Catholic Medical Research Articles

Real-world eligibility and cost-effectiveness analysis for empagliflozin in patients with heart failure

Abstract Background/Introduction Empagliflozin was approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for reducing cardiovascular mortality and heart failure (HF) hospitalization in both patients with HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). Purpose Limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and cost-effectiveness based on a nationwide prospective HF registry. Methods For the study, 3108 HFrEF and 2070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analysed. Eligibility was estimated by FDA and EMA label criteria and by inclusion and exclusion criteria of EMPEROR-Reduced and EMPEROR-Preserved trials. The cost-effectiveness analysis was performed using the decision tree model, where effectiveness was the avoidance of the first hospitalization. Results Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The main factor for exclusion in the clinical trial-based empagliflozin eligibility was low systolic blood pressure, including 18.7% of HFrEF and 11.0% of HFpEF patients. Other factors were acute (<4 weeks) myocardial infarction and impaired renal function (eGFR <20 mL/min/1.73 m2 or requiring dialysis). The overall expected hospitalization rate and cost reduction were 3.6 and US$ 14,885 per 100 eligible HF patients per year. In HFrEF patients, hospitalization rate and cost reduction were 4.8 and US$ 28,442. However, in HFpEF, the cost was increased by US$ 7,576, while hospitalization reduction was 1.7. Conclusion(s) There is a large discrepancy of real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. The cost-effectiveness benefit was more evident in patients with HFrEF than HFpEF. The efficacy and safety of empagliflozin in real-world patients should be further investigated for a broader range of clinical applications. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Minister of Science and Information and Communication Technologies (NRF-2021R1F1A1063430), by the Catholic Medical Center Research Foundation (2022), and by the Research of Korea Centers for Disease Control and Prevention (2010-E63003-00, 2011-E63002-00, 2012-E63005-00, 2013-E6300300, 2014-E63003-01, 2015-E63003-02, 2016-ER6303-00, and 2017-ER6303-01).

Community Health Agents Advancing Women’s Empowerment: A Qualitative Data Analysis

Community health agents (CHAs) play a critical role in primary healthcare delivery and health promotion in low-resource settings. Though there is substantial evidence of the benefits of CHAs in achieving targeted community health outcomes, there is limited research into the impact of empowerment experienced by CHAs themselves. This study examined how working as a CHA impacts the lives and self-perceptions of women in Peru volunteering with Catholic Medical Mission Board’s (CMMB) markedly successful robust CHA model. We conducted six focus group discussions (FGDs) of 53 CHAs who implement CMMB programming in Trujillo and Huancayo, Peru. The FGDs were designed to explore themes related to empowerment, changes in women’s lives, and perceptions of themselves. We identified four major themes related to women’s empowerment: achievements, agency, meaningfulness, and resources. The most common empowerment theme was achievements, expressed through subthemes of changes in family behavior, self worth, education, health and nutrition, and rights and politics. The second most common empowerment theme was agency, with subthemes related to increases in using their voice, confidence, decision making, and participation. CHAs also reported experiencing empowerment through enhanced meaningfulness. CMMB’s CHA model is an example of how well-structured community programs can facilitate women’s empowerment. Providing meaningful community leadership opportunities can have far-reaching effects on women’s perceptions of themselves as valuable, capable, and empowered leaders. This work deepens our understanding of how to practically improve community health through empowering women to catalyze gender equality in communities with disproportionate barriers and limited opportunities burdening them.

Finding Joy in Being Counter-cultural: Lessons for Catholic Medical Professionals.

Catholic medical professionals face increasing challenges to adhering to the faith in the exercise of their professional functions. Growing opposition to traditional Church teaching-particularly with regard to issues of human sexuality and end-of-life care-threaten faithful Catholic clinicians with a form of "white martyrdom," characterized by loss of professional standing. Threats to rights of conscience come from various segments of contemporary society, including professional medical societies and publications that increasingly resemble strident activists rather than dispassionate and measured consensus-builders. Reflection on the relationship between counter-culturalism and joy can be a source of strength for those Catholic physicians facing opposition based on their adherence to the faith in their practice. A review of the historical developments of Christian medicine highlights its counter-cultural stance in contrast to the ancient Greco-Roman traditions that preceded it. Counter-cultural figures such as Ss. Cosmas and Damian, St Basil, and St Philip Neri serve as examples of courageous Christian counter-cultural witnesses in their times. Additionally, St Philip Neri's cheerful ministry in Rome also exemplifies Christian joy as a means of evangelizing in the midst of a culture in decline (as was the Eternal City in the 16th century). The lives of saints who suffered for the Faith remind us that being counter-cultural has consequences. While being called to "speak the truth in love" (Ephesians 4:15), Catholic medical professionals are to show compassion in words and actions as the singular signs of a faithful Christian.

The Catholic Medical Association Should Officially Oppose the Utilization of Neurologic Criteria to Determine Death in Clinical Practice.

The Catholic Medical Association Should Officially Oppose the Utilization of Neurologic Criteria to Determine Death in Clinical Practice.

Outcomes from LDCT screening for lung cancer in an undeserved population: A quality initiative.

e13504 Background: Lung cancer is the leading cause of cancer-related mortality worldwide. USPSTF recommends annual lung cancer screening with low dose computed tomography (LDCT) for adults aged 50-80 years with 20-pack year smoking history and are currently smoking or have quit within the past 15 years. Unfortunately, adherence rates with screenings remain suboptimal. This study aimed to assess the compliance rates with LDCT recommendations in a community hospital and propose an implementation plan to enhance patient adherence. Methods: A retrospective study was conducted by analyzing the medical charts of 1090 patients who underwent LDCT screenings at Mercy Catholic Medical Center between January 2018 and June 2021. Medical records were reviewed to determine whether patients had appropriate follow-ups done based on the LUNG-RADs category with focus on those with higher LUNG-RADs designations. A survey was administered to current internal medicine residents to evaluate their understanding of screening guidelines. Based on the survey results and literature review, a plan to enhance adherence with screenings is proposed. Results: Total 1090 patients underwent LDCT screenings, comprising of 522 males and 568 females. 166 patients were assigned LUNG-RADs category 3, 4A, 4B, or 4X. Amongst these 166 patients, compliance rate with recommended follow-up imaging and/or biopsies was only 51.2% (95% confidence interval [CI], 44.0-59.0). 15% of patients had biopsies that were positive for malignancies. 70% of the residents participated in the survey. Only 57% demonstrated knowledge of the recommended age group for screening; only 47% knew the pack-year criteria for screening. Questions gauging the understanding of when to stop screening, implications of imaging findings, and estimated mortality reduction from LDCT screenings underscored the knowledge gap amongst physicians as a factor needing improvement. Conclusions: This study comprised of a patient population primarily from poor socioeconomic and educational background. Therefore, many of the patients in this study may not have fully comprehended the LDCT implications solely from receiving a letter with radiology impressions, leading to the high non-compliance rate observed. To enhance follow-ups, residents should be educated on LDCT screening indications and benefits so they can promote patient health better. After receiving LDCT results, providers should inform patients about the findings either via phone calls or in-person office visits and emphasize the importance of specific follow-ups. We propose the appointment of a designated coordinator to call patients who failed to follow-up to re-emphasize the importance and identify barriers to adherence (i.e., transportation, cost). Studies found an increase in adherence to screening from 22% to 66% after hiring a coordinator. Adherence rates can, thus, be improved by a collaborative team approach.

Risk factors and clinical impact of COVID-19-associated pulmonary aspergillosis: Multicenter retrospective cohort study.

Background/AimsThe risk factors and clinical impacts of coronavirus disease 2019 (COVID-19)-associated pulmonary aspergillosis (CAPA) remain controversial, and no data have been reported in Korea. This study aimed to investigate the epidemiology and importance of CAPA diagnostic efforts and to identify the predictors of CAPA and the impacts on clinical outcomes.MethodsBetween January 2020 and May 2021, data of severely to critically ill COVID-19 patients were extracted from seven hospitals of the Catholic Medical Center through a clinical data warehouse. Corticosteroid use was subcategorized into total cumulative dose, early 7-day dose, mean daily dose, and duration of use.ResultsA total of 2,427 patients were screened, and 218 patients were included. CAPA was diagnosed in 4.6% (10/218) of all hospitalized and 11.2% (10/89) of intensive care unit patients. Total cumulative dose (over 1,000 mg as methylprednisolone) and daily high-dose corticosteroid use (over 60 mg/day) were independent predictors but not early 7-day high-dose corticosteroid use (over 420 mg/week) (odds ratio [OR], 1.731; 95% confidence interval [CI], 0.350 to 8.571) nor prolonged use (OR, 2.794; 95% CI, 0.635 to 13.928). In-hospital overall mortality was 11.9% (26 of 218). CAPA itself did not affect the outcome; rather, daily high-dose steroid use significantly increased the 30-day mortality (hazard ratio, 5.645; 95% CI, 1.225 to 26.091).ConclusionsCAPA was not uncommon, especially in critically ill patients. Daily high-dose corticosteroid use was the predictor of CAPA and associated with high mortality rates. High-dose corticosteroids use after early inflammatory phase should be avoided, and active surveillance methods for CAPA are essential for those high-risk patients.

Conscience: Position Paper of the Catholic Medical Association.

Conscience: Position Paper of the Catholic Medical Association.

Pre-Exposure Prophylaxis for HIV (PrEP): Position Paper of the Catholic Medical Association.

Pre-Exposure Prophylaxis for HIV (PrEP): Position Paper of the Catholic Medical Association.

Erectile Dysfunction (ED) Treatment: Position Paper of the Catholic Medical Association.

Erectile Dysfunction (ED) Treatment: Position Paper of the Catholic Medical Association.

Long-term outcomes of rectal neuroendocrine tumors according to the risk after endoscopic resection: A multicenter study.

505 Background: The detection of rectal neuroendocrine tumors has increased with advances in diagnostic endoscopy. Endoscopic resection (ER) is highly effective treatment option for small rectal neuroendocrine tumors (NETs) confined to submucosa. However, there was no risk classification for evaluating the clinical outcomes. In this study, we analyzed long-term outcomes of rectal neuroendocrine tumors after ER. Methods: In this multicenter retrospective study, we analyzed the medical records of patients who underwent ER of rectal NETs from 2009 to 2018 and were followed for ≥ 12 months at five university hospitals under the Catholic Central Medical Center in Korea. Data were collected through Catholic Medical Center Clinical Data Warehouse. We classified patients into three risk groups (low, intermediate, an high) according to clinicopathologic status of rectal NETs. The high-risk group was defined if the tumors have any of the followings: size ≥ 10mm, lymphovascular invasion, muscularis propria or deeper invasion, positive resection margins, or mitotic count ≥ 2/10. Results: A total of 346 patients were included in our study, with 144 (41.6%), 121 (35.0%), and 81 (23.4%) patients in the low-, intermediate-, and high-risk groups, respectively. Among the high-risk group, only seven patients (7/81, 8.6%) received salvage treatment at 2.1 ± 4.1 months after initial treatment. Of them, three patients underwent endoscopic submucosal dissection and the other four patients underwent surgery. There was no extracolonic metastasis in all 7 patients. During follow-up period of all included patients, although there was no local recurrence, four patients (4/346, 1.1%) had extracolonic metastasis (2 liver, 2 perirectal lymph node) at 70.5 ± 33.9 months after initial treatment. Three of them (75%) were high-risk patients without salvage treatment. The risk of extracolonic metastasis is significantly higher in the high-risk group compared with the others (P=0.041, Fisher exact test). Conclusions: Although the prognosis of the patients who underwent ER of rectal NETs showed favorable outcomes, physicians should be concerned with the possibility of metastasis during long-term follow-up of high-risk patients and consider salvage treatment.

Intraperitoneal Triamcinolone Reduces Postoperative Adhesions, Possibly through Alteration of Mitochondrial Function.

Adhesions frequently occur postoperatively, causing morbidity. In this noninterventional observational cohort study, we enrolled patients who presented for repeat abdominal surgery, after a history of previous abdominal myomectomy, from March 1998 to June 20210 at St. Vincent’s Catholic Medical Centers. The primary outcome of this pilot study was to compare adhesion rates, extent, and severity in patients who were treated with intraperitoneal triamcinolone acetonide during the initial abdominal myomectomy (n = 31) with those who did not receive any antiadhesion interventions (n = 21), as documented on retrospective chart review. Adhesions were blindly scored using a standard scoring system. About 32% of patients were found to have adhesions in the triamcinolone group compared to 71% in the untreated group (p < 0.01). Compared to controls, adhesions were significantly less in number (0.71 vs. 2.09, p < 0.005), severity (0.54 vs. 1.38, p < 0.004), and extent (0.45 vs. 1.28, p < 0.003). To understand the molecular mechanisms, human fibroblasts were incubated in hypoxic conditions and treated with triamcinolone or vehicle. In vitro studies showed that triamcinolone directly prevents the surge of reactive oxygen species triggered by 2% hypoxia and prevents the increase in TGF-β1 that leads to the irreversible conversion of fibroblasts to an adhesion phenotype. Triamcinolone prevents the increase in reactive oxygen species through alterations in mitochondrial function that are HIF-1α-independent. Controlling mitochondrial function may thus allow for adhesion-free surgery and reduced postoperative complications.

Catholic Medical Association Endorses Appropriate Documentation at the Time of Birth.

Catholic Medical Association Endorses Appropriate Documentation at the Time of Birth.

Clinicopathological features and management strategy for superficial nonampullary duodenal tumors: a multi-center retrospective study.

PurposeWe investigated the clinicopathological features and management for superficial nonampullary duodenal tumors (SNADTs). The safety and feasibility of laparoscopic management, especially laparoscopic endoscopic cooperative surgery (LECS), were evaluated.MethodsA total of 59 patients with SNADTs who underwent operations from January 2009 to December 2018 at all 8 institutions of the Catholic Medical Center were identified in our comprehensive multi-institutional database. Clinicopathological and surgical data on the 4 anatomical regions of the duodenum were collected and compared. Characteristics of conventional laparoscopic procedure (laparoscopy-only) and LECS procedures were also compared.ResultsThere were significantly more asymptomatic patients with tumors in the first and second vs. third and fourth duodenal regions. Gastrointestinal stromal tumors (GISTs), carcinoids, and ectopic pancreatic tumors were identified in 32, 12, and 5 cases, respectively. Forty-two patients (71.2%) underwent laparoscopy. Of patients undergoing laparoscopy, the LECS group exhibited significantly more endophytic features and smaller tumor sizes (P < 0.001 and P < 0.001, respectively). Although no significant difference in the wedge resection or postoperative complication rate was seen between the 2 groups (P = 0.096 and P = 0.227, respectively), the wedge resection rate was higher, and the complication rate lower, in the LECS group than the conventional laparoscopic surgery group.ConclusionMost of the SNADTs located in proximal duodenum were detected incidentally. GISTs were the most common diagnoses of SNADTs in all locations. In treating these tumors, laparoscopic resection is safe and feasible. Especially, LECS may be ideal for treating small endophytic tumors, minimizing over-resection and postoperative complications.

Factors Predicting Worse Outcomes in an Asian Cohort of Patients With Bronchiectasis.

Bronchiectasis has long been neglected, unlike chronic obstructive pulmonary disease (COPD) and asthma. Recent clinical trials have shown that long-term use of azithromycin or erythromycin reduce exacerbations of non-cystic fibrosis (non-CF) bronchiectasis. Because of this, we should actively try to treat patients susceptible to severe status. We enrolled patients who had been diagnosed with bronchiectasis at five branches of the Catholic Medical Center between January 2015 to December 2017. We retrospectively analyzed these patients for demographic characteristics such as sex, age, body mass index (BMI), history of smoking and tuberculosis, bacterial colonization, pulmonary function, hospitalizations, and other exacerbations. Colonization was shown to have a statistically significant association with hospitalization. A three-year follow up period showed that the mean frequency of hospitalization in patients without colonization was 0.8 times, compared to 0.7 times and 1.9 times, respectively in patients with NTM colonization and with other bacterial colonization (p-value=0.03). Patients with a lower BMI also had an increased risk of hospitalization (p-value=0.024). Current smokers had increased risk of mortality as compared to those who had never smoked (HR=11.29, p-value 0.015). Patients with a high BMI also had low risk of mortality as compared to patients with a low BMI (HR=0.76, p-value 0.005). Patients with bronchiectasis having chronic colonization, low BMI, or who are current smokers tend to be at greater risk for severe illness. Therefore, physicians should actively treat these patients to prevent exacerbations and mortality.

Catholic Medical Association Joins Alliance Defending Freedom in Lawsuit Challenging Biden Transgender Mandate.

Catholic Medical Association Joins Alliance Defending Freedom in Lawsuit Challenging Biden Transgender Mandate.

Catholic Medical Association Commends Texas for Life Affirming Law Banning Abortion as Early as 6 Weeks.

Catholic Medical Association Commends Texas for Life Affirming Law Banning Abortion as Early as 6 Weeks.

Epidemiology, Comorbidities, and Prescription Patterns of Korean Prurigo Nodularis Patients: A Multi-Institution Study.

Prurigo nodularis (PN) is a chronic dermatosis typified by extraordinarily itchy nodules. However, little is known of the nature and extent of PN in Asian people. This study aimed to describe the epidemiology, comorbidities, and prescription pattern of PN in Koreans based on a large dermatology outpatient cohort. Patients with PN were identified from the Catholic Medical Center (CMC) clinical data warehouse. Anonymized data on age, sex, diagnostic codes, prescriptions, visitation dates, and other relevant parameters were collected. Pearson correlation analysis was used to calculate the correlation between PN prevalence and patient age. Conditional logistic regression modeling was adopted to measure the comorbidity risk of PN. A total of 3591 patients with PN were identified at the Catholic Medical Center Health System dermatology outpatient clinic in the period 2007–2020. A comparison of the study patients with age- and sex-matched controls (dermatology outpatients without PN) indicated that PN was associated with various comorbidities including chronic kidney disease (adjusted odds ratio (aOR), 1.48; 95% confidence interval (CI), 1.29–1.70), dyslipidemia (aOR, 1.88; 95% CI, 1.56–2.27), type 2 diabetes mellitus (aOR, 1.37; 95% CI, 1.22–1.54), arterial hypertension (aOR, 1.50; 95% CI, 1.30–1.73), autoimmune thyroiditis (aOR, 2.43; 95% CI, 1.42–4.16), non-Hodgkin’s lymphoma (aOR, 1.95; 95% CI, 1.23–3.07), and atopic dermatitis (aOR, 2.16, 95% CI, 1.91–2.45). Regarding prescription patterns, topical steroids were most favored, followed by topical calcineurin inhibitors; oral antihistamines were the most preferred systemic agent for PN. PN is a relatively rare but significant disease among Korean dermatology outpatients with a high comorbidity burden compared to dermatology outpatients without PN. There is great need for breakthroughs in PN treatment.

Reoperation rates for recurrence of fibroids after abdominal myomectomy in women with large uterus.

BackgroundThe population of women undergoing abdominal myomectomy for symptomatic large fibroid uterus is unique. We seek to characterize the timing, risk factors as well as the presenting symptoms which led patients to undergo repeat surgery in this patient population.Methods and findingsWe followed 592 patients who underwent an abdominal myomectomy from March 1998 to June 2010 at St. Vincent’s Catholic Medical Center and presented later during the study period with a recurrence of symptoms attributable to a reemergence of fibroids and who chose to undergo repeat surgical management. Twelve percent of patients exhibited symptoms of fibroid uterus which led to reoperation within the study period. The mean age at repeat surgery was 44.1 ± 0.6 years old (n = 69) and the mean time between operations was 7.9 ± 0.3 years. Presentation was variable but included bleeding, pain and infertility. Patients presented for surgery with a significantly smaller sized uterus than at their initial surgery. Timing between surgeries correlated with age at initial surgery and uterine size but race, number of fibroids, aggregate weight of fibroids removed, operative time or blood loss at the initial surgery did not correlate. Data is suggestive that intraperitoneal triamcinolone may reduce reoperation rates but not timing of recurrence.ConclusionThese results may help in counseling patients, particularly younger women, on the risks of fibroid recurrence necessitating repeat surgery. Further research is necessary to assess if triamcinolone can alter fibroid reurrence in patients who undergo uterus sparing procedures.

The Catholic Medical Association's The Linacre Quarterly and Doctor, Doctor Receive 12 Catholic Media Association Awards.

The Catholic Medical Association's The Linacre Quarterly and Doctor, Doctor Receive 12 Catholic Media Association Awards.

Catholic Medical Association Dismayed After Ban on Federally Funded Fetal Tissue Research is Reversed.

Catholic Medical Association Dismayed After Ban on Federally Funded Fetal Tissue Research is Reversed.