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Center for Drug Safety and Effectiveness

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  1. Falude-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral direct acting agent therapy for hepatitis C:  A systematic review. Ann Intern Med. 2017 Mar 21. [Epub ahead of print]
    PubMed
     
  2. Susukida R, Crum R, Ebnesajjad C, Stuart EA, Mojtabai R. Generalizability of Findings from Randomized Controlled Trials: Application to the National Institute of Drug Abuse Clinical Trials Network. Addiction. 2017 Feb 3. [Epub ahead of print]
    PubMed
     
  3. Nguyen TQ, Cole S, Ebnesajjad C, Stuart EA. Sensitivity Analysis for an Unobserved Moderator in RCT-to-Target-Population Generalization of Treatment Effects. Ann Appl Stat. 2017;11(1):225-47.   
     
  4. Green AR, Segal J, Tian J, Oh E, Roth DL, Hilson L, Dodson JL, Boyd CM. Use of Bladder Antimuscarinics in Older Adults with Impaired Cognition. J Am Geriatr Soc. 2017;65(2):390-4.
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  5. Fraenkel L, Lim J, Tsao G, Reyna V, Monto A, Bridges J. Variation in treatment priorities for chronic hepatitis C: A latent class analysis. Patient. 2016;9(3):241-9.
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  6. Jackson JW. Diagnostics for Confounding of Time-varying and Other Joint Exposures. Epidemiology. 2016;27(6):859-69.
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  7. Greene, JA, Anderson G, Sharfstein JM. Role of the FDA in Affordability of Off-Patent Pharmaceuticals. JAMA. 2016;315(5):461-2.
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  8. Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. 2016. JAMA Intern Med. 2016;176(2):238-46.
    PubMed
     
  9. Sharfstein JM, Pstay BM. Evaluation of the Cardiovascular Risk of Naltrexone-Bupropion: A Study Interrupted. JAMA. 2016;315(10):984-6.
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  10. Green AR, Leff B, Wang Y, Spatz ES, Masoudi FA, Peterson PN, Daugherty SL, Matlock DD. Geriatric Conditions in Patients Undergoing Defibrillator Implantation for Prevention of Sudden Cardiac Death: Prevalence and Impact on Mortality. Circ Cardiovasc Qual Outcomes. 2016;9(1):23-30.
    PubMed
     
  11. Hendrix CW, Andrade A, Bumpus NN, Kashuba AD, Marzinke M, Moore A, Anderson PL, Bushman LR, Fuchs E, Wiggins I, Radebaugh C, Prince HA, Bakshi R, Wang R, Richardson P, Shieh E, McKinstry L, Li X, Donnell D. Elharrar V, Mayer K, Patterson KB. Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine after Directly Observed Dosing in Healthy Volunteers to establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retrovir. 2016;32(1):32-43.
    PubMed
     
  12. Furlong P, Bridges J, Charnas L, Fallon J, Fischer R, Flanigan K, Franson T, Gulati N, McDonald C, Peay H, Sweeney L. How a Patient Advocacy Group Developed the First Proposed Draft Guidance Document for Industry for Submission to the U.S. Food and Drug Administration. Orphanet J Rare Dis. 2015;10:82.
    PubMed
     
  13. Jackson JW, Swanson SA. Toward a clearer portrayal of confounding bias in instrumental variable applications. Epidemiology. 2015;26(4):498-504.
    PubMed
     
  14. Sharfstein JM, Charo A. The Promotion of Medical Products in the 21st Century: Off-label Marketing and First Amendment Concerns. JAMA. 2015;314(17):1795-6.
    PubMed
     
  15. Rutkow L, Chang HY, Daubresse M, Webster DW, Stuart EA, Alexander GC. Effect of Florida’s Prescription Drug Monitoring Program and pill mill laws on opioid prescribing and use. JAMA Intern Med. 2015;175(10):1642-9.
    PubMed
     
  16. Fuchs EJ, Schwartz J, Memon MA, Bakshi RP, Coleman J, Hendrix CW. A Pilot Study to Measure the Distribution and Permeability of a Vaginal HIV Microbicide Gel Vehicle using MRI, SPECT/CT, and Radiolabeled Small Molecule. AIDS Res Hum Retrovir. 2015;31(11):1109-15.
    PubMed
     
  17. Li P, Stuart EA, Allison DB. Multiple imputation: A flexible tool for handling missing data. JAMA. 2015;314(18):1966-7.
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  18. Chang HY, Zhou M, Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: Population based retrospective cohort study. BMJ. 2015;350:h1585. 
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  19. Webb-Vargas Y, Rudolph KE, Lenis D, Murakami P, Stuart EA. An imputation-based solution to using mismeasured covariates in propensity score analysis. Stat Methods Med Research. Published online June 3, 2015.
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  20. Greene JA, Watkins ES. The vernacular of risk – rethinking direct-to-consumer advertising of pharmaceuticals. NEJM. 2015;373(12):1087-9.
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  21. Green AR, Boyd CM, Rickard J, Gomon R, Leff B. Attitudes of older adults with serious competing health risks toward their implantable cardioverter-defibrillators: A pilot study. BMC Geriatr. 2015;15(1):173. 
    PubMed
     
  22. Leyva F, Fuchs EJ, Bakshi R, Carballo-Dieguez A, Ventuneac A, Yue C, Caffo B, Du Y, Torbenson M, Li L, Mullin G, Lee L, Rohan L, Anton PA, Hendrix CW. Simultaneous evaluation of safety, acceptability, peri-coital kinetics, and ex vivo pharmacodynamics comparing four rectal microbicide vehicle candidates. AIDS Res Hum Retroviruses. 2015;31(11):1089-97.
    PubMed
     
  23. Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015;314(3):233-4.
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  24. Kanavos P, Ferrario A, Vandoros A, Anderson GF. Higher US branded drug prices and spending compared to other countries may stem partly from quick uptake of new drugs. Health Aff (Millwood). 2013;32(4): 753-61.
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  25. Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med. 2015;372(12):1171-5.
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  26. Rutkow L, Turner L, Lucas E, Hwang C, Alexander GC. Most primary care physicians are aware of prescription drug monitoring programs, but many find the data difficult to access. Health Aff (Millwood). 2015;34(3):484-92.
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  27. Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee D-G, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis a randomized trial. Ann Intern Med. 2015;162(2):81-9. 
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  28. Chang H-YDaubresse MKruszewski SPAlexander GC. Prevalence and treatment of pain in EDs in the United States, 2000 to 2010. Am J Emerg Med. 2014;32(5):421-31. 
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  29. Chen L-Y, Strain EC, Alexandre PK, Alexander GCMojtabai R, Martins SS. Correlates of nonmedical use of stimulants and methamphetamine use in a national sample. Addict Behav. 2014; 39(5): 829-36. 
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  30.  Daubresse M, Gleason PP, Peng Y, Shah ND, Ritter ST, Alexander GC. Impact of a drug utilization review program on high-risk use of prescription controlled substances. Pharmacoepidemiol Drug Saf. 2014;23(4):419-27.
    PubMed
     
  31. Baxi SM, Greenblatt RM, Bacchetti P, Scherzer R, Minkoff H, Huang Y, Anastos K, Cohen M, Gange SJ, Young M Shlipak MG, Gandhi M. Common clinical conditions-age, low BMI, ritonavir use, mild renal impairment-affect tenofovir pharmacokinetics in a large cohort of HIV-infected women. AIDS. 2014;28(1):59-66.
    PubMed
     
  32. He D, Mathews SC, Kalloo AN, Hutfless S. Mining high-dimensional administrative claims data to predict early hospital readmissions. J Am Med Inform Assoc. 2014;21(2):272-9.
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  33. Cranston RD, Hoesley C, Carballo-Diéguez A, Hendrix CW, Husnik M, Levy  L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures. AIDS Res Hum Retroviruses. 2014;30(2):184-9.
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  34. Akshintala VS, Hutfless SM, Colantuoni E, Kim KJ, Khashab MA, Li T, Elmunzer BJ, Puhan MA, Sinha A, Kamal A, Lennon AM, Okolo PI, Palakurthy MK, Kalloo AN, Singh VK. Systematic review with network meta-analysis: Pharmacological prophylaxis against post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013;38(11-12):1325-37.
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  35. Cobb LK, McAdams-Demarco MA, Huxley RR, Woodward M, Koton S, Coresh J, Anderson CAM. The association of spousal smoking status with the ability to quit smoking: The atherosclerosis risk in communities study. Am J Epidemiol. 2014;179(10):1182-7.
    PubMed
     
  36. McAdams-Demarco MA, Grams ME, King E, Desai NM, Segev DL. Sequelae of early hospital readmission after kidney transplantation. Am J Transplant. 2014;14(2);397-40.
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  37. Maynard JW, McAdams-Demarco MA, Law A, Kao L, Gelber AC, Coresh J, Baer AN. Racial differences in gout incidence in a population-based cohort: Atherosclerosis risk in communities study. Am J Epidemiol. 2014;179(5):576-83.
    PubMed
     
  38. Mojtabai R, Olfson M. National trends in long-term use of antidepressant medications: Results from the US National Health and Nutrition Examination Survey. J Clin Psychiatry. 2014;75(2):169-77.
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  39. Takayanagi Y, Spira AP, Roth KB, Gallo JJ, Eaton WW, Mojtabai R. Accuracy of reports of lifetime mental and physical disorders: Results from the baltimore epidemiological catchment area study. JAMA Psychiatry. 2014;71(3):273-80.
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  40. Carras MC, Mojtabai R, Furr-Holden CD, Eaton W, Cullen BAM. Use of mobile phones, computers and internet among clients of an inner-city community psychiatric clinic. J Psychiatr Pract. 2014;20(2):94-103.
    PubMed
     
  41. Nakimuli-Mpungu E, Wamala K, Okello J, Alderman S, Odokonyero R, Musisi S, Mojtabai R. Developing a culturally sensitive group support intervention for depression among HIV infected and non-infected Ugandan adults: A qualitative study. J Affect Disord. 2014;163:10-7.
    PubMed
     
  42. Achenbach CJ, Buchanan AL, Cole SR, Hou L, Mugavero MJ, Crane HM, Moore RD, Haubrich RH, Gopal S, Eron JJ, Hunt PW, Rodriguez B, Mayer K, Saag MS, Kitahata MM. HIV viremia and incidence of non-Hodgkin lymphoma in patients successfully treated with antiretroviral therapy. Clin Infect Dis. 2014;58(11):1599-1606.
    PubMed
     
  43. Laws MB, Lee Y, Rogers WH, Beach MC, Saha S, Korthuis PT, Sharp V, Cohn J, Moore R, Wilson IB. Provider-Patient Communication About Adherence to Anti-retroviral Regimens Differs by Patient Race and Ethnicity. AIDS Behav. 2014;18(7):1279-87.
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  44. Shin DW, Cho J, Roter DL, Kim SY, Park JH, Cho B, Eom H-S, Chung J-S, Yang H-K, Park J-H. Attitudinal concordance toward uptake and disclosure of genetic testing for cancer susceptibility in patient-family member dyads Clin Genet. 2014;86(2):112-20.
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  45. Guan Y, Roter DL, Huang A, Erby LAH, Chien Y-H, Hwu W-L. Parental discussion of G6PD deficiency and child health: Implications for clinical practice. Arch Dis Child. 2014;99(3):251-5.
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  46. Cai L, Wu Y, Wilson RF, Segal JB, Kim,MT, Wang Y. Effect of childhood obesity prevention programs on blood pressure: A systematic review and meta-analysis. Circulation. 2014;129(18):1832-9.
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  47. Romanelli RJ, Wu FM, Gamba R, Mojtabai RSegal JB. Behavioral therapy and serotonin reuptake inhibitor pharmacotherapy in the treatment of obsessive-compulsive disorder: A systematic review and meta-analysis of head-to-head randomized controlled trials. Depress Anxiety. 2014;31(8):641-52.
    PubMed
     
  48. Schmittdiel JA, Adams SR, Segal J, Griffin MR, Roumie CL, Ohnsorg K, Grant RW, O'Connor PJ. Novel use and utility of integrated electronic health records to assess rates of prediabetes recognition and treatment: Brief report from an integrated electronic health records pilot study. Diabetes Care. 2014;37(2):565-8.
    PubMed
     
  49. Seal BS, Sullivan SD, Ramsey SD, Shermock KM, Ren J, Kreilick C, Boklage S, Valluri S, Sarma S, Asche CV. Systemic therapy for colorectal cancer: Patterns of chemotherapy and biologic therapy use in nationally representative US claims database. BioDrugs. 2014;28(2):229-36.
    PubMed
     
  50. Lee GP, Stuart EA, Ialongo NS, Martins SS. Parental monitoring trajectories and gambling among a longitudinal cohort of urban youth. Addiction. 2014;109(6):977-85.
    PubMed
     
  51. Varadhan R, Yao W, Matteini A, Beamer BA, Xue Q-L, Yang H, Manwani B, Reiner A, Jenny N, Parekh N, Fallin M, Newman A, Bandeen-Roche K, Tracy R, Ferrucci L, Walston J. Simple biologically informed inflammatory index of two serum cytokines predicts 10 year all-cause mortality in older adults. J Gerontol A Biol Sci Med Sci. 2014;69(2):165-73.
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  52. Weiss CO, Varadhan R, Puhan MA, Vickers A, Bandeen-Roche K, Boyd CM, Kent DM. Multimorbidity and evidence generation. J Gen Intern Med. 2014;29(4):653-60.
    PubMed