Total Person-time Research Articles

Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring in South Korea

Objectives: This study aimed to estimate background incidence rates (IR) for adverse events of special interest (AESI) associated with COVID-19 vaccines in South Korea. Methods: We used data from the Korean National Health Insurance Service-National Sample Cohort from January 1, 2015 to December 31, 2019, with IR calculated annually. Eight AESIs including acute myocarditis, acute pericarditis, acute disseminated encephalomyelitis (ADEM), acute transverse myelitis (ATM), encephalitis, anaphylaxis, Bell’s palsy, and lymphadenitis were evaluated. Two operational strategies were implemented: a broad definition using ICD-10 codes for primary or secondary diagnoses to enhance sensitivity, and a narrow definition integrating ICD-10 codes with procedure and drug codes for enhanced accuracy and specificity. IR was calculated by dividing the number of incident cases by the total person-time at risk, with separate analyses by sex and age. Results: During the study period, the incidence of anaphylaxis, Bell’s palsy, and lymphadenitis under the broad definition continued to increase. Under the narrow definition, there were no reported cases of acute myocarditis or Bell’s palsy from 2015 to 2019. Additionally, the incidence rates for acute pericarditis, ADEM, ATM, encephalitis, anaphylaxis, and lymphadenitis were lower than those calculated under the broad definition. Males generally had higher rates, except for Bell’s palsy and lymphadenitis. Most AESIs were more common in individuals aged 65 and older, whereas ADEM and lymphadenitis were higher in children aged 0-19 years. Conclusions: Variability in AESI rates emphasizes the importance of considering definitions and demographics when establishing background rates for surveillance, which is a critical aspect of monitoring vaccine safety.

Incidence of switching to second-line antiretroviral therapy and its predictors among children on antiretroviral therapy at general hospitals, Northern Ethiopia: A survival analysis.

With expanding access to pediatric antiretroviral therapy, several patients in the developing world were switched to the second-line regimen, and some require third-line medications. A delay in a second-line switch is associated with an increased risk of mortality and other undesired therapeutic outcomes, drives up program costs, and challenges the pediatric antiretroviral therapy service. Nevertheless, there remain limited and often conflicting estimates on second-line antiretroviral therapy use during childhood, especially in resource-limited settings like Ethiopia. Thus, this study intended to determine the incidence and predictors of switching to second-line antiretroviral therapy among children. A retrospective cohort study was conducted by reviewing records of 424 randomly selected children on first-line antiretroviral therapy from January 2014 to December 2018 at public hospitals in the Central and Southern Zones of Tigray, Northern Ethiopia. Data were collected using extraction tool; entered into Epi-data; cleaned, and analyzed by STATA version-14. Kaplan-Meier curve, log-rank test, and life table were used for data description and adjusted hazard ratios and p-value for analysis by Cox proportional hazard regression. Variables at a P-value of ≤0.20 in the bi-variable analysis were taken to multivariable analysis. Finally, statistical significance was declared at a P-value of ≤0.05. Analysis was conducted on 424 charts with a total person-time observation of 11686.1 child-months and an incidence switch rate of 5.6 (95%CI: 4.36-7.09) per 1000 child-month-observations. Being orphan [AHR = 2.36; 95%CI: 1.10-5.07], suboptimal adherence [AHR = 2.10; 95% CI: 1.12-3.92], drug toxicity [AHR = 7.05; 95% CI: 3.61-13.75], advanced latest clinical stage [AHR = 2.75; 95%CI: 1.05-7.15], and tuberculosis co-infection at baseline [AHR = 3.08; 95%CI: 1.26-7.51] were significantly associated with switch to second-line antiretroviral therapy regimen. Moreover, a long duration of follow-up [AHR = 0.75; 95% CI: 0.71-0.81] was associated with decreased risk of switching. Hence, it is better to prioritize strengthening the focused evaluation of tuberculosis co-infection and treatment failure with continuous adherence monitoring. Further research is also needed to evaluate the effect of drug resistance.

#5448 INCIDENCE OF ACUTE PULMONARY EDEMA AFTER THE SYSTEMATIC USE OF ULTRASOUND B-LINES

Abstract Background and Aims Acute pulmonary edema (APE) due to fluid overload is considered the most feared complication in hemodialysis patients. Various diagnostic tests have been proposed to assess fluid status in patients with end stage kidney failure (ESKF) and among these lung ultrasound (by measuring the number of B-Lines) is emerging as a promising tool to identify pulmonary congestion in this patient-population. Method In the setting of a retrospective study, we pragmatically compared the incidence rate of APE in our center before and after the implementation of lung ultrasound as a routine practice in our unit. Two periods were considered. A pre-implementation period [from 01/01/2007 to 31/12/2008, total person-time: 1913 months/patient, n = 98 patients (Group 1), 85 prevalent and 13 incident patients] and a post-implementation period [from 01/01/2017 to 31/12/2018, total person-time: 2061 months/patient, n = 108 patients (Group 2), 81 prevalent and 27 incident patients]. By accurately reviewing the electronic medical records, all episodes of APE were counted, i.e. all episodes characterized by sudden or worsening dyspnea associated with signs of salt and water overload, confirmed by chest auscultation or chest X-Ray, which required an additional dialysis session and excluding events due to infectious or irritating problems. Results The two groups (Group 1 vs Group 2) were quite similar between them as for age (64±15 vs 67±14 years, p = 0.06), proportion of males (65% vs 62%, p = 0.37) and median dialysis vintage [40 months (interquartile Range, IQR: 16–93 months) vs 46 months (IQR: 12–92), p = 0.76]. The two groups did not differ as for diabetes (21% vs 25%, P = 0.33), hypertension (75% vs 71%, p = 0.36), and smoking habit (29% vs 28%, p = 0.51). Of note, the proportion of patients with background cardiovascular comorbidities was significantly higher in patients of Group 2 (enrolled in the post-implementation period) than in those of Group 1 (31% vs 19%, p = 0.04]. A total of 37 APE episodes in 18 patients (from 1 to 4 episodes per patient) were identified in patients of Group 1 vs 7 APE episodes in 5 patients (from 1 to 2 episodes per patient) in those of Group 2. The incidence rate of APE was 82% lower in patients during the post-implementation period (4 episodes per 100 patients/year, 95% CI: 1–8) than in those during the post implementation period (23 episodes per 100 patient/year, 95% CI: 17–32) (incidence rate ratio: 0.18, 95% CI: 0.10-0.29, p<0.001). Conclusion The systematic use of lung ultrasound (simple, easy to learn, rapid and non-invasive method, easily performed at the patient's bed) in every day clinical practice drastically reduced (-82%) the episodes of APE in hemodialysis patients. Further observational and interventional studies are needed to confirm these results.

Estimating HIV Incident Diagnoses Among Men Who Have Sex With Men Eligible for Pre-exposure Prophylaxis but Not Taking It: Protocol and Feasibility Assessment of Data Sources and Methods

HIV incidence estimates are published each year for all Ending the HIV Epidemic (EHE) counties, but they are not stratified by the demographic variables highly associated with risk of infection. Regularly updated estimates of HIV incident diagnoses available at local levels are required to monitor the epidemic in the United States over time and could contribute to background incidence rate estimates for alternative clinical trial designs for new HIV prevention products. We describe methods using existing, robust data sources within areas in the United States to reliably estimate longitudinal HIV incident diagnoses stratified by race and age categories among men who have sex with other men (MSM) eligible for pre-exposure prophylaxis (PrEP) but not taking it. This is a secondary analysis of existing data sources to develop new estimates of incident HIV diagnoses in MSM. We reviewed past methods used to estimate incident diagnoses and explored opportunities to improve these estimates. We will use existing surveillance data sources and population sizes of HIV PrEP-eligible MSM estimated from population-based data sources (eg, US Census data and pharmaceutical prescription databases) to develop metropolitan statistical area-level estimates of new HIV diagnoses among PrEP-eligible MSM. Required parameters are number of new diagnoses among MSM, estimates of MSM with an indication for PrEP, and prevalent PrEP use including median duration of use; these parameters will be stratified by jurisdiction and age group or race or ethnicity. Preliminary outputs will be available in 2023, and updated estimates will be produced annually thereafter. Data to parameterize new HIV diagnoses among PrEP-eligible MSM are available with varying levels of public availability and timeliness. In early 2023, the most recent available data on new HIV diagnoses were from the 2020 HIV surveillance report, which reports 30,689 new HIV infections in 2020, and 24,724 of them occurred in an MSA with a population of ≥500,000. Updated estimates for PrEP coverage based on commercial pharmacy claims data through February 2023 will be generated. The rate of new HIV diagnoses among MSM can be estimated from new diagnoses within each demographic group (numerator) and the total person-time at risk of diagnosis for each group (denominator) by metropolitan statistical area and year. To estimate time at risk, the person-time of individuals on PrEP or person-time after incident HIV infection but before diagnosis should be removed from stratified population size estimates of the total number of person-years with indications for PrEP. Reliable, serial, cross-sectional estimates for rates of new HIV diagnoses for MSM with PrEP indications can serve as benchmark community estimates of failures of HIV prevention and opportunities to improve services and will support public health epidemic monitoring and alternative clinical trial designs. DERR1-10.2196/42267.

Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study.

In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 vaccines. A dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events. A total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively. Given the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE.

Optimal Presignal Control for Two-Mode Traffic at Isolated Signalized Intersections

Delay imposed on buses is witnessed at isolated signalized intersections, as part of the delay is created due to bus and car interactions at the signalized approaches. Inexpensive solutions that do not involve new infrastructure are the most desired. Toward reducing person delay, presignal lights are installed at the upstream of the intersection. Presignal is a control tool that can manage the interaction and space conflict between cars and buses at the mixed lanes, located after the presignals, approaching the intersection. This paper presents an optimal presignal control policy that determines signal settings based on minimization of total person-time spent. The developed model is comprised of a simplified signalized intersection with one approach, where two presignal lights are located: one for bus lane and one for car lane. A continuous-time model is first developed to describe the queue dynamics for the mixed lanes after the presignals and the bus and car lanes before the presignals. The optimal solutions are derived analytically via the Pontryagin maximum principle, and the optimal presignal control policy is determined and synthesized. The derived analytical solutions are verified through the use of the optimal control software, DIDO, which uses an advanced optimization method and solves complex dynamic optimization problems without prior knowledge of the analytical computations or the solution. Several examples are used to test and analyze the derived solutions. Finally, the microscopic simulation software AIMSUN is used to test, assess, and evaluate the performance of the proposed optimal control policy in a more realistic traffic condition, where stochastic arrivals are incorporated. Supplemental Material: The online appendix is available at https://doi.org/10.1287/trsc.2022.1172 .

Time to occurrence, predictors, and patterns of opportunistic infections incidence among HIV-positive patients attending Antiretroviral Therapy Clinic of Salale University Comprehensive Specialized Hospital: A retrospective cohort study.

Opportunistic infections (OIs) in HIV patients are infections that are more common or more severe as a result of HIV-mediated immunosuppression. The advances in the capacity of antiretroviral therapy (ART) have diminished the incidence of OIs. However, even in the ART era, HIV-related OIs continue to be major causes of hospitalization and mortality. Therefore, this study aims to identify time to occurrence, predictors, and patterns of OIs incidence among HIV-positive patients attending ART clinic of Salale University Comprehensive Specialized Hospital, Ethiopia. A retrospective cohort study was conducted between 1st September 2016 and 1st September 2021. All 419 patients diagnosed during the study period were recruited. Data were extracted from both patient medical records and ART logbooks. Stata-16 was used for data analysis. Follow-up time was calculated from the date of HIV diagnosis to the date of OIs occurrence or censoring. Cox proportional hazards regression model was used to identify the predictors of OIs incidence. The total person-time of the follow-up was 8656 person-months of observation. During the follow-up time, 199 (47.49%) of the patients had developed OIs. The incidence rate of OIs was 23 (95%CI: 20, 26) per 1000 person-months of observation. The median OIs free survival time was 36 (95%CI: 31, 40) months. Predictors such as residence, cd4 category, baseline hemoglobin level, ART side effects, isoniazid preventive therapy, and chronic disease comorbidity were significantly predicted OIs incidence. The study area’s OIs incidence remained high, requiring prompt action. To reduce the morbidity and mortality associated with OIs, HIV-positive patients with the predictors of rural residence, low CD4 category, low baseline hemoglobin level, ART side effects, not taking IPT, and baseline chronic disease comorbidity necessitate close follow-up and monitoring. Thus, we recommend focused and evidence-informed strategies to address OIs burden and improve outcomes.

COVID-19 mortality rate and its associated factors during the first and second waves in Nigeria.

COVID-19 mortality rate has not been formally assessed in Nigeria. Thus, we aimed to address this gap and identify associated mortality risk factors during the first and second waves in Nigeria. This was a retrospective analysis of national surveillance data from all 37 States in Nigeria between February 27, 2020, and April 3, 2021. The outcome variable was mortality amongst persons who tested positive for SARS-CoV-2 by Reverse-Transcriptase Polymerase Chain Reaction. Incidence rates of COVID-19 mortality was calculated by dividing the number of deaths by total person-time (in days) contributed by the entire study population and presented per 100,000 person-days with 95% Confidence Intervals (95% CI). Adjusted negative binomial regression was used to identify factors associated with COVID-19 mortality. Findings are presented as adjusted Incidence Rate Ratios (aIRR) with 95% CI. The first wave included 65,790 COVID-19 patients, of whom 994 (1∙51%) died; the second wave included 91,089 patients, of whom 513 (0∙56%) died. The incidence rate of COVID-19 mortality was higher in the first wave [54∙25 (95% CI: 50∙98-57∙73)] than in the second wave [19∙19 (17∙60-20∙93)]. Factors independently associated with increased risk of COVID-19 mortality in both waves were: age ≥45 years, male gender [first wave aIRR 1∙65 (1∙35-2∙02) and second wave 1∙52 (1∙11-2∙06)], being symptomatic [aIRR 3∙17 (2∙59-3∙89) and 3∙04 (2∙20-4∙21)], and being hospitalised [aIRR 4∙19 (3∙26-5∙39) and 7∙84 (4∙90-12∙54)]. Relative to South-West, residency in the South-South and North-West was associated with an increased risk of COVID-19 mortality in both waves. In conclusion, the rate of COVID-19 mortality in Nigeria was higher in the first wave than in the second wave, suggesting an improvement in public health response and clinical care in the second wave. However, this needs to be interpreted with caution given the inherent limitations of the country's surveillance system during the study.

EPRO-based digital symptom monitoring in a community oncology practice to reduce emergency room and inpatient utilization.

1508 Background: We have previously reported on the successful implementation of an electronic patient-reported outcomes (ePRO)-based symptom monitoring tool in a community oncology practice. Basch et al reported that use of such a tool in the academic trial setting reduced ER visits and hospitalizations. We have examined the impact of the tool on ER and inpatient utilization in this real world patient population. Methods: Highlands Oncology Group (HOG) is a 21 physician oncology group located in Northwest Arkansas. Beginning in June 2020, HOG offered patients receiving parenteral cancer therapy enrollment onto Expain, an EMR-integrated ePRO system which enables remote symptom monitoring during therapy. EMR data were linked with the Arkansas State Health Alliance for Records Exchange (SHARE), the state’s Health Information Exchange (HIE), to obtain ER visits/hospitalization data. All patients at HOG treated between September 30, 2020 and November 30, 2021 were included in this analysis. Clinical and demographic characteristics were compared in patients who enrolled on Expain versus those who did not, and corresponding p-values were calculated using Mann-Whitney and Chi-square tests. Crude rates for ER visits / hospitalizations were calculated as the total number of events per total person-time. Results: There were 855 patients enrolled on the ePRO system. Concurrently, in the same practice, 1773 patients were treated but not enrolled. Reasons for non-enrollment included patient’s choice to not participate and patient not yet offered enrollment due to rolling enrollment. The non-ePRO cohort was slightly older (66.7 vs 63.3 yrs, p <.001), more commonly male (47.3% vs 39.3%, p <.001) and less likely to be White (85.3% vs 89.4%, p = 0.003). The cohorts were comparable with respect to cancer site distribution and included a diverse and representative distribution of common malignancies receiving systemic therapy in a community practice. The proportion of patients with metastatic disease was comparable (ePRO 52.9% vs non-ePRO 51.6%, p = 0.55). Health resource utilization rates were lower for patients in the ePRO cohort: ER visits: 1.72 vs 2.34 per 100 patient-months, rate ratio and 95% CI = 0.74 (0.60, 0.92), p-value = 0.005; hospitalizations: 4.76 vs 5.41 per 100 patient-months, rate ratio and 95% CI = 0.87 (0.77, 0.99), p-value = 0.04. Conclusions: Our findings confirm the substantial benefits of using an ePRO tool in reducing health care resource utilization, and extend the initial findings of previous publications in the academic, clinical trial setting to the real world setting. This observational data is subject to confounding factors and we are evaluating the robustness using various methods to address non-comparability of the cohorts. We are further examining the benefits in specific patient subsets and attempting to correlate these benefits with improved survival.

Time to switching to second-line antiretroviral therapy and its predictors among HIV/AIDS infected children, Northern Ethiopia, 2020

Background: With expanding access to pediatric antiretroviral therapy, a growing amount of patients in the developing world has switched to second-line therapy, and some requiring third-line medications. A delay in switch increases mortality and risk of developing opportunistic infections. There remain limited and often conflicting estimates on the use of second-line ART in children. Thus, this study intended to determine the incidence and predictors of switching to second-line antiretroviral therapy among children. Methods: Retrospective follow up study was conducted. Single population proportion formula was used to estimate the sample size and all charts were taken for review. Data were collected by extraction tool; entered using Epi-data manager; cleaned and analyzed by Stata V-14. Kaplan-Meier curve, log-rank test, life table, and crude hazard ratios were used for data description and adjusted hazard ratios and p-value for analysis by Cox proportional hazard regression. Any variable at P≤0.25 in the bi-variable analysis was taken to multivariate analysis and significance was declared at P≤0.05. Data were presented using texts, tables, and figures. Results: An overall 424 charts were incorporated for analysis. The total person-time observation was 11686.1 child-months with the incidence switch rate of 5.6 (95% CI 4.36-7.09) per 1000 child-months of observation. Being orphaned [AHR=2.36; 95%CI: 1.10-5.07], suboptimal ART adherence [AHR= 2.10; 95% CI: 1.12-3.92], drug toxicity [AHR= 7.05; 95% CI: 3.61-13.75], advanced recent WHO stage [AHR=2.75; 95%CI: 1.05-7.15], and initiating ART with TB co-infection [AHR=3.08; 95%CI: 1.26-7.51] were significantly associated with switch to second-line ART regimen. Moreover, long duration of ART follow up [AHR=0.75; 95% CI: 0.71-0.81] was found to be protective against switching. Conclusion and recommendation: A remarkable delay in switching to second-line ART drugs was observed. Having sub-optimal adherence, baseline TB infection, advanced WHO stage on follow-up, ART toxicity, being an orphan, and duration of follow up were independent predictors of switching. Hence, it is better to give priority for strengthening the focused evaluation of tuberculosis co-infection and treatment failure with continuous adherence monitoring. Further research is also needed to evaluate the effect of drug resistance.

Survival of Patients with Floor of Mouth Squamous Cell Carcinoma Treated with Surgical Resection and Reconstruction

To identify predictors of survival in patients with floor of mouth Squamous Cell Carcinoma (FOMSCC) in order to improve patient selection for resource intensive resection and reconstruction procedures. A retrospective record review of patients who underwent resection and reconstruction for FOMSCC at Charlotte Maxeke Johannesburg Academic Hospital. Patient data were collected and analyzed with respect to age, sex, race, tobacco usage, alcohol usage, tumour stage and post-operative chemo-radiation. One- and five-year recurrence and survival rates were also evaluated. Within the study period, 20 patients were identified that were treated with resection and reconstruction for FOMSCC. The mean age at diagnosis was 56.85 years, with 70 percent of the sample being male and fifty percent being black. Amongst the sample, 90 percent of patients used tobacco and 60 percent were frequent alcohol users. The most common stage at diagnosis was stage IVA which was found in 40 percent of the sample. There were no significant factors associated with recurrence at 1 year. At 5 years, alcohol usage was a significant predictor of recurrence (P=0.044).There were no significant factors associated with death at 1 year however tumour stage at 5 years was a significant predictor (P=0.035). Out of 20 patients, five patients had recurrence. Total person-time was 72.9 person-years, with a mean follow-up time of 3.65 (SD 2.04) years per person. Out of 20 patients, nine patients died within 5 years (45%). Alcohol was the only statistically significant factor associated with increased mortality. Our findings suggest earlier diagnosis, and active treatment of early stage disease may be the best means of improving 5-year survival rates. Efforts to improve quality of care and manage limited resources should concentrate on choosing the appropriate disease stage for surgical management, improve cancer surveillance and strengthen referral system so as to improve early detection of disease and provide, social support and counselling for adjunctive habits such alcohol and tobacco use cessation which will improve patient outcomes.

Predictors of Mortality among Adult People Living with HIV and Its Implications for Appointment Spacing Model Approach Care.

Ethiopia has been motivated to achieve a goal of "appointment spacing model approach care." However, little has been documented on the predictor of mortality and challenges of sustainable HIV care. Therefore, the aim of this study was to determine predictors of mortality among adult people living with HIV/AIDS on antiretroviral therapy (ART). A retrospective cohort study was conducted on 676 adult people living with HIV who enrolled to ART clinic from September 01, 2012 - August 30, 2016. Multivariable Cox Regression analysis was done where adjusted hazard ratio (AHR)with corresponding 95% confidence interval (CI) at P value ≤ 0.05 cut of point was used to identify predictors of mortality. The total person-time contributed was 28,209 person-months with an overall mortality incidence rate of 11 per 1000 person-months observation. The cumulative mortality incidence among females over the study period was 16.8% (64/382). Severe undernourishment and moderate malnutrition at baseline, younger age, female sex, single, divorced, illiterate, lack of disclosure, advanced WHO clinical stage, seeking treatment outside catchment area, rural residence and immunological failure were found to be independent predictors of mortality. Poor nutritional status at baseline, advanced stage of HIV disease, occurrence of treatment failure, female sex, substance abuse, lack of social support, immunological failure, clinical failure, and younger age, low level of education and poor physical access to healthcare facility were found to be important predictors of mortality. Intervening, those factors as routine and part of the appointment spacing model care can improve survival of PLWHA.

Long-term audiological benefit with an active transcutaneous bone-conduction device: a retrospective cohort analysis.

To evaluate long-term audiological, surgical and safety outcomes of a complex patient cohort treated with an active transcutaneous bone-conduction device (tBCD). This retrospective, monocentric cohort analysis involves 31 adults with conductive (CHL) and mixed hearing loss (MHL). For outcome analysis, study results were divided into short-term follow-up data (< 12months) and long-term follow-up data (> 12months). 31 patients with a total person-time of 90.4years and an average number of 3.2 ± 1.5 preoperatively performed surgeries on the implanted side were investigated. Mean BCD-aided PTA4 thresholds were significantly lower than unaided PTA4AC before surgery (64.7 ± 16.1dB HL; CHL 50.6 ± 10.6dB HL; MHL 72.8 ± 12.8dB HL) and did not change between short-term (42.3 ± 13.1dB HL; CHL 35.8 ± 6.8dB HL; MHL 45.2 ± 14.3dB HL) and long-term (43.4 ± 10.0dB HL; CHL 35.8 ± 4.3dB HL; MHL 48.1 ± 9.6dB HL) follow-up periods. Speech intelligibility in the Freiburg monosyllables test at 65dB improved significantly, from 16.3 ± 21.5% (CHL 26.8 ± 19.0%; MHL 8.7 ± 20.5%) in the unaided condition to 82.7 ± 15.5% (CHL 90.0 ± 12.2%; MHL 79.4 ± 16.3%) in the short-term and 85.5 ± 13.2% (CHL 93.8 ± 7.9%; MHL 79.5 ± 13.3%) BCD-aided in the long-term follow-up periods. Ten minor procedure-related and 6 implant-related (5 minor, 1 major) AEs occurred over the total follow-up period. The device provides satisfactory audiological and speech benefit over long-term follow-up periods, up to 7years. Explant rates were very low, while the overall rate of manageable AEs was high in this complex patient cohort. The device is considered a safe and effective option in the long-term hearing rehabilitation of patients with CHL and MHL.

Preventive service utilization among low-income cancer survivors

PurposeAdequate access to and utilization of preventive services are vital among cancer survivors. This study examined preventive service utilization of cancer survivors compared to matched patients with no history of cancer among patients seeking care at community health centers (CHCs).MethodsWe utilized electronic health record data from the OCHIN network between 2014 and 2017. Cancer survivors (N = 20,538) ages ≥ 18 years were propensity score matched to three individuals with no history of cancer (N = 61,617) by age, sex, region, urban/rural, ethnicity, race, BMI, and Charlson Comorbidity Index. Preventive screenings included cancer, mental health and substance abuse, cardiovascular, and infectious disease screenings, and vaccinations. Patient-level preventive service indices were calculated for each screening as the total person-time covered divided by the total person-time eligible. Preventive service rate ratios comparing cancer survivors to patients with no history of cancer were estimated using negative binomial regression.ResultsCancer survivors had higher overall preventive service utilization (incidence rate ratio = 1.11, 95% confidence interval = 1.09–1.13) and higher rates of cancer screenings (IRR = 1.16, 95% CI = 1.12–1.20). There was no difference between the two groups in mental health screenings.ConclusionsCancer survivors were more likely to be up-to-date with preventive care than their matched counterparts. However, mental health and substance abuse screenings were low in both groups, despite reports of increased mental health conditions among cancer survivors.Implications for Cancer SurvivorsWith the growing number of cancer survivors in the USA, efforts are needed to ensure their access to and utilization of preventive services, especially related to behavioral and mental healthcare.

PIH21 Impact of Medical Home Implementation on Potentially Inappropriate Medication Use Among Older Adults: A Longitudinal Population-Based Study in Parma, Italy

Seventeen Medical Homes (MHs) were established in the Local Health Authority (LHA) of Parma, Emilia-Romagna, Italy, between 2011 and 2016. We evaluated the association between MH implementation and potentially inappropriate medication (PIM) use as a quality indicator. We conducted a retrospective cohort study (01/01/2011-12/31/2017) using the Parma LHA administrative healthcare database. Patients were ≥ 65 years, lived in Parma for ≥1 year, had ≥1 medication dispensed, and had a documented primary care physician (PCP). PIM utilization was determined based on medications that should be always avoided in the 2011 and 2014 Maio criteria, an Italian modified version of the Beers criteria. MH exposure was determined by time-varying PCP affiliation with MHs (non-MH, pre-MH, and post-MH). Rates of PIM use were compared between exposure groups using repeated events Cox proportional hazards models and further examined based on MH complexity (high/medium or low). Among 129,938 older adults included, 22% of their total person-time was under exposure to MHs. Compared with non-MH patients, MH patients had higher rates of PIM use before MH opening (HR=1.06; 95% CI: 1.04-1.08) but lower rates once MHs opened (HR=0.97; 95% CI: 0.96-0.98). The MH implementation was associated with an 8% decrease in PIM (post-MH vs. pre-MH HR=0.92; 95% CI: 0.89-0.93). After MH implementation, patients in both high/medium and low complexity MHs had lower use of PIMs but the reduction was greater for those in low complexity MHs (HR=0.86; 95% CI: 0.83-0.89) than in high complexity MHs (HR=0.93; 95% CI: 0.91-0.95). Accounting for pre-existing differences in prescribing between MH and non-MH PCPs, the MH implementation was associated with a significant decrease in PIM use. Notably, this improvement was greater among patients in low complexity MHs. More research is needed to understand whether the reduction in PIP exposure will be sustained as MHs progress.

PIH24 Medical Home Implementation Reduced Inappropriate Medication Use Among Older Adults in Parma, Italy: Does Early Adoption and Duration of Experience Matter?

Medical home (MH) implementation in the Local Health Authority (LHA) of Parma, Emilia-Romagna, Italy, was associated with a reduction in potentially inappropriate medication (PIM) use among older adults. We examine heterogeneity in this association between early and late adopter MHs, and between the early and later post-implementation periods. We conducted a retrospective cohort study using the Parma LHA administrative healthcare database between 01/01/2011-12/31/2017. Adults ≥65 years who lived in Parma >1 year, had ≥1 medication dispensed, and had a documented primary care physician (PCP) were studied. PIM exposure was determined based on medications that should be always avoided according to the 2011 and 2014 Maio criteria, an Italian modified version of the Beers criteria. Exposure to MH care was time-varying and was operationalized using three levels (non-MH, pre-MH, and MH). Repeated events Cox proportional hazards models were used to compare rates of PIM for 1) early (2011-2012) versus late (after 2012) MH adopters and 2) first year versus later years after MH implementation. Among the 129,938 elderly included, 22% of their total person-time was under exposure to MH. Overall, MH implementation was associated with a decreased rate of PIM use regardless of adoption status, (early MH adopters: post vs. pre, HR=0.89; 95% CI: 0.86-0.92; late MH adopters: post vs pre HR = 0.92; 95% CI 0.90-0.95). Additionally, improvement in PIM exposure over time was seen in MH, as the rate of PIM decreased after the first year in MH vs the first year in MH (HR =0.75; 95% CI: 0.73-0.77). Our findings suggest that MH implementation can reduce PIM use for older adults regardless of when PCPs entered into a MH. Larger decreases among early adopters and those with longer experience in a MH suggests that performance improvement continues after the initial implementation period.

Adherence to cardiomyopathy screening guidelines among adolescent and young adult cancer survivors exposed to chest radiation and/or anthracyclines.

Cancer survivors are at risk for late effects from therapeutic exposures, including cardiovascular complications. To improve outcomes among adolescents and young adults (AYA) with cancer, the National Comprehensive Cancer Network (NCCN) released guidelines for screening services (based on the Children's Oncology Group Long-Term Follow-Up [LTFU] guidelines) for survivors of AYA cancer. To better understand survivorship care gaps, we conducted a baseline evaluation of cardiomyopathy screening among survivors of AYA cancers. Members of Kaiser Permanente Southern California diagnosed with cancer between ages 15 and 39 from 2000 to 2010 with at least 5-year survival after diagnosis who were exposed to chest radiation and/or anthracyclines were included. We calculated the Prevention Index ([PI], proportion of person-time covered by receipt of preventive services relative to the total person-time eligible) to evaluate adherence to recommended cardiomyopathy screenings based on the LTFU through 2016. Predictors for screening were evaluated in multivariable logistic regression. Among 479 survivors recommended for cardiomyopathy screening, 28 received at least one screening, and the mean PI was 2.38% (SD = 13.05%, median = 0.00%). Compared to stage I, survivors of stage II (odds ratio [OR] = 5.56 [1.05-29.46]) and stage III/IV cancer (OR = 6.08 [1.10-33.54]) were more likely to receive cardiomyopathy screening. Cardiomyopathy screening among survivors was low around the time when NCCN AYA oncology guidelines were released. Our study highlights significant room for improvement for adherence to cardiomyopathy screening recommendations among survivors of AYA cancer. Attention is needed to ensure that recommended cardiomyopathy screenings are met for better management of cardiomyopathy late effects.

Prevalence Of Hepatotoxicity In HIV-Positive, Tuberculosis And HIV+TB Co Infected Patients In Tertiary Care Hospitals , Sindh

Hepatotoxicity is historically the 3rd most common reason for drug withdrawal and toxicity-related discontinuation of treatment. This study was aimed at determining the incidence and the onset of hepatotoxicity and at evaluating the relationship of some risk factors for hepatotoxicity among Human Immunodeficiency Virus- (HIV-) positive, tuberculosis (TB), and HIV/TB patients on treatment. This was a prospective follow-up study involving 125 participants from the HIV/AIDS and TB treatment centres in Tertiary Care hospital of Larkana and Sukkur, Sindh. These TB and HIV patients were initiated on RHEZ (R = Rifampicin, H = Isoniazid, E = Ethambutol, and P = Pyrazinamide) and TELE (efavirenz/tenofovir/lamivudine), respectively, and followed up for 12 weeks between September 2018 and November 2019. The levels of liver enzymes (transaminases, gamma- glutamyltransferase, alkaline phosphatase, and unconjugated/total bilirubin) were measured spectrophotometrically using serum. The Chi-squared (χ2) test was used to assess the association between risk factors and hepatotoxicity, while the Kaplan-Meier survival analysis with the log-rank test was used to determine the occurrence of hepatotoxicity in the different groups. We followed the general study population for a total person time of 6580 person-days, with an incidence rate and cumulative incidence of 8 cases per 1000 person-days (53/6580 person-days) and 42.4% (53/125), respectively (95% confidence interval), recorded after 12 weeks of follow-up of all the participants. The onset of hepatotoxicity in the total study population was statistically significant (χ2 = 9:5334; p = 0:022979; CI = 95%), with the majority observed at week eight of follow-up. Also, the incidence rate and cumulative incidence of hepatotoxicity with respect to HIV/AIDS, TB, and HIV/TB patients, respectively, at 95% confidence interval were: 8 cases per 1000 person-days (32/3843 person-days) and 32/76 (42.1%), 6 cases per 1000 person- days (12/1932 person-days) and 12/32 (37.5%), and 11 cases per 1000 person-days (9/805 person-days) and 9/17 (52.9%). This study shows that the incidence rate and cumulative incidence of hepatotoxicity in HIV/AIDS, TB, and HIV/TB patients on treatment were high . Also, it is very important to check these patients’ liver function especially within the first 12 weeks of treatment.

Abnormal Levels of Liver Enzymes and Hepatotoxicity in HIV-Positive, TB, and HIV/TB-Coinfected Patients on Treatment in Fako Division, Southwest Region of Cameroon.

Hepatotoxicity is historically the 3rd most common reason for drug withdrawal and toxicity-related discontinuation of treatment. This study was aimed at determining the incidence and the onset of hepatotoxicity and at evaluating the relationship of some risk factors for hepatotoxicity among Human Immunodeficiency Virus- (HIV-) positive, tuberculosis (TB), and HIV/TB patients on treatment. This was a prospective follow-up study involving 125 participants from the HIV/AIDS and TB treatment centres in three hospitals in Fako Division of Cameroon. These TB and HIV patients were initiated on RHEZ (R = Rifampicin, H = Isoniazid, E = Ethambutol, and P = Pyrazinamide) and TELE (efavirenz/tenofovir/lamivudine), respectively, and followed up for 12 weeks between September 2018 and November 2019. The levels of liver enzymes (transaminases, gamma-glutamyltransferase, alkaline phosphatase, and unconjugated/total bilirubin) were measured spectrophotometrically using serum. The Chi-squared (χ2) test was used to assess the association between risk factors and hepatotoxicity, while the Kaplan-Meier survival analysis with the log-rank test was used to determine the occurrence of hepatotoxicity in the different groups. We followed the general study population for a total person time of 6580 person-days, with an incidence rate and cumulative incidence of 8 cases per 1000 person-days (53/6580 person-days) and 42.4% (53/125), respectively (95% confidence interval), recorded after 12 weeks of follow-up of all the participants. The onset of hepatotoxicity in the total study population was statistically significant (χ2 = 9.5334; p = 0.022979; CI = 95%), with the majority observed at week eight of follow-up. Also, the incidence rate and cumulative incidence of hepatotoxicity with respect to HIV/AIDS, TB, and HIV/TB patients, respectively, at 95% confidence interval were: 8 cases per 1000 person-days (32/3843 person-days) and 32/76 (42.1%), 6 cases per 1000 person-days (12/1932 person-days) and 12/32 (37.5%), and 11 cases per 1000 person-days (9/805 person-days) and 9/17 (52.9%). This study shows that the incidence rate and cumulative incidence of hepatotoxicity in HIV/AIDS, TB, and HIV/TB patients on treatment were high in Fako Division, Cameroon. Also, it is very important to check these patients' liver function especially within the first 12 weeks of treatment.

PMH48 HEPATITIS C TESTING AMONG FLORIDA MEDICAID BENEFICIARIES WITH SUBSTANCE USE DISORDERS

The United States Preventive Services Task Force and Centers for Disease Control and Prevention recommend screening for hepatitis C virus (HCV) infection periodically for persons at high risk for infection, including those with substance use disorders (SUD). Little is known about HCV testing rate among patients with SUD in real-world clinical practice over time. This study aimed to examine the HCV testing rate and to identify characteristics associated with non-receipt of HCV testing among Medicaid beneficiaries with SUD. A retrospective cohort study included Florida Medicaid Data from 2012-2018. We identified patients aged 18-64 years with a SUD diagnosis or medications for the treatment of SUD. Patients were excluded if they had HCV diagnosis or HCV treatments one year before the date of first SUD diagnosis. Annual crude HCV testing rate was calculated as the number of patients with SUD who received the first HCV testing divided by the total follow-up person-time. A multivariable logistic model with generalized estimating equation, using a binomial distribution and a logit link, was used to examine the trend of HCV testing and to identify factors associated with non-receipt of HCV testing. Among 159,126 eligible Florida Medicaid beneficiaries with SUD(mean age=39±14 year;males=40%; white=51%) from 2012-2018, the overall HCV testing rate was estimated at 10.9 per 100 person-years. No significant change exists in the annual HCV testing rate(Ptrend=0.06) over time. Factors associated with a decreased odds of receiving HCV testing among Florida Medicaid beneficiaries included white(odds ratio[OR]=0.68, 95% confidence interval(95%CI)=0.66-0.70), male(OR=0.70, 95%CI=0.68-0.72]), younger age(18 ≤age≤35 years compared to 51≤age≤64 years)(OR=0.71, 95%CI=0.69-0.74), and having opioid use disorder(OR=0.86, 95%CI=0.82–0.90). HCV testing rates among Florida Medicaid beneficiaries with SUD remained very low from 2012 to 2018, despite the national recommendations for screening. Our findings underscore the need to identify the barriers to HCV testing, especially among Medicaid beneficiaries with SUD.