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Administrative claims databases often do not capture date or fact of death, so studies using these data may inappropriately treat death as a censoring event—equivalent to other withdrawal reasons—rather than a competing event. We examined 1-, 3-, and 5-year inverse-probability-of-treatment weighted cumulative risks of a composite cardiovascular outcome among 34 527 initiators of telmisartan (exposure) and ramipril (referent), who were aged ≥55 years, in Optum (United States) claims data from 2003 to 2020. Differences in cumulative risks of the cardiovascular endpoint due to censoring of death (cause-specific), as compared with treating death as a competing event (subdistribution), increased with greater follow-up time and older age, where event and mortality risks were higher. Among ramipril users, 5-year cause-specific and subdistribution cumulative risk estimates per 100, respectively, were 16.4 (95% CI, 15.3-17.5) and 16.2 (95% CI, 15.1-17.3) among ages 55-64 (difference = 0.2) and were 43.2 (95% CI, 41.3-45.2) and 39.7 (95% CI, 37.9-41.4) among ages ≥75 (difference = 3.6). Plasmode simulation results demonstrated the differences in cause-specific versus subdistribution cumulative risks to increase with increasing mortality rate. We suggest researchers consider the cohort's baseline mortality risk when deciding whether real-world data with incomplete death information can be used without concern. This article is part of a Special Collection on Pharmacoepidemiology. [ABSTRACT FROM AUTHOR]

To determine the incidence of being lost to follow-up (LTFU) and nonpersistence in patients with neovascular age-related macular degeneration (AMD) treated with anti–VEGF injections in the United States. Retrospective cohort study using the IRIS® (Intelligent Research in Sight) Registry data. One hundred fifty-six thousand three hundred twenty-seven treatment-naive patients with neovascular AMD who subsequently were treated with anti-VEGF therapy from 2013 through 2015 and followed up through 2019. Multivariable logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Being LTFU was defined as no follow-up within 12 months from last intravitreal injection. Nonpersistence was defined as no follow-up within 6 months from last intravitreal injection. For neovascular AMD, 11.6% of patients (95% CI, 11.4%–11.7%) were LTFU, and 88.4% of patients were followed up within 12 months. The rate of being LTFU generally was higher with increasing age, with odds of being LTFU greatest for patients between 81 and 84 years of age (OR, 2.51; 95% CI, 2.31–2.74; P < 0.001) compared with patients 70 years of age and younger. Odds of being LTFU for Black or African American patients (OR, 1.32; 95% CI, 1.08–1.61; P = 0.007) were greater than for White patients. Odds of being LTFU were higher for patients with Medicaid insurance (OR, 1.27; 95% CI, 1.01–1.60; P = 0.04) and lower for patients with Medicare Fee-For-Service insurance (OR, 0.69; 95% CI, 0.64–0.74; P < 0.001) than for patients with private insurance. Furthermore, 14.3% (95% CI, 14.1–14.4) of patients were nonpersistent, and 85.7% of patients underwent follow-up within 6 months. Odds of nonpersistence also were greatest among patients between 81 and 84 years of age (OR, 2.13; 95% CI, 1.98–2.29; P < 0.001) compared with patients 70 years of age or younger. Odds of nonpersistence for Black or African-American patients (OR, 1.38; 95% CI, 1.15–1.65; P < 0.001) and Hispanic patients (OR, 1.13; 95% CI, 1.03–1.24; P = 0.009) were greater than odds for White patients. Nearly 1 of 9 patients with neovascular AMD treated with anti-VEGF injections became LTFU, whereas 1 of 7 patients were nonpersistent. Risk factors identified included increasing age, male sex, unilateral involvement, diabetes, Medicaid insurance, and race or ethnicity. Proprietary or commercial disclosure may be found after the references. [ABSTRACT FROM AUTHOR]

Background: The increasing number of childhood cancer survivors necessitates continued follow‐up to monitor for long‐term complications. Inequities in loss to follow‐up for patients enrolled on pediatric clinical trials have not been well studied. Methods: This was a retrospective study of 21,084 patients residing in the United States enrolled on phase 2/3 and phase 3 Children's Oncology Group (COG) trials between January 1, 2000 and March 31, 2021. Rates of loss to follow‐up to COG were evaluated using log‐rank tests and multivariable Cox proportional hazards regression models with adjusted hazard ratios (HRs). Demographic characteristics included age at enrollment, race, ethnicity, and zip code level socioeconomic data. Results: Adolescent and young adult (AYA) patients 15–39 years old at diagnosis had an increased hazard of loss to follow‐up compared to patients 0–14 years old (HR, 1.89; 95% confidence interval (CI), 1.76–2.02). In the overall cohort, non‐Hispanic Blacks were found to have an increased hazard of loss to follow‐up compared to non‐Hispanic Whites (HR, 1.56; 95% CI, 1.43–1.70). Among AYAs, the highest loss to follow‐up rates were among non‐Hispanic Blacks (69.8% ± 3.1%), patients on germ cell tumor trials (78.2% ± 9.2%), and patients living in zip codes with a median household income ≤150% of the federal poverty line at diagnosis (66.7% ± 2.4%). Conclusions: AYAs, racial and ethnic minority patients, and those living in lower socioeconomic status areas had the highest rates of loss to follow‐up among clinical trial participants. Targeted interventions are warranted to ensure equitable follow‐up and improved assessment of long‐term outcomes. Plain Language Summary: Little is known about disparities in loss to follow‐up for pediatric cancer clinical trial participants.In this study, we found that participants who were adolescents and young adults when treated, those who identified as a racial and/or ethnic minority, or those residing in areas with lower socioeconomic status at diagnosis were associated with higher rates of loss to follow‐up.As a result, the ability to assess their long‐term survival, treatment‐related health conditions, and quality of life is hindered.These findings suggest the need for targeted interventions to improve long‐term follow‐up among disadvantaged pediatric clinical trial participants. In this study, significant disparities in loss to follow‐up among pediatric cancer clinical trial participants were documented for those who were adolescents and young adults at enrollment, racial and ethnic minorities, or residing in areas with lower socioeconomic status. Targeted interventions are warranted to achieve more equitable follow‐up and less biased assessment of long‐term survival and health outcomes among these clinical trial participants. [ABSTRACT FROM AUTHOR]

Background: Lifelong continuity of care is essential for patients with congenital heart disease (CHD) to maximize health outcomes; unfortunately, gaps in care (GIC) are common. Trends in GIC and of social determinants of health factors contributing to GIC are poorly understood., Methods and Results: This retrospective cohort study included patients with CHD, aged 0 to 34 years, who underwent surgery between January 2003 and May 2020, followed up at a pediatric subspeciality hospital. Patients were categorized as having simple, moderate, and complex CHD based on 2018 American Heart Association and American College of Cardiology guidelines. Social determinants of health, such as race, ethnicity, language, insurance status, and Child Opportunity Index, based on home address zip code, were analyzed. Of 2012 patients with CHD, a GIC of ≥3 years was identified in 56% (n=1119). The proportion of patients with GIC per year increased by 0.51% ( P <0.001). Multivariable longitudinal models showed that the odds of GIC were higher for patients who were ≥10.5 years old, had simple CHD, lived out of state, lived farther from care site, received public insurance, had less protection with additional insurance plans, and with low Child Opportunity Index. A separate model for patients with only moderate/complex CHD showed similar findings. Race and ethnicity were not associated with the odds of experiencing GIC over time., Conclusions: GIC have increased over time for patients with CHD. Social determinants of health, like insurance, access, and neighborhood opportunity, are key risk factors for increasing GIC. Efforts to reduce GIC in patients with CHD should focus on addressing the impact of specific social determinants of health.

To examine associations between factors associated with loss to follow-up and effectiveness in the TelAbortion project, which provided medication abortion by direct-to-patient telemedicine and mail in the United States. The study population for this descriptive analysis included abortions among participants enrolled in the TelAbortion study with data present in a web-based database tool from November 2018 to September 2021 who were mailed a medication package. The analysis included information on abortions across nine sites. In this analysis, we used generalized estimating equations to examine factors associated with loss to follow-up and effectiveness. Of the 1831 abortions included in this analysis, 1553 (84.8%) were classified as having complete follow-up and 278 (15.2%) were classified as lost to follow-up. In a multivariable analysis, factors significantly associated with loss to follow-up included history of medical abortion, education, gestational age, study site, and whether the TelAbortion was performed pre- or post-COVID-19 onset (p < 0.05). The rate of treatment failure (i.e., abortions resulting in continuing pregnancy or uterine evacuation) reported in this study was 5.1%. The only covariate associated with both loss to follow-up and treatment failure was higher gestational age. However, using gestational age to impute missing abortion outcomes did not substantially change the estimated failure rate. Abortions that were lost to follow-up differed substantially from those with complete follow-up, which could bias the effectiveness estimate. However, imputing outcomes based on available and appropriate pretreatment data did not substantially affect the estimate. This finding is encouraging, although it does not exclude the possibility of bias due to unmeasured factors. Significant differences between abortion cases with complete follow-up and those lost to follow-up provide insights into abortion cases that may be at a higher risk for being lost. The low treatment failure rate indicates that the telemedicine provision of medication abortion is effective. [ABSTRACT FROM AUTHOR]

Background: State cancer registries in the United States are data sources for estimating population-based cancer survival. However, the completeness of patient follow-up can affect the accuracy of survival estimates. Like many registries, the New York State Cancer Registry (NYSCR) conducts patient follow-up largely through linkages with other data sources. Even after expending great effort on linkages, a small proportion of patients remain lost to follow-up (LTFU). In this study, we identified factors that are associated with the likelihood of LTFU in the NYSCR., Methods: First primary cancers (sequence number, 00 or 01 and excluding death-certificate- and autopsy-only cases) diagnosed during 2000-2018 among New York State residents were selected for study. All patients were followed through December 31, 2018. Based on each patient's vital status and last contact date, follow-up status was categorized into 2 groups: patients LTFU and patients not LTFU. Patients LTFU were examined by demographic and tumor characteristics. Multivariate logistic regression analyses were performed to evaluate the association between demographic/tumor characteristics and likelihood of LTFU. For patients LTFU, the timing of LTFU (within 1 year, 1 to <5 years, 5 to <10 years, or >10 years) was further described. LTFU rates within 5 years after cancer diagnosis were also examined., Results: Among 1,797,228 patients, 74,722 were LTFU prior to December 31, 2018, representing 4.2% of all patients and 7.6% of alive patients. About 60% of LTFU occurred within 1 year after cancer diagnosis. Compared to the reference group, logistic regression analyses indicated that patients LTFU were more likely to be female, Black, Asian/Pacific Islander (API), Hispanic, foreign born, insured by Medicaid, uninsured, aged <20 years, and living in New York City or metropolitan counties. Cases reported by laboratories only and physician offices also had a higher likelihood of LTFU. Similar patterns and effects were identified when evaluating 5-year LTFU., Conclusion: Identifying factors associated with patient LTFU is important for cancer registries to improve follow-up data. We found that LTFU is not random; rather, certain patient groups have higher LTFU rates than others. For registries that conduct follow-up through linkages, it is critical to collect high-quality and complete demographic data, especially for females, children, the foreign born, and minority race/ethnicity groups., (© 2022 National Cancer Registrars Association.)

The intent-to-treat principle requires analyses according to the treatment groups to which patients were randomized and that patients be followed to the occurrence of the endpoint or the end of study. This provides unbiased comparisons with valid p values. For many trials the limitations of the data will not be known until the data are analyzed. In this article, the loss-to-follow-up with respect to the intent-to-treat principle on the most important efficacy endpoints was evaluated for clinical trials of anticancer biologic products submitted to the FDA from August 2005 to October 2008. We provide recommendations in light of the results. [ABSTRACT FROM AUTHOR]

Background: Lost to follow-up (LTF) represents an understudied barrier to effective management of chronic subdural hematoma (cSDH). Understanding the factors associated with LTF after surgical treatment of cSDH could uncover pathways for quality improvement efforts and modify discharge planning. We sought to identify the demographic and clinical factors associated with patient LTF., Methods: A single-institution, retrospective cohort study of patients treated surgically for convexity cSDH from 2009 to 2019 was conducted. The primary outcome was LTF, with neurosurgical readmission as the secondary outcome. Univariate analysis was conducted using the student-t test and χ 2 test. Multivariate logistic regression was performed to identify the factors associated with LTF and neurosurgical readmission., Results: A total of 139 patients were included, 29% of whom were LTF. The mean first postoperative follow-up duration was 60 days. On univariate analysis, uninsured/Medicaid coverage was associated with increased LTF compared with private insurance/Medicare coverage (62.5% vs. 41.4%; P = 0.039). A higher discharge modified Rankin scale score was also associated with LTF (3.7 vs. 3.5; P < 0.001). On multivariate analysis, uninsured/Medicaid patients had a significantly greater risk of LTF compared with private insurance/Medicare patients (odds ratio, 2.44; 95% confidence interval, 1.13-5.23; P = 0.022). LTF was independently associated with an increased risk of neurosurgical readmission (odds ratio, 1.94; 95% confidence interval, 1.17-3.24; P = 0.011)., Conclusions: Uninsured and Medicaid patients had a greater likelihood of LTF compared with private insurance and Medicare patients. LTF was further associated with an increased risk of neurosurgical readmission. The results from the present study emphasize the need to address barriers to follow-up to reduce readmission after surgery for cSDH. These findings could inform improved discharge planning, such as predischarge repeat imaging studies and postdischarge contact., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Expanded access to antiretroviral therapy (ART) leads to improved HIV/AIDS treatment outcomes in Nigeria, however, increasing rates of loss to follow-up among those on ART is threatening optimal standard achievement. Therefore, this retrospective cross-sectional study is aimed at identifying correlates and predictors of loss to follow-up in patients commencing ART in a large HIV program in Nigeria. Methods: Records of all patients from 432 US CDC Presidents Emergency Plan for AIDS Relief (PEPFAR) supported facilities across 10 States and FCT who started ART from 2004 to 2017 were used for this study. Bivariate and multivariate analysis of the demographic and clinical parameters of all patients was conducted using STATA version 14 to determine correlates and predictors of loss to follow-up. Results: Within the review period, 245,257 patients were ever enrolled on anti-retroviral therapy. 150,191 (61.2%) remained on treatment, 10,960 (4.5%) were transferred out to other facilities, 6926 (2.8%) died, 2139 (0.9%) self-terminated treatment and 75,041 (30.6%) had a loss to follow-up event captured. Males (OR: 1.16), Non-pregnant female (OR: 4.55), Patients on ≥ 3-monthly ARV refills (OR: 1.32), Patients with un-suppressed viral loads on ART (OR: 4.52), patients on adult 2nd line regimen (OR: 1.23) or pediatric on 1st line regimen (OR: 1.70) were significantly more likely to be lost to follow-up. Conclusion: Despite increasing access to anti-retroviral therapy, loss to follow-up is still a challenge in the HIV program in Nigeria. Differentiated care approaches that will focus on males, non-pregnant females and paediatrics is encouraged. Reducing months of Anti-retroviral drug refill to less than 3 months is advocated for increased patient adherence. [ABSTRACT FROM AUTHOR]

Loss to follow-up (LTF) has been associated with worse outcomes after procedures. We sought to identify differences in lower extremity peripheral vascular intervention (PVI) patients with and without LTF, and to determine if LTF impacted survival. Patients in the PVI registry of the Vascular Quality Initiative (VQI) were included ( n = 39,342), where t -test and chi-squared analysis were used to compare those with and without LTF. Multivariable logistic regression was used to identify factors associated with LTF while Cox regression analysis was applied to compare survival among those with and without LTF. The overall 1-year follow-up rate was 91.6%. LTF patients were more often male, Hispanic, of black race, and had a higher rate of diabetes, coronary artery disease, congestive heart failure, and dialysis. LTF patients had a higher prevalence of critical limb ischemia, underwent popliteal or distal intervention, and were intervened upon urgently. There was also a higher rate of postoperative complications, and a lower rate of technical success for LTF patients. After controlling for center effects, the independent variables associated with LTF included male sex, age, diabetes, dialysis dependence, ASA class 3 or greater, as well as complications requiring admission. Preoperative aspirin, preadmission home living status, prior carotid intervention, and discharge aspirin were protective against LTF. Adjusted survival analysis showed decreased survival in LTF, with those returning face-to-face surviving longer than those with phone follow-up. Efforts should be focused on understanding these differences to improve follow-up rates and help improve overall survival.

Purpose: This report describes outcomes of an ongoing quality-improvement project (VitalSign6) in a large US metropolitan area to improve recognition, treatment, and outcomes of depressed patients in 16 primary care clinics (6 charity clinics, 6 federally qualified health care centers, 2 private clinics serving low-income populations, and 2 private clinics serving patients with either Medicare or private insurance)., Methods: Inclusion in this retrospective analysis was restricted to the first 25,000 patients (aged ≥12 years) screened with the 2-item Patient Health Questionnaire (PHQ-2) in the aforementioned quality-improvement project. Further evaluations with self-reports and clinician assessments were recorded for those with positive screen (PHQ-2 >2). Data collected from August 2014 though November 2016 were available at 3 levels: (1) initial PHQ-2 (n = 25,000), (2) positive screen (n = 4,325), and (3) clinician-diagnosed depressive disorder with 18 or more weeks of enrollment (n = 2,160)., Results: Overall, 17.3% (4,325/25,000) of patients screened positive for depression. Of positive screens, 56.1% (2,426/4,325) had clinician-diagnosed depressive disorder. Of those enrolled for 18 or more weeks, 64.8% were started on measurement-based pharmacotherapy and 8.9% referred externally. Of the 1,400 patients started on pharmacotherapy, 45.5%, 30.2%, 12.6%, and 11.6% had 0, 1, 2, and 3 or more follow-up visits, respectively. Remission rates were 20.3% (86/423), 31.6% (56/177), and 41.7% (68/163) for those with 1, 2, and 3 or more follow-up visits, respectively. Baseline characteristics associated with higher attrition were: non-white, positive drug-abuse screen, lower depression/anxiety symptom severity, and younger age., Conclusion: Although remission rates are high in those with 3 or more follow-up visits after routine screening and treatment of depression, attrition from care is a significant issue adversely affecting outcomes., (© 2019 Annals of Family Medicine, Inc.)

Most studies that follow subjects over time are challenged by having some subjects who dropout. Double sampling is a design that selects and devotes resources to intensively pursue and find a subset of these dropouts, then uses data obtained from these to adjust naïve estimates, which are potentially biased by the dropout. Existing methods to estimate survival from double sampling assume a random sample. In limited-resource settings, however, generating accurate estimates using a minimum of resources is important. We propose using double-sampling designs that oversample certain profiles of dropouts as more efficient alternatives to random designs. First, we develop a framework to estimate the survival function under these profile double-sampling designs. We then derive the precision of these designs as a function of the rule for selecting different profiles, in order to identify more efficient designs. We illustrate using data from the United States President's Emergency Plan for AIDS Relief-funded HIV care and treatment program in western Kenya. Our results show why and how more efficient designs should oversample patients with shorter dropout times. Further, our work suggests generalizable practice for more efficient double-sampling designs, which can help maximize efficiency in resource-limited settings., (Copyright © 2014 John Wiley & Sons, Ltd.)