost-efficient. Otherwise an adapted linear accelerator is most likely to be beneficial because of its flexibility. One Health Technology Assessment (HTA) states, that the cost for a Gamma Knife and a dedicated linear accelerator are comparable, while an adapted version is cheaper. No reports concerning ethical, legal and social aspects are identified. Discussion: Overall, quantity and quality of identified studies is limited. However, the identified studies indicate that the prognosis of patients with brain metastases is despite highly developed and modern treatment regimes still limited. Conclusive evidence with regard to the effectiveness of identified interventions is only available for the combined treatment of SRS and WBRT compared to SRS or WBRT alone. Furthermore, there is insufficient evidence to compare SRS with WBRT, NS or HCSRT. The efficiency of the different equipments depends to a great extent on the number and the indications of the patients treated. If dedicated systems are used to their full capacity, there is some evidence for superior cost-effectiveness. If more treatment flexibility is required, adapted systems seem to be advantageous. However, equal treatment effectiveness is a necessary assumption for these conclusions. The need for a treatment precision can influence the purchase decision. No reports concerning more recent therapeutic alternatives are currently available. Conclusion: Combination of SRS and WBRT is associated with improved local tumour control and neurological function compared to SRS or WBRT alone. However, only for patients with single metastasis there is strong evidence that this results in improved survival compared to WBRT alone. Methodologically rigorous studies are warranted to investigate SRS compared to WBRT and NS and to investigate the quality of life in patients undergoing these treatment regimes.Concerning the type of equipment used, economic efficiency depends to a great extend on the capacity at which the system can be used. Dedicated systems might be favourable for a high number of patients, while lower patient counts probably favour adapted systems with their superior treatment flexibility. Using the equipment at its full capacity may result in a limited number of machines, what in turn may give rise to the question of an equal and easy access to this technology. Studies focusing on the comparative effectiveness and cost-effectiveness of different treatment options and their combinations, especially for the German setting, are warranted

Collaborative Ambulatory Orthopaedic Care in Patients with Hip and Knee Osteoarthritis: A Retrospective Comparative Cohort Study on Health Utilisation and Economic Outcomes

Objective: To evaluate a novel healthcare programme for the treatment of patients with hip and knee osteoarthritis in southern Germany in terms of clinical and health economic outcomes. The study is based on claims data from 2014 to 2017. Methods: We conducted a retrospective comparative cohort study of 9768 patients with hip and knee osteoarthritis, of whom 9231 were enrolled in a collaborative ambulatory orthopaedic care programme (intervention group), and 537 patients received usual orthopaedic care (control group). Key features of the programme are coordinated care, morbidity-adapted reimbursement and extended consultation times. Multivariable analysis was performed to determine effects on health utilisation outcomes. The economic analysis considered annual costs per patient from a healthcare payer perspective, stratified by healthcare service sector. Besides multivariable regression analyses, bootstrapping was used to estimate confidence intervals for predicted mean costs by group. Results: Musculoskeletal-disease-related hospitalisation was much less likely among intervention group patients than control group patients [odds ratio (OR): 0.079; 95% CI: 0.062–0.099]. The number of physiotherapy prescriptions per patient was significantly lower in the intervention group (RR: 0.814; 95% CI: 0.721–0.919), while the likelihood of participation in exercise programmes over one year was significantly higher (OR: 3.126; 95% CI: 1.604–6.094). Enrolment in the programme was associated with significantly higher ambulatory costs (€1048 vs. €925), but costs for inpatient care, including hospital stays, were significantly lower (€1003 vs. €1497 and €928 vs. €1300 respectively). Overall annual cost-savings were €195 per patient. Conclusions: Collaborative ambulatory orthopaedic care was associated with reduced hospitalisation in patients with hip and knee osteoarthritis. Health costs for programme participants were lower overall, despite higher costs for ambulatory care

Associations of baseline use of biologic or targeted synthetic DMARDs with COVID-19 severity in rheumatoid arthritis : Results from the COVID-19 Global Rheumatology Alliance physician registry

Funding Information: Competing interests JAS is supported by the National Institute of Arthritis and Funding Information: Musculoskeletal and Skin Diseases (grant numbers K23 AR069688, R03 AR075886, L30 AR066953, P30 AR070253 and P30 AR072577), the Rheumatology Research Foundation (K Supplement Award and R Bridge Award), the Brigham Research Institute, and the R Bruce and Joan M Mickey Research Scholar Fund. JAS has received research support from Amgen and Bristol-Myers Squibb and performed consultancy for Bristol-Myers Squibb, Gilead, Inova, Janssen and Optum, unrelated to this work. ZSW reports grant support from Bristol-Myers Squibb and Principia/ Sanofi and performed consultancy for Viela Bio and MedPace, outside the submitted work. His work is supported by grants from the National Institutes of Health. MG is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant numbers K01 AR070585 and K24 AR074534; JY). KLH reports she has received speaker’s fees from AbbVie and grant income from BMS, UCB and Pfizer, all unrelated to this study. KLH is also supported by the NIHR Manchester Biomedical Research Centre. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories such as, among other institutions, AbbVie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal and UCB Pharma. LG reports research grants from Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz and Sanofi; consulting fees from AbbVie, Amgen, BMS, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi Aventis and UCB, all unrelated to this study. EFM reports that LPCDR received support for specific activities: grants from AbbVie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal, MSD, Celgene, Medac, Pharma Kern and GAfPA; grants and non-financial support from Pfizer; and non-financial support from Grünenthal, outside the submitted work. AS reports grants from a consortium of 13 companies (among them AbbVie, BMS, Celltrion, Fresenius Kabi, Lilly, Mylan, Hexal, MSD, Pfizer, Roche, Samsung, Sanofi Aventis and UCB) supporting the German RABBIT register, and personal fees from lectures for AbbVie, MSD, Roche, BMS and Pfizer, outside the submitted work. AD-G has no disclosures relevant to this study. His work is supported by grants from the Centers for Disease Control and Prevention and the Rheumatology Research Foundation. KMD is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (T32-AR-007258) and the Rheumatology Research Foundation. NJP is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (T32-AR-007258). PD has received research support from Bristol-Myers Squibb, Chugai and Pfizer, and performed consultancy for Boehringer Ingelheim, Bristol-Myers Squibb, Lilly, Sanofi, Pfizer, Chugai, Roche and Janssen, unrelated to this work. NS is supported by the RRF Investigator Award and the American Heart Association. MFU-G reports grant support from Janssen and Pfizer. SB reports no competing interests related to this work. He reports non-branded consulting fees for AbbVie, Horizon, Novartis and Pfizer (all <$10 000). RG reports no competing interests related to this work. Outside of this work she reports personal and/or speaking fees from AbbVie, Janssen, Novartis, Pfizer and Cornerstones, and travel assistance from Pfizer (all <$10 000). JH reports no competing interests related to this work. He is supported by grants from the Rheumatology Research Foundation and the Childhood Arthritis and Rheumatology Research Alliance. He has performed consulting for Novartis, Sobi and Biogen, all unrelated to this work (<$10 000). JL has received research funding from Pfizer, outside the submitted work. ES is a Board Member of the Canadian Arthritis Patient Alliance, a patient-run, volunteer-based organisation whose activities are largely supported by independent grants from pharmaceutical companies. PS reports no competing interests related to this work. He reports honorarium for doing social media for American College of Rheumatology journals (<$10 000). PMM has received consulting/speaker’s fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this study (all <$10 000). PMM is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). PCR reports no competing interests related to this work. Outside of this work he reports personal consulting and/or speaking fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB, and travel assistance from Roche (all <$10 000). JY reports no competing interests related to this work. Her work is supported by grants from the National Institutes of Health, Centers for Disease Control, and the Agency for Healthcare Research and Quality. She has performed consulting for Eli Lilly and AstraZeneca, unrelated to this project. Publisher Copyright: © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.Objective To investigate baseline use of biologic or targeted synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs) and COVID-19 outcomes in rheumatoid arthritis (RA). Methods We analysed the COVID-19 Global Rheumatology Alliance physician registry (from 24 March 2020 to 12 April 2021). We investigated b/tsDMARD use for RA at the clinical onset of COVID-19 (baseline): abatacept (ABA), rituximab (RTX), Janus kinase inhibitors (JAKi), interleukin 6 inhibitors (IL-6i) or tumour necrosis factor inhibitors (TNFi, reference group). The ordinal COVID-19 severity outcome was (1) no hospitalisation, (2) hospitalisation without oxygen, (3) hospitalisation with oxygen/ventilation or (4) death. We used ordinal logistic regression to estimate the OR (odds of being one level higher on the ordinal outcome) for each drug class compared with TNFi, adjusting for potential baseline confounders. Results Of 2869 people with RA (mean age 56.7 years, 80.8% female) on b/tsDMARD at the onset of COVID-19, there were 237 on ABA, 364 on RTX, 317 on IL-6i, 563 on JAKi and 1388 on TNFi. Overall, 613 (21%) were hospitalised and 157 (5.5%) died. RTX (OR 4.15, 95% CI 3.16 to 5.44) and JAKi (OR 2.06, 95% CI 1.60 to 2.65) were each associated with worse COVID-19 severity compared with TNFi. There were no associations between ABA or IL6i and COVID-19 severity. Conclusions People with RA treated with RTX or JAKi had worse COVID-19 severity than those on TNFi. The strong association of RTX and JAKi use with poor COVID-19 outcomes highlights prioritisation of risk mitigation strategies for these people.publishersversionPeer reviewe

Economical rapid-prototyping of aspherical lenses

We present a rapid-prototyping process to fabricate aspherical lens arrays based on surface deformation due to thermal expansion of PDMS. Using laser-structuring and molding in combination with an FEM-based shape optimization, we were able to design, fabricate and characterize different micro-lens arrays. This fabrication process can be used for almost any kind of arbitrary lens shape, which allows for a large design freedom for micro lenses

Economical rapid-prototyping of aspherical lenses

We present a rapid-prototyping process to fabricate aspherical lens arrays based on surface deformation due to thermal expansion of PDMS. Using laser-structuring and molding in combination with an FEM-based shape optimization, we were able to design, fabricate and characterize different micro-lens arrays. This fabrication process can be used for almost any kind of arbitrary lens shape, which allows for a large design freedom for micro lenses

Cardiovascular safety of clonidine and dexmedetomidine in critically Ill patients after cardiac surgery

Purpose. The aim of this retrospective study was to assess the haemodynamic adverse effects of clonidine and dexmedetomidine in critically ill patients after cardiac surgery. Methods. 2769 patients were screened during the 30-month study period. Heart rate (HR), mean arterial pressure (MAP), and norepinephrine requirements were assessed 3-hourly during the first 12 hours of the continuous drug infusion. Results are given as median (interquartile range) or numbers (percentages). Results. Patients receiving clonidine (n = 193) were younger (66 (57–73) vs 70 (63–77) years, p=0.003) and had a lower SAPS II (35 (27–48) vs 41 (31–54), p=0.008) compared with patients receiving dexmedetomidine (n = 141). At the start of the drug infusion, HR (90 (75–100) vs 90 (80–105) bpm, p=0.028), MAP (70 (65–80) vs 70 (65–75) mmHg, p=0.093), and norepinephrine (0.05 (0.00–0.11) vs 0.12 (0.03–0.19) mcg/kg/min, p&lt;0.001) were recorded in patients with clonidine and dexmedetomidine. Bradycardia (HR &lt; 60 bpm) developed in 7.8% with clonidine and 5.7% with dexmedetomidine (p=0.51). Between baseline and 12 hours, norepinephrine remained stable in the clonidine group (0.00 (−0.04–0.02) mcg/kg/min) and decreased in the dexmedetomidine group (−0.03 (−0.10–0.02) mcg/kg/min, p=0.007). Conclusions. Dexmedetomidine and the low-cost drug clonidine can both be used safely in selected patients after cardiac surgery