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Appalachian regions of Kentucky and Ohio are hotspots for colorectal cancer (CRC) mortality in the USA. Screening reduces CRC incidence and mortality; however, screening uptake is needed, especially in these underserved geographic areas. Implementation science offers strategies to address this challenge. The aim of the current study was to conduct multi-site, transdisciplinary research to evaluate and improve CRC screening processes using implementation science strategies. The study consists of two phases (Planning and Implementation). In the Planning Phase, a multilevel assessment of 12 health centers (HC) (one HC from each of the 12 Appalachian counties) was conducted by interviewing key informants, creating community profiles, identifying HC and community champions, and performing HC data inventories. Two designated pilot HCs chose CRC evidence-based interventions to adapt and implement at each level (i.e., patient, provider, HC, and community) with evaluation relative to two matched control HCs. During the Implementation Phase, study staff will repeat the rollout process in HC and community settings in a randomized, staggered fashion in the remaining eight counties/HCs. Evaluation will include analyses of electronic health record data and provider and county surveys. Rural HCs have been reluctant to participate in research because of concerns about capacity; however, this project should demonstrate that research does not need to be burdensome and can adapt to local needs and HC abilities. If effective, this approach could be disseminated to HC and community partners throughout Appalachia to encourage the uptake of effective interventions to reduce the burden of CRC.

Background Exocrine pancreatic insufficiency (EPI) is a known consequence of pancreatic resection; however, its incidence following distal pancreatectomy is not well defined. The aim of this study was to describe the prevalence of EPI in patients undergoing distal pancreatectomy and moreover identify risk factors for developing de-novo EPI after distal pancreatectomy. Methods A prospectively maintained institutional pancreatic resection database was interrogated to identify patients who underwent distal pancreatectomy from 2005 to 2015. Pre- and post-operative exocrine function, histopathology, demographics and volume of pancreas resected were analyzed. Results The cohort consisted of 324 patients, 22 (6.8%) presented with EPI pre-operatively. 38 (12.6%) patients developed new onset EPI requiring pancreatic enzyme replacement therapy. There was no relationship between patient demographics or diabetes status and requirement for pancreatic enzyme replacement therapy, and no significant effect of resection volume on the need for pancreatic enzyme replacement therapy post-operatively (p ≥ 0.05). Having an underlying obstructive pancreatic pathology (p = 0.002) or a presenting history of acute pancreatitis (p Conclusion These results indicate that pre-existing EPI at time of surgery is not uncommon. Patients presenting for distal pancreatectomy should be assessed pre-operatively for the need for pancreatic enzyme replacement therapy.

This study describes the development of a colorectal cancer (CRC) screening multilevel intervention with four primary care clinics in rural Appalachian Kentucky. We also discuss barriers experienced by the clinics during COVID-19 and how clinic limitations and needs informed project modifications. Four primary care clinics were recruited, key informant interviews with clinic providers were conducted, electronic health record (EHR) capacity to collect data related to CRC screening and follow-up was assessed, and a series of meetings were held with clinic champions to discuss implementation of strategies to impact clinic CRC screening rates. Analysis of interviews revealed multilevel barriers to CRC screening. Patient-level barriers included fatalism, competing priorities, and financial and literacy concerns. The main provider- and clinic-level barriers were provider preference for colonoscopy over stool-based testing and EHR tracking concerns. Clinics selected strategies to address barriers, but the onset of COVID-19 necessitated modifications to these strategies. Due to COVID-19, changes in clinic staffing and workflow occurred, including provider furloughs, a state-mandated pause in elective procedures, and an increase in telehealth. Clinics adapted screening strategies to match changing needs, including shifting from paper to digital educational tools and using telehealth to increase annual wellness visits for screening promotion. While significant delays persist for scheduling colonoscopies, clinics were encouraged to promote stool-based tests as a primary screening modality for average-risk patients.

Background Colorectal cancer (CRC) screening rates are lower in Appalachian regions of the United States than in non-Appalachian regions. Given the availability of various screening modalities, there is critical need for culturally relevant interventions addressing multiple socioecological levels to reduce the regional CRC burden. In this report, we describe the development and baseline findings from year 1 of “Accelerating Colorectal Cancer Screening through Implementation Science (ACCSIS) in Appalachia,” a 5-year, National Cancer Institute Cancer MoonshotSM-funded multilevel intervention (MLI) project to increase screening in Appalachian Kentucky and Ohio primary care clinics. Methods Project development was theory-driven and included the establishment of both an external Scientific Advisory Board and a Community Advisory Board to provide guidance in conducting formative activities in two Appalachian counties: one in Kentucky and one in Ohio. Activities included identifying and describing the study communities and primary care clinics, selecting appropriate evidence-based interventions (EBIs), and conducting a pilot test of MLI strategies addressing patient, provider, clinic, and community needs. Results Key informant interviews identified multiple barriers to CRC screening, including fear of screening, test results, and financial concerns (patient level); lack of time and competing priorities (provider level); lack of reminder or tracking systems and staff burden (clinic level); and cultural issues, societal norms, and transportation (community level). With this information, investigators then offered clinics a menu of EBIs and strategies to address barriers at each level. Clinics selected individually tailored MLIs, including improvement of patient education materials, provision of provider education (resulting in increased knowledge, p = .003), enhancement of electronic health record (EHR) systems and development of clinic screening protocols, and implementation of community CRC awareness events, all of which promoted stool-based screening (i.e., FIT or FIT-DNA). Variability among clinics, including differences in EHR systems, was the most salient barrier to EBI implementation, particularly in terms of tracking follow-up of positive screening results, whereas the development of clinic-wide screening protocols was found to promote fidelity to EBI components. Conclusions Lessons learned from year 1 included increased recognition of variability among the clinics and how they function, appreciation for clinic staff and provider workload, and development of strategies to utilize EHR systems. These findings necessitated a modification of study design for subsequent years. Trial registration Trial NCT04427527 is registered at https://clinicaltrials.gov and was registered on June 11, 2020.

Background Sleeve gastrectomy is the most commonly performed bariatric surgery in the United States. Leaks after sleeve gastrectomy (SGL) occur in 1% to 3% of patients. Endoscopic therapies are increasingly used for treatment of SGLs, but few data exist on their outcomes. Objectives The aim of this study was to assess technical success, leak resolution, and reoperation rates of patients undergoing endoscopic therapy for repair SGLs. Setting Eight high-volume academic endoscopy centers. Methods Patients undergoing endoscopic therapy for SGLs from 2007 to 2017 were identified. Patients were excluded if the index endoscopic therapy for SGL was performed elsewhere or if no follow-up data were available. Leaks were classified as acute (≤7 d of SG), early (1–6 wk), late (7–12 wk), and chronic (>12 wk). Leak resolution was defined as lack of extraluminal air, extravasation on oral contrast radiography, cross-sectional imaging, or resolution of percutaneous drain output. Demographic and procedural data were recorded as rates of additional therapy, adverse events, and surgical revision. Results A total of 85 patients met criteria for analysis (70 women, age 42.6 ± 10.8 yr). A total of 295 endoscopic sessions (median 3, range 1–14) were performed across the cohort. SGLs resolved after index endoscopic therapy in 43 (50.1%) patients. The primary outcome of endoscopic resolution of SGL was observed in 62 patients (72.9%). There were 34 (11.5%) PRAE (the majority occurring with self-expandable metal stents), all but 1 of which were managed endoscopically. Surgical revision was required in 23 (21.7%) patients. On univariate analyses independent variables associated with the need for surgical revision included both acute and chronic SGLs (P = .028), loculated subphrenic collections/abscesses (P = .03), and intraabdominal sepsis (P = .03). On multivariable logistic regression using statistically significant predictors from the univariate analyses, acute SGLs were significantly associated with a need for surgical revision (odds ratio 4.8, 95% confidence interval 1.2–18.9, P = .025). Conclusion Endoscopic therapy for SGLs is associated with good clinical success, avoiding the need for surgical revision in 73% of patients, with an acceptable adverse event profile. Patients with acute or chronic SGLs and those with loculated abscesses or intraabdominal sepsis are more likely to undergo surgical revision. Endoscopic therapy is an appropriate first-line modality for the management of SGLs, especially those not classified as acute or chronic.

Background: Colorectal cancer (CRC) mortality is disproportionately higher in Appalachian counties of Kentucky than in non-Appalachian regions. Part of the mortality gap can be explained by lower screening rates in Appalachian counties. Researchers at Markey Cancer Center partnered with primary care clinics in eastern Kentucky to address this disparity by identifying strategies to implement evidence-based interventions (EBIs) to improve CRC screening and follow-up in Appalachian Kentucky. Methods: Members of the research team conducted formative research activities to identify multilevel barriers to CRC screening. A menu of EBIs was then created to address these barriers, and clinic champions selected EBIs that were feasible in their respective practices. However, because of restrictions during COVID-19, clinics experienced multiple changes to workflow and operations, necessitating modifications to program activities. Over a series of virtual meetings, clinic champions selected adaptations that could allow clinics to continue promoting CRC screening in their practices despite COVID-related limitations. Results: Changes in clinic staffing and workflow resulting from COVID-19 included provider furloughs, a state-mandated pause in elective procedures, mandatory parking lot visits for many in-person visits, and an increase in telehealth. Among our clinic partners, total in-person visits were reduced by nearly half from first to second quarter of 2020, whereas telehealth visits were 23 times higher, though telehealth visits were cut in half by third quarter. To match these changing modes of practice, clinics adapted creative strategies for communicating CRC screening recommendations to patients, including shifting from paper to digital educational tools, promoting screening via telehealth visits, and prioritizing recommendations for stool-based tests over colonoscopy for average-risk patients. As a result, orders for FIT and FIT-DNA were 2 and 3 times higher, respectively, from second to third quarter of 2020. Conclusion: Rural primary care clinics in Appalachia continue to promote CRC screening despite the multiple challenges related to COVID-19. One relevant reference for clinicians is the National Colorectal Cancer Roundtable’s playbook for reigniting CRC screening during COVID-19, a document that promotes stool-based screening for average-risk patients. While elective procedures remain backlogged in rural areas due to state regulations, research partners should emphasize the need to prioritize stool-based CRC screening for average-risk populations and reserve scheduling colonoscopies for high-risk individuals or those with abnormal stool-based test results. While our clinical partners had previously focused on a “colonoscopy first” approach to screening, our findings suggest that our clinic partners increased orders for stool-based CRC tests. Nevertheless, continued outreach is needed to ensure CRC screening rates remain optimal. Citation Format: Aaron J. Kruse-Diehr, Mark Cromo, Melinda Rogers, Angela Carman, Bin Huang, David Gross, Sue Russell, Vickie Fairchild, Mark Dignan. Colorectal cancer screening in Appalachian Kentucky primary care clinics during COVID-19 [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2021 Feb 3-5. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(6_Suppl):Abstract nr P12.

Background: Colorectal cancer (CRC) screening is lower in Appalachian regions of Kentucky and Ohio than in their non-Appalachian counterparts, with lower screening contributing to increased CRC incidence and mortality. To address CRC disparities in these underserved regions, researchers from the University of Kentucky and The Ohio State University partnered with two federally qualified health centers (FQHCs) to develop and implement multilevel interventions (MLIs) during year one of a 5-year National Cancer Institute funded Cancer Moonshot project to increase CRC screening and follow-up in Appalachian Kentucky and Ohio. Methods: Drawing from the Model for the Analysis of Population Health and Health Disparities and using a social determinants of health framework, researchers selected and partnered with Community Advisory Boards (CAB) to guide project formation in two Appalachian counties, one in Kentucky and one in Ohio. These formative activities included creating community profiles, conducting key informant interviews with clinic and community champions, and completing data inventories to assess clinic capacity, ultimately resulting in two primary care clinics being selected for pilot year implementation activities. Results: Key informant interviews revealed barriers to CRC screening at multiple levels: patient (e.g., fear of screening results), provider (e.g., competing priorities), clinic (e.g., lack of reminder or tracking systems), and community (e.g., cultural norms). Clinic champions were provided with menus of evidence-based interventions (EBIs) to address barriers at each level and were encouraged to select locally relevant, implementable EBIs. Clinics chose to implement the following EBIs: improved patient education materials (patient-level), additional provider education (provider-level), improvement of electronic health record (EHR) reporting and creation of clinic-wide screening protocols (clinic-level), and provision of interactive screening education at community events (community- level). Conclusion: Results from pilot year activities were used to refine the project approach for years two through five. Project activities will be expanded to 10 more Appalachian counties in Kentucky and Ohio using a design wherein counties will be paired by participating clinic patient volume. As in pilot year activities, clinic/community champions will be encouraged to select EBIs appropriate to their patients, providers, clinics, and communities. To measure clinical outcomes, self- reported screening will be monitored using data from county-wide telephone surveys with additional data from clinic EHRs. Using an MLI approach may be well- received in underserved rural Appalachian communities and may ultimately be successful at reducing CRC screening disparities. Citation Format: Aaron J. Kruse-Diehr, Jill M. Oliveri, Mira L. Katz, Mark Cromo, Robin C. Vanderpool, Michael L. Pennell, Darrell M. Gray II, Paul L. Reiter, Bin Huang, Gregory S. Young, Darla Fickle, Melinda Rogers, David Gross, Sue Russell, Electra D. Paskett, Mark Dignan. Increasing colorectal cancer screening in rural underserved communities with multilevel interventions: Formative evaluation of accelerating colorectal cancer screening and follow-up through implementation science in Appalachia [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-253.

Background and study aims Incomplete colonoscopy may occur as a result of colon angulation (adhesions or diverticulosis), endoscope looping, or both. Specialty endoscopes/devices have been shown to successfully complete prior incomplete colonoscopies, but may not be widely available. Radiographic or other image-based evaluations have been shown to be effective but may miss small or flat lesions, and colonoscopy is often still indicated if a large lesion is identified. The purpose of this study was to develop and validate an algorithm to determine the optimum endoscope to ensure completion of the examination in patients with prior incomplete colonoscopy. Patients and methods This was a prospective cohort study of 175 patients with prior incomplete colonoscopy who were referred to a single endoscopist at a single academic medical center over a 3-year period from 2012 through 2015. Colonoscopy outcomes from the initial 50 patients were used to develop an algorithm to determine the optimal standard endoscope and technique to achieve cecal intubation. The algorithm was validated on the subsequent 125 patients. Results The overall repeat colonoscopy success rate using a standard endoscope was 94 %. The initial standard endoscope specified by the algorithm was used and completed the colonoscopy in 90 % of patients. Conclusions This study identifies an effective strategy for completing colonoscopy in patients with prior incomplete examination, using widely available standard endoscopes and an algorithm based on patient characteristics and reasons for prior incomplete colonoscopy.

The societal use of genetic information raises ethical concerns, and the views of working persons regarding genetic information have received little attention. We performed an empirical project to characterize perspectives of 63 employees at two sites who expressed strong interest in learning about and protecting their personal genetic information. Genetic data were seen as more sensitive than other health data, and disclosure of genetic susceptibility was perceived as having negative consequences. This study suggests the value of exploring the perspectives of key stakeholders most directly affected by genetic applications across diverse societal settings.

This chapter reports the results of research into how frequently students perceive faculty to engage in classroom improprieties and what they tend to do about it.

Study designs involving medication-free intervals have become the subject of controversy in the current dialogue on the ethics of serious mental-illness research. Schizophrenia patients (n=59; response rate 75%; 48% inpatients) and psychiatrists (n=70; response rate 83%) responded to ten questions about a hypothetical scenario in which a schizophrenia study participant experienced the re-emergence of serious symptoms during the "wash-out" phase of a psychopharmacological trial. Patients provided their personal views, and psychiatrists gave their personal views and made predictions as to how schizophrenia patients in general would respond. Schizophrenia patients and psychiatrists judged the hypothetical protocol as moderately harmful. Both expressed relatively low likelihood of willingness to participate in the study, given this potential outcome. Schizophrenia patients and psychiatrists found the decision fairly easy. Psychiatrists underestimated the level of harm and overestimated the difficulty of the decision as perceived by schizophrenia patients. Schizophrenia patients acknowledged that the offer of money and request by their doctor or family would increase the likelihood of their participation, and psychiatrists accurately predicted these responses. In hypothetical decisions about the symptomatic study participant, 38% of patients and 39% of psychiatrists said they would allow him to leave the hospital. A majority of both groups (63% and 52%, respectively) indicated that medication should be given despite the study participant's objection. Psychiatrists incorrectly predicted this response, expecting instead that most schizophrenia patients would support the discharge request and few would support involuntary administration of medication. Patients and psychiatrists offered similar reasons for participation decisions but differed in their strategies for handling the situation. These findings suggest potential strengths of decisionally capable schizophrenia patients in assessing ethically important design elements of psychopharmacological trials. Implications for informed consent for research, expectations of the therapeutic obligations of clinical investigators, and the role of psychiatric advance directives in psychopharmacological research are outlined.

Sodium-glucose cotransporter 2 inhibitors are a new class of oral hypoglycemic agents, and thus safety data are limited. We present a 48-year-old woman with type 2 diabetes mellitus and Child’s Class A cirrhosis secondary to nonalcoholic steatohepatitis presenting with jaundice and acute cholestatic liver injury. Other than starting dapagliflozin, she reported no medication changes or supplement use. Before treatment, her total bilirubin was 1.2 mg/dL. On admission, her liver values were elevated and liver biopsy was consistent with drug-induced liver injury. This report raises awareness about the potential hepatotoxic effects of dapagliflozin, particularly in patients with chronic liver disease.

Objective Medical students experience a range of mental and physical illnesses during training and may encounter significant barriers in seeking health care. Little is known about the issues surrounding the dual role as both learner and patient when a medical student seeks care at his or her training institution. Method A confidential survey examining medical students' health care needs, practices, and concerns was administered at 9 US medical schools. One part of the survey focused on responses to 4 medical student–patient vignettes. The vignettes systematically varied preexisting student vs preexisting patient status before assuming a medical student–patient role, and the vignettes also varied illness situations that were more vs less stigmatizing. Responses were analyzed using χ 2 and multivariate analysis of variance tests. Results A total of 1027 students participated. We found that students were more likely to accept the dual role as medical student–patient in vignettes depicting a preexisting patient role than a preexisting student role. Students sought to avoid the dual role as student-patient in the context of stigmatizing health concerns. Women students were more likely than men to reject the dual role in all cases. Conclusion Medical students appear to be sensitive to the conflicts that may be associated with the dual role as both medical student and patient when seeking care at their training institution. Our data suggest the importance of substantive efforts to promote the health, interests, and well-being of medical student–patients.

Background Physician impairment is defined by the presence of a physical, mental, or substance-related disorder that interferes with the ability to practice medicine competently and safely. The seeds of impairment may be sown early in adulthood, and medical students experience health issues that may receive insufficient attention in the context of a rigorous training period. Few empirical studies have examined the attitudes of medical students toward recognizing and acting upon signs of potentially impairing illnesses in peers. Method Medical students at 9 medical schools were invited to participate in a written survey exploring personal health care issues during training. As part of this larger project, students were asked to imagine their response in 3 situations to a medical student who is discovered to have serious symptoms and potential impairment secondary to mental illness, substance abuse, or diabetes. Results Responses were gathered from 955 students (52% overall response rate). For all of the vignettes, “tell no one but encourage him/her to seek professional help” was the most prevalent reaction (45%, 53%, and 49%, respectively) as opposed to seek advice (37%, 35%, and 42%) and notify the Dean's office (18%, 12%, and 9%). Willingness to report varied by school, and women were somewhat less likely to formally report medical student illness. Conclusion This study suggests that medical students attach great importance to preserving the confidentiality of fellow medical students who may experience even very severe symptoms. This pattern may have important implications for the early recognition and treatment of potentially impairing disorders. Greater attention to these issues may help assure the health of early career physicians as well as the many patients whose safety and well-being are entrusted to their care.

Purpose Insights from genetic research may greatly improve our understanding of physical and mental illnesses and assist in the prevention of disease. Early experience with genetic information suggests that it may lead to stigma, discrimination, and other psychosocial harms, however, and this may be particularly salient in some settings, such as the workplace. Despite the importance of these issues, little is known about how healthy adults, including workers, perceive and understand ethically important issues in genetic research pertaining to physical and mental illness. Method We developed, pilot tested, and administered a written survey and structured interview to 63 healthy working adults in 2 settings. For this paper, we analyzed a subset of items that assessed attitudes toward ethically relevant issues related to participation in genetic research on physical and mental illness, such as its perceived importance, its acceptability for various populations, and appropriate motivations for participation. Results Our respondents strongly endorsed the importance of physical and mental illness genetic research. They viewed participation as somewhat to very acceptable for all 12 special population groups we asked about, including persons with mental illness. They perceived more positives than negatives in genetic research participation, giving neutral responses regarding potential risks. They affirmed many motivations for participation to varying degrees. Men tended to affirm genetic research participation importance, acceptability, and motivations more strongly than women. Conclusion Healthy working persons may be willing partners in genetic research related to physical and mental illnesses in coming years. This project suggests the feasibility and value of evidence-based ethics inquiry, although further study is necessary. Evidence regarding stakeholders' perspectives on ethically important issues in science may help in the development of research practices and policy.

Objective : To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. Method : A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. Results : Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most ( n =23) recalled speaking with someone before enrolling in the protocol, and most ( n =26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person ( n =27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most ( n =23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., “something wrong”) was discovered during the protocol. Conclusion : The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

To explore medical students' views of assisted death practices in patient cases that describe different degrees and types of physical and mental suffering, an anonymous survey was administered to all students at one medical school. Respondents were asked about the acceptability of assisted death activities in five patient vignettes and withdrawal of life support in a sixth vignette. In the vignettes, actions were performed by four possible agents: the medical student personally; a referral physician; physicians in general; or non-physicians. Of 306 medical students, 166 (54%) participated. Respondents expressed opposition or uncertainty about assisted death practices in the five patient cases that illustrated severe forms of suffering which were secondary to amyotrophic lateral sclerosis, treatment-resistant depressive and somatoform disorders, antisocial and sexually violent behavior, or AIDS. Students supported the withdrawal of life support in the sixth vignette depicting exceptional futility secondary to AIDS. Students were especially opposed to their own involvement and to the participation of non-physicians in assisted death activities. Differences in views related to sex, religious beliefs, and personal philosophy were found. Medical students do not embrace assisted death practices, although they exhibit tolerance regarding the choices of medical colleagues. How these attributes of medical students will translate into future behaviors toward patients and peers remains uncertain. Medical educators must strive to understand the perspectives of physicians-in-training. Expanded, empirically informed education that is attuned to the attitudes of medical students may be helpful in fulfilling the responsibility of imparting optimal clinical care skills.