A framework and process for community-engaged, mixed-methods cancer needs assessments.

PURPOSE: Community health needs assessments are required for most state and local public health agencies and non-profit hospitals. Typically based on community health improvement planning models, these assessments encompass overall community health and multiple diseases to inform program planning. National Cancer Institute (NCI)-designated Cancer Centers and community-based cancer-focused programs share the goal of reducing cancer burden in the catchment areas they serve. However, to date, no published models exist to guide cancer-specific needs assessments for a determined geographic area that can inform both public health and research initiatives. The purpose of this article is to outline a cancer needs assessment (CNA) framework and community-engaged, mixed-methods process, along with a case study of how we applied it in Kentucky. METHODS: We convened a steering committee of key organizational partners to provide input throughout the process. We developed a conceptual framework of multi-level determinants affecting cancer-related outcomes. We incorporated both quantitative and qualitative data gathered through a variety of means, including a novel application of group concept mapping to guide definition of priorities. RESULTS: The resulting CNA has helped guide strategic planning and priorities for Kentucky's Cancer Action Plan, Markey Cancer Center, state agencies, and community-based organizations. CONCLUSION: This framework and process can be used collaboratively by cancer center Community Outreach and Engagement offices, public health agencies, oncology programs, and community partners to plan impactful cancer control programs and research in their catchment areas. Universities can also use them to inform the planning of community engagement and health equity research efforts.

Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial.

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.

We conducted a multi-site study to evaluate and improve CRC screening processes using implementation science strategies at multiple levels including the patient, provider, health center, and community. Our goals were to increase rates of guideline-recommended CRC screening, follow-up, and referral-to-care in an Appalachian, medically underserved population.

Building Cancer Prevention and Control Research Capacity in Rural Appalachian Kentucky Primary Care Clinics During COVID-19: Development and Adaptation of a Multilevel Colorectal Cancer Screening Project.

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.

Development of a multilevel intervention to increase colorectal cancer screening in Appalachia.

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.

Exocrine pancreatic insufficiency in distal pancreatectomy: incidence and risk factors.

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 < 0.001) significantly predicted development of de-novo EPI. 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.

Reevaluation of the body mass estimate for the KNM-ER 5428 Homo erectus talus.

OBJECTIVES: In this study, we reexamined the body mass estimate for the Homo erectus specimen KNM-ER 5428 based on talus dimensions. Previous estimates of >90 kg for this fossil are large in comparison to body mass estimates for other H. erectus specimens. MATERIALS AND METHODS: The study sample consisted of tali and femora of 132 modern cadaver males from a documented body mass skeletal collection. We recorded the talus trochlear mediolateral (TTML) breadth and femoral head diameter (FHD) for each modern human specimen, and obtained KNM-ER 5428's TTML values from the literature. We developed regression formulae based on TTML using the body mass estimated from FHD for the entire human sample and for known body masses from a normal-BMI subsample, and then used these formulae to calculate body mass for KNM-ER 5428. In addition, we examined the range of body masses for individuals with TTML measurements comparable to KNM-ER 5428. RESULTS: The body masses of normal-BMI individuals with a TTML ≥32.3 mm (the smaller of the two fossil measurements from the literature) ranged between 60.3 and 86.2 kg and averaged 72.3 kg. The body masses of normal-BMI individuals with a TTML ≥33.7 mm (the larger measurement) ranged between 63.5 and 86.2 kg with a mean of 73.6 kg. The correlations between TTML and body mass are moderate. Revised body mass point estimates for KNM-ER 5428 ranged between 69.2 and 81.6 kg based on TTML, and average 70.5 and 76.0 kg. DISCUSSION: Results suggest previously published body mass estimates of KNM-ER 5428's are too large. Its body mass was likely between 70 and 76 kg rather than >90 kg.

Outcomes of endoscopic treatment of leaks and fistulae after sleeve gastrectomy: results from a large multicenter U.S. cohort.

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.

Development and validation of an algorithm to complete colonoscopy using standard endoscopes in patients with prior incomplete colonoscopy.

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.

Dapagliflozin-Induced Acute-on-Chronic Liver Injury.

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.

Medical students as patients: implications of their dual role as explored in a vignette-based survey study of 1027 medical students at nine medical schools.

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.

Medical student illness and impairment: a vignette-based survey study involving 955 students at 9 medical schools.

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.

Perspectives on use and protection of genetic information in work settings: results of a preliminary study.

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.

Employees' perspectives on ethically important aspects of genetic research participation: a pilot study.

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.

Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

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.

Schizophrenia patients' and psychiatrists' perspectives on ethical aspects of symptom re-emergence during psychopharmacological research participation.

RATIONALE: Study designs involving medication-free intervals have become the subject of controversy in the current dialogue on the ethics of serious mental-illness research. METHODS: 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. RESULTS: 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. CONCLUSION: 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.