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Wendy Y Cheng,1 Sujata P Sarda,2 Nikita Mody-Patel,2 Sangeeta Krishnan,2 Mihran Yenikomshian,1 Colin Kunzweiler,1 Jensen Duy Vu,1 Hoi Ching Cheung,1 Mei Sheng Duh1 1Analysis Group, Inc., Boston, MA, USA; 2Apellis Pharmaceuticals, Inc., Waltham, MA, USACorrespondence: Wendy Y Cheng, Analysis Group, Inc., 111 Huntington Ave, 14th Floor, Boston, MA, 02199, USA, Tel +1 617 425 8219, Fax +1 617 425 8000, Email Wendy.Cheng@analysisgroup.comPurpose: Current pharmacologic management of paroxysmal nocturnal hemoglobinuria (PNH) consists of C5 inhibitors, eculizumab and ravulizumab; however, because patients experience incomplete symptom control, off-label doses may be utilized. We conducted a retrospective, longitudinal cohort study of provider-based claims data to assess the real-world eculizumab dosing patterns in PNH patients.Patients and Methods: Patients were ≥ 12 years, received ≥ 2 eculizumab infusions between January 1, 2015 and September 30, 2019, and had ≥ 3 months of continuous clinical activity prior to index. The index date was the first claim for eculizumab. Patients with ≥ 1 diagnosis of another indication for eculizumab were excluded. Treatment patterns including the proportion with high, label-recommended, and low dosages during induction (first 28 days) and maintenance (beginning day 29) phases were described. The proportion and time-to-first dose escalation, defined as an increase in dose or frequency of infusion, were assessed among a subset of patients (ie, escalation analysis cohort).Results: A total of 707 patients were examined. Mean (standard deviation [SD]) starting dose was 862mg (412mg) and was higher than label-recommended 600mg for 64% of the patients. Mean (SD) dose per infusion was 859mg (391mg) during the induction phase; average dose was higher than label-recommended 600mg for 68%. Mean (SD) dose per infusion during the maintenance phase was 1005mg (335mg); average dose was higher than label-recommended 900mg for 43%. Dose escalation occurred in 40/121 escalation analysis cohort patients. Median time-to-first dose escalation was ∼ 12 months.Conclusion: Results suggest that deviations from label-recommended dosing patterns were common. Future budget impact assessments of eculizumab should account for real-world dosing patterns to comprehensively assess costs and benefits.Keywords: complement inhibitors, dose escalation, dosing patterns, eculizumab, paroxysmal nocturnal hemoglobinuria

Objective: The purpose of this study was to describe clinical complications and healthcare resource utilization (HCRU) among patients with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) and patients with transfusion-dependent β-thalassemia (TDT) in Germany., Methods: The Betriebskrankenkasse (BKKs) Database was used to identify patients with SCD or TDT. To be eligible for inclusion, patients with SCD were required to have ≥ 2 VOCs/year in any two consecutive years and ≥ 12 months of available data before and after the index date (second VOC in the second consecutive year). Patients with TDT were required to have ≥ 8 red blood cell transfusions (RBCTs) in any 12-month period and ≥ 12 months of available data after the index date (first RBCT). Clinical and HCRU outcomes were analyzed during follow-up., Results: Overall, 84 patients with SCD with recurrent VOCs and 68 patients with TDT were identified in the BKKs database. Among patients with SCD with recurrent VOCs, the most prevalent complications were retinopathy (45.2%), multisystem organ disease/failure (40.5%), and mental health complications (31.0%); among patients with TDT, they were endocrine (69.1%) and cardiopulmonary (55.9%) complications and malignancies (44.1%). Patients with SCD experienced a mean of 4.0 (standard deviation [SD] 3.9) VOCs and 1.9 (SD 2.5) hospitalizations per patient per year (PPPY) during follow-up. Patients with TDT had a mean (SD) of 16.4 (11.2) RBCTs and 59.4 (40.8) outpatient visits PPPY., Conclusions: Patients with SCD with recurrent VOCs or TDT in Germany experience significant clinical complications and HCRU., Competing Interests: Declarations. Funding: The study and publication fees were supported by Vertex Pharmaceuticals Incorporated. Conflict of interest: Chuka Udeze, Nanxin Li, Jessica Baldwin, and Petra Tuzin are employees of Vertex Pharmaceuticals Incorporated and may hold stock or stock options in the company. Colin Kunzweiler is a former employee of Vertex Pharmaceuticals Incorporated and may hold stock or stock options in the company. Sebastian Dietmar Zingel, Céline Vetter, and Silvia Dombrowski are employees of IQVIA Commercial GmbH & Co. and may hold stock or stock options in the company. Céline Vetter received consulting fees for the National Institutes of Mental Health. Elena Georgiadou-Schmidt and Aranzazu Alba are employees of Team Gesundheit GmbH, which received funding from IQVIA for conducting the statistical analysis in this study. Roland Meisel has received reimbursement for clinical trial participation from Vertex Pharmaceuticals Incorporated; received consulting fees for bluebird bio and Vertex Pharmaceuticals Incorporated; served as an advisory board member for bluebird bio and Vertex Pharmaceuticals Incorporated; and acted as Board Member for the Pediatric Diseases Working Party and the Hemoglobinopathy Working Party of the European Society for Blood and Marrow Transplantation (EMBT). Availability of data and material: Data for this study were obtained from the Betriebskrankenkassen (BKKs) German Sickness Fund Database. Ethics approval: Not applicable. Consent to participate: Not applicable. Consent for publication: Not applicable. Code availability: Not applicable. Author contributions: All authors contributed to the study conceptualization, design, and interpretation of the results per ICJME guidelines. Initial data analysis was performed by Sebastian Dietmar Zingel, Céline Vetter, Silvia Dombrowski, Elena Georgiadou-Schmidt, and Aranzazu Alba in consultation with Chuka Udeze, Colin Kunzweiler, Nanxin Li, Jessica Baldwin, Petra Tuzin, and Roland Meisel. All authors have reviewed the results and have read and approved the final manuscript., (© 2025. The Author(s).)

Immunosenescence (IS) occurs as a natural outcome of ageing and may be described as a decline in immune system flexibility and adaptability to sufficiently respond to new, foreign antigens. Potential factors that may precipitate IS include persistent herpesvirus infections, such as cytomegalovirus (CMV). Here, we conducted a review of the literature evaluating the potential association between CMV and IS. Twenty-seven epidemiologic studies that included direct comparisons between CMV-seropositive and CMV-seronegative immunocompetent individuals were analysed. The majority of these studies (n = 20) were conducted in European populations. The strength of evidence supporting a relationship between CMV, and various IS-associated immunologic endpoints was assessed. T-cell population restructuring was the most prominently studied endpoint, described in 21 studies, most of which reported a relationship between CMV and reduced CD4:CD8 T-cell ratio or modified CD8 + T-cell levels. Telomere length (n = 4) and inflammageing (n = 3) were less frequently described in the primary literature, and the association of these endpoints with CMV and IS was less pronounced. An emergent trend from our review is the potential effect modification of the CMV-IS relationship with both sex and age, indicating the importance of considering various effector variables when evaluating associations between CMV and IS. Our analysis revealed plausible mechanisms that may underlie the larger epidemiologic trends seen in the literature that support the indirect effect of CMV on IS. Future studies are needed to clarify CMV-associated and IS-associated immunologic endpoints, as well as in more diverse global and immunocompromised populations., (© 2024 John Wiley & Sons Ltd.)

Introduction: Complement factor 5 inhibitors eculizumab and, recently, ravulizumab are standard therapies for paroxysmal nocturnal hemoglobinuria (PNH). However, some patients experience suboptimal response and may benefit from dosage adjustments. Ravulizumab is administered less frequently than eculizumab on the basis of patient's body weight. This retrospective analysis of insurance claims investigated ravulizumab dosing patterns among patients with PNH from the USA., Methods: Patients aged ≥ 12 years with ≥ 2 ravulizumab infusions between June 21, 2019 and May 6, 2021, and ≥ 6 months of continuous clinical activity prior to first ravulizumab infusion (index date) were identified from the Symphony Health Integrated Dataverse (IDV®) database. Observed mean (standard deviation, SD) ravulizumab doses administered were reported and stratified by previous eculizumab use. Scenarios adjusting for patients' body weights (unavailable in Symphony Health IDV) based on the US general population distribution were performed to estimate percentages of patients receiving label-recommended doses., Results: Among 433 patients (mean [SD] age 47 [17] years), the mean (SD) loading dose was 3316.3 (2931.7) mg, greater than the maximal label-recommended loading dose (3000 mg for patients ≥ 100 kg). The mean (SD) loading doses were 3581.3 (3673.7) mg for eculizumab-naive versus 3093.1 (2096.8) mg for eculizumab-experienced patients. Over a mean (SD) treatment period of 11.8 (6.9) months, the mean (SD) average maintenance dose was 3403.7 (1024.4) mg, falling between label-recommended maintenance dose categories (3300 mg for ≥ 60 to < 100 kg; 3600 mg for ≥ 100 kg). Estimated percentages of patients receiving label-recommended loading and maintenance doses were 23.1% and 39.2%, respectively; 59.1% and 28.4% were estimated to receive above label-recommended loading and average maintenance doses, respectively., Conclusion: Although limited by missing clinical characteristics including body weight, this study of ravulizumab dosing patterns in patients with PNH identified potential deviations from label-recommended dosing, warranting further investigations of treatment response to complement inhibitors in PNH., (© 2023. The Author(s).)

Objectives: Novel therapies improve clinical outcomes in chronic lymphocytic leukemia (CLL), although adverse event (AE) profiles differ. This study evaluated time and personnel costs of AE management among healthcare professionals (HCPs) treating patients with CLL with novel therapies., Methods: A non-interventional prospective survey was conducted over 2 months. Eligible HCPs reported the time per day spent performing AE management activities for CLL patients treated with acalabrutinib, ibrutinib, or venetoclax. Mean time and personnel costs (USD) per activity were summarized and used to estimate the total annual costs of AE management for an average-sized oncology practice., Results: For an average-sized practice (28 HCPs with an average of 56 CLL patients), the mean annual personnel cost of AE management for CLL patients on novel agents was estimated at $115,733. The personnel cost associated with acalabrutinib ($20,912) was less than half that of ibrutinib ($53,801) and venetoclax ($41,884), potentially due to fewer severe AEs and less time spent by oncologists managing AEs compared to other HCP types., Conclusion: The substantial burden of AE management for patients with CLL may vary by treatment used. Acalabrutinib was associated with lower annual costs of AE management at an oncology practice level compared to ibrutinib and venetoclax.

Introduction: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder characterized by anemia and debilitating fatigue. Limited evidence characterizes the association between hemoglobin, an indicator of anemia and disease activity, and patient-reported fatigue scales. This review identifies benchmarks for clinically meaningful improvements in patients with and without PNH., Methods: MEDLINE, Embase, Cochrane, and PsycINFO databases were searched along with Google Scholar to identify publications for patients with and without PNH. Full-text articles and conference abstracts of clinical trials or observational studies that examined patient-reported fatigue or associations between fatigue and hemoglobin were included., Results: Fourteen publications were included in this study. Four clinical trials conducted in patients with PNH reported that patients achieved and sustained clinically meaningful improvements in fatigue. However, these studies did not examine the association between fatigue and hemoglobin. Ten studies conducted in patients with cancer and anemia (with or without chemotherapy) demonstrated an association between increased hemoglobin and improvements in fatigue (P < 0.05). The greatest incremental gain in fatigue improvement was observed when hemoglobin increased from 11 to 12 g/dL., Conclusion: Evidence among patients with cancer without PNH demonstrates that increased hemoglobin levels are associated with clinically significant improvements in fatigue. Future studies should validate this relationship among patients with PNH., (© 2022. The Author(s).)

Objective: In the absence of a head-to-head study, we assessed the comparative effectiveness of pegcetacoplan, a targeted C3 complement inhibitor, vs. ravulizumab, a C5 complement inhibitor, among patients with paroxysmal nocturnal hemoglobinuria (PNH) previously treated with eculizumab using matching-adjusted indirect comparison methodology., Methods: Individual patient data from the PEGASUS study (NCT03500549) comparing pegcetacoplan and eculizumab enabled adjustment for baseline differences compared with published results from the ALXN1210-PNH-302 study (NCT03056040), comparing ravulizumab and eculizumab. Adjusted differences and 95% confidence intervals (CIs) were computed via weighted Wald tests for comparisons of pegcetacoplan vs. ravulizumab, anchored to the common comparator eculizumab., Results: Sixty-eight patients from PEGASUS (36 pegcetacoplan; 32 eculizumab) and 195 from ALXN1210-PNH-302 (97 ravulizumab; 98 eculizumab) were included. Compared with ravulizumab, treatment with pegcetacoplan was associated with more transfusion avoidance (adjusted difference [95% CI] = +71.4% [53.5%, 89.3%]), hemoglobin level stabilization (+75.5% [56.4%, 94.6%]), lactate dehydrogenase (LDH) level normalization (+64.0% [41.8%, 86.1%]), and fewer blood transfusions (-5.7 units [-7.2, -4.2]). Additionally, patients who received pegcetacoplan experienced clinically meaningful improvements in fatigue (+8.2 points [3.8, 12.6]), global health status (+9.6 points [0.1, 19.0]), physical functioning (+11.5 points [3.6, 19.5]), and fatigue symptoms (-13.3 points [-23.7, -3.0]), compared with ravulizumab. Mean change from baseline in LDH level was not significantly different for pegcetacoplan vs. ravulizumab., Conclusions: Results suggest that among patients previously treated with eculizumab, clinical, hematological, and quality of life endpoints were better for patients who received the C3 complement inhibitor pegcetacoplan vs. patients who received ravulizumab, a C5 complement inhibitor.

Background: Patients with chronic obstructive pulmonary disease (COPD) are potentially at increased risk of herpes zoster (HZ). Little is known about the impact of an HZ episode on health care resource utilization (HRU) and costs among patients with COPD., Methods: This retrospective cohort study of individuals aged ≥50 years in the United States (US) used administrative claims data from Optum's de-identified Clinformatics Data Mart Database for commercially insured and Medicare Advantage members (2013-2018). Two cohorts of patients with COPD, with HZ (COPD+/HZ+) and without HZ (COPD+/HZ-), were identified. All-cause and COPD-related HRU rates and costs (2018 US dollars) were compared between cohorts for up to 12 months of follow-up. Comparisons were controlled for baseline differences through propensity score adjustment., Results: A total of 3415 COPD+/HZ+ and 35,360 COPD+/HZ- patients (mean ages 73.2 ± 9.0 and 72.4 ± 9.4 years, respectively) were identified. Patients in the COPD+/HZ+ versus COPD+/HZ- cohort had increased use of all-cause (adjusted incidence rate ratio [aIRR] 1.17; 95% confidence interval [CI] 1.14, 1.21) and COPD-related (aIRR 1.27; 95% CI 1.21, 1.34) medical services (both P <0.001) and higher mean total all-cause ($4140 versus $3749 per person per month [PPPM]; adjusted cost difference +$313 PPPM) and COPD-related ($1541 versus $1231 PPPM; +$152 PPPM) costs (both P <0.004) in the year after HZ., Conclusions: HRU and cost burden is higher in patients with COPD with vs without HZ. These results could help to estimate the potential cost benefits of HZ vaccination among patients with COPD., (JCOPDF © 2021.)

Aims: Single-tablet regimens (STRs) can improve antiretroviral therapy (ART) adherence; however, the relationship between long-term adherence and patient healthcare resource utilization (HRU) is unclear. The objective of this study was to assess long-term ART adherence among people living with HIV (PLHIV) using STRs and multi-tablet regimens (MTRs) and compare HRU over time by adherence., Materials and Methods: This retrospective study analyzed medical and pharmacy claims (Optum Clinformatics Data Mart Database). Included PLHIV were aged ≥18 years, had ≥1 medical claim with an HIV diagnosis, and had pharmacy claims for a complete STR or MTR. Adherence was analyzed as the proportion of days covered (PDC), stratified as ≥95%, very high; 90-95%, high; 80-90%, moderate; <80%, low. Cumulative all-cause and HIV-related HRU were calculated across 4 years. Among PLHIV with ≥4-year follow-up, HRU was assessed by adherence., Results: Among 15,153 PLHIV included, 63% achieved PDC ≥90% during Year 1. Among the subgroup of PLHIV with ≥4-year follow-up ( N  = 3,818), the proportion maintaining PDC ≥90% fell from 67% in Year 1 to 54% by Year 4. The difference from Years 1 to 4 in the proportion of PLHIV with PDC ≥90% was 13% and 17% in the STR and MTR groups, respectively. Cumulative HRU across the 4-year follow-up was higher in PLHIV with low vs high adherence (27% with low adherence had ≥1 emergency room visit vs 17% for very high, p  < .0001; 15% with low adherence had ≥1 inpatient stay vs 7% for very high, p  < .0001)., Conclusions: ART adherence showed room for improvement, particularly over the long term. PLHIV receiving STRs exhibited higher adherence vs those receiving MTRs; this difference increased over time. The proportion of PLHIV with higher HRU was significantly higher among those with lower adherence and became greater over time. Interventions and alternative therapies to improve adherence among PLHIV should be explored.

Introduction: Most gay, bisexual and other men who have sex with men (GBMSM) live in rights-constrained environments making retaining them in research to be as hard as recruiting them. To evaluate Anza Mapema, an HIV risk-reduction programme in Kisumu, Kenya, we examined the enrolment sociodemographic, behavioural, psychosocial and clinical factors associated with missing two or more follow-up visits for GBMSM participating in Anza Mapema., Methods: Between August 2015 and November 2017, GBMSM were enrolled and followed in a prospective cohort study with quarterly visits over 12 months. At enrolment, men were tested for HIV and sexually transmitted infections and completed questionnaires via audio computer-assisted self-interview. Because the Kenya Ministry of Health recommends HIV testing every three to six months for GBMSM, the retention outcome in this cross sectional analysis was defined as missing two consecutive follow-up visits (vs. not missing two or more consecutive visits). Multivariable logistic regression estimated the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the associations of the enrolment characteristics with the binary outcome of retention., Results and Discussion: Among 609 enrolled HIV-negative GBMSM, the median age was 23 years (interquartile range, 21 to 28 years), 19.0% had completed ≤8 years of education and 4.1% had resided in the study area <1 year at enrolment. After enrolment, 19.7% missed two consecutive follow-up visits. In the final multivariable model, the odds of missing two consecutive follow-up visits were higher for men who: resided in the study area <1 year at enrolment (aOR, 4.14; 95% CI: 1.77 to 9.68), were not living with a male sexual partner (aOR, 1.59; 95% CI: 1.01 to 2.50), and engaged in transactional sex during the last three months (aOR, 1.70; 95% CI: 1.08 to 2.67)., Conclusions: One in five men missed two consecutive follow-up visits during this HIV prevention study despite intensive retention efforts and compensation for travel and participation. Participants with recent community arrival may require special support to optimize their retention in HIV prevention activities. Live-in partners of participants may be enlisted to support greater engagement in prevention programmes, and men who engage in transactional sex will need enhanced counselling and support to stay in longitudinal studies., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: We describe Data to Care processes of the Massachusetts Partnerships for Care (MA P4C) project and identify factors associated with engagement, retention, and viral suppression outcomes., Methods: The Massachusetts Department of Public Health and participating community health centers generated lists of patients not in care based on a temporal gap in laboratory results, missed clinic visits, and provider concern regarding engagement. The Massachusetts Department of Public Health and community health centers reviewed the lists monthly and identified out-of-care patients in need of linkage or re-engagement., Results: Between October 2015 and June 2017, of 1418 patients potentially out of care, 83 (5.9%) were confirmed to be out of care. Forty-four of those out of care (53%) received services or were re-engaged in care within 90 days, 45 (54%) were retained in care, and 40 (48%) were virally suppressed. The odds of being re-engaged or retained were lower for patients who were 6 months out-of-care (vs. those newly diagnosed). Patients with an AIDS-defining condition had increased odds of retention and viral suppression. The odds of viral suppression were reduced for patients who reported exposure categories other than men who have sex with men and were younger (30-49 years vs. ≥50 years)., Conclusions: Although rates of re-engagement, retention, and viral suppression were low, the MA P4C Data to Care procedures provided a means for accurate ascertainment of out-of-care status. Future Data to Care programs should investigate the factors that contribute to disengagement from care.

Objectives: In settings where laboratory capacity is limited, the WHO recommends presumptive treatment for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in asymptomatic men who have sex with men (MSM) at high risk for these infections. However, little is known about how best to target this intervention. We aimed to identify correlates of anorectal NG/CT infection in Kenyan MSM with and without anorectal symptoms and evaluate the performance of an empirical, model-based risk score to identify cases in asymptomatic men., Methods: Anorectal NG/CT infections were diagnosed by the Abbott RealTime NG/CT nucleic acid amplification testamong 698 MSM at enrolment into the Anza Mapema study. Multivariable logistic regression was used to identify correlates of anorectal NG/CT infection in men with and without anorectal symptoms. Using coefficients from the final multivariable model for asymptomatic men, we calculated a risk score for each participant. Risk score performance was determined by calculating the sensitivity, specificity and number needed to treat (NNT) to identify one NG/CT infection., Results: Overall anorectal NG/CT infection prevalence was 5.2% (n=36), of which 58.3% (n=21) were asymptomatic. Factors associated with anorectal NG/CT infection in asymptomatic men were aged 18-24 years (aOR=7.6; 95% CI: 1.7 to 33.2), HIV positive serostatus (aOR=6.9; 95% CI: 2.2 to 21.6) and unprotected anal sex in the past 3 months (aOR=3.8; 95% CI: 1.2 to 11.9). Sensitivity and specificity were optimal (81.0% and 66.1%, respectively) at a model-derived risk score cut-point ≥3, and the NNT was 12., Conclusions: A model-derived risk score based on correlates of anorectal NG/CT infection in asymptomatic participants would be sensitive and efficient (i.e, low NNT) for targeting presumptive treatment. If validated in other settings, this risk score could improve on the WHO algorithm and help reduce the burden of asymptomatic anorectal NG/CT infections among MSM in settings where diagnostic testing is not available., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Evidence on the association between residential surrounding greenness (RSG) in urban areas with asthma and asthma symptoms is inconsistent., Objective: To examine the association of RSG with respiratory outcomes in a sample of Mexican American children living in inner-city Chicago, Illinois., Methods: This study is based on parent-reported data on 1915 Mexican American children. We calculated RSG using the normalized difference vegetation index based on satellite imagery within buffers of 100, 250, and 500 m of each child's residence. Multivariable multilevel mixed-effect logistic regression was used to estimate adjusted odds ratios (aORs) for the effect of a 1-interquartile range increase in greenness., Results: In adjusted analyses, a protective effect of greenness within 100 m was observed for lifetime wheezing (aOR, 0.82; 95% CI, 0.69-0.96). Environmental tobacco smoke (ETS) exposure modified the association of RSG with lifetime asthma and current dry cough at night. For all buffer distances, increased greenness was associated with lower odds of lifetime asthma among children with current ETS exposure (100 m: aOR, 0.43; 95% CI, 0.22-0.87; 250 m: aOR, 0.39; 95% CI, 0.18-0.84; 500 m: aOR, 0.48; 95% CI, 0.26-0.90) and lower odds of current dry cough at night among children with perinatal ETS exposure (100 m: aOR, 0.53; 95% CI, 0.31-0.92; 250 m: aOR, 0.55; 95% CI, 0.31-0.98; 500 m: aOR, 0.55; 95% CI, 0.35-0.87)., Conclusion: Our results suggest inverse associations of urban greenness with respiratory outcomes, especially in children exposed to ETS. Further research is needed to examine the mechanisms through which RSG may be associated with the risk of asthma and contribute to health., (Copyright © 2018 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: There is increasing evidence that neighborhood-level factors, in addition to individual-level factors, may contribute directly or indirectly to childhood asthma by affecting environmental and lifestyle factors. Exposure to neighborhood crime and violence has been associated with poor health outcomes, especially among underserved and minority populations, and its effect on respiratory health is an area of active research., Objective: To examine the association of residential neighborhood crime with asthma and asthma-related outcomes among Mexican American children., Methods: This cross-sectional study was conducted with parents of 2,023 Mexican American children. We derived measures of neighborhood (census tract) violent, property, and drug abuse crime and used multilevel generalized estimating equations to test associations of neighborhood crime counts with respiratory conditions., Results: In multiple regression models, a 1-SD increase in neighborhood property crimes significantly increased the odds of lifetime asthma, lifetime wheezing, lifetime emergency department (ED) visits attributable to asthma or wheezing, and lifetime hospitalization attributable to asthma or wheezing by 25%, 18%, 44%, and 62%, respectively. A 1-SD elevation in neighborhood violent crime was positively and significantly associated with 21% and 57% higher odds of lifetime wheezing and ED visits, respectively. We also observed 13% and 44% significantly increased odds of lifetime wheezing and ED visits, respectively, for a 1-SD increase in drug abuse crime. These findings were not explained or modified by individual- and neighborhood-level covariates., Conclusion: Higher neighborhood crime was associated with greater odds of asthma and asthma morbidity in Mexican American children., (Copyright © 2016 American College of Allergy, Asthma & Immunology. All rights reserved.)

Objective: To examine the associations of in utero and early life exposure to cats/dogs and birds with the risk of lifetime doctor-diagnosed asthma and other respiratory conditions in a sample of Mexican American (MA) children 4-18 years of age., Methods: This study is a population-based cross-sectional investigation of 1816 MA children. We conducted multiple logistic models examining the relationship of asthma and wheezing with exposures to cats/dogs and birds in utero, infancy and at the time of the survey adjusted for country of birth, family history of asthma/allergies, antibiotics use in infancy and other covariates., Results: In adjusted analyses, in utero exposure to cats/dogs and birds jointly was associated with increased odds of asthma (adjusted odds ratio (aOR): 2.89; 95% confidence interval (CI): 1.34-6.23), ever wheezing (aOR: 1.96; 95% CI: 1.11-3.46) and current exercise-induced wheezing (aOR: 3.16; 95% CI: 1.27-7.85) compared to children not exposed to these pets in utero. Children who were exposed to both cats/dogs and birds in utero had an elevated, albeit statistically non-significant, odds of current wheezing. Exposures in infancy and at the time of the survey to cats/dogs and birds were not associated with asthma or wheezing., Conclusions: In utero exposure to pets might be associated with an increased risk of asthma and respiratory conditions in a sample of non-affluent MA children.

Objective: This study examined the associations of antibiotic use in infancy with lifetime doctor-diagnosed asthma and current wheeze among Mexican American children., Methods: In a population-based, cross-sectional investigation, parents of 2023 children 4-18 years of age completed a questionnaire/interview addressing respiratory conditions, antibiotic use, and covariates., Results: In adjusted analyses, among children without history of ear infections in infancy, children who used antibiotics ≥3 times and 1-2 times were more likely to report doctor-diagnosed asthma compared with their peers who did not use antibiotics in infancy [adjusted odds ratio (aOR) = 5.14, 95% confidence interval (CI): 2.88-9.17, and aOR = 2.15, 95% CI: 1.26-3.69, respectively, p trend < 0.0001]. The respective aORs for current wheeze were 3.67 (95% CI: 1.95-6.89) and 1.63 (95% CI: 0.91-2.95). Antibiotic use in infancy was not associated with asthma or current wheeze in children who had ear infections in infancy. In additional analyses, antibiotic use in infancy was associated with asthma in children without parental history of asthma or allergies (aOR = 2.73, 95% CI: 1.70-4.39) but not in those with parental history of asthma or allergies. Among Mexico-born participants born in rural areas, antibiotic use in infancy was associated with a seven-fold increase in risk of asthma (aOR = 7.21, 95% CI: 1.46-35.65), while the association was non-significant in Mexico-born children born in urban areas in Mexico., Conclusions: Antibiotic use in infancy may increase the risk of asthma and wheezing, but these associations were limited to subgroups of children.

Background: With Direct Acting Antivirals for Hepatitis C virus (HCV), cure is possible in > 95% including those with HIV/HCV co-infection. Achieving strategic targets for cure requires addressing barriers including suboptimal care engagement. We adapted Data to Care (D2C), a public health strategy designed to identify and link persons out of care (OOC) for HIV, for persons with HIV/HCV co-infection untreated for HCV. Methods: In partnership with Connecticut Department of Public Health (DPH), persons OOC for HIV (defined as no HIV surveillance laboratory tests from 10/1/2018–10/1/2019) were matched to a list of persons co-infected with HIV/HCV (through 12/31/2019). We used a three-phase follow-up approach (pre-work, case conferencing, and Disease Intervention Specialist (DIS) follow-up) to track outreach outcomes and re-engagement/HCV cure success. Results: There were 90 HIV/HCV co-infected persons who were OOC for HIV. The pre-work and case conferencing phases determined that 33 (36.7%) had previous HCV cure or were in treatment. There were 41 eligible for DIS-follow-up of which 21 (51%) were successfully contacted and 7 (33%) successfully re-engaged (kept appointment with HCV provider). No new HCV treatment initiations were recorded. Conclusions: Using a D2C approach, we identified and conducted outreach to persons who were OOC for HIV to promote HCV treatment. This approach resulted in intensive data clean-up and outreach efforts which produced modest re-engagement and no HCV treatment initiations. Future studies should develop alternative and complementary interventions to promote effective re-engagement and HCV treatment. [ABSTRACT FROM AUTHOR]

Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease characterized by complement-mediated hemolysis. OPERA is the first US longitudinal real-world study on C3 inhibitor therapy, known as pegcetacoplan. Methods: OPERA enrolled US patients with PNH, age ≥18, who were prescribed pegcetacoplan, and data were collected from routine care. Hemoglobin was reported by patients during regular follow-up (censored from transfusions). The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (0–52 score) and Patient-Reported Outcomes Measurement Information System scale for Cognitive Function Abilities (PROMIS-CF; 23.27–67.09 t-score) were completed electronically (low score = negative outcome). Patients self-reported incidence of healthcare resource utilization (HCRU). Results: By January 2024, 70 patients (mean age 44.6 years; 57.1% female) reported up to 9 months of pegcetacoplan treatment, with a median [IQR] follow-up of 6.6 [3.8] months. The latest reported hemoglobin levels improved by a mean (SD) of 2.6 (1.9) g/dL from baseline. At 3, 6 and 9 months, patients reported clinically meaningful improvements (≥5 points) in FACIT-F (53.3–69.0%) and (≥2 points) PROMIS-CF (46.7–55.2%). Patients reported a <10% incidence rate per person month of all HCRU events. Conclusions: This first longitudinal real-world US study indicates a positive trend in Hb, fatigue, and cognition with limited HCRU during pegcetacoplan treatment in adults with PNH. [ABSTRACT FROM AUTHOR]

Numerous epidemiologic studies have used remote sensing to quantify the contribution of greenness, air pollution, and wildfire smoke to asthma and other respiration outcomes. This is the first review paper to evaluate the influence of remote sensing exposures on specific outcome severity and risk factors in different ecological settings. Literature searches utilizing PubMed and Google Scholar identified 61 unique studies published between 2009 and 2023, with 198 specific outcomes. Respiration-specific outcomes were lower in greenness and higher in air pollution and wildfire ecological settings. Aerosol optical depth (AOD)-PM2.5 readings and specific outcomes were higher in economically developing than in economically developed countries. Prospective studies found prenatal and infant exposure to higher ambient AOD-PM2.5 concentration level readings contributed to higher childhood asthma incidence. Lung function was higher in greenness and lower in the other two ecological settings. Age, environment, gender, other, and total risk factors showed significant differences between health outcomes and ecological settings. Published studies utilized physiologic mechanisms of immune, inflammation, and oxidative stress to describe obtained results. Individual and total physiologic mechanisms differed between ecological settings. Study results were used to develop a descriptive physiologic asthma model and propose updated population-based asthma intervention program guidelines. [ABSTRACT FROM AUTHOR]

Background: Men who have sex with men (MSM) are disproportionately affected by sexually transmitted infections (STI) including Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). The lack of robust data on STIs among African MSM has limited the development of evidence-based screening strategies. This study aimed at documenting the pooled prevalence of Ng/Ct among MSM in sub-Saharan Africa (SSA). Methods: This systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) 2020 guidelines. Relevant articles from the following databases were searched: PubMed, Scopus, ISI Web of Science, and the Directory of Open Access Journals (DOAJ). Eligible studies reported on the prevalence of Ng/Ct among the MSM population in SSA. Publication bias was assessed using the Hoy tool, Doi plot, and LFK ratio. Due to heterogeneity among studies, subgroup analyses were performed using the MetaXL add-on tool for Microsoft Excel. Results: Of 525 articles screened, 20 were selected for inclusion. Six were cross-sectional, four had a prospective cohort study design, and one was an epidemiological study. The pooled prevalence of Ng/Ct in MSM was 27% (95% CI, 19–39%), with an I2 of 98% signifying heterogeneity among the studies. Subgroup analysis by country revealed South Africa had the highest prevalence (38%). Discussion: Interpretation The high prevalence of Ng/Ct infection among MSM in SSA is of concern. Limitations Due to limited data available on Ng/Ct prevalence, the true prevalence of SSA and its associated risk factors is uncertain. Conclusion: As the first study to systematically review the available literature on STI prevalence among the MSM population in SSA, it showed the burden of Ng/Ct is higher than in other regions, warranting the strengthening of health systems to improve education, testing, and treatment in MSM population. Systematic review registration: PROSPERO CRD42022327095. [ABSTRACT FROM AUTHOR]

Introduction: Noncommunicable diseases (NCDs) are the leading cause of morbidity and mortality worldwide, accounting for 74% of deaths annually. Satellite imagery provides previously unattainable data about factors related to NCDs that overcome limitations of traditional, non-satellite-derived environmental data, such as subjectivity and requirements of a smaller geographic area of focus. This systematic literature review determined how satellite imagery has been used to address the top NCDs in the world, including cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes. Methods: A literature search was performed using PubMed (including MEDLINE), CINAHL, Web of Science, Science Direct, Green FILE, and Engineering Village for articles published through June 6, 2023. Quantitative, qualitative, and mixed-methods peer-reviewed studies about satellite imagery in the context of the top NCDs (cancer, cardiovascular disease, chronic respiratory disease, and diabetes) were included. Articles were assessed for quality using the criteria from the Oxford Centre for Evidence-Based Medicine. Results: A total of 43 studies were included, including 5 prospective comparative cohort trials, 22 retrospective cohort studies, and 16 cross-sectional studies. Country economies of the included studies were 72% high-income, 16% upper-middle-income, 9% lower-middle-income, and 0% low-income. One study was global. 93% of the studies found an association between the satellite data and NCD outcome(s). A variety of methods were used to extract satellite data, with the main methods being using publicly available algorithms (79.1%), preprocessing techniques (34.9%), external resource tools (30.2%) and publicly available models (13.9%). All four NCD types examined appeared in at least 20% of the studies. Conclusion: Researchers have demonstrated they can successfully use satellite imagery data to investigate the world's top NCDs. However, given the rapid increase in satellite technology and artificial intelligence, much of satellite imagery used to address NCDs remains largely untapped. In particular, with most existing studies focusing on high-income countries, future research should use satellite data, to overcome limitations of traditional data, from lower-income countries which have a greater burden of morbidity and mortality from NCDs. Furthermore, creating and refining effective methods to extract and process satellite data may facilitate satellite data's use among scientists studying NCDs worldwide. [ABSTRACT FROM AUTHOR]

Background: Although complement component 5 inhibitors (C5is) eculizumab and ravulizumab improve paroxysmal nocturnal hemoglobinuria (PNH) outcomes, patients may experience persistent anemia. This post hoc analysis investigated whether the complement component 3-targeted therapy pegcetacoplan also improved hematologic outcomes and reduced fatigue in patients with PNH and mild/moderate anemia. Methods: Patients with PNH and hemoglobin ≥10.0 g/dL at baseline of PADDOCK (N = 6), PRINCE (N = 8), and PEGASUS (N = 11) were included. Before receiving pegcetacoplan, PADDOCK and PRINCE patients were C5i-naive; PEGASUS patients had hemoglobin <10.5 g/dL despite stably dosed eculizumab. Hemoglobin concentrations, percentages of patients with concentrations ≥12 g/dL, and sex-specific normalization were assessed at baseline and after 16 weeks of pegcetacoplan, as were absolute reticulocyte counts (ARCs) and normalization and fatigue scores and normalization. Results: From baseline to week 16, mean (SD) hemoglobin concentrations increased in C5i-naive patients (PADDOCK: 10.5 [0.4] to 12.7 [1.1] g/dL; PRINCE: 11.3 [1.0] to 14.0 [1.3] g/dL) and those with suboptimal eculizumab responses (PEGASUS: 10.2 [0.2] to 12.8 [2.6] g/dL). Percentage of patients with hemoglobin ≥12 g/dL increased (PADDOCK: 0 to 60.0% [3 of 5 patients]; PRINCE: 25.0% [2 of 8] to 87.5% [7 of 8]; PEGASUS: 0 to 72.7% [8 of 11]). Sex-specific hemoglobin normalization at week 16 occurred in 40.0% (2 of 5) (PADDOCK), 62.5% (5 of 8) (PRINCE), and 63.6% (7 of 11) (PEGASUS). In all studies, mean ARCs decreased from above normal to normal and ARC normalization increased. Mean Functional Assessment of Chronic Illness Therapy–Fatigue scores improved from below to above or near normal. Two patients had serious adverse events (PEGASUS: post-surgery sepsis, breakthrough hemolysis); breakthrough hemolysis resolved without study discontinuation. Conclusion: Patients with PNH and mild/moderate anemia who were C5i-naive or who had suboptimal hemoglobin concentrations despite eculizumab treatment had improved hematologic outcomes and reduced fatigue after initiating or switching to pegcetacoplan. Trial registration: Trial registration numbers: PADDOCK (NCT02588833), PRINCE (NCT04085601; EudraCT, 2018-004220-11), PEGASUS (NCT03500549). [ABSTRACT FROM AUTHOR]

Background: Individuals with transfusion-dependent β-thalassemia (TDT) experience symptoms and functional impacts that reduce their health-related quality of life. However, EQ-5D-derived health utility index scores in TDT often indicate good HRQoL, suggesting the EQ-5D may not adequately capture the impact of TDT. This study explored the disease and treatment burden of TDT and examined the appropriateness of the EQ-5D-5L descriptive system (DS) in measuring HRQoL in TDT. Methods: Adults with TDT in the United Kingdom, United States, and France completed a background questionnaire and EQ-5D-5L DS, followed by 60-minute semi-structured interviews on symptoms and HRQoL impacts of TDT (concept elicitation) and appropriateness of EQ-5D-5L DS (cognitive debrief). Transcribed interviews were analyzed using thematic and content analyses. The relationship between TDT symptoms and impacts were summarized in a conceptual model. EQ-5D-5L DS was mapped to concepts identified in the qualitative data to assess its capture of HRQoL concepts. Participants' EQ-5D-5L DS scores were compared to their qualitative descriptions for each dimension to assess their concordance. Results: Thirty participants in the United States (n = 14 [46.7%]), United Kingdom. (n = 12 [40.0%]), and France (n = 4 [13.3%]) completed the study (73.3% female; mean age = 28.4 years [standard deviation (SD) = 5.1]; mean annual red blood cell transfusion [RBCT] frequency = 18.4 [SD = 7.6]). Participants reported TDT symptoms and impacts on HRQoL, all fluctuating across the RBCT cycle. EQ-5D-5L DS did not fully capture 11 of 16 (68.8%) HRQoL concepts reported. Most participants (n = 20/27 [74.1%]) reported that EQ-5D-5L DS did not capture important aspects of living with TDT, and 42.9% (n = 12/28) reported negative/neutral overall impressions of EQ-5D-5L DS. The highest degree of discordance between participants' qualitative data and EQ-5D-5L DS dimension scores was observed with mobility (42.3%) and self-care (34.6%), where the qualitative descriptions relating to these dimensions were worse than their quantitative scores. Conclusion: Current findings suggest that EQ-5D-5L DS lacks content validity and the derived health utility index score may not fully represent the burden of disease in TDT. [ABSTRACT FROM AUTHOR]

Men who have sex with men (MSM) across South Africa face significant health disparities rooted in stigmatization due to their sexual orientation, which negatively affects their health. Toward curbing sexually transmitted diseases and ensuring equitable distribution of access to health services for MSM, this study developed a framework capable of providing equal health for MSM in South Africa. The study aims to develop a framework that promote equitable health among MSM in South Africa. This study adopted a qualitative method with in-depth consented interviews targeted at MSM in Umlazi township, South Africa. A total of 25 MSM were interviewed, and their responses were analyzed using Nvivo 11, supported by content analysis. The Equitable Health Access Framework (EHAF) was developed using the study findings, guided by the WHO framework for social health determinants, and underpinned by the systems theory. The framework was structured around three factors: input, processes and output. The key finding depicted that the implementation and collaboration of the input and process will result in an output of equitable health access for MSM. Based on the study findings, the processes and key factors to be considered are sensitization training, community engagement and support, MSM empowerment program, and health promotion. At the same time, the input are finance, human resources, infrastructure, medical equipment and consumables. The "framework" could guide policymakers and health professionals by providing structured processes and key elements to ensure better health space and equal healthcare delivery to MSM in the research setting and similar settings in developing countries. Plain language summary: A detailed plan to ensure fair healthcare services access for men who have sex with other men in South Africa The focus of this study is on South Africa, men who have sex with men who are often seen to suffer with health problems because of their sexual orientation. And in order to help them in dealing with their health issues researcher talked to 25 MSM in Umlazi and learnt about their personal stories. And it was the result of their feedback that help in developing the study framework which is called the Equitable Health Access Framework (EHAF). The framework describes mechanisms that can be used to grant MSM population platform to better access healthcare with the interventions like health education, trainings and community support. It's expected that with this framework different policy makers, health care workers and program implementers will be able to use the mechanism to better support MSM in accessing health services withouth any fear, stigma or discimination. [ABSTRACT FROM AUTHOR]

From the results of well-performed population health studies, we now have excellent data demonstrating that deficits in adult lung function may be present early in life, possibly as a result of developmental disorders, incurring a lifelong risk of obstructive airway diseases such as asthma and chronic obstructive pulmonary disease. Suboptimal fetal development results in intrauterine growth restriction and low birth weight at term (an outcome distinct from preterm complications), which are associated with subsequent obstructive disease. Numerous prenatal exposures and disorders compromise fetal development and these are summarized herein. Various physiological, structural, and mechanical abnormalities may result from prenatal disruption, including changes to airway smooth muscle structure-function, goblet cell biology, airway stiffness, geometry of the bronchial tree, lung parenchymal structure and mechanics, respiratory skeletal muscle contraction, and pulmonary inflammation. The literature therefore supports the need for early life intervention to prevent or correct growth defects, which may include simple nutritional or antioxidant therapy. © 2024 American Physiological Society. Compr Physiol 14:5729-5762, 2024., (Copyright © 2024 American Physiological Society. All rights reserved.)

Globally, gay, bisexual, and other men who have sex with men (GBMSM) are disproportionately affected by HIV, but few interventions address mental health and HIV outcomes among GBMSM living with HIV. The purpose of this study was to pilot a multicomponent intervention, integrating emotional well-being (EW) and health navigation for GBMSM living with HIV in Guatemala City. We implemented a 12-month intervention, including a four-session EW component and a health navigation component among newly diagnosed and reengaged GBMSM with HIV (n = 112). We conducted socio-behavioral surveys at baseline and endline to measure patient characteristics and HIV, and mental health outcomes as well as viral load testing. We documented participation in EW sessions and used a smartphone application to track navigation mode, frequency, and content. Using first-difference estimation modeling, we assessed associations between participation in EW and navigation and mental health (depression and anxiety symptoms) and HIV outcomes (HIV treatment adherence, viral suppression). Acceptability was high for EW (86%) and navigation (99%). During the intervention, viral suppression increased significantly and anxiety and depression decreased significantly. Participation in EW sessions and greater navigation frequency and duration were associated with being suppressed, whereas higher emotional navigator support was associated with being unsuppressed. Participation in EW sessions was associated with reduced anxiety. Findings suggest that multicomponent interventions integrating individual counseling and navigation may promote EW and sustained viral suppression. Future intervention research is needed to confirm whether HIV and mental health outcomes are attributable to the intervention and to assess mechanisms of influence. [ABSTRACT FROM AUTHOR]

A cohort of individuals in care for HIV infection who were identified as being recently out-of-care (OOC) was recruited for a trial using a data-to-care approach and an intervention to facilitate re-engagement and retention in care. This allowed for analysis of demographic and clinical characteristics correlated with recently being OOC, re-engagement, and successful retention in care and viral suppression. Recently OOC persons with HIV infection (PWH) were identified for enrollment in the Cooperative Re-engagement Controlled Trial (CoRECT). CoRECT employed a data-to-care strategy, using both clinical and surveillance data, and an active public health re-engagement intervention. We estimated relative risks (RRs), unadjusted and with multivariate log binomial regression models, to analyze associations between sociodemographic and clinical predictors of being OOC, re-engagement, retention in care, and viral suppression. Of the 630 OOC PWH enrolled in CoRECT, most were male (72.7%) and over 30 years old (91.3%). Almost 40.0% were Black non-Hispanic, 29.7% were non-US born, and 41.6% were men who have sex with men (MSM). Possible predictors of re-engagement, retention in care, and viral suppression included younger age, Hispanic race/ethnicity, birth in a US dependency, AIDS status, and HIV exposure mode. Viral suppression status within 1-year pre-enrollment was significantly associated with all outcomes: re-engagement (aRR 1.28), retention (aRR 1.72), viral suppression (aRR 1.81), and durable viral suppression (aRR 3.30). Findings elucidate factors associated with care engagement and continuity for recently OOC PWH which can be used to inform targeted re-engagement activities for priority populations and guide future data-to-care interventions., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

We study the 2‐parity conjecture for Jacobians of hyperelliptic curves over number fields. Under some mild assumptions on their reduction, we prove the conjecture over quadratic extensions of the base field. The proof proceeds via a generalisation of a formula of Kramer and Tunnell relating local invariants of the curve, which may be of independent interest. A new feature of this generalisation is the appearance of terms which govern whether or not the Cassels–Tate pairing on the Jacobian is alternating, which first appeared in work of Poonen–Stoll. We establish the local formula in many instances and show that in remaining cases, it follows from standard global conjectures. [ABSTRACT FROM AUTHOR]

no abstract [ABSTRACT FROM AUTHOR]

Exposure to greenness is increasingly linked to beneficial health outcomes, but the associations between greenness and the disease burden of lower respiratory infections (LRIs) are unclear. We used the normalized difference vegetation index (NDVI) and the leaf area index (LAI) to measure greenness and incidence, death, and disability-adjusted life years (DALYs) due to LRIs to represent the disease burden of LRIs. We applied a generalized linear mixed model to evaluate the association between greenness and LRI disease burden and performed a stratified analysis, after adjusting for covariates. Additionally, we assessed the potential mediating effects of fine particulate matter (PM2.5), ozone (O3), nitrogen dioxide (NO2), and heat on the association between greenness and the disease burden of LRIs. In the adjusted model, one 0.1 unit increase of NDVI and 0.5 increase in LAI were significantly inversely associated with incidence, death, and DALYs due to LRIs, respectively. Greenness was negatively correlated with the disease burden of LRIs across 15–65 age group, both sexes, and low SDI groups. PM2.5, O3, and heat mediated the effects of greenness on the disease burden of LRIs. Greenness was significantly negatively associated with the disease burden of LRIs, possibly by reducing exposure to air pollution and heat. [ABSTRACT FROM AUTHOR]

Background: Bacterial sexually transmitted infections (STIs) including Neisseria gonorrhoeae and Chlamydia trachomatis are common in men who have sex with men (MSM). These infections increase the risk of acquiring and transmitting human immunodeficiency virus (HIV) in this key population. Access to MSM in many countries in sub-Saharan Africa remains generally difficult due to discrimination or criminalization of their sexual orientation which could lead to depression and risky sexual practices associated with prevalence. This protocol therefore proposes to undertake a systematic review and meta-analysis of literature on the prevalence of gonococcal and chlamydial infections among MSM in Sub-Saharan Africa. Methods: This review which aims to ascertain the pooled prevalence and risk factors of these infections in sub-Saharan Africa's MSM population will follow the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines. The search strategy will review relevant articles from the following databases: PubMed, Scopus, ISI Web of Science and the Directory of Open Access Journals (DOAJ). Articles screening for eligibility and data extraction will be conducted by two independent reviewers. All discrepancies will be resolved by the third and fourth reviewers. Heterogeneity in studies will be evaluated using the I2 statistic and where heterogeneity is high and significant, a random effect model will be used to estimate the pooled prevalence. Publication bias will be assessed using the Doi plot. Extracted data will be analysed using MetaXL add-on for Microsoft excel. Data will be presented in tables and graphically presented in forest plots. Discussion: In this study, we anticipate being able to systematically determine the prevalence of Neisseria gonorrhoeae and Chlamydia trachomatis among MSM as well as explore possible risk factors associated with prevalence. The outcomes of the systematic review and meta-analyses will serve to support researchers and public health stakeholders in identifying healthcare priorities and in addressing issues pertaining to the overall wellbeing of the MSM community. Systematic review registration: PROSPERO CRD42022327095 [ABSTRACT FROM AUTHOR]

Objective: To estimate the incremental healthcare resource utilization (HRU) and cost burden posed by herpes zoster (HZ) in adult patients with rheumatoid arthritis (RA) in the United States. Methods: A retrospective cohort study was conducted using an administrative claims database containing commercial and Medicare Advantage with Part D data, between October 2015 and February 2020. Patients with RA and HZ (RA+/HZ+) or RA without HZ (RA+/HZ−) were identified based on diagnosis codes and relevant medications. Outcomes measured included HRU and medical, pharmacy, and total costs at month 1, quarter 1, and year 1 after the index date (HZ diagnosis for RA+/HZ+ cohort, randomly assigned for RA+/HZ− cohort). Generalized linear models incorporating propensity scores and other covariates were used to estimate differences in outcomes between cohorts. Results: A total of 1866 patients from the RA+/HZ+ cohort and 38,846 patients from the RA+/HZ− cohort were included. Hospitalizations and emergency department visits occurred more frequently in the RA+/HZ+ than the RA+/HZ− cohort, especially in the month after HZ diagnosis (adjusted incidence rate ratio [95% confidence interval (CI)] for hospitalizations: 3.4 [2.8; 4.2]; emergency department visits: 3.7 [3.0; 4.4]). Total costs were also higher in the month after HZ diagnosis (mean adjusted cost difference [95% CI]: $3404 [$2089; $4779]), with cost differences driven by increased medical costs ($2677 [$1692; $3670]). Conclusions: These findings highlight the high economic burden of HZ among individuals with RA in the United States. Strategies to reduce the risk of HZ in patients with RA (such as vaccination) may serve to reduce this burden. 5XaYxHPE7TWLkoqv3bZsDY Video abstract [ABSTRACT FROM AUTHOR]