Supporting Error Management and Safety Climate in Ambulatory Care Practices: The CIRSforte Study.

BACKGROUND: To improve patient safety, it is important that healthcare facilities learn from critical incidents. Tools such as reporting and learning systems and team meetings structure error management and promote learning from incidents. To enhance error management in ambulatory care practices, it is important to promote a climate of safety and ensure personnel share views on safety policies and procedures. In contrast to the hospital sector, little research has been dedicated to developing feasible approaches to supporting error management and safety climate in ambulatory care. In this study, we developed, implemented, and evaluated a multicomponent intervention to address how error management and safety climate can be improved in ambulatory care practices. METHODS: In a prospective 1-group pretest-posttest implementation study, we sought to encourage teams in German ambulatory practices to use proven methods such as guidelines, workshops, e-learning, (online) meetings, and e-mail newsletters. A pretest-posttest questionnaire was used to evaluate level and strength of safety climate and psychological behavioral determinants for systematic error management. Using 3 short surveys, we also assessed the state of error management in the participating practices. In semistructured interviews, we asked participants for their views on our intervention measures. RESULTS: Overall, 184 ambulatory care practices nationwide agreed to participate. Level of safety climate and safety climate strength (rwg) improved significantly. Of psychological behavioral determinants, significant improvements could be seen in "action/coping planning" and "action control." Seventy-six percent of practices implemented a new reporting and learning system or modified their existing system. The exchange of information between practices also increased over time. Interviews showed that the introductory workshop and provided materials such as report forms or instructions for team meetings were regarded as helpful. CONCLUSIONS: A significant improvement in safety climate level and strength, as well as participants' knowledge of how to analyze critical incidents, derive preventive measures and develop concrete plans suggest that it is important to train practice teams, to provide practical tips and tools, and to facilitate the exchange of information between practices. Future randomized and controlled intervention trials should confirm the effectiveness of our multicomponent intervention.Trial registration: Retrospectively registered on 18. November 2019 in German Clinical Trials Register No. DRKS00019053.

Facility-Based Indicators to Manage and Scale Up Cervical Cancer Prevention and Care Services for Women Living With HIV in Sub-Saharan Africa: a Three-Round Online Delphi Consensus Method.

BACKGROUND: Of women with cervical cancer (CC) and HIV, 85% live in sub-Saharan Africa, where 21% of all CC cases are attributable to HIV infection. We aimed to generate internationally acceptable facility-based indicators to monitor and guide scale up of CC prevention and care services offered on-site or off-site by HIV clinics. METHODS: We reviewed the literature and extracted relevant indicators, grouping them into domains along the CC control continuum. From February 2021 to March 2022, we conducted a three-round, online Delphi process to reach consensus on indicators. We invited 106 experts to participate. Through an anonymous, iterative process, participants adapted the indicators to their context (round 1), then rated them for 5 criteria on a 5-point Likert-type scale (rounds 2 and 3) and then ranked their importance (round 3). RESULTS: We reviewed 39 policies from 21 African countries and 7 from international organizations; 72 experts from 15 sub-Saharan Africa countries or international organizations participated in our Delphi process. Response rates were 34% in round 1, 40% in round 2, and 44% in round 3. Experts reached consensus for 17 indicators in the following domains: primary prevention (human papillomavirus prevention, n = 2), secondary prevention (screening, triage, treatment of precancerous lesions, n = 11), tertiary prevention (CC diagnosis and care, n = 2), and long-term impact of the program and linkage to HIV service (n = 2). CONCLUSION: We recommend that HIV clinics that offer CC control services in sub-Saharan Africa implement the 17 indicators stepwise and adapt them to context to improve monitoring along the CC control cascade.

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.

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 cross-sectional safety climate survey results in operating room staff associated with the surgical site infection rates in Swiss hospitals?

OBJECTIVES: The aim of this study was to investigate the association between surgical site infections (SSIs), a major source of patient harm, and safety and teamwork climate. Prior research has been unclear regarding this relationship. DESIGN: Based on the Swiss national SSI surveillance and a survey study assessing (a) safety climate and (b) teamwork climate, associations were analysed for three kinds of surgical procedures. SETTING AND PARTICIPANTS: SSI surveillance data from 20 434 surgeries for hip and knee arthroplasty from 41 hospitals, 8321 for colorectal procedures from 28 hospitals and 4346 caesarean sections from 11 hospitals and survey responses from Swiss operating room personnel (N=2769) in 54 acute care hospitals. PRIMARY AND SECONDARY OUTCOMES: The primary endpoint of the study was the 30-day (all types) or 1-year (knee/hip with implants) National Healthcare Safety Network-adjusted SSI rate. Its association with climate level and strength was investigated in regression analyses, accounting for respondents' professional background, managerial role and hospital size as confounding factors. RESULTS: Plotting climate levels against infection rates revealed a general trend with SSI rate decreasing as the safety climate increased, but none of the associations were significant (5% level). Linear models for hip and knee arthroplasties showed a negative association between SSI rate and climate perception (p=0.02). For climate strength, there were no consistent patterns, indicating that alignment of perceptions was not associated with lower infection rates. Being in a managerial role and being a physician (vs a nurse) had a positive effect on climate levels regarding SSI in hip and knee arthroplasties, whereas larger hospital size had a negative effect. CONCLUSIONS: This study suggests a possible negative correlation between climate level and SSI rate, while for climate strength, no associations were found. Future research should study safety climate more specifically related to infection prevention measures to establish clearer links.

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.

Effects of a computerised diagnostic decision support tool on diagnostic quality in emergency departments: study protocol of the DDx-BRO multicentre cluster randomised cross-over trial.

INTRODUCTION: Computerised diagnostic decision support systems (CDDS) suggesting differential diagnoses to physicians aim to improve clinical reasoning and diagnostic quality. However, controlled clinical trials investigating their effectiveness and safety are absent and the consequences of its use in clinical practice are unknown. We aim to investigate the effect of CDDS use in the emergency department (ED) on diagnostic quality, workflow, resource consumption and patient outcomes. METHODS AND ANALYSIS: This is a multicentre, outcome assessor and patient-blinded, cluster-randomised, multiperiod crossover superiority trial. A validated differential diagnosis generator will be implemented in four EDs and randomly allocated to a sequence of six alternating intervention and control periods. During intervention periods, the treating ED physician will be asked to consult the CDDS at least once during diagnostic workup. During control periods, physicians will not have access to the CDDS and diagnostic workup will follow usual clinical care. Key inclusion criteria will be patients' presentation to the ED with either fever, abdominal pain, syncope or a non-specific complaint as chief complaint. The primary outcome is a binary diagnostic quality risk score composed of presence of an unscheduled medical care after discharge, change in diagnosis or death during time of follow-up or an unexpected upscale in care within 24 hours after hospital admission. Time of follow-up is 14 days. At least 1184 patients will be included. Secondary outcomes include length of hospital stay, diagnostics and data regarding CDDS usage, physicians' confidence calibration and diagnostic workflow. Statistical analysis will use general linear mixed modelling methods. ETHICS AND DISSEMINATION: Approved by the cantonal ethics committee of canton Berne (2022-D0002) and Swissmedic, the Swiss national regulatory authority on medical devices. Study results will be disseminated through peer-reviewed journals, open repositories and the network of investigators and the expert and patients advisory board. TRIAL REGISTRATION NUMBER: NCT05346523.

Preventing Surgical Site Infections: Are Safety Climate Level and Its Strength Associated With Self-reported Commitment To, Subjective Norms Toward, and Knowledge About Preventive Measures?

OBJECTIVES: Surgical site infections (SSIs) represent a major source of preventable patient harm. Safety climate in the operating room personnel is assumed to be an important factor, with scattered supporting evidence for the association between safety climate and infection outcome so far. This study investigated perceptions and knowledge specific to infection prevention measures and their associations with general assessments of safety climate level and strength. METHODS: We invited operating room personnel of hospitals participating in the Swiss SSI surveillance program to take a survey (response rate, 38%). A total of 2769 responses from 54 hospitals were analyzed. Two regression analyses were performed to identify associations between subjective norms toward, commitment to, as well as knowledge about prevention measures and safety climate level and strength, taking into account professional background and number of responses per hospital. RESULTS: Commitment to perform prevention measures even when situational pressures exist, as well as subjective norm of perceiving the expectation of others to perform prevention measures were significantly ( P < 0.05) related to safety climate level, while for knowledge about preventative measures this was not the case. None of the assessed factors was significantly associated with safety climate strength. CONCLUSIONS: While pertinent knowledge did not have a significant impact, the commitment and the social norms to maintain SSI prevention activities even in the face of other situational demands showed a strong influence on safety climate. Assessing the knowledge about measures to prevent SSIs in operating room personnel opens up opportunities for designing intervention efforts in reducing SSIs.

Speaking up about patient safety concerns: view of nursing students.

BACKGROUND: "Speaking up" is considered an important patient safety behaviour. The main idea is to voice patient safety concerns; however, several studies revealed that the organisational culture can be obstructive. In previous studies, we already identified barriers for doctors, nurses and medical students. In the current study, we explore how nursing students use "speaking up" during their internship in an academic teaching hospital. METHODS: Between 2019 and 2020, 212 nursing students were invited to take part in the survey. The validated Speaking Up about Patient Safety Questionnaire (SUPS-Q) was used to assess speaking up behaviours in nursing students. The SUPS-Q consisted of three behaviour related scales (11 items), three culture related scales (11 items), a question regarding barriers to speak up as well as a clinical vignette assessing a hypothetical speaking up situation. RESULTS: In total, 118 nursing students took part in the survey (response rate: 56%). Most of them noticed specific safety concerns, observed errors or rule violations. The vignette was seen as very realistic and harmful to the patient. However, the majority responded that they did not speak up and remained silent. They reported a rather discouraging environment and high levels of resignation towards speaking up. However, more advanced students were less likely to speak up than less advanced students (p = 0.027). Most relevant barriers were fear of negative reaction (64%), reaction not predictable (62%) and ineffectiveness (42%). CONCLUSIONS: Survey results of nursing students imply that speaking-up behaviours and remaining silent are common behaviours and coexist in the same individual. The clinical vignette and barriers to speaking up revealed that a hierarchical system does not support speaking-up behaviours. Organizational development is needed to foster professional teamwork, support attentive listening, encourage critical thinking, and problem-solving skills.

Strength of Safety Measures Introduced by Medical Practices to Prevent a Recurrence of Patient Safety Incidents: An Observational Study.

OBJECTIVE: The aim of this study was to analyze the strength of safety measures described in incident reports in outpatient care. METHODS: An incident reporting project in German outpatient care included 184 medical practices with differing fields of specialization. The practices were invited to submit anonymous incident reports to the project team 3 times for 17 months. Using a 14-item coding scheme based on international recommendations, we deductively coded the incident reports and safety measures. Safety measures were classified as "strong" (likely to be effective and sustainable), "intermediate" (possibly effective and sustainable), or "weak" (less likely to be effective and sustainable). RESULTS: The practices submitted 245 incident reports. In 160 of them, 243 preventive measures were described, or an average of 1.5 per report. The number of documented measures varied from 1 in 67% to 4 in 5% of them. Four preventive measures (2%) were classified as strong, 37 (15%) as intermediate, and 202 (83%) as weak. The most frequently mentioned measures were "new procedure/policy" (n = 121) and "information/notification/warning" (n = 45). CONCLUSIONS: The study provides examples of critical incidents in medical practices and for the first time examines the strength of ensuing measures introduced in outpatient care. Overall, the proportion of weak measures is (too) high, indicating that practices need more support in identifying strong measures.

Efficiency and Safety of Electronic Health Records in Switzerland-A Comparative Analysis of 2 Commercial Systems in Hospitals.

OBJECTIVES: Differences in efficiency and safety between 2 electronic health record (systems A and B) in Swiss hospitals were investigated. METHODS: In a scenario-based usability test under experimental conditions, a total of 100 physicians at 4 hospitals were asked to complete typical routine tasks, like medication or imaging orders. Differences in number of mouse clicks and time-on-task as indicators of efficiency and error type, error count, and rate as indicators of patient safety between hospital sites were analyzed. Time-on-task and clicks were correlated with error count. RESULTS: There were differences in efficiency and safety between hospitals. Overall, physicians working with system B required less clicks (A: 511, B: 442, P = 0.001) and time (A: 2055 seconds, B: 1713 seconds, P = 0.055) and made fewer errors (A: 40%, B: 27%, P < 0.001). No participant completed all tasks correctly. The most frequent error in medication and radiology ordering was a wrong dose and a wrong level, respectively. Time errors were particularly prevalent in laboratory orders. Higher error counts coincided with longer time-on-task (r = 0.50, P < 0.001) and more clicks (r = 0.47, P < 0.001). CONCLUSIONS: The variations in clicks, time, and errors are likely due to naive functionality and design of the systems and differences in their implementation. The high error rates coincide with inefficiency and jeopardize patient safety and produce economic costs and burden on physicians. The results raise usability concerns with potential for severe patient harm. A deeper understanding of differences as well as regulative guidelines and policy making are needed.

Accuracy of Spinal Anesthesia Drug Concentrations in Mixtures Prepared by Anesthetists.

OBJECTIVE: Medication errors include the indirect dosing of drugs. For spinal anesthesia mixtures of local anesthetics, opioids are drawn from ampoules and combined in a syringe, according to clinical practice. We set out to determine the accuracy of the drug mixtures. METHODS: Physicians of our department were invited to prepare the mixture used for spinal anesthesia for cesarean section, consisting of 10-mg hyperbaric bupivacaine (2-mL volume), 20-µg fentanyl (0.4-mL volume), and 100-µg morphine (0.1-mL volume). Concentrations of these drugs were determined by means of high performance liquid chromatography. Interindividual and intraindividual variations were assessed. RESULTS: We analyzed 96 samples from 31 physicians. Fifty-one percent of the measured bupivacaine concentrations were in ±10% deviation range of the intended concentration; 17% of the fentanyl and 24% of the morphine concentrations were in this range. A total of 2.1% of the samples had a bupivacaine concentration corresponding to a dose of 8 mg or less, and 11.5% of the samples had a morphine concentration corresponding to a dose of 150 µg or greater. Intraindividual variations were 10.9% for bupivacaine, 24.7% for fentanyl, and 38.9% for morphine. CONCLUSIONS: Our results show a high deviation of the obtained from the intended concentrations. Two percent of the samples had bupivacaine concentrations that probably resulted into an insufficient analgesia, and 11% of the samples had morphine concentrations that, according to guidelines, would require a longer monitoring period than with the intended dose.

A quality improvement initiative using peer audit and feedback to improve compliance.

BACKGROUND: The Surgical Safety Checklist (SSC) published by the WHO in 2009 is used as standard in surgery worldwide to reduce perioperative patient mortality. However, compliance with the SSC and quality of its application are often not satisfactory. Internal audits and feedbacks seem promising for improving SSC application. OBJECTIVE: The purpose of this study is to investigate whether an intervention consisting of peer observation and immediate peer feedback can be implemented with high fidelity and acceptance. METHOD: Data were obtained from a national pilot programme that was initiated in Switzerland in 2018 to measure and improve compliance with the SSC using peer audit and feedback. A total of 11 hospitals with 14 sites implemented the full intervention. Each hospital formed an interprofessional project team that should perform at least 30 observations with feedback on SSC application documented in an observation tool developed specifically for this programme. Since the SSCs of the study hospitals differ greatly regarding checklist items, for each of the three SSC sections standard items were defined: four at Sign In, five at Team Time Out and two at Sign Out. Frequency analyses were performed for initiation characteristics, SSC application at item level, feedback characteristics and programme evaluation. RESULTS: The 11 hospitals documented 715 valid observations, and feedback on SSC application was provided for 79% of the observations. In 61%, all team members stopped their work for the SSC application, and in 71%, the items were read off from the checklist (instead of recalled from memory). On average, 86% of the standard items were read out by the checklist coordinator, whilst the two items at Sign Out were read out only in 60% and 74%. Additional visual checks with another source (e.g. patient wristband) took place in only 41%, and verbal confirmation of the items (by someone else other than the checklist coordinator) was obtained on an average of 76% across all three checklist sections. The surgical teams reacted positively in 64% to the peer feedback. CONCLUSION: Both implementation fidelity and acceptability of the intervention were high-the present intervention seems suitable for regular monitoring of the quality of SSC application with internal resources. Peer observation facilitated identifying weaknesses regarding the SSC process and application at item level. Across all hospitals, the Sign Out section in general, visual control for item checks and lack of work interruption of all team members during SSC application showed up as the main areas of improvement.

The Impact of a 22-Month Multistep Implementation Program on Speaking-Up Behavior in an Academic Anesthesia Department.

BACKGROUND: Speaking-up is a method of assertive communication that increases patient safety but often encounters barriers. Numerous studies describe programs introducing speaking-up with varying success; the common denominator seems to be the need for a multimodal and sustained approach to achieve the required change in behavior and culture for safer health care. METHODS: Before implementing a 22-month multistep program for establishing and strengthening speaking-up at our institution, we assessed perceived safety culture using the "Safety Attitudes Questionnaire." After program completion, participants completed parts of the same Safety Attitudes Questionnaire relevant to speaking-up, and preresult and postresult were compared. In addition, levels of speaking-up and assertive communication were compared with a Swiss benchmark using results from the "Speaking-up About Patient Safety Questionnaire." RESULTS: Safety Attitudes Questionnaire scores were significantly higher after program completion in 2 of 3 answered questions (median [first quartile, third quartile), 5.0 [4.0, 5.0] versus 4.0 [4.0, 5.0], P = 0.0002, and 5.0 [4.0, 5.0] versus 4.0 [4.0, 4.0] P = 0.002; n = 34). Our composite score on the Speaking-up About Patient Safety Questionnaire was significantly higher (mean ± SD, 5.9 ± 0.7 versus 5.2 ± 1.0; P < 0.001) than the benchmark (n = 65). CONCLUSIONS: A long-term multimodal program for speaking-up was successfully implemented. Attitude and climate toward safety generally improved, and postprogram perceived levels of assertive communication and speaking-up were higher than the benchmark. These results support current opinion that multimodal programs and continued effort are required, but that speaking-up can indeed be strengthened.

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.

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. 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.

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.