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Background Immune checkpoint inhibitors (ICIs) treatment is a breakthrough in managing metastatic solid tumours, but its use is associated with a high financial burden for public health care systems. Validated tools such as the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) are frameworks that might help to better assess the clinical benefit of these novel innovative cancer drugs. Methods Here, we systematically analysed the number of European Medicines Agency-approved ICIs labels with an ESMO-MCBS grade, Highlights • Most European Medicines Agency-approved ICIs have an ESMO-MCBS with significant clinical benefit. • In hard-to-treat types of cancer such as TNBC or SCLC, the ESMO-MCBS is

Background: Prolonged hospitalization after tonsillectomy up to three nights was implemented to decrease mortality due to post-tonsillectomy hemorrhage.Aims: To assess if extension of postoperative...

Background Intrahospital patient transports (IHTs) in intensive care involve an appreciable risk of adverse events (AEs). Research on determinants of AE occurrence during IHT has hitherto focused on patient, transport, and intensive care unit (ICU) characteristics. By contrast, the role of "soft" factors, although arguably relevant for IHTs and a topic of interest in general health care settings, has not yet been explored. Purpose The study aims at examining the effect of safety climate and team processes on the occurrence of AE during IHT and whether team processes mediate the effect of safety climate. Methodology/approach Data stem from a noninterventional, observational multicenter study in 33 ICUs (from 12 European countries), with 858 transports overall recorded during 28 days. AEs include medication errors, dislodgments, equipment failures, and delays. Safety climate scales were taken from the "Patient Safety Climate in Healthcare Organizations" (short version), team processes scales from the "Leiden Operating Theatre and Intensive Care Safety" questionnaire. Patient condition was assessed with NEMS (Nine Equivalents of Nursing Manpower Use Score). All other variables could be directly observed. Hypothesis testing and assessment of effects rely on bivariate correlations and binomial logistic multilevel models (with ICU as random effect). Findings Both safety climate and team processes are comparatively important determinants of AE occurrence, also when controlling for transport-, staff-, and ICU-related variables. Team processes partially mediate the effect of safety climate. Patient condition and transport duration are consistently related with AE occurrence, too. Practice implications Unlike most patient, transport, and ICU characteristics, safety climate and team processes are basically amenable to managerial interventions. Coupled with their considerable effect on AE occurrence, this makes pertinent endeavors a potentially promising approach for improving patient safety during IHT. Although literature suggests that safety climate is slow and hard to change (also compared to team processes), efforts to improve safety climate should not be forgone.

Background: Safety climate (SC) and more recently patient engagement (PE) have been identified as potential determinants of patient safety, but conceptual and empirical studies combining both are lacking. Purposes: On the basis of extant theories and concepts in safety research, this study investigates the effect of PE in conjunction with SC on perceived error occurrence (pEO) in hospitals, controlling for various staff-, patient-, and hospital-related variables as well as the amount of stress and (lack of) organizational support experienced by staff. Besides the main effects of PE and SC on error occurrence, their interaction is examined, too. Methodology/Approach: In 66 hospital units, 4,345 patients assessed the degree of PE, and 811 staff assessed SC and pEO. PE was measured with a new instrument, capturing its core elements according to a recent literature review: Information Provision (both active and passive) and Activation and Collaboration. SC and pEO were measured with validated German-language questionnaires. Besides standard regression and correlational analyses, partial least squares analysis was employed to model the main and interaction effects of PE and SC on pEO, also controlling for stress and (lack of) support perceived by staff, various staff and patient attributes, and potential single-source bias. Findings: Both PE and SC are associated with lower pEO, to a similar extent. The joint effect of these predictors suggests a substitution rather than mutually reinforcing interaction. Accounting for control variables and/or potential single-source bias slightly attenuates some effects without altering the results. Practice Implications: Ignoring PE potentially amounts to forgoing a potential source of additional safety. On the other hand, despite the abovementioned substitution effect and conjectures of SC being inert, PE should not be considered as a replacement for SC.

Defensive medical practice represents an increasing concern in European countries and is reported to account for rising health care expenditures. Malpractice liability, current jurisdiction and the increasing claim for accountability appear to result in additional diagnostic requests with marginal clinical benefit. Investigations that evaluate the national Austrian prevalence and contextual principles and consequences of defensive medicine are lacking so far.Orthopaedic and trauma surgeons as well as radiologists from public hospitals in Austria were invited to complete a study questionnaire retrieving personal estimation of the quantity of patient contacts and defensive requests in a typical month, subjective judgement of medico-legal climate, evolving defensive trends, working time usage for defensive considerations and prior confrontations with malpractice liability claims.The prevalence of defensive medicine was found to be 97.7%. The average orthopaedic or trauma surgeon requests 19.6 investigations per month for defensive reasons, which represents 28% of all diagnostic examinations. High-quality imaging modalities and short-term admissions yield increasing defensive significance. Participants are confronted with 1.4 liability claims per month. During the treatment of high-risk patients, 81% of doctors request additional diagnostic procedures for defensive considerations. Expenditure of time for defensive practice amounts to 9.2 hours/month in radiology and to 17 and 18% of total working time, respectively, in orthopaedic and trauma surgery.Defensive medical practice represents a serious and common challenge in Austria. Our results indicate the urgent necessity for confrontation with and solution for the increasing effort of self-protection within the health care system.

Background: Hospitals face an increasing pressure towards efficiency and cost reduction while ensuring patient safety. This warrants a closer examination of the trade-off between production and protection posited in the literature for a high-risk hospital setting (intensive care). Purposes: Based on extant literature and concepts on both safety management and organizational/safety culture, this study investigates to which extent production pressure (i.e., increased staff workload and capacity utilization) and safety culture (consisting of safety climate among staff and safety tools implemented by management) influence the occurrence of medical errors and if/how safety climate and safety tools interact. Methodology / Approach: A prospective, observational, 48-hour cross-sectional study was conducted in 57 intensive care units. The dependent variable is the incidence of errors affecting those 378 patients treated throughout the entire observation period. Capacity utilization and workload were measured by indicators such as unit occupancy, nurse-/physician-to-patient ratios, levels of care, or NEMS scores. The safety tools considered include Critical Incidence Reporting Systems, audits, training, mission statements, SOPs/checklists and the use of barcodes. Safety climate was assessed using a psychometrically validated four-dimensional questionnaire. Linear regression was employed to identify the effects of the predictor variables on error rate, as well as interaction effects between safety tools and safety climate. Findings: Higher workload has a detrimental effect on safety while safety climate - unlike the examined safety tools - has a virtually equal opposite effect. Correlations between safety tools and safety climate as well as their interaction effects on error rate are mostly nonsignificant. Practice Implications: Increased workload and capacity utilization increase the occurrence of medical error; an effect that can be offset by a positive safety climate but not by formally implemented safety procedures and policies.

Background: Older patients (≧65 years) are exposed to more harm resulting from adverse events in hospitals than younger patients. Theoretical considerations and empirical findings suggest that safety culture is the key to improving the quality of health care. Objective: To describe the development of a German-language instrument for assessing patient safety culture (PSC) and its reliability and validity; to verify criterion validity by means of a cross-sectional analysis of the impact of PSC on clinical quality that compares acute geriatric units with a sample from intensive care, surgery and trauma surgery departments, and to report variations in the PSC profile between these groups. Methodology: Using a review of existing safety culture surveys, multidimensional scaling procedures and expert interviews, we tested the content and convergent validity of a 158-item questionnaire completed by 508 physicians and nurses from 31 acute geriatric units and 7 comparison departments. Criterion validity was verified by various regression models with a self-reported measure of adverse events. Differences in PSC profiles were analyzed using a one-factorial ANOVA and regression models. Results: We identified 7 constructs of PSC and demonstrated substantial convergent and criterion validity. In the acute geriatric units, higher levels of ‘management commitment to patient safety’ and lower levels of ‘error fatalism’ were associated with a reduced incidence of medical errors. In the comparison group, only the variable ‘active learning from mistakes’ was relevant for safety performance. Our results also indicate that acute geriatric units display higher standards than the comparison group in all the aspects of patient safety examined. Conclusion: It is possible to measure salient features of PSC using a valid and reliable survey. Some aspects of PSC are more closely related to safety events than others. In acute geriatric units, patient safety appears to be influenced mainly by management’s determination of how things are done whereas improvement of the system itself in a more incremental manner is required in the other high-risk ward types.