Yale University-Mayo Clinic CERSI
Press
“A Real-World Case Study of Levothyroxine Use Addresses Institutional Concerns About Generic Product Interchangeability”
(CDER Spotlight Series, May 5, 2022)
"Real-world evidence from a narrow therapeutic index product (Levothyroxine) reflects the therapeutic equivalence of generic drug products"
(CDER Spotlight Series, October 08, 2020)
"High-tech pump may increase risk of death and bleeding, study finds"
(Yale News, February 10, 2020)
"Impella vs IABP: AHA analyses signal urgent need for randomized control trial"
(Medscape, December 12, 2019)
"Yale and Mayo Clinic awarded FDA grant to study opioid prescribing and use"
(Yale News, July 30, 2019)
"Yale and Mayo Clinic awarded FDA grant to study opioid prescribing and use"
(Yale News, July 30, 2019)
"NESTcc establishes data quality and methods subcommittees to support real-world evidence studies"
(NEST, June 6, 2018)
"Yale experts selected to conduct medical device surveillance research"
(Yale News, October 2, 2017)
"FDA grant establishes Yale-Mayo Clinic center to advance regulatory science"
(Yale News, January 31, 2017)
CERSI-Supported Publications
Baum LVM, Kc M, Soulos PR, Jeffery MM, Ruddy KJ, Lerro CC, Lee H, Graham DJ, Rivera DR, Leapman MS, Jairam V, Dinan MA, Gross CP, Park HS. Trends in new and persistent opioid use in older adults with and without cancer. J Natl Cancer Inst. 2024 Feb 8;116(2):316-323. doi: 10.1093/jnci/djad206. PMID: 37802882.
Thanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington S, Jeffery MM, Jones L, Noble B, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy K, Schellhorn S, Tarver M, Dueck AC, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open. 2024 Jan 10;14(1):e074030. doi: 10.1136/bmjopen-2023-074030. PMID: 38199641; PMCID: PMC10806877.
Hart S, Garcia V, Dudgeon SN, Hanna MG, Li X, Blenman KR, Elfer K, Ly A, Salgado R, Saltz J, Gupta R, Hytopoulos E, Larsimont D, Lennerz J, Gallas BD. Initial interactions with the FDA on developing a validation dataset as a medical device development tool. J Pathol. 2023 Dec;261(4):378-384. doi: 10.1002/path.6208. Epub 2023 Oct 4. PMID: 37794720; PMCID: PMC10841854.
Wallach JD, Deng Y, Polley EC, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Jeffery MM, Lyon TD, Ross JS, McCoy RG. Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials. Clin Trials. 2023 Aug 17:17407745231193137. doi: 10.1177/17407745231193137. Epub ahead of print. PMID: 37589143.
Mooghali M, Ross JS, Kadakia KT, Dhruva SS. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Intern Med. 2023;183(7):735–737. doi:10.1001/jamainternmed.2023.0727
Mooghali M, Ross JS, Kadakia KT, Dhruva SS. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Med Devices (Auckl). 2023;16:111-122. https://doi.org/10.2147/MDER.S412802
Thanarajasingam G, Kluetz PG, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington SF, Jeffery MM, Jones L, Noble BN, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy KJ, Schellhorn SE, Tarver ME, Dueck AC, Gross CP. Integrating 4 Measures to Evaluate Physical Function in Patients with Cancer (In4M): Protocol for a prospective study. medRxiv 2023.03.08.23286924; doi: https://doi.org/10.1101/2023.03.08.23286924
Ngufor C, Yao X, Inselman JW, Ross JS, Dhruva SS, Graham DJ, Lee JY, Siontis KC, Desai NR, Polley E, Shah ND, Noseworthy PA. Identifying treatment heterogeneity in atrial fibrillation using a novel causal machine learning method. Am Heart J. 2023 Mar 7;260:124-140. doi: 10.1016/j.ahj.2023.02.015. Epub ahead of print. PMID: 36893934.
Howell BA, Black AC, Grau LE, Lin H, Greene C, Lee H, Heimer R, Hawk KE, D’Onofrio G, Fiellin DA, Becker WC. Concordance between controlled substance receipt and post-mortem toxicology in opioid-detected overdose deaths: A statewide analysis. Drug and Alcohol Dependence 2023; 244. doi: https://doi.org/10.1016/j.drugalcdep.2023.109788.
Coles TM, Lucas N, McFatrich M, Henke D, Ridgeway JL, Behnken EM, Weinfurt K, Reeve BB, Corneli A, Dunlay SM, Spertus JA, Lin L, Piña IL, Bocell FD, Tarver ME, Dohse H, Saha A, Caldwell B. Investigating gender-based differential item functioning on the Kansas City Cardiomyopathy Questionnaire (KCCQ) using qualitative content analysis. Qual Life Res. 2022 Nov 2:1–12. doi: 10.1007/s11136-022-03276-y. Epub ahead of print. PMID: 36322269; PMCID: PMC9628332.
Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. BMJ 2022; 379. doi: https://doi.org/10.1136/bmj-2022-070717.
Jeffery MM, Ahadpour M, Allen S, et al. Acute pain pathways: protocol for a prospective cohort study. BMJ Open. 2022;12:e058782. doi: 10.1136/bmjopen-2021-058782
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Intern Med. 2022 Feb 28. Doi: 10.1001/jamainternmed.2022.0045. Epub ahead of print. PMID: 35226058.
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Rates of, and factors associated with, switching among generic levothyroxine preparations in commercially insured American adults. Endocrine. 2022 Feb 2. doi: 10.1007/s12020-022-02987-z. Epub ahead of print. PMID: 35107758.
Wallach JD, Deng Y, McCoy RG, Dhruva SS, Herrin J, Berkowitz A, Polley EC, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Shah ND, Ross JS, Lyon TD. Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment. JAMA Netw Open. 2021;4(10):e2130587. doi:10.1001/jamanetworkopen.2021.30587.
Brito JP, Ross JS, Deng Y, Sangaralingham L, Graham DJ, Qiang Y, Wang Z, Yao X, Zhao L, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Cardiovascular outcomes and rates of fractures and falls among patients with brand-name versus generic L-thyroxine use. Endocrine. 2021 Jun 5. doi: 10.1007/s12020-021-02779-x.
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz AP, Masoudi FA, Messenger JC, Parzynski CS, Ngufor CG, Girotra S, Amin AP, Shah ND, Desai NR. Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Netw Open. 2021 Feb 1;4(2):e2037748. doi: 10.1001/jamanetworkopen.2020.37748.
Becker WC, Heimer R, Dormitzer CM, Doernberg M, D'Onofrio G, Grau LE, Hawk K, Lin HJ, Secora AM, Fiellin DA. Merging statewide data in a public/university collaboration to address opioid use disorder and overdose. Addict Sci Clin Pract. 2021 Jan 4;16(1):1. doi: 10.1186/s13722-020-00211-9.
Akar JG, Hummel JP, Yao X, Sangaralingham L, Dhruva S, Dong J, Ward R, Shah ND, Ross JS, Noseworthy PA. Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology.BMJ Surg, Interven, & Health Tech. 2020;2:e000058. Doi:10.1136/bmjsit-2020-000058
Yao X, Inselman JW, Ross JS, Izem R, Graham DJ, Martin DB, Thompson AM, Ross Southworth M, Siontis KC, Ngufor CG, Nath KA, Desai NR, Nallamothu BK, Saran R, Shah ND, Noseworthy PA. Comparative effectiveness and safety of oral anticoagulants across kidney function in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2020 Oct 5:CIRCOUTCOMES120006515. doi: 10.1161/CIRCOUTCOMES.120.006515. Epub ahead of print. PMID: 33012172.
Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Netw Open. 2020 Sep 1;3(9):e2017645. doi: 10.1001/jamanetworkopen.2020.17645. PMID: 32997127.
Dhruva SS, Ross JS, Akar JG, Caldwell B, Childers K, Chow W, Ciaccio L, Coplan P, Dong Jun, Dykhoff HJ, Johnston S, Kellogg T, Long C, Noseworthy PA, Roberts K, Saha A, Yoo A, Shah N. Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform. NPJ Digit Med. 2020;3:60. doi:10.1038/s41746-020-0265-z
Jeffery MM, Chaisson CE, Hane C, Rumanes L, Tucker J, Hang L, McCoy R, Chen CL, Bicket MC, Hooten WM, Larochelle M, Becker WC, Kornegay C, Racoosin JA, Sanghavi D. Assessment of potentially inappropriate prescribing of opioid analgesics requiring prior opioid tolerance. JAMA Netw Open. 2020;3(4):e202875. doi:10.1001/jamanetworkopen.2020.2875
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of use of an intravascular microaxial left ventricular assist device vs intra-aortic balloon pump with in-hospital mortality and major bleeding among patients with acute myocardial infarction complicated by cardiogenic shock.JAMA. Published online February 10, 2020. doi:10.1001/jama.2020.0254
Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and brand-name thyroid hormone drug use among commercially insured and Medicare beneficiaries, 2007 through 2016. J Clini Endocrinol Metab. 2019; 104(6):2305-2314.
Other Relevant Publications
- Premarket Regulatory Review and Approval
Ross JS, Krumholz HM. Bringing Vioxx back to market. BMJ. 2018;360:k242.
Hakim A, Gupta R, Ross JS. High costs of FDA approval for formerly unapproved marketed drugs. JAMA. 2017;318(22):2181-2182.
Hakim A, Ross JS. Challenges to biosimilar substitution-reply. JAMA. 2017;318(12):1186-11871.
Downing NS, Zhang AD, Ross JS. Regulatory review of new therapeutic agents - FDA versus EMA, 2011-2015. NEJM. 2017;376(14):1386-1387.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An observational study of the consequences for drug prices and shortages in the United States. J Manag Care Spec Pharm. 2017;23(10):1066-1076.
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration clearance of moderate-risk otolaryngologic devices via the 510(k) process, 1997-2016. Otolaryngol Head Neck Surg. 2017;157(4):608-617.
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: A cohort study. BMJ Open. 2017;7(2):e014582.
Gupta R, Kesselheim AS, Downing NS, Greene J, Ross JS. Generic drug approvals since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-1393.
Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals. Trials. 2016;17(1):199.
Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reason why the FDA requires multiple reviews before approval. Health Aff. 2015;34(4):681-688.
Downing NS, Shah ND, Krumholz HM, Ross JS. Regulatory Watch: Characterizing the US FDA's approach to promoting transformative innovation. Nat Rev Drug Discov. 2015;14:740-741.
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA. 2015;314(6):604-612.
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutics, 2005-2012. JAMA. 2014;311(4):368-377.
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics: Comparison of three regulatory agencies. NEJM. 2012;366(24):2284-2293.
- Adoption/De-adoption of Medical Technologies
Jeffery MM, Hooten WM, Hess EP, Meara ER, Ross JS, Henk HJ, Borgundvaag B, Shah ND, Bellolio MF. Opioid prescribing for opioid-naive patients in emergency departments and other settings: Characteristics of prescriptions and association with long-term use. Ann Emerg Med. 2018;71:326-336.
Charalel RA, Durack JC, Mao J, Ross JS, Meltzer AJ, Sedrakyan A. Statewide inferior vena cava filter placement, complications, and retrievals: Epidemiology and recent trends. Med Care. 2018;56:260-265.
Sangaralingham LR, Sangaralingham SJ, Shah ND, Yao X, Dunlay SM. Adoption of Sacubitril/Valsartan for the management of patients with heart failure. Circ Heart Fail. 2018;11(2):e004302.
Lipska KJ, Yao X, Herrin J, McCoy RG, Ross JS, Steinman MA, Inzucchi SE, Gill TM, Krumholz HM, Shah ND. Trends in drug utilization, glycemic control, and rates of severe hypoglycemia, 2006-2013. Diabetes Care. 2017;40(4):468-475.
Motosue M, Bellolio MF, Van Houten HK, Shah ND, Campbell RL. Predictors of epinephrine dispensing and allergy follow-up after emergency department visit for anaphylaxis. Ann Allergy Asthma Immunol. 2017;119(5):452-458.e1.
Parikh R, Ross JS, Sangaralingham LR, Adelman RA, Shah ND, Barkmeier AJ. Trends of anti-vascular endothelial growth factor use in ophthalmology among privately insured and Medicare Advantage patients. Opthalmology. 2017;124(3):352-358.
McCoy RG, Lipska KJ, Yao X, Ross JS, Montori VM, Shah ND. Intensive treatment and severe hypoglycemia among adults with type 2 diabetes. JAMA Intern Med. 2016;176(7):969-978.
Yao X, Sangaralingham LR, Ross JS, Shah ND, Tadawalker JA. Adoption of new agents and changes in treatment patterns for hepatitis C: 2010-2014. Am J Manag Care. 2016;22(6):e224-232.
McCoy R, VanHouten H, Ross JS, Montori VM, Shah ND. HbA1c overtesting and overtreatment among adults with controlled type 2 diabetes, 2001-2013: Observational population based study. BMJ. 2015;351:h6138.
Lipska KJ, Ross JS, Miao Y, Shah ND, Lee SJ, Steinman MA. Potential overtreatment of diabetes among older adults with tight glycemic control. JAMA Intern Med. 2015;175(3):356-362.
Psutka SP, Kim SP, Gross CP, Van Houten H, Thompson RH, Abouassaly R, Weight C, Boorjian SA, Leibovich BC, Shah ND. The impact of targeted therapy of management of metastatic renal cell carcinoma: Trends in systemic therapy and cytoreductive nephrectomy utilization. Urology. 2015;85(2):442-450.
Ross JS, Frazee SG, Garavaglia SB, Levin R, Novshadian H, Jackevicius CA, Stettin GS, Krumholz HM. Trends in use of ezetimibe after the ENHANCE trial, 2007-2010. JAMA Intern Med. 2014;174(9):1486-1493.
Lipska KJ, Ross JS, van Houten HK, Beran D, Yudkin JS, Shah ND. Use and out-of-pocket costs of insulin for type 2 diabetes mellitus from 2000 to 2010. JAMA. 2014;311(22):2331-2333.
Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA. Impact of the ENHANCE trial on the use of ezetimibe in the United States and Canada. Am Heart J. 2014;167(5):683-689.
Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of fibrates in the United States and Canada. JAMA. 2011;305(12):1217-1224.
Jackevicius CA, Tu JV, Ross JS, Ko DT, Krumholz HM. Use of ezetimibe in the United States and Canada. NEJM. 2008;358:1819-1828.
- Postmarket: Real World Evidence
Dhruva SS, Ross JS, Desai NR, Fleurence R, Krumholz HM. New federal rules pave the way for patient-driven health information exchange and real-world evidence on COVID-19 surveillance and treatment. Health Affairs Blog. 2020.
Dhruva SS, Ross JS, Desai NR. Real-world evidence: Promise and peril for medical production evaluation. P T. 2018;43(8):464-472.
Yao X, Tangri N, Gersh BJ, Sangaralingham LR, Shah ND, Nath KA, Noseworthy PA. Renal outcomes in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol. 2017;70(21):2621-2632.
Yao X, Gersh BJ, Sangaralingham LR, Kent DM, Shah ND, Abraham NS, Noseworthy PA. Comparison of the CHA2DS2-VASc, CHADS2, HAS-BLED, ORBIT, and ATRIA risk scores in predicting non-vitamin K antagonist oral anticoagulants-associated bleeding in patients with atrial fibrillation. Am J Cardiol. 2017;120(9):1549-1556.
Motosue MS, Bellolio MF, Van Houten HK, Shah ND, Campbell RL. Increasing emergency department visits for anaphylaxis, 2005-2014. J Allergy Clin Immunol Pract. 2016;5(1):171-175.
Yao X, Abraham NS, Sangaralingham LR, Bellolio MF, McBane RD, Shah ND, Noseworthy PA. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. 2016;5(6):e003725.
Del-Carpio Munoz F, Yao X, Abraham NS, Bellolio MF, Rabinstein AA, Asirvatham SJ, McBane RD, Gersh BJ, Shah ND, Noseworthy PA. Dabigatran versus warfarin in relation to renal function in patients with atrial fibrillation. J Am Coll Cardiol. 2016;68(1):129-131.
Noseworthy PA, Yao X, Shah ND, Gersh BJ. Stroke and bleeding risks in NOAC- and warfarin-treated patients with hypertrophic cardiomyopathy and atrial fibrillation. J Am Coll Cardiol. 2016;67(25):3020-3021.
Singh S, Heien HC, Sangaralingham LR, Schilz SR, Kappelman MD, Shah ND, Loftus EV Jr. Comparative effectiveness and safety of anti-tumor necrosis factor agents in biologic-naïve patients with crohn's disease. Clin Gastroenterol Hepatol. 2016;14(8);1120-1129.
Yao X, Abraham NS, Alexander GC, Crown W, Montori VM, Sangaralingham LR, Gersh BJ, Shah ND, Noseworthy PA. Effect of adherence to oral anticoagulants on risk of stroke and major bleeding among patients with atrial fibrillation. J Am Heart Assoc. 2016;5(2):e003074.
Jackevicius CA, Tu J, Austin P, Stukel T, Ross JS, Krumholz HM, Ko DT. Comparative effectiveness of generic atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome. J Am Heart Assoc. 2016;5(4):e003350.
Noseworthy PA, Yao X, Abraham NS, Sangaralingham LR, McBane RD, Shah ND. Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation. PubMed. 2016;150(6):1302-1312.
Abraham NS, Singh S, Alexander GC, Heien H, Haas LR, Crown W, Shah ND. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: Population based cohort study. BMJ. 2015;350:h1857.
Pachman DR, Ruddy K, Sangaralingham LR, Grothey A, Shah ND, Beutler AS, Hubbard JM, Loprinzi CL. Calcium and magnesium use for oxaliplatin-induced neuropathy: A case study to assess how quickly evidence translates into practice. J Natl Compr Canc Netw. 2015;13(9):1097-1101.
Rank MA, Liesinger JT, Branda ME, Gionfriddo MR, Schatz M, Zeiger RS, Shah ND. Comparative safety and costs of stepping down asthma medications in patients with controlled asthma. J Allergy Clin Immunol. 2015;137(5):1373-1379.
Noseworthy PA, Yao X, Deshmukh AJ, Van Houten H, Sangaralingham LR, Siontis KC, Piccini JP, Asirvatham SJ, Friedman PA, Packer DL, Gersh BJ, Shah ND. Patterns of anticoagulation and cardioembolic risk after catheter ablation for atrial fibrillation. J Am Heart Assoc. 2015;4(11):e002597.
- Postmarket: Safety Surveillance
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun J, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the US food and drug administration between 2001 and 2010. JAMA. 2017;317:1854-1863.
Abraham NS, Noseworthy PA, Yao X, Sangaralingham LR, Shah ND. Gastrointestinal safety of direct oral anticoagulants: A large population-based study. Gastroeterology. 2016;152(5):932-934.
Noseworthy PA, Kapa S, Deshmukh AJ, Madhavan M, Houten HV, Haas LR, Mulpuru SK, McLeod CJ, Asirvatham SJ, Friedman PA, Shah ND, Packer DL. Risk of stroke after catheter ablation versus cardioversion for atrial fibrillation: A propensity matched study of 24,244 patients. Heart Rhythm. 2015;12(6):1154-1161.
Rank MA, Liesinger JT, Branda ME, Gionfriddo MR, Schatz M, Zeiger RS, Shah ND. Comparative safety and costs of stepping down asthma medications in patients with controlled asthma. J Allergy Clin Immunol. 2015;137(5):1373-1379.
Dunlay SM, Haas L, Herrin J, Schilz SR, Stulak JM, Kushwaha SS, Shah ND. Use of post-acute care services and readmissions after left ventricular assist device implantation in privately insured patients. J Card Fail. 2015;21(10):816-823.
Ross JS, Bount KL, Ritchie JE, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: A cross-sectional survey. Med Devices. 2015;2015(8):241-249.
Ross JS, Jackevicius CA, Krumholz HM, Ridgeway JL, Montori VM, Alexander GC, Zerzan JT, Fan J, Shah ND. State Medicaid programs did not make use of prior authorization to promote safer prescribing after rosiglitazone warning. Health Aff. 2012;31(1):188-198.
- Postmarket: Other Regulatory Issues
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: Systematic review. BMJ. 2017;357:j1680.
Samuel AM, Rathi VK, Grauer JA, Ross JS. How do orthopaedic devices change after their initial FDA premarket approval? Clin Orthop. 2016;474(4):1053-1068.
Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket modifications of high-risk therapeutic devices in otolaryngology cleared by US Food and Drug Administration. Otolaryngol Head Neck Surg. 2015;153(3):400-408.
Korenstein D, Keyhani S, Medelson A, Ross JS. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing. PLoS ONE. 2011;6(8):e23336.
- Advanced Analytics and Methods
Varma T, Mello M, Ross JS, Gross C, Miller J. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study.BMJ Medicine 2023;2:e000395. doi: 10.1136/bmjmed-2022-000395
Agoritsas T, Merglen A, Shah ND, O'Donnell M, Guyatt GH. Adjusted analyses in studies addressing therapy and harm: Users' guides to the medical literature. JAMA. 2017;317(7):748-759.
Crown W, Chang J, Olson M, Kahler K, Swindle J, Buzinec P, Shah N, Borah B. Can statistical linkage of missing variables reduce bias in treatment effect estimates in comparative effectiveness research studies? J Comp Eff Res. 2015;4(5):455-463.
Paulus JK, Shah ND, Kent DM. All else being equal, men and women are still not the same: Using risk models to understand gender disparities in care. Circ Cardiovasc Qual Outcomes. 2015;8(3):317-320.
- Shared decision-making
Schaffer JT, Hess EP, Hollander JE, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Inselman J, Herrin J, Montori VM, Shah ND. Impact of a shared decision making intervention on health care utilization: A secondary analysis of the chest pain choice multicenter randomized trial. Acad Emerg Med. 2018;25(3):293-300.
Blevins CH, Egginton JS, Shah ND, Johnson ML, Iyer PG. Comparative assessment of patient preferences and tolerability in Barrett esophagus screening: Results from a randomized trial. J Clin Gastroenterol. 2018 Jan 23 [Epub ahead of print]
Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: Prospective randomized pragmatic trial. BMJ. 2016;355:i6165.
Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. Percutaneous coronary intervention choice decision aid for stable coronary artery disease: A randomized trial. Circ Cardiovasc Qual Outcomes. 2016;10(3).
Hargraves I, LeBlanc A, Shah ND, Montori VM. Shared decision making: The need for patient-clinician conversation, not just information. Health Aff. 2016;35(4):627-629.
Inselman J, Branda M, Castaneda-Guarderas A, Gionfriddo MR, Zeballos-Palacios CL, Morris MM, Shah ND, Montori VM, LeBlanc A. Uptake and documentation of the use of an encounter decision aid in usual practice: A retrospective analysis of the use of the statin/aspirin choice decision aid. Med Decis Making. 2015;36(4):557-561.
LeBlanc A, Herrin J, Williams MD, Inselman JW, Branda ME, Shah ND, Heim EM, Dick SR, Linzer M, Boehm DH, Dall-Winther KM, Matthews MR, Yost KJ, Shepel KK, Montori VM. Shared decision making for antidepressants in primary care: A cluster randomized trial. JAMA Intern Med. 2015;175(11):1761-1770.
LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter decision aid vs. clinical decision support or usual care to support patient-centered treatment decisions in osteoporosis: The Osteoporosis Choice randomized trial II. PLoS One. 2015;10(5):e0128063.
Wang EH, Gross CP, Tilburt JC, Yu JB, Nguyen PL, Smaldone MC, Shah ND, Abouassally R, Sun M, Kim SP. Shared decision making and use of decision aids for localized prostate cancer: Perceptions from radiation oncologists and urologists. JAMA Intern Med. 2015;175(5):792-799.
Hess EP, Coylewright M, Frosch DL, Shah ND. Implementation of shared decision making in cardiovascular care: Past, present and future. Circ Cardiovasc Qual Outcomes. 2014;7(5):797-803.
Coylewright M, Branda M, Inselman JW, Shah ND, Hess E, Leblanc A, Montori VM, Ting HH. Impact of sociodemographic patient characteristics on the efficacy of decision aids: A patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes. 2014;7(3):360-7.
Bouma AB, Tiedje K, Poplau S, Boehm DH, Shah ND, Commers MJ, Linzer M, Montori VM. Shared decision making in the safety net: Where do we go from here? J Am Board Fam Med. 2014;27(2):292-294.
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