"Against the silence": Development and first results of a patient survey to assess experiences of safety-related events in hospital

BACKGROUND: Involvement of patients in the detection and prevention of safety related events and medical errors have been widely recommended. However, it has also been questioned whether patients at large are willing and able to identify safety-related events in their care. The aim of this study was to develop and pilot test a brief patient safety survey applicable to inpatient care in Swiss hospitals. METHODS: A survey instrument was developed in an iterative procedure. The instrument asks patients to report whether they have experienced specific undesirable events during their hospital stay. The preliminary version was developed together with experts and tested in focus groups with patients. The adapted survey instrument was pilot-tested in random samples of patients of two Swiss hospitals (n = 400). Responders to the survey that had reported experience of any incident were sampled for qualitative interviews (n = 18). Based on the interview, the researcher classified the reported incidents as confirmed or discarded. RESULTS: The survey was generally well accepted in the focus groups and interviews. In the quantitative pilot test, 125 patients returned the survey (response rate: 31%). The mean age of responders was 55 years (range 17-91, SD 18 years) and 62.5% were female. The 125 participating patients reported 94 "definitive" and 34 "uncertain" events. 14% of the patients rated any of the experienced events as "serious". The definitive and uncertain events reported with highest frequency were phlebitis, missing hand hygiene, allergic drug reaction, unavailability of documents, and infection. 23% of patients reported some or serious concerns about their safety. The qualitative interviews indicate that both, the extent of patients' uncertainty in the classification of events and the likelihood of confirmation by the interviewer vary very much by type of incident. Unexpectedly, many patients reported problems and incidents related to food and dietary intake. Overall, the in-depth interviews confirmed experiences from the focus groups that many patients feel reluctant to report undesirable events without acknowledging the presence or absence of individual responsibility or failure. Many patients reported that they did not ask or communicate about errors or near misses with staff and some patients even develop strategies to improve their safety but do not disclose these to staff. CONCLUSION: Many patients experience undesirable events during hospitalization and a significant number of patients is seriously concerned about their safety. Surveying patients about experiences with safety-related events in hospital seems a valuable tool for identifying and monitoring problematic areas of care and undesirable events. Evidence from the qualitative interviews indicates that safety remains an unsaid word between patients and their care providers

Root causes and preventability of unintentionally retained foreign objects after surgery: a national expert survey from Switzerland.

BACKGROUND Retained foreign objects (RFO) after surgery are rare, serious patient safety events. In international comparisons based on routine data, Switzerland had remarkably high RFO rates. The objectives of this study were to 1) explore national key stakeholders' views on RFO as a safety problem, its preventability and need for action in Switzerland; and 2) to assess their interpretation of Switzerland's RFO incidence compared to other countries. METHODS A semi-structured expert survey was conducted among national key representatives, including clinician experts, patient advocates, health administration representatives and other relevant stakeholders (n = 21). Data were coded and analyzed to generate themes related to the study questions following a deductive approach. RESULTS Experts in this study unequivocally emphasized the tragedy for individual patients affected by RFOs. Productivity pressure and the strong economization of operating rooms were perceived as detrimental to safety culture, which was seen as essential for RFO prevention, specifically by those working in the OR. RFOs were seen as "maximally minimizable" but not completely preventable. There was strong agreement that within country differences in RFO risk between Swiss hospitals existed. On the systems level and compared to other safety issues, RFO were having less urgency for most experts. The international comparison of RFO incidences raised serious skepticism across all groups of experts. The validity of the data was questioned and the dominant interpretation of Switzerland's high RFO incidence compared to other countries was a "reporting artifact" based on high coding quality in Swiss hospitals. While most experts thought that the published RFO incidence warrants in-depth analysis of the data, there was little agreement about who's role it was to initiate any further activities. CONCLUSIONS This investigation offers valuable insights into the perspectives of significant stakeholders concerning RFOs, their root causes, and preventability. The findings demonstrate how international comparative safety data are perceived, interpreted, and utilized by national experts to derive conclusive insights

Are temporal trends in retained foreign object rates after surgery in Switzerland impacted by increasing coding intensity? A retrospective analysis of hospital routine data from 2000 to 2019.

OBJECTIVES Retained foreign objects (RFOs) after surgery can cause harm to patients and negatively impact clinician and hospital reputation. RFO incidence based on administrative data is used as a metric of patient safety. However, it is unknown how differences in coding intensity across hospitals and years impact the number of reported RFO cases. The objective of this study is to investigate the temporal trend of RFO incidence at a national level and the impact of changes in coding practices across hospitals and years. DESIGN Retrospective study using administrative hospital data. SETTING AND PARTICIPANTS 21 805 005 hospitalisations at 354 Swiss acute-care hospital sites PRIMARY AND SECONDARY OUTCOME MEASURES: RFO incidence over time, the distribution of RFOs across hospitals and the impact of differences in coding intensity across the hospitals and years. RESULTS The annual RFO rate more than doubled between 2000 and 2019 (from 4.6 to 11.8 with a peak of 17.0 in 2014) and coincided with increasing coding intensity (mean number of diagnoses: 3.4, SD 2.0 in 2000; 7.40, SD 5.2 in 2019). After adjusting for patient characteristics, two regression models confirmed that coding intensity was a significant predictor of both whether RFO cases were reported at the hospital level (OR: 12.94; 95% CI: 7.38 to 22.68) and the number of reported cases throughout the period at the national level (Incidence Rate Ratio (IRR): 5.95; 95% CI: 1.11 to 31.82). CONCLUSIONS Our results raise concerns about the use of RFO incidence for comparing hospitals, countries and years. Utilising coding indices could be employed to mitigate the effects of coding intensity on RFO rates

Registration and Management of "Never Events" in Swiss Hospitals-The Perspective of Clinical Risk Managers.

BACKGROUND In Switzerland, there is no mandatory reporting of "never events." Little is known about how hospitals in countries with no "never event" policies deal with these incidents in terms of registration and analyses. OBJECTIVE The aim of our study was to explore how hospitals outside mandatory "never event" regulations identify, register, and manage "never events" and whether practices are associated with hospital size. METHODS Cross-sectional survey data were collected from risk managers of Swiss acute care hospitals. RESULTS Clinical risk managers representing 95 hospitals completed the survey (55% response rate). Among responding risk and quality managers, only 45% would be formally notified through a designated reporting channel if a "never event" has happened in their hospital. Averaged over a list of 8 specified events, only half of hospitals could report a systematic count of the number of events. Hospital size was not associated with "never event" management. Respondents reported that their hospital pays "too little attention" to the recording (46%), the analysis (34%), and the prevention (40%) of "never events." All respondents rated the systematic registration and analysis of "never events" as very (81%) or rather important (19%) for the improvement of patient safety. CONCLUSIONS A substantial fraction of Swiss hospitals do not have valid data on the occurrence of "never events" available and do not have reliable processes installed for the registration and exam of these events. Surprisingly, larger hospitals do not seem to be better prepared for "never events" management

Patient Safety: What Is It All about?

Patient safety is a major concern in health care systems worldwide. Patients with serious conditions, multimorbidity, and with intense and fragmented health care utilization, like end-stage renal disease (ESRD) patients, are at increased risk for suffering adverse events. In this chapter, the fundamental terms and concepts of patient safety are introduced. Essential epidemiological data relating to the frequency of adverse events and medical errors are provided. The chapter reports important safety threats for ESRD patients and describes examples of key innovations which contribute to patient safety. Recommendations and risk reduction strategies to improve care of ESRD patients are presented. © 2015 S. Karger AG, Basel

Speaking up or remaining silent about patient safety concerns in rehabilitation: A cross-sectional survey to assess staff experiences and perceptions.

Background and Aims Patient safety incidents may be prevented if healthcare workers speak up to voice their concerns when they observe hazardous clinical situations. This study aims to investigate the frequency of speaking up and healthcare workers' perception of organizational climate in rehabilitation clinics. Methods An online survey was conducted in five rehabilitation clinics. An existing survey instrument (Speaking Up About Patient Safety Questionnaire [SUPS-Q]) was adapted for this purpose. The instrument includes items on self-reported speak-up-related behavior (perceived safety concerns, withholding voice, and speaking up), anticipated speak-up behavior, barriers to speaking up, and speak-up-related climate measures (psychological safety, encouraging environment, and resignation). Data analysis included descriptive statistics, one-way analysis of variance for differences between groups, multiple regression, and measures for validity and reliability of the scales.\ud Results Four hundred seventy-one individuals participated in the survey (response rate of 32%). In the 4 weeks preceding the survey, 81% of respondents had specific concerns about patient safety, 83% performed speak up and 41% remained silent in one or more instances. Expected differences between professional groups were confirmed, but surprisingly, we found no effect of hierarchical level on speaking up behavior and perception of the speak-up climate. Factors that most frequently prevented healthcare workers from speaking up were ineffectiveness (38%), presence of patients (26%), and unpredictability of the actor's reaction (25%). The psychometric evaluation of the adapted SUPS-Q showed acceptable results for validity and reliability. Conclusions Healthcare workers in rehabilitation clinics frequently perceive safety concerns. The study underlines the importance of promoting a culture of safety and speaking up. The short survey instrument SUPS-Q can be used by rehabilitation clinics to initiate discussions related to facilitators and barriers to speaking up and to identify areas for improvement within the organization

Compliance with the surgical safety checklist in Switzerland: an observational multicenter study based on self-reported data.

BACKGROUND Since publication of the surgical safety checklist by the WHO in 2009, it has been introduced in many hospitals. However, frequency and quality of surgical safety checklist use is often low probably limiting the effectiveness of the checklist in preventing patient harm. The focus of this study was to examine the current state of compliance with the surgical safety checklist in Switzerland and to evaluate how the data relates to international comparative data. METHODS Between November 2020 and March 2021 twelve hospitals with 15 sites collected for at least 200 surgical interventions each whether the three sections of the surgical safety checklist (Sign In, Team Time Out, Sign Out) have been applied. This data collection was part of a large quality improvement project focusing on measuring and improving compliance with the surgical safety checklist via peer observation and feedback. Descriptive statistics were used to analyze the data; chi-square tests were used to compare sub-samples. RESULTS The hospitals collected valid compliance data for 8622 surgical interventions. Mean compliance rate was 91% when distinguishing between the two categories applied (including partially applied) and not applied. In line with previous research, Sign In (93%) and Team Time Out (94%) sections have been applied more frequently than Sign Out (86%). All three surgical safety checklist sections have been applied in 79% of the surgical interventions, no sections in 1%. CONCLUSIONS The results of this study indicate that the overall application of the surgical safety checklist in Switzerland can be considered high, although the completeness, especially of the Sign Out section, could be improved. At present, it seems difficult to compare compliance rates from different studies as measurement methods and definitions of compliance vary widely. A systematization and homogenization of the methodology within, but also beyond, national borders is desirable for the future

The economic benefits of health and prevention in a high-income country: the example of Germany

This paper complements the current health policy debate, which is largely confined to the cost aspects of health systems, by considering explicitly the potential economic benefits of investing in health in general and via - chiefly primary - prevention. While concerns about high and rising health care costs are justified, we see a pressing need to also measure the benefits, ultimately enabling a complete economic assessment of the socially optimal level of resources for health. Despite the use of Germany as our point of reference, our approach and findings likely apply to a wider set of European highincome countries. Using new and already existing data, we find that in sheer health terms Germany has a lot to gain from more and better illness prevention. Assuming part of this existing burden can be reduced via effective preventive interventions, we find that the resulting economic benefits - expressed in people's willingness to pay for a reduction in mortality risk - would be substantial. We also gather Germany-specific evidence to suggest that the existing burden of ill health - whether caused by lack of prevention or treatment - negatively impacts a number of important economic outcomes at the individual and macro-economic level. Referring to work carried out in parallel to this project, we find that a number of cost-effective, primary preventive interventions exist to tackle part of the avoidable disease burden. Yet we note a deficit of economic evaluations, in particular in non-clinical interventions - a finding that underlines the role of government in the production of research on specifically non-clinical prevention. In light of the market failures discussed, from an economic perspective the role of government not only consists of research, but also - surprisingly to many - extends to actual interventions to address the health behaviour-related determinants of chronic disease. With the stakes as high and the economic justification for action in place, the case for scaling up preventive efforts in Germany, backed up by solid epidemiological and economic research, is hard to deny. -- Die vorliegende Studie ergänzt die gegenwärtige gesundheitspolitische Debatte, die sich vorwiegend auf Kostenaspekte des Gesundheitswesens konzentriert, indem sie den potentiellen ökonomischen Nutzen von Gesundheitsinvestitionen im allgemeinen und (Primär-)Prävention im besonderen hervorhebt. Auch wenn die Sorge um hohe und steigende Kosten des Gesundheitswesens berechtigt ist, bleibt die Notwendigkeit, auch den Nutzen der Gesundheitsausgaben zu erfassen, um somit zu einer ökonomisch vollständigen Einschätzung des sozial optimalen Niveaus der Gesundheitsausgaben zu gelangen. Trotz des Fokus auf Deutschland sind unser Ansatz und die Ergebnisse auch auf andere Mitgliedsländer der EU übertragbar. Wir zeigen anhand neuer und schon bekannter Daten, dass der Spielraum für Gesundheitsverbesserungen, vorwiegend durch Prävention, in Deutschland erheblich ist. Der ökonomische Nutzen - gemessen an der Zahlungsbereitschaft der Bevölkerung - der durch Reduktion eines Teils dieser Krankheitslast mittels Interventionen erzielt werden kann, ist nach unseren Berechnungen beachtlich. Darüber hinaus zeigen mehrere Studien, wie die aktuell gegebene Krankheitslast, ob durch einen Mangel an Prävention oder Versorgung verursacht, eine Reihe relevanter ökonomischer Grössen auf individueller und gesamtwirtschaftlicher Ebene beeinträchtigt. Wie eine parallel durchgeführte Studie der Autoren ergab, existieren auch eine Reihe kosten-effektiver Interventionen im Bereich der primären Prävention. Dennoch bestehen noch Lücken in der ökonomischen Bewertung insbesondere nicht-klinischer Interventionen - ein Ergebnis, das die Rolle des Staates in der Evaluation dieser Interventionen unterstreicht. Aufgrund von Marktversagen in einigen relevanten Bereichen besteht eine ökonomische Rechtfertigung für staatliches Handeln nicht nur im Bereich der Forschung, sondern - überraschend für manche - auch im Bereich der (Primär-)Prävention der nicht-ansteckenden und mit dem individuellen Gesundheitsverhalten verbundenen Krankheiten. Aufgrund des in diesem Papier dokumentierten hohen gesundheitlichen und ökonomischen Nutzens sowie der ökonomischen Rechtfertigung der Rolle des Staates kann das Argument für eine Verstärkung der Prävention in Deutschland nur schwer bestritten werden.

Implementation status of safety measures to prevent errors with non-oncologic methotrexate: surveys in community and hospital pharmacies.

BACKGROUND Accidental overdose of low-dose methotrexate can lead to serious patient harm. Different safety measures are recommended to prevent errors, yet, as errors continue to happen, their implementation is questionable. AIM To evaluate the implementation status of safety measures for methotrexate in community and hospital pharmacies. METHOD An electronic questionnaire was sent to head pharmacists of 163 community and 94 hospital pharmacies in Switzerland. The implementation of recommended safety measures (general measures, safety working procedures, IT-based measures) was assessed and descriptive analysis performed. An analysis of sales data underlined the relevance of our results, i.e., the population under risk for overdose. RESULTS A response was obtained from 53% (n = 87) of community and 50% (n = 47) of hospital pharmacists. Pharmacies had implemented a median of 6 (IQR 3, community) and 5 (IQR 5, hospital) safety measures overall. Most of these were defined safety procedures, instructing staff on how to handle methotrexate prescriptions. Across all safety measures, compliance with single procedures was perceived as "very likely" by 54% of community pharmacies. IT-based measures (e.g., alerts) were absent in 38% (n = 31) of community and 57% (n = 27) of hospital pharmacies. On average, every community pharmacy dispensed 22 packages annually. CONCLUSION Safety in relation to methotrexate in pharmacies relies mostly on staff instructions, which are considered weak measures. In light of the serious risk imposed on patients, pharmacies should set a focus on stronger IT-based measures that rely less on human performance