Kenneth G Saag

University of Alabama, Tuscaloosa, Alabama, United States

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Publications (343)1555.38 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Background Denosumab 60mg is a biologic used to treat osteoporosis. Its safety profile given concurrently with biologics for rheumatoid arthritis [RA] has not been well studiedObjective We evaluated hospitalized infections among patients treated with RA biologics who initiated denosumab or zoledronic acid[ZA], a parenteral bisphosphonate without known associations with infection. We hypothesized that the rate of hospitalized infection on denosumab would be non-inferior to ZA.Methods We identified RA patients enrolled in Medicare in 2006-2012 treated with biologics who initiated Dmab or ZA. Cox proportional hazards models compared the risk for hospitalized infection, comparing denosumab to ZA users and adjusting for potentially confounding factors . A non-inferiority margin was specified a-priori to demonstrate that denosumab had no greater infection risk than ZA if the upper bound of the 95% CI of the hazard ratio (HR) was less than 1.5.ResultsEligible RA patients receiving biologics initiated denosumab (n=1,354) or ZA (n=4,460). Characteristics of the denosumab users: mean (SD) age 73.0(8.9), 98.2% women, with a majority receiving infliximab (35.7%) or abatacept (18.6%). Denosumab users had a higher prevalence of prior infections (11.5% hospitalized, 48.3% outpatient) and infection-related risk factors. The crude rate of hospitalized infection for Dmab (14.9/100py; 95% CI 12.2-18.1) was comparable to ZA (13.9/100py; 95% CI 12.5-15.4). After adjustment, the HR of hospitalized infection for denosumab users was non-inferior to ZA (HR=0.89, 95% CI 0.69 - 1.15)Conclusion The rate of hospitalized infection among RA patients receiving denosumab concurrently with biologics for RA was not increased compared to zoledronate. This article is protected by copyright. All rights reserved.
    Arthritis & Rheumatology. 02/2015;
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    ABSTRACT: Context. Several fracture prediction models that combine fractures at different sites into a composite outcome are in current use. However, to the extent individual fracture sites have differing risk factor profiles, model discrimination is impaired. Objective. To improve model discrimination by developing a 5-yr composite fracture prediction model for fracture sites that display similar risk profiles. Design. Prospective, observational cohort study. Setting. Primary care practices in 10 countries. Patients. Women aged ≥55 years. Intervention. Self-administered questionnaires collected data on patient characteristics, fracture risk factors and previous fractures. Main Outcome Measure. Main outcome is time to first clinical fracture of hip, pelvis, upper leg, clavicle, or spine, each of which exhibits a strong association with advanced age. Results. Of four composite fracture models considered, model discrimination (c index) is highest for an age-related fracture model (c index 0.75, 47,066 women), and lowest for FRAX major fracture and a 10-site model (c indices 0.67 and 0.65). The unadjusted increase in fracture risk for an additional 10 yr of age ranges from 80% to 180% for the individual bones in the age-associated model. Five other fracture sites not considered for the age-associated model (upper arm/shoulder, rib, wrist, lower leg, and ankle) have age associations for an additional 10 yr of age from a 10% decrease to a 60% increase. Conclusions. After examining results for 10 different bone fracture sites, advanced age appeared the single best possibility for uniting several different sites, resulting in an empirically based composite fracture risk model.
    The Journal of Clinical Endocrinology and Metabolism 12/2014; · 6.31 Impact Factor
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    ABSTRACT: To identify modifiable patient and provider factors associated with allopurinol adherence and the achievement of a serum urate acid (SUA) goal in gout. We identified a retrospective cohort of patients with gout, newly treated with allopurinol. All patient data came from administrative datasets at a large integrated health delivery system. Patients were ≥ 18 years old at time of initial allopurinol dispensing, and had 12 months or more of membership and drug eligibility prior to the index date. Allopurinol adherence was defined as a proportion of days covered ≥ 0.80, evaluated during the first 12 months of observation after the initial dispensing. Multivariable logistic regression was used to examine factors associated with allopurinol nonadherence and attaining an SUA concentration < 6.0 mg/dl. We identified 13,341 patients with gout with incident allopurinol use (mean age 60 yrs, 78% men). Of these, 9581 patients (72%) had SUA measured both at baseline and during followup. Only 3078 patients (32%) attained an SUA target of < 6.0 mg/dl during followup. Potentially modifiable factors associated with treatment adherence and obtaining the SUA goal in the multivariable analysis included concomitant diuretic use, prescriber specialty, and allopurinol dosing practices. Adherent patients were 2.5-fold more likely than nonadherent patients to achieve an SUA < 6.0 mg/dl during observation. Among patients with gout initiating allopurinol in our study, 68% did not reach the SUA goal and 57% of patients were nonadherent. Modifiable factors, including allopurinol dose escalation, treatment adherence, rheumatology referral, and concomitant medication use, could be important factors to consider in efforts aimed at optimizing gout treatment outcomes.
    The Journal of rheumatology. 12/2014;
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    ABSTRACT: Background: This study examines whether concomitant methotrexate (MTX) use is associated with better biologic persistence and whether self-administered anti-TNF therapies are used at reduced doses in real-world clinical care settings, not just clinical trials.Methods: We conducted a retrospective cohort study among RA patients using Medicare claims data from 2006 to 2012. Subjects were new initiators of etanercept, infliximab, adalimumab, abatacept and tocilizumab with at least 12 months of continuous medical and pharmacy coverage after treatment initiation. We examined the association between concomitant MTX use and persistence on biologics using Cox proportional hazard regression adjusting for demographics and baseline co-morbidities. We further identified a subgroup of patients who initiated and were adherent on etanercept or adalimumab for at least 12 months and examined the proportion of patients who subsequently used these therapies at reduced doses continuously for an additional 12, 18, and 24 months.Results: Of 26,510 eligible RA patients, 10,511 initiated biologic monotherapy. Overall, patients initiated biologic monotherapy were 1.4 (95% CI, 1.3-1.5) times more likely to discontinue at 1-year and 1.8 (95% CI, 1.7-2.0) times more likely if starting infliximab monotherapy. Approximately 10-20% of patients who initiated and adhered to etanercept and adalimumab for ≥ 12 months subsequently used reduced-dose therapy for an 12 additional months and beyond.Conclusion: In real-world practice, concomitant MTX was associated with improved persistence on biologic therapy, especially for infliximab users; reduced-dose injectable anti-TNF therapy was used by a substantial proportion of RA patients. © 2014 American College of Rheumatology.
    Arthritis Care & Research. 11/2014;
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    ABSTRACT: Objective: The aim of this study was to evaluate screening questions for estimating nonsteroidal anti-inflammatory drug (NSAID) risk knowledge. Methods: Cross-sectional data from a telephone interview of NSAID users 50 years or older from 39 physician practices in Alabama were used. Patient-reported awareness of prescription NSAID risk and health literacy were the independent variables, and a cumulative index score of objectively tested knowledge of 4 prominent NSAID risks was the dependent variable. General linearized latent and mixed model ordered logistic regression was used to estimate associations among the independent variables, covariates, and objectively tested NSAID risk knowledge. Population-averaged probabilities for levels of objectively tested NSAID risk knowledge were subsequently estimated. Results: Subjective awareness of any prescription NSAID risk (adjusted odds ratio [AOR], 2.40; 95% confidence interval [CI], 1.55-3.74), adequate health literacy (AOR, 1.71; 95% CI, 1.04-2.83), and physician counseling about 1 or more NSAID risks (AOR, 1.69; 95% CI, 1.09-2.61) were significantly and positively associated with NSAID risk knowledge. The probability of correctly answering at least 1 of the 4 NSAID risk knowledge questions was 70% in the absence of any subjective risk awareness and in less than adequate health literacy. Whereas the probability of correctly answering at least 1 of the 4 NSAID risk knowledge questions increased to 86% in the presence of subjective awareness of any prescription NSAID risk and adequate health literacy. Conclusions: Screening questions for subjective NSAID risk awareness and health literacy are predictive of objectively tested NSAID knowledge and can be used to triage patients as well as subsequently initiate and direct a conversation about NSAID risk.
    Journal of Patient Safety 10/2014; · 0.88 Impact Factor
  • Osteoporosis International 09/2014; · 4.17 Impact Factor
  • ASBMR 2014, Houston, Texas; 09/2014
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    ABSTRACT: Objective: To evaluate whether the risks of herpes zoster (HZ) differed by biologics with different mechanisms of actions (MOAs) in older rheumatoid arthritis (RA) patients.Methods: Using Medicare data from 2006-2011, among RA patients with prior biologic use and no history of cancer or other auto-immune diseases, this retrospective cohort study identified new treatment episodes of abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab and tocilizumab. Follow up started on the new biologic initiation and ended at the earliest date of: first HZ, a 30 day gap in current exposure, death, diagnosis of other auto-immune disease or cancer, loss of coverage or Dec 31, 2011. We calculated proportion of RA patients vaccinated for HZ in each calendar year prior to biologic initiation and HZ incidence rate (IR) for each biologic. We compared HZ risks among therapies using Cox regression adjusted for potential confounders.Results: Of 29,129 new biologic treatment episodes, 28.7% used abatacept, 15.9% adalimumab, 14.8 % rituximab, 12.4% infliximab, 12.2% etanercept, 6.1% tocilizumab, 5.8% certolizumab and 4.4% golimumab. Proportion of RA patients vaccinated for HZ prior to biologic initiation ranged from 0.4% in 2007 to 4.1% in 2011. We identified 423 HZ diagnoses with the highest HZ IR for certolizumab (2.45/100 PYs) and the lowest for golimumab (1.61/100 PYs). Neither the crude incidence rate nor the adjusted hazard ratio differed significantly among biologics. Glucocorticoid use had a significant association with HZ.Conclusion: Among older patients with RA, the HZ risk was similar across biologics, including those with different MOAs. © 2014 American College of Rheumatology.
    Arthritis Care & Research. 09/2014;
  • Sebastian E Sattui, Kenneth G Saag
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    ABSTRACT: The rates of incident osteoporotic fractures seem to be stabilizing; however, fragility fractures are still associated with considerable disability, costs and an increased risk of mortality, which is particularly the case for fractures of the hip and vertebra. Mortality is usually highest during the first year after fracture; however, a notably increased mortality risk might persist for several years after the event. In addition to its efficacy in the prevention of new and recurrent osteoporotic fractures, medical treatment has been associated with improved survival after osteoporotic fractures. Observational studies and randomized controlled clinical trials have reported increased survival in patients with a fracture who are treated with bisphosphonates. Rates of medical treatment in patients with osteoporosis remain low, and although the rationale for the putative increase in survival is unclear, this emerging evidence might help further justify the use of medical treatment after fracture. However, further work is needed before medical therapy for mortality prevention in patients with osteoporotic fractures is accepted.
    Nature Reviews Endocrinology 08/2014; · 12.96 Impact Factor
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    ABSTRACT: Few studies have assessed the effectiveness of different drugs for osteoporosis (OP). We aimed to determine if fracture and mortality rates vary among patients initiating different OP medications.
    Clinical and experimental rheumatology 07/2014; · 2.97 Impact Factor
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    ABSTRACT: Despite national guidelines recommending bone mineral density screening with dual-energy x-ray absorptiometry (DXA) in women aged 65 years and older, many women do not receive initial screening.
    Medical Care 06/2014; · 2.94 Impact Factor
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    ABSTRACT: Background Although methotrexate (MTX) is the cornerstone of RA treatment, use of oral and subcutaneous (SC) preparations in real-world settings is not well characterized. Methods Using data from rheumatoid arthritis patients enrolled in a U.S. commercial health plan and the U.S. Medicare program 2006-2011, we identified RA patients initiating oral MTX. Persistence with MTX (oral or subcutaneous) was defined as no gap >90 days. Results New oral MTX users in Medicare (n=20406) were 76.9% women, mean+-SD age 69.7+-11.7 years and contributed median (IQR) follow-up of 2.6 (1.7, 3.5) years; 32% never changed MTX and remained at their starting dose (most common: 7.5mg/week, 22%; and 10mg/week, 23%). Only 39% used doses of >= 20mg/week at any time. At 1 year and beyond, 76% stayed on oral MTX (with or without dose increase) and did not add or switch to HCQ, SSZ, LEF, or SC MTX. The remainder switched or added HCQ (12%), SSZ (5%), LEF (9%) or switched to SC MTX (4%). New commercially-insured oral MTX users (n=4,048) were similar to Medicare patients except for age. In Medicare, 19% of patients starting oral MTX initiated a biologic, mostly (85%) anti-TNF. Of these, 33% never used MTX at a dose of >= 15mg. In commercially insured patients, 35% initiated a biologic, mostly (90%) anti-TNF. Of these, 22% never used MTX at a dose of >= 15mg. Conclusions Titration to higher dose oral MTX and use of SC MTX among RA patients is infrequent and may be underutilized. Further work to optimize MTX dosing before patients are switched to a biologic may be warranted. © 2014 American College of Rheumatology.
    Arthritis care & research. 06/2014;
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    ABSTRACT: Frequent use and serious adverse effects related to non-steroidal anti-inflammatory drugs (NSAIDs) underscore the need to raise patient awareness about potential risks. Partial success of patient- or provider-based interventions has recently led to interest in combined approaches focusing on both patient and physician. This research tested a shared decision-making intervention for increasing patient-reported awareness of NSAID risk.
    Journal of Evaluation in Clinical Practice 06/2014; · 1.58 Impact Factor
  • Annals of the Rheumatic Diseases 06/2014; 73(Suppl 2):452-452. · 9.27 Impact Factor
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    ABSTRACT: NSAIDs are associated with risks of gastrointestinal (GI) and cardiovascular (CV) toxicities. It has been reported that the risks of GI and CV events are dose related, resulting in guidance explicitly emphasizing the use of NSAIDs at the lowest effective dose for the shortest duration. To understand the potential benefits of using lower doses of diclofenac, a more detailed understanding of the relationship of diclofenac dose and the risks of GI and CV events is required.
    Clinical Therapeutics 05/2014; · 2.59 Impact Factor
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    ABSTRACT: Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.
    Annals of the rheumatic diseases 05/2014; · 9.27 Impact Factor
  • Kenneth G. Saag
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    ABSTRACT: Glucocorticoids are widely used internationally for the treatment of inflammatory disease, such as rheumatoid arthritis (RA). Although the benefit of glucocorticoids in RA on both disease activity and severity are well known, there remain unanswered questions about the overall bone safety of chronic low-dose glucocorticoids in RA. Debate exists about the merits of glucocorticoids for bone health on the basis of their benefits in promoting activity and reducing proinflammatory cytokines. Overall current evidence supports the view that bone loss is a disease related both to RA and to glucocorticoid use independently. Calcium and vitamin D, along with prescription antiosteoporosis therapies, particularly bisphosphonates and teriparatide, play an important role in stabilizing bone mineral density and potentially lowering spinal fracture risk at the spine. International guidelines provide pathways for appropriate prevention of glucocorticoid-induced osteoporosis (GIOP). Despite the evidence and these guidelines, many patients do not receive adequate management to prevent GIOP.
    Annals of the New York Academy of Sciences 05/2014; · 4.38 Impact Factor
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    ABSTRACT: Low adherence to bisphosphonate therapy is associated with increased fracture risk. Factors associated with discontinuation of osteoporosis medications have not been studied in-depth. This study assessed medication discontinuation and switching patterns among Medicare beneficiaries who were new users of bisphosphonates and evaluated factors possibly associated with discontinuation. We identified patients initiating bisphosphonate treatment using a 5% random sample of Medicare beneficiaries with at least 24 months of traditional fee-for-service and part D drug coverage from 2006 through 2009. We classified medication status at the end of follow-up as: continued original bisphosphonate, discontinued without switching or restarting, restarted the same drug after a treatment gap (>= 90 days), or switched to another anti-osteoporosis medication. We conducted logistic regression analyses to identify baseline characteristics associated with discontinuation and a case-crossover analysis to identify factors that precipitate discontinuation. Of 21,452 new users followed respectively for 12 months, 44% continued their original therapy, 36% discontinued without switching or restarting, 8% restarted the same drug after a gap greater than 90 days, and 11% switched to another anti-osteoporosis medication. Factors assessed during the 12-month period before initiation were weakly associated with discontinuation. Several Factors measured during follow-up were associated with discontinuation, including more physician visits, hospitalization, having a dual-energy X-ray absorptiometry test, higher Charlson comorbidity index scores, higher out-of-pocket drug payments, and upper gastrointestinal problems. Patterns were similar for 4,738 new users followed for 30 months. Among new bisphosphonates users, switching within and across drug classes and extended treatment gaps are common. Robust definitions and time-varying considerations should be considered to characterize medication discontinuation more accurately.
    BMC Musculoskeletal Disorders 04/2014; 15(1):112. · 1.90 Impact Factor
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    ABSTRACT: The goal of our study was to estimate the prevalence of osteoporosis and low bone mass based on bone mineral density (BMD) at the femoral neck and the lumbar spine in adults 50 years and older in the United States (US). We applied prevalence estimates of osteoporosis or low bone mass at the femoral neck or lumbar spine (adjusted by age, sex, and race/ethnicity to the 2010 Census) for the non-institutionalized population age 50 years and older from the National Health and Nutrition Examination Survey 2005–2010 to 2010 US Census population counts to determine the total number of older US residents with osteoporosis and low bone mass. There were over 99 million adults 50 years and older in the US in 2010. Based on an overall 10.3% prevalence of osteoporosis, we estimated that in 2010 10.2 million older adults had osteoporosis. The overall low bone mass prevalence was 43.9%, from which we estimated that 43.4 million older adults had low bone mass. We estimated that 7.7 million non-Hispanic White, 0.5 million non-Hispanic Black, and 0.6 million Mexican American adults had osteoporosis and another 33.8, 2.9, and 2.0 million had low bone mass, respectively. When combined, osteoporosis and low bone mass at the femoral neck or lumbar spine affected an estimated 53.6 million older US adults in 2010. Although most of the individuals with osteoporosis or low bone mass were non-Hispanic White women, a substantial number of men and women from other racial/ethnic groups also had osteoporotic BMD or low bone mass. © 2014 American Society for Bone and Mineral Research
    Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research 04/2014; · 6.04 Impact Factor
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    ABSTRACT: The risk of subsequent infections in rheumatoid arthritis (RA) patients who receive biologic therapy after a serious infection is unclear. To compare the subsequent risk of hospitalised infections associated with specific biologic agents among RA patients previously hospitalised for infection while receiving anti-tumour necrosis factor (anti-TNF) therapy. Using 2006-2010 Medicare data for 100% of beneficiaries with RA enrolled in Medicare, we identified patients hospitalised with an infection while on anti-TNF agents. Follow-up began 61 days after hospital discharge and ended at the earliest of: next infection, loss of Medicare coverage or 18 months after start of follow-up. We calculated the incidence rate of subsequent hospitalised infection for each biologic and used Cox regression to control for potential confounders. 10 794 eligible hospitalised infections among 10183 unique RA patients who contributed at least 1 day of biologic exposure during follow-up. We identified 7807 person-years of exposure to selected biologics-333 abatacept, 133 rituximab and 7341 anti-TNFs (1797 etanercept, 1405 adalimumab, 4139 infliximab)-and 2666 associated infections. Mean age across biologic exposure cohorts was 64-69 years. The crude incidence rate of subsequent hospitalised infection ranged from 27.1 to 34.6 per 100 person-years. After multivariable adjustment, abatacept (HR: 0.80, 95% CI 0.64 to 0.99) and etanercept (HR: 0.83, 95% CI 0.72 to 0.96) users had significantly lower risks of subsequent infection compared to infliximab users. Among RA patients who experienced a hospitalised infection while on anti-TNF therapy, abatacept and etanercept were associated with the lowest risk of subsequent infection compared to other biologic therapies.
    Annals of the rheumatic diseases 03/2014; · 9.27 Impact Factor

Publication Stats

9k Citations
1,555.38 Total Impact Points

Institutions

  • 2010–2014
    • University of Alabama
      Tuscaloosa, Alabama, United States
    • University of Sydney
      Sydney, New South Wales, Australia
  • 2001–2014
    • University of Alabama at Birmingham
      • • Department of Medicine
      • • Division of Clinical Immunology and Rheumatology
      Birmingham, Alabama, United States
  • 2013
    • Cambridge University Hospitals NHS Foundation Trust
      Cambridge, England, United Kingdom
  • 2012–2013
    • Oregon Health and Science University
      • Department of Public Health & Preventive Medicine
      Los Angeles, CA, United States
    • HUMANA Inc.
      Louisville, Kentucky, United States
    • Creighton University
      • Division of General Internal Medicine
      Omaha, NE, United States
  • 2011–2012
    • Kaiser Permanente
      Oakland, California, United States
    • Washington University in St. Louis
      • Department of Pathology and Immunology
      San Luis, Missouri, United States
    • Université René Descartes - Paris 5
      Lutetia Parisorum, Île-de-France, France
    • Vanderbilt University
      • Department of Preventive Medicine
      Nashville, MI, United States
    • Instituto de Salud Carlos III
      Madrid, Madrid, Spain
    • Alfried Krupp Krankenhaus
      Essen, Lower Saxony, Germany
  • 2005–2012
    • Charité Universitätsmedizin Berlin
      • Medical Department, Division of Rheumatology and Clinical Immunology
      Berlín, Berlin, Germany
  • 1996–2012
    • University of Iowa
      • • College of Public Health
      • • Department of Internal Medicine
      Iowa City, Iowa, United States
  • 2009–2010
    • University of California, Los Angeles
      • Division of Rheumatology
      Los Angeles, California, United States
    • Brigham and Women's Hospital
      • Center for Brain Mind Medicine
      Boston, MA, United States
    • VU University Medical Center
      • Department of Rheumatology
      Amsterdam, North Holland, Netherlands
  • 2008–2009
    • University Medical Center Utrecht
      Utrecht, Utrecht, Netherlands
    • American Society of Health-System Pharmacists
      Maryland, United States
  • 2007
    • RAND Corporation
      Santa Monica, California, United States
  • 2006–2007
    • Duke University
      Durham, North Carolina, United States
    • University of Nebraska at Omaha
      • Division of Rheumatology and Immunology
      Omaha, Nebraska, United States
    • Hospitais da Universidade de Coimbra
      Coímbra, Coimbra, Portugal
    • Duke University Medical Center
      • Center for the Study of Aging and Human Development
      Durham, NC, United States
    • University of Massachusetts Medical School
      • Department of Medicine
      Worcester, Massachusetts, United States
  • 2003–2006
    • University of Nebraska Medical Center
      • Division of Rheumatology and Immunology
      Omaha, Nebraska, United States
  • 2002
    • University of California, San Francisco
      • Division of Hospital Medicine
      San Francisco, California, United States
    • Mayo Foundation for Medical Education and Research
      • Department of Health Sciences Research
      Scottsdale, AZ, United States