Current Models for Development of Disease-Modifying Osteoarthritis Drugs.

Osteoarthritis (OA) is a painful and disabling disease that affects millions of people worldwide. Symptom-alleviating treatments exist, although none with long-term efficacy. Furthermore, there are currently no disease-modifying OA drugs (DMOADs) with demonstrated efficacy in OA patients, which is, in part, attributed to a lack of full understanding of the pathogenesis of OA. The inability to translate findings from basic research to clinical applications also highlights the deficiencies in the available OA models at simulating the clinically relevant pathologies and responses to treatments in humans. In this review, the current status in the development of DMOADs will be first presented, with special attention to those in Phase II-IV clinical trials. Next, current in vitro, ex vivo, and in vivo OA models are summarized and the respective advantages and disadvantages of each are highlighted. Of note, the development and application of microphysiological or tissue-on-a-chip systems for modeling OA in humans are presented and the issues that need to be addressed in the future are discussed. Microphysiological systems should be given serious consideration for their inclusion in the DMOAD development pipeline, both for their ability to predict drug safety and efficacy in human clinical trials at present, as well as for their potential to serve as a test platform for personalized medicine. Impact statement At present, no disease-modifying osteoarthritis (OA) drugs (DMOADs) have been approved for widespread clinical use by regulatory bodies. The failure of developing effective DMOADs is likely owing to multiple factors, not the least of which are the intrinsic differences between the intact human knee joint and the preclinical models. This work summarizes the current OA models for the development of DMOADs, discusses the advantages/disadvantages of each, and then proposes future model development to aid in the discovery of effective and personalized DMOADs. The review also highlights the microphysiological systems, which are emerging as a new platform for drug development.

"I Cannot Take This Any More!": Preparing Interns to Identify and Help a Struggling Colleague.

BACKGROUND: Few programs train residents in recognizing and responding to distressed colleagues at risk for suicide. AIM: To assess interns' ability to identify a struggling colleague, describe resources, and recognize that physicians can and should help colleagues in trouble. SETTING: Residency programs at an academic medical center. PARTICIPANTS: One hundred forty-five interns. PROGRAM DESIGN: An OSCE case was designed to give interns practice and feedback on their skills in recognizing a colleague in distress and recommending the appropriate course of action. Embedded in a patient "sign-out" case, standardized health professionals (SHP) portrayed a resident with depressed mood and an underlying drinking problem. The SHP assessed intern skills in assessing symptoms and directing the resident to seek help. PROGRAM EVALUATION: Interns appreciated the opportunity to practice addressing this situation. Debriefing the case led to productive conversations between faculty and residents on available resources. Interns' skills require further development: while 60% of interns asked about their colleague's emotional state, only one-third screened for depression and just under half explored suicidal ideation. Only 32% directed the colleague to specific resources for his depression (higher among those that checked his emotional state, 54%, or screened for depression, 80%). DISCUSSION: This OSCE case identified varying intern skill levels for identifying and assessing a struggling colleague while also providing experiential learning and supporting a culture of addressing peer wellness.

Surgical clerkship or medical clerkship first: Does it make a difference?

INTRODUCTION: This study compares NBME surgical clerkship scores of students who completed their medicine clerkship before their surgical clerkship with the performance of those who had not previously completed their medical clerkship. METHODS: The study included 815 New York University School of Medicine students from the years 2014-2018 (571 students took medicine first, while 244 took surgery first). Performance on the surgical clerkship was assessed using the NBME SHELF examination. Statistical comparisons were performed via 2-tailed, independent-samples, unequal-variance t-tests. RESULTS: Mean NBME surgical SHELF scores of the students who had previously taken medicine were significantly higher than students who had not (mean 78.6 vs. 73.5, p < 0.001). Students who had solely medicine (as their first clerkship) before surgery also performed significantly better (mean 78.8 vs. 73.5, p < 0.001). Students who completed surgery later in the year did not perform better on the surgical SHELF, so long as both surgical clerkship cohorts had completed medicine. CONCLUSION: Students who completed their core medical clerkship prior to their surgical clerkship scored significantly better on the NBME surgical SHELF examination.

Midclerkship feedback in the surgical clerkship: the "Professionalism, Reporting, Interpreting, Managing, Educating, and Procedural Skills" application utilizing learner self-assessment.

BACKGROUND: The Liaison Committee on Medical Education requires midclerkship formative (low stakes) feedback to students regarding their clinical skills. Student self-assessment is not commonly incorporated into this evaluation. We sought to determine the feasibility of collecting and comparing student self-assessment with that of their preceptors using an iPad application. These student self-ratings and preceptor ratings are jointly created and reviewed as part of a face-to-face midclerkship feedback session. METHODS: Using our iPad application for Professionalism, Reporting, Interpreting, Managing, Educating, and Procedural Skills ("PRIMES"), students answer 6 questions based on their self-assessment of performance at midclerkship. Each skill is rated on a 3-point scale (beginning, competent, and strong) with specific behavioral anchors. The faculty preceptors then complete the same PRIMES form during the face-to-face meeting. The application displays a comparison of the 2 sets of ratings, facilitating a discussion to determine individualized learning objectives for the second half of the clerkship. RESULTS: A total of 209 student-preceptor pairs completed PRIMES ratings. On average, student-preceptor ratings were in agreement for 38% of the time. Agreement between students and preceptors was highest for Professionalism (70%) and lowest for Procedural Skills (22%). On average, 60% of student-preceptor ratings did not agree. Students rated themselves lower than preceptors 52% of the time, while only 8% of students rated themselves higher than their preceptors' ratings (this difference is significant at the P value <.05 level). CONCLUSIONS: This study demonstrates the value of using the PRIMES framework to incorporate surgery clerkship students' self-assessment into formative face-to-face midclerkship feedback sessions with their preceptors with the goal to improve performance during the second half of the clerkship.

Professionalism Training For Surgical Residents: Documenting the Advantages of a Professionalism Curriculum.

OBJECTIVES: Professionalism education is a vital component of surgical training. This research attempts to determine whether an annual, year-long professionalism curriculum in a large surgical residency can effectively change professionalism attitudes. SUMMARY OF BACKGROUND DATA: The ACGME mandated 6 competencies in 2003. The competencies of Professionalism and Interpersonal/Professional Communication Skills had never been formally addressed in surgical resident education in the past. METHODS: A professionalism curriculum was developed focusing on specific resident professionalism challenges: admitting mistakes, effective communication with colleagues at all levels, delivering the news of an unexpected death, interdisciplinary challenges of working as a team, the cultural challenge of obtaining informed consent through an interpreter, and the stress of surgical practice on you and your family. These professionalism skills were then evaluated with a 6-station Objective Structured Clinical Examination (OSCE). Identical OSCE scenarios were administered to 2 cohorts of surgical residents: in 2007 (before instituting the professionalism curriculum in 2008) and again in 2014. Surgical residents were rated by trained Standardized Patients according to a behaviorally anchored professionalism criteria checklist. RESULTS: An analysis of variance was conducted of overall OSCE professionalism scores (% well done) as the dependent variable for the 2 resident cohorts (2007 vs 2014). The 2007 residents received a mean score of 38% of professionalism items "well done" (SD 9%) and the 2014 residents received a mean 59% "well done" (SD 8%). This difference is significant (F = 49.01, P < .001). CONCLUSIONS: Professionalism education has improved surgical resident understanding, awareness, and practice of professionalism in a statistically significant manner from 2007 to 2014. This documented improvement in OSCE performance reflects the value of a professionalism curriculum in the care of the patients we seek to serve.

When surgeons decide to become surgeons: new opportunities for surgical education.

BACKGROUND: When surgeons decide to become surgeons has important implications. If the decision is made prior to or early in medical school, surgical education can be more focused on surgical diseases and resident skills. METHODS: To determine when surgeons - compared with their nonsurgical colleagues - decide on their medical path, residents in surgery, internal medicine, obstetrics and gynecology, pediatrics, psychiatry, and emergency medicine were surveyed. Timing of residency choice, demographic data, personal goals, and reason for residency choice were queried. RESULTS: A total of 234 residents responded (53 surgical residents). Sixty-two percent of surgeons reported that they were "fairly certain" of surgery before medical school, 13% decided during their preclinical years, and 25% decided during their clerkship years. This compares with an aggregate 40%, 7%, and 54%, respectively, for the other 5 residency specialties. These differences were statistically significant (P = .001). When the 234 residents were asked about their primary motivation for choosing their field, 51% pointed to expected job satisfaction and 44% to intellectual curiosity, and only 3% mentioned lifestyle, prestige, or income. CONCLUSIONS: General surgery residents decide on surgery earlier than residents in other programs. This may be advantageous, resulting in fast-tracking of these medical students in acquiring surgical knowledge, undertaking surgical research, and early identification for surgical residency programs. Surgical training in the era of the 80-hour work week could be enhanced if medical students bring much deeper knowledge of surgery to their first day of residency.

Cutting too deep? Assessing the impact of a shorter surgery clerkship on students' clinical skills and knowledge.

BACKGROUND: The aim of this study was to compare the performance of students completing an 8-week versus a 6-week surgery clerkship on an objective structured clinical examination (OSCE) and the National Board of Medical Examiners (NBME) clinical science surgery examination. METHODS: One hundred fifteen students from the 8-week clerkship and 99 from the 6-week clerkship were included. Performance on a summative OSCE was assessed using behaviorally anchored checklists. NBME exams were graded using the NBME's standard scaled scores. Results were compared using 2-tailed, independent-samples, unequal-variance t tests. RESULTS: Mean OSCE scores for the 8-week and 6-week curricula were not statistically different. Mean NBME scores also did not statistically differ. Six-week students performed significantly better in the specific OSCE subdomains of blood pressure, orthostatic blood pressure, rectal exam, and fecal occult blood test. CONCLUSIONS: Overall OSCE and NBME exam performance did not differ between 8-week and 6-week surgery clerkship students.

The stress of residency: recognizing the signs of depression and suicide in you and your fellow residents.

BACKGROUND: Stress, depression, and suicide are universal but frequently unrecognized issues for women and men in residency training. Stress affects cognitive and psychomotor performance both inside and outside of the operating room. Stress impairs the 2 key components of a surgeon's responsibilities: intellectual judgment and technical skill. We hypothesized that the recognition of depression, substance abuse, failing personal relationships, and potential suicide is poor among surgeons. If residents can recognize the signs of stress, depression, and suicide among colleagues, we believe it will not only improve their quality of life but also may preserve it. METHODS: We first determined baseline resident knowledge of the signs of surgical stress including fatigue; burn out; depression; physician suicide; drug and alcohol abuse; and their effects on family, friends, and relationships. We then developed a curriculum to identify these signs in first, second, third, and fourth year surgical residents were identified as the target learners. The major topics discussed were depression; physician suicide; drug and alcohol abuse; and the effects of stress on family, friends, and our goals. Secondary objectives included identifying major sources of stress, general self-awareness, understanding professional choices, and creating a framework to manage stress. Residents participated in an interactive seminar with a surgical facilitator. Before and after the seminar, a multiple-choice test was administered with questions to assess knowledge of the signs of stress (eg, fatigue, burn out, and depression). RESULTS: Twenty-one residents participated in this study. Seventeen completed the pretest, and 21 participated in the interactive seminar and completed the post-test. The pretest revealed that surgical residents were correct in 46.8% (standard deviation [SD] = 25.4%) of their responses. The postseminar test showed an improvement to 89.7% (SD = 6.1%, P < .001, paired Student t test = 5.37). The same test administered 4 months later to 17 of the 21 learners revealed 76.9% (SD = 18.7%) correct answers, suggesting that the information had been internalized. Cronbach α was calculated to be .67 for the pretest and .76 for the post-test, suggesting a moderate to high degree of internal consistency. CONCLUSIONS: Stress is a significant and regularly overlooked component of a surgeon's life. Because its effects often go unrecognized, stress frequently remains unresolved. To prevent its associated consequences such as depression, substance abuse, divorce, and suicide, educating house staff about stress is crucial. This study suggests that the symptoms, causes, and treatment of stress among surgeons can be taught effectively to surgical resident learners.

The professionalism curriculum as a cultural change agent in surgical residency education.

BACKGROUND: Teaching professionalism effectively to fully engaged residents is a significant challenge. A key question is whether the integration of professionalism into residency education leads to a change in resident culture. METHODS: The goal of this study was to assess whether professionalism has taken root in the surgical resident culture 3 years after implementing our professionalism curriculum. Evidence was derived from 3 studies: (1) annual self-assessments of the residents' perceived professionalism abilities to perform 20 defined tasks representing core Accrediting Council on Graduate Medical Education professionalism domains, (2) objective metrics of their demonstrated professionalism skills as rated by standardized patients annually using the objective structure clinical examination tool, and (3) a national survey of the Surgical Professionalism and Interpersonal Communications Education Study Group. RESULTS: Study 1: aggregate perceived professionalism among surgical residents shows a statistically significant positive trend over time (P = .016). Improvements were seen in all 6 domains: accountability, ethics, altruism, excellence, patient sensitivity, and respect. Study 2: the cohort of residents followed up over 3 years showed a marked improvement in their professionalism skills as rated by standardized patients using the objective structure clinical examination tool. Study 3: 41 members of the national Surgical Professionalism and Interpersonal Communications Education Study Group rated their residents' skills in admitting mistakes, delivering bad news, communication, interdisciplinary respect, cultural competence, and handling stress. Twenty-nine of the 41 responses rated their residents as "slightly better" or "much better" compared with 5 years ago (P = .001). Thirty-four of the 41 programs characterized their department's leadership view toward professionalism as "much better" compared with 5 years ago. CONCLUSIONS: All 3 assessment methods suggest that residents feel increasingly prepared to effectively deal with the professionalism challenges they face. Although professionalism seminars may have seemed like an oddity several years ago, residents today recognize their importance and value their professionalism skills. As importantly, department chairpersons report that formal professionalism education for residents is viewed more favorably compared with 5 years ago.

Perspective: Malpractice in an academic medical center: a frequently overlooked aspect of professionalism education.

Understanding how medical malpractice occurs and is resolved is important to improving patient safety and preserving the viability of a physician's career in academic medicine. Every physician is likely to be sued by a patient, and how the physician responds can change his or her professional life. However, the principles of medical malpractice are rarely taught or addressed during residency training. In fact, many faculty at academic medical centers know little about malpractice.In this article, the authors propose that information about the inciting causes of malpractice claims and their resolution should be incorporated into residency professionalism curricula both to improve patient safety and to decrease physician anxiety about a crucial aspect of medicine that is not well understood. The authors provide information on national trends in malpractice litigation and residents' understanding of malpractice, then share the results of their in-depth review of surgical malpractice claims filed during 2001-2008 against their academic medical center. The authors incorporated those data into an evidence-driven curriculum for residents, which they propose as a model for helping residents better understand the events that lead to malpractice litigation, as well as its process and prevention.

Can professionalism be taught? Encouraging evidence.

BACKGROUND: Teaching and assessing the Accreditation Council for Graduate Medical Education (ACGME) competencies of Professionalism and Communication have proven to be a challenge for surgical residency training programs. This study used innovative pedagogic approaches and tools in teaching these two competencies. The purpose of this study was to determine whether the learners actually are assimilating and using the concepts and values communicated through this curriculum. METHODS: A six-station Objective Structured Clinical Examination (OSCE) was designed using standardized patients to create varying Professionalism and Communication scenarios. The surgical resident learners were evaluated using these OSCEs as a baseline. The faculty then facilitated a specially designed curriculum consisting of six interactive sessions focusing on information gathering, rapport building, patient education, delivering bad news, responding to emotion, and interdisciplinary respect. At the conclusion of this curriculum, the surgical resident learners took the same six-station OSCE to determine if their professionalism and communication skills had improved. RESULTS: The surgical resident learners were rated by the standardized patients according to a strict task checklist of criteria at both the precurricular and postcurricular OSCEs. Improvement in the competencies of Professionalism and Communication did achieve statistical significance (P = .029 and P = .011, respectively). CONCLUSIONS: This study suggests that the Communication and Professionalism ACGME competencies can be taught to surgical resident learners through a carefully crafted curriculum. Furthermore, these newly learned competencies can affect surgical resident interactions with their patients positively.

The timing of surgery for cholecystitis: a review of 202 consecutive patients at a large municipal hospital.

BACKGROUND: Traditionally, cholecystectomy for cholecystitis is performed within 3 days of the onset of symptoms or after 5 weeks, allowing for resolution of the inflammatory response. This study reviewed the outcomes of cholecystectomy performed for patients with gallstone disease in the acute (n = 45), intermediate (n = 55), and delayed (n = 102) periods after the onset of symptoms. METHODS: The medical records of 202 patients who underwent laparoscopic cholecystectomy at a large municipal hospital were reviewed retrospectively. The primary outcomes studied were length of hospital stay, conversion to open cholecystectomy, and complications. RESULTS: There was no significant difference in the conversion rate (acute [18%] vs intermediate [20%] vs delayed [11%]) or complication rate (acute [16%] vs intermediate [9%] vs delayed [7%]) among the 3 groups. The delayed group had a significantly shorter length of hospital stay than the intermediate or acute group (3.1 +/- 3.8 vs 4.3 +/- 3.8 vs 1.7 +/- 2.1, respectively, P < .001). CONCLUSIONS: Patients who present with acute symptoms of cholecystitis should undergo surgery during the same admission, regardless of the duration of symptoms.

Acellular dermal matrix allograft in the treatment of mucogingival defects in children: illustrative case report.

Mucogingival defects can occur in children and are of particular concern when orthodontic treatment is indicated. The rationale for surgical intervention is predicated on the need to repair the mucogingival defect and to establish adequate thickness of attached gingiva. The free gingival graft, usually obtained from the hard palate, is often used to increase the amount of attached gingiva. The prospect of a second surgical site, and its inherent risks and complications, which may include pain, discomfort, and bleeding, is especially undesirable in children. Important to consider is the possibility that a child may not have adequate tissue thickness at the donor site. A case report is presented utilizing the alternative soft tissue graft, Alloderm, to correct a mucogingival defect prior to orthodontic treatment. Adhering to the free gingival autograft technique, an acellular dermal matrix allograft was utilized at the graft site. The patient revealed good post-operative healing, tissue vascularization, and a healthy zone of attached gingiva at the six month follow up visit. Comparable results to the conventional autograft were obtained with less surgical time, surgical sites, and discomfort to the patient.