Development and refinement of privacy-protecting methods
  • Toh S, Gagne JJ, Rassen JA, Fireman BH, Kulldorff M, Brown JS. Confounding adjustment in comparative effectiveness research conducted within distributed research networks. Med Care 2013:51(8 Suppl 3):S4-S10 [PubMed]
  • Toh S, Reichman RE, Houstoun M, Ding X, Fireman BH, Gravel E, Levenson M, Li L, Moyneur E, Shoaibi A, Zornberg G, Hennessy S. Multivariable confounding adjustment in distributed data networks without sharing of patient-level data. Pharmacoepidemiol Drug Saf 2013;22(11):1171-1177 [PubMed]
  • Toh S, Shetterly S, Powers JD, Arterburn D. Privacy-preserving analytic methods for multi-site comparative effectiveness and patient-centered outcomes research. Med Care 2014;52(7):664-668 [PubMed]
  • Mazor KM, Richards A, Gallagher M, Arterburn DE, Raebel MA, Nowell WB, Curtis JR, Paolino AR, Toh S. Stakeholders’ views on data sharing in multi-center studies. J Comp Eff Res 2017;6(6):537-547 [PubMed][Free Fulltext]
  • Her QL, Malenfant JM, Malek S, Vilk Y, Young J, Li L, Brown J, Toh S. A query workflow design to perform automatable distributed regression analysis in large distributed data networks. eGEMs: The Journal of Electronic Health Data and Methods 2018;6(2):11[PubMed][Free Fulltext]
  • Her QL, Vilk Y, Young J, Zhang Z, Malenfant JM, Malek S, Toh S. A distributed regression analysis application based on SAS software. Part I: Linear and logistic regression [Free Preprint Fulltext]
  • Vilk Y, Zhang Z, Young J, Her QL, Malenfant JM, Malek S, Toh S, A distributed regression analysis application based on SAS software. Part II: Cox proportional hazards regression [Free Preprint Fulltext]
  • Yoshida K, Gruber S, Fireman BH, Toh S. Comparison of privacy-protecting analytic and data-sharing methods: a simulation study. Pharmacoepidemiol Drug Saf 2018;27(9):1034-1041 [PubMed][Free Fulltext]
  • Li X, Fireman BH, Curtis JR, Arterburn DE, Fisher DP, Moyneur E, Gallagher M, Raebel MA, Nowell WB, Lagreid L, Toh S. Validity of privacy-protecting analytical methods that use only aggregate-level information to conduct multivariable-adjusted analysis in distributed data networks. Am J Epidemiol 2019;188(4):709-723 [PubMed][Free Fulltext]
  • Toh S, Wellman R, Coley RY, Horgan C, Sturtevant J, Moyneur E, Janning C, Pardee R, Coleman KJ, Arterburn D, McTigue K, Anau J, Cook AJ, on behalf of the PCORnet Bariatric Study Collaborative. Combining distributed regression and propensity scores: A doubly privacy-protecting analytic method for multicenter research. Clin Epidemiol 2018;10:1773-1786 [PubMed][Free Fulltext]
  • Shu D, Young JG, Toh S. Privacy-protecting estimation of adjusted risk ratios using modified Poisson regression in multi-center studies. BMC Med Res Methodol 2019;228(1):19 [PubMed][Free Fulltext]
  • Toh S. Analytic and data sharing options in real-world multi-database studies of comparative effectiveness and safety of medical products. Clin Pharmacol Ther 2020;107(4):834-842 [PubMed]
  • Shu D, Yoshida K, Fireman BH, Toh S. Inverse probability weighted Cox model in multi-site studies without sharing individual-level data. Stat Methods Med Res 2020;29(6):1668-1681 [PubMed]
  • Toh S, Rifas-Shiman SL, Bailey LC, Forrest CB, Horgan CE, Lin PD, Lunsford D, Moyneur E, Sturtevant JL, Young JG, Block JP, on behalf of the PCORnet Antibiotics and Childhood Growth Study Group. Privacy-protecting multivariable-adjusted distributed regression analysis for multi-center pediatric study. Pediatr Res 2020;87(6):1086-1092 [PubMed][Free Fulltext]
  • Her Q, Malenfant J, Zhang Z, Vilk Y, Young J, Tabano D, Hamilton J, Johnson R, Raebel M, Boudreau D, Toh S. A distributed regression analysis application in large distributed data networks: Analysis of precision and operational performance. JMIR Med Inform 2020;8(6):e15073 [PubMed][Free Fulltext]
  • Shu D, Toh S. ppmHR: A privacy-protecting tool to fit inverse probability weighted Cox models in multi-site studies. Epidemiology 2021;32(2):e6-e7 [PubMed]

  • Shu D, Han P, Wang R, Toh S. Estimating marginal hazard ratios by simultaneously using a set of propensity score models: A multiply robust approach. Stat Med 2021;40(5):1224-1242 [PubMed]

Applications of privacy-protecting methods
  • Fireman B, Toh S, Butler MG, Go AS, Joffe HV, Graham DJ, Nelson JC, Daniel GW, Selby JV. A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent. Pharmacoepidemiol Drug Saf 2012;21(S1):282-290 [PubMed][Free Fulltext]

  • Toh S, Reichman ME, Houstoun M, Ross Southworth M, Ding X, Hernandez AF, Levenson M, Li L, McCloskey C, Shoaibi A, Wu E, Zornberg G, Hennessy S. Comparative risk for angioedema associated with the use of drugs that target the renin-angiotensin-aldosterone system. Arch Intern Med 2012;172(20):1582-1589 [PubMed][Free Fulltext]

  • Toh S, Baker MA, Brown JS, Kornegay C, Platt R. Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration’s Mini-Sentinel program. JAMA Intern Med 2013;173(9):817-819 [PubMed][Free Fulltext]

  • Toh S, Hampp C, Reichman ME, Graham DJ, Balakrishnan S, Pucino F, Hamilton J, Lendle S, Iyer A, Rucker M, Pimentel M, Nathwani N, Griffin MR, Brown NJ, Fireman BH. Risk of hospitalized heart failure among new users of saxagliptin, sitagliptin, and other antihyperglycemic drugs: A retrospective cohort study. Ann Intern Med 2016;164(11):705-714 [PubMed][Free Fulltext]

  • Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss, Toh S. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse-event association. Clin Pharmacol Ther 2016;100(5):558-564 [PubMed]

  • Zhou M, Wang SV, Leonard CE, Gagne JJ, Fuller C, Hampp C, Archdeacon P, Toh S, Iyer A, Woodworth TS, Cavagnaro E, Panozzo CA, Axtman S, Carnahan RM, Chrischilles EA, Hennessy S. Sentinel modular program for propensity-score matched cohort analyses: Application to glyburide, glipizide, and serious hypoglycemia. Epidemiology 2017;28(6):838-846 [PubMed]

  • Connolly JG, Wang SV, Fuller CC, Toh S, Panozzo CA, Cocoros N, Zhou M, Gagne JJ, Maro JC. Development and application of two semi-automated tools for targeted medical product surveillance in a distributed data network. Curr Epidemiol Rep 2017;4(4):298-306 [PubMed]

  • Gagne JJ, Houstoun M, Reichman ME, Hampp C, Marshall JE, Toh S. Safety assessment of niacin in the US Food and Drug Administration’s mini-sentinel system. Pharmacoepidemiol Drug Saf 2018;27(1):30-27 [PubMed]

  • Toh S, Reichman ME, Graham DJ, Hampp C, Zhang R, Butler MG, Iyer A, Rucker M, Pimentel M, Hamilton J, Lendle S, Fireman BH; for the Mini-Sentinel AMI-Saxagliptin Surveillance Writing Group. Prospective post-marketing surveillance of acute myocardial infarction in new users of saxagliptin: A population-based study. Diabetes Care 2018;41(1):39-48 [PubMed]

  • Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM. Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System. Pharmacoepidemiol Drug Saf 2018;27(3):263-271 [PubMed]

  • Carnahan RM, Kuntz JL, Wang SV, Fuller C, Gagne JJ, Leonard CE, Hennessy S, Meyer T, Archdeacon P, Chen CY, Panozzo CA, Toh S, Katcoff H, Woodworth T, Iyer A, Axtman S, Chrischilles EA. Evaluation of the US Food and Drug Administration Sentinel analysis tools in confirming previously observed drug-outcome associations: the case of clindamycin and Clostridium difficile infection. Pharmacoepidemiol Drug Saf 2018;27(7):731-739 [PubMed]

  • Li J, Panucci G, Moeny D, Liu W, Maro JC, Toh S, Huang TY. Association of risk for venous thromboembolism with use of low-dose extended- and continuous-cycle combined oral contraceptives – A safety study using the Sentinel Distributed Database. JAMA Intern Med 2018;178(11):1482-1488 [PubMed]

  • Carnahan RM, Gagne JJ, Hampp C, Leonard CE, Toh S, Fuller CC, Hennessy S, Hou L, Cocoros NM, Panucci G, Woodworth T, Cosgrove A, Iyer A, Chrischilles EA. Evaluation of the US Food and Drug Administration Sentinel analysis tools using a comparator with a different indication: Comparing the rates of gastrointestinal bleeding in warfarin and statin users. Pharmaceut Med 2019;33(1):29-43 [Link]

  • Taylor LG, Panucci G, Mosholder AD, Toh S, Huang TY. Antipsychotic use and stroke: a retrospective comparative study in a non-elderly population. J Clin Psychiatry 2019;80(4):18m12636 [PubMed]

  • Sansing-Foster VV, Haug N, Mosholder A, Cocoros NM, Bradley M, Ma Y, Pennap D, Dee EC, Toh S, Pestine E, Petrone AB, Kim I, Lyons JG, Eworuke E. Risk of psychiatric adverse events among montelukast users. J Allergy Clin Immunol Pract 2021;9(1):385-393 [PubMed]

Distributed data networks and data sharing

  • Toh S, Platt R, Steiner JF, Brown JS. Comparative-effectiveness research in distributed health data networks. Clin Pharmacol Ther 2011;90(6):883-887 [PubMed]

  • Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, Nelson JC, Racoosin JA, Robb M, Schneeweiss S, Toh S, Weiner MG. The U.S. Food and Drug Administration’s Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012;21(S1):1-8 [PubMed][Free Fulltext]

  • Brown JS, Kahn M, Toh S. Data quality assessment for comparative effectiveness research in distributed data networks. Med Care 2013:51(8 Suppl 3):S22-S29 [PubMed][Free Fulltext]

  • Toh S, Platt R. Is size the next big thing in epidemiology? Epidemiology 2013;24(3):349-351 [PubMed][Free Fulltext]

  • Toh S, Platt R. RE: Big data in epidemiology: Too big to fail? Epidemiology 2013;24(6):939 [PubMed][Free Fulltext]

  • Bell C, Chakravarty A, Gruber S, Heckbert SR, Levenson M, Martin D, Nelson JC, Pinheiro S, Psaty BM, Reich CG, Schneeweiss S, Shoaibi A, Toh S, Walker AM. Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems. Pharmacoepidemiol Drug Saf 2014;23(11):1223-1225 [PubMed]

  • Cameron C, Fireman B, Hutton B, Clifford T, Coyle D, Wells G, Dormuth CR, Platt R, Toh S. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities. Syst Rev 2015;4:147 [PubMed][Free Fulltext]

  • Gruber S, Chakravarty A, Heckbert SR, Levenson M, Martin D, Nelson JC, Psaty BM, Pinheiro S, Reich CG, Toh S, Walker AM. Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association. Pharmacoepidemiol Drug Saf 2016;25(9):973-981 [PubMed]

  • Toh S, Rasmussen-Torvik LJ, Harmata EE, Pardee R, Saizan R, Malanga E, Sturtevant JL, Horgan CE, Anau J, Janning CD, Wellman RD, Coley RY, Cook AJ, Courcoulas AP, Coleman KJ, Williams NA, McTigue KM, Arterburn D, McClay J, for the PCORnet Bariatric Study Collaborative. The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, methods, and baseline characteristics. JMIR Res Protoc 2017;6(12):e222 [PubMed][Free Fulltext]

  • Lu CY, Williams MS, Ginsburg GS, Toh S, Brown J, Khoury MJ. A proposed approach to accelerate evidence generation for genomic-based technologies in the context of a learning health system. Genet Med 2018;20(4):390-396 [PubMed]

  • Martin D, Gagne JJ, Gruber S, Izem R, Nelson JC, Nguyen MD, Ouellet-Hellstrom R, Schneeweiss S, Toh S, Walker AM. Sequential surveillance for drug safety in a regulatory environment. Pharmacoepidemiol Drug Saf 2018;27(7):707-712 [PubMed]

  • Inge TH, Coley RY, Bazzano LA, Xanthakos SA, McTigue K, Arterburn D, Williams N, Wellman R, Coleman KJ, Courcoulas A, Desai NK, Anau J, Pardee R, Toh S, Janning C, Cook A, Sturtevant J, Horgan C, Zebrick AJ, Michalsky M; PCORnet Bariatric Study Collaborative. Comparative effectiveness of bariatric procedures among adolescents: The PCORnet bariatric study. Surg Obes Relat Dis doi: 10.1016/j.soard.2018.04.002 [PubMed][Free Fulltext]

  • Panozzo CA, Woodworth TS, Welch EC, Huang YT, Her QL, Haynes K, Rogers C, Menzin TJ, Ehrmann M, Frietas KE, Haug NR, Toh S. Early impact of the ICD-10-CM transition on selected health outcomes in 13 electronic healthcare databases in the United States. Pharmacoepidemiol Drug Saf 2018;27(8):839-847 [PubMed]

  • Cocoros NM, Panucci G, Haug N, Maher C, Reichman M, Toh S. Outpatient influenza antivirals in a distributed data network for influenza surveillance. Influenza Other Respir Viruses 2018;12(6):804-807 [PubMed][Free Fulltext]

  • Arterburn D, Wellman R, Emiliano A, Smith SR, Odegaard AO, Murali S, Williams N, Coleman KJ, Courcoulas A, Coley RY, Anau J, Pardee R, Toh S, Janning C, Cook A, Sturtevant J, Horgan C, McTigue KM, for the PCORnet Bariatric Study Collaborative. Comparative effectiveness and safety of bariatric procedures for weight loss: A PCORnet cohort study. Ann Intern Med 12018;69(11):741-750 [PubMed][Free Fulltext]

  • Block JP, Bailey LC, Gillman MW, Lunsford D, Daley MF, Eneli I, Finkelstein J, Heerman W, Horgan CE, Hsia DS, Jay M, Rao G, Reynolds JS, Rifas-Shiman SL, Sturtevant JL, Toh S, Trasande L, Young J, Forrest CB, on behalf of the PCORnet Antibiotics and Childhood Growth Study Group. Early antibiotic exposure and weight outcomes in young children. Pediatrics 2018;142(6):e20180290 [PubMed]

  • Heerman WJ, Daley MF, Boone-Heinonen J, Rifas-Shiman SL, Bailey LC, Forrest CB, Young JG, Gillman MW, Horgan CE, Janicke DM, Jenter C, Kharbanda EO, Lunsford D, Messito MJ, Toh S, Block JP; on behalf of the PCORnet Antibiotics and Childhood Growth Study Group. Maternal antibiotic use during pregnancy and childhood obesity at age 5 years. Int J Obes 2019;43(6):1202-1209 [PubMed]

  • Lin PD, Daley MF, Boone-Heinonen J, Rifas-Shiman SL, Bailey LC, Forrest CB, Horgan CE, Sturtevant JL, Toh S, Young JG, Block JP; on behalf of the PCORnet Antibiotics and Childhood Growth Study Group. Comparing prescribing and dispensing data of the PCORnet Common Data Model within PCORnet Antibiotics and Childhood Growth Study. eGEMs: The Journal of Electronic Health Data and Methods 2019;7(1):11 [PubMed][Free Fulltext]

  • Huang TY, Welch EC, Shinde MU, Platt RW, Filion KB, Azoulay L, Maro JC, Platt R, Toh S. Reproducing protocol-based studies using parameterizable tools – Comparison of analytic approaches used by two national medical product surveillance networks. Clin Pharmacol Ther doi:10.1002/cpt.1698 [PubMed]

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Department of Population Medicine

Harvard Medical School and Harvard Pilgrim Health Care Institute

401 Park Drive, Suite 401 East, Boston, MA 02215