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1.  Primary care providers’ knowledge, beliefs and treatment practices for gout: results of a physician questionnaire 
Rheumatology (Oxford, England)  2013;52(9):1623-1629.
Objective. We sought to examine primary care providers’ gout knowledge and reported treatment patterns in comparison with current treatment recommendations.
Methods. We conducted a national survey of a random sample of US primary care physicians to assess their treatment of acute, intercritical and tophaceous gout using published European and American gout treatment recommendations and guidelines as a gold standard.
Results. There were 838 respondents (response rate of 41%), most of whom worked in private practice (63%) with >16 years experience (52%). Inappropriate dosing of medications in the setting of renal disease and lack of prophylaxis when initiating urate-lowering therapy (ULT) accounted for much of the lack of compliance with treatment recommendations. Specifically for acute podagra, 53% reported avoidance of anti-inflammatory drugs in the setting of renal insufficiency, use of colchicine at a dose of ≤2.4 mg/day and no initiation of a ULT during an acute attack. For intercritical gout in the setting of renal disease, 3% would provide care consistent with the recommendations, including initiating a ULT at the appropriate dose with dosing titration to a serum urate level of ≤6 mg/dl and providing prophylaxis. For tophaceous gout, 17% reported care consistent with the recommendations, including ULT use with dosing titration to a serum urate level of ≤6 mg/dl and prophylaxis.
Conclusion. Only half of primary care providers reported optimal treatment practices for the management of acute gout and <20% for intercritical or tophaceous gout, suggesting that care deficiencies are common.
PMCID: PMC3741476  PMID: 23620554
gout knowledge; medication use; treatment practices
2.  Cost-Related Medication Nonadherence in Older Rheumatoid Arthritis Patients 
The Journal of rheumatology  2013;40(2):10.3899/jrheum.120441.
Economic access to costly medications including biologic agents can be challenging. Our objective was to examine whether patients with rheumatoid arthritis (RA) are at particular risk for cost-related medication nonadherence (CRN) and spending less on basic needs.
We identified a nationally-representative sample of older adults with RA (n=1100) in the (2004–2008) Medicare Current Beneficiary Survey and compared them to older adults with other morbidities categorized by chronic disease count: 0 (n=5,898), 1–2 (n=30,538), and ≥ 3 (n=34,837). We compared annual rates of self-reported CRN (skipping or reducing medication doses or not obtaining prescriptions due to cost) as well as spending less on basic needs to afford medications and tested for differences using survey-weighted logistic regression analyses adjusted for demographic characteristics, health status, and prescription drug coverage.
In the RA sample, the unadjusted weighted prevalence of CRN ranged from 20.7% in 2004 to 18.4% in 2008 as compared to 18.5% and 11.9% respectively in patients with 3 or more nonRA conditions. In adjusted analyses having RA was associated with a 3.5-fold increase in the risk of CRN (OR: 3.52; 95% CI: 2.63–4.71) and almost 2.5-fold risk of spending less on basic needs (OR: 2.41; 95% CI 1.78–3.25) as compared to those without a chronic condition.
Patients with RA experience a high prevalence of CRN and forgoing basic needs that is greater than that of older adults with multiple chronic conditions and did not improve during a period of policy change aimed at alleviating high drug costs.
PMCID: PMC3815617  PMID: 23322458
rheumatoid arthritis; biologics; disease modifying anti-rheumatic drugs; costs; adherence
3.  Time Trends in Medication Use and Expenditures in Older Rheumatoid Arthritis Patients 
The American journal of medicine  2012;125(9):937.e9-937.e15.
We sought to examine how expansions in insurance coverage of nonbiologic and biologic disease modifying anti-rheumatic drugs (DMARDs) impacted the access, costs and health status of older patients with rheumatoid arthritis.
We identified a nationally-representative sample of older adults with rheumatoid arthritis in the 2000–2006 Medicare Current Beneficiary Survey (unweighted n=1051). We examined changes in DMARD use, self-reported health status, functional status (activities of daily living [ADL]), and total costs and out-of-pocket costs for medical care and prescription drugs. Tests for time trends were conducted using weighted regressions.
Between 2000 and 2006, the proportion of older adults with rheumatoid arthritis who received biologics tripled (4.6% vs. 13.2%, p=0.01), while the proportion of people that used a nonbiologic did not change. During the same period, the proportion of older rheumatoid arthritis patients rating their health as excellent/good significantly increased (43.0% in 2000 to 55.6% in 2006; p=0.015). Significant improvements occurred in activities of daily living measures of functional status. Total prescription drug costs (in 2006 US dollars) increased from $2645 in 2000 to $4685 in 2006, p=0.0001, while out-of-pocket prescription costs remained constant ($842 in 2000 vs. $832 in 2006; p=0.68). Total medical costs did not significantly increase ($16563 in 2000 vs. $19510 in 2006; p=0.07).
Receipt of biologics in older adults with rheumatoid arthritis increased over a period of time where insurance coverage was expanded without increasing patients’ out-of-pocket costs. During this time period concurrent improvements in self-reported health status and functional status suggest improved arthritis care.
PMCID: PMC3432666  PMID: 22682794
Rheumatoid Arthritis; Disease Modifying Anti-Rheumatic Drugs (DMARD); Biologic Response Modifiers; Medication; Costs
4.  Prescribing Practices in a US cohort of Rheumatoid Arthritis Patients Before and After Publication of the ACR Treatment Recommendations 
Arthritis and Rheumatism  2012;64(3):630-638.
To examine prescribing of biologic and nonbiologic disease-modifying anti-rheumatic drugs (nbDMARDs) in Rheumatoid Arthritis (RA) before and after publication of the American College of Rheumatology (ACR) treatment recommendations.
We identified biologic naïve RA patients cared for by US rheumatologists participating in the CORRONA registry with visits prior to and/or at least 6 months after publication of the ACR recommendations (time periods: 2/02 - 6/08 vs. 12/08 - 12/09). The population was divided into two mutually exclusive cohorts: 1) methotrexate (MTX) monotherapy users; and 2) multiple nbDMARD users. Initiation or dose escalation of biologic and nbDMARDs in response to active disease was assessed cross-sectionally and longitudinally in comparison to the ACR recommendations. The impact of the publication of the ACR recommendations on treatment practices was compared using logistic regression stratified by disease activity adjusting for clustering of physicians and geographic region.
After one visit, 24 to 37% of MTX monotherapy users with moderate disease activity and poor prognosis or high disease activity received care consistent with the recommendations; it was 34 to 56% after 2 visits. In the multiple nbDMARD users, 30 to 47% of those with moderate or high disease activity received care consistent with the recommendation after one visit and 43 to 51% after 2 visits. Publication of the recommendations did not significantly change treatment patterns for active disease.
Substantial numbers of RA patients with active disease did not receive care consistent with the current ACR treatment recommendations. Innovative approaches to improve care are necessary.
PMCID: PMC3253907  PMID: 21953645
5.  Patients and providers view gout differently: a qualitative study 
Chronic illness  2010;6(4):263-271.
We sought to examine patients’ and providers’ views on the treatment of gout to better understand why management is suboptimal.
In-depth telephone interviews were conducted with gout patients (n=26) who initiated treatment with a urate-lowering drug (ULD) in the prior 6 months and with providers who care for gout patients (n=15). The interviews were audiotaped and transcribed verbatim. Using qualitative methods, results were analyzed and themes were identified. Interviews focused on the acute management, chronic management, and prevention and improvement strategies.
Providers viewed the majority of patients as having excellent relief with nonsteroidal anti-inflammatories, colchicine and glucocorticoids while some patients felt these medications were ineffective. Providers felt most patients had a good understanding of the rationale for ULD therapy and that patients responded well. Some patients felt ULDs triggered, worsened or had no impact on their disease. Most providers thought medication adherence was relatively good. Some patients reported discontinuing medications. Discontinuations were largely purposeful and due to clinical or financial concerns. Most providers thought their skills adequate to teach disease self-management behaviors. Patients requested more information and longer visit times.
Providers view gout as easily managed while patients report challenges and purposeful nonadherence.
PMCID: PMC3134238  PMID: 20675361
medication use; gout treatment; medication adherence; qualitative
6.  The Dynamics of Chronic Gout Treatment: medication gaps and return to therapy 
To identify gaps in therapy with urate-lowering drugs for the treatment of gout as well as factors associated with resuming therapy.
We identified persons from two integrated delivery systems 18 years or older with a diagnosis of gout who initiated use of a urate-lowering drug from January 1, 2000 through June 30, 2006 and who had a gap in therapy. A gap was defined as a period of over 60 days after the completion of one prescription in which no refill for a urate-lowering drug was obtained. Survival curves were used to assess return to therapy of urate-lowering drugs. Cox proportional hazards analysis estimated the association between covariates and return to therapy.
There were 4,166 new users of urate-lowering drugs (97% received allopurinol) of whom 2,929 (70%) had a gap in therapy. Among those with a gap, in 75% it occurred in the first year of therapy. Fifty percent of patients with a gap returned to therapy within 8 months, and by 4 years it was 75%. Age 45 to 74 (<45 referent) and greater duration of urate-lowering drug use prior to the gap was associated with resuming treatment within one year. In contrast, receipt of NSAIDs or glucocorticoids in the year prior to the gap was associated with a reduced likelihood of resuming therapy.
The majority of gout patients with gaps in urate-lowering drug use returned to treatment. More investigation is needed to better understand why patients may go for months without refilling prescriptions given the clinical consequences of nonadherence.
PMCID: PMC2813203  PMID: 20102992
persistence; adherence; compliance; gout; urate lowering drugs
7.  Medication Adherence of Patients with Selected Rheumatic Conditions: A Systematic Review of the Literature 
Nonadherence with medication treatment has been found to occur in large proportions of patients with a broad range of chronic conditions. Our aim was to perform a systematic review of the literature examining adherence with treatments for inflammatory rheumatic conditions to assess the magnitude of the problem in this patient population.
A MEDLINE search of English language literature was performed to identify studies published between January 1, 1985 and November 30, 2007 that evaluated adherence with chronic medications needed in the treatment of rheumatic conditions.
A total of 20 articles met the criteria for evaluation, the majority of which focused on the treatment of rheumatoid arthritis. Most of the studies examined the use of nonsteroidal anti-inflammatory medications and disease modifying anti-rheumatic drugs. Adherence was assessed based on self-report, pill counts, pharmacy dispensings, openings of pill containers using electronic devices, laboratory assays, and physician assessment. Adherence varied greatly based on the adherence measure used, arthritic condition evaluated and medication under study. Overall, the highest rates of adherence were based on self-reports for a wide variety of medications and conditions (range of persons reporting adherence was 30 to 99%), while the lowest adherence rates were for allopurinol based on pharmacy dispensings (18–26%).
Adherence has not been widely examined for most chronic inflammatory rheumatic conditions and the few studies that exist used different definitions and populations, thus limiting any conclusions. However, the current literature does suggest that nonadherence is a substantial problem.
PMCID: PMC2695137  PMID: 18336875
adherence; arthritis
8.  Association of Medication Beliefs and Self-Efficacy with Adherence in Urban Hispanic and African American Rheumatoid Arthritis Patients 
Annals of the rheumatic diseases  2013;73(1):317-318.
PMCID: PMC3940270  PMID: 23904474
rheumatoid arthritis; medication adherence; minority health; self-efficacy; medication beliefs
9.  Racial and Ethnic Disparities in Disease Activity in Rheumatoid Arthritis Patients 
The American journal of medicine  2013;126(12):1089-1098.
Observational studies of patients with rheumatoid arthritis have suggested that racial and ethnic disparities exist for minority populations. We compared disease activity and clinical outcomes across racial and ethnic groups using data from a large, contemporary United States registry.
We analyzed data from two time periods (2005-2007 and 2010-2012). The Clinical Disease Activity Index was examined as both a continuous measure and as dichotomous measures of disease activity states. Outcomes were compared in unadjusted and a series of cross-sectional and longitudinal multivariable regression models.
For 2005-2007, significant differences of mean disease activity level (p<0.001) were observed across racial and ethnic groups. Over the five-year period, modest improvements in disease activity were observed across all groups, including whites [3.7 (95% CI 3.2 - 4.1) compared with African Americans [4.3 (95% CI 2.7 – 5.8)] and Hispanics [2.7 (95% CI 1.2 – 4.3)]. For 2010-2012, significant differences of mean disease activity level persisted (p<0.046) across racial and ethnic groups, ranging from 11.6 (95% CI 10.4-12.8) in Hispanics to 10.7 (95% CI 9.6-11.7) in whites. Remission rates remained significantly different across racial/ethnic groups across all models for 2010-2012, ranging from 22.7 (95% CI 19.5-25.8) in African Americans to 27.4 (95% CI 24.9-29.8) in whites.
Despite improvements in disease activity across racial and ethnic groups over a 5-year period, disparities persist in disease activity and clinical outcomes for minority groups versus white patients.
PMCID: PMC4006346  PMID: 24262723
Rheumatoid Arthritis; Disparities; Disease activity
10.  The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network 
The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify patient and provider barriers to implementing T2T management. This initial paper focuses on the novel study design and methods created to provide these insights.
This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care (UC) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity. Specific medication choices are left to the investigator and patient, rather than being specified in the protocol. Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 patients. During the 12-month follow-up, visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group. Safety data are collected at each visit. The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups.
This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States.
Trial registration
PMCID: PMC4258022  PMID: 25416400
Treat to target; Rheumatoid arthritis; Corrona; Usual care
11.  Validity of Diagnostic Codes and Prevalence of Psoriasis and Psoriatic Arthritis in a Managed Care Population, 1996–2009 
Few population-based studies have reported the prevalence of psoriatic disease.
We validated computerized diagnoses to estimate the prevalence of psoriasis and psoriatic arthritis.
We identified adults with ≥1 ICD-9 diagnosis codes of 696.0 (psoriatic arthritis) or 696.1 (psoriasis) in clinical encounter data during 1996–2009, and used chart review to confirm the diagnoses in random samples of patients. We then used the best performing case-finding algorithms to estimate the point prevalence of psoriasis and psoriatic arthritis.
The number of persons with a diagnosis for psoriasis (ICD-9 code 696.1) was 87,827. Chart review of a random sample of 101 cases with at least one dermatologist-rendered psoriasis code revealed a positive predictive value (PPV) of 90% (95% CI, 83–95) with sensitivity 88% (95% CI, 80–93). Psoriatic arthritis (code 696.0) was recorded for 5,187 patients, with the best performing algorithm requiring ≥2 diagnoses recorded by a rheumatologist or ≥1 diagnosis recorded by a rheumatologist together with ≥1 psoriasis diagnoses recorded by a dermatologist; the PPV was 80% (95% CI, 70–88) with sensitivity 73% (95% CI, 63–82). Among KPNC adults, the point prevalence of psoriasis, with or without psoriatic arthritis, was 939 (95% CI, 765–1142) per 100,000, and the overall prevalence of psoriatic arthritis, with or without psoriasis, was 68 (95% CI, 54–84) per 100,000.
Within an integrated health care delivery system, the use of computerized diagnoses rendered by relevant disease specialists is a valid method for identifying individuals with psoriatic disease.
PMCID: PMC3720770  PMID: 23637091
Psoriasis; Psoriatic Arthritis; Epidemiology; Incidence; Prevalence; Health Maintenance Organizations; Computerized Medical Information
12.  Association Between Anti-TNF-α Therapy and Interstitial Lung Disease 
Anti-TNF-α agents have been hypothesized to increase the risk of interstitial lung disease (ILD), including its most severe manifestation, pulmonary fibrosis.
We conducted a cohort study among autoimmune disease patients who were members of Kaiser Permanente Northern California, 1998–2007. We obtained therapies from pharmacy data and diagnoses of ILD from review of X-ray and computed tomography reports. We compared new users of anti-TNF-α agents to new users of non-biologic therapies using Cox proportional hazards analysis to adjust for baseline propensity scores and time-varying use of glucocorticoids. We also made head-to-head comparisons between anti-TNF-α agents.
Among the 8,417 persons included in the analysis, 38 (0.4%) received a diagnostic code for ILD by the end of follow-up, including 23 of 4,200 (0.5%) who used anti-TNF-α during study follow-up, and 15 of 5,423 (0.3%) who used only non-biologic therapies. The age- and gender-standardized incidence rate of ILD, per 100 person-years, was 0.21 (95% CI 0–0.43) for rheumatoid arthritis and appreciably lower for other autoimmune diseases. Compared to use of non-biologic therapies, use of anti-TNF-α therapy was not associated with a diagnosis of ILD among RA patients (adjusted hazard ratio, 1.03; 95% CI 0.51–2.07). Nor did head-to-head comparisons across anti-TNF-α agents suggest important differences in risk, although the number of cases available for analysis was limited.
The study provides evidence that compared to non-biologic therapies anti-TNF-α therapy does not increase the occurrence of ILD among patients with autoimmune diseases, and informs research design of future safety studies of ILD.
PMCID: PMC3618622  PMID: 23359391
Rheumatoid arthritis; psoriatic arthritis; psoriasis; Crohn’s Disease; ulcerative colitis; inflammatory bowel disease; pharmacoepidemiology; drug safety; drug toxicity; adverse events; cohort studies; propensity scores; automated healthcare data; interstitial lung disease; pulmonary fibrosis
13.  The comparative effectiveness of abatacept versus anti-tumour necrosis factor switching for rheumatoid arthritis patients previously treated with an anti-tumour necrosis factor 
Annals of the Rheumatic Diseases  2013;74(2):430-436.
We compared the effectiveness of abatacept (ABA) versus a subsequent anti-tumour necrosis factor inhibitor (anti-TNF) in rheumatoid arthritis (RA) patients with prior anti-TNF use.
We identified RA patients from a large observational US cohort (2/1/2000–8/7/2011) who had discontinued at least one anti-TNF and initiated either ABA or a subsequent anti-TNF. Using propensity score (PS) matching (n:1 match), effectiveness was measured at 6 and 12 months after initiation based on mean change in Clinical Disease Activity Index (CDAI), modified American College of Rheumatology (mACR) 20, 50 and 70 responses, modified Health Assessment Questionnaire (mHAQ) and CDAI remission in adjusted regression models.
The PS-matched groups included 431 ABA and 746 anti-TNF users at 6 months and 311 ABA and 493 anti-TNF users at 12 months. In adjusted analyses comparing response following treatment with ABA and anti-TNF, the difference in weighted mean change in CDAI (range 6–8) at 6 months (0.46, 95% CI −0.82 to 1.73) and 12 months was similar (−1.64, 95% CI −3.47 to 0.19). The mACR20 responses were similar at 6 (28–32%, p=0.73) and 12 months (35–37%, p=0.48) as were the mACR50 and mACR70 (12 months: 20–22%, p=0.25 and 10–12%, p=0.49, respectively). Meaningful change in mHAQ was similar at 6 and 12 months (30–33%, p=0.41 and 29–30%, p=0.39, respectively) as was CDAI remission rates (9–10%, p=0.42 and 12–13%, p=0.91, respectively).
RA patients with prior anti-TNF exposures had similar outcomes if they switched to a new anti-TNF as compared with initiation of ABA.
PMCID: PMC4316858  PMID: 24297378
Rheumatoid Arthritis; Anti-TNF; DMARDs (biologic)
14.  Association Between Anti-TNF-α Therapy and All-Cause Mortality 
Pharmacoepidemiology and drug safety  2012;21(12):1311-1320.
To compare mortality among patients with selected autoimmune diseases treated with anti-tumor necrosis factor alpha (TNF-α) agents with similar patients treated with non-biologic therapies.
Cohort study set within several large health care programs, 1998–2007. Autoimmune disease patients were identified using diagnoses from computerized healthcare data. Use of anti-TNF-α agents and comparison non-biologic therapies were identified from pharmacy data and mortality was identified from vital records and other sources. We compared new users of anti-TNF-α agents to new users of non-biologic therapies using propensity scores and Cox proportional hazards analysis to adjust for baseline differences. We also made head-to-head comparisons among anti-TNF-α agents.
Among the 46,424 persons included in the analysis, 2,924 (6.3%) had died by the end of follow-up, including 1,754 (6.1%) of the 28,941 with a dispensing of anti-TNF-α agent and 1,170 (6.7%) of the 17,483 who used non-biologic treatment alone. Compared to use of non-biologic therapies, use of anti-TNF-α therapy was not associated with an increased mortality in patients with rheumatoid arthritis (adjusted hazard ratio [aHR] 0.93 with 95% CI 0.85–1.03); psoriasis, psoriatic arthritis, or ankylosing spondylitis (combined aHR 0.81 with CI 0.61–1.06; or inflammatory bowel disease (aHR 1.12 with CI 0.85–1.46). Mortality rates did not differ to an important degree between patients treated with etanercept, adalimumab, or infliximab.
Anti-TNF-α therapy was not associated with increased mortality among patients with autoimmune diseases.
PMCID: PMC3565563  PMID: 23065964
Rheumatoid arthritis; psoriatic arthritis; psoriasis; Crohn’s Disease; ulcerative colitis; inflammatory bowel disease; pharmacoepidemiology; drug safety; drug toxicity; adverse events; cohort studies; propensity scores; automated healthcare data; mortality
15.  Mini-Sentinel Systematic Evaluation of Health Outcome of Interest Definitions for Studies Using Administrative and Claims Data 
Pharmacoepidemiology and drug safety  2012;21(0 1):10.1002/pds.2313.
To identify and describe the validity of algorithms used to detect heart failure (HF) using administrative and claims data sources.
Systematic review of PubMed and Iowa Drug Information Service (IDIS) searches of the English language were performed to identify studies published between 1990 and 2010 that evaluated the validity of algorithms for the identification of patients with HF using and claims data. Abstracts and articles were reviewed by two study investigators to determine their relevance based on predetermined criteria.
The initial search strategy identified 887 abstracts. Of these, 499 full papers were reviewed and 35 studies included data to evaluate the validity of identifying patients with HF. Positive predictive values (PPVs) were in the acceptable to high range, with most being very high (>90%). Studies that included patients with a primary hospital discharge diagnosis of ICD-9 code 428.X had the highest PPV and specificity for HF. PPVs for this algorithm ranged from 84% - 100%. This algorithm, however, may compromise sensitivity since many HF patients are managed on an outpatient basis. The most common ‘gold standard’ for the validation of HF was the Framingham Heart Study criteria.
The algorithms and definitions employed to identify HF using administrative and claims data perform well, particularly when using a primary hospital discharge diagnosis. Attention should be paid to whether patients who are managed on an outpatient basis are included in the study sample. Including outpatient codes in the described algorithms would increase the sensitivity for identifying new cases of HF.
PMCID: PMC3808171  PMID: 22262599
congestive heart failure; validation; administrative data
16.  Comparative safety of infliximab and etanercept on the risk of serious infections – Does the association vary by patient characteristics? 
Infliximab, a chimeric monoclonal anti-TNFα antibody, has been found to increase the risk of serious infections compared with the TNF receptor fusion protein etanercept in some studies. It is unclear whether the risk varies by patient characteristics. We conducted a study to address this question.
We identified members of Kaiser Permanente Northern California who initiated infliximab (n=793) or etanercept (n=2,692) in 1997–2007. Using a Cox model, we estimated the propensity score-adjusted hazard ratio (HR) and 95% confidence interval (CI) of serious infections requiring hospitalization or opportunistic infections comparing infliximab with etanercept following treatment initiation. We tested whether the adjusted HR differed by age, sex, race/ethnicity, body mass index, and smoking status.
The crude incidence rate of serious infections per 100 person-years was 5.4 (95% CI: 3.8, 7.5) in patients <65 years and 16.0 (10.4, 23.4) in patients ≥65 years during the first three months following treatment initiation. Compared with etanercept, the adjusted HR during this period was elevated for infliximab in patients <65 years (HR 3.01; 95% CI: 1.49, 6.07), but not in those ≥65 years (HR 0.94; 0.41, 2.13). Findings did not suggest that the HR varied by other patient characteristics examined.
An increased risk of serious infections associated with infliximab relative to etanercept did not appear to be modified by patients’ sex, race/ethnicity, body mass index, or smoking status. There was an indication that the increased risk might be limited to patients <65 years. Additional studies are warranted to verify or refute this finding.
PMCID: PMC3330193  PMID: 22411435
Anti-TNF agents; Database; Pharmacoepidemiology; Propensity score; Serious infections
17.  A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack Using Administrative Data 
Pharmacoepidemiology and drug safety  2012;21(Suppl 1):100-128.
To perform a systematic review of the validity of algorithms for identifying cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs) using administrative and claims data.
PubMed and Iowa Drug Information Service (IDIS) searches of the English language literature were performed to identify studies published between 1990 and 2010 that evaluated the validity of algorithms for identifying CVAs (ischemic and hemorrhagic strokes, intracranial hemorrhage and subarachnoid hemorrhage) and/or TIAs in administrative data. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to pre-specified criteria.
A total of 35 articles met the criteria for evaluation. Of these, 26 articles provided data to evaluate the validity of stroke, 7 reported the validity of TIA, 5 reported the validity of intracranial bleeds (intracerebral hemorrhage and subarachnoid hemorrhage), and 10 studies reported the validity of algorithms to identify the composite endpoints of stroke/TIA or cerebrovascular disease. Positive predictive values (PPVs) varied depending on the specific outcomes and algorithms evaluated. Specific algorithms to evaluate the presence of stroke and intracranial bleeds were found to have high PPVs (80% or greater). Algorithms to evaluate TIAs in adult populations were generally found to have PPVs of 70% or greater.
The algorithms and definitions to identify CVAs and TIAs using administrative and claims data differ greatly in the published literature. The choice of the algorithm employed should be determined by the stroke subtype of interest.
PMCID: PMC3412674  PMID: 22262598
cerebrovascular accident; transient ischemic attack; validation; administrative data
18.  Patients’ knowledge and beliefs concerning gout and its treatment: a population based study 
For patients to effectively manage gout, they need to be aware of the impact of diet, alcohol use, and medications on their condition. We sought to examine patients’ knowledge and beliefs concerning gout and its treatment in order to identify barriers to optimal patient self-management.
We identified patients (≥18 years of age) cared for in the setting of a multispecialty group practice with documentation of at least one health care encounter associated with a gout diagnosis during the period 2008–2009 (n = 1346). Patients were sent a questionnaire assessing knowledge with regard to gout, beliefs about prescription medications used to treat gout, and trust in the physician. Administrative electronic health records were used to identify prescription drug use and health care utilization.
Two hundred and forty patients returned surveys out of the 500 contacted for participation. Most were male (80%), white (94%), and aged 65 and older (66%). Only 14 (6%) patients were treated by a rheumatologist. Only a minority of patients were aware of common foods known to trigger gout (e.g., seafood [23%], beef [22%], pork [7%], and beer [43%]). Of those receiving a urate-lowering medication, only 12% were aware of the short-term risks of worsening gout with initiation. These deficits were more common in those with active as compared to inactive gout.
Knowledge deficits about dietary triggers and chronic medications were common, but worse in those with active gout. More attention is needed on patient education on gout and self-management training.
PMCID: PMC3517442  PMID: 22995041
Beliefs; Treatment; Gout; Dietary influence; Physician-patient communication
19.  Adherence and Occurrence of Fractures after Switching to Once-Monthly Oral Bisphophonates 
Pharmacoepidemiology and drug safety  2010;19(12):1233-1240.
Reducing dosing demands of medications generally increases adherence, although this relationship has not been demonstrated with the once-monthly oral bisphosphonates (BP). The study aim is to test whether switching from once-weekly BPs to once-monthly BPs improves adherence and fracture risk.
This is an interrupted times-series analysis of new users of once-weekly BPs in a nationwide administrative health database from 2003–2007. Participants include 1835 individuals who switched to once-monthly BPs and two propensity-matched comparator groups: 1835 individuals who switched to a different once-weekly BP, and 1835 who did not switch. We measured changes in adequate adherence pre- and post-switch as monthly medication possession ratio >0.80, and calculated incidence rate ratios [IRR] of osteoporotic fractures.
All study groups experienced major adherence failure in the first year of therapy: the proportion of adequate adherers was 42% among once-monthly switchers, 47% among once-weekly switchers, and 37% among nonswitchers. However, the once-monthly switch was associated with less adherence failure (4% fewer adherers per month pre-switch vs. 1% fewer adherers per month post-switch, p<.000). There was no statistically significant change in adherence rates for the other groups. We did not detect significantly reduced fracture risk with once-monthly switch: 1 year post-switch, the fracture incidence risk ratios for once-monthly switchers relative to once-weekly switchers were IRR 0.83, 95% CI: 0.50–1.36, and IRR 0.90, 95% CI: 0.54–1.49, relative to nonswitchers).
Reducing the dosing demands of oral bisphosphonates from once-weekly to once-monthly decreased adherence failure but had an uncertain impact on fracture risk.
PMCID: PMC3079953  PMID: 21108489
patient compliance; bisphosphonates; osteoporosis; osteoporotic fractures; medication adherence
20.  Adoption of Once-monthly Oral Bisphosphonates and the Impact on Adherence 
The American journal of medicine  2010;123(3):275-280.
The extent of the adoption of once-monthly bisphosphonates into general clinical practice is not known, nor is it known if the novel formulation improves adherence.
We analyzed administrative claims 2003-2006 from a large employer-based health insurance database for incident use of oral bisphosphonates and stratified users by daily, weekly and monthly dosing regimen. We measured adherence as the medication possession ratio (MPR) during the first year of therapy. We compared patient characteristics by dosing regimen and evaluated how the dosing regimen influenced the MPR.
We identified 61,125 incident users of bisphosphonates (n=1034 daily, n=56,925 weekly, n=3166 monthly). Monthly bisphosphonate users were, on average, slightly older than the other groups (mean age 66 years monthly vs. 65 weekly or 66 daily, p<.05.) and more often lived in the U.S. North Central or South (76% vs. 72% weekly or 69% daily users, p<.05). There were no detectable differences among the dosing groups in the history of serious GI risk, comorbidity burden, or prior osteoporotic fractures. During the first year of bisphosphonate therapy, 49% of monthly users had MPR ≥80% compared to 49% weekly users (N.S.) or 23% daily users (p<.0001).
We found little evidence of preferential prescribing of monthly bisphosphonates to certain types of patients. Furthermore, we found no evidence of improved bisphosphonate adherence with monthly dosing relative to weekly dosing, although adherence with either weekly or monthly dosing was significantly better than with daily dosing.
PMCID: PMC2831769  PMID: 20193837
patient compliance; bisphosphonates; novel formulation
21.  Physician Preference Motivates Use of Anti-TNF Therapy Independent of Clinical Disease Activity 
Arthritis care & research  2010;62(1):101-107.
Physician preference has been previously shown to be an important determinant of prescription patterns, independent of patient-specific factors. We evaluated whether physician preference was important in the decision to select anti-TNF therapy rather than non-biologic disease modifying anti-rheumatic drugs (DMARDS) among rheumatoid arthritis (RA) patients initiating a new RA medication.
Using data from the Consortium of Rheumatology Researchers of North America (CORRONA), we identified biologic-naïve RA patients initiating either anti-TNF therapy or a DMARD in 2001–2008. Physician preference for use of anti-TNF agents was calculated using data from the preceding calendar year for each physician’s other RA patients. Multivariable logistic regression with generalized estimated equations accounted for clustering of patients within physician practice and evaluated the relationship between physician preference and receipt of anti-TNF therapy, controlling for patient-related factors and disease activity using the Clinical Disease Activity Index (CDAI).
We identified 1,532 RA patients initiating anti-TNF therapy or a DMARD. In models adjusting for tender and swollen joint counts and global disease activity, physician preference for use of anti-TNF therapy was an independent predictor of receipt of these agents. Patients of physicians in the highest and middle tertiles of physician preference had a 2.50 (95% CI 1.76 – 3.56) and 1.70 (1.22 – 2.39) greater likelihood to receive anti-TNF medications, respectively.
Physician preference is an important determinant of patients’ receipt of anti-TNF therapy and may be useful to examine in future studies of RA treatment patterns, costs, and medication safety.
PMCID: PMC2913388  PMID: 20191497
rheumatoid arthritis; tumor necrosis factor; disease modifying anti-rheumatic drugs (DMARDs); physician preference; instrumental variable; channeling
22.  Evaluation of composite measures of treatment response without acute-phase reactants in patients with rheumatoid arthritis 
Rheumatology (Oxford, England)  2009;48(6):686-690.
Objectives. To evaluate composite measures of response without acute-phase reactants in RA patients. Specifically, Clinical Disease Activity Index (CDAI)-derived response criteria were compared with the European League Against Rheumatism (EULAR) response criteria, and the modified ACR (mACR) response criteria were compared to the ACR response criteria.
Methods. Data from 10 108 RA patients enrolled in the Consortium of Rheumatology Researchers of North America registry were examined, including 649 patients initiating DMARD therapy. CDAI cut-off points for disease activity levels and responses were derived using receiver operating characteristic curves with the DAS28 and EULAR response criteria as gold standards. The κ-statistics were applied to assess agreement between CDAI-derived and EULAR-defined responses, as well as ACR20 and ACR50 with mACR20- and mACR50-defined responses, respectively.
Results. For the components of the EULAR response, the derived CDAI cut-off points for DAS28 levels of 3.2 and 5.1 were 7.6 and 19.6, respectively. The derived CDAI cut-off points were 4.3 and 10.0 for DAS28 changes of 0.6 and 1.2, respectively. There were moderate to substantial agreements between CDAI-derived and EULAR responses (κ = 0.57–0.71). Agreement of ACR20 and ACR50 with mACR20 and mACR50 responses, respectively, was excellent (κ = 0.88–0.95).
Conclusions. Agreement between composite measures of response without acute-phase reactants and standard measures ranged from moderate to excellent. The mACR20 and mACR50 criteria as well as CDAI-derived response criteria, can serve as composite measures of response in clinical practice and research settings without access to acute-phase reactants.
PMCID: PMC2722796  PMID: 19395544
Rheumatoid arthritis; Acute-phase reactants; Response criteria
23.  Adherence with urate-lowering therapies for the treatment of gout 
Adherence to urate-lowering drugs (ULDs) has not been well evaluated among those with gout. Our aim was to assess the level and determinants of non-adherence with ULDs prescribed for gout.
We identified persons using two integrated delivery systems aged 18 years or older with a diagnosis of gout who initiated use of allopurinol, probenecid or sulfinpyrazone from 1 January 2000 to 30 June 2006. Non-adherence was measured using the medication possession ratio (MPR) over the first year of therapy and defined as an MPR < 0.8. Descriptive statistics were calculated and logistic regression was used to estimate the strength of the association between patient characteristics and non-adherence.
A total of 4,166 gout patients initiated ULDs; 97% received allopurinol. Median MPR for any ULD use was 0.68 (interquartile range (IQR) 0.64). Over half of the patients (56%) were non-adherent (MPR < 0.8). In adjusted analyses, predictors of poor adherence included younger age (odds ratio (OR) 2.43, 95% confidence interval (CI) 1.86 to 3.18 for ages <45 and OR 1.44, 95% CI 1.08 to 1.93 for ages 45 to 49), fewer comorbid conditions (OR 1.46, 95% CI 1.20 to 1.77), no provider visits for gout prior to urate-lowering drug initiation (OR 1.28, 95% CI 1.05 to 1.55), and use of non-steroidal anti-inflammatory drugs in the year prior to urate-lowering drug initiation (OR 1.15, 95% CI 1.00 to 1.31).
Non-adherence amongst gout patients initiating ULDs is exceedingly common, particularly in younger patients with less comorbidity and no provider visits for gout prior to ULD initiation. Providers should be aware of the magnitude of non-adherence with ULDs.
PMCID: PMC2688196  PMID: 19327147
24.  Strategies for Detecting Adverse Drug Events among Older Persons in the Ambulatory Setting 
Objective: To examine various strategies for the identification of adverse drug events (ADEs) among older persons in the ambulatory clinical setting.
Design: A cohort study of Medicare enrollees (n = 31,757 per month) receiving medical care from a large multispecialty group practice during a 12-month observation period (July 1, 1999 through June 30, 2000).
Measurements: Possible drug-related incidents occurring in the ambulatory clinical setting were detected using signals from multiple sources.
Results: During the tracking period, there were 1,523 identified ADEs, of which 421 (28%) were considered preventable. Across all sources, 23,917 signals were found; 12,791 (53%) were potential incidents that led to review of a patient's medical record and 2,266 (9%) were presented to physician reviewers. Although the positive predictive value (PPV) for reports from providers was high compared with other sources (54%), only 11% of the ADEs and 6% of the preventable ADEs were identified through this source. PPVs for other sources ranged from a low of 4% for administrative incident reports to a high of 12% for free-text review of electronic notes. Computer-generated signals were the source for 31% of the ADEs and 37% of the preventable ADEs. Electronic notes were the source for 39% of the ADEs and 29% of the preventable ADEs. There was little overlap in the ADEs identified across all sources.
Conclusion: Our findings emphasize the limitations of voluntary reporting by health care providers as the principal means for detection of ADEs and suggest that multiple strategies are required to detect ADEs in geriatric ambulatory patients.
PMCID: PMC524629  PMID: 15299000
25.  Narrowing Gender Differences in Procedure Use for Acute Myocardial Infarction 
To examine age-specific gender differences and trends over time in the management of patients with acute myocardial infarction (AMI).
Cross-sectional study of patients admitted with AMI from a community-wide perspective over a 10-year period (1990–1999).
All hospitals in the Worcester (Mass) metropolitan area (1990 census = 437,000).
We identified 2,037 women and 2,645 men who were hospitalized in the Worcester metropolitan area with confirmed AMI during six 1-year periods between 1990 and 1999. Four age groups (<55, 55 to 64, 65 to 74 and ≥75 years) of men and women were studied.
Use of echocardiography, exercise treadmill testing (ETT), cardiac catheterization, percutaneous coronary interventions (PCI), and coronary artery bypass grafting (CABG) during the index hospitalization was examined in relation to age and gender. Overall, women were less likely to undergo ETT, cardiac catheterization, and CABG than were men, and these trends remained after controlling for potentially confounding factors. Between 1990 and 1999, there was a dramatic decrease in ETT, whereas the use of echocardiography remained unchanged. There were marked increases over time in the use of cardiac catheterization and PCI in women and men. Use of cardiac catheterization and PCI increased to a greater extent in women as compared to men. In patients who underwent cardiac catheterization, rates of coronary revascularization were similar between men and women.
Our data suggest that women and men with AMI are treated differently with respect to use of diagnostic and revascularization procedures. However, gender differences in the use of these diagnostic and interventional approaches have narrowed over time.
PMCID: PMC1494881  PMID: 12823649
myocardial infarction; gender differences; procedures

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