Endothelial-to-Mesenchymal Transition in Human and Murine Models of Congenital Diaphragmatic Hernia.

INTRODUCTION: Congenital diaphragmatic hernia (CDH) is a complex congenital disorder, characterized by pulmonary hypertension (PH) and hypoplasia. PH secondary to CDH (CDH-PH) features devastating morbidity and mortality (25-30%) among neonates. An unmet need is determining mechanisms triggering CDH-PH to save infants. Prior data suggest abnormal remodeling of the pulmonary vascular extracellular matrix (ECM), presumed to be driven by endothelial-to-mesenchymal transition (EndoMT), hinders postnatal vasodilation and limits anti-PH therapy in CDH. There are limited data on the role of EndoMT in CDH-PH. METHODS: The purpose of the study was to investigate how EndoMT contributes to CDH-PH by identifying cells undergoing EndoMT noted by alpha smooth muscle actin (α-SMA) expression in human umbilical vein endothelial cells (HUVECs) and lung tissue obtained from murine pups using the nitrofen model. N = 8 CDH, N = 8 control HUVECs were stained for α-SMA and CD31 after being exposed for 24 h to TGFB, a known EndoMT promoter. N = 8 nitrofen, N = 8 control murine pup lungs were also stained for α-SMA and CD31. α-SMA and CD31 expression was quantified in HUVECs and murine tissue using Fiji imaging software and normalized to the total number of cells per slide noted by DAPI staining. RESULTS: CDH HUVECs demonstrated a 1.1-fold increase in α-SMA expression (p = 0.02). The murine model did not show statistical significance between nitrofen and control pup lungs; however, there was a 0.4-fold increase in α-SMA expression with a 0.8-fold decrease in CD31 expression in the nitrofen pup lungs when compared to controls. CONCLUSION: These results suggest that EndoMT could potentially play a role in the ECM remodeling seen in CDH-PH.

The Safer Culture Framework: An Application to Healthcare Based on a Multi-Industry Review of Safety Culture Literature.

BACKGROUND: Errors and preventable harm to patients remain regrettably common and expensive in healthcare. Improvement requires transforming the culture of the healthcare industry to put a greater emphasis on safety. Safety culture involves holding collective attitudes, values, and behaviors that prioritize safety. The Safer Culture framework, previously established through a narrative review of literature in multiple industries, provides a consensus on what impacts safety culture, how it manifests in behavior, and how it influences safety-related outcomes. METHODS: Through a theoretical review, we validate, refine, and provide nuance to this framework for the development of safety culture in healthcare contexts. To accomplish this, we conceptually map existing dimensions pulled through the literature onto our Safer Culture framework. RESULTS: A total of 360 articles were reviewed. We present specific elements for each dimension in our framework and apply the dimension to healthcare contexts. CONCLUSION: We provide an evidence-based and comprehensive framework that can be used by patient safety leaders and researchers to guide the evaluation of safety culture and develop interventions to foster patient safety culture and improve patient safety outcomes.

Implementing a Robust Process Improvement Program in the Neonatal Intensive Care Unit to Reduce Harm.

INTRODUCTION: Preventable harm continues to occur with critically ill neonates despite efforts by hospital neonatal intensive care units (NICUs) to improve processes and reduce harm. Attaining significant and sustainable improvements will require training including leadership support, mentoring, and patient family engagement to improve care processes. This paper describes the implementation of a robust process improvement (RPI) program in the NICU to reduce harm. METHODS: Leaders, staff, and parents were trained in RPI concepts and tools. Multidisciplinary teams including parent members applied the training and received regular mentorship for their improvement initiatives. RESULTS: Participants (N = 67) completed pretraining and post-training surveys. Training scores (0-10 scale) improved from an average of 4.45-7.60 (p < .001) for confidence in leading process improvement work, 2.36 to 7.49 (p < .001) for RPI knowledge, and 2.19 to 7.30 (p < .001) for confidence in using RPI tools; relative improvement of 71%, 217%, and 233% respectively. Participants applied their RPI training on improvement initiatives that resulted in improvements of central line blood stream infections, very low birth weight infant nutrition, and unplanned extubations. CONCLUSIONS: Implementing an RPI program in the NICU to reduce harm resulted in significant and sustainable improvements on their improvement initiatives.

Development and testing of the Stakeholder Quality Improvement Perspectives Survey (SQuIPS).

BACKGROUND: To create a theory-informed survey that quality improvement (QI) teams can use to understand stakeholder perceptions of an intervention. METHOD: We created the survey then performed a cross-sectional survey of QI stakeholders of three QI projects. The projects sought to: (1) reduce unplanned extubations in a neonatal intensive care unit; (2) maintain normothermia during colorectal surgery and (3) reduce specimen processing errors for ambulatory gastroenterology procedures. We report frequencies of responses to survey items, results of exploratory factor analysis, and how QI team leaders used the results. RESULTS: Overall we received surveys from 319 out of 386 eligible stakeholders (83% response rate, range for the three QI projects 57%-86%). The QI teams found that the survey results confirmed existing concerns (eg, the intervention would not make work easier) and revealed unforeseen concerns such as lack of consensus about the overall purpose of the intervention and its importance. The results of our factor analysis indicate that one 7-item scale (Cronbach's alpha 0.9) can efficiently measure important aspects of stakeholder perceptions, and that two additional Likert-type items could add valuable information for leaders. Two QI team leaders made changes to their project based on survey responses that indicated the intervention made stakeholders' jobs harder, and that there was no consensus about the purpose of the intervention. CONCLUSIONS: The Stakeholder Quality Improvement Perspectives Survey was feasible for QI teams to use, and identified stakeholder perspectives about QI interventions that leaders used to alter their QI interventions to potentially increase the likelihood of stakeholder acceptance of the intervention.

Barriers to Transition to Home From the Neonatal Intensive Care Unit: A Qualitative Perspectives of Parents and Healthcare Providers.

The objective of this study was to explore the challenges faced by parents of former neonatal intensive care unit (NICU) patients in transitioning home from parents' and healthcare providers' perspective. We conducted semistructured individual and group interviews with parents of former NICU patients and healthcare providers. Themes from the individual interviews framed the group interviews' contents. The group interviews were recorded and transcribed, and thematic analysis was performed to identify themes. We conducted individual and group interviews with 16 parents and 33 inpatient and outpatient providers from November 2017 to June 2018. Individual interview participants identified several barriers experienced by parents when transitioning their infant home from the NICU including parental involvement and engagement during NICU stay and during the discharge process. Further exploration within group interviews revealed opportunities to improve discharge communication and processes, standardization of parental education that was lacking due to NICU resource constraints, support for parents' emotional state, and use of technology for infant care in the home. Parents of NICU patients face serious emotional, logistical, and knowledge challenges when transitioning their infant home from the NICU. Understanding and mitigating the challenges of transitioning infants from NICU to home require multistakeholder input from both parents and providers.

Telemedicine for Children With Medical Complexity: A Randomized Clinical Trial.

BACKGROUND: Telemedicine is widely used but has uncertain value. We assessed telemedicine to further improve outcomes and reduce costs of comprehensive care (CC) for medically complex children. METHODS: We conducted a single-center randomized clinical trial comparing telemedicine with CC relative to CC alone for medically complex children in reducing care days outside the home (clinic, emergency department, or hospital; primary outcome), rate of children developing serious illnesses (causing death, ICU admission, or hospital stay >7 days), and health system costs. We used intent-to-treat Bayesian analyses with neutral prior assuming no benefit. All participants received CC, which included 24/7 phone access to primary care providers (PCPs), low patient-to-PCP ratio, and hospital consultation from PCPs. The telemedicine group also received remote audiovisual communication with the PCPs. RESULTS: Between August 22, 2018, and March 23, 2020, we randomly assigned 422 medically complex children (209 to CC with telemedicine and 213 to CC alone) before meeting predefined stopping rules. The probability of a reduction with CC with telemedicine versus CC alone was 99% for care days outside the home (12.94 vs 16.94 per child-year; Bayesian rate ratio, 0.80 [95% credible interval, 0.66-0.98]), 95% for rate of children with a serious illness (0.29 vs 0.62 per child-year; rate ratio, 0.68 [0.43-1.07]) and 91% for mean total health system costs (US$33 718 vs US$41 281 per child-year; Bayesian cost ratio, 0.85 [0.67-1.08]). CONCLUSION: The addition of telemedicine to CC likely reduced care days outside the home, serious illnesses, other adverse outcomes, and health care costs for medically complex children.

Long-Term Impacts Faced by Patients and Families After Harmful Healthcare Events.

BACKGROUND: Patients and families report experiencing a multitude of harms from medical errors resulting in physical, emotional, and financial hardships. Little is known about the duration and nature of these harms and the type of support needed to promote patient and family healing after such events. We sought to describe the long-term impacts (LTIs) reported by patients and family members who experienced harmful medical events 5 or more years ago. METHODS: We performed a content analysis on 32 interviews originally conducted with 72 patients or family members about their views of the factors contributing to their self-reported harmful event. Interviews selected occurred 5 or more years after the harmful event and were grouped by time since event, 5 to 9 years (22 interviews) or 10 or more years (10 interviews) for analysis. We analyzed these interviews targeting spontaneous references of ongoing impacts experienced by the participants. RESULTS: Participants collectively described the following four LTIs: psychological, social/behavioral, physical, and financial. Most cited psychological impacts with half-reporting ongoing anger and vivid memories. More than half reported ongoing physical impacts and one-third experienced ongoing financial impacts. Long-term social and behavioral impacts such as alterations in lifestyle, self-identity, and healthcare seeking behaviors were the most highly reported. CONCLUSIONS: These patients and families experienced many profound LTIs after their harmful medical event. For some, these impacts evolved into secondary harms ongoing 10 years and more after the event. Our results draw attention to the persistent impacts patients and families may experience long after harmful events and the need for future research to understand and support affected patients and families.

Safety Culture: An Integration of Existing Models and a Framework for Understanding Its Development.

OBJECTIVE: This study reviews theoretical models of organizational safety culture to uncover key factors in safety culture development. BACKGROUND: Research supports the important role of safety culture in organizations, but theoretical progress has been stunted by a disjointed literature base. It is currently unclear how different elements of an organizational system function to influence safety culture, limiting the practical utility of important research findings. METHOD: We reviewed existing models of safety culture and categorized model dimensions by the proposed function they serve in safety culture development. We advance a framework grounded in theory on organizational culture, social identity, and social learning to facilitate convergence toward a unified approach to studying and supporting safety culture. RESULTS: Safety culture is a relatively stable social construct, gradually shaped over time by multilevel influences. We identify seven enabling factors that create conditions allowing employees to adopt safety culture values, assumptions, and norms; and four behaviors used to enact them. The consequences of these enacting behaviors provide feedback that may reinforce or revise held values, assumptions, and norms. CONCLUSION: This framework synthesizes information across fragmented conceptualizations to clearly depict the dynamic nature of safety culture and specific drivers of its development. We suggest that safety culture development may depend on employee learning from behavioral outcomes, conducive enabling factors, and consistency over time. APPLICATION: This framework guides efforts to understand and develop safety culture in practice and lends researchers a foundation for advancing theory on the complex, dynamic processes involved in safety culture development.

Barriers to Speaking Up About Patient Safety Concerns.

OBJECTIVES: We sought to examine the association between willingness of health-care professionals to speak up about patient safety concerns and their perceptions of two types of organizational culture (ie, safety and teamwork) and understand whether nursing professionals and other health-care professionals reported the same barriers to speaking up about patient safety concerns. METHODS: As part of an annual safety culture survey in a large health-care system, we asked health-care professionals to tell us about the main barriers that prevent them from speaking up about patient safety concerns. Approximately 1341 respondents completed the anonymous, electronic survey. RESULTS: A little more than half (55%) of the participants mentioned leadership (fear of no change or retaliation) and personal (ie, fear of negative feedback or being wrong) barriers concerning why they would not speak up about patient safety concerns. The remaining participants (45%) indicated they would always speak up. These findings about barriers were consistent across nurses and other health-care professionals. Safety culture (SC) and teamwork culture (TC) scores were significantly more positive in those indicating they would always speak up (SC = 89%, TC = 89%) than in those who provided reasons for not speaking up (SC = 63%, TC = 64%) (t1205 = 13.99, P < 0.05, and t1217 = 13.61, P < 0.05, respectively). CONCLUSIONS: Health-care professionals emphasized leadership and personal barriers as reasons for not speaking up. We also demonstrated an association between not speaking up and lower safety and teamwork culture scores.

An Ethnography of Parents' Perceptions of Patient Safety in the Neonatal Intensive Care Unit.

BACKGROUND: Parents of neonates are integral components of patient safety in the neonatal intensive care unit (NICU), yet their views are often not considered. By understanding how parents perceive patient safety in the NICU, clinicians can identify appropriate parent-centered strategies to involve them in promoting safe care for their infants. PURPOSE: To determine how parents of neonates conceptualize patient safety in the NICU. METHODS: We conducted qualitative interviews with 22 English-speaking parents of neonates from the NICU and observations of various parent interactions within the NICU over several months. Data were analyzed using thematic content analysis. Findings were critically reviewed through peer debriefing. FINDINGS: Parents perceived safe care through their observations of clinicians being present, intentional, and respectful when adhering to safety practices, interacting with their infant, and communicating with parents in the NICU. They described partnering with clinicians to promote safe care for their infants and factors impacting that partnership. We cultivated a conceptual model highlighting how parent-clinician partnerships can be a core element to promoting NICU patient safety. IMPLICATIONS FOR PRACTICE: Parents' observations of clinician behavior affect their perceptions of safe care for their infants. Assessing what parents observe can be essential to building a partnership of trust between clinicians and parents and promoting safer care in the NICU. IMPLICATIONS FOR RESEARCH: Uncertainty remains about how to measure parent perceptions of safe care, the level at which the clinician-parent partnership affects patient safety, and whether parents' presence and involvement with their infants in the NICU improve patient safety.

A Multi-Stakeholder Consensus-Driven Research Agenda for Better Understanding and Supporting the Emotional Impact of Harmful Events on Patients and Families.

BACKGROUND: The nature and consequences of patient and family emotional harm stemming from preventable medical error, such as losing a loved one or surviving serious medical injury, is poorly understood. Patients and families, clinicians, social scientists, lawyers, and foundation/policy leaders were brought together to establish research priorities for this issue. METHODS: A one-day conference of diverse stakeholder groups to establish a consensus-driven research agenda focused on (1) priorities for research on the short-term and long-term emotional impact of harmful events on patients and families, (2) barriers and enablers to conducting such research, and (3) actionable steps toward better supporting harmed patients and families now. RESULTS: Stakeholders discussed patient and family experiences after serious harmful events, including profound isolation, psychological distress, damaging aspects of medical culture, health care aversion, and negative effects on communities. Stakeholder groups reached consensus, defining four research priorities: (1) Establish conceptual framework and patient-centered taxonomy of harm and healing; (2) Describe epidemiology of emotional harm; (3) Determine how to make emotional harm and long-term impacts visible to health care organizations and society at large; and (4) Develop and implement best practices for emotional support of patients and families. The group also created a strategy for overcoming research barriers and actionable "Do Now" approaches to improve the patient and family experience while research is ongoing. CONCLUSION: Emotional and other long-term impacts of harmful events can have profound consequences for patients and families. Stakeholders designed a path forward to inform approaches that better support harmed patients and families, with both immediately actionable and longer-term research strategies.

Steps in Developing a Patient-Centered Measure of Hospital Design Factors.

Patients and families are at the center of care and have important perspectives about what they see occurring surrounding their healthcare, yet organizations do not routinely collect such perspectives from patients/families. Creating patient-centered measures is essential to understanding what they perceive about the environment as well as achieving the goal of patient-centered care. We focus this research methodology column on describing a four-step medical ethnography approach that can be used in developing patient-centered measures of interest to those studying built environments. In this column, we use this approach to illustrate how one might develop a measure that can be used to understand parent perceptions of the safety culture in neonatal intensive care units.

Patients as Partners in Learning from Unexpected Events.

IMPORTANCE: Patient safety experts believe that patients/family members should be involved in adverse event review. However, it is unclear how aware patients/family members are about the causes of adverse events they experienced. OBJECTIVE: To determine whether patients/family members interviewed could identify at least one contributing factor for the event they experienced. Secondary objectives included understanding the way patients/family members became aware of adverse events, the types of contributing factors patients/family members identified for different types of adverse events, and recommendations provided by patients/family members to address the contributing factors. DESIGN: We interviewed patients/family members using semistructured interviews to understand their perceptions about why these adverse events occurred. The adverse events occurred between 1991 and 2014. SETTING: Participants described adverse events that occurred in various types of health care organizations (i.e., hospitals, ambulatory facilities/clinics, and dental clinics). PARTICIPANTS: We interviewed 72 patients and family members who each described a unique adverse event. Eligibility requirements were that patients/family members spoke English or Spanish and were aware of an adverse event that happened to them or a loved one. INTERVENTION(S) FOR CLINICAL TRIALS OR EXPOSURE(S) FOR OBSERVATIONAL STUDIES: N/A. MAIN OUTCOME(S) AND MEASURE(S): The main outcome was determining whether patients/family members could identify at least one contributing factor they perceived as related to the adverse event they described. RESULTS: Each participant identified at least one contributing factor and on average identified 3.67 contributing factors for their event. The most frequently mentioned contributing factors were Staff Qualifications/Knowledge (79 percent), Safety Policies/Procedures (74 percent), and Communication (64 percent). Participants knew about the contributing factors from personal observation only (32 percent), personal reasoning (11 percent), personal research (7 percent), record review (either their own medical records or reports they received in their own investigation; 6 percent), and being told by a physician (5 percent). Finally, patients/family members were able to provide recommendations that address each of the nine contributing factors we examined. CONCLUSIONS AND RELEVANCE: Patients/family members identified contributing factors related to their adverse event. Given that these contributing factors might not be known to health care organizations because most participants stated that they were not involved in the analysis process, opportunities for organizational learning from patients are potentially being missed. Health care organizations should interview patients/family about the event that harmed them to help ensure a full understanding of the causes of the event.

Improving Communication and Resolution Following Adverse Events Using a Patient-Created Simulation Exercise.

OBJECTIVE: The response to adverse events can lack patient-centeredness, perhaps because the involved institutions and other stakeholders misunderstand what patients and families go through after care breakdowns. STUDY SETTING: Washington and Texas. STUDY DESIGN: The HealthPact Patient and Family Advisory Council (PFAC) created and led a five-stage simulation exercise to help stakeholders understand what patients experience following an adverse event. The half-day exercise was presented twice. DATA COLLECTION AND ANALYSIS: Lessons learned related to the development and conduct of the exercise were synthesized from planning notes, attendee evaluations, and exercise discussion notes. PRINCIPAL FINDINGS: One hundred ninety-four individuals attended (86 Washington and 108 Texas). Take-homes from these exercises included the fact that the response to adverse events can be complex, siloed, and uncoordinated. Participating in this simulation exercise led stakeholders and patient advocates to express interest in continued collaboration. CONCLUSIONS: A PFAC-designed simulation can help stakeholders understand patient and family experiences following adverse events and potentially improve their response to these events.

How Should Surgical Residents Be Educated About Patient Safety: A Pilot Randomized Controlled Trial.

INTRODUCTION: The Accreditation Council for Graduate Medical Education mandates patient safety education without specific curricular guidelines. We hypothesized that a dedicated, adjunctive resident safety workshop (SW) led by surgical faculty compared with an online curriculum (OC) for hospital personnel alone would improve residents' patient safety perceptions and behaviors. MATERIALS AND METHODS: A pilot randomized controlled trial was performed from 2014 to 2015 within a university-based general surgery residency. Control and intervention groups, stratified by postgraduate year, participated in a hospital-based OC; the intervention group participated in an additional SW. Primary outcomes were perceptions of safety culture, teamwork, and speaking up as per the validated safety attitudes questionnaire (SAQ) at 6 and 12 months postintervention. Secondary outcomes included behavioral scores from blinded surgical faculty using the Oxford NonTechnical Skills scale. RESULTS: A total of 51 residents were enrolled (control = 25, intervention = 26). SAQ response rates were 100%, 100%, and 76% at baseline, 6 months, and 12 months, respectively. SAQ scores were similar at baseline between groups and did not change significantly at 6 or 12 months, independent of postgraduate year (PGY) level. Overall NonTechnical Skills scores were similar between groups, but senior residents (≥PGY 4) in the OC + SW group scored significantly higher in teamwork, decision-making, and situation awareness (all p < 0.05). CONCLUSION: An adjunctive, dedicated resident SW compared with a hospital-based OC alone did not significantly improve overall perceptions of patient safety. However, senior residents participating in the SW demonstrated improved patient safety perceptions and had significantly better intraoperative safety behaviors than senior residents in the OC group. Future curricular enhancements should include PGY-level specific education, iterative reviews, and increased faculty involvement. A larger randomized trial may be warranted.

Structuring patient and family involvement in medical error event disclosure and analysis.

The study of adverse event disclosure has typically focused on the words that are said to the patient and family members after an event. But there is also growing interest in determining how patients and their families can be involved in the analysis of the adverse events that harmed them. We conducted a two-phase study to understand whether patients and families who have experienced an adverse event should be involved in the postevent analysis following the disclosure of a medical error. We first conducted twenty-eight interviews with patients, family members, clinicians, and administrators to determine the extent to which patients and family members are included in event analysis processes and to learn how their experiences might be improved. Then we reviewed our interview findings with patients and health care experts at a one-day national conference in October 2011. After evaluating the findings, conference participants concluded that increasing the involvement of patients and their families in the event analysis process was desirable but needed to be structured in a patient-centered way to be successful. We conclude by describing when and how information from patients might be incorporated into the event analysis process and by offering recommendations on how this might be accomplished.

Development and evaluation of a crowdsourcing methodology for knowledge base construction: identifying relationships between clinical problems and medications.

OBJECTIVE: We describe a novel, crowdsourcing method for generating a knowledge base of problem-medication pairs that takes advantage of manually asserted links between medications and problems. METHODS: Through iterative review, we developed metrics to estimate the appropriateness of manually entered problem-medication links for inclusion in a knowledge base that can be used to infer previously unasserted links between problems and medications. RESULTS: Clinicians manually linked 231,223 medications (55.30% of prescribed medications) to problems within the electronic health record, generating 41,203 distinct problem-medication pairs, although not all were accurate. We developed methods to evaluate the accuracy of the pairs, and after limiting the pairs to those meeting an estimated 95% appropriateness threshold, 11,166 pairs remained. The pairs in the knowledge base accounted for 183,127 total links asserted (76.47% of all links). Retrospective application of the knowledge base linked 68,316 medications not previously linked by a clinician to an indicated problem (36.53% of unlinked medications). Expert review of the combined knowledge base, including inferred and manually linked problem-medication pairs, found a sensitivity of 65.8% and a specificity of 97.9%. CONCLUSION: Crowdsourcing is an effective, inexpensive method for generating a knowledge base of problem-medication pairs that is automatically mapped to local terminologies, up-to-date, and reflective of local prescribing practices and trends.