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 (ß = 0.09, p-value <0.001), those that resided in non-metro areas (ß = -0.86, p-value = 0.045), and those that lived in Northeastern Montana (ß = 1.27, p-value = 0.025). Additionally, death at last known follow-up was significantly associated with enrollment in 2021-2022 (ß = -1.52, p-value <0.001), enrolled in more than one study (ß = 0.84, p-value = 0.023), in internationally sponsored trials (ß = -2.08, p-value <0.001), in Phase I (ß = 5.34, p-value <0.001), in Phase II trials (ß = 1.37, p-value = 0.013), diabetes as a primary trial target (ß = -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.

Predicting risk factors for pediatric mortality in clinical trial research: A retrospective, cross-sectional study using a Healthcare Cost and Utilization Project database.

Introduction: Incorporating real-world data using "big data" analysis in healthcare are useful to extract specific information for healthcare delivery system improvement. All-cause mortality is an essential measure to enhance patient safety in clinical trial research, especially for underrepresented pediatric participants. Objective: This study aimed to determine the associations between pediatric mortality and patient-specific factors using the Healthcare Cost and Utilization Project (HCUP) database. Methods: Data from the 2019 the HCUP Kids' Inpatient Database (KID) were used to conduct a logistic regression analysis to determine associations between pediatric patients' the chance of survival and their demographic and socioeconomic background, discharge records, and hospital information. Results: Total number of diagnoses (OR = 0.84), total number of procedures (OR = 0.86), length of stay (OR = 1.04), age intervals greater than 1 year (OR > 1.0), transfer into the hospital from a different acute care (OR = 0.34), major diagnoses of multiple significant trauma (OR = 0.03) or hepatobiliary system and pancreas (OR = 0.10), region of hospital - west and midwest (OR > 1.0), and medium or larger hospital bed size (OR > 1.0) were all significantly associated with the chance of survival for patients participating in pediatric clinical trials (p < 0.05). Conclusion: Real-world clinical trial data analysis showed the potential improvement area including reallocating trial resources to promote trial quality and safe participation for pediatric patients. Pediatric trials need tools that are developed using user-centered design approaches to satisfy the unique needs and requirements of pediatric patients and their caregivers. Safe intrahospital transfer procedures and active dissemination of successful trial best practices are crucial to trial management, adherence, quality, and safety.

Rural implementation of the perioperative surgical home: A case-control study.

BACKGROUND: Perioperative surgical home (PSH) is a novel patient-centric surgical system developed by American Society of Anesthesiologist to improve outcomes and patient satisfaction. PSH has proven success in large urban health centers by reducing surgery cancellation, operating room time, length of stay (LOS), and readmission rates. Yet, only limited studies have assessed the impact of PSH on surgical outcomes in rural areas. AIM: To evaluate the newly implemented PSH system at a community hospital by comparing the surgical outcomes using a longitudinal case-control study. METHODS: The research study was conducted at an 83-bed, licensed level-III trauma rural community hospital. A total of 3096 TJR procedures were collected retrospectively between January 2016 and December 2021 and were categorized as PSH and non-PSH cohorts (n = 2305). To evaluate the importance of PSH in the rural surgical system, a case-control study was performed to compare TJR surgical outcomes (LOS, discharge disposition, and 90-d readmission) of the PSH cohort against two control cohorts [Control-1 PSH (C1-PSH) (n = 1413) and Control-2 PSH (C2-PSH) (n = 892)]. Statistical tests including Chi-square test or Fischer's exact test were performed for categorical variables and Mann-Whitney test or Student's t-test were performed for continuous variables. The general linear models (Poisson regression and binomial logistic regression) were performed to fit adjusted models. RESULTS: The LOS was significantly shorter in PSH cohort compared to two control cohorts (median PSH = 34 h, C1-PSH = 53 h, C2-PSH = 35 h) (P value < 0.05). Similarly, the PSH cohort had lower percentages of discharges to other facilities (PSH = 3.5%, C1-PSH = 15.5%, C2-PSH = 6.7%) (P value < 0.05). There was no statistical difference observed in 90-d readmission between control and PSH cohorts. However, the PSH implementation reduced the 90-d readmission percentage (PSH = 4.7%, C1-PSH = 6.1%, C2-PSH = 3.6%) lower than the national average 30-d readmission percentage which is 5.5%. The PSH system was effectively established at the rural community hospital with the help of team-based coordinated multi-disciplinary clinicians or physician co-management. The elements of PSH including preoperative assessment, patient education and optimization, and longitudinal digital engagement were vital for improving the TJR surgical outcomes at the community hospital. CONCLUSION: Implementation of the PSH system in a rural community hospital reduced LOS, increased direct-to-home discharge, and reduced 90-d readmission percentages.

Predicting Length of Stay using machine learning for total joint replacements performed at a rural community hospital.

BACKGROUND: Predicting patient's Length of Stay (LOS) before total joint replacement (TJR) surgery is vital for hospitals to optimally manage costs and resources. Many hospitals including in rural areas use publicly available models such as National Surgical Quality Improvement Program (NSQIP) calculator which, unfortunately, performs suboptimally when predicting LOS for TJR procedures. OBJECTIVE: The objective of this research was to develop a Machine Learning (ML) model to predict LOS for TJR procedures performed at a Perioperative Surgical Home implemented rural community hospital for better accuracy and interpretation than the NSQIP calculator. METHODS: A total of 158 TJR patients were collected and analyzed from a rural community hospital located in Montana. A random forest (RF) model was used to predict patient's LOS. For interpretation, permuted feature importance and partial dependence plot methods were used to identify the important variables and their relationship with the LOS. RESULTS: The root mean square error for the RF model (0.7) was lower than the NSQIP calculator (1.21). The five most important variables for predicting LOS were BMI, Duke Activity Status-Index, diabetes, patient's household income, and patient's age. CONCLUSION: This pilot study is the first of its kind to develop an ML model to predict LOS for TJR procedures that were performed at a small-scale rural community hospital. This pilot study contributes an approach for rural hospitals, making them more independent by developing their own predictions instead of relying on public models.

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.

Occupational injuries and patient lift usage among physical rehabilitation therapists.

BACKGROUND: Physical therapists (PTs) and physical therapist assistants (PTAs) are at high risk for work-related musculoskeletal pain and discomfort. OBJECTIVE: Determine the prevalence and exposure risk factors for work-related injuries (WRIs) among rehabilitation PTs and PTAs. METHODS: A cross-sectional research survey was conducted among 170 PTs and 67 PTAs at 51 free-standing rehabilitation hospitals and rehabilitation units embedded in general hospitals in the Midwestern states of Iowa, Kansas, Missouri and Nebraska. The prevalence of WRIs and significant risk factors for developing WRIs were determined for PTs and PTAs. RESULTS: The 1-year prevalence of WRIs among PTs and PTAs working in physical rehabilitation was 29.5%. Multifaceted causes were identified including frequently bending/twisting, over-exerting force during patient handling activities, inadequate lifting devices, and lack of ongoing training for mechanical lifting device usage. CONCLUSIONS: Equipment usage barriers point to a critical need for technology creation, research, and education to advance worker safety while simultaneously enhancing patient outcomes.

Psychometric properties of the 7-item version of the Concise Health Risk Tracking Self-Report Scale for rural adults enrolled in an Internet-delivered self-help program for depression.

PURPOSE: Monitoring suicide risk in clinical practice requires valid and reliable assessment instruments. This study evaluated the psychometric properties of the 7-item version of the Concise Health Risk Tracking Self-Report, CHRT-SR7 in a primarily rural population. METHODS: The sample comprised 788 participants (81.7% female) of an effectiveness trial of an internet-based self-help intervention for depression. Participants completed self-report questionnaires, including the CHRT-SR7 , Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Work and Social Adjustment Scale, Connor-Davidson Resilience Scale-10, and Barriers to Seeking Mental Health Care. Four-week test-retest reliability was calculated for a subsample of 147 participants randomized to a waitlist control group. FINDINGS: The CHRT-SR7 internal consistency was α = 0.80 (total sample), α = 0.80 (women), and α = 0.83 (men). The 4-week test-retest reliability was strong for women (r = 0.78) and moderate for men (r = 0.66). Confirmatory factor analysis supported the original 3-factor solution: Hopelessness (2 items), Perceived Lack of Social Support (2 items), and Current Suicidal Thoughts and Plans (3 items), which was invariant across gender and rural status. Convergent and divergent validity was supported as reflected in significant correlations of the CHRT-SR7 and its subscales with measures of depression, anxiety, adjustment, and resilience. Limitations include the limited demographic diversity (mostly non-Hispanic White women) and reliance on self-report data. CONCLUSIONS: Our findings complement those reported in prior studies of patients with severe depression and support the use of the CHRT-SR7 for measuring suicide risk in rural adults; future studies should further test the instrument's psychometric properties in racial or ethnic minority rural residents.

Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study.

BACKGROUND: Internet-based cognitive behavior therapy (iCBT) interventions have the potential to help individuals with depression, regardless of time and location. Yet, limited information exists on the longer-term (>6 months) effects of iCBT and adherence to these interventions. OBJECTIVE: The primary aim of this study was to evaluate the longitudinal (12 months) effectiveness of a fully automated, self-guided iCBT intervention called Thrive, designed to enhance engagement with a rural population of adults with depression symptoms. The secondary aim was to determine whether the program adherence enhanced the effectiveness of the Thrive intervention. METHODS: We analyzed data from 181 adults who used the Thrive intervention. Using self-reports, participants were evaluated at baseline, 8 weeks, 6 months, and 12 months for the primary outcome of depression symptom severity using the Patient Health Questionnaire-9 (PHQ-9) scale and secondary outcome measures, namely, the Generalized Anxiety Disorder Scale-7 (GAD-7) scores, Work and Social Adjustment Scale (WSAS) scores, Conner-Davidson Resilience Scale-10 (CD-RISC-10) scores, and suicidal ideation (ninth item of the PHQ-9 scale) scores. The Thrive program adherence was measured using the numbers of program logins, page views, and lessons completed. RESULTS: The assessment response rates for 8-week, 6-month, and 12-month outcomes were 58.6% (106/181), 50.3% (91/181), and 51.4% (93/181), respectively. By 8 weeks, significant improvements were observed for all outcome measures. These improvements were maintained at 12 months with mean reductions in severities of depression (mean -6.5; P<.001) and anxiety symptoms (mean -4.3; P<.001). Improvements were also observed in work and social functioning (mean -6.9; P<.001) and resilience (mean 4.3; P<.001). Marked decreases were observed in suicidal ideation (PHQ-9 ninth item score >1) at 6 months (16.5%) and 12 months (17.2%) compared to baseline (39.8%) (P<.001). In regard to the program adherence, cumulative counts of page views and lessons completed were significantly related to lower PHQ-9, GAD-7, and WSAS scores and higher CD-RISC-10 scores (all P values <.001 with an exception of page views with WSAS for which P value was .02). CONCLUSIONS: The Thrive intervention was effective at reducing depression and anxiety symptom severity and improving functioning and resilience among a population of adults from mostly rural communities in the United States. These gains were maintained at 1 year. Program adherence, measured by the number of logins and lessons completed, indicates that users who engage more with the program benefit more from the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878.

Correction: Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study.

[This corrects the article DOI: 10.2196/21336.].

Crossover Assessment of Intraoral and Cuffed Ventilation by Emergency Responders.

OBJECTIVES: A cuffed bag valve mask (BVM) is the most common device used by emergency medical responders to ventilate patients. The BVM can be difficult for users to seal around the patient's mouth and nose. An intraoral mask (IOM) with snorkel-like design may facilitate quicker and better ventilation particularly under austere conditions. METHODS: Both a BVM and IOM were utilized by 27 trained emergency medical technicians and paramedics to ventilate a lightly embalmed cadaver. Ventilation efficacy, workload, and usability were assessed for both devices across four study conditions. RESULTS: The IOM was superior to the BVM in delivered tidal volume ratio (measure of leak, p < 0.03) and minute ventilation (p < 0.0001). Workload, ergonomic and usability assessments indicated that the IOM facilitated gripping through the reduced hand interface size (p < 0.01), decreased user effort (p < 0.001), and reduced upper limb workload (p = 0.0088). CONCLUSIONS: In the assessed model, the IOM represented a better choice for airway management than the standard cuffed BVM. An emergency medical device that is intuitive, efficacious and less demanding has the potential to reduce responder stress and improve resuscitation efforts, especially during austere rescue and patient transport.

Kinematic and ergonomic assessment of laparoendoscopic single-site surgical instruments during simulator training tasks.

While laparoendoscopic single-site surgery (LESS) appears to be feasible and safe, instrument triangulation, tissue handling, and other bimanual tasks are difficult even for experienced surgeons. Novel technologies emerged to overcome LESS' procedural and ergonomic difficulties of "tunnel vision" and "instrument clashing." Surgeon kinematics, self-reported workload and upper body discomfort were used to compare straight, bent and two articulating instruments while performing two basic surgical tasks in a LESS simulator. All instruments resulted in bilateral elevation and rotation of the shoulders, excessive forearm motion and flexion and ulnar deviation of wrists. Surgeons' adopted non-neutral upper extremity postures and performed excessive joint excursions to compensate for reduced freedom of movement at the single insertion site and to operate the instrument mechanisms. LESS' cosmetic benefits continue to impact laparoscopic surgery and by enabling performance through improved instruments, ergonomic improvement for LESS can reduce negative impact on surgeon well-being and patient safety.

Ergonomic comparison of laparoscopic hand instruments in a single site surgery simulator with novices.

BACKGROUND: Single-site surgery improves cosmesis but increases procedural difficulty. Enhanced instruments could improve procedural efficiency leading to better patient outcomes. MATERIAL AND METHODS: One pair of non-articulating (straight) and two different pairs of articulating laparoscopic instruments were evaluated using a peg-transfer surgical task simulator by premedical college students. The instruments were comparatively tested using task performance measures, ergonomic measures, and participant questionnaires. RESULTS: The straight instrument produced significantly higher task performance scores and lower task times compared to both articulating instruments (p < 0.05). The straight instrument required less muscle activation and less wrist deviation than the articulating instruments to perform the same task. Participants rated the straight instrument significantly easier to use and less difficult to complete the task than with either articulating instrument (p < 0.05 for both). CONCLUSIONS: This exploratory study suggests that novices have difficulty using articulating instruments and perform better using straight laparoscopic instruments when first attempting LESS surgical tasks. Although a study with post-graduate medical trainees is needed to confirm these results, trainees should initially practice LESS with non-articulating instruments to gain proficiency at basic laparoscopic tasks. Additionally, redesigning articulating instruments to specifically address the spatial constraints and learning curve of LESS may also improve trainee performance and instrument usability.

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.

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.

Comparative usability testing of conventional and single incision laparoscopic surgery devices.

OBJECTIVE: The objective was to perform competitive usability testing to assess the user experience of conventional laparoscopic and laparoendoscopic single-site surgery (LESS) devices. BACKGROUND: Recent advancements in single-incision instrumentation have created more interest in and usage of LESS. However, neither LESS nor its novel multichannel access devices have been thoroughly studied. METHOD: Using a simulation test bed and standardized laparoscopic surgery task, the user experience of three commercially available LESS devices was compared to conventional laparoscopic ports based on time on task, errors, task success, and perceived ease of use. RESULTS: There were no significant differences between devices for time on task, errors, or task success (p > .05). For all devices, there were significantly more recoverable than unrecoverable errors, and errors occurred more frequently during the second phase of the task when the dominant hand was more active (p < .0001). Conventional laparoscopy was rated as easier to use than were the LESS devices (p < .01). CONCLUSION: Device performance of a basic laparoscopic task was similar in both conventional laparoscopy and LESS. Each of the LESS devices facilitated efficient and accurate aiming and grasping movements compared to conventional laparoscopy. Further investigation of human factors and ergonomics of LESS is needed to further develop, evaluate, and refine single-site surgery technologies to create a user experience equivalent to conventional laparoscopy. APPLICATION: Competitive usability testing of medical devices yields objective performance data that can be used to inform purchase decisions and future device design improvements.

Comparative kinematic and electromyographic assessment of clinician- and device-assisted sit-to-stand transfers in patients with stroke.

BACKGROUND: Workplace injuries from patient handling are prevalent. With the adoption of no-lift policies, sit-to-stand transfer devices have emerged as one tool to combat injuries. However, the therapeutic value associated with sit-to-stand transfers with the use of an assistive apparatus cannot be determined due to a lack of evidence-based data. OBJECTIVE: The aim of this study was to compare clinician-assisted, device-assisted, and the combination of clinician- and device-assisted sit-to-stand transfers in individuals who recently had a stroke. DESIGN: This cross-sectional, controlled laboratory study used a repeated-measures design. METHODS: The duration, joint kinematics, and muscle activity of 4 sit-to-stand transfer conditions were compared for 10 patients with stroke. Each patient performed 4 randomized sit-to-stand transfer conditions: clinician-assisted, device-assisted with no patient effort, device-assisted with the patient's best effort, and device- and clinician-assisted. RESULTS: Device-assisted transfers took nearly twice as long as clinician-assisted transfers. Hip and knee joint movement patterns were similar across all conditions. Forward trunk flexion was lacking and ankle motion was restrained during device-assisted transfers. Encouragement and guidance from the clinician during device-assisted transfers led to increased lower extremity muscle activation levels. LIMITATIONS: One lifting device and one clinician were evaluated. Clinician effort could not be controlled. CONCLUSIONS: Lack of forward trunk flexion and restrained ankle movement during device-assisted transfers may dissuade clinicians from selecting this device for use as a dedicated rehabilitation tool. However, with clinician encouragement, muscle activation increased, which suggests that it is possible to safely practice transfers while challenging key leg muscles essential for standing. Future sit-to-stand devices should promote safety for the patient and clinician and encourage a movement pattern that more closely mimics normal sit-to-stand biomechanics.

Ergonomic evaluation of laparoendoscopic single-site surgery ports in a validated laparoscopic training model.

Although laparoendoscopic single-site surgery (LESS) is feasible among expert laparoscopic surgeons, it poses many technical challenges not seen in conventional laparoscopy (CL). Recent technological advancements in single-incision instrumentation have created more interest and widespread usage of LESS. However, neither LESS nor its novel instrumentation have been thoroughly studied or evaluated using human factors and ergonomics techniques. Consequently, the aim of this study was to compare the physical performance of LESS to CL using a standardized task. Wrist and elbow angular movements, range of motion and physical discomfort were assessed for 24 novice participants. There were no significant differences for physical comfort/discomfort ratings or elbow and wrist flexion/extension range of motion between CL and LESS. However, wrist radial/ulnar range of motion was significantly greater in LESS compared to CL (p < 0.05). Additionally, wrist radial/ ulnar range of motion was significantly greater using the SILS Port compared to the GelPOINT (p < 0.05). Although further investigation is needed, LESS resulted in greater wrist deviation and range of motion due to the close proximity of the instruments, restrictive nature of the single-port devices, and the need to achieve adequate instrument triangulation and visualization.