Factors associated with adherence to medications for lowering breast cancer risk between female Medicare beneficiaries in Alabama and nationwide.

PURPOSE: The U.S. Preventive Services Task Force recommends use of selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) for breast cancer (BC) prevention. We examined factors associated with adherence to SERMs/AI treatments among female Medicare beneficiaries in Alabama and those nationwide. METHODS: This retrospective new user cohort study analyzed the 2013-2016 Medicare administrative claims data files (100% Alabama and random 5% national samples). Female Medicare beneficiaries without invasive BC and osteoporosis, continuously enrolled in Medicare Parts A, B, and D for at least 18 months (with a 6-month washout and a 12-month follow-up period) in 2013-2016. Among beneficiaries who initiated (6-month washout) any of the SERMs/AIs (tamoxifen, raloxifene, anastrozole, and exemestane), we examined their 1-year treatment adherence using proportion of days covered (PDC) and operationalized as both continuous (0-1) and dichotomized (≥ 80% as adherent and < 80% as non-adherent) outcomes. Multivariable logistic models were used to identify factors associated with adherence (PDC ≥ 80%) among Alabama and national samples, respectively. RESULTS: A total of 885 women in Alabama and 1,213 women in national sample initiated these SERMs/AI treatments. Among those with ≥ 2 prescriptions (n = 479 in Alabama and n = 870 in national sample), Mean PDC was 0.74 [standard deviation (SD) = 0.30] among Alabamian women, similar to those in the national sample [0.71 (SD = 0.31), p = 0.09]. Use of mammography prior to treatment initiation was associated with higher likelihood of adherence to treatments in both samples. CONCLUSION: Our findings highlight the importance of access to preventive services such as mammography to better adherence to BC preventive treatments among female Medicare beneficiaries.

Impact of social determinants of health on time to antiretroviral therapy initiation and HIV viral undetectability for migrants enrolled in a multidisciplinary HIV clinic with rapid, free, and onsite B/F/TAF: 'The ASAP study'.

OBJECTIVE: Multidisciplinary care with free, rapid, and on-site bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) dispensation may improve health outcomes among migrants living with HIV. However, models for rapid B/F/TAF initiation are not well studied among migrants living with HIV, and an understanding of how social determinants of health (SDH) may affect HIV-related health outcomes for migrants enrolled in such care models is limited. METHODS: Within a 96-week pilot feasibility prospective cohort study at a multidisciplinary HIV clinic, participants received free B/F/TAF rapidly after care linkage. The effects of SDH (i.e., birth region, sexual orientation, living status, education, employment, French proficiency, health coverage, use of a public health facility outside our clinic for free blood tests, and time in Canada) and other covariates (i.e., age, sex) on median time to antiretroviral therapy (ART) initiation and HIV viral undetectability from care linkage were calculated via survival analyses. RESULTS: Thirty-five migrants were enrolled in this study. Median time to ART initiation and HIV undetectability was 5 days (range 0-50) and 57 days (range 5-365), respectively. Those who took significantly longer to initiate ART were aged <35 years, identified as heterosexual, had less than university-level education, or were unemployed. No factor was found to significantly affect time to undetectability. CONCLUSION: Despite the provision of free B/F/TAF, several SDH were linked to delays in ART initiation. However, once initiated and engaged, migrants living with HIV reached HIV undetectability efficiently. Findings provide preliminary support for adopting this care model with migrants living with HIV and suggest that SDH should be considered when designing clinical interventions for more equitable outcomes.

The Association Between Oncology Outreach and Timely Treatment for Rural Patients with Breast Cancer: A Claims-Based Approach.

BACKGROUND: Oncology outreach is a common strategy for increasing rural access to cancer care, where traveling oncologists commute across healthcare settings to extend specialized care. Examining the extent to which physician outreach is associated with timely treatment for rural patients is critical for informing outreach strategies. METHODS: We identified a 100% fee-for-service sample of incident breast cancer patients from 2015 to 2020 Medicare claims and apportioned them into surgery and adjuvant therapy cohorts based on treatment history. We defined an outreach visit as the provision of care by a traveling oncologist at a clinic outside of their primary hospital service area. We used hierarchical logistic regression to examine the associations between patient receipt of preoperative care at an outreach visit (preoperative outreach) and > 60-day surgical delay, and patient receipt of postoperative care at an outreach visit (postoperative outreach) and > 60-day adjuvant delay. RESULTS: We identified 30,337 rural-residing patients who received breast cancer surgery, of whom 4071 (13.4%) experienced surgical delay. Among surgical patients, 14,501 received adjuvant therapy, of whom 2943 (20.3%) experienced adjuvant delay. In adjusted analysis, we found that patient receipt of preoperative outreach was associated with reduced odds of surgical delay (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.61-0.91); however, we found no association between patient receipt of postoperative outreach and adjuvant delay (OR 1.04, 95% CI 0.85-1.25). CONCLUSIONS: Our findings indicate that preoperative outreach is protective against surgical delay. The traveling oncologists who enable such outreach may play an integral role in catalyzing the coordination and timeliness of patient-centered care.

The State of Hepatitis C Elimination from the Front Lines: A Qualitative Study of Provider-Perceived Gaps to Treatment Initiation.

BACKGROUND: Hepatitis C (HCV) is a curable chronic infection, but lack of treatment uptake contributes to ongoing morbidity and mortality. State and national strategies for HCV elimination emphasize the pressing need for people with HCV to receive treatment. OBJECTIVE: To identify provider-perceived barriers that hinder the initiation of curative HCV treatment and elimination of HCV in the USA. APPROACH: Qualitative semi-structured interviews with 36 healthcare providers who have evaluated patients with HCV in New York City, Western/Central New York, and Alabama. Interviews, conducted between 9/2021 and 9/2022, explored providers' experiences, perceptions, and approaches to HCV treatment initiation. Transcripts were analyzed using hybrid inductive and deductive thematic analysis informed by established health services and implementation frameworks. KEY RESULTS: We revealed four major themes: (1) Providers encounter professional challenges with treatment provision, including limited experience with treatment and perceptions that it is beyond their scope, but are also motivated to learn to provide treatment; (2) providers work toward building streamlined and inclusive practice settings-leveraging partnerships with experts, optimizing efficiency through increased access, adopting inclusive cultures, and advocating for integrated care; (3) although at times overwhelmed by patients facing socioeconomic adversity, increases in public awareness and improvements in treatment policies create a favorable context for providers to treat; and (4) providers are familiar with the relative advantages of improved HCV treatments, but the reputation of past treatments continues to deter elimination. CONCLUSIONS: To address the remaining barriers and facilitators providers experience in initiating HCV treatment, strategies will need to expand educational initiatives for primary care providers, further support local infrastructures and integrated care systems, promote public awareness campaigns, remove prior authorization requirements and treatment limitations, and address the negative reputation of outdated HCV treatments. Addressing these issues should be considered priorities for HCV elimination approaches at the state and national levels.

Long-term physical and psychiatric morbidities and mortality of untreated, deferred, and immediately treated epilepsy.

OBJECTIVE: In Australia, 30% of newly diagnosed epilepsy patients were not immediately treated at diagnosis. We explored health outcomes between patients receiving immediate, deferred, or no treatment, and compared them to the general population. METHODS: Adults with newly diagnosed epilepsy in Western Australia between 1999 and 2016 were linked with statewide health care data collections. Health care utilization, comorbidity, and mortality at up to 10 years postdiagnosis were compared between patients receiving immediate, deferred, and no treatment, as well as with age- and sex-matched population controls. RESULTS: Of 603 epilepsy patients (61% male, median age = 40 years) were included, 422 (70%) were treated immediately at diagnosis, 110 (18%) received deferred treatment, and 71 (12%) were untreated at the end of follow-up (median = 6.8 years). Immediately treated patients had a higher 10-year rate of all-cause admissions or emergency department presentations than the untreated (incidence rate ratio [IRR] = 2.0, 95% confidence interval [CI] = 1.4-2.9) and deferred treatment groups (IRR = 1.7, 95% CI = 1.0-2.8). They had similar 10-year risks of mortality and developing new physical and psychiatric comorbidities compared with the deferred and untreated groups. Compared to population controls, epilepsy patients had higher 10-year mortality (hazard ratio = 2.6, 95% CI = 2.1-3.3), hospital admissions (IRR = 2.3, 95% CI = 1.6-3.3), and psychiatric outpatient visits (IRR = 3.2, 95% CI = 1.6-6.3). Patients with epilepsy were also 2.5 (95% CI = 2.1-3.1) and 3.9 (95% CI = 2.6-5.8) times more likely to develop a new physical and psychiatric comorbidity, respectively. SIGNIFICANCE: Newly diagnosed epilepsy patients with deferred or no treatment did not have worse outcomes than those immediately treated. Instead, immediately treated patients had greater health care utilization, likely reflecting more severe underlying epilepsy etiology. Our findings emphasize the importance of individualizing epilepsy treatment and recognition and management of the significant comorbidities, particularly psychiatric, that ensue following a diagnosis of epilepsy.

Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol.

BACKGROUND: As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411-93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1-3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside 'one-stop-shop' approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic's current practice of usual care, which includes comprehensive patient navigation. METHODS: A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization. DISCUSSION: Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. TRIAL REGISTRATION: We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Patient Navigation in Cancer Treatment: A Systematic Review.

PURPOSE OF REVIEW: Patient navigation promotes access to timely treatment of chronic diseases by eliminating barriers to care. Patient navigation programs have been well-established in improving screening rates and diagnostic resolution. This systematic review aimed to characterize the multifaceted role of patient navigators within the realm of cancer treatment. RECENT FINDINGS: A comprehensive electronic literature review of PubMed and Embase databases was conducted to identify relevant studies investigating the role of patient navigators in cancer treatment from August 1, 2009 to March 27, 2023. Fifty-nine articles were included in this review. Amongst studies focused on cancer treatment initiation, 70% found a significant improvement in treatment initiation amongst patients who were enrolled in patient navigation programs, 71% of studies focused on treatment adherence demonstrated significant improvements in treatment adherence, 87% of studies investigating patient satisfaction showed significant benefits, and 81% of studies reported a positive impact of patient navigators on quality care indicators. Three palliative care studies found beneficial effects of patient navigation. Thirty-seven studies investigated disadvantaged populations, with 76% of them concluded that patient navigators made a positive impact during treatment. This systematic review provides compelling evidence supporting the value of patient navigation programs in cancer treatment. The findings suggest that patient navigation plays a crucial role in improving access to care and optimizing treatment outcomes, especially for disadvantaged cancer patients. Incorporating patient navigation into standard oncology practice can reduce disparities and improve the overall quality of cancer care.

Predictive modeling of initiation and delayed mental health contact for depression.

BACKGROUND: Depression is prevalent among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans, yet rates of Veteran mental health care utilization remain modest. The current study examined: factors in electronic health records (EHR) associated with lack of treatment initiation and treatment delay; the accuracy of regression and machine learning models to predict initiation of treatment. METHODS: We obtained data from the VA Corporate Data Warehouse (CDW). EHR data were extracted for 127,423 Veterans who deployed to Iraq/Afghanistan after 9/11 with a positive depression screen and a first depression diagnosis between 2001 and 2021. We also obtained 12-month pre-diagnosis and post-diagnosis patient data. Retrospective cohort analysis was employed to test if predictors can reliably differentiate patients who initiated, delayed, or received no mental health treatment associated with their depression diagnosis. RESULTS: 108,457 Veterans with depression, initiated depression-related care (55,492 Veterans delayed treatment beyond one month). Those who were male, without VA disability benefits, with a mild depression diagnosis, and had a history of psychotherapy were less likely to initiate treatment. Among those who initiated care, those with single and mild depression episodes at baseline, with either PTSD or who lacked comorbidities were more likely to delay treatment for depression. A history of mental health treatment, of an anxiety disorder, and a positive depression screen were each related to faster treatment initiation. Classification of patients was modest (ROC AUC = 0.59 95%CI = 0.586-0.602; machine learning F-measure = 0.46). CONCLUSIONS: Having VA disability benefits was the strongest predictor of treatment initiation after a depression diagnosis and a history of mental health treatment was the strongest predictor of delayed initiation of treatment. The complexity of the relationship between VA benefits and history of mental health care with treatment initiation after a depression diagnosis is further discussed. Modest classification accuracy with currently known predictors suggests the need to identify additional predictors of successful depression management.

Using standardized workflows and quantitative data-driven management to reduce time interval from simulation to treatment initiation.

PURPOSE: External beam radiotherapy is a complex process, involving timely coordination among multiple teams. The aim of this study is to report our experience of establishing a standardized workflow and using quantitative data and metrics to manage the time-to-treatment initiation (TTI). METHODS AND MATERIALS: Starting in 2014, we established a standard process in a radiation oncology-specific electronic medical record system (RO-EMR) for patients receiving external beam radiation therapy in our department, aiming to measure the time interval from simulation to treatment initiation, defined as TTI, for radiation oncology. TTI data were stratified according to the following treatment techniques: three-dimensional (3D) conformal therapy, intensity-modulated radiotherapy (IMRT), and stereotactic body radiotherapy (SBRT). Statistical analysis was performed with the Mann-Whitney test for the respective metrics of aggregate data for the initial period 2012- 2015 (PI) and the later period 2016-2019 (PII). RESULT: Over 8 years, the average annual number of treatments for PI and PII were 1760 and 2357 respectively, with 3D, IMRT, and SBRT treatments accounting for 53, 29, 18% and 44, 34, 22%, respectively, of the treatment techniques. The median TTI for 3D, IMRT, and SBRT for PI and PII were 1, 6, 7, and 1, 5, 7 days, respectively, while the 90th percentile TTI for the three techniques in both periods were 5, 9, 11 and 4, 9, 10 days, respectively. From the aggregate data, the TTI was significantly reduced (p = 0.0004, p < 0.0001, p < 0.0001) from PI to PII for the three treatment techniques. CONCLUSION: Establishing a standardized workflow and frequently measuring TTI resulted in shortening the TTI during the early years (in PI) and maintaining the established TTI in the subsequent years (in PII).

Hazardous Drinking Interventions Delivered During Medical-Surgical Care: Patient and Provider Views.

Addressing hazardous drinking during medical-surgical care improves patients' health. This formative evaluation examined patients' consideration of options to change drinking and engage in treatment. It explored whether interventions such as "DO-MoST" overcome treatment barriers. We interviewed 20 medical-surgical patients with hazardous drinking in a trial of DO-MoST, and 16 providers. Analyses used a directed content approach. Patients were receptive to and comfortable discussing drinking during medical-surgical care. Interventions like DO-MoST (patient-centered, motivational approach to shared decision making) addressed some treatment barriers. Patients and providers viewed such interventions as helpful by building a relationship with a psychologist who facilitated self-awareness of drinking behaviors, and discussing connections between alcohol- and physical health-related problems and potential strategies to address drinking. However, both groups expressed concerns about individual and system-level barriers to long-term change. Interventions like DO-MoST bridge the gap between the patient's medical treatment episode and transition to other health care settings. TRIAL REGISTRATION: The study is registered on ClinicalTrials.gov (ID: NCT03258632).

Impact of Point-of-Care Testing on the Management of Sexually Transmitted Infections in South Africa: Evidence from the HVTN702 Human Immunodeficiency Virus Vaccine Trial.

BACKGROUND: Alternative approaches to syndromic management are needed to reduce rates of sexually transmitted infections (STIs) in resource-limited settings. We investigated the impact of point-of-care (POC) versus central laboratory-based testing on STI treatment initiation and STI adverse event (STI-AE) reporting. METHODS: We used Kaplan-Meier and Cox regression models to compare times to treatment initiation and STI-AE reporting among HVTN702 trial participants in South Africa. Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) were diagnosed POC at eThekwini clinic and in a central laboratory at Verulam/Isipingo clinics. All clinics used POC assays for Trichomonas vaginalis (TV) testing. RESULTS: Among 959 women (median age, 23 [interquartile range, 21-26] years), median days (95% confidence interval [95%CI]) to NG/CT treatment initiation and NG/CT-AE reporting were 0.20 (.16-.25) and 0.24 (.19-.27) at eThekwini versus 14.22 (14.12-15.09) and 15.12 (13.22-21.24) at Verulam/Isipingo (all P < .001). Median days (95%CI) to TV treatment initiation and TV-AE reporting were 0.17 (.12-.27) and 0.25 (.20-.99) at eThekwini versus 0.18 (.15-.2) and 0.24 (.15-.99) at Verulam/Isipingo (all P > .05). Cox regression analysis revealed that NG/CT treatment initiation (adjusted hazard ratio [aHR], 39.62 [95%CI, 15.13-103.74]) and NG/CT-AE reporting (aHR, 3.38 [95%CI, 2.23-5.13]) occurred faster at eThekwini versus Verulam/Isipingo, while times to TV treatment initiation (aHR, 0.93 [95%CI, .59-1.48]) and TV-AE reporting (aHR, 1.38 [95%CI, .86-2.21]) were similar. CONCLUSIONS: POC testing led to prompt STI management with potential therapeutic and prevention benefits, highlighting its utility as a diagnostic tool in resource-limited settings.

Race, geography, and risk of breast cancer treatment delays: A population-based study 2004-2015.

BACKGROUND: Treatment delays affect breast cancer survival and constitute poor-quality care. Black patients experience more treatment delay, but the relationship of geography to these disparities is poorly understood. METHODS: We studied a population-based, retrospective, observational cohort of patients with breast cancer in North Carolina between 2004 and 2017 from the Cancer Information and Population Health Resource, which links cancer registry and sociodemographic data to multipayer insurance claims. We included patients >18 years with Stage I-III breast cancer who received surgery or chemotherapy as their first treatment. Delay was defined as >60 days from diagnosis to first treatment. Counties were aggregated into nine Area Health Education Center regions. Race was dichotomized as Black versus non-Black. RESULTS: Among 32,626 patients, 6190 (19.0%) were Black. Black patients were more likely to experience treatment delay >60 days (15.0% of Black vs. 8.0% of non-Black). Using race-stratified modified Poisson regression, age-adjusted relative risk of delay in the highest risk region was approximately twice that in the lowest risk region among Black (relative risk, 2.1; 95% CI, 1.6-2.6) and non-Black patients (relative risk, 1.9; 95% CI, 1.5-2.3). Adjustment for clinical and sociodemographic features only slightly attenuated interregion differences. The magnitude of the racial gap in treatment delay varied by region, from 0.0% to 9.4%. CONCLUSIONS: Geographic region was significantly associated with risk of treatment delays for both Black and non-Black patients. The magnitude of racial disparities in treatment delay varied markedly between regions. Future studies should consider both high-risk geographic regions and high-risk patient groups for intervention to prevent delays.

Factors affecting time to treatment initiation after diagnosis for multidrug-resistant/rifampicin-resistant tuberculosis patients: A mixed-methods study in Jakarta, Indonesia.

OBJECTIVE: To investigate the time to treatment initiation (TTI) for multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) patients after diagnosis in Indonesia and biological, psychological and social factors associated with the time interval. METHODS: This study was conducted in Persahabatan Hospital, Jakarta using a mixed-methods approach. Registry data and medical records of MDR/RR-TB patients were collected and matched (hospital dataset), and linked with psychosocial assessment results (linked dataset). Descriptive analysis was conducted to understand patient characteristics and the distribution of TTI after RR-TB diagnosis by GeneXpert. Generalised linear regression was used to analyse factors associated with delay duration, and logistic regression to explore factors associated with the delay longer than the median duration for both datasets (basic vs. extended model). In-depth interviews were conducted with patients and healthcare workers to understand the procedure of treatment initiation and how different factors led to delay. RESULTS: The hospital dataset included 275 patient-matched cases, and 188 were further linked with psychosocial assessment results. The median time interval was 24 days [interquartile range (IQR) 23.5] and 26 days (IQR 21.25), respectively. Regression analysis showed that in the extended model, comorbidities (exp [coefficient]= 1.93), unemployment (exp [coefficient] = 1.80) and poor knowledge of MDR/RR-TB (exp (coefficient) = 1.67) seemed to have the strongest effects on prolonging the time interval (p < 0.05). Unsuccessful TB treatment history was the only factor that significantly increased the risk of delay longer than the median duration (p < 0.05) in the basic model, while none of the factors were significant in the extended model. The qualitative study identified provider-side factors (centralised service provision and insufficient human resources) and patient-side factors (physical weakness, psychological stress and financial concern) associated with treatment delay. CONCLUSION: MDR/RR-TB patients in Persahabatan Hospital, Jakarta, Indonesia waited around 25 days for treatment initiation after RR-TB diagnosis. Health system solutions are needed to address challenges facing both MDR/RR-TB patients and healthcare providers to reduce delay in treatment initiation.

Adherence to prescription medication during pregnancy: Do pregnant women use pharmacological treatment as prescribed?

AIMS: Pregnant women are hypothesized to have low adherence to prescribed medication, because of concerns about harmful effects on the unborn child. However, very little is known about the actual adherence to prescribed medication during pregnancy. We determined to what extent women follow treatment recommendations regarding prescribed medication use in mid-pregnancy. METHODS: Dutch women participating in the PRIDE Study completed a 6-week diary on medication use. Additionally, pharmacy records were obtained. For each medication dispensed, we determined 3 measures of adherence: (i) whether use was reported in the diary (actual use); (ii) difference between dispensing date and date of first reported use (initiation time); and (iii) proportion of days with at least the correct number of doses taken (implementation adherence). RESULTS: During the 6-week study period, 235 of 816 women (29%) were dispensed medication. Actual use was highest for medications used for chronic conditions (88%; 95% confidence interval [95% CI] 81-93), followed by medication for pregnancy-related conditions (79%; 95% CI 71-86) and medication for occasional and short-time use (69%; 95% CI 60-77). We observed a ≥1-day delay in treatment initiation for 42% of medications dispensed for the first time in the study period. Mean implementation adherence was 74.2% (95% CI 69.3-79.2) for medications that were actually used. CONCLUSION: Although actual use of medications dispensed was high, many pregnant women did not adhere to treatment recommendations. This nonadherence may impact maternal and child health and lead to overestimation of medication use in studies in perinatal pharmacoepidemiology relying on administrative databases.

COVID-19 pandemic and initiation of treatment for atrial fibrillation: a nationwide analysis of claims data.

BACKGROUND: The COVID-19 pandemic profoundly disrupted the delivery of medical care. It remains unclear whether individuals diagnosed with new onset disease during the pandemic were less likely to initiate treatments after diagnosis. We sought to evaluate changes in the treatment initiation of patients newly diagnosed with atrial fibrillation (AF) after the onset of the COVID-19 pandemic. METHODS: In this retrospective cohort study, we identified individuals with incident AF from 01/01/2016-09/30/2021 using Optum's de-identified Clinformatics® Data Mart Database. The primary outcome was initiation of oral anticoagulation (OAC) within 30 days of AF diagnosis. Secondary outcomes included initiation of OAC within 180 days of diagnosis, initiation of warfarin, direct oral anticoagulants (DOACs), rhythm control medications and electrical cardioversion within 30 days of diagnosis. We constructed interrupted time series analyses to examine changes in the outcomes following the onset of the pandemic. RESULTS: A total of 573,524 patients (age 73.0 ± 10.9 years) were included in the study. There were no significant changes in the initiation of OAC, DOAC, and rhythm control medications associated with the onset of the pandemic. There was a significant decrease in initiation of electrical cardioversion associated with the onset of the pandemic. The rate of electronic cardioversion within 30 days of diagnosis decreased by 4.9% per 1,000 patients after the onset of the pandemic and decreased by about 35% in April 2020, compared to April 2019, from 5.53% to 3.58%. CONCLUSION: The COVID-19 pandemic did not affect the OAC initiation within 30 days of AF diagnosis but was associated with a decline in the provision of procedures for patients newly diagnosed with AF.

Using modified intention-to-treat as a principal stratum estimator for failure to initiate treatment.

BACKGROUND: A common intercurrent event affecting many trials is when some participants do not begin their assigned treatment. For example, in a double-blind drug trial, some participants may not receive any dose of study medication. Many trials use a 'modified intention-to-treat' approach, whereby participants who do not initiate treatment are excluded from the analysis. However, it is not clear (a) the estimand being targeted by such an approach and (b) the assumptions necessary for such an approach to be unbiased. METHODS: Using potential outcome notation, we demonstrate that a modified intention-to-treat analysis which excludes participants who do not begin treatment is estimating a principal stratum estimand (i.e. the treatment effect in the subpopulation of participants who would begin treatment, regardless of which arm they were assigned to). The modified intention-to-treat estimator is unbiased for the principal stratum estimand under the assumption that the intercurrent event is not affected by the assigned treatment arm, that is, participants who initiate treatment in one arm would also do so in the other arm (i.e. if someone began the intervention, they would also have begun the control, and vice versa). RESULTS: We identify two key criteria in determining whether the modified intention-to-treat estimator is likely to be unbiased: first, we must be able to measure the participants in each treatment arm who experience the intercurrent event, and second, the assumption that treatment allocation will not affect whether the participant begins treatment must be reasonable. Most double-blind trials will satisfy these criteria, as the decision to start treatment cannot be influenced by the allocation, and we provide an example of an open-label trial where these criteria are likely to be satisfied as well, implying that a modified intention-to-treat analysis which excludes participants who do not begin treatment is an unbiased estimator for the principal stratum effect in these settings. We also give two examples where these criteria will not be satisfied (one comparing an active intervention vs usual care, where we cannot identify which usual care participants would have initiated the active intervention, and another comparing two active interventions in an unblinded manner, where knowledge of the assigned treatment arm may affect the participant's choice to begin or not), implying that a modified intention-to-treat estimator will be biased in these settings. CONCLUSION: A modified intention-to-treat analysis which excludes participants who do not begin treatment can be an unbiased estimator for the principal stratum estimand. Our framework can help identify when the assumptions for unbiasedness are likely to hold, and thus whether modified intention-to-treat is appropriate or not.

Early initiation of treatment with oral propranolol for infantile hemangioma improves success rate.

BACKGROUND/OBJECTIVES: Early referral and treatment of infantile hemangioma (IH) is a major challenge for treatment success. However, there is a lack of data supporting a specific threshold for initiating treatment with oral propranolol. The aim of this analysis was to find factors, such as age at treatment initiation, leading to a higher success rate with oral propranolol treatment. METHODS: Based on data from the pivotal phase 2-3 clinical trial of oral propranolol in IH, we used Generalized Additive Model (GAM) charts with Generalized Linear Models (GLM), then a rule discovery algorithm, to identify sub-groups presenting a high probability of occurrence of the predefined outcome (i.e., success [complete or nearly complete resolution of the target hemangioma] at 6 months of treatment). RESULTS: Our analyses identified that patients who started oral propranolol 3 mg/kg/day before the age of 10 weeks had a success rate of 86%, higher than the 60% success rate for all patients that received the same regimen commencing after 10 weeks of age. CONCLUSIONS: Treatment initiation before 10 weeks of age was associated with a significantly higher rate of treatment success with oral propranolol 3 mg/kg/day. Infants with IH requiring treatment should be referred to an expert center and treated as soon as possible.

Prognostic significance of time trends in treatment of head and neck squamous cell carcinoma.

PURPOSE: To analyze the impact of demographic, clinical, and management variables on time to treatment initiation (TTI) and overall survival (OS). STUDY DESIGN: Retrospective chart review. MATERIALS AND METHODS: Medical records of patients diagnosed with head and neck cancer from 2018 to 2020 were reviewed. Univariate linear and Cox-regressions identified predictors of TTI and OS. Kaplan Meier (KM) curves assessed the difference in survival by diagnostic year and TTI. RESULTS: 381 patients met eligibility criteria. Median TTI was 35.0 days (IQR: 25.0-49.0). Only 10.8 % of all patients reported any treatment delay, with TTI exceeding 90 days found in 3.7 % of patients. TTI increased with African American race (p = 0.02), ED referrals (p = 0.02), and direct admission status (p = 0.01). When compared to treatment with surgery alone, TTI was shorter in patients undergoing surgery with adjuvant radiation (p = 0.02), adjuvant chemoradiation (p = 0.04), and salvage surgery (p = 0.04). Univariate Cox-regressions found smoking (p = 0.01), direct admission status (p = 0.02), increased duration of symptoms (p = 0.02), placement of PEG tubes (p < 0.01) and tracheostomies (p < 0.01), combination treatment (p < 0.01), and surgery with adjuvant chemoradiation treatment (p = 0.01) to increase mortality risk. Disease characteristics, including tumor size (p < 0.01), presence of nodal disease (p = 0.02), and late-stage disease (p < 0.01), increased mortality risk. TTI and diagnostic year did not impact survival. CONCLUSIONS: Our analysis determined several demographic, referral, and treatment factors impacted TTI. However, increased TTI did not impact survival. Characteristics consistent with advanced disease worsened OS. Despite the pandemic burden, patients diagnosed in 2020 showed no difference in short-term survival compared to prior years.

Factors Associated with Engaging in Evidence-Based Psychotherapy During the First Year of Posttraumatic Stress Disorder Treatment Between 2017 and 2019.

To address the burden of posttraumatic stress disorder (PTSD), the Veterans Health Administration (VHA) implemented evidence-based psychotherapies (EBPs) for PTSD at all VHA medical centers. Prior investigations show EBP utilization has increased following the initial nationwide implementation. However, most patients still do not engage in EBPs and those who do often have substantial delays between diagnosis and treatment which is associated with poorer treatment outcomes. The goal of the current study is to identify patient and clinical factors associated with initiating EBP and completing a minimally adequate dose of treatment within the first year of a new PTSD diagnosis. Overall, 263,018 patients started PTSD treatment between 2017 and 2019 and 11.6% (n = 30,462) initiated EBP during their first year of treatment. Of those who initiated EBP, 32.9% (n = 10,030) received a minimally adequate dose. Older patients were less likely to initiate EBP, but more likely to receive an adequate dose when they did initiate. Black, Hispanic/Latino/a, and Pacific Islander patients' likelihood of initiating EBP was not significantly different than White patients, but these patients were less likely to receive an adequate dose. Patients with comorbid depressive disorders, bipolar disorder, psychotic disorders, or substance use disorders were less likely to initiate EBP, while patients reporting MST were more likely to initiate EBP. This study identifies several patient-level disparities that could be prioritized to increase EBP utilization. In our evaluation, most patients did not engage in EBP during their first year of PTSD treatment, which is consistent with previous evaluations of EBP utilization. Future research should focus on understanding the flow of patients from PTSD diagnosis to treatment to support effective PTSD care delivery.

Breast cancer treatment patterns by age and time since last pregnancy in the Carolina Breast Cancer Study Phase III.

PURPOSE: To describe breast cancer treatment patterns among premenopausal women by age and time since last pregnancy. METHODS: Data were analyzed from 1179 women diagnosed with premenopausal breast cancer in the Carolina Breast Cancer Study. Of these, 160 had a recent pregnancy (within 5 years of cancer diagnosis). Relative frequency differences (RFDs) and 95% confidence intervals (CIs) were used to compare cancer stage, treatment modality received, treatment initiation delay (> 30 days), and prolonged treatment duration (> 2 to > 8 months depending on the treatment received) by age and recency of pregnancy. RESULTS: Recently postpartum women were significantly more likely to have stage III disease [RFD (95% CI) 12.2% (3.6%, 20.8%)] and to receive more aggressive treatment compared to nulliparous women. After adjustment for age, race and standard clinical tumor characteristics, recently postpartum women were significantly less likely to have delayed treatment initiation [RFD (95% CI) - 11.2% (- 21.4%, - 1.0%)] and prolonged treatment duration [RFD (95% CI) - 17.5% (- 28.0%, - 7.1%)] and were more likely to have mastectomy [RFD (95% CI) 14.9% (4.8%, 25.0%)] compared to nulliparous. Similarly, younger women (< 40 years of age) were significantly less likely to experience prolonged treatment duration [RFD (95% CI) - 5.6% (- 11.1%, - 0.0%)] and more likely to undergo mastectomy [RFD (95% CI) 10.6% (5.2%, 16.0%)] compared to the study population as a whole. CONCLUSION: These results suggest that recently postpartum and younger women often received prompt and aggressive breast cancer treatment. Higher mortality and recurrence among recently pregnant women are unlikely to be related to undertreatment.