Surgical endoscopy education research: how are we doing?

BACKGROUND: Surgical endoscopy (SE), the official journal of the Society of American Gastrointestinal and Endoscopic Surgeons and the European Association for Endoscopic Surgery, is an important source of new evidence pertaining to surgical education in the field. However, qualitative deficiencies in medical education research have prompted medical education leaders to advocate for increased methodological rigor. The purpose of this study is to review the quality of education-focused research published through SE. METHODS: A PubMed search examining all SE articles categorized as education-related research from 2010 to 2019 was conducted; studies not meeting inclusion criteria were excluded. Remaining publications were independently reviewed, classified, and scored by 7 raters using the medical education research study quality instrument (MERSQI). Intraclass correlation was calculated and data were examined with descriptive statistics. RESULTS: A total of 227 studies met inclusion criteria. There was no significant difference in number of publications by year (average 25.88 [SD 5.6]); 60% were conducted outside of the United States, and 47% (n = 106) were funded. The average MERSQI was 12.5 (SD 2). Most studies used two-group non-random (42%, n = 96) or post/cross-sectional designs (29%, n = 65). Thirty-six (16%) were randomized controlled trials. Multi-institutional studies comprised 24% (n = 54). Of the manuscripts, 96% (n = 217) reported at least one measure of validity evidence and 28% (n = 67) described three levels of validity evidence. Studies primarily reported changes in skills or knowledge (45%, n = 103) or satisfaction or general facts (44%, n = 99), while patient-related outcomes encompassed 3% (n = 6) of studies. ICC between raters was 0.93 (CI 0.90-0.93, p < 0.001). CONCLUSIONS: Based on publications to date, this journal's peer review process appears to facilitate the dissemination of education-related studies of moderate to good quality. However, there were uncovered deficits, ranging from validity evidence to study designs and level of outcomes. This journal's breadth of viewership offers a potential venue to advance education-related research.

The Utility of Peers and Trained Raters in Technical Skill-based Assessments a Generalizability Theory Study.

OBJECTIVE: The gold standard for evaluation of resident procedural competence is that of validated assessments from faculty surgeons. A provision of adequate trainee assessments is challenged by a shortage of faculty due to increased clinical and administrative responsibilities. We hypothesized that with a well constructed assessment instrument and training, there would be minimal differences in procedural assessments made by near-peer resident raters (RR), faculty raters (FR), and trained raters (TR). DESIGN: Deidentified videos of residents performing hand-sewn (HA) and stapled (SA) anastomoses were distributed to blinded reviewers of 3 types. Intra-class correlation (ICC) of RR, FR and TR assessments was determined for each procedure. A fully-crossed design was used to examine the internal structure validity in a generalizability study. A Decision study was performed to make projections on the number of raters needed for a g-coefficient > 0.70. SETTING: This study was conducted within a private academic institution, using the creation of intestinal anastomoses as the procedural model. PARTICIPANTS: Raters consisted of residents who were untrained to the assessment (UTA) tool, UTA faculty surgeons, and individuals with training. RESULTS: Twenty nine videos were reviewed (15 HA and 14 SA) by a total of 9 video reviewers (4 RR, 2 FR, and 3 TR). HA ICC values were 0.84 (Confidence Interval [CI]:0.81-0.87) for RR, 0.89 (CI:0.86-0.92) for FR, and 0.88 (CI:0.86-0.90) for TR. SA ICC values were 0.77 (CI:0.72-0.80) for RR, 0.79 (CI:0.75-0.83) for FR, and 0.86 (CI:0.83-0.88) for TR. The g-coefficient was RR = 0.72, FR = 0.85, and TR = 0.77 for HA; and RR = 0.33, FR = 0.38, and TR = 0.4 for SA. The D-study indicated that at least 2 raters of any type were needed for HA and > 11 FR for SA. CONCLUSIONS: Faculty without training have high assessment agreement. Peers for surgical skills assessment is an option for formative evaluation without training. Training to assessment tools should be performed for any assessment, formative or summative, for the optimal evaluation of procedural competence.

A Novel Blended Curriculum for Communication of Informed Consent With Surgical Interns.

BACKGROUND: Interns often conduct procedural informed consent discussions (ICDs), identified as a core entrustable professional activity. Deficiencies in the training process for ICDs span across specialties. OBJECTIVE: We provide evidence for a curriculum and assessment designed to standardize the training process and ensure ICD competency in surgical interns. METHODS: In March 2019, PowerPoint educational materials were emailed to one academic institution's new surgical interns, who in June participated in an onsite 1-hour role-play "hot seat" group activity (GA) with an untrained simulated patient, and in October completed a single trained simulated patient (real-time raters) verification of proficiency (VOP) assessment. Curriculum evaluation was measured through intern pre-/post-confidence (5-point scale), and the VOP's Cronbach's alpha and test-retest were examined. Data were analyzed with descriptive statistics, paired t tests, and 2-way random effects models. RESULTS: Of 44 new interns, 40 (91%) participated in the remote teaching and live GA and were assessed by the VOP. Pre-/post-GA confidence increased a mean difference of 1.3 (SD = 0.63, P < .001). The VOP's Cronbach's alpha was 0.88 and test-retest was 0.84 (95% CI 0.67-0.93, P < .001), with a 95% pass rate. The 2 first-time fail students required remediation. Time commitment included 1 hour maximum for individual training and implementation and 30 minutes for assessment. The use of volunteers and donated space mitigated additional costs. CONCLUSIONS: Remote asynchronous and group skills teaching for new general surgical interns improved their confidence in conducting procedural ICDs. A patient-simulation verification process appeared feasible with preliminary evidence of retest and internal consistency.

In situ interprofessional operating room simulations: Empowering learners in crisis resource management principles.

BACKGROUND: Given the multifaceted nature of operating room teams, miscommunication at various perioperative stages leads to lapses in teamwork and communication, which potentiates adverse events. In situ interprofessional operating room simulations are a valuable tool in identifying the possible threats to patient safety in the operating room. Participant confidence may also increase; however, perceived confidence in specific areas of team communication in the clinical environment remains unclear. This research aims to study how in situ interprofessional operating room simulations increase participants' individual confidence in 4 team principles derived from crisis resource management: using effective communication, utilizing resources, establishing role clarity, and using effective situational awareness. METHODS: Over a 2-year period, interdisciplinary operating room team members were assigned to participate in 13 simulated surgical case scenarios, which were chosen based on the volunteer surgeon's specialty. These cases were designed to engage all team members and included a crisis scenario (ie, hemorrhage, airway emergency, arrhythmia, or cardiac arrest). All statistical analyses were performed using RStudio version 1.2.1335 software. We analyzed matched pre- and postsimulation self-assessment of individual confidence using the Wilcoxon signed-rank test for each of the 4 aforementioned constructs of interest derived from crisis resource management training principles. Significance was set at P < .0038, using Bonferroni correction, for all comparisons to account for the multiple comparisons problem. RESULTS: There was a statistically significant shift in the 4-point scale toward greater self-reported confidence from presimulation to postsimulation for each of the 4 team principles: using effective communication (P = .0019, r = 0.18), utilizing resources well (P = .0014, r = 0.18), establishing role clarity (P < .0010, r = 0.22), and using effective situational awareness (P < .0010, r = 0.27). CONCLUSION: In this pilot study, we describe how teaching crisis resource management principles in an in situ operative simulation is an effective way to increase the confidence of communication skills among the members of an interdisciplinary procedure/operative team during crisis scenarios. In situ simulation can be used to evaluate system competence and interdisciplinary dynamics, and to identify latent conditions that predispose to medical error. As we continue to conduct these sessions, we aim to evaluate their impact on individual confidence and the advancement of interdisciplinary efforts to improve patient care.

A Generalizable Multimodal Scrub Training Curriculum in Surgical Sterile Technique.

Introduction: Recent endeavors from governing bodies such as the AAMC have formally recognized the importance of aseptic technique. AAMC guidelines include activities that all graduating physicians should be able to perform with minimum indirect supervision and were developed to recognize these needs. For example, the skills necessary for aseptic technique include daily safety habits and general physician procedures. Methods: We developed a scrub training curriculum and evaluated the program through a quasi-experimental study with a pre- and posttest design. Questions were developed to examine students' perceived knowledge and skills as related to the objectives of the course and to their anxieties, concerns, and future training needs. Results: Between February 2020 and March 2020, 44 students completed the curriculum. Students indicated that self-efficacy significantly increased in all aspects of the curricular goals following curriculum completion. Students identified understanding OR etiquette as the most anxiety-provoking element associated with scrub training. They felt that more time could be spent elucidating this etiquette. On the other hand, tasks such as surgical hand hygiene were the least anxiety-inducing. Discussion: We share this multimodal scrub training curriculum, mapped to the AAMC's guidelines, to reduce variability in teaching strategies and skills acquisition through a standardized curriculum. Also, we effectively imparted these skills and instilled a sense of confidence in learners as they worked to provide their best in patient care and safety.

Operating Room In Situ Interprofessional Simulation for Improving Communication and Teamwork.

BACKGROUND: Effective teamwork and communication are correlated with improved patient care quality and outcomes. The belief that each team member contributes to excellent patient care in the operating room (OR) leads to a more productive work environment. However, poor teamwork and communication lead to poorer OR outcomes. We qualitatively and quantitatively explored perspectives of three OR professions (nursing, anesthesiology, and surgery) on teamwork and communication in the OR preinterprofessional and postinterprofessional in situ OR simulation. MATERIALS AND METHODS: One-on-one semi-structured interviews were conducted; 14 pre-in situ simulations during July-October 2017 (three surgery, four anesthesiology, and six nursing staff), and 10 post-in situ simulations during August-November 2017 (five surgery, four anesthesiology, and one nursing staff). Themes were identified inductively to create a codebook. The codebook was used to consensus code all interviews. This analysis informed the development of a quantitative survey distributed to all contactable interviewees (22). RESULTS: Presimulation and postsimulation interview participants concurred on teamwork and communication importance, believed communication to be key to effective teamwork, and identified barriers to communication: lack of cordiality, lack of engagement from other staff, distractions, role hierarchies, and lack of familiarity with other staff. The large majority of survey participants-all having participated in simulations-believed they could use effective communication in their workplace. CONCLUSIONS: Establishing methods for improving and maintaining the ability of OR professionals to communicate with each other is imperative for patient safety. Effective team communication leads to safe and successful outcomes, as well as a productive and supportive OR work environment.

Well-Being without a Roof: Examining Well-Being among Unhoused Individuals Using Mixed Methods and Propensity Score Matching.

The morbidity and mortality experiences of people who are unhoused have been well-described, but much less is known about the overall well-being of these individuals. In this mixed methods study, housed and unhoused participants completed a multi-faceted 10 domain measure of well-being (the Stanford WELL Survey), and a subset of unhoused participants shared their experiences during qualitative interviews. Using propensity score matching, unhoused participants (n = 51) were matched at a ratio of 1:5 with housed participants (n = 255). The mean overall well-being score of the unhoused participants was significantly lower than that of the matched housed participants (B = -5.022, p = 0.013). Additionally, the two groups differed on some of the constituent domains of well-being, with unhoused participants reporting statistically significantly lower mean scores on social connectedness (B = -1.086, p = 0.000), lifestyle and daily practices (B = -1.219, p = 0.000), stress and resilience (B = -0.493, p = 0.023), experience of emotions (B = -0.632, p = 0.009), physical health (B = -0.944, p = 0.0001), and finances (B = -3.099, p = 0.000). The unhoused participants had a statistically significantly higher mean score for spirituality and religiosity (B = 2.401, p = 0.000) than their matched housed counterparts. The qualitative interviews further highlighted spirituality and religion as a coping mechanism for the unhoused. The results of this study highlight both unexpected strengths exhibited by the unhoused individuals and areas of challenge.

Preclinical Surgical Preparatory Course and the NRMP Match: Early Exposure and Surgical Recruitment a 10-Year Follow-Up.

OBJECTIVE: Many medical students mentally commit to specialties prior to entering clerkships. This is why early preclinical interactions with surgical specialties, through mentorship and/or interest groups, increases the opportunity to nurture enthusiasm for surgery. In 2007, a course providing preclinical medical students with introductory surgical skills training and preparation for the surgical environment ("SURG205") was established at our institution. The course underwent a major revision in 2016, increasing intraoperative mentorship by matching students to surgical attendings and requiring students to scrub into operative cases together. We anticipate that the positive surgical experiences created by the course will lead to further development and enhancement of student interest in surgical specialties-interest that we hypothesized would reflect in their National Resident Matching Program (NRMP) Match outcomes. DESIGN: NRMP results from 2010 to 2019 were cross-referenced with a database of students who participated in the SURG205 course from 2007 to 2016. With this, we examined the correlation between student participation in SURG205 and surgical specialty match. Descriptive statistics were used to review the trends of the NRMP results, and Pearson's correlation was used to determine the relationship and its significance. SETTING: This study was conducted in a single private medical school in California. PARTICIPANTS: Specialties considered "surgical" included: General Surgery, integrated programs-such as Plastic, Thoracic, or Vascular surgery, Obstetrics and Gynecology, Orthopedic Surgery, Otolaryngology, Neurosurgery, and Urology. All other specialties were considered nonsurgical. Students identified as having participated in SURG205 and who then also took part in the NRMP. RESULTS: Seven hundred eighty students underwent the Match process from 2010 to 2019. 144 (18.5%) of these students participated in SURG205 between 2007 and 2016. Each Match class ranged in size from 62 to 91 (median = 77.5, IQR = 14.5) students. (Table 1) Two-hundred and nineteen students (28.1%) matched into a surgical specialty, of which 34 (15.5%) selected general surgery. From 2010 to 2019 the rate of students who matched into surgical specialties averaged 28.1% per year with a slight nonstatistically significantly increasing trend over that time period R2 = 0.30 (p = 0.09; Fig. 1). There was a significant increase in trend in proportion of students who took the course and matched into any specialty between 2010 and 2019 (R2 = 0.85, p = 0.0002; Fig. 2). And, there was a statistically significant positive relationship between students taking the course and matching into a surgical specialty (R2 = 0.63, p = 0.01; Fig. 3). CONCLUSION: Our results highlight the increasing tendency of students who pursue surgical specialties having previously participated in this early exposure courses. Not only is student interest created and encouraged through positive mentorship experiences, but that interest may be associated with increases in application rates and eventual match into the specialty. General surgery training programs might consider these trends when designing courses to ease transitions into first-year residency positions-such as fourth-year surgical boot camps, surgical procedure-based anatomy courses, and mentorship frameworks. This information further justifies the cost and time commitment required to administer these programs for students.

Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management.

Regulated drug bioanalysis (i.e., determination of drug concentrations in biological matrices for regulated studies) usually refers to animal toxicokinetics, bioavailability/bioequivalence and clinical pharmacokinetic studies. However, there is another important regulated drug bioanalysis - therapeutic drug management (TDM). In the USA, TDM is regulated by Clinical Laboratory Improvement Amendments. In this article, we review and compare human pharmacokinetic sample analysis and TDM sample analysis. The US FDA/Bioanalytical Method Validation Guidance and the American Association for Clinical Chemistry/TDM Roundtable Recommended Generic Assay Validation Guidance are also compared. Some regulated drug bioanalysis issues, such as terminology, validation concepts and acceptance criteria, are discussed. Fostering interaction between bioanalysts from pharmaceutical science and clinical chemistry and reducing the regulatory gaps between different agencies for drug bioanalysis is our objective.

Matrix effect and recovery terminology issues in regulated drug bioanalysis.

Understanding the meaning of the terms used in the bioanalytical method validation guidance is essential for practitioners to implement best practice. However, terms that have several meanings or that have different interpretations exist within bioanalysis, and this may give rise to differing practices. In this perspective we discuss an important but often confusing term - 'matrix effect (ME)' - in regulated drug bioanalysis. The ME can be interpreted as either the ionization change or the measurement bias of the method caused by the nonanalyte matrix. The ME definition dilemma makes its evaluation challenging. The matrix factor is currently used as a standard method for evaluation of ionization changes caused by the matrix in MS-based methods. Standard additions to pre-extraction samples have been suggested to evaluate the overall effects of a matrix from different sources on the analytical system, because it covers ionization variation and extraction recovery variation. We also provide our personal views on the term 'recovery'.

Microanalysis of the antiretroviral nevirapine in human hair from HIV-infected patients by liquid chromatography-tandem mass spectrometry.

Sufficient drug exposure is crucial for maintaining durable responses to HIV treatments. However, monitoring drug exposure using single blood samples only provides short-term information and is highly subject to intra-individual pharmacokinetic variation. Drugs can accumulate in hair over a long period of time, so hair drug levels can provide drug exposure information over prolonged periods. We now report on a specific, sensitive, and reproducible liquid chromatography-tandem mass spectrometry method for measuring nevirapine (NVP), a widely used antiretroviral drug, levels in human hair using even a single short strand of hair. Hair samples are cut into small segments, and the drug is extracted in methanol/trifluoroacetic acid (v/v, 9:1) shaken at 37 °C in a water bath overnight, followed by liquid-liquid extraction under alkaline conditions. The extracted samples are then separated on a BDS-C(18) column with a mobile phase composed of 50% acetonitrile containing 0.15% acetic acid and 4 mM ammonium acetate with an isocratic elution for a total run time of 3 min and detected by triple quadrupole electrospray multiple reaction mode at precursor/product ion at 267.0 > 225.9 m/z. Deuterated nevirapine-d5 was used as an internal standard. This method was validated from 0.25 to 100 ng/mg using 2 mg hair samples. The accuracies for spiked NVP hair control samples were 98-106% with coefficients of variation (CV) less than 10%. The CV for incurred hair control samples was less than 7%. The extraction efficiency for incurred control hair samples was estimated at more than 95% by repeated extractions. This method has been successfully applied to analyze more than 1,000 hair samples from participants in a large ongoing cohort study of HIV-infected participants. We also showed that NVP in human hair can easily be detected in a single short strand of hair. This method will allow us to identify drug non-adherence using even a single strand of hair.

Risk factors for persistent ductus arteriosus patency during indomethacin treatment.

OBJECTIVE: To test the hypothesis that patent ductus arteriosus that fail to close with prostaglandin inhibition may be regulated by mechanisms that act independently of prostaglandin production. STUDY DESIGN: We examined a cohort of 446 infants who were treated with indomethacin (within 15 hours of birth) to inhibit prostaglandin production. We used multiple logistic regression modeling to determine which perinatal/neonatal variables were most closely associated with the persistence of ductus patency in the presence of diminished prostaglandin production. RESULTS: We identified 4 variables (immature gestational age, lack of exposure to antenatal betamethasone, severity of respiratory distress, and Caucasian race) that were significantly and independently associated with the degree of ductus patency. CONCLUSION: Gestational age, antenatal glucocorticoid exposure, respiratory distress, and race are independent risk factors that appear to affect ductus closure even when indomethacin has been used to inhibit prostaglandin production. Future studies of these risk factors may identify new potential targets for patent ductus arteriosus treatment.