Sustained Reduction of Elevated Intact Parathyroid Hormone Concentrations with Extended-Release Calcifediol Slows Chronic Kidney Disease Progression in Secondary Hyperparathyroidism Patients.

INTRODUCTION: Chronic kidney disease (CKD) drives onerous human and healthcare costs, underscoring an urgent need to avert disease progression. Secondary hyperparathyroidism (SHPT) develops as CKD advances, and persistently elevated parathyroid hormone (PTH) may be nephrotoxic and associated with earlier dialysis onset. This study examines, for the first time, the hypothesis that sustained reduction of elevated intact PTH (iPTH) with extended-release calcifediol (ERC) reduces the nephrotoxic impact of SHPT and forestalls renal decline. METHODS: Changes in estimated glomerular filtration rate (eGFR) were analyzed post hoc in 126 adults with SHPT, stage 3-4 CKD, and low serum 25-hydroxyvitamin D (25D) treated for 1 year with ERC in pivotal trials. ERC was administered at 30 µg/day increasing, as needed, to 60 µg/day to achieve ≥30% reductions in iPTH. Calcium, phosphorus, 25D, 1,25-dihydroxyvitamin D (1,25D), iPTH, eGFR, fibroblast growth factor-23 (FGF23), bone turnover markers (BTMs), and urine albumin-to-creatinine ratio (uACR) were measured at baseline and regular intervals. Participants were categorized by achievement (or not) of sustained ≥30% iPTH reductions over the last 2 quarters of treatment to evaluate differences in eGFR decline. RESULTS: For all participants, 25D increased 58.5 ± 2.3 (SE) ng/mL (p < 0.001) by the end of treatment (EOT), 1,25D increased 10.1 ± 1.8 pg/mL (p < 0.001), iPTH decreased from 143.8 ± 5.8 pg/mL to 108.8 ± 7.2 (p < 0.001), BTMs improved (p < 0.01), and eGFR declined 2.2 ± 0.5 mL/min/1.73 m2 (p < 0.001). The rate of eGFR decline was >5-fold higher (p = 0.014) in participants who did not achieve sustained iPTH reductions of ≥30% (3.2 ± 0.7; 12.7 ± 2.2%) than in those who did (0.6 ± 0.8; 2.9 ± 2.4%). It was highest in the 30 participants who did not exhibit an iPTH lowering response in both of the last 2 quarters of treatment (5.4 ± 0.9; 20.9 ± 3.4%). Duration of iPTH reduction had no impact on safety parameters. Degree of iPTH reduction at EOT was also associated with slower CKD progression. CONCLUSION: Sustained reduction of elevated iPTH with ERC treatment was associated with slower rates of eGFR decline in patients with SHPT and stage 3-4 CKD without raising safety concerns. A prospective trial is warranted to confirm this finding.

Exploring Competency-Based Medical Education Through the Lens of the UME-GME Transition: A Qualitative Study.

PURPOSE: Competency-based medical education (CBME) represents a shift to a paradigm with shared definitions, explicit outcomes, and assessments of competence. The groundwork has been laid to ensure all learners achieve the desired outcomes along the medical education continuum using the principles of CBME. However, this continuum spans the major transition from undergraduate medical education (UME) to graduate medical education (GME) that is also evolving. This study explores the experiences of medical educators working to use CBME assessments in the context of the UME-GME transition and their perspectives on the existing challenges. METHOD: This study used a constructivist-oriented qualitative methodology. In-depth, semistructured interviews of UME and GME leaders in CBME were performed between February 2019 and January 2020 via Zoom. When possible, each interviewee was interviewed by 2 team members, one with UME and one with GME experience, which allowed follow-up questions to be pursued that reflected the perspectives of both UME and GME educators more fully. A multistep iterative process of thematic analysis was used to analyze the transcripts and identify patterns across interviews. RESULTS: The 9 interviewees represented a broad swath of UME and GME leadership positions, though most had an internal medicine training background. Analysis identified 4 overarching themes: mistrust (a trust chasm exists between UME and GME); misaligned goals (the residency selection process is antithetical to CBME); inadequate communication (communication regarding competence is infrequent, often unidirectional, and lacks a shared language); and inflexible timeframes (current training timeframes do not account for individual learners' competency trajectories). CONCLUSIONS: Despite the mutual desire and commitment to move to CBME across the continuum, mistrust, misaligned goals, inadequate communication, and inflexible timeframes confound such efforts of individual schools and programs. If current efforts to improve the UME-GME transition address the themes identified, educators may be more successful implementing CBME along the continuum.

Evaluation of an Individualized Learning Plan Template for the Transition to Residency.

Background Specialty-specific individualized learning plans (ILPs) have been promoted to improve the undergraduate to graduate medical education transition, yet few pilots have been described. Objective To create and report on the feasibility and acceptability of a pilot internal medicine (IM) ILP template. Methods The ILP was created by a group of diverse IM expert stakeholders and contained questions to stimulate self-reflection and collect self-reported readiness data from incoming interns. US IM residency programs were invited to pilot the ILP with interns in spring 2022. Data was used at the programs' discretion. The pilot was evaluated by a post-pilot survey of programs to elicit perceptions of the impact and value of the ILP and analyze anonymous ILP data from 3 institutions. Results Fifty-two IM residency programs agreed to participate with a survey response rate of 87% (45 of 52). Of responding programs, 89% (40 of 45) collected ILPs, thus we report on data from these 40 programs. A total of 995 interns enrolled with 782 completing ILPs (79%). One hundred eleven ILPs were analyzed (14%). Most programs found the ILP valuable to understand incoming interns' competencies (26 of 40, 65%) and areas for improvement (24 of 40, 60%) and thought it should continue (29 of 40, 73%). Programs estimated the ILP took interns 29.2±14.9 minutes and 21.6±10.3 minutes for faculty mentors to complete. The most common barrier was faculty mentor participation. Conclusions An ILP based on interns' self-reported data was feasible and valuable to IM residency programs in understanding interns' competencies and areas for improvement.

REsCue trial: Randomized controlled clinical trial with extended-release calcifediol in symptomatic COVID-19 outpatients.

OBJECTIVES: This double-blind randomized controlled trial investigated raising serum 25-hydroxyvitamin D (25D) with extended-release calcifediol (ERC) on time to symptom resolution in patients with mild to moderate COVID-19. METHODS: COVID-19 outpatients received oral ERC (300 mcg on days 1-3 and 60 mcg on days 4-27) or placebo (NCT04551911). Symptoms were self-reported daily. Primary end points were raising 25D to ≥50 ng/mL and decreasing resolution time for five aggregated symptoms (three respiratory). RESULTS: In all, 171 patients were randomized, 160 treated and 134 (65 ERC, 69 placebo) retained. The average age was 43 y (range 18-71), 59% were women. The mean baseline 25D was 37 ± 1 (SE) ng/mL. In the full analysis set (FAS), 81% of patients in the ERC group achieved 25D levels of ≥50 ng/mL versus 15% in the placebo group (P < 0.0001). In the per-protocol (PP) population, mean 25D increased with ERC to 82 ± 4 (SE) ng/mL (P < 0.0001) by day 7; the placebo group trended lower. Symptom resolution time was unchanged in the FAS by ERC (hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.695-1.390; P = 0.922). In the PP population, respiratory symptoms resolved 4 d faster when 25D was elevated above baseline level at both days 7 and 14 (median 6.5 versus 10.5 d; HR, 1.372; 95% CI, 0.945-1.991; P = 0.0962; Wilcoxon P = 0.0386). Symptoms resolved in both treatment groups to a similar extent by study end. Safety concerns including hypercalcemia were absent with ERC treatment. CONCLUSION: ERC safely raised serum 25D to ≥50 ng/mL in outpatients with COVID-19, possibly accelerating resolution of respiratory symptoms and mitigating the risk for pneumonia. These findings warrant further study.

Competency-Based Medical Education in the Internal Medicine Clerkship: A Report From the Alliance for Academic Internal Medicine Undergraduate Medical Education Task Force.

As medical educators continue to redefine learning and assessment across the continuum, implementation of competency-based medical education in the undergraduate setting has become a focus of many medical schools. While standards of competency have been defined for the graduating student, there is no uniform approach for defining competency expectations for students during their core clerkship year. The authors describe the process by which an Alliance for Academic Internal Medicine task force developed a paradigm for competency-based assessment of students during their inpatient internal medicine (IM) clerkship. Building on work at the resident and fellowship levels, the task force focused on the development of key learning outcomes as defined by entrustable professional activities (EPAs) that were specific to educational experiences on the IM clerkship, as well as identification of high-priority assessment domains. The work was informed by a national survey of clerkship directors.Six key EPAs emerged: generating a differential diagnosis, obtaining a complete and accurate history and physical exam, obtaining focused histories and clinically relevant physical exams, preparing an oral presentation, interpreting the results of basic diagnostic studies, and providing well-organized clinical documentation. A model for assessment was proposed, with descriptors aligned to the scale of supervision and mapped to Accreditation Council for Graduate Medical Education domains of competence. The proposed paradigm offers a standardized template that may be used across IM clerkships, and which would effectively bridge competency evaluation in the clerkship to fourth-year assessment as well as eventual postgraduate training.

Urinary Catheter Management for Nonurologists: A Resident Driven Educational Initiative.

INTRODUCTION: Prevention of catheter associated urinary tract infection relies on timely catheter removal and care of indwelling catheters. Educational and quality improvement initiatives to prevent catheter associated urinary tract infection should address the basics of urinary catheter placement and management. Internal medicine residents are an appropriate target for these efforts and they may lack formal training in these issues. We developed a resident driven orientation session that covers basic Foley catheter management principles called the TIPS (Troubleshooting, Indications and Practice Sessions) program. METHODS: Urology residents at our institution were queried on common consultations for urinary catheter related issues. The incoming intern internal medicine class at our institution completed a pre-TIPS survey that evaluated their baseline urological experience and knowledge. A 1-hour didactic session led by urology residents was followed by hands-on directed practice with mannequins. The web based survey was repeated 1 month later. RESULTS: Of the total of 60 residents 54 (90%) completed the initial survey. In medical school 38 of 54 residents (70%) had never rotated in urology. Upon repeating the survey at 1 month the response rate was 34 of 60 residents (57%). The proportion of residents confident in their ability to troubleshoot catheter problems increased from 50% to 88% (p <0.05). Knowledge of indications, clot retention and proper catheter technique also improved (p <0.05). CONCLUSIONS: A focused educational session about common urological catheter management scenarios resulted in improved internal medicine resident confidence in catheter troubleshooting and knowledge of basic urinary catheter placement indications. These educational sessions may be a method to improve nonurology resident education and awareness of common urological issues.

Shortening the Miles to the Milestones: Connecting EPA-Based Evaluations to ACGME Milestone Reports for Internal Medicine Residency Programs.

The Next Accreditation System requires internal medicine training programs to provide the Accreditation Council for Graduate Medical Education (ACGME) with semiannual information about each resident's progress in 22 subcompetency domains. Evaluation of resident "trustworthiness" in performing entrustable professional activities (EPAs) may offer a more tangible assessment construct than evaluations based on expectations of usual progression toward competence. However, translating results from EPA-based evaluations into ACGME milestone progress reports has proven to be challenging because the constructs that underlay these two systems differ.The authors describe a process to bridge the gap between rotation-specific EPA-based evaluations and ACGME milestone reporting. Developed at the University of Washington in 2012 and 2013, this method involves mapping EPA-based evaluation responses to "milestone elements," the narrative descriptions within the columns of each of the 22 internal medicine subcompetencies. As faculty members complete EPA-based evaluations, the mapped milestone elements are automatically marked as "confirmed." Programs can maintain a database that tallies the number of times each milestone element is confirmed for a resident; these data can be used to produce graphical displays of resident progress along the internal medicine milestones.Using this count of milestone elements allows programs to bridge the gap between faculty assessments of residents based on rotation-specific observed activities and semiannual ACGME reports based on the internal medicine milestones. Although potentially useful for all programs, this method is especially beneficial to large programs where clinical competency committee members may not have the opportunity for direct observation of all residents.

Pap smear receipt among Vietnamese immigrants: the importance of health care factors.

OBJECTIVE: Recent US data indicate that women of Vietnamese descent have higher cervical cancer incidence rates than women of any other race/ethnicity, and lower levels of Pap testing than white, black, and Latina women. Our objective was to provide information about Pap testing barriers and facilitators that could be used to develop cervical cancer control intervention programs for Vietnamese American women. DESIGN: We conducted a cross-sectional, community-based survey of Vietnamese immigrants. Our study was conducted in metropolitan Seattle, Washington, DC. A total of 1532 Vietnamese American women participated in the study. Demographic, health care, and knowledge/belief items associated with previous cervical cancer screening participation (ever screened and screened according to interval screening guidelines) were examined. RESULTS: Eighty-one percentage of the respondents had been screened for cervical cancer in the previous three years. Recent Pap testing was strongly associated (p<0.001) with having a regular doctor, having a physical in the last year, previous physician recommendation for testing, and having asked a physician for testing. Women whose regular doctor was a Vietnamese man were no more likely to have received a recent Pap smear than those with no regular doctor. CONCLUSION: Our findings indicate that cervical cancer screening disparities between Vietnamese and other racial/ethnic groups are decreasing. Efforts to further increase Pap smear receipt in Vietnamese American communities should enable women without a source of health care to find a regular provider. Additionally, intervention programs should improve patient-provider communication by encouraging health care providers (especially male Vietnamese physicians serving women living in ethnic enclaves) to recommend Pap testing, as well as by empowering Vietnamese women to specifically ask their physicians for Pap testing.

Development of intervention materials for individuals with limited English proficiency: lessons learned from "Colorectal Cancer Screening in Chinese Americans".

BACKGROUND: According to recent US census data, 52 million people reported speaking a language other than English at home, and almost 45% of this population reported limited English proficiency (LEP). Colorectal cancer (CRC) ranks among the top 3 most common cancers for several Asian ethnic groups, yet screening remains underutilized by Asian Americans. OBJECTIVES: This article describes the development of culturally and linguistically appropriate intervention materials for individuals with LEP. We discuss lessons learned from this research and implications for the translation of research into practice. METHODS: The Health Behavior Framework served as the conceptual model for this study, and qualitative findings guided the development of our intervention materials (a video and pamphlet). To recommend Western preventive behaviors, the research team bridged the gap between Western and Chinese values and beliefs by devoting particular attention to: (1) the target population's sociocultural values and health beliefs; and (2) unique linguistic features of the Chinese language. RESULTS: Key lessons learned from this study include the importance of: (1) a conceptual framework to guide intervention development; (2) incorporating sociocultural values and health beliefs into the intervention; (3) addressing and capitalizing on complex linguistics issues; (4) using qualitative methodology in cross-cultural research; and (5) contributions from a multicultural and multilingual research team. Other lessons relate to the translation of research findings into practice. We surmise that lessons learned from this study may be pertinent to the promotion of CRC screening among other patient groups with LEP and applicable to additional cancer screening tests.

Impact of cyclooxygenase inhibitors in the Women's Health Initiative hormone trials: secondary analysis of a randomized trial.

OBJECTIVES: We evaluated the hypothesis that cyclooxygenase (COX) inhibitor use might have counteracted a beneficial effect of postmenopausal hormone therapy, and account for the absence of cardioprotection in the Women's Health Initiative hormone trials. Estrogen increases COX expression, and inhibitors of COX such as nonsteroidal anti-inflammatory agents appear to increase coronary risk, raising the possibility of a clinically important interaction in the trials. DESIGN: The hormone trials were randomized, double-blind, and placebo-controlled. Use of nonsteroidal anti-inflammatory drugs was assessed at baseline and at years 1, 3, and 6. SETTING: The Women's Health Initiative hormone trials were conducted at 40 clinical sites in the United States. PARTICIPANTS: The trials enrolled 27,347 postmenopausal women, aged 50-79 y. INTERVENTIONS: We randomized 16,608 women with intact uterus to conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily or to placebo, and 10,739 women with prior hysterectomy to conjugated estrogens 0.625 mg daily or placebo. OUTCOME MEASURES: Myocardial infarction, coronary death, and coronary revascularization were ascertained during 5.6 y of follow-up in the estrogen plus progestin trial and 6.8 y of follow-up in the estrogen alone trial. RESULTS: Hazard ratios with 95% confidence intervals were calculated from Cox proportional hazard models stratified by COX inhibitor use. The hazard ratio for myocardial infarction/coronary death with estrogen plus progestin was 1.13 (95% confidence interval 0.68-1.89) among non-users of COX inhibitors, and 1.35 (95% confidence interval 0.86-2.10) among continuous users. The hazard ratio with estrogen alone was 0.92 (95% confidence interval 0.57-1.48) among non-users of COX inhibitors, and 1.08 (95% confidence interval 0.69-1.70) among continuous users. In a second analytic approach, hazard ratios were calculated from Cox models that included hormone trial assignment as well as a time-dependent covariate for medication use, and an interaction term. No significant interaction was identified. CONCLUSIONS: Use of COX inhibitors did not significantly affect the Women's Health Initiative hormone trial results.

Hepatitis B knowledge and practices among Chinese immigrants to the United States.

INTRODUCTION: Chinese immigrants to the United States experience high rates of liver cancer. Chronic carriage of hepatitis B virus (HBV) is the most common underlying cause of liver cancer among Chinese Americans. Our objective was to describe Chinese immigrants' hepatitis B knowledge, testing, and vaccination levels. METHODS: A community-based, in-person survey of Chinese men and women was conducted in Seattle during 2005. Our study sample included 395 individuals. RESULTS: Less than one-half (48%) of our study group indicated they had received a hepatitis B blood test, and about one-third (31%) indicated they had been vaccinated against hepatitis B. The proportions of respondents who knew HBV can be spread during childbirth, during sexual intercourse, and by sharing razors were 70%, 54%, and 55%, respectively. Less than one-quarter of the study group knew that HBV cannot be spread by eating food that was prepared by an infected person (23%) and by sharing eating utensils with an infected person (16%). DISCUSSION: Over 50% of our respondents did not recall being tested for HBV. Important knowledge deficits about routes of hepatitis B transmission were identified. Continued efforts should be made to develop and implement hepatitis B educational campaigns for Chinese immigrant communities.

Health care access and sociodemographic factors associated with hepatitis B testing in Vietnamese American men.

Chronic hepatitis B viral (HBV) infection greatly increases the risk for cirrhosis and hepatocellular carcinoma. HBV serologic testing is important for the identification of chronically infected individuals, who may benefit from antiviral treatment and regular monitoring for disease sequelae. Elevated rates of cirrhosis and hepatocellular carcinoma among Vietnamese American men can largely be attributed to high rates of chronic HBV infection. We surveyed 509 Vietnamese men aged 18-64 years in Seattle, Washington and examined sociodemographic and health care access factors associated with HBV serology testing. Nearly two-thirds (65%) reported past testing. The following were among those factors associated with HBV testing in bivariate comparisons: older age; short proportion of life in the US; low English fluency; private health insurance; identifying a regular source of medical care; reporting no long waits for medical appointments; and having access to interpreter services. The following were independently associated with HBV testing in multiple logistic regression analysis: older age; college education; low English fluency; private health insurance; having a regular medical provider; and reporting no long waits for medical appointments. Younger and less educated men, and those with difficulty accessing medical care may be at particular risk for never having had HBV testing. Programs to reduce HBV transmission and sequelae should make special effort to target these vulnerable Vietnamese Americans.

Lay beliefs about hepatitis among North American Chinese: implications for hepatitis prevention.

The objective was to learn about the hepatitis prevention behavior of relatively unacculturated North American Chinese adults, along with their knowledge, beliefs, and perceptions with regard to hepatitis, screening, and vaccination. Forty Chinese men and women, aged 18-64, were recruited from immigrant communities in Seattle, Washington, and Vancouver, British Columbia. Semi-structured interviews (Cantonese or Mandarin) were audiotaped, translated, transcribed verbatim, and coded. Open coding, axial coding, constant comparison methods, and QSR NUD*IST 5 software was used for analysis. Findings were validated using eight focus groups. Findings indicated that many interviewees lack accurate knowledge with regard to hepatitis, often confusing the different types. Perceived causes of hepatitis included potentially harmful food (e.g., fried foods or potentially contaminated foods), alcohol, contact with infected individuals, stress, and inadequate rest. Preventive strategies associated with Chinese health beliefs included the use of Chinese herbal medicine, maintaining a stress-free mind, strengthening the body's natural defenses, and getting enough sleep. Other preventive strategies were the practice of good hygiene, vaccination, and the avoidance of contact with infected persons. Vaccination was not seen as primary, as 65% of those who had heard of hepatitis vaccination did not cite it as a means for hepatitis prevention until asked. Also, participants lacked information about the types and purposes of hepatitis vaccination and were worried about side effects. In conclusion, any attempt to promote hepatitis testing and vaccination among the North American Chinese should take traditional beliefs and practices into consideration.