Improving Health Care Quality and Safety: The Development and Assessment of Laparoscopic Surgery Instrumentation, Practices and Procedures

Adverse events due to medical errors are a leading cause of death in the United States exceeding the mortality rates of motor vehicle accidents, breast cancer and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors since they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. In order to mitigate errors and protect patients, a multidisciplinary approach was taken to improve minimally invasive surgery. Clinical, human factors, and biomedical engineering principles and methodologies were used to develop and assess laparoscopic surgery instrumentation, practices and procedures. First, the foundational understanding and the imperative to transform health care into a high quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. The remainder of this dissertation presents the experimental results of four studies used to develop and assess laparoscopic surgery instrumentation, practices and procedures. In the first experiment, a novel hand-controlled electrosurgical laparoscopic grasper was developed and evaluated to eliminate the use of foot pedals, reduce surgery-related discomfort, and minimize the risk of actuation errors. The final three studies compared the emerging technique of single-incision surgery to conventional laparoscopic surgery to determine whether there were any technical, physical or subjective performance differences across the two surgical techniques. In all, these studies contribute towards the improvement of the quality and safety of minimally invasive surgery. Advisor: M. Susan Hallbec

Improving Health Care Quality and Safety: The Development and Assessment of Laparoscopic Surgery Instrumentation, Practices and Procedures

Adverse events due to medical errors are a leading cause of death in the United States exceeding the mortality rates of motor vehicle accidents, breast cancer and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors since they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. In order to mitigate errors and protect patients, a multidisciplinary approach was taken to improve minimally invasive surgery. Clinical, human factors, and biomedical engineering principles and methodologies were used to develop and assess laparoscopic surgery instrumentation, practices and procedures. First, the foundational understanding and the imperative to transform health care into a high quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. The remainder of this dissertation presents the experimental results of four studies used to develop and assess laparoscopic surgery instrumentation, practices and procedures. In the first experiment, a novel hand-controlled electrosurgical laparoscopic grasper was developed and evaluated to eliminate the use of foot pedals, reduce surgery-related discomfort, and minimize the risk of actuation errors. The final three studies compared the emerging technique of single-incision surgery to conventional laparoscopic surgery to determine whether there were any technical, physical or subjective performance differences across the two surgical techniques. In all, these studies contribute towards the improvement of the quality and safety of minimally invasive surgery. Advisor: M. Susan Hallbec

Emotional Intelligence and Safety Citizenship among Army aviators

The purpose of this study was to develop an understanding of the relationship between trait emotional intelligence and safety citizenship among United States Army aviators. The study includes analysis of survey responses from 29 individual aviators. Regression analysis was performed to evaluate the relationship between safety citizenship, emotional intelligence, and 15 emotional intelligence facets. Results indicate a significant association (F(1,28) = 15.45; p = 0.001) between safety citizenship and emotional intelligence, and between safety citizenship and 3 emotional intelligence facets: Adaptability (F(1,25) = 23.91; p \u3c 0.001), Self Esteem (F(1,25) = 10.75; p = 0.003), and Optimism (F(1,25) = 8.71; p = 0.007). Increased Adaptability and Self Esteem can increase safety citizenship behaviors among aviators. Training and selection of Army aviators with these traits could result in safer air travel and possibly reduced human factor-related aviation incidents

Digital patient engagement at a perioperative surgical home implemented community hospital

Patients in rural areas typically require more perioperative ‘optimization’ for surgery. The rural healthcare systems often overwhelmed with coordinating perioperative services and deliver less than optimal surgical outcomes. This is due to limited supporting microsystems and ability to effectively engage and track patients over the 120-day perioperative period to limit post-surgical complications. The study assessed longitudinal patient engagement within a newly established Perioperative Surgical Home (PSH) at a rural community hospital serving 10+ surrounding counties to identify barriers and best practices for engagement. A digital patient engagement platform was implemented and used to assess longitudinal patient outcomes and engagement from 30 days preoperative to 90 days postoperative. The research team (health systems engineers teamed with clinicians) analyzed 2-years of collected patient data (n= 301) primarily consisting of Total Joint Replacement (TJR) procedures. The digital patient engagement system’s email and text messages allowed patients and PSH staff to track outcomes, experience, and collaborate on post-surgical events. The average patient engagement was low (less than 40%). However, the average survey completion was 90%, i.e., if a patient responded to a survey on a particular day, on average patients finished 90% of the survey. Patient engagement was critically important to improving surgical care in rural areas. Digital longitudinal patient engagement implemented by PSH clinic was successful at rural community hospitals serving patients from 10+ surrounding counties. Experience Framework This article is associated with the Innovation & Technology lens of The Beryl Institute Experience Framework (https://www.theberylinstitute.org/ExperienceFramework). Access other PXJ articles related to this lens. Access other resources related to this len

Quality and Safety of Minimally Invasive Surgery: Past, Present, and Future

Adverse events because of medical errors are a leading cause of death in the United States (US) exceeding the mortality rates of motor vehicle accidents, breast cancer, and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors because they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery (MIS) has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. To mitigate errors and protect patients, a multidisciplinary approach is needed to improve MIS. Clinical human factors, and biomedical engineering principles and methodologies can be used to develop and assess laparoscopic surgery instrumentation, practices, and procedures. First, the foundational understanding and the imperative to transform health care into a high-quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. Finally, the future of this field and the research needed to further improve the quality and safety of MIS is discussed

Trait emotional intelligence in American pilots

There is a dearth of trait emotional intelligence (trait EI) research within an aviation context. Using the Trait Emotional Intelligence Questionnaire (TEIQue), the present study investigated potential trait EI differences between pilots and general population controls in the United States. The forty-four pilots who volunteered to participate were primarily male (93%) and between 24 and 67 years with a wide range of flight experience (150-5000 + hrs.) They were matched with controls based on age, gender, and ethnicity. Comparisons on global trait EI and the four trait EI factors revealed significant differences, with pilots scoring consistently lower than their matched counterparts in global trait EI, Well-being, Emotionality, and Sociability, but not Self-control. Overall, the findings indicated that pilots felt less connected to their emotional world than controls. Though limited by sample size and participant diversity, the results provide a basis for future studies into the trait EI profile of pilots, which had not been previously investigated

Strengths and opportunities to clinical trial enrollment among BIPOC, rural dwelling patients in the northwest United States: a retrospective study

Introduction: Clinical trials investigating the safety and efficacy of experimental drugs and devices are the cornerstone of medicinal advancement. Enrolling sufficient participants in these trials is vital to ensure adequate statistical power and generalizability. Clinical trial participation is particularly low among certain populations, including medically underserved communities (i.e., rural areas) and Black, Indigenous, and People of Color (BIPOC).Methods: A retrospective study design was used to understand patient outcomes and access/barriers to clinical trial participation in the rural northwest United States. A quantitatively focused retrospective chart review was conducted for adult participants enrolled in at least one clinical trial in a single northwest health system between 1999 and 2022. Descriptive and inferential statistical analyses were performed to assess trial outcomes at a significance level 0.05.Results: The retrospective chart review yielded 833 clinical trial records with 753 individual enrolled participants. The all-cause relative frequency of death at last known follow-up amongst clinical trial participants was 8.90% (n = 67). Based on logistic regression, the death was significantly associated with the participants’ age at initial trial screening (β = 0.09, p-value <0.001), those that resided in non-metro areas (β = −0.86, p-value = 0.045), and those that lived in Northeastern Montana (β = 1.27, p-value = 0.025). Additionally, death at last known follow-up was significantly associated with enrollment in 2021–2022 (β = −1.52, p-value <0.001), enrolled in more than one study (β = 0.84, p-value = 0.023), in internationally sponsored trials (β = −2.08, p-value <0.001), in Phase I (β = 5.34, p-value <0.001), in Phase II trials (β = 1.37, p-value = 0.013), diabetes as a primary trial target (β = −2.04, p-value = 0.003).Conclusion: As decentralized trial design and remote or virtual elements of traditional trials become normative, representation of rural and frontier populations is imperative to support the generalizability of trial data encouraged by the FDA

Task analysis method for procedural training curriculum development

A central venous catheter (CVC) is an important medical tool used in critical care and emergent situations. Integral to proper care in many circumstances, insertion of a CVC introduces the risk of central line-associated blood stream infections and mechanical adverse events; proper training is important for safe CVC insertion. Cognitive task analysis (CTA) methods have been successfully implemented in the medical field to improve the training of postgraduate medical trainees, but can be very time-consuming to complete and require a significant time commitment from many subject matter experts (SMEs). Many medical procedures such as CVC insertion are linear processes with well-documented procedural steps. These linear procedures may not require a traditional CTA to gather the information necessary to create a training curriculum. Accordingly, a novel, streamlined CTA method designed primarily to collect cognitive cues for linear procedures was developed to be used by medical professionals with minimal CTA training. This new CTA methodology required fewer trained personnel, fewer interview sessions, and less time commitment from SMEs than a traditional CTA. Based on this study, a streamlined CTA methodology can be used to efficiently gather cognitive information on linear medical procedures for the creation of resident training curricula and procedural skills assessments

A blood DNA methylation biomarker for predicting short-term risk of cardiovascular events

Background. Recent evidence highlights the epidemiological value of blood DNA methylation (DNAm) as surrogate biomarker for exposure to risk factors for non-communicable diseases (NCD). DNAm surrogate of exposures predict diseases and longevity better than self-reported or measured exposures in many cases. Consequently, disease prediction models based on blood DNAm surrogates may outperform current state-of-art prediction models. This study aims to develop novel DNAm surrogates for cardiovascular diseases (CVD) risk factors and develop a composite biomarker predictive of CVD risk. We compared the prediction performance of our newly developed risk score with the state-of-art DNAm risk scores for cardiovascular diseases, the ‘next-generation’ epigenetic clock DNAmGrimAge, and the prediction model based on traditional risk factors SCORE2. Results. Using data from the EPIC Italy cohort, we derived novel DNAm surrogates for BMI, blood pressure, fasting glucose and insulin, cholesterol, triglycerides, and coagulation biomarkers. We validated them in four independent datasets from Europe and the US. Further, we derived a DNAmCVDscore predictive of the time-to-CVD event as a combination of several DNAm surrogates. ROC curve analyses show that DNAmCVDscore outperforms previously developed DNAm scores for CVD risk and SCORE2 for short-term CVD risk. Interestingly, the performance of DNAmGrimAge and DNAmCVDscore was comparable (slightly lower for DNAmGrimAge, although the differences were not statistically significant). Conclusions. We described novel DNAm surrogates for CVD risk factors useful for future molecular epidemiology research, and we described a blood DNAm-based composite biomarker, DNAmCVDscore, predictive of short-term cardiovascular events. Our results highlight the usefulness of DNAm surrogate biomarkers of risk factors in epigenetic epidemiology to identify high-risk populations. In addition, we provide further evidence on the effectiveness of prediction models based on DNAm surrogates and discuss methodological aspects for further improvements. Finally, our results encourage testing this approach for other NCD diseases by training and developing DNAm surrogates for disease-specific risk factors and exposures