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Books, Articles & Publications

Books

Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM.  Developing a protocol for observational comparative effectiveness research:  A user’s guide.  2014  Conducted under Contract No. 290-2005-0035-I.  AHRQ Publication No. 12(13)-EHC099. Rockville, MD: Agency for Healthcare Research and Quality. January 2013

Download PDF in English and Chinese

 

Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide.  Conducted under Contract No. 290 2014 00004-C.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014.  1st edition, 2007; 2nd Edition, 2010; Third edition, 2014. Also available in Korean (Korean National Evidence-based Healthcare Collaborating Agency, published December 2010), and in Chinese (University of Peking, published December 2012). 

Download 3rd edition PDF in English (vol1), English Vol 2 and Chinese, 2nd edition

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Gliklich RE, Leavy MB, Dreyer NA (sr eds). Registries for Evaluating Patient Outcomes: A User’s Guide. 4th ed. (Prepared by L&M Policy Research, LLC, under Contract No. 290-2014-00004-C with partners OM1 and IQVIA) AHRQ Publication No. 19(20)-EHC020. Rockville, MD: Agency for Healthcare Research and Quality; September 2020. Posted final reports are located on the Effective Health Care Program search page. https://effectivehealthcare.ahrq.gov/products/registries-guide-4th-edition/users-guide.

 

Gliklich R, Dreyer N, Leavy M, eds. Tools and Technologies for Registry Interoperability.  Registries for Evaluating Patient Outcomes: A User’s Guide.  Addendum 2.  AHRQ Publication No. 19(20)-EHC017-EF, October 2019

 

Gliklich RE, Dreyer NA, Levy M, Christian JB (eds).  21st Century Patient Registries. Registries for Evaluating Patient Outcomes: A User’s Guide.  EBook Addendum to Third Edition. (Prepared by L&M Policy Research, LLC, with partners OM1 and QuintilesIMS under Contract No. HHSA290201400004C.) AHRQ Publication No. 17(18)-EHC013-EF. Rockville, MD: Agency for Healthcare Research and Quality. March, 2018

 

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Published Articles and Book Chapters

  1. Dreyer NA:  Sex roles and delay behaviour.  Journal of Chronic Disease 1978; 31:493-495.

  2. Dreyer NA, Pizzo SV:  Blood coagulation and idiopathic thromboembolism in fertile women.  Contraception 1980; 22(2):123-135.

  3. Dreyer NA, Woods NF, James SA:  ISRO:  A scale for measuring sex role orientation in women.  Sex Roles 1981; 7(2):173-182.

  4. Pizzo SV, Lewis JG, Campbell EE, Dreyer NA:  Fibrinolytic response and oral contraceptive-associated thromboembolism.  Contraception 1981; 23(2):181-186.

  5. Dreyer NA, Loughlin JE, Friedlander ER, et al.:  Choosing populations for study of human health effects of low-dose ionizing radiation.  American Journal of Public Health 1981;71(11):1247-1252.

  6. Dreyer NA, Loughlin JE, Fahey FH, Harley N:  The feasibility of epidemiologic studies of cancer in people residing near Rocky Flats.  Health Physics 1982;42(1):65-68.

  7. Walker AM, Dreyer NA, Friedlander ER, et al.:  An independent analysis of the National Cancer Institute study on non-nutritive sweeteners and bladder cancer.  American Journal of Public Health 1982;72(4):376‑381, 1982.

  8. Dreyer NA, Friedlander ER:  Identifying the health risks from very low-dose sparsely ionizing radiation.  American Journal of Public Health 1982; 72(6):585-588.

  9. Dreyer NA, Friedlander ER:  Response to I.D.J. Bross on low-dose radiation re:  study challenged.  American Journal of Public Health 1982;72:1301.

  10. Walker AW, Loughlin JE, Friedlander ER, Rothman KJ, Dreyer NA:  Projections of asbestos-related disease, 1980-2009.  Journal of Occupational Medicine 1983;25(5):409-425.

  11. Dreyer NA:  Analgesic-associated nephropathy:  Aetiology or tautology?  Royal Society of Medicine Services International Congress and Symposium Series 1985;96:19-24.

  12. Lanes SF, Poole C, Dreyer NA, Lanza L:  Toxic shock syndrome, contraceptive methods and vaginitis.  American Journal of Obstetrics and Gynecology 1986;154(5):989-991.

  13. Walker AM, Feldstein ML, Dreyer NA, Lanza L:  Gastrointestinal illness rates on passenger cruise ships, 1975-1978.  Travel Medicine International 1986;4(3):120-124.

  14. Lanes SF, Delzell E, Dreyer NA, Rothman KJ:  Analgesics and kidney disease.  International Journal of Epidemiology 1986;15:454-455.

  15. Dreyer NA, Loughlin JE, Lanes SF, Rothman KJ:  Mortality among employees of a nuclear power company.  Journal of Occupational Medicine 1988;30:988-989.

  16. Rothman KJ, Funch DP, Dreyer NA:  Bromocriptine and puerperal seizures. Epidemiology 1990;1(3):232-238.

  17. Lanes SF, Cohen A, Rothman KJ, Dreyer NA, Soden KJ:  Mortality of cellulose fiber production workers.  Scandinavian Journal of Work, Environment and Health 1990; 16(4):247-51.

  18. Wilkinson GS, Dreyer NA:  Leukemia among nuclear workers with protracted exposure to low-dose ionizing radiation.  Epidemiology 1991; 2(4):305-309.

  19. Dreyer NA: Ethical Forum:  Publication Rights – A Case Study.  The Epidemiology Monitor 1992;13(3):4.

  20. Maintaining Radiation Protection Records.  National Council on Radiation Protection and Measurements, Scientific Committee 46-5, NCRP Report No. 114, November 30, 1992.

  21. Poole C, Kavet R, Funch DP, Donelan K, Charry JM, Dreyer NA:  Depression and headaches in relation to an alternating-current electric power transmission line.  American Journal of Epidemiology 1993;137:318-30.

  22. Walker AW, Funch D, Dreyer NA, Tolman KG, Kremer JM, Alarcón GS, Lee RG, Weinblatt ME:  Determinants of serious liver disease among patients receiving low-dose methotrexate for rheumatoid arthritis.  Arthritis and Rheumatism 1993;36 (3):329-335.

  23. Funch D, Dreyer NA, Bassin LG, Crawley JA, Brickley MG, Walker AM:  The validity of case reports in a pharmacoepidemiologic study.  Post Marketing Surveillance 1993;7:283-289.

  24. Poole C, Dreyer NA, Satterfield MH, Levin LL, Rothman KJ:  Kidney cancer among petroleum refinery workers.  Journal of Environmental Health Perspectives 1993;101(6):53-62.

  25. Lanes SF, Rothman KJ, Dreyer NA, Soden KJ:  Mortality update of cellulose fiber production workers.  Scandinavian Journal of Work, Environment & Health 1993;19:426-428.

  26. Lanes SF, Rothman KJ, Dreyer NA, Soden KJ:  Mortality among workers exposed to glycerol polyglicidyl ether.  American Journal of Industrial Medicine 1994;25(5):689-696.

  27. Dreyer NA:  An epidemiologic view of causation:  How it differs from the legal.  Defense Counsel Journal 1994;61(1):40-44.

  28. Lanza LL, Walker AM, Bortnichak EA, Dreyer NA:  Peptic ulcer and gastrointestinal hemorrhage associated with NSAID use in patients under 65 years of age: a large health maintenance organization cohort study.  Archives of Internal Medicine 1995;155:1371-1377.

  29. Lanza LL, Walker MA, Bortnichak EA, Gause DO, Dreyer NA:  Incidence of symptomatic liver function abnormalities in a cohort of NSAID users.  Pharmacoepidemiology & Drug Safety 1995;4:231-237.

  30. Lanza LL, Dreyer NA, Schultz N, Walker AM:  Use of insurance claims in epidemiologic research:   identification of peptic ulcers, GI bleeding, pancreatitis, hepatitis and renal disease.  Pharmacoepidemiology & Drug Safety 1995;4:239-248.

  31. Walker AM, Funch DP, Sulsky SI, Dreyer NA:  Patient factors associated with strut fracture in Björk-Shiley 60° convexo-concave heart valves.  Circulation 1995;92(11):3235-3239.

  32. Walker AM, Funch DP, Sulsky SI, Dreyer NA:  Manufacturing characteristics associated with strut fracture in Björk-Shiley 60° convexo-concave heart valves.  Journal of Heart Valve Disease 1995;6(4):640‑648.

  33. Rothman KJ, Loughlin JE, Funch DP, Dreyer NA: Overall mortality of cellular telephone customers.  Epidemiology 1996;7:303-305.

  34. Funch DP, Rothman KJ, Loughlin JE, Dreyer NA:  Utility of telephone company records for epidemiologic studies of cellular telephones.  Epidemiology 1996;7:299-302.

  35. Lanes SF, Birmann BM. Walker AM, Sheffer AL, Rosello RA, Lewis BE, Dreyer NA: Characterization of asthma management at Fallon Community Health Plan, 1988-1991. Pharmacoeconomics 1996;10(4):378-385.

  36. Lanes SF, Sulsky S, Walker AM, Isen J, Grier CE, Lewis BE, Dreyer NA:  A cost density analysis of benign prostatic hyperplasia.  Clinical Therapeutics 1996;18(5):993-1004.

  37. Rothman KJ, Lanza L, Lal A, Peskin EG, Dreyer NA:  Incidence of pelvic inflammatory disease among women treated for gonorrhea and chlamydia.  Pharmacoepidemiology & Drug Safety 1996;5(6):409-414.

  38. Lanes SF, Lanza LL, Radensky PW, Yood YA, Meenan RF, Walker AM, Dreyer NA:  Resource utilization and cost of care for rheumatoid arthritis and osteoarthritis in a managed care setting:  the importance of drug and surgery costs.  Arthritis and Rheumatism 1997;40(8):1475-1481.

  39. Walker AM, Szneke P, Bianchi LA, Field LF, Sutherland LR, Dreyer NA:  5-aminosalicylates, sulfasalazine, steroid use, and complications in patients with ulcerative colitis.  American Journal of Gastroenterology 1997;92(5):816-820.

  40. Loughlin JE, Dreyer NA:  In defense of the Social Security Administration Death Master File.  Epidemiology 1997;8(6)690-691.

  41. Loughlin JE, Rothman KR, Dreyer NA: Lymphatic and haematopoietic cancer mortality in a population attending school adjacent to styrene-butadiene facilities, 1963-1993.  Journal of Epidemiology and Community Health 1999;53:283-287.

  42. Dreyer NA, Loughlin JE, Rothman KJ:  Epidemiologic safety surveillance of cellular telephones in the U.S.  Radiation Protection Dosimetry 1999;83(1-2):159-163.

  43. Walker AM, Szneke P, Weatherby LB, Dicker LW, Lanza LL, Loughlin JE, Yee CL, Dreyer NA:  Evaluating the risk of serious cardiac side effects among cisapride users in the United Kingdom and Canada.  American Journal of Medicine 1999;107:356-362.

  44. Maradit Kremers H, Funch DP, Robson RA, Nalesnik MA, Ebrahim S, Cecka MJ, Opelz G, Dreyer NA, Walker AM:  A combination study design to examine mycophenolate mofetil (MMF) and PTLD in renal transplant patients.  Pharmacoepidemiology & Drug Safety 1999;8:509-518.

  45. Dreyer NA, Loughlin JE, Rothman KJ:  Cause-specific mortality in cellular telephone users.  JAMA 1999;282(19):1814-1816.

  46. Dreyer NA: Accessing third party data for research: Trust me?  Trust me not?  Pharmacoepidemiology and Drug Safety 2001; 10:385-388.

  47. Funch DP, Brady J, Ko HH, Dreyer NA, Walker AM:  Methods and objectives of a large US multicenter case-control study of post-transplant lymphoproliferative disorder in renal transplant patients.  Recent Results Cancer Research 2002;159:81-88.

  48. Rothman KJ, Funch DP, Alfredson T, Brady J, Dreyer NA:  Randomized Field trial of vaginal douching, Pelvic Inflammatory Disease, and Pregnancy.  Epidemiology 2003;14:340-348.

  49. Dreyer NA:  Relative risk and statistical significance:  Epidemiology 101 for lawyers.  Defense Research Institute, March 19, 2004

  50. Dreyer, NA:  Tap into a global community of care.  Web-based registries for orphan diseases.  Good Clinical Practice Journal, 17-19 December, 2005.

  51. Dreyer NA, Bertagna M, Gliklich RE:  Designing and assessing registries to evaluate the safety of medical products.  The Monitor.  Association of Clinical Trials Professionals 2007; 21(4):47-50.

  52. Elijovich L, Dreyer NA, Van Den Bos J, Johnston SC: Under-treatment and outcomes of non-traumatic subarachnoid hemorrhage by hospital volume: A multi-state study.  Stroke 2008; 39:536-536.

  53. Dreyer NA, Sheth N, Trontell A, Gliklich RE:  Good practices for handling adverse events detected through patient registries.  Drug Information Journal 2008;42(5):421-428.

  54. Dreyer NA, Garner S:  Registries for robust evidence.  JAMA 2009; 302(7):790-791.

  55. Dreyer NA, Schneeweiss S, McNeil B, Berger ML, Walker A, Ollendorf  D, Gliklich RE: GRACE Principles: Recognizing high-quality observational studies of comparative effectiveness.  American Journal of Managed Care 2010;16(6):467-471.

  56. Adisasmito W, Chan PKS, Lee N, Oner AF, Gasimov V, Aghayev F, Zaman M, Bamgboye E, Dogan N, Coker R, Starzyk K, Dreyer NA, Toovey S:  Effectiveness of antiviral treatment in human influenza H5N1 infections:  analysis from a global patient registry.  Journal of Infectious Disease 2010; 202(8):1154–1160.

  57. Dreyer NA. Tunis SR, Berger M, Ollendorf  D, Mattox PW, Gliklich RE: Why observational studies should be among the tools used in comparative effectiveness research.  Health Affairs 2010;29(10): 1818-1825.

  58. Setoguchi S, Shrank WH, Liu J, Lee JC, Saya U, Winkelmayer WC, Dreyer NA.  Angiotensin Receptor Blockers and Angiotensin-Converting Enzyme Inhibitors: Challenges in comparing effectiveness of angiotensin receptor blockers vs. angiotensin-converting enzyme inhibitors for hypertension in Medicare data. Clinical Pharmacology & Therapeutics 2011; 89(5):674-82.

  59. Dreyer NA.  Making observational studies count: shaping the future of comparative effectiveness research.  Epidemiology 2011; 22(3):295-297.

  60. Li Q, Glynn RJ, Dreyer NA, Liu J, Mogun H, Setoguchi S. Validity of Claims-based Definitions of Impaired Left Ventricular Systolic Function in Medicare Patients.  Pharmacoepidemiology and Drug Safety 2011; 20(7); 700-708.

  61. Zaman M, Toovey S, Dreyer NA.  An extended review of human infection with influenza H5N1 virus in North West Frontier Province (NWFP), Pakistan in 2007.  Emerging Infectious Diseases 2011;17:1056-1059.

  62. Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand, SL.  Prospective observational studies to assess comparative effectiveness: ISPOR good research practices task force report.  Value in Health 2012;15(2):217-30.

  63. Gliklich R, Glennie J, Mattox PW, Graff JS, Garner S, Marrone CM, Shaya FT, Hansen J, Lewin J, Blackburn S, Berger M, Dreyer NA.  Survey of Real-World Research Workforce, Training, and Education: Report from the DIA Real-World Outcomes Task Force.   Drug Information Journal 2012;26:185-191.

  64. Dreyer NA, Velentgas P.  Registries.  In Pharmacoepidemiology, Strom B, Kimmel S, Hennessy S, Eds.  Fifth edition, John Wiley & Sons Ltd., 2012

  65. Oner AF, Dogan N, Gasimov V, Adisasmito W, Coker R, Chan PKS, Lee N, Tsang O, Hanshaoworakul W, Zaman M, Bamgboye E, Swenson A, Toovey S and Dreyer NA:  H5N1 Avian Influenza in Children.  Clinical Infectious Disease 2012; 55:26-32. 

  66. Gliklich RE, Leavy MB, Velentgas P, Dreyer NA, Tunis SR, Mohr P, Messner DA, Moloney RM, Karkare Su, Dubois RW, Graff JS: Incorporating Stakeholder Perspectives in Developing a Translation Table Framework for Comparative Effectiveness Research.  Journal of Comparative Effectiveness Research  2012; 1(3):281-292.

  67. REGISTER Group (Campbell B, Patrick H, Dreyer NA, Grilli R, Franklin GM, Lee Robin SH, Maddern G, Tunis S, Lyratzopoulos). International collaboration in the use of registries for new devices and procedures.  British Journal of Surgery 2012; 99: 744–745.

  68. Chan PKS, Lee N, Zaman M, Adisasmito W, Coker R, Hanshaoworakul W, Gasimov V, Oner AF, Dogan N, Tsang O, Phommasack B, Touch S, Bamgboye E, Swenson A, Toovey S, Dreyer N: Determinants of Antiviral Effectiveness in H5N1 Avian Influenza.  Journal of Infectious Disease 2012; 206: 1359-66.

  69. Adisasmito W, Aisyah DN, Aditama TY, Kusriastuti R, Trihono, Suwandono A, Sampurno OD, Prasenohadi, Sapada NA, Mamahit MJN, Swenson A, Dreyer NA, Coker R. Human influenza A H5N1 in Indonesia health care service-associated delays in treatment initiation, BMC Public Health 2013; 13:571-577.

  70. Dreyer NA, Toovey S, Oner AF, Bamgboye E, Dogan N, Zaman M, Gasimov V, Adisasmito W, Coker R, Chan PKS, Lee N, Tsang O, Hanshaoworakul W, Phommasack B, Touch S, Swenson A, Reddy D. Investigating outbreaks of novel infectious disease: an international case study.  Journal of Clinical Studies 2013; 5(2):52-53

  71. Dreyer NA.  Using observational studies for comparative effectiveness: Finding quality with GRACE.  Journal of Comparative Effectiveness Research 2013; 2(5):413-418.

  72. Dreyer NA, Dixon JB, Okerson T, Finkelstein EA, Globe D.  Prevalence of Comorbidities and Baseline Characteristics of LAP-BAND AP® Subjects in the Helping Evaluate Reduction in Obesity (HERO) Study.  PLOS One 2013; 8(11):  e78971. doi:10.1371/journal.pone.0078971

  73. Mack CD, Dreyer NA, Bosco J, Fabre A.  Using real-world evidence to inform decision making.  Chinese Journal of  Pharmacoepidemiology 2014; 24: 17-28.

  74. Velentgas P, Dreyer NA, Wu AW.  Outcome definition and measurement.  In Velentgas P, Dreyer, NA, Nourjah P et al., eds.  Developing a Protocol for Observational Comparative Effectiveness Research.  A User’s Guide.   Rockville, MD:  Agency for Healthcare Research and Quality. 2013: Chapter 6, pp. 71-92.

  75. Dreyer NA, Velentgas P, Westrich K, Dubois R.  The GRACE Checklist for Rating the Quality of Observational Studies of Comparative Effectiveness:  A Tale of Hope and Caution.  Journal of Managed Care & Specialty Pharmacy 2014;20(3):301-08.

  76. Cleeland CS, Mayer M, Dreyer NA, Yim YM, Yu E, SuZ, Mun Y, Sloan JA, Kaufman PA.  Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort study.  Breast 2014; 23(6): 763-769. doi: 10.1016/j.breast.2014.08.004.  

  77. Mendelsohn AB, Dreyer NA, Mattox PW, Su Z, Swenson A, Li R, Turner JR, Velentgas P.  Characterization of missing data in clinical registry studies. Therapeutic Innovation & Regulatory Science 2014; 48(5): 574-582.

  78. Dreyer NA. Generating real-world evidence for using drugs and devices: delivering the right approach for the right question.  SCRIP Regulatory Affairs, March, 2014.

  79. Dreyer NA, Duggirala HJ, Samsa G, Stang P, Velentgas P.  Registry Design.  In Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014: Chapter 3, pp 47-72.

  80. Dreyer, NA, Gliklich RE, Sheth N, Trontell AE.  Adverse Event Detection, Processing, and Reporting. In Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014: Chapter 12, pp 277-290.

  81. Dreyer, NA. Eloff, BC, Kirklin, JK, Naftel DC, Toovey S. Public-Private Partnerships.  In Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014: Chapter 24, pp 215-230.

  82. Dreyer NA, Garner S. Assessing Quality.  In Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014: Chapter 25, pp 231-250.

  83. Mack, CD, Su Z, Mendelsohn AB, Dreyer NA.  Prevention, examination and treatment of missing data in nonexperimental pharmacoepidemiologic studies. Chinese Journal of Pharmacoepidemiology 2015; 24(1): 14-22.

  84. Dreyer N, Blackburn S, Hliva V, Mt-Isa S, Richardson J, Jamry-Dziurla A, Bourke A, Johnson R.  Balancing the Interests of Patient Data Protection and Medication Safety Monitoring in a Public-Private Partnership.  JMIR Medical Informatics 2015;3(2):e18 doi:10.2196/medinform.3937

  85. Lao W-L, Malone DC, Armstrong EP, Voellinger D, Somers S, Jin J, Dreyer N, Globe D.  Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2-year analysis   Current Medical Research & Opinion 2015;31(8): 1451-1460 Posted on-line July 8, 2015.  doi: 10.1185/03007995.2015.1059802 Informa Healthcare, 2015/8/3

  86. Dreyer NA, Blackburn SCF, Mt-Isa S, Richardson JL,  Thomas S, Laursen M, Zetstra-van der Woude AP, Jamry-Dziurla A, Hliva V, Bourke A, de Jong-van den Berg, LTW.  Direct-to-patient research: piloting a new approach to understanding drug safety during pregnancy.  JMIR Public Health and Surveillance 2015; 1(2); e22.  doi:10.2196/publichealth.4939

  87. Mack CD, Parmenter L, Brinkley E, Liu L, Dreyer NA.  Using enriched real-world research for deeper insights.  Chinese Journal of Pharmacoepidemiology 2016; 25:27-37

  88. Richardson JL,  Stephens S, Thomas SHL, Jamry-Dziurla A, de Jong-van den Berg LTW, Zetstra-van der Woude AP, Laursen M, Hliva V, Mt-Isa S, Bourke A, Dreyer NA, Blackburn SCF.  An international study of the ability and cost-effectiveness of advertisement methods to facilitate study participant self-enrolment into a pilot pharmacovigilance study during early pregnancy.  JMIR Public Health and Surveillance 2016; 2(1) e13: 1-10

  89. Dreyer NA, Rodriguez AM.  Fast route to evidence development for value in health care.  Current Medical Research and Opinion.  July 11, 2016   DOI: 10.1080/03007995.2016.1203768

  90. Dreyer NA.  Using Enriched Studies for Post-Approval Evidence Needs” In Vivo, July/August 2016

  91. NEST Planning Board (Anthony ES, Blake K, Deem M, Dreyer NA, et al.). NEST: Priorities for Effective Early Implementation. A NEST Planning Board Report- White Paper. September 2016

  92. Dreyer NA, Bryant A, Velentgas P. The GRACE Checklist: A Validated Assessment Tool for High Quality Observational Studies of Comparative Effectiveness.  Journal of Managed Care & Specialty Pharmacy 2016; 22(10) 1107-1113

  93. Courbet T, Dreyer NA, Moussalli R, Wai K.  Impact and importance of real world data in Asia: A physician’s perspective.   Value in Health 2016; 19(7), A852, 201

  94. Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn SB, Dreyer NA.   Lessons learned on the design and the conduct of Post-Authorization Safety Studies: Review of 3 years of Pharmacovigilance Risk Assessment Committee (PRAC) oversight.  British Journal of Clinical Pharmacology 83(4), 884-893, 2017

  95. Urushihara H, Parmenter L, Tashiro S, Matsui, K, Dreyer N.  Bridge the Gap: the need for harmonized regulatory and ethical standards for post-marketing observational studies.    Pharmacoepidemiology & Drug Safety 2017;26:1299–1306. https://doi.org/10.1002/pds.4269, http://dx.doi.org/10.1002/pds.4269

  96. Bosco JF, Bryant A, Dreyer NA. The Current Biosimilars Landscape and Methodological Considerations for Real-World Evidence Generation., A journal of ISPOR.2017; 3 (5): 15-18.

  97. Dreyer NA.  Advancing a framework for regulatory use of real-world evidence: When real is reliable.  Therapeutic Interventions and Regulatory Affairs 2018; 52(3) 362-368   http://journals.sagepub.com/doi/full/10.1177/2168479018763591

  98. Dreyer N, Franklin P, Haynes KM, Mehta P, Ritchey MB.  Direct-to-patient registry and other patient-centric designs.  Chapter 4. Gliklich RE, Dreyer NA, Levy M, Christian JB (eds).  21st Century Patient Registries. Registries for Evaluating Patient Outcomes: A User’s Guide.  Addendum to Third Edition. (Prepared by L&M Policy Research, LLC, with partners OM1 and QuintilesIMS under Contract No. HHSA290201400004C.) AHRQ Publication No. 17(18)-EHC013-EF. Rockville, MD: Agency for Healthcare Research and Quality. March, 2018

  99. Christian JB, Dreyer NA.  Enriched Studies. Chapter 4.4.   Ali AK, Hartzema AG (eds)  Post-Authorization Safety Studies of Medicinal Products.  The PASS book.  Academic Press, 2018

  100. Bosco JL, Dreyer, NA, Ali AK.  Post-Authorization safety studies for biosimilars and interchangeable biologic products.  Chapter 7.1.  Ali AK, Hartzema AG (eds)  Post-Authorization Safety Studies of Medicinal Products.  The PASS book.  Academic Press, 2018

  101. Girman CJ, Ritchey ME, Zhou W, Dreyer NA. Considerations in Characterizing Real World Data Relevancy and Quality for Regulatory Purposes:  A Commentary.  Pharmacoepidemiology & Drug Safety 2018; Dec 5. Doi: 10:10.1002/pds.4697

  102. Christian JB, Brouwer ES, Girman CJ, Bennett D, Davis KJ, Dreyer NA.  Masking in pragmatic trials: who, what and when to blind.  Therapeutic Innovation & Regulatory Science.  2019; Apr;28(4):439-442. doi: 10.1002/pds.469

  103. Mack C, Meisel P, Herzog M, Oakkar EE, Walden T, Callahan L, Shapre J, Dreyer N, DiFiori J.  The Establishment and Refinement of the National Basketball Association Player Injury and Illness Database.  Journal of Athletic Training 2019; 54(5): 466-471 . https://doi.org/10.4085/1062-6050-18-19

  104. Dreyer NA. Mack CD, Anderson RB, Wojtys EM, Hershman EB, Sills A. Lessons on Data Collection and Curation from the NFL Injury Surveillance Program.  Sports Health 2019; 11(5): 440-445.  DOI: 10.1177/1941738119854759

  105. Stewart M, Norden AD, Dreyer N, Henk HJ, Abernethy AP, Chrischilles E, Kushi L, Mansfield AS, Khozin S, Sharon E, Arunajadai S, Carnahan R, Christian JB, Miksad RA, Sakoda LC, Torres AZ, Valice E, Allen J. An Exploratory Analysis of Real-World Endpoints for Assessing Outcomes Among Immunotherapy-Treated Patients with Advanced Non-Small Cell Lung Cancer.  JCO Clinical Care Informatics 2019. 3:1-15. PMID: 31335166

  106. Herzog MM, Mack CD, Dreyer NA, Wikstrom EA, Padua DA, Kocher MS, DiFiori JP, Marshall SW.  Ankle Sprains in the National Basketball Association, 2013-14 through 2016-17.  American Journal of Sports Medicine 2019 Sep;47(11):2651-2658. doi: 10.1177/0363546519864678. Epub 2019 Aug 7

  107. Dreyer NA, Macedo AF, Velentgas P.  Primary data collection for pharmacoepidemiology.  In Pharmacoepidemiology, 342-354, Strom B, Kimmel S, Hennessy S, Eds.  Sixth edition, John Wiley & Sons Ltd., 2019.

  108. Mack C, Christian J, Brinkley E, Warren EJ, Hall M, Dreyer N. When context is hard to come by: external comparators and how to use them.  Therapeutic Innovation & Regulatory Science  Epub November, 2019.  DOI: 10.1177/2168479019878672

  109. Baumfeld Andre E, Reynolds R, Caubel P, Azoulay L, Dreyer NA.  Trial designs using real-world data: the changing landscape of the regulatory approval process.  Pharmacoepidemiology & Drug Safety 2020:29:1201-1212. doi.org/10.1002/pds.4932

  110. Dreyer NA, Hall M, Christian JB. Modernizing regulatory evidence with trials and real-world studies.  Therapeutic Innovation & Regulatory Sciences 54(5), 1112-1115 doi.org/10.1007/s43441-020-00131-5

  111. Laursen M, Hallgreen CE, Dreyer N, Bourke A, Mt-Isa S, Blackburn S. Comparison of electronic self-reported prescription medication use during pregnancy with the national prescription register in Denmark.  Pharmacoepidemiology & Drug Safety  2020;29:328-336, doi.org/10.1002/pds.4937

  112. Burcu M, Dreyer NA, Franklin JM, Blum MC, Critchlow CW, Perfetto EM, Zhou W.  Real-world evidence to support regulatory decision making for medicines: considerations for external control arms.  Pharmacoepidemiology & Drug Safety 2020 Mar 11. doi: 10.1002/pds.4975. [Epub ahead of print] PMID: 32162381

  113. Reynolds M, Bourke A, Dreyer NA.  Considerations when evaluating real-world data quality in the context of fitness for purpose.  Pharmacoepidemiology & Drug Safety 2020;29:1316-1318.  DOI: 10.1002/pds.5010

  114. Reynolds MW, Christian JB, Mack CD, Hall M, Dreyer NA.  Leverage real-world data for COVID-19 research: challenges and opportunities.  Precision Medicine 2020; 6 (2), June

  115. Sheffield KM, Dreyer NA, Murray J, Faries DE, Klopchin.  Replication of Randomized Clinical Trial Results Using Real World Data: paving the way for effectiveness decisions.  J Comparative Effectiveness  First published on-line September 13, 2020.  www.futuremedicine.com/doi/10.2217/cer-2020-0161

  116. Seeger JD, Davis KJ, Iannacone MR, Zhou W, Dreyer N, Winterstein AG, Santanello N, Gertz B, Berlin JA.  Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials.  Pharmacoepidemiology& Drug Safety 2020;29(11):1382-1392.  doi.org/10.1002/pds.5141. 

  117. Cocoros NM, Arlett P, Dreyer NA, Ishiguro C, Iyasu S, Sturkenboom M, Zhou W, Toh, S.  The Certainty Framework for assessing real-world data in studies of medical product safety and effectiveness.  Clinical Pharmacology & Therapeutics 2020; 109:1189-1196., https://doi.org/10/1002/cpt.2045 

  118. Dreyer NA, Reynolds M, Mack CD, Brinkley E, Petruski-Ivelva N, Hawaldar K, Toovey S, Morris J.  Self-reported symptoms from exposure to COVID-19 provide support to clinical diagnosis, triage and prognosis: an exploratory analysis.  Travel Medicine and Infectious Disease 2020; 38:101909  doi.org/10.1016/j.tmaid.2020.101909

  119. Gliklich RE, Leavy MB, Dreyer NA.  Planning a Registry.  In Registries for Evaluating Patient Outcomes: A User’s Guide,.  Gliklich R, Dreyer N, Leavy M, eds.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. 4th edition, 2020

  120. Gliklich RE, Leavy MB, Dreyer NA.  Principles of registry ethics, data ownership and privacy.  In Registries for Evaluating Patient Outcomes: A User’s Guide,.  Gliklich R, Dreyer N, Leavy M, eds.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. 4th edition, 2020

  121. Gliklich RE, Leavy MB, Dreyer NA.  Registry Governance.  In Registries for Evaluating Patient Outcomes: A User’s Guide.  Gliklich R, Dreyer N, Leavy M, eds.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. 4th edition, 2020

  122. Gliklich RE, Leavy MB, Dreyer NA.  Data sources for registries.  In Registries for Evaluating Patient Outcomes: A User’s Guide,.  Gliklich R, Dreyer N, Leavy M, eds.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. 4th edition, 2020

  123. Gliklich RE, Leavy MB, Dreyer NA.  Obtaining data and quality assurance.  In Registries for Evaluating Patient Outcomes: A User’s Guide.  Gliklich R, Dreyer N, Leavy M, eds.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. 4th edition, 2020

  124. Gliklich RE, Leavy MB, Dreyer NA.  Analysis, interpretation and reporting of registry data to evaluate outcomes.  In Registries for Evaluating Patient Outcomes: A User’s Guide,.  Gliklich R, Dreyer N, Leavy M, eds.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. 4th edition, 2020

  125. LoCasale R, Pashos CL, Gutierrez B, Dreyer NA, Collins T, Calleja A, Seewald MJ, Plumb JM, Liwing J, Tepie MF, Khosla S.  Bridging the gap between RCTs and RWE through endpoint selection.  Commentary. Therapeutic Innovation & Regulatory Science, 2021; 55-90-96. doi.org/10.1007/s43441-020-00193-5

  126. Franklin JM , Liaw KL, Iyasu S, Critchlow C, Dreyer N.  Real-world evidence to support regulatory decision making: New or expanded medical product indications.  Pharmacoepidemiology & Drug Safety 2021; 30(6): 685-693. doi.org/10.1002/pds.5222

  127. Dreyer N, Petruski-Ivleva N, Albert L, Mohamed D, Brinkley E, Reynolds M, Toovey S.  Identification of a vulnerable group for post-acute sequelae of SARS-CoV-2 (PASC): people with autoimmune diseases recover more slowly from COVID-19. International Journal of General Medicine 2021:14 3941–3949.  doi.org/10.2147/IJGMS313486. eCollection 2021

  128. Wang CY, Berlin J, Gertz B, Davis K, Li J, Dreyer N, Zhou W, Seeger J, Santanello N, Winterstein A.  Uncontrolled Extensions of Clinical Trials and the Use of External Controls - scoping opportunities and methods.    Clinical Pharmacology & Therapeutics 2021, June 24. doi: 10.1002/cpt.2346.

  129. Simon G, Bindman A, Dreyer N, Platt R, Watanabe J, Horberg M, Hernandez A, Califf R.  When can we trust real-world data to evaluate new medical treatments?  Clinical Pharmacology & Therapeutics 2022; 111(1):24-29, 2022/1

  130. Franklin JM, Platt R, Dreyer NA, London AJ, Simon GE, Watanabe JW, Horberg M, Hernandez A, Califf R.  When can nonrandomized studies support valid inference regarding effectiveness or safety of new medical treatments?  Clinical Pharmacology & Therapeutics 2022 Jan;111(1):108-115.doi: 10.1002/cpt.2255. Epub 2021 May 9

  131. Kilpatrick RD, Sanchez-Solin O, Alami NN. Johnson C . Fang Y. Wegrzyn LR, Krueger WS, Ye Y, Dreyer N, Gray GC. EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study.  Infectious Disease and Therapy 2022; 1-13.  doi.org/10.1007/s40121-022-00593-0

  132. Dreyer NA, Reynolds MW, Albert L, Brinkley E, Kwon T, Mack C, Toovey S.  How frequent are acute reactions to COVID-19 vaccination and who is at risk?  Vaccine 2022; 40 (12): 1904-1912.   doi.org/10.1016/j.vaccine.2021.12.072

  133. Helanterä I, Snyder J, Åsberg A, Cruzado JM, Bell S, Legendre C, Tedesco Silva Jr H, Tedesco Barcelos G, Geissbühler Y, Prieto L, J Christian J, Scalfaro E, Dreyer A.  Demonstrating Benefit-Risk Profiles of Novel Therapeutic Strategies in Kidney Transplantation: Opportunities and Challenges of Real-World Evidence.  Transplant International 2022; 35.

  134. Reynolds MW, Xie Y, Knuth KB, Mack CD, Brinkley E, Toovey S, Dreyer NA.  COVID-19 vaccination breakthrough infections in a real-world setting:  Using community reporters to evaluate vaccine effectiveness.  Infection and Drug Resistance 2022:15 5167–5182.

  135. Dreyer NA.  A community study on COVID-19 vaccine side effects. How community-based insights from patient registries can help us to better understand the side effects of COVID-19 vaccinations.  Pharmaceutical market Europe, June 2022: 24-25

  136. Dreyer NA.  Strengthening evidence-based medicine with real-world evidence.  Invited Commentary.  Lancet Healthy Longevity 2022 September 20, https://doi.org/10.1016/S2666-7568(22)00214-8

  137. Reynolds MW, Secora A, Joules A, Albert L, Brinkley E, Kwon T, Mack C, Toovey S. Dreyer NA.   Evaluating real world COVID-19 vaccine effectiveness using a test-negative case-control design.  J Comparative Effectiveness Research 2022; Sep: 10.2217/cer-2022-0069.  Published online 2022 Sep 23. doi: 10.2217/cer-2022-0069

  138. Sridhara R, Marchenko O, Jiang Q, Barksdale E, Chen, J Dreyer N, Fashoyin-Aje L, Garrett-Mayer E, Gormley N, Gwise T, Hess L, Mandrekar S, Pignatti F, Rantell K, Raven A, Shen YL,  Singh H,  Tendler CL,  Theoret M, Pazdur R.  Evaluation of treatment effect in underrepresented population in cancer trials: Discussion with International Regulators.  Statistics in Biopharmaceutical Research 2022: 1-7

  139. Largent JA, Xie X, Knuth KB, Toovey S, Reynolds MW, Brinkley E, Mack CD, Dreyer NA. Cognitive and other neuropsychiatric symptoms in COVID-19: Analysis of person-generated longitudinal health data from a community-based registry,. BMJ Open 2023;13:e069118. doi:10.1136/ bmjopen-2022-069118

  140. Dreyer NA and Mack CD.  Tactical considerations for designing real world studies: Fit-for-purpose designs that bridge research and practice. Pragmatic and Observational Research 2023:14 101–110 

  141. Brinkley E, Knuth K, Kwon T, Mack C, Leister Tebbe H, Boa W, Reynolds MW, Dreyer N.  Daily COVID-19 symptom assessment over 28 days–findings from a daily direct-to-patient registry of COVID-19 positive patients.  Journal of Patient-‌Reported Outcomes 2023; 7 (1), 1-‌5.

  142. Dreyer NA, Knuth KB, Xie Y, Reynolds MW, Mack CD. COVID-19 reactions and risk of breakthrough infecctinos among people with diabetes: cohort study derived from community reporters.  JMIR Diabetes 2024; e45536, https://diabetes.jmir.org/2024/1/e45536/  doi: 10.2196/45536

  143. Sánchez-Soliño O, Kilpatrick RD, Johnson C, Fang Y, Ye Y, Alami NN,  Zarish K, Krueger WS, Dreyer N, Gray GC.  Longitudinal molecular and serological evidence of SARS-CoV-2 infections and vaccination status: Community-based surveillance study (CONTACT).  Infectious Diseases and Therapy 2024; https://doi.org/10.1007/s40121-024-00923-4

  144. Dreyer NA and Blackburn SCF.  Power to the people: Why person-generated health data is important for pharmacoepidemiology.  American Journal of Epidemiology 2024;  https://doi.org/10.1093/aje/kwae035

  145. Eckrote MJ, Nielson C, Lu M, Alexander T, Shah RG, Low KW, Zhang Z, Eliazar A, Klesh R, Kress A, Bryant M, Asiimwe A, Gatto NM, Dreyer, NA.   ­Linking Clinical Trial Participants to Their U.S. Real-World Data Through Tokenization: A Practical Guide. Contemporary Clinical Trial Communications 2024; 41 (October) 101354.  ISSN 2451-8654  https://doi.org/10.1016/j.conctc.2024.101354

Letters

  1. Dreyer NA:  Low-level ionizing radiation:  Just how great is the cancer risk?  Your Patient and Cancer 1982; 2(10):74-82.

  2. Dreyer NA, Harley N:  Response to Johnson by Dreyer and Harley.  American Journal of Public Health 1983; 73:599-600.

  3. Dreyer NA, Harley N:  Response to Dr. Johnson.  Health Physics 1983; 42:814-815.

  4. Dreyer NA:  Risk evaluation through epidemiology.  Risk Management 1984; 31(1):50-54.

  5. Lanes SF, Dreyer NA, Rothman KJ, Loughlin JE:  Motor vehicle accidents and nuclear utility workers.  The authors reply.  Journal of Occupational Medicine 1989; 31:799.

  6. Dreyer NA:  Bioequivalence of levothyroxine preparations:  issues of science, publication, and advertising.  JAMA 1997; 278(11):897.

  7. Loughlin JE, Rothman KJ, Dreyer NA:  Lymphatic and hematopoietic cancer mortality in a population attending school adjacent to styrene-butadiene facilities, 1963-1993. Authors Reply.  Journal of Epidemiology and Community Health 2000; 54:480.

  8. Dreyer NA:  Relative risk and statistical significance:  Epidemiology 101 for lawyers.  Defense Research Institute, March 19, 2004.

  9. Dreyer NA, Garner S:  Patient registries, predictive models and optimal care.  JAMA 2009; 302(24):2662.

  10. Adisasmito W, Chan PKS, Lee N, Oner AF, Gasimov V,  Zaman M, Bamgboye E, Dogan N, Starzyk K, Dreyer NA, Toovey S Strengthening Observational Evidence for Antiviral Effectiveness in H5N1.  Journal of Infectious Disease 2011;204: 810-811.

  11. Greenacre A, Mack C, Dreyer NA, Pimenta J. Developing a cohort of linked mother-baby pairs to study preterm labor: Harmonizing real-world data from four large United States integrated delivery networks. Value in Health 2014;17(3): A183

  12. Mack CD, Herzog MM, DiFiori JP, Meisel PL, Dreyer NA, A Second Look at NBA Game Schedules: Response to Teramoto et al. Journal of Science and Medicine in Sport 2017, www.sciencedirect.com/science/article/pii/S1440244017309842

  13. Dreyer NA, Mack CD, Christian JB.  Totality of evidence will strengthen our understanding of COVID-19, treatments and recovery.  JAMA Internal Medicine.  On-line Comment, August 3, 2020. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768882

  14. Brinkley E. Mack CD, Albert L, Knuth K, Reynolds MW, Toovey S, Dreyer NA.  COVID-19 vaccinations in pregnancy: comparative evaluation of acute side effects and self-reported impact on quality of life between pregnant and non-pregnant women in the US.  Am J Perinatology 2022 May 6. PMID: 35523212, doi: 10.1055/s-0042-1748158

Selected Scientific Abstracts

  1. Dreyer NA:  Prospects for epidemiologic studies of low-level ionizing radiation.  Society for Epidemiologic Research, June 1980, Minneapolis, MN.  American Journal of Epidemiology 1980; 112(3):424-425.

  2. Dreyer NA:  Examining the puzzle of health effects of low-dose ionizing radiation.  American Public Health Association, Detroit, MI, October, 1980.

  3. Dreyer NA, Kohn HI:  Radiation-induced risk of resettling Bikini Atoll.  American Public Health Association, Dallas, TX, November, 1983.

  4. Loughlin JE, Dreyer NA:  Control selection in occupational mortality surveillance.  International Epidemiology Association, Helsinki, Finland, August, 1987.

  5. Poole C, Dreyer NA, Satterfield MH, Levin L, Rothman KJ:  Kidney cancer among petroleum refinery workers.  XIIth Scientific Meeting of the International Epidemiological Association, Los Angeles, CA, August, 1990.

  6. Wilkinson GS, Dreyer NA:  Epidemiology of leukemia among nuclear workers:  A quantitative analysis of results from 8 published studies.  International Radiation Protection Association Annual Meeting, Montréal, Québec, Canada, May, 1992.

  7. Funch D, Dreyer NA, Brickley MG, Walker AM:  The validity of case reports in a pharmacoepidemiologic study.  8th International Society for Pharmacoepidemiology, September, 1992.

  8. Lanes SL, Birmann BM, Walker AM, Sheffer A, Rosiello R, Dreyer NA:  Characterization of asthma management.  Pharmacoepidemiology & Drug Safety 1994; 3(1):S31.  Presented at the 10th International Conference on Pharmacoepidemiology, Stockholm, Sweden.

  9. Sutherland L, Walker AM, Szneke P, Bianchi LA, Dreyer NA, Field LG:  Clinical course of ulcerative colitis patients.  Gastroenterology 1995; 108(4):A924.

  10. Loughlin JE, Rothman KJ, Dreyer NA:  Mortality from lymphatic and hematopoietic cancer among former students of the Port Neches-Groves High School, 1963-1993.  Presented at the Society for Epidemiologic Research, Edmonton, Canada, June 14, 1997.

  11. Funch DP, Cecka JM, Sagiv SK, et al:  Incidence of post transplant lymphoproliferative disorder among renal transplant patients in the U.S.  Presented at the International Society of Pharmacoepidemiology, Boston, MA, August 29, 1999.

  12. Velentgas P, Cali C, Dreyer NA, Walker AM, Verberg KM:  Risk of myocardial infarction and cardiac death among users of non-steroidal anti-inflammatory medications.  Pharmacoepidemiology & Drug Safety 2001; 10(1):S241.

  13. Velentgas P, Cali C, Diedrick G, Heinen MJ, Walker AM, Verberg K, Dreyer NA:  A survey of aspirin use, non-prescription NSAID use and cigarette smoking among  users and non-users of prescription NSAIDs:  Estimates of the effect of unmeasured confounding by these factors in studies of NSAID use and risk of myocardial infarction.  Pharmacoepidemiology & Drug Safety 2001; 10(1):S242.

  14. Van Den Bos JV, Dreyer NA:  Hospital-based outcomes associated with non-traumatic subarachnoid hemorrhage.  International Society for Pharmacoeconomics and Outcomes Research.  Arlington, VA, May, 2007.

  15. Dreyer NA, Starzyk K, Wilcock K, Toovey S:  A global registry for understanding clinical presentation, treatment outcomes, and survival from human avian influenza.  Bangkok International Conference on Avian Influenza.  2008 Jan 23; Bangkok:  National Center for Genetic Engineering and Biotechnology; p. 155, 2008.

  16. Elijovitch L, Dreyer NA, Van Den Bos J, Johnston SC:  Under-treatment and outcomes of non‑traumatic subarachnoid hemorrhage by hospital volume: a multi-state study.  American Heart Association, New Orleans, LA, January, 2008.

  17. Bringman S, Dreyer N, Heniford BT, Ramshaw B, Divilio LT, Simpkins DL:  Prospective assessment of long-term health outcomes following mesh hernia repair:  the international hernia mesh registry.  European Hernia Society, Sevilla, Spain, May, 2008.

  18. Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M:  How will FDAAA change our approach to REMS?  International Society of Pharmacoepidemiology, Mid-Year Meeting Symposium, Boston, MA, May, 2008.

  19. Takemoto SK, Dreyer NA, Faria C, Wang F:  Recommendations for the use of patient registry data as a complement to randomized clinical trials.  International Society for Pharmacoeconomics and Outcomes Research, Toronto, Canada, May, 2008.

  20. Dreyer NA, Berger M, Sullivan S, LeLorier J:  Are good practices principles for observational comparative effectiveness studies needed?  International Society for Pharmacoeconomics and Outcomes Research, Toronto, Canada, May, 2008.

  21. Adisasmito W, Zaman M, Chan P, Lee N, Gasimov V, Aghayev FF,  Oner A, Bamgboye E, Dogan N, Starzyk K, Layton A, Coker R, Toovey S,  Dreyer N:  Human avian influenza: development of a shoe-leather approach to evaluating treatment effectiveness.  International Society of Pharmacoepidemiology, Providence, RI, August, 2009.

  22. Zhao S, Dreyer NA, Cole A, Stemhagen A, Feltelius N, Haas J:  Can registries deliver?  The methods and use of registries for biologics.  Pharmacoepidemiology & Drug Safety 2009; 18:S27.

  23. Dreyer NA, Rubino A, L’Italien GJ, Schneeweiss S:  Developing good practice guidance for non‑randomized studies of comparative effectiveness:  a workshop on quality and transparency.  Pharmacoepidemiology & Drug Safety 2009;18:S123.

  24. Avian Influenza Expert Group (Adisasmito W, Zaman M, Chan P, Lee N, Gasimov V, Aghayev FF,  Oner A, Bamgboye E, Dogan N, Toovey S,  Dreyer N):  First results from an avian influenza registry.  American Society for Microbiology 47th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September, 2009.

  25. Adisasmito W, Latief K, Seitzman R, Layton A, Toovey S, Dreyer N:  Avian influenza in Indonesia:  a descriptive analysis – Indonesia.  2005-2009.  5th TEPHINET Southeast Asia and Western Pacific Bi‐Regional Scientific Conference, Seoul, Korea, November, 2009.

  26. Adisasmito W, Chan PKS, Lee N, Oner AF, Gasimov F, Zaman M, Bamgboye E, Dogan N, Coker R, Toovey S, Dreyer NA:  Improving the odds of surviving H5N1.  International Symposium on Respiratory Viral Infections, Taipei, Taiwan, March, 2010.

  27. Zaman M, Chan PKS, Lee N, Oner AF, Gasimov V, Bamgboye E, Dogan N, Toovey S, Dreyer NA:   The avian flu registry:  How we got it, and what it tells us.  ChestCON 2010, 9th Biennial International Conference, Pakistan Chest Society, Bhurbon, Murree Pakistan, March, 2010.

  28. Oner AF, Bamgboye E, Gasimov V, Zaman M, Chan PKS, Lee N, Dogan N, Adisasmito W, Toovey S, Dreyer NA:  Avian influenza infections in children:  symptoms & treatment.  European Society for Paediatric Infectious Diseases, Nice, France, May, 2010. 

  29. Kaufman PA, Dreyer NA, Mayer M, Sloan JA, Chung CY, Sing A, Yim YM, Yu E, Mathias SD, Cleeland CS:  Capturing breast cancer patients experience beyond disease progression: implementation of a patient-reported outcome (PRO) substudy in the VIRGO metastatic breast cancer observational cohort study.  American Society of Clinical Oncology, Chicago, June, 2010.

  30. Dreyer, N. Generating evidence for decision making.  Am J Epidemiol 2010; 171(Suppl):S158-S165. 

  31. Williams R, Fu Q, Danis R, Dreyer N.  Anti-VEGF treatment patterns among age-related macular degeneration patients in U.S. clinics:  the PRACTICE study.  2010 Joint Meeting of the American Academy of Ophthalmology and the Middle East Africa Council of Ophthalmology, Chicago, IL, October, 2010.

  32. Adisasmito W, Chan PKS, Lee N, Oner AF, Gasimov V, Aghayev F, Zaman M, Bamgboye E, Dogan N, Coker R, Starzyk K, Dreyer NA, Toovey S:  Global patient registry for influenza A/ H5N1: Strengthening results using multiple imputation.  XII International Symposium on Respiratory Viral Infections, Rome, Italy,  13-16 March 2011.

  33. Dreyer NA, Toovey S, Adisasmito W, Bamgboye, Chan PKS, Coker R, Dogan N, Gasimov V, Hanshaoworakul W, Lee N, Oner AF, M Zaman:  Global patient registry for A/H5N1: A modest success story.  XII International Symposium on Respiratory Viral Infections, Rome, Italy,  13-16 March 2011.

  34. Dreyer, NA, Toovey S, Adisasmito W, Bamgboye E, Chan PKS, Coker R, Dogan N, Gasimov V, Hanshaoworakul W, Lee N, Oner AF, Zaman M.  Handling Missing Data in Prospective Registries.  Agency for Healthcare Research and Quality Comparative Effectiveness Research Methods Symposium, June 6-7, 2011.

  35. Jalbert JJ,. Chen CY, Schneeweiss S, Hammill BG, Dreyer NA, Delaney JAC, Gerhard T, Setoguchi.  Database Linkage and Methodological Issues in Comparative Effectiveness Research (CER) of Medical Devices vs. Medications: Lessons from an Ongoing Project.  Pharmacoepidemiology and Drug Safety 2011; 20: S1–S364

  36. Swenson AJ, Mack C, Dreyer N, Adisasmito W, Bamgboye E, Chan PKS, Coker R, Dogan N, Gasimov V, Hanshaoworakul W, Lee N, Oner AF, Toovey S, Zaman M. Multiple Imputation: Application to a Global Avian Influenza Registry. Int’l Conference on Pharmacoepidemiology & Therapeutic Risk Management.  Pharmacoepidemiology and Drug Safety  2011; 20: S1–S364

  37. Adisasmito W, Chan PKS, Lee N, Oner AF,  Gasimov V, Zaman M, Bamgboye E,  Dogan N,  Coker R, Hanshaoworakul W, Swenson A, Toovey S, Dreyer NA.  Effectiveness of Oseltamivir Treatment in Human Influenza A (H5N1) Infections: An Updated Analysis. The Fourth European Scientific Working group on Influenza Conference.  Malta, 11-14 Sep 2011

  38. Zaman M, Adisasmito W, Bamgboye E, Coker R, Gasimov V, Hanshaoworakul W, Oner A, Swenson A, Dreyer N, Toovey S.  Clinical Characteristics & Treatment Effectiveness in Possible Human Cases of H5N1.  The Fourth European Scientific Working group on Influenza Conference.  Malta, 11-14 Sep 2011

  39. Dixon JB, Dreyer N, Finkelstein EA, Su Z, Globe D, Okerson T.  Assessing real-world European patient profiles in the Helping Evaluate Reduction in Obesity (HERO) study.  EuroPrevent.  Dublin, Ireland, 3 May 2012

  40. Zaman M, Adisasmito W, Hanshaoworakul W, Oner AF, Chan PKS, Lee N, Tsang O, Gasimov V, Bamgboye E, Dogan N, Coker R, Swenson A, Dreyer NA, Tooey S.  Macrolides and Anti-Inflammatory Agents in the Treatment of Avian Influenza (H5N1).  XIV International Symposium on Respiratory Viral Infections, 23 – 26 March 2012, Istanbul, Turkey

  41. Dixon JB, Finkelstein EA, Dreyer N, Menon V, Globe D, Okerson T.  Helping Evaluate Reduction in Obesity: Characterizing Patients Who Choose LAP-BAND in the HERO Observational Study.  Poster presentation at: the 29th Annual Meeting of the American Society for Metabolic and Bariatric Surgery.  June 17-22, 2012; San Diego, CA 

  42. Dreyer N, Leavy MB, Velentgas P.  Studies to inform decision-making: the need for a two-phase approach to assessing quality and appropriateness.  [abstract].  ISPOR 5th Asia-Pacific Conference, 2-4 September 2012, Taipei, Taiwan

  43. Dixon JB, Okerson T, Burk C, Rui S, Ng-Mak C, Globe D, Dreyer NA. One Year Change in Metabolic Syndrome Components in the Helping Evaluate Reduction in Obesity (HERO) study.  European Association for the Study of Diabetes.  2-5 October, 2012, Berlin, Germany

  44. Dixon JB, Okerson TE, Burk CT, Shi R, Ng-Mak DS, Globe D, Dreyer NA.  One Year Evaluation of Metabolic Syndrome in the Helping Evaluate Reduction in Obesity (HERO) Study.  Canadian Journal of Diabetes 2012 (October);36(5) S:68

  45. Kaufman PA, Mayer M, Dreyer NA, Yim YM, Yu E, Su Z, Mun Y, Sloan JA, Cleeland CS.  Patient-reported outcomes in patients with metastatic breast cancer form the VIRGO observational cohort study.  ASCO Breast Cancer Symposium, Sep 13 - 15, 2012, San Francisco, CA.

  46. Dreyer NA, Velentgas P, Westrich K, Dubois, RW.  There but for GRACE?  A Validated Screening Tool for Quality Observational Studies of comparative effectiveness.  [Winner, best poster award] ISPOR, May 26, 2013, New Orleans, LA

  47. Gliklich, RE, Dreyer NA, Leavy MB, Khurana L, Mattox P, Berliner E, Kremer JM, Pappa D. Nesting Studies within Patient Registries.   Poster,  AcademyHealth Annual Research Meeting.  June 2013. Baltimore, MD

  48. Toovey S, Zaman M, Oner AF, Adisasmito W, Coker R, Bamgboye EL, Chan PKS, Hanshaoworakul W, Lee N, Touch S, Phommasack B, Tsang O, Swenson A, Dreyer NA.  Recognizing true H5N1 infections during confirmed outbreaks.  Options for the Control of Influenza.  Cape Town, South Africa, September 5-13, 2013

  49. Dreyer NA, Velentgas P, Westrich K, DuBois R: Using the GRACE Checklist for Quality in Observational Research.  DIA, June, 2014, San Diego, CA

  50. Dreyer NA.  Public-Private Partnerships: An Innovative Strategy for Patient Registries, DIA, June, 2014, San Diego, CA

  51. Richardson JL Stephens S, Thomas SHL, Latos-Bielenska A, Jamry-Dziurla A, de Jong-van den Berg LTW, Zetstra-van der Woude P, Laursen M,  Dreyer N, Hliva V, Mt-Isa  S, Blackburn SCF.  Participant Recruitment to the PROTECT Pregnancy Study: a Non-interventional, Prospective Study of Self-Reported Medication Use and Obstetric Outcomes as Provided by a Cohort of Pregnant Women.  2nd International OTIS-ENTIS Conference at The Hospital for Sick Children, Toronto, Canada September 19–21, 2014.   Birth Defects Res Part A:  Clinical Molecular Teratology 2014;100 (7): s. 548-549.

  52. Dreyer NA, Bryant A, Su Z, Velentgas P.  Use of the GRACE checklist for rating the quality of observational comparative effectiveness research.  Value in Health 2014; 7(17): A732.

  53. Noh E, Dreyer NA,  Ahn J, Alshammari TM, Ritchey ME, Layton JB, Caffrey AR.  Guidelines and Recommendations for Comparative Effectiveness Research (CER) Methods: International Assessment and Exchange.  International Society of Pharmacoepidemiology, Taipei, Taiwan. Pharmacoepidemiology & Drug Safety 2014; 23(s1): 205.

  54. Engel P, Bulliard M, Parmenter L, Starzyk K, Dreyer N.  Lessons Learned on the Design of European Post Authorisation Safety Studies (PASS): Review of 18 Months of PRAC Oversight. Pharmacoepidemiology & Drug Safety 2014; 23(S1): 330-331.

  55. Richardson JL, Holt, SHL Thomas, Stephens S, Jamry A, Latos-Bielenska A, Zetstra-van der Woude PA, de Jong-van den Berg L,TW, Laursen M, Mt-Isa S, Bigouret-Hliva V, Dreyer NA, Blackburn, SCF.  Internet advertisement methods provide highest levels of recruitment to a pilot study of self-reported medication use and pregnancy outcomes. Pharmacoepidemiology & Drug Safety 2014; 23(S1): 312-13.

  56. Dreyer NA, Mt-Isa S, Richardson JL, Laursen M, Zetstra-van der Woude PA,de Jong-van den Berg L, Jamry-Dziuria A, Thomas SHL, Blackburn SCF.  Direct-from-patient information on medication Use: PROTECT pregnancy study results.  Pharmacoepidemiology & Drug Safety 2014; 23(S1): 305.

  57. Francisco G, Bandari D, Adams Manack A, Dreyer N, Velentgas P, Esquenazi A. Utilization Patterns and Effectiveness of OnabotulinumtoxinA for the Treatment of Spasticity: The Adult Spasticity International Registry on BOTOX Treatment (ASPIRE) Study Methods. Poster presented at the 9th World Congress of the International Society of Physical and Rehabilitation Medicine (ISPRM). June 19-23, 2015. Berlin, Germany.

  58. Dreyer NA, Mt-Isa S, Jamry A, Blackburn S, Bourke A.  The feasibility and comparison of self-reported data: a pilot study in pregnancy.  EUROmediCAT European Conference “Safety of Medication Use in Pregnancy”, Poznan, Poland, 2-4 February 2015.

  59.  Dreyer NA, Bryant A, Velentgas, P, Su Z.  Best methods to get your comparative effectiveness paper cited: how GRACE helps.  Poster presented at the International Society of Pharmacoepidemiology August 24-26, 2015.  Pharmacoepidemiology & Drug Safety 2015; 24: 360-361

  60. Dreyer NA, Mt-Isa S, Richardson JL, et al.  Direct-to-patient Research: The Future of Pharmacovigilance?  Pharmacoepidemiology and Drug Safety 2015:24:268-269

  61. Mack CD, Franke K, McCarron O, Bryant A, Jablonski R, Barboza M, Dreyer NA.  NFL Injury Surveillance and Analytics: Improving Data Collection through Use of Electronic Medical Records.  Pharmacoepidemiology & Drug Safety 2015;24:523.

  62. Mack CD, McNeil A, Parmenter L, Davis K, Dreyer NA.  Hybrid prospective studies: combining existing and new data sources to achieve research goals.  Pharmacoepidemiology & Drug Safety 2015;24:544-545.

  63. Bosco JL, Dreyer NA, Neyerapally G, Brown JS.  Generating real-world safety and effectiveness for biosimilars:  current issues and methodological considerations.  Pharmacoepidemiology & Drug Safety 2015;24:416-417.

  64. Bryant A, Mendelsohn AB, Viswanathan S. Dreyer NA.  What impacts the quality of comparative effectiveness research:  A classification and regression tree analysis using the GRACE checklist.  Value in Health 2016: 19(3), A277, Elsevier, 2016/5/1

  65. Mack C, Parmenter L, Velentgas P, Franke K, Jablonski R, Dreyer NA.  Delivering actionable results for observational studies through rapid evaluation processes.  Value in Health 2016: 19(3), A85, Elsevier, 2016/5/1

  66. Brinkley E, Mack CD, Christian JB, Dreyer NA. Developing research partnerships with health networks for real-world evidence generation. Abstract. DIA Annual Meeting.  Chicago, IL   June 2017.

  67. Brinkley E, Midha Y, Lobeck F, Dreyer N, Lang K, Christian JB.    Optimizing Global Protocols for Local Implementation Using Real-World Data: A Multi-Country Approach in Ulcerative Colitis.  Pharmacoepidemiology & Drug Safety 2017; 26:561.

  68. Ritchey ME, Lystig TC, Velentgas P, Brouwer ES, Canos DA, Lund J, Berlin JA, Dreyer NA. Fit-for-purpose non-traditional RCTs. What will it take to convince a skeptical community? International Society of  Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2017. Montreal, Canada. [abstract] Pharmacoepidemiology & Drug Safety 2017 Aug; 26(Suppl 2):29. doi: 10.1002/pds

  69. Brinkley E, Midha Y, Lobeck F, Dreyer NA, Lang K, Christian JB.  Using real-world data to support protocol optimization: a multi country approach in ulcerative colitis.  Value in Health 2017; 20 (5), A319-A319.

  70. Bourke A, Laursen M, Dreyer N, Erikstrup Hallgreen C, Blackburn S.  Can patients accurately report their drugs? A comparison of self-reported medication with a national register in Demark in a subset of the PROTECT Pregnancy Cohort.  Poster.  International Society of Pharmacoepidemiology & Risk Management, 2018 annual conference.  Pharmacoepidemiology & Drug Safety 2018; 27 (2):87

  71. Mack C, Herzog M, Oakkar E, Shiue K, Meisel P, Dreyer NA, DiFiori J. EHR-driven Evidence for Health and Wellness Research: Lessons from the NBA.  International Society of Pharmacoepidemiology & Drug Safety, 2018 Annual Conference.  Pharmacoepidemiology & Drug Safety 2018; 27 (2):329-330 

  72. Wang CY, Gretenkord J, Seeger JD, Davis KJ, Iannacone MR, Zhou W et al. Frequency and characteristics of uncontrolled long-term extensions to randomized controlled trials.  Pharmacoepidemiology & Drug Safety 2020: 29:373.

  73. Herzog MM, Marshall SW, Dreyer NA, Mack DC. Lookback period definition in electronic medical record research. Pharmacoepidemiology & Drug Safety 2020: 29:405-406.

  74. Dreyer N, Petruski-Ivleva N, Albert L, Brinkley E, Mack C, Reynolds M. COVID-19 symptom severity among smokers: Insights from a direct-to-community registry. Pharmacoepidemiology & Drug Safety 2021: 187

  75. Petruski-Ivleva N, Joules A. Warner M, Long P, Cooper A, Dreyer NA.  Collider bias in COVID-19 studies: explaining the smoking paradox.  Pharmacoepidemiology & Drug Safety 2021: 30:103-10

  76. Dreyer N, Petruski-Ivleva N, Albert L, Brinkley E, Mohamed D, Mack C, Reynolds C. Persistence of COVID-19 symptoms 90 days post-acute infection: insights from a community-based registry. Pharmacoepidemiology & Drug Safety 2021: 30:26

  77. Weiss L, Dohse H, Teltsch DY, Dreyer NA, Cai J, Gardarsdottir.  From the individual through the health system and back: the interdisciplinary promise and challenges of digital epidemiology for improved outcomes.  Pharmacoepidemiology & Drug Safety 2021: 30:7

  78. Bourke A, Petruski-Ivleva, Albert L, Dreyer NA.  Comparing two geographic sources of patient-generated health data in a COVID-19 registry.  Pharmacoepidemiology & Drug Safety 2021: 30:178-179

  79. Bratton EW, Petruski-Ivleva N, Albert L, Dreyer NA.  Women of reproductive age in the COVID-19 active research experience (CARE) registry.  Pharmacoepidemiology & Drug Safety 2021: 30:399

  80. Brinkley E, Mack C, Petruski-Ivleva N, Reynolds M, Bourke A, Hawalder K, Dreyer NA. Patients tell all: using a direct-to-patient community registry to understand patient burden of COVID-19. Pharmacoepidemiology & Drug Safety 2021: 30:98

  81. Kosta K, Hall M, Reich C, Dreyer NA, Reynolds M.  Old methods and new data: a near real-time plan for vaccine surveillance and signal detection in COVID-19.  Pharmacoepidemiology & Drug Safety 2021: 30:284

  82. Herzog MM, Marshall SW, Dreyer NA, Mack CD.  Methodologic considerations for quantifying prior injury studies of injury recurrence.  International Olympic Committee poster.  2021, British Journal of Sports Medicine 55 (Suppl 1), A157-‌A157, 2021

  83. Herzog MM, Mack CD, Dreyer NA, Winstrom EA, Padua DA, Kocher MS, Marshall S.  Association between ankle sprain history and ankle sprain incidence in National Basketball Association Games.  International Olympic Committee poster, 2021, British Journal of Sports Medicine 55 (Suppl 1), A43-‌A44, 2021

  84. Brinkley E, Mack CD, Albert L, Knuth K, Reynolds MW, Toovey S, Dreyer NA.  COVID-19 vaccinations in pregnancy: a comparative evaluation of acute side effects and impact on quality of life between pregnant and non-pregnant women in the US. Poster, 2021 International Society for Influenza and other Respiratory Virus Diseases – World Health Organization Conference. 19-21 October 2021

  85. Reynolds M, Xie Y, Knuth K, Brinkley E, Kwon T, Mack C, Dreyer N.  Hospitalizations after COVID-19 Vaccination: Self-reported patient characteristics.  Pharmacoepidemiology & Drug Safety 2022

  86. Knuth K, Reynolds MW, Brinkley E, Xie Y, Kwon T, Mack CD, Dreyer NA.  Diabetics report fewer side effects from COVID-19 vaccination than non-diabetics in the US.  Pharmacoepidemiology & Drug Safety 2022

  87. Xie Y, Reynolds MW, Knuth K, Brinkley E, Kwon T, Mack CD, Dreyer N.  What distinguishes people who experience side effects of COVID-19 vaccines from those who don’t?  Pharmacoepidemiology & Drug Safety 2022

  88. Largent J, Xie Y, Reynolds MW, Knuth KB, Brinkley E, Mack CD, Toovey S, Dreyer NA.  COVID brain: the CARE experience. Pharmacoepidemiology & Drug Safety 2022

  89. Largent J, Xie Y, Reynolds MW, Knuth KB, Brinkley E, Mack CD, Toovey S, Dreyer NA.  Cognitive and other neuropsychiatric symptoms in COVID-19: Analysis of person-generated health data from a community-based registry.  Pharmacoepidemiology & Drug Safety 2022

  90. Sanchez-Solino O, Kilpatrick RD, Johnson C, Fang Y, Zarish K, Ye Y, Dreyer NA, Gray GC.  EPH66 Epidemiological Population Study of Sars-Cov-2 in Lake County, Illinois: Contact: Health-Related Quality of Life Assessment.  Value Health 2023; Jun; 26(6): S176

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