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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]

PROFESSOR EMERITUS FRANK POMMERSHEIM The Board of Editors of the South Dakota Law Review is pleased to dedicate Volume 65 to Professor Emeritus Frank Pommersheim. Frank Pommersheim was born in [...]

BackgroundIntravenous iron use in hemodialysis patients has greatly increased over the last decade, despite limited studies on the safety of iron.MethodsWe studied the association of receipt of intravenous iron with hospitalizations in an incident cohort of hemodialysis patients. We examined 9544 patients from Dialysis Clinic, Inc. (DCI). We ascertained intravenous iron use from DCI electronic medical record and USRDS data files, and hospitalizations through Medicare claims. We examined the association between iron exposure accumulated over 1-, 3- or 6-month time windows and incident hospitalizations in the follow-up period using marginal structural models accounting for time-dependent confounders. We performed sensitivity analyses including recurrent events models for multiple hospitalizations and models for combined outcome of hospitalization and death.ResultsThere were 22 347 hospitalizations during a median follow-up of 23 months. Higher cumulative dose of intravenous iron was not associated with all-cause, cardiovascular or infectious hospitalizations [HR 0.97 (95% CI: 0.77-1.22) for all-cause hospitalizations comparing >2100 mg versus 0-900 mg of iron over 6 months]. Findings were similar in models examining the risk of hospitalizations in 1- and 3-month windows [HR 0.88 (95% CI: 0.79-0.99) and HR 0.88 (95% CI: 0.74-1.03), respectively] or the risk of combined outcome of hospitalization and death in the 6-month window [HR 0.98 (95% CI: 0.78-1.23)].ConclusionsHigher cumulative dose of intravenous iron may not be associated with increased risk of hospitalizations in hemodialysis patients. While clinical trials are needed, employing higher iron doses to reduce erythropoiesis-stimulating agents does not appear to increase morbidity in routine clinical care.

We conducted a randomized, controlled prospective pilot study to determine feasibility and impact of food bank and health system collaboration to home-delivered food to adults with type 2 diabetes mellitus experiencing food insecurity. Treatment group received biweekly, ethnically tailored, home-delivered food for 24 weeks. Analysis included intervention feasibility and impact on healthcare utilization, HbA1c, and other health-related measures. Intervention was feasible and successful with high levels of participant satisfaction. At baseline, participants with highest HbA1c reported poorer health, lower medication adherence and self-care, and higher diabetes distress and medicine for food tradeoffs. At 24 weeks, treatment group reported improved food security and health status. There were no differences in HbA1c or healthcare utilization measures between the two groups. It is feasible for a community food bank and nearby hospital to successfully collaborate and provide supplemental food staples to food insecure adults with type 2 diabetes and improve food insecurity and health status. Public policy efforts should utilize and expand this strategy with the goal of improving health and reducing health disparities. Future work could include more comprehensive food support focused on those with poorest glycemic control, and expanded, coordinated interventions directed at other social determinants of health. Future programming and policies should be cocreated with community input to ensure greatest success. [ABSTRACT FROM AUTHOR]

The Board of Editors of the South Dakota Law Review is honored to dedicate Volume 62 to Dean and Professor Emeritus of the University of South Dakota School of Law, [...]

Purpose: This narrative review describes the application of negative control outcome (NCO) methods to assess potential bias due to unmeasured or mismeasured confounders in non‐randomized comparisons of drug effectiveness and safety. An NCO is assumed to have no causal relationship with a treatment under study while subject to the same confounding structure as the treatment and outcome of interest; an association between treatment and NCO then reflects the potential for uncontrolled confounding between treatment and outcome. Methods: We focus on two recently completed NCO studies that assessed the comparability of outcome risk for patients initiating different osteoporosis medications and lipid‐lowering therapies, illustrating several ways in which confounding may result. In these studies, NCO methods were implemented in claims‐based data sources, with the results used to guide the decision to proceed with comparative effectiveness or safety analyses. Results: Based on this research, we provide recommendations for future NCO studies, including considerations for the identification of confounding mechanisms in the target patient population, the selection of NCOs expected to satisfy required assumptions, the interpretation of NCO effect estimates, and the mitigation of uncontrolled confounding detected in NCO analyses. We propose the use of NCO studies prior to initiating comparative effectiveness or safety research, providing information on the potential presence of uncontrolled confounding in those comparative analyses. Conclusions: Given the increasing use of non‐randomized designs for regulatory decision‐making, the application of NCO methods will strengthen study design, analysis, and interpretation of real‐world data and the credibility of the resulting real‐world evidence. [ABSTRACT FROM AUTHOR]