Purpose

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.

Methods

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.

Results

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.

Conclusions

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.

Objective

We sought to examine patients’ and providers’ views on the treatment of gout to better understand why management is suboptimal.

Methods

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.

Results

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.

Conclusions

Providers view gout as easily managed while patients report challenges and purposeful nonadherence.

Purpose

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.

Methods

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.

Results

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.

Conclusions

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.

Objective

To identify gaps in therapy with urate-lowering drugs for the treatment of gout as well as factors associated with resuming therapy.

Methods

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.

Results

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.

Conclusions

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.

Objective

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.

Methods

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.

Results

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%).

Conclusions

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.

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Purpose

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.

Methods

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.

Results

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).

Conclusions

Reducing the dosing demands of oral bisphosphonates from once-weekly to once-monthly decreased adherence failure but had an uncertain impact on fracture risk.

Background

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.

Methods

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.

Results

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).

Conclusions

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.

Introduction

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.

Methods

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).

Results

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.

Conclusion

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.

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.

Introduction

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.

Methods

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.

Results

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).

Conclusions

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.

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.

OBJECTIVE

To examine age-specific gender differences and trends over time in the management of patients with acute myocardial infarction (AMI).

DESIGN

Cross-sectional study of patients admitted with AMI from a community-wide perspective over a 10-year period (1990–1999).

SETTING

All hospitals in the Worcester (Mass) metropolitan area (1990 census = 437,000).

PATIENTS/PARTICIPANTS

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.

MEASUREMENTS AND MAIN RESULTS

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.

CONCLUSIONS

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.

OBJECTIVE

To critically evaluate the differences between generalist physicians and specialists in terms of knowledge, patterns of care, and clinical outcomes of care.

METHODS

English-language articles (January 1981 to January 1998) were identified through a Medlinesearch and examination of bibliographies of identified articles. Systematic evaluation of articles relevant to adult medicine that had a direct comparison between generalist physicians and specialists in terms of knowledge relative to widely accepted standards of care, patterns of care (including use of medications, ancillary services, procedures, and resource utilization), and outcomes of care was performed.

MAIN RESULTS

In many survey studies, specialists were reported to be more knowledgeable about conditions encompassed within their specialty. In terms of overall practice patterns, specialists practicing in their area of expertise were more likely to use medications associated with improved survival and to comply with routine health maintenance screening guidelines; they used more resources including diagnostic tests, procedures, and longer hospital stays. In the limited number of studies examining the care of patients with acute myocardial infarction, acute nonhemorrhagic stroke, and asthma, specialists had superior outcomes compared with generalists.

CONCLUSIONS

There is evidence in the literature suggesting differences between specialists and generalists in terms of knowledge, patterns of care, and clinical outcomes of care for a broad range of diseases. In published studies, specialists were generally more knowledgeable about their area of expertise and quicker to adopt new and effective treatments than generalists. More research is needed to examine whether these patterns of care translate into superior outcomes for patients. Further work is also needed to delineate the components of care for which generalists and specialists should be responsible, in order to provide the highest quality of care to patients while most effectively utilizing existing physician manpower.