Eligible Group Research Articles

Population-level health impact of hypothetical waning 1-dose human papillomavirus vaccination and 2-dose mitigation strategies in a high cervical cancer burden setting.

We simulated the impact of hypothetical waning scenarios of a 1-dose human papillomavirus (HPV) vaccination paired with switching to 2-dose mitigation strategies guided by empirical vaccine trial reporting timelines. Using 2 independent mathematical models fitted to a high-burden setting, we projected the cumulative cervical cancer cases averted over 85 years for alternative HPV vaccination scenarios under 2 program adoption timelines: 1) de novo introduction of a 1-dose HPV vaccination and 2) a switch from an existing 2-dose HPV vaccination program to a 1-dose vaccination. We assumed 80% vaccination coverage with the bivalent vaccine and an average duration of a 1-dose HPV vaccine protection of either 30 or 25 years with 100% efficacy. We varied the eligible age group(s) at program introduction and the 2-dose mitigation (single-age cohort or multi-age cohort). If needed for mitigation, reintroduction of 2-dose vaccination was assumed to occur in 2036 (ie, 30 years after initiation of the Costa Rica Vaccine Trial). Under both vaccine adoption timelines, the models projected that countries could achieve the same level of health benefits by switching to 2 doses in 2036 using a multi-age cohort approach as with initiating a 2-dose or 1-dose vaccination program with no waning. With only a single-age cohort 2-dose mitigation approach, 98%-99% of cases would be prevented compared with the health benefits of 2 doses or a noninferior, durable 1 dose. Countries hesitant to adopt a 1-dose HPV vaccination program may have opportunities to leverage the benefits and efficiency of a 1-dose schedule while awaiting longer-term reporting from 1-dose durability studies, including Costa Rica Vaccine Trial.

Uptake of cervical screening and acceptability of HPV self-sampling in Irish Traveller women

Abstract Introduction Irish Travellers are a minority ethnic group. The 2010 All-Ireland Traveller Health Study noted the life expectancy of Traveller women was 11 years shorter than women in the general population. Coverage of the CervicalCheck, the Irish cervical screening programme, is 78.7% overall, however, there is no recently published data on the attendance of Traveller women. This study sought to determine participation by eligible Traveller women in CervicalCheck and the acceptability of HPV self-sampling. Methodology A face-to-face cross-sectional survey, adapted from the National Cancer Control Programme’s 2022 National Survey on Cancer Awareness, was disseminated to Irish Travellers via Primary Health Care Travellers Project peer researchers, following ethical approval, May to December 2023. Results 451 Travellers participated; 286 (63.4%) were female. Of these, 178 (62.2%) were in the eligible age group for cervical screening. 134 (75.3%) advised they had received an invitation to screening; 121 (68% of all eligible; 90% of all receiving an invitation) advised they had attended at least once (regular attenders 88 (49.4%); 27 (15.2%) irregular attenders). Of all responders in the screening eligible age group, 36 (20.2%) reported HPV self-sampling as acceptable; 18 (50%) of these were non or irregular attenders at screening. Similar proportions of 25-45 year-olds (20.4%) and 46-65 year-olds (20%) reported HPV self-sampling as acceptable. Conclusions Irish Traveller women face barriers to accessing mainstream health services. Uptake of cervical screening overall is lower compared to the general population in this study; one issue may be unreliable postal service to Travellers and non-receipt of invitations. While the overall acceptability of HPV self-sampling was low at 20.2%, half of those who would self-sample did not attend or attended irregularly. HPV self-sampling has the potential to improve cervical screening rates among Traveller women. Key messages • Irish Traveller women’s uptake of cervical screening is lower than general population. • HPV self sampling has potential to improve cervical screening rates in Travellers.

Comparing PCSK9 inhibitor prescription rates within high-risk populations: diabetes mellitus, multi-territory vascular disease, multivessel and recurrent coronary artery disease

Abstract Background Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are subsidised in Australia for treatment of hypercholesterolemia in particularly high-risk patients with atherosclerotic cardiovascular disease (ASCVD). These high-risk groups are defined as: diabetes mellitus (with age≥60, Aboriginal or Torres Strait Islander origin or microalbuminuria), recurrent ASCVD (≥2 events within 5 years), multivessel coronary disease (≥50% stenosis in ≥2 large vessels) and multi-territory vascular disease (concurrent cerebrovascular or peripheral vascular disease). Methods A retrospective observational analysis was conducted on high-risk patients with LDL>2.6 admitted to a quaternary hospital with ASCVD between 2020-2022. Australian Pharmaceutical Benefits Scheme (PBS) criteria was applied to assess and compare PCSK9 inhibitor eligibility and prescription rates within high-risk populations. Results In total, 477 ASCVD patients with LDL>2.6 were included. This was further categorised into: multivessel coronary disease (n=239, 50.1%), diabetes mellitus (n=60, 12.6%), recurrent ASCVD (n=55, 11.5%) and multi-territory vascular disease (n=32, 6.7%), p<0.001. When 2020 PBS criteria was applied, the number of eligible patients were 16/239 (6.7%), 5/60 (8.3%), 13/55 (23.6%) and 4/32 (12.5%) respectively, p=0.002. Of PBS eligible patients, the number prescribed PCSK9 inhibitors were: 7/16 (43.8%) for multi-vessel coronary disease, 1/5 (20%) for diabetes mellitus, 4/13 (30.8%) for recurrent ASCVD and 1/4 (25%) for multi-territory vascular disease patients (p=0.73). Conclusion Although there was a significantly higher prevalence and proportion of eligible multivessel coronary disease patients, prescribing rates for PCSK9 inhibitor therapy remain low amongst all high-risk eligible groups including diabetes mellitus, multi-territory vascular disease, multivessel and recurrent coronary artery disease.

Improved survival and decreased cancer deaths in young adults with cancer after passage of the Affordable Care Act Dependent Coverage Expansion.

The Patient Protection and Affordable Care Act (ACA) allowed Americans aged 19-25 years to remain on their parents' health insurance plans until age 26 years (the Dependent Care Expansion [DCE]). Have those with cancer diagnoses benefited? The ACE DCE 7-year age range of 19-25 years was compared for changes in cancer survival and mortality before and after enactment of the ACA with groups that were younger and older (in 7-year age spans: ages 12-18 and 26-32 years, respectively). Cancer death data for the entire United States were obtained from the Centers for Disease Control and Prevention, and relative survival data of patients who were diagnosed with cancer were obtained from the National Cancer Institute Surveillance, Epidemiology, and End Results regions representing 42%-44% of the country. Joinpoint analysis identified the DCE-eligible cohort as the only age group of the three groups evaluated that have had improvements in both cancer survival and death rate trends after ACA implementation and that 2010, the year the ACA was passed, was the inflection year for both survival and deaths. By 6 years, the relative survival after cancer diagnosis was 2.6 and 3.9 times greater in the DCE-eligible age group than in the younger and older control groups, respectively (both p<.001), and the cancer death rate in the DCE-eligible age group improved 2.1 and 1.5 times greater than in the younger and older control age groups, respectively (both p<.01). During the first decade of the ACA, eligible young adults with cancer have had significantly improved survival and mortality. Additional policies expanding insurance coverage and enabling earlier cancer diagnosis among young adults are needed. The Patient Protection and Affordable Care Act (ACA) Dependent Care Expansion (DCE) that began in the United States in 2011 allowed young adults aged 19-25 years to remain on their parents' health insurance plans until age 26 years. The survival rate at 6 years in young adult patients diagnosed with cancer was 2.6 to 3.9 times greater in the DCE-eligible age group compared with the younger and older age groups, and the rate of deaths from cancer improved 1.5 to 2.1 times more. During the first decade of the ACA, young adults with cancer who were in the eligible group had significantly longer survival and reduced deaths from cancer. Additional policies that expand insurance coverage and allow the diagnosis of cancer sooner are needed in young adults.

Applying the SOUND Trial for Omitting Axillary Surgery in Patients With Early Breast Cancer in Bahrain.

The Sentinel Node vs. Observation After Axillary Ultra-Sound (SOUND) trial reported that omission of axillary surgery was not inferior to sentinel lymph node biopsy (SLNB) in those with cT1 breast cancer and negative preoperative axillary ultrasound. The aim of our study was to evaluate the clinical characteristics of early breast cancer patients undergoing breast conserving surgery (BCS) at our institution in order to investigate the exportability of SOUND criteria to our patient population. We retrospectively reviewed patients with cT1N0 breast cancer undergoing BCS and adjuvant radiotherapy according to the SOUND trial criteria. Comparison was made between the eligible group of our cohort and the SLNB arm of the SOUND trial. The proportion of younger patients was higher in our eligible cohort (37.7% vs. 17.5%, p = 0.002). Postmenopausal patients were more prevalent in the SOUND trial (79.4% vs. 56.6%, p = 0.004). On final pathology, tumours were more likely to be upgraded to T2 in our group (26.4% vs. 4.4%, p = 0.001). Patients in our cohort were more likely to receive adjuvant chemotherapy (37.7% vs. 20.1%, p = 0.002). The clinicopathological differences between our cohort and the SOUND trial population could be attributed to aggressive tumours in Bahrain compared to Western countries. Our study may influence others to investigate the applicability of the SOUND trial in clinical practice. Nevertheless, it is a study that should generate multidisciplinary discussion in the de-escalation of axillary surgery.

Planning and adjusting the COVID-19 booster vaccination campaign to reduce disease burden

As public health policies shifted in 2023 from emergency response to long-term COVID-19 disease management, immunization programs started to face the challenge of formulating routine booster campaigns in a still highly uncertain seasonal behavior of the COVID-19 epidemic. Mathematical models assessing past booster campaigns and integrating knowledge on waning of immunity can help better inform current and future vaccination programs. Focusing on the first booster campaign in the 2021/2022 winter in France, we used a multi-strain age-stratified transmission model to assess the effectiveness of the observed booster vaccination in controlling the succession of Delta, Omicron BA.1 and BA.2 waves. We explored counterfactual scenarios altering the eligibility criteria and inter-dose delay. Our study showed that the success of the immunization program in curtailing the Omicron BA.1 and BA.2 waves was largely dependent on the inclusion of adults among the eligible groups, and was highly sensitive to the inter-dose delay, which was changed over time. Shortening or prolonging this delay, even by only one month, would have required substantial social distancing interventions to curtail the hospitalization peak. Also, the time window for adjusting the delay was very short. Our findings highlight the importance of readiness and adaptation in the formulation of routine booster campaign in the current level of epidemiological uncertainty.

Knowledge and beliefs about lung cancer screening among Black individuals at high risk: a qualitative approach.

Despite its efficacy in reducing lung cancer (LC)-specific mortality by 20%, screening with low-dose computed tomography (LDCT) in eligible groups remains low (5-16%). Black individuals are more commonly affected by LC than other racial/ethnic groups in the United States (U.S.) but less likely to undergo LC screening (LCS). Our study aimed to explore the knowledge and beliefs of Black individuals at high risk regarding LCS. Black individuals (n=17) who met the 2021 United States Preventive Services Task Force (USPSTF) LCS eligibility criteria were recruited in upstate New York. In-depth semi-structured interviews were conducted, audio recorded, and transcribed to explore knowledge and beliefs that could influence the uptake of LCS. A qualitative thematic analysis method was used to identify and analyze themes within the data. We identified principal themes about LC and LCS. Although most participants reported that smoking was the major risk factor for LC, some participants placed more emphasis on other factors as the major risk factors for LC and de-emphasized the role of smoking. Most participants were not aware that screening for LC existed. Several barriers and facilitators for LCS were identified. Awareness about LCS among Black individuals is low. Addressing barriers may help increase LCS rates among Black individuals, ultimately reducing their LC mortality. The findings from our study have important implications in designing more effective interventions involving community health workers and healthcare clinicians to increase LCS uptake among Black individuals at high risk.

The Impact of Leave Length on After Leave Experience under Family and Medical Leave Policy in the U.S.

This research examines employee experiences under the Family and Medical Leave Policy in the United States and to what extent the length of leave affects the post-leave employment experience. The data source comes from the Family Medical Leave Act Employee Survey, which was conducted by the U.S. Department of Labor in 2018. This research further investigates whether females are more likely to be discriminated against than males and whether the eligibility of FMLA would decrease the possibility of being treated differently. Three hypotheses were 1) the longer leave one takes, the higher the possibility of being treated differently; 2) females have a higher possibility than males of being treated differently; and 3) FMLA-eligible employees have less possibility than their counterparts of being treated differently. This study found that longer leave length is associated with a higher possibility of being treated differently. Another important finding is that females have a higher possibility than males of being treated differently after controlling for other factors. Also, this study suggests that there is no significant difference between FMLA eligible groups and non-FMLA eligible groups. This study discussed policy implications regarding the length of most recent leave and gender, including the need to expand the length and types of family leave coverage, the need for government-mandated paid leave, and approaches for increasing employee knowledge of leave rights.

Prognostic impact of selection criteria of current adjuvant endocrine therapy trials NATALEE and monarchE in postmenopausal HRpos/HER2neg breast cancer patients treated with upfront letrozole

BackgroundThe monarchE and NATALEE trials demonstrated the benefit of CDK4/6 inhibitor (CDK4/6i) therapy in adjuvant breast cancer (BC) treatment. Patient selection, based on clinical characteristics, delineated those at high (monarchE) and high/intermediate recurrence risk (NATALEE). This study employed a historical patient cohort to describe the proportion and prognosis of patients eligible for adjuvant CDK4/6i trials. MethodsBetween 2009 and 2011, 3529 patients were enrolled in the adjuvant PreFace clinical trial (NCT01908556). Eligibility criteria included postmenopausal patients with hormone receptor-positive (HRpos) BC for whom a five-year upfront therapy with letrozole was indicated. Patients were categorized into prognostic groups according to monarchE and NATALEE inclusion criteria, and their invasive disease-free survival (iDFS) and overall survival (OS) were assessed. ResultsAmong 2891 HRpos patients, 384 (13.3 %) met the primary monarchE inclusion criteria. The majority (n = 261) qualified due to having ≥ 4 positive lymph nodes. For NATALEE, 915 out of 2886 patients (31.7 %) met the eligibility criteria, with 126 patients (13.7 %) being node-negative. Patients from monarchE with ≥ 4 positive lymph nodes and NATALEE with stage III BC exhibited the poorest prognosis (3-year iDFS rate 0.87). Patients ineligible for the trials demonstrated prognoses similar to the most favorable patient groups within the eligibility criteria. ConclusionPatient populations eligible for monarchE and NATALEE trials differed. Nearly a third of the postmenopausal HRpos population, previously under upfront letrozole treatment, met the NATALEE prognostic eligibility criteria. As certain eligible groups had a prognosis similar to non-eligible patients, it might be interesting to explore additional patient groups for CDK4/6i therapy.

Comparison of clinical features of cystic fibrosis patients eligible but not on CFTR modulators to ineligible for CFTR modulators.

Cystic fibrosis transmembrane conductance regulator (CFTR) modulator drugs target the underlying defect and improve CFTR function. They are a part of standard care in many countries, but not all patients are eligible for these drugs due to age and genotype. Here, we aimed to determine the characteristics of non-eligible patients for CFTR modulators in the CF registry of Turkey (CFRT) to highlight their clinical needs. This retrospective cohort study included CF patient data from the CFRT in 2021. The decision of eligibility for the CFTR modulator was determined according to the 'Vertex treatment-Finder' on the Vertex® website. Demographic and clinical characteristics of patients were compared between eligible (group 1) and ineligible (group 2) groups for CFTR modulators. Among the study population (N = 1527), 873 (57.2%) were in group 1 and 654 (42.8%) were in group 2. There was no statistical difference between groups regarding sex, meconium ileus history, diagnoses via newborn screening, FEV1 z-score, CF-associated complications, organ transplant history, and death. Patients in group 2 had a higher incidence of pancreatic insufficiency (87.7% vs. 83.2%, p = .010), lower median height z-scores (-0.87 vs. -0.55, p < .001), lower median body mass index z-scores (-0.65 vs. -0.50, p < .001), longer days receiving antibiotics due to pulmonary exacerbation (0 [interquartile range, IQR: 0-2] vs. 0 [IQR: 0-7], p = 0.001), and more non-invasive ventilation support (2.6% vs. 0.9%, p = 0.008) than patients in group 1. The ineligible group had worse clinical outcomes than the eligible group. This highlights their need for life-changing drugs to improve clinical outcomes.

Best anticoagulation strategy with and without appendage occlusion for stroke-prophylaxis in postablation atrial fibrillation patients with cardiac amyloidosis.

Both atrial fibrillation (AF) and amyloidosis increase stroke risk. We evaluated the best anticoagulation strategy in AF patients with coexistent amyloidosis. Consecutive AF patients with concomitant amyloidosis were divided into two groups based on the postablation stroke-prophylaxis approach; group 1: left atrial appendage occlusion (LAAO) in eligible patients and group 2: oral anticoagulation (OAC). Group 1 patients were further divided into Gr. 1A: LAAO + half-does NOAC (HD-NOAC) for 6 months followed by aspirin 81 mg/day and Gr. 1B: LAAO + HD-NOAC. In group 1 patients, with complete occlusion at the 45-day transesophageal echocardiogram, patients were switched to aspirin, 81 mg/day at 6 months. In case of leak, or dense "smoke"in the left atrium (LA) or enlarged LA, they were placed on long-term half-dose (HD)NOAC. Group 2 patients remained on full-dose NOAC during the whole study period. A total of 92 patients were included in the analysis; group 1: 56 and group 2: 36. After the 45-day TEE, 31 patients from group 1 remained on baby-aspirin and 25 on HDNOAC. At 1-year follow-up, four stroke, oneTIA and six device-thrombus were reported in group 1A, compared to none in patients in group 1B (5/31 vs. 0/25, p = .03). No bleeding events were reported in group 1, whereas group 2 had five bleeding events (one subdural hematoma, one retinal hemorrhage, and fourGI bleedings). Additionally, one stroke was reported in group 2 that happened during brief discontinuation of OAC. In patients with coexistent AF and amyloidosis, half-dose NOAC following LAAO was observed to be the safest stroke-prophylaxis strategy.

Abstract PO2-03-02: Technology-enabled identification of low-risk breast cancer survivors for personalized survivorship care

Abstract Background. Advancements in cancer medicine have resulted in prolonged survival for the majority of patients. Personalized care pathways which account for clinical needs of this growing population of cancer survivors—and which address oncology workforce shortages—are urgently needed. Rapid identification of low-risk cancer survivors who could be cared for in other settings is a critical element of personalized care. Here we present final algorithm performance on risk-stratification from an ongoing clinical trial evaluating a primary care physician-led cancer survivorship clinic for breast cancer survivors. We captured data on real-time clinical risk stratification of early-stage patients between 6-36 months post-treatment. Methods. With oncology stakeholder input, we developed a screening algorithm to identify low-risk breast cancer survivors from the electronic medical record based on data from pathology, treatment, and utilization records. The algorithm identified patients meeting study eligibility: adult stage 0-IIb breast cancer patients diagnosed with first primary cancer, excluding those with treatments indicative of high-risk or metastatic disease, ongoing ovarian suppression, neoadjuvant therapy, or enrollment in other cancer clinical trials. Next, the treating oncologist was asked to confirm or deny patient eligibility; if denied, we tracked and categorized the reason provided for ineligibility. We describe: 1) characteristics and proportions of patients identified by the algorithm; 2) a breakdown of patients confirmed or denied eligibility; and 3) oncologists’ reasons for ineligibility. Results. The algorithm identified 1186 patients. Of those, 91 were flagged by oncology as not followed (e.g., consult only), and 204 were not categorized. Of the remaining 890 patients, 716 (81%) were categorized as eligible. Mean age was 62 years (SD: 11.4, Table 1). There were significant differences by stage, with a higher proportion of stage 0 in the eligible group (24% vs. 18%) and a lower proportion of stage II (24% vs. 35%). There was also a significant difference by HER2 status, with a greater proportion of HER2+ patients categorized as eligible (21% vs. 16%). There were significant differences by race/ethnicity, with a higher proportion of Asian and Black patients categorized eligible (14% vs. 8%, and 28% vs. 17%, respectively) and fewer Hispanic and White patients categorized eligible (26% vs. 36%, and 30% vs. 37%, respectively). There were not significant differences by ER/PR, surgery, or endocrine therapy. Reasons for ineligibility included: suspicious for recurrence (6%), new primary disease (3%), considered high-risk based on genetic/tumor factors (9%), co-occurring heme/oncology disorder (9%), treatment-related concerns (e.g., patient declined chemotherapy) (7%), complex case/condition (11%), patient preference per conversation with oncologist (32%), other (19%), and lost to follow-up (4%). Conclusions. Leveraging technology to support survivorship in the primary care setting is critical. Our findings demonstrate that consensus-based risk algorithms with oncologist review can effectively perform identification of low-risk patients who may be appropriately transitioned to other settings for survivorship care. These patients may benefit from primary care-led survivorship with a focus on healthy lifestyle, managing comorbid conditions, and psychosocial care. Eligible/Ineligible per oncologist by patient demographics and cancer characteristics Citation Format: Farah Brasfield, Aiyu Chen, Eric Haupt, Lindsay Lyons, Talar Habeshian, Corrine Munoz-Plaza, Ernest Shen, Huong Nguyen, Michael Gould, Alexander Ferreira, Allen Joo, Seyed Monemian, Christy Lai, Yung-Mee Park, Hollis Lee, Steven Steinberg, Patricia Ganz, Erin Hahn. Technology-enabled identification of low-risk breast cancer survivors for personalized survivorship care [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-03-02.

Routine tuberculosis contact investigation yield and preventive treatment cascade in central Ethiopia

IntroductionThere is a global gap between tuberculosis incident cases and the notified cases. Active household contact investigation is one of the strategies to narrow this gap. It has the advantage of giving early diagnosis and preventive treatment to vulnerable and eligible groups. This study assessed the practice of contact investigation and tuberculosis preventive treatment adherence in central Ethiopia. MethodA cross-sectional study covering all registered bacteriologically confirmed pulmonary tuberculosis patients and their close contacts was conducted in central Ethiopia from January 1, 2022, to December 30, 2022. ResultA total of 1372 household contacts were declared by the index cases. From these 79.44 % (1090) contacts received a one-time tuberculosis screening giving a total of four (0.36 %) active TB cases. Among 484 household contacts of drug-resistant tuberculosis index cases, 5.53 % (14) had presumptive tuberculosis and 0.79 % (2) had active tuberculosis. While among 837 household contacts of drug-susceptible tuberculosis index cases presumptive TB cases were 1.91 % (16) and active TB cases were 0.23 % (2). Of the 142 eligible under 15 children 81.69 % (116) had started tuberculosis preventive treatment and 84.48 % (98) completed the treatment. On multivariable logistic regression, the associated factor for tuberculosis preventive treatment non-adherence was age 2–5 years (aOR, 0.02, 95 % CI (0.002–0.20) and age 5–15 years (aOR, 0.04,95 % CI (0.002–0 0.95)) P=<0.05). ConclusionThere was low contact screening practice in the DR-TB index cases as compared to national and global targets. The yield of routine contact investigation was low and it indicates the quality of screening. Tuberculosis preventive treatment initiation and completion rates were also low as compared to those of many other countries and global achievements which need further improvement, especially for completion. Alternative mechanisms should be planned to increase the yield of tuberculosis screening and tuberculosis preventive treatment adherence.

Stable Clinical and Radiological Outcomes at Medium and over 5 Year Follow Up of Calcaneus Fracture Open Reduction Internal Fixation Using a Sinus Tarsi Approach

The sinus tarsi approach is increasingly growing in popularity for open reduction internal fixation of calcaneus fractures. Multiple studies have demonstrated favorable short-term results compared to the traditional extensile L incision, however long-term data over 5 years is currently limited to a single retrospective case series. Following local ethical approval, all patients who had completed a minimum 5 years from time of operation were contacted with a Standardized Telephone Questionnaire completed. This followed a previous retrospective chart review, with follow up telephone or clinic consultation performed by Davey et al. of this cohort at mean 35 months. Thirty-four fractures (31 patients) completed minimum 5 year follow up from the eligible group of 54 fractures (49 patients). Regarding functional outcomes, a significant improvement in mean Maryland Foot Score was observed between short- (mean 35.8 months) and medium-term (mean 81.9 months) of 77.6 (SD 15.0) to 86 (SD 7.9) (p = .0082). There was no significant difference in postoperative and long term radiographic Bohler's angle (p = .9683). Eleven feet (32%) proceeded to require reoperation, with removal of metal performed in 10 (29%), fusion in 2 (6%), and skin grafting following wound breakdown for 1 (3%). Four feet (12.9%) experienced post operative wound complications, including 3 (9.68%) cases of infection and 2 (6.45%) of delayed wound healing. This study demonstrated stable clinical and radiographic outcomes over 5 years following Calcaneus Fracture Open Reduction Internal Fixation using a sinus tarsi approach, supporting its continued usage when treating intraarticular calcaneus fractures for which operative intervention is indicated.

Representativeness of the PIONEER-HF and PARAGLIDE-HF in patients hospitalized with acute heart failure.

The PIONEER-HF and PARAGLIDE-HF trials aimed to determine the efficacy and safety of the in-hospital initiation of sacubitril/valsartan in patients hospitalized for AHF. However, whether the inclusion and exclusion criteria of the trials apply to patients encountered in real-world routine care is unclear. This study aimed to investigate the applicability of the PIONEER-HF and PARAGLIDE-HF trials to real-world AHF patients. We identified 28293 AHF hospitalized patients between August 2008 to August 2017 from the Chang Gung Research Database and classified them into four groups based on left ventricular ejection fraction (LVEF) and trial criteria. Cox proportional hazards models were used to compare the risk of HF hospitalization and cardiovascular (CV) death. We defined PIONEER-HF eligible (n=3683) and non-eligible (n=3502) patients with an LVEF ≤40%, and PARAGLIDE-HF eligible (n=5191) and non-eligible (n=5832) patients with an LVEF >40%. Over a mean follow-up of 3.5years, the PIONEER-HF non-eligible and eligible groups exhibited similar rates of HF hospitalization and CV death (41.1% vs. 41.8%, adjusted hazard ratio [aHR]: 0.95; 95% CI: 0.88-1.04). No significant difference was found in the composite outcome between PARAGLIDE-HF non-eligible and eligible groups (36.7% vs. 38.6%; aHR: 0.97; 95% CI: 0.90-1.04). Using trial criteria, only 31.3% of AHF patients were eligible for sacubitril-valsartan. Yet, non-eligible patients demonstrated similar outcomes to eligible patients, indicating a need for further evaluation of sacubitril-valsartan benefits in non-eligible AHF patients.

Potential impact of annual vaccination with reformulated COVID-19 vaccines: Lessons from the US COVID-19 scenario modeling hub.

Coronavirus Disease 2019 (COVID-19) continues to cause significant hospitalizations and deaths in the United States. Its continued burden and the impact of annually reformulated vaccines remain unclear. Here, we present projections of COVID-19 hospitalizations and deaths in the United States for the next 2 years under 2 plausible assumptions about immune escape (20% per year and 50% per year) and 3 possible CDC recommendations for the use of annually reformulated vaccines (no recommendation, vaccination for those aged 65 years and over, vaccination for all eligible age groups based on FDA approval). The COVID-19 Scenario Modeling Hub solicited projections of COVID-19 hospitalization and deaths between April 15, 2023 and April 15, 2025 under 6 scenarios representing the intersection of considered levels of immune escape and vaccination. Annually reformulated vaccines are assumed to be 65% effective against symptomatic infection with strains circulating on June 15 of each year and to become available on September 1. Age- and state-specific coverage in recommended groups was assumed to match that seen for the first (fall 2021) COVID-19 booster. State and national projections from 8 modeling teams were ensembled to produce projections for each scenario and expected reductions in disease outcomes due to vaccination over the projection period. From April 15, 2023 to April 15, 2025, COVID-19 is projected to cause annual epidemics peaking November to January. In the most pessimistic scenario (high immune escape, no vaccination recommendation), we project 2.1 million (90% projection interval (PI) [1,438,000, 4,270,000]) hospitalizations and 209,000 (90% PI [139,000, 461,000]) deaths, exceeding pre-pandemic mortality of influenza and pneumonia. In high immune escape scenarios, vaccination of those aged 65+ results in 230,000 (95% confidence interval (CI) [104,000, 355,000]) fewer hospitalizations and 33,000 (95% CI [12,000, 54,000]) fewer deaths, while vaccination of all eligible individuals results in 431,000 (95% CI: 264,000-598,000) fewer hospitalizations and 49,000 (95% CI [29,000, 69,000]) fewer deaths. COVID-19 is projected to be a significant public health threat over the coming 2 years. Broad vaccination has the potential to substantially reduce the burden of this disease, saving tens of thousands of lives each year.

Disparities in chronic spontaneous urticaria: Eligibility for drug reimbursement associated with clinical outcomes

BackgroundChronic spontaneous urticaria (CSU) is an immunological condition with an estimated prevalence of 0.1%. For poorly controlled CSU despite antihistamines, omalizumab is the only treatment approved and recommended by international guidelines. ObjectiveTo outline the impact of treatment accessibility on CSU outcomes in the real world. MethodsSerial data of adult CSU patients receiving care of at least 6 months at a dedicated, immunologist-led Urticaria Clinic at Grantham Hospital in Hong Kong between 2018 and 2023 were analysed. Their clinicodemographic data, drug eligibility status (eligible for reimbursement or not), treatment step, and disease activity (weekly Urticaria Activity Score [UAS7]) were collected and compared according to drug eligibility status. ResultsThis study included 238 patients, 80 (33.6%) of whom were eligible for reimbursement whereas 158 were not. No significant clinicodemographic differences including disease activity were found at baseline. At latest follow-up, significantly more patients in the eligible group were receiving omalizumab (28.7% vs 5.7%, p<0.001), equivalent to a multivariate odds ratio of 9.35 (95%CI=3.689-23.703, p<0.001). The discrepancy persisted even in patients with moderate-to-severe CSU whose UAS7≥16 (40.6% [13/32] vs. 10.2% [6/59], p<0.001). Besides, there was significantly less dose reduction (below 300mg every 4 weeks) in eligible omalizumab users (4.3% vs. 44.4%, p=0.015). Clinically, significantly greater improvements in UAS7 were reported by the eligible group (median change: -8.0 vs. -5.0, p=0.021). ConclusionPatterns of management varied largely among patients with different drug eligibility statuses and led to disparities in health outcomes. More efforts are warranted to secure equitable access to guideline-based CSU care.

Applicability and impact of the COMPASS trial in a Canadian population of patients with atherosclerotic disease

Background and aimsIn the COMPASS trial, low-dose rivaroxaban with aspirin improved cardiovascular outcomes in patients with atherosclerotic cardiovascular disease (ASCVD). We aimed to assess the potential clinical implications of this therapy in a generalizable population. Methods and ResultsA retrospective cohort of adults with ASVCD was formed using healthcare administrative databases in Alberta, Canada (population 4.4 million). Patients with a new diagnosis between 2008 and 2019 formed the epidemiological cohort (n = 224,600) and those with long-term follow-up (>5 years) formed the outcomes cohort (n = 232,460). The primary outcome of major adverse cardiovascular events (MACE) was assessed and categorized based on the COMPASS trial eligibility. In the outcomes cohort, 77% had only coronary artery disease, 15% had only peripheral artery disease, and 8% had both. Of those, 37% met the COMPASS trial eligibility criteria, 36% met exclusion criteria and 27% did not meet inclusion criteria. Over a median of 7.8 years, the COMPASS exclusion group demonstrated the highest rate of MACE (5.9 per 100 person-years), following by the eligible group and the group that did not meet COMPASS inclusion criteria (3.1 and 1.4 per 100 person-years respectively). The expected net clinical benefit of antithrombotic therapy in the eligible group was 5.6 fewer events per 1000 person-years. ConclusionsIn a real-world population of 4.4 million adults, there are roughly 20,000 new cases of ASVCD diagnosed yearly, with ∼40% being eligible for the addition of low-dose rivaroxaban therapy to antiplatelet therapy. The theoretical implementation of dual antithrombotic treatment in this population could result in a substantial reduction in cardiovascular morbidity and mortality.

Reasonable Hopes and Little Progress!

In this article, we aim to describe how the Operational Programme for the Support of Disadvantaged People (POAD), part of the European Fund for the Most Disadvantaged People (FEAD), has contributed to reducing the number of people at risk of poverty and social exclusion in Romania. We highlight the role of the auxiliary measures that accompanied the food support programme, as well as the added-value element of the implementation of the programme in Romania, emphasising the introduction of electronic social vouchers for hot meals for the eligible target group and electronic social vouchers to provide educational support for disadvantaged children. The research methodology used considered combinations of quantitative and qualitative methods, combining multiple data sources to reflect the perspectives of all stakeholders and relating quantitative data to representative samples using a participatory approach. Macro-level data on risk-of-poverty and social exclusion indicators, as well as information from sectoral analyses (social transfers), show an improvement in the situation of people in the POAD target group and a decrease in the number of people at risk of poverty and social exclusion. However, progress is limited, and it is difficult to determine the degree to which this is due to the POAD. Romania still ranks lowest in the European Union in terms of indicators measuring the risk of poverty and social exclusion. The provision and monitoring of accompanying programmes are an area where the potential of POAD could be further exploited. The need to strengthen the accompanying measures is extraordinarily strong and emerges from the analysis of information provided by final beneficiaries and public authorities responsible for the implementation of the programme. The distribution of social vouchers enables final beneficiaries to choose the goods they need. Purchases with social vouchers are less affected by the risks of financial corrections, final beneficiaries can monitor the consumption of the support received in real time, the number of supporting documents is reduced, and reimbursement is issued only for the amounts used by final beneficiaries.

LDCT screening results among eligible and ineligible screening candidates in preventive health check-ups population: a real world study in West China

To compare the LDCT screening results between eligible and ineligible screening candidates in preventive health check-ups population. Using a real-world LDCT screening results among people who took yearly health check-up in health management center of West China Hospital between 2006 and 2017. Objects were classified according to the China National Lung Cancer Screening Guideline with Low-dose Computed Tomography (2018 version) eligibility criteria. Descriptive analysis were performed between eligible and ineligible screening candidates. The proportion of ineligible screening candidates was 64.13% (10,259), and among them there were 4005 (39.04%) subjects with positive screenings, 80 cases had a surgical lung biopsy. Pathology results from lung biopsy revealed 154 cancers (true-positive) and 26 benign results (false-positive), the surgical false-positive biopsy rate was 4.17%, and ineligible group (7.69%) was higher than eligible group (2.47%), P < 0.05. Further, in ineligible screening candidates, the proportion of current smokers was higher among males compared to females (53.85% vs. 4.88%, P < 0.05). Of the 69 lung cancer patients detected in ineligible screening candidates, lung adenocarcinoma accounts for a high proportion of lung cancers both in male (75.00%) and female (85.00%). The proportion of ineligible screening candidates and the surgical false-positive biopsy rate in ineligible candidates were both high in health check-ups population.