About

Joseph Koopmeiners, PhD, is the Mayo Professor and Division Head of the Division of Biostatistics & Health Data Science at the University of Minnesota School of Public Health. He develops statistical methods to improve the accuracy and efficiency of questions related to cancer prevention, detection, and treatment. His research combines statistical methods in biomarker validation and Bayesian adaptive methods for clinical trials, with a focus on collaborations within the University of Minnesota Masonic Cancer Center. His work includes developing methods for detecting prostate cancer using MRI, tobacco regulatory science, and early phase cancer clinical trials. Dr. Koopmeiners holds a PhD in Biostatistics from the University of Washington and an MS in Biostatistics from the University of Minnesota. He also earned a BA in Mathematics from St. John's University. He is a member of professional associations such as the American Statistical Association, the International Biometrics Society, and the Society for Clinical Trials. In addition to his research, he teaches in the Biostatistics program, advising master's and PhD students, and courses include Clinical Trials: Design, Implementation, and Analysis. He is also a member of the Masonic Cancer Center and serves as Scientific Co-director of the RapidEVAL Program at the Center for Learning Health Systems Sciences.

Research topics

• Medicine
• Internal medicine
• Pathology
• Immunology
• Gastroenterology
• Anesthesia
• Pediatrics
• Emergency medicine

Selected publications

• Exploring Patient Perspectives on a Digital Opioid Management Tool After Surgery: A Qualitative Study (Preprint)

  2026-02-24

  articleOpen access

  <sec> <title>BACKGROUND</title> EHR-integrated digital tools offer a scalable, low-burden way to deliver opioid education, tapering support, and promote safe disposal. Despite this, the usability and patient-perceived value of such tools in surgical populations are not well characterized. </sec> <sec> <title>OBJECTIVE</title> We developed OPY (Opioid Program for You), a patient portal-embedded, patient-facing application grounded in behavioral economics to operationalize effective postoperative opioid stewardship. This study evaluates OPY from the patient perspective to assess their unique experiences, tool usability, and utility. </sec> <sec> <title>METHODS</title> This qualitative study included both online surveys (n=64) and virtual, semi-structured interviews (n=19). Participants were recruited from a large academic health system from July–August 2025. This study was prospectively registered (NCT06124079) and adheres to Standards for Reporting Qualitative Research (SRQR) guidelines. Survey results were descriptively analyzed and qualitative data was coded using grounded thematic analysis. </sec> <sec> <title>RESULTS</title> The majority, 70% (30 of 43), of participants reported being satisfied with the OPY tool, and said they were likely, 75% (24 of 32), to recommend OPY to friends or family. Qualitative themes identified were: overall OPY usage patterns, perceptions of OPY features (positive and negative), patients' reactions to the introduction of the OPY application, and suggestions for tool improvement. </sec> <sec> <title>CONCLUSIONS</title> Most participants valued the OPY tool for its educational content, safety guidance, and usability, yet emphasized the need for personalized content and functionality, along with a stronger introduction to OPY from providers at the point of care to enhance engagement and implementation of an embedded digital health tool. </sec> <sec> <title>CLINICALTRIAL</title> (ClinicalTrials.gov NCT06124079) </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> RR2-10.2196/52882 </sec>

  PublisherDOI

• Aligning cardiac monitoring with American Heart Association Guidelines: Impact on utilization, hemodynamic monitoring, and outcomes

  PLoS ONE · 2026-01-30

  articleOpen access

  BACKGROUND: Overuse of continuous cardiac monitoring can lead to poor patient experience, increased costs, and decreased efficiency. Because significant variation in continuous cardiac monitoring ordering exists, implementation strategies that promote care in alignment with practice standards and an examination of use cases that fall outside of standards are needed. The purpose of this study, therefore, was to evaluate if implementation of American Heart Association (AHA) practice standards on continuous cardiac monitoring could reduce utilization without jeopardizing patient safety. METHODS: We conducted a prospective pre-post study including a 2 year prospectively collected baseline against a 10-month post intervention period within a 10-hospital health system. An electronic health record (EHR) order set was implemented to align care with AHA continuous cardiac monitoring practice standards. We compared continuous cardiac monitoring utilization, adherence to standards, as well as clinical outcomes including mortality and length of stay. Finally, we investigated the rate and impact of hemodynamically significant events (hypotension, bradycardia, and tachycardia) before and after the intervention. RESULTS: We compared 117,814 hospitalizations pre-implementation against 49,006 post implementation finding significant reductions in total telemetry use, and no significant change in outcomes. Overall, patients with telemetry use outside of standards had higher mortality, longer length of stay, and higher readmission rates. The intervention was associated with a higher rate of hypotensive events which occurred off cardiac monitoring. This was not associated with worse outcomes. CONCLUSIONS: An EHR tool to align care with continuous cardiac monitoring practice standards safely reduced overall continuous cardiac monitoring utilization. Use outside of practice standards persisted and was primarily focused on monitoring for potential hemodynamic instability. We found no evidence that continuous cardiac monitoring was associated with improved outcomes in unstable patients. Continuous cardiac monitoring for potentially unstable patients can likely be replaced for non-cardiac indications with continuous heart rate monitoring.

  PublisherDOI

• Jointly modeling multiple endpoints for efficient treatment effect estimation in randomized controlled trials

  Biometrics · 2025-12-05

  preprintOpen access

  Randomized controlled trials are the gold standard for evaluating the efficacy of an intervention. However, there is often a trade-off between selecting the most scientifically relevant primary endpoint versus a less relevant, but more powerful, endpoint. For example, in the context of tobacco regulatory science many trials evaluate cigarettes per day as the primary endpoint instead of abstinence from smoking due to limited power. Additionally, it is often of interest to consider subgroup analyses to answer additional questions; such analyses are rarely adequately powered. In practice, trials often collect multiple endpoints. Intuitively, if multiple endpoints demonstrate a similar treatment effect, we would be more confident in the results of this trial. However, there is limited research on leveraging information from secondary endpoints besides using composite endpoints, which can be difficult to interpret. In this paper, we develop an estimator for the treatment effect on the primary endpoint based on a joint model for primary and secondary efficacy endpoints. This estimator gains efficiency over the standard treatment effect estimator when the model is correctly specified but is robust to model misspecification via model averaging. We illustrate our approach by estimating the effect of very low nicotine content cigarettes on the proportion of Black people who smoke who achieve abstinence and find our approach reduces the standard error by 27%.

  PublisherOA PDFDOI

• Examining covariate-specific treatment effects in individual participant data meta-analysis: Framing aggregation bias in terms of trial-level confounding and funnel plots

  Research Synthesis Methods · 2025-10-23

  articleOpen access

  Abstract To understand a treatment’s potential impact at the individual level, it is crucial to explore whether the effect differs across patient subgroups and covariate values. Meta-analysis provides an important tool for detecting treatment–covariate interactions, as it can improve power compared to a single study. However, aggregation bias can occur when estimating individual-level treatment–covariate interactions in meta-analysis, due to trial-level confounding. This refers to when the association between the covariate and treatment effect across trials (at the aggregate level) differs from that observed within trials (at the individual level). It is, thus, recommended that heterogeneity in the treatment effect at the individual level should be disentangled from that at the trial level, ideally using an individual participant data (IPD) meta-analysis. Here, we explain this issue and provide new intuition about how trial-level confounding is impacted by differences in within-trial distributions of covariates and how this corresponds to asymmetry in subgroup-specific funnel plots in the case of categorical covariates. We then propose a sensitivity analysis to assess the robustness of interaction estimates to potential trial-level confounding. We illustrate these concepts using simulated and real data from an IPD meta-analysis of trials conducted on the TICO/ACTIV-3 platform, which assessed passive immunotherapy treatments for inpatients with COVID-19.

  PublisherOA PDFDOI

• E-Liquid Flavor Availability Significantly Affects Cigarette and E-Liquid Purchasing in an Experimental Marketplace Simulating a Low Nicotine Product Standard

  Nicotine & Tobacco Research · 2025-06-20

  articleOpen access

  INTRODUCTION: This study evaluated whether e-liquid nicotine concentration and non-tobacco flavor availability affected very low nicotine content (VLNC) and normal nicotine content (NNC) cigarette purchasing within an online experimental tobacco marketplace (ETM). AIMS AND METHODS: Adults who smoked daily (n = 67) completed four study visits. At each visit, using a pre-allocated balance, participants completed successive ETM shopping trips to purchase a week's worth of cigarettes, e-cigarette e-liquid, and nicotine gum. In one trip, the only cigarettes available had VLNC. In others, both NNC and VLNC cigarettes were available, with the price of NNC cigarettes escalating across trips ($0.12 to $2.00 / cigarette) while VLNC cigarette price remained constant ($6.00 / pack). Across visits, e-liquid available in the ETM varied by nicotine concentration (50 mg/mL, 25 mg/mL) and flavor availability (multiple flavors, one tobacco flavor). We compared cigarette purchasing by a linear mixed model with a random effect for subject. RESULTS: When the only cigarettes available had VLNC, participants purchased fewer cigarettes when multiple e-liquid flavors (vs. one tobacco flavor) were simultaneously available in the ETM (-8.55 cigarettes, 95% confidence interval [CI] = -15.85, -1.25). The nicotine concentration of available e-liquid (50 vs. 25 mg/mL) did not significantly affect cigarette purchasing. NNC cigarette demand across escalating prices was similar regardless of e-liquid condition, except average maximum expenditure was lower when multiple e-liquid flavors were available (-$2.54, 95% CI = -$4.08, -$1.00). CONCLUSIONS: Within an ETM where NNC cigarettes were unavailable, participants purchased fewer VLNC cigarettes when non-tobacco e-liquid flavors were available versus only a tobacco flavor. IMPLICATIONS: Access to a variety of non-tobacco (eg, fruit, mint, and dessert) flavored e-liquids could moderate initial VLNC cigarette and nicotine e-liquid purchasing if a low nicotine product standard for cigarettes is implemented. Future studies should investigate how the nicotine concentration, the flavor variety, and risk perceptions of vaping products affect VLNC cigarette purchasing and use over time.

  PublisherOA PDFDOI

• Oncologist perspectives on the acceptability, appropriateness, and feasibility of the Cancer and Aging Research Group (CARG) chemotherapy toxicity prediction tool for older adults

  Journal of Geriatric Oncology · 2025-06-27

  article
  PublisherDOI

• I CAN DO Surgical ACP (Improving Completion, Accuracy and Dissemination of Surgical Advanced Care Planning): a protocol for a multisite, single-blinded, pragmatic randomised controlled trial to improve ACP completion in older adults in the presurgical setting

  BMJ Open · 2025-09-01 · 1 citations

  articleOpen access

  INTRODUCTION: Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE's use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions. METHODS AND ANALYSIS: This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1(AArm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines. ETHICS AND DISSEMINATION: The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT06090552. PROTOCOL NUMBER: Advarra Pro 00070994. UNIVERSITY OF CALIFORNIA, SAN FRANCISCO IRB IRIS NUMBER: 23-38948.Protocol Date: 24 October 2024. PROTOCOL VERSION: 4.

  PublisherOA PDFDOI

• Accounting for Carryover Toxicity in Phase I Clinical Trials with Intra‐Patient Dose Escalation

  Statistics in Medicine · 2025-05-01

  articleOpen accessSenior author

  Intra-patient dose escalation (IPDE) provides a strategy for more efficient Phase I clinical trials. However, IPDE poses additional challenges due to the need to account for carryover toxicity from previous dosings a patient has received. To that end, we propose two CRM-based approaches to IPDE that incorporate potential carryover toxicity. We compare these methods to the CRM without IPDE and the AIDE-CRM, an existing Bayesian adaptive approach to IPDE. In simulations across a range of scenarios, we show that our approaches have similar operating characteristics to the CRM without IPDE, but with a 20% reduction in time and participants needed to complete the trial; these results hold even in the presence of strong carryover toxicity that hinders the performance of the AIDE-CRM.

  PublisherOA PDFDOI

• Optimizing sepsis care within a learning health system: qualitatively examining the perspectives of those involved in sepsis care

  Journal of Critical Care · 2025-12-06

  article
  PublisherDOI

• Assessment of cost-related medication nonadherence during routine hospital-based care: Association with racial disparities and hospital utilization

  American Journal of Health-System Pharmacy · 2025-07-18

  article

  PURPOSE: Cost-related medication nonadherence (CRNA) is a prevalent public health problem tied to social determinants of health. The purpose of this study was to describe a method to collect CRNA and the association this has with hospital utilization, as well as potential racial disparities in the prevalence of CRNA. METHODS: We conducted a pilot prospective observational study by embedding 2 validated survey questions aimed at capturing CRNA into the admission process in an academic 10-hospital system. We evaluated process adherence and the association between CRNA and patient demographics, outcomes, and overall hospital utilization. RESULTS: During the study period, 7,831 patients were admitted, of whom 2,878 were screened for CRNA. Of those screened, 144 (5.0%) reported experiencing CRNA in the last year and 99 (3.4%) reported experiencing CRNA in the last 3 months. Patients with CRNA were younger, more likely to be male and nonwhite, and had higher rates of chronic comorbidities. Patients who reported experiencing CRNA in the last 3 months had a longer initial length of stay, but only 5% had an ambulatory pharmacy follow-up visit. Overall process adherence was higher for white patients, largely due to hospital-level effects. CONCLUSION: Embedding assessment for CRNA into routine care captures a medically complex and socially vulnerable population. Assessment of CRNA represents a critical first step in addressing an important social determinant of health and represents an opportunity to standardize care to reduce cost, as well as improve equity and patient outcomes.

  PublisherDOI

Recent grants

• Innovative Statistical Methods for Estimating the Impact of Tobacco Product Standards

  NIH · $2.4M · 2018–2030

• Evaluating New Nicotine Standards for Cigarettes

  NIH · $126.0M · 2011–2025

• Innovative Statistical Methods for Detecting and Accounting for Non-Compliance in Randomized Trials of Very Low Nicotine Content Cigarettes

  NIH · $229k · 2016–2019

Frequent coauthors

• Dorothy K. Hatsukami

  55 shared

• Claudia A. Salinas

  Boehringer Ingelheim (Germany)

  53 shared

• Jennifer W. Tidey

  Brown University

  52 shared

• Stephen C. Schmechel

  52 shared

• Eric C. Donny

  Wake Forest University

  50 shared

• Janet L. Stanford

  43 shared

• Elaine A. Ostrander

  National Institutes of Health

  41 shared

• Erika M. Kwon

  38 shared

Education

• MS, Biostatistics

  University of Minnesota

  2004

Awards & honors

• Delta Omega, Honorary Society in Public Health
• Member, Masonic Cancer Center (MCC)
• Scientific Co-director, RapidEVAL Program, Center for Learni…