Hrishikesh Chakraborty
· Professor of Biostatistics & BioinformaticsVerifiedDuke University · Biostatistics and Bioinformatics
Active 1971–2026
About
Hrishikesh Chakraborty is a Professor of Biostatistics and Bioinformatics at Duke University, serving as a member in the Duke Clinical Research Institute. He is affiliated with the Division of Biostatistics within the Department of Biostatistics and Bioinformatics. His work involves biostatistics, epidemiology, and research design, contributing to the scholarly culture and accountability plan at Duke. His contact information includes an email at hrishikesh.chakraborty@duke.edu and office addresses at 300 W. Morgan Street, Room # 487, Durham, NC, and 3850, Office Room# 4114, Durham, NC.
Research topics
- Medicine
- Internal medicine
- Surgery
- Cardiology
- Intensive care medicine
- Physical therapy
Selected publications
Open Forum Infectious Diseases · 2026-01-01
articleOpen accessAbstract Background Lower respiratory tract infections (LRTIs) impose a significant burden on healthcare systems, including in Sri Lanka. This study explored the attitudes, perceptions, and experiences of Sri Lankan physicians regarding their current approach to diagnosing and managing LRTIs (including the use of guidelines, rapid diagnostic tests [RDTs], and clinical decision support tools [CDSTs]). We also assessed physicians’ perspectives on the value and drawbacks of using electronic CDSTs (eCDSTs), with the goal of developing an eCDST in future to improve LRTI management. Methods Semi-structured interviews were conducted with 15 physicians working in six public hospitals in the Western and Southern provinces of Sri Lanka. The interview guide topics included current decision-making processes in managing LRTIs, use of guidelines and pathogen-based & biomarker-based RDTs , experience with CDSTs, and the value and drawbacks of using eCDSTs in clinical practice. Results Physicians reported relying mainly on clinical judgment when managing LRTIs and generally did not consult guidelines for typical cases. When used, guidelines served as a “framework” for decision-making and were often accessed online. Physicians felt that RDTs hold value, if cost is not a barrier. Twelve physicians reported using CDSTs, such as CURB-65, TIMI score, and Wells’ score, with most accessing them via MDCalc on mobile phones. Perceived benefits of eCDSTs included improved evidence-based decision-making, enhanced efficiency, and uniformity to standardize care and reduce bias. Potential drawbacks included the tools’ inability to account for patients' unique characteristics, local reliability concerns, inconsistent internet access, and unavailability of required inputs. Conclusion Physicians relied on clinical judgment for LRTI management, using guidelines as a framework. RDTs were valued but limited by cost. CDSTs were commonly accessed and eCDSTs were seen as beneficial for evidence-based decision-making, efficiency, and standardization but raised concerns including applicability across differing patient characteristics, local relevance, internet access issues, and missing inputs. Effective eCDSTs for LRTI would need to address these limitations. Disclosures Christopher W. Woods, MD, MPH, Biomeme: Patents on differentiating bacterial from viral infections|Biomeme: Ownership Interest|Biomeme: Stocks/Bonds (Private Company) Evan Myers, MD, MPH, Hologic, Inc: Advisor/Consultant|Merck, Inc: Advisor/Consultant|Moderna, Inc: Advisor/Consultant
CYP2D6 phenotype and post-surgical pain control with hydrocodone and oxycodone
Frontiers in Pharmacology · 2026-05-11
articleOpen accessBackground Hydrocodone and oxycodone are widely used for acute postoperative pain and are metabolized by CYP2D6 to more potent agonists. The clinical impact of CYP2D6 metabolizer status on hydrocodone and oxycodone analgesic response remains uncertain. This secondary analysis of A Depression and Opioid Pragmatic Trial in Pharmacogenetics (ADOPT PGx) evaluated associations between CYP2D6 phenotype and postoperative pain and opioid consumption among patients taking hydrocodone or oxycodone. Methods This analysis included participants from the ADOPT PGx Acute Pain Trial (NCT05966129). Among patients who consumed hydrocodone or oxycodone postoperatively, analyses were conducted separately by drug, comparing outcomes between poor (PM) vs. normal (NM) and intermediate (IM) vs. normal CYP2D6 metabolizers, with phenotypes predicted by genotype and concomitant CYP2D6 inhibitor use. A positive control analysis was performed among tramadol users. Outcomes were cumulative opioid use (morphine milligram equivalents) and composite Patient-Reported Outcomes Measurement Information System® pain intensity scores at 10 days post-surgery. Regression models adjusted for demographics, surgery type, trial site, and non-opioid analgesic use; P -values were corrected for multiple comparisons. Results The cohort primarily underwent orthopedic procedures and concomitant non-opioid analgesic use was common across hydrocodone, oxycodone, and tramadol cohorts, with 88%–100% of patients receiving at least one non-opioid analgesic or nerve block. Among hydrocodone users, predicted CYP2D6 phenotype was not associated with postoperative hydrocodone consumption (PM vs. NM: mean ratio [MR] = 1.12, 95% CI 0.92–1.36, P = 0.262) or pain intensity (PM vs. NM: odds ratio [OR] = 1.13, 95% CI 0.66–1.92, P = 0.668). Among oxycodone users, CYP2D6 phenotype was not associated with postoperative oxycodone consumption (PM vs. NM: MR = 1.02, 95% CI 0.79–1.34, P = 0.880) or pain intensity (PM vs. NM: OR = 0.84, 95% CI 0.47–1.51, P = 0.568). Similarly, in the positive control tramadol cohort, CYP2D6 phenotype was not associated with tramadol consumption (PM vs. NM: MR = 1.02, 95% CI 0.79–1.32, P = 0.847) or pain intensity (PM vs. NM: OR = 1.43, 95% CI 0.66–3.00, P = 0.668). Conclusion Predicted CYP2D6 metabolizer status was not associated with postoperative pain control or opioid use in patients taking hydrocodone, oxycodone, or positive-control tramadol, suggesting that multimodal analgesic use may have weakened pharmacogenetic effects. These findings suggest that CYP2D6 phenotype associations with hydrocodone or oxycodone analgesic response, if present, are attenuated in multimodal postoperative pain management.
Indian Heart Journal · 2026-03-01
articleOpen accessSARS-COV-2 virus affects the cardiovascular system by various pathophysiological mechanisms. The incidence of Acute coronary syndrome (ACS) seems to be on rise in the peri-covid era. The proinflammatory and prothrombotic milieu is primarily responsible. Traditional atherosclerotic risk factors do not seem to be responsible for this increased incidence of ACS. We chose to test this hypothesis on young Indian population lacking the traditional atherosclerotic risk factors. If established, Covid 19 infection will at least be considered a risk modifier in causing ACS in future. Subsequently, we went on to study the differences in presentation, diagnostic implications, revascularization and management strategies and finally outcomes in ACS patients in the Peri-covid compared to the pre-covid era. To the best of our knowledge, this seems to be the first of its kind study from eastern India.
Genetic Testing for <i>APOL1</i> in Adults With Hypertension
JAMA Network Open · 2026-03-05
articleOpen accessImportance: Apolipoprotein L1 locus (APOL1) high-risk alleles are associated with incidence of chronic kidney disease (CKD) among people with African ancestry. Few studies have examined the effect of genetic return of results on blood pressure (BP) management and control. Objective: To determine whether providing APOL1 high-risk genotype results to people with hypertension and their clinicians would reduce systolic BP (SBP) and improve CKD screening and diagnosis. Design, Setting, and Participants: From July 1, 2020, to September 30, 2023, adults aged 18 to 70 years with hypertension and self-reported African ancestry were enrolled at 14 institutions and 54 clinical sites across the US. Eligible patients either (1) lacked diagnoses of diabetes and CKD or (2) had a diagnosis of CKD with or without diabetes. Interventions: Participants were randomized to receive APOL1 genotype results immediately (intervention) or 6 months after enrollment (control). Clinical decision support encouraged appropriate CKD screening, diagnosis, and antihypertensive therapy. Main Outcomes and Measures: The primary outcome was change in SBP in individuals with APOL1 high-risk allelles at 3 months, assessed in a modified intention-to-treat analysis. Prespecified per-protocol subgroup analyses included those with uncontrolled BP (baseline SBP ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg), uncontrolled BP while receiving antihypertensive therapy, and CKD at enrollment. Secondary outcomes included urine microalbumin screening and new CKD diagnoses. Results: Of 6754 individuals recruited (mean [SD] age, 55.3 [10.3] years; 4310 women [63.8%]), 954 (14.1%; mean [SD] age, 54.9 [10.0] years; 600 women [62.9%]) had 2 APOL1 risk alleles. At 3 months, there was no difference in SBP between the intervention and control groups (between-group difference, -0.3 mm Hg [95% CI, -2.7 to 2.1 mm Hg]). Among 377 individuals with uncontrolled BP, the mean SBP change was -4.1 mm Hg (95% CI, -7.7 to -0.5 mm Hg) more in the intervention group than the control group (P = .004). SBP improvement was also observed for the intervention in the subgroup of patients with uncontrolled BP receiving antihypertensive therapy (SPB difference, -4.3 mm Hg [95% CI -8.0 to -0.5 mm Hg]; P = .004), but not the CKD subgroup (SPB difference, 0.8 mm Hg [95% CI, -3.0 to 4.5 mm Hg]). Provision of APOL1 genotype led to increased urine microalbumin screening (between-group difference, 17.3% [95% CI, 9.6%-24.9%]; P < .001) and CKD diagnoses (between-group difference, 5.7% [95% CI, 2.2%-9.3%]; P = .002) at 6 months. Conclusions and Relevance: Provision of APOL1 genotype high-risk results to participants and clinicians was not associated with SBP reduction overall. Among the subset of patients with uncontrolled BP, the intervention group had a significant SBP reduction. APOL1 disclosure also increased the rate of CKD screening and diagnosis. Effects of reporting APOL1 genotype merit further investigation among those with uncontrolled BP. Trial Registration: ClinicalTrials.gov Identifier: NCT04191824.
Genotype-Guided Antidepressant Prescribing for Patients With Depression
JAMA Network Open · 2026-05-06
articleOpen accessImportance: The effectiveness of pharmacogenetics to guide prescribing of selective serotonin reuptake inhibitors (SSRIs) for depression remains unclear, despite the well-established association between SSRI pharmacokinetics and genetic variation. Objective: To determine whether pharmacogenetic-guided prescribing of SSRIs improves treatment response in patients with depression. Design, Setting, and Participants: The ADOPT PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) Depression pragmatic randomized clinical trial was conducted from August 10, 2021, through April 27, 2024, at primary care, psychiatry, or family medicine clinics at enrolling sites throughout the US. Patients were aged 8 years or older and had experienced depression for 3 months or longer. Intervention: Patients were randomized to genotype-guided SSRI prescribing (intervention group) or usual care (control group). Actionable drug metabolism phenotypes were defined as those for which pharmacogenetic clinical guidelines recommend alternative medication selection or dose adjustment. Main Outcomes and Measures: The primary outcome was change in Patient-Reported Outcomes Measurement Information System (PROMIS) depression T scores at 3 months among patients with the actionable phenotype. Secondary end points included adverse effect severity of SSRIs at 3 months and depression remission (measured with PROMIS depression scores and Patient Health Questionnaire-8 [PHQ-8] scores) at 6 months. Results: This study of 1460 patients included 1239 adults (84.9%) (mean [SD] age, 40.6 [16.7] years) and 221 children (15.1%) (mean [SD] age, 14.6 [1.8] years). Most patients were female (1096 [75.1%]). A total of 692 patients (47.4%) had an actionable phenotype; 351 (50.7%) were assigned to the intervention, and 341 (49.3%) were assigned to usual care. At baseline, 463 of the 692 patients (66.9%) reported having depressive symptoms for more than 2 years, 603 (87.1%) were receiving pharmacologic treatment, and 354 (51.2%) were receiving nonpharmacologic treatment. At 3 months, no significant differences were observed between the intervention and usual care groups in change in PROMIS depression T scores (mean [SD] change, -4.3 [8.4] vs -4.0 [8.1]; P = .68), medication adverse effect burden (mean [SD] change, 8.2 [4.3] vs 7.8 [4.5]; P = .37), or Patient Health Questionnaire-8 score change (mean [SD] change, -3.3 [5.2] vs -2.7 [4.8]; P = .13). However, at 6 months, the PROMIS depression T-score remission rate (score ≤16) was higher in the intervention group compared with the usual care group (153 of 317 patients [48.3%] vs 122 of 310 patients [39.4%]; P = .02). Conclusions and Relevance: In this randomized clinical trial, genotype-guided prescribing of SSRIs did not improve control of depression symptoms at 3 months compared with usual care but was associated with higher depression remission rates at 6 months. These findings suggest a possible longer-term clinical benefit and indicate that future studies should focus on the durability and long-term impact of genotype-guided prescribing in the management of depressive symptoms. Trial Registration: ClinicalTrials.gov Identifiers: NCT04445792 (Master Protocol Research Program platform trial) and NCT05966155 (ADOPT PGx Depression trial).
Trials · 2026-03-18
articleOpen accessBACKGROUND: Lower respiratory tract infection (LRTI) is a leading cause of hospitalization and antibacterial use globally. In low- and middle-income countries (LMICs), limited diagnostic resources contribute to inappropriate antibacterial use for LRTI. The aim of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on LRTI management in Southern Sri Lanka. METHODS: This is a prospective, open-label, stepped-wedge, cluster-randomized trial that will be conducted at three public hospitals. A total of 765 patients aged ≥ 14 years who are hospitalized with LRTI will be enrolled across 9 clusters; each cluster consists of a pair of wards (1 male and 1 female). The intervention consists of implementing an eCDST (RespiQuestAB) that physicians use on their mobile phones. RespiQuestAB integrates real-time influenza incidence in Sri Lanka with epidemiological and clinical predictors of LRTI etiology to estimate the probability of the following diagnoses: influenza, other viral (including SARS-CoV-2) infection, bacterial infection, noninfectious condition, or indeterminate. Point-of-care (POC) tests for influenza, SARS-CoV-2, Streptococcus pneumoniae, or procalcitonin are recommended if a positive result increases the probability of the associated diagnosis by at least 5%; clinicians may also order these tests independently. RespiQuestAB provides treatment recommendations regarding antibacterial and antiviral (oseltamivir) use based on the probability of diagnosis. Participants will be followed longitudinally to assess antibacterial prescription and clinical outcomes. The co-primary outcomes are as follows: (1) Duration of antibacterial prescription for the index visit and (2) a composite clinical outcome associated with worsening LRTI by day 30. Secondary outcomes include the individual clinical outcomes of the composite outcome, receipt, and duration of antibacterial and antiviral prescriptions and physician adherence to diagnostic tests and treatments recommended by RespiQuestAB. Exploratory outcomes include Desirability of Outcome Ranking (DOOR) level arranged in an ordinal scale, individual DOOR levels, and prescription of immunomodulatory therapy for SARS-CoV-2. DISCUSSION: Results of this clinical trial will provide information on the impact of the RespiQuestAB on antibacterial use and clinical outcomes among patients with LRTI in an LMIC setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT06331364. Registered on March 25, 2024.
R package to estimate intracluster correlation coefficient for nominal and ordinal data
Computer Methods and Programs in Biomedicine Update · 2025-01-01
articleOpen access1st authorCorresponding: The intracluster correlation coefficient (ICC) is a critical parameter to assess the degree of similarity or correlation between observations within the same cluster or group. It is commonly applied in cluster-randomized trials to estimate average within-cluster correlation. Although methods to estimate ICC exist for binary, continuous, and survival data, a new resampling-based approach has been developed for nominal or ordinal responses with more than two categories. The objective of this paper is to present both the resampling methods estimator and method of moments (MoM) based estimator for categorical ICC estimation. To facilitate the adoption and use of these estimators we developed an R package, iccmult , which calculates the ICC point estimate and confidence interval (CI) for categorical response data under each of these two methods. : In this paper we incorporated the resampling based estimation method and MoM originally developed to characterize population genetic structure. A simulation study was conducted to compare estimates from MoM to the resampling method under different event rates, varying numbers of clusters, and various cluster sizes. The iccmult package provides two estimates of ICC and its CI, computed using these two methods. Additionally, the package also generates clustered categorical response data. : The iccmult package provides two functions for users. The function rccat() generates clustered categorical data, while the function iccmulti() estimates ICC and its CI. The simulation study revealed that the resampling and MoM methods perform nearly identically in estimating population ICC. However, the MoM method demonstrated greater precision in scenarios with fewer clusters and smaller cluster sizes. : The R package iccmult offers easy-to-use ways to generate clustered categorical data and estimate ICC and its CI for a nominal or ordinal response using different methods. The package is freely available for use with R from the CRAN repository ( https://cran.r-project.org/package=iccmult ). We believe that this package can be a very useful tool for researchers designing cluster randomized trials with a categorical outcome. • Method of moments translated for the purposes of ICC estimation on nominal or ordinal response data. • R package developed to facilitate generation of categorical response data and estimation of the ICC and its confidence interval for categorical outcomes. • Simulation study showed that the resampling based estimation method is comparable in performance to the method of moments based estimation method.
Acc on essential residuals and colon ideals
Asian-European Journal of Mathematics · 2025-08-01 · 1 citations
article1st authorIn this paper, we introduced and studied the properties of modules and ring satisfying acc on essential residuals and colon ideals, respectively. An [Formula: see text]-module [Formula: see text] is said to hold ascending chain condition on essential residuals (satisfy e-accr), if the ascending chain of essential residuals [Formula: see text] stabilizes for every submodule [Formula: see text] and every finitely generated ideal [Formula: see text] of [Formula: see text]. We showed that the property of modules being e-accr is closed under factor modules, submodules and finite direct sum. Furthermore, we extended the Artin–Rees Lemma and Krull Intersection Theorem for e-accr. A ring [Formula: see text] is said to satisfy e-accr, if it has e-accr on colon ideals as a module over itself. Also we succeed to establish a proof of the generalization of a well-known theorem and its converse stated as a ring [Formula: see text] is e-accr if and only if its polynomial ring [Formula: see text] over finitely many variables is also e-accr. Furthermore, we characterize several rings in terms of acc on annihilators.
Higher versus Lower Phosphate Targets for Patients Undergoing In-Center Hemodialysis
Journal of the American Society of Nephrology · 2025-07-10 · 5 citations
articleOpen accessKey Points The HiLo pragmatic, multicenter randomized trial compared a higher versus lower serum phosphate target in patients undergoing maintenance hemodialysis. The HiLo trial was terminated early due to insufficient enrollment and inadequate phosphate separation between groups. HiLo demonstrated the feasibility of embedding a randomized intervention in routine dialysis care and identified challenges to inform future trials. Background Serum phosphate targets in maintenance hemodialysis are based on observational studies. The Pragmatic Trial of Higher versus Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) trial aimed to compare the effect of a higher versus a lower phosphate target on clinical events in patients receiving maintenance hemodialysis. Methods HiLo was a pragmatic, multicenter randomized trial that compared higher (≥6.5 mg/dl; “Hi”) versus lower (<5.5 mg/dl; “Lo”) phosphate targets in patients undergoing maintenance hemodialysis. The goal was to enroll 4400 cluster-randomized patients to assess the primary hierarchical composite outcome of all-cause mortality, followed by all-cause hospitalization using the win ratio. Owing to an imbalance in baseline serum phosphate between groups, raising concern for biased recruitment due to postrandomization consent, HiLo transitioned to individual randomization 23 months after the trial began. Ultimately, HiLo was stopped early due to insufficient enrollment and inadequate phosphate separation between groups. For this report, we combined the cluster-randomized and individually randomized cohorts, analyzing the individually randomized cohort as two additional clusters and applying a variance inflation factor to account for site-level clustering effects. Results Between March 2020 and November 2023, 352 patients in the Hi group and 441 in the Lo group were enrolled. After a median follow-up of 1.4 years (quartiles 1–3: 0.5–2.8 years), there were 11 deaths per 100 person-years in the Hi group and 13 per 100 person-years in the Lo group. The Hi group experienced 134 hospitalizations per 100 person-years compared with 96 per 100 person-years in the Lo group. The primary hierarchical composite outcome did not differ between groups (win ratio for Hi versus Lo targets was 0.97; 95% confidence interval, 0.55 to 1.71). Conclusions Insufficient enrollment and inadequate phosphate separation between groups preclude inferences about the effects of phosphate targets on clinical outcomes. Clinical Trial registry name and registration number: ClinicalTrials.gov, NCT04095039.
Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory
Contemporary Clinical Trials · 2025-02-25 · 2 citations
articleOpen access
Recent grants
The IGNITE II CC: Engagement, Coordination, Demonstration, and Dissemination
NIH · $15.1M · 2018–2026
Frequent coauthors
- 97 shared
Shivaprasad S. Goudar
Jawaharlal Nehru Medical College
- 90 shared
Tyler Hartwell
RTI International
- 87 shared
Richard J. Derman
Thomas Jefferson University
- 86 shared
Stacie Geller
University of Illinois Chicago
- 85 shared
Mrutyunjaya Bellad
- 85 shared
Shobhana Patted
Jawaharlal Nehru Medical College
- 84 shared
Bhalchandra S. Kodkany
KLE University
- 84 shared
Vijaya A. Naik
KLE University
Education
DrPH, Biostatistics
University of North Carolina at Chapel Hill
MA, Socialogy
Louisiana State University
MSc, Statistics
Jahangirnagar University
BSc, Statistics
Jahangirnagar University
MS, Biostatistics
University of North Carolina at Chapel Hill
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