Predictors of treatment initiation with tumor necrosis factor-α inhibitors in patients with rheumatoid arthritis.

BACKGROUND: Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has revolutionized treatment in patients with rheumatoid arthritis (RA). However, due to substantially higher costs of biologics compared with nonbiologics, patients with less insurance generosity may have difficulty affording these agents, which may lead to potential access disparities. OBJECTIVE: To identify factors affecting treatment initiation with tumor necrosis factor (TNF)-α inhibitor biologics in patients with RA. METHODS: Health insurance claims data derived from Truven's MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits (2007-2010) were used to conduct a retrospective cohort study. Two separate cohorts of RA patients were identified: (1) monotherapy nonbiologic DMARD users and (2) combination therapy nonbiologic DMARD users. The primary outcome was TNF-α inhibitor initiation 12 months following an index inpatient or outpatient RA visit during 2008-2009. Predictors were measured 12 months pre-index and grouped into predisposing, enabling, or need factors based on Andersen's Behavior Model. Predisposing variables included age, sex, and geographic location; enabling variables included insurance-related factors such as capitation, payer type, and insurance generosity, which was defined using cost-sharing information from prescriptions filled by the patients in the previous year; and need variables included disease-related factors such as severity of RA, use of pain control medications, and presence of other comorbidities. Hierarchical logistic regression models were used to derive estimates of the impact of individual predictors. RESULTS: Initiation of TNF-α inhibitors was observed in 10.31% of the monotherapy nonbiologic DMARD users (1,922 of 18,641) and 13.09% of combination nonbiologic DMARD users (983 of 7,508). Among monotherapy nonbiologic DMARD users, initiation with TNF-α inhibitors was associated with the predisposing factors of age (OR = 0.98, 95% CI = 0.97-0.98 for each year increase) and geographic region (Midwest vs. South OR = 0.83, 95% CI = 0.73-0.93; Northeast vs. South OR = 0.77, 95% CI = 0.64-0.92; and West vs. South OR = 0.86, 95% CI = 0.74-0.99); enabling factors of visit to rheumatologists (1 visit vs. no visit OR = 1.22, 95% CI = 1.01-1.46), health insurance type (commercial vs. Medicare supplemental OR = 0.79, 95% CI = 0.66-0.95), and drug benefit generosity (above average vs. poor OR = 1.16, 95% CI = 1.01-1.34 and most generous vs. poor OR = 1.21, 95% CI = 1.05-1.40); and need factors of RA severity (OR = 1.19, 95% CI = 1.14-1.23 for each unit increase in a claims-based RA severity index [CIRAS]), pre-index pain reliever use (steroids OR = 1.81, 95% CI = 1.62-2.02; nonselective nonsteroidal anti-inflammatory drugs [NSAID] OR = 1.17, 95% CI = 1.05-1.31; COX-2 inhibitors OR = 1.22, 95% CI = 1.05-1.41), and comorbidities (OR = 0.94, 95% CI = 0.90-0.99 for each unit increase in a comorbidity index). Treatment initiation with TNF-α inhibitors among patients with combination therapy nonbiologic DMARDs use at baseline was associated with age (OR = 0.98, 95% CI = 0.97-0.99 for each year increase) and region (Midwest vs. South OR = 0.81, 95% CI = 0.68-0.96). Stronger associations with some of the need factors were observed (CIRAS OR = 1.28, 95% CI = 1.21-1.35 for each unit increase, steroids use OR = 2.05, 95% CI = 1.73-2.42, and nonselective NSAID use OR = 1.36, 95% CI = 1.17-1.58) in these patients compared with the monotherapy nonbiologic DMARD users. However, unlike the monotherapy DMARD user group, the enabling factors of health insurance type and drug benefit generosity were not found to be associated with TNF-α inhibitor initiation among nonbiologic DMARD combination therapy users. CONCLUSIONS: Potential disparities in the initiation of TNF-α inhibitors among RA patients on monotherapy DMARDs at baseline were noted among older patients, patients in certain geographic region of the United States, and patients with less generous prescription drug benefits. Although future research should examine the impact of these disparities on health outcomes, payers should be aware of the potential for undertreatment among these groups of RA patients when making formulary decisions.

Tumor necrosis factor-α inhibitor treatment and the risk of incident cardiovascular events in patients with early rheumatoid arthritis: a nested case-control study.

OBJECTIVE: To compare the risk of cardiovascular (CV) events between use of tumor necrosis factor-α inhibitors (TNFi) and nonbiologic disease-modifying antirheumatic drugs (DMARD) in patients with early rheumatoid arthritis (RA). METHODS: A nested case-control study was conducted using data from Truven's MarketScan commercial and Medicare claims database for patients with early RA who started treatment with either a TNFi or a nonbiologic DMARD between January 1, 2008, and December 31, 2010. Date of CV event diagnosis for cases was defined as the event date, and 12 age-matched and sex-matched controls were sampled using incidence density sampling. Drug exposure was defined into the following mutually exclusive categories hierarchically: (1) current use of TNFi (with or without nonbiologics), (2) past use of TNFi (with or without nonbiologics), (3) current use of nonbiologics only, and (4) past use of nonbiologics only. Current use was defined as any use in the period 90 days prior to the event date. Conditional logistic regression models were used to derive incidence rate ratios (IRR). RESULTS: From the cohort of patients with early RA, 279 cases of incident CV events and 3348 matched controls were identified. The adjusted risk of CV events was not significantly different between current TNFi users and current nonbiologic users (IRR 0.92, 95% CI 0.59-1.44). However, past users of nonbiologics showed significantly higher risk compared to current nonbiologic users (IRR 1.47, 95% CI 1.04-2.08). CONCLUSION: No differences in the CV risk were found between current TNFi and current nonbiologic DMARD treatment in patients with early RA.

Discussions between medical providers and children/caregivers about the benefits of asthma-control medications.

OBJECTIVES: To describe the content of discussions between general pediatric providers and children and their caregivers about the benefits of asthma-control medication; describe the extent to which these discussions occur; and examine factors that are associated with medication benefit discussions. DESIGN: Cross-sectional secondary analysis of audiotaped medical visits. SETTING: Five primary care pediatric clinics in North Carolina. PARTICIPANTS: 35 pediatric providers and 248 children with persistent asthma and their caregivers. MAIN OUTCOME MEASURES: Presence of discussion about benefits associated with asthma-control medications. RESULTS: Providers discussed benefits associated with asthma-control medications during 56% of medical visits. Benefits were more likely to be discussed when the child was younger and when medication adherence was discussed during the visit. When providers discussed benefits of asthma-control medications, they were most likely to ask questions and make statements regarding symptom control/prevention. CONCLUSION: General pediatric medical providers often do not discuss the benefits of asthma-control medications. Pharmacists could fill this information gap by counseling both children and their caregivers about benefits that a child with asthma can expect as a result of treatment.

Examining the relationship between adjunctive psychotherapy use and antipsychotic persistence and hospitalization.

This study assessed whether the addition of adjunctive psychotherapy to antipsychotic pharmacotherapy improved antipsychotic persistence and reduced the risk of hospitalization among patients with schizophrenia using 2001-2003 Medicaid claims data from four states: Illinois, Kansas, Minnesota, and North Carolina. New antipsychotic users aged 18 or older were included. Our study showed that adjunctive psychotherapy use was associated with increased antipsychotic persistence during the first two months of treatment but was not associated with risk of hospitalization. Further research is needed to understand how to optimize the benefits of psychotherapy in terms of frequency of appointments, duration, and type.

Completion of advance directives among U.S. consumers.

BACKGROUND: Current, ongoing national surveys do not include questions about end-of-life (EOL) issues. In particular, population-based data are lacking regarding the factors associated with advance directive completion. PURPOSE: To characterize U.S. adults who did and did not have an advance directive and examine factors associated with their completion, such as the presence of a chronic condition and regular source of health care. METHODS: Data were analyzed in 2013 from adults aged 18 years and older who participated in the 2009 or 2010 HealthStyles Survey, a mail panel survey designed to be representative of the U.S. population. Likelihood ratio tests were used to examine the associations between advance directive completion and demographic and socioeconomic variables (education, income, employment status); presence of a chronic condition; regular source of health care; and self-reported EOL concerns or discussions. Multiple logistic regression analyses identified independent predictors related to advance directive completion. RESULTS: Of the 7946 respondents, 26.3% had an advance directive. The most frequently reported reason for not having one was lack of awareness. Advance directive completion was associated with older age, more education, and higher income and was less frequent among non-white respondents. Respondents with advance directives also were more likely to report having a chronic disease and a regular source of care. Advance directives were less frequent among those who reported not knowing if they had an EOL concern. CONCLUSIONS: These data indicate racial and educational disparities in advance directive completion and highlight the need for education about their role in facilitating EOL decisions.

Provider-caregiver-child discussions about risks associated with asthma control medications: content and prevalence.

OBJECTIVES: The objectives of this study were to: (1) describe the extent to which general pediatric providers discuss risks associated with asthma control medications with families, and (2) examine factors that are associated with risk discussions. STUDY DESIGN: This study was a cross-sectional secondary analysis of audio taped medical visits involving 35 pediatric providers and 248 children with asthma with their caregivers. Transcripts of the visits were coded for discussions about asthma medication risks. Generalized estimating equations were used to analyze the data. RESULTS: Providers discussed asthma control medication risks during 23% of visits. Risks were more likely to be discussed when the visit was longer and when the provider prescribed a new asthma control medication. When providers discussed asthma control medication risks, they were most likely to ask the family general questions and make general statements. Across all of the visits, caregivers asked a total of 16 questions and made a total of 20 statements about risks associated with asthma medications; children asked a total of 3 questions and made two statements about risks associated with asthma control medications. CONCLUSION: Providers discussed risks associated with asthma control medications in less than one-quarter of medical visits. Providers should involve families in discussions about risks associated with medications during every visit to assess potential barriers to medication adherence.

Examining external validity in efficacy and secondary articles of home-based depression care management interventions for older adults.

INTRODUCTION: Information on external validity enables public health practitioners to generalize conclusions about an intervention to future or different conditions and is critical to moving research into practice. Prior reviews examining external validity focused on efficacy publications only. Our objective was to determine the extent to which secondary articles could enhance information about external validity presented in efficacy studies. METHODS: We identified a group of interventions recommended by the Guide to Community Preventive Services for home-based depression care management for older adults. We searched online databases for secondary articles using a list of the study authors' names and study acronyms. Five articles were ineligible (intervention was not effective or articles lacked data on external validity) and 14 articles were eligible and reviewed (6 efficacy and 8 secondary articles). We examined 15 elements of external validity based on 4 of the 5 dimensions of the RE-AIM framework: reach, adoption, implementation, and maintenance. RESULTS: The 6 efficacy studies documented 1 or more elements of reach and implementation, and 5 studies included 1 or more elements of maintenance. Secondary articles included 4 to 9 elements on external validity and addressed 1 to 5 unique elements of external validity not reported in the efficacy publications. CONCLUSION: Secondary articles enrich the amount of information about external validity and may be published years before or after the efficacy publication. Reviewing only primary publications of efficacy trials may provide a limited view of external validity, at least for publications describing home-based depression care management.

Mixed treatment comparison of the treatment discontinuations of biologic disease-modifying antirheumatic drugs in adults with rheumatoid arthritis.

BACKGROUND: Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has considerably changed treatment options for rheumatoid arthritis (RA) over the past decade. Very little information is available on comparative discontinuation rates of the biologics. OBJECTIVE: To compare treatment discontinuations for 9 biologic DMARDs in adults with RA. METHODS: We searched electronic databases through May 2012 to retrieve randomized controlled trials (RCTs) of patients with RA that compared biologic DMARDs with placebo or another biologic DMARD. The primary outcome was treatment discontinuation during the blinded phase of the trials, measured as overall withdrawals, withdrawals resulting from lack of efficacy, and withdrawals resulting from adverse events. Random-effects meta-analysis estimated the effect size for individual agents, and adjusted indirect comparisons were made between biologics using mixed treatment comparisons (MTC) meta-analysis. RESULTS: Forty-four trials were included in the analysis. In comparison with placebo, biologics were less likely to be withdrawn because of lack of efficacy (OR 0.22, 95% CI 0.17 to 0.27) and more likely to be withdrawn because of an adverse event (OR 1.41, 95% CI 1.16 to 1.70). Based on the MTC, certolizumab had the most favorable overall withdrawal profile, followed by etanercept and rituximab. Certolizumab had lower relative withdrawal rates resulting from lack of efficacy than adalimumab, anakinra, and infliximab. Anakinra had higher relative withdrawal rates resulting from lack of efficacy than most other biologics. Certolizumab and infliximab had more, while etanercept had fewer, withdrawals because of adverse events than most other drugs. CONCLUSIONS: Based on MTC using data from RCTs, differences in discontinuation rates were observed, generally favoring certolizumab, etanercept, and rituximab over other biologic DMARDs. These potential differences need to be further explored in head-to-head trials or well-conducted observational studies.

Understanding pharmacists' experiences with advice-giving in the community pharmacy setting: a focus group study.

OBJECTIVE: To examine the experiences of community pharmacists providing advice about symptoms and complementary and alternative medicines (CAM). METHODS: Ten licensed pharmacists and 21 student pharmacists working in community settings participated in 4 focus groups to discuss: patients' questions about symptoms and CAM, comfort level providing advice, and factors prompting physician referrals. Focus group recordings were transcribed verbatim and interpreted using thematic text analysis. RESULTS: Pharmacists' dual role as advisors and medical liaisons emerged as primary themes. Participants reported that patients often seek their advice about self-care of symptoms to delay physician visits. Participants were comfortable giving advice; lack of medical history decreased their comfort level. Most were uncomfortable recommending CAM because of the lack of regulation and evidence. Participants suggested that pharmacy curricula expand training on symptom triage, pharmacist-patient communication, and CAM to prepare graduates for employment in community settings. CONCLUSION: Student and licensed pharmacists of this study voiced that they are often asked for advice on symptom management, but reported needing training to help provide appropriate advice to patients. PRACTICE IMPLICATIONS: The findings suggest that training strategies could help pharmacists appropriately triage and advise patients seeking self-care advice for their symptoms in the community setting.

The quality of care for adults with epilepsy: an initial glimpse using the QUIET measure.

BACKGROUND: We examined the quality of adult epilepsy care using the Quality Indicators in Epilepsy Treatment (QUIET) measure, and variations in quality based on the source of epilepsy care. METHODS: We identified 311 individuals with epilepsy diagnosis between 2004 and 2007 in a tertiary medical center in New England. We abstracted medical charts to identify the extent to which participants received quality indicator (QI) concordant care for individual QI's and the proportion of recommended care processes completed for different aspects of epilepsy care over a two year period. Finally, we compared the proportion of recommended care processes completed for those receiving care only in primary care, neurology clinics, or care shared between primary care and neurology providers. RESULTS: The mean proportion of concordant care by indicator was 55.6 (standard deviation = 31.5). Of the 1985 possible care processes, 877 (44.2%) were performed; care specific to women had the lowest concordance (37% vs. 42% [first seizure evaluation], 44% [initial epilepsy treatment], 45% [chronic care]). Individuals receiving shared care had more aspects of QI concordant care performed than did those receiving neurology care for initial treatment (53% vs. 43%; X(2) = 9.0; p = 0.01) and chronic epilepsy care (55% vs. 42%; X(2) = 30.2; p < 0.001). CONCLUSIONS: Similar to most other chronic diseases, less than half of recommended care processes were performed. Further investigation is needed to understand whether a shared-care model enhances quality of care, and if so, how it leads to improvements in quality.

Engaging communication experts in a Delphi process to identify patient behaviors that could enhance communication in medical encounters.

BACKGROUND: The communication literature currently focuses primarily on improving physicians' verbal and non-verbal behaviors during the medical interview. The Four Habits Model is a teaching and research framework for physician communication that is based on evidence linking specific communication behaviors with processes and outcomes of care. The Model conceptualizes basic communication tasks as "Habits" and describes the sequence of physician communication behaviors during the clinical encounter associated with improved outcomes. Using the Four Habits Model as a starting point, we asked communication experts to identify the verbal communication behaviors of patients that are important in outpatient encounters. METHODS: We conducted a 4-round Delphi process with 17 international experts in communication research, medical education, and health care delivery. All rounds were conducted via the internet. In round 1, experts reviewed a list of proposed patient verbal communication behaviors within the Four Habits Model framework. The proposed patient verbal communication behaviors were identified based on a review of the communication literature. The experts could: approve the proposed list; add new behaviors; or modify behaviors. In rounds 2, 3, and 4, they rated each behavior for its fit (agree or disagree) with a particular habit. After each round, we calculated the percent agreement for each behavior and provided these data in the next round. Behaviors receiving more than 70% of experts' votes (either agree or disagree) were considered as achieving consensus. RESULTS: Of the 14 originally-proposed patient verbal communication behaviors, the experts modified all but 2, and they added 20 behaviors to the Model in round 1. In round 2, they were presented with 59 behaviors and 14 options to remove specific behaviors for rating. After 3 rounds of rating, the experts retained 22 behaviors. This set included behaviors such as asking questions, expressing preferences, and summarizing information. CONCLUSION: The process identified communication tasks and verbal communication behaviors for patients similar to those outlined for physicians in the Four Habits Model. This represents an important step in building a single model that can be applied to teaching patients and physicians the communication skills associated with improved satisfaction and positive outcomes of care.

Recommendations of community pharmacists and health food store employees regarding undiagnosed symptoms of diabetes.

BACKGROUND: Consumers may seek health advice from health food store employees (HFSEs) and pharmacists. Delays in the diagnosis of time-critical illnesses may increase the likelihood of morbidity, mortality and healthcare expenditures. OBJECTIVE: To describe the information provided by HFSEs and pharmacists for symptoms of undiagnosed Type 1 diabetes. DESIGN: A standardized actor portrayed a consumer with symptoms of Type 1 diabetes at eight community pharmacies and 12 health food stores (HFSs) in Pittsburgh, Pennsylvania, and Chapel Hill and Durham, North Carolina. He inquired about potential diagnoses, the need to see a physician, and product recommendations. SUBJECTS: The subjects included twelve HFSEs and eight licensed pharmacists. RESULTS: Four of eight (50%) pharmacists and two of 12 (17%) HFSEs mentioned diabetes as a potential diagnosis. Although six pharmacists recommended urgent physician follow-up, only two HFSEs did so; two HFSEs explicitly advised against a physician visit. One pharmacist recommended a product. Nine HFSEs recommended at least one product (monthly costs, range: $24.70-$209.96). CONCLUSIONS: Even when presented with classic symptoms of Type 1 diabetes, under-recognition of diabetes was common among HFSEs and community pharmacists. Delays in treatment present a health risk to consumers. Further research could confirm these results and inform educational interventions to improve diabetes recognition by both groups.

Novel approach, using end-of-life issues, for identifying items for public health surveillance.

Using end-of-life (EOL) issues to provide context, we introduce a novel approach to identify potential items for public health surveillance. Our method involved an environmental scan of existing EOL surveys and included the following steps: 1) consulting experts for advice on critical EOL topics, 2) identifying a broad sample of EOL surveys, and 3) using an abstraction tool to characterize surveys and survey items. We identified 36 EOL surveys; of these, 10 were state-based surveys. Of the 1,495 EOL items (range, 4 to 126 items per survey), 333 items could be classified in 1 of 11 topic areas of interest. Information on the surveys and these 333 items was entered into a database. As a result of this process, we identified topics for which many EOL items already exist and topics for which items should be developed. We describe the value of this approach and potential next steps for our project.

Improving methods for measuring quality of care: a patient-centered approach in chronic disease.

As health care systems seek to provide patient-centered care as a cornerstone of quality, how to measure this aspect of quality has become a concern. Previous development of quality indicators for treating individual chronic disease has rarely included patient perspectives on quality of care. Using epilepsy as an exemplar, the authors sought to develop an approach to measuring patient-centered quality of care. They conducted six focus groups with adults with epilepsy. Using qualitative methods, the authors initially identified 10 patient-generated quality indicators, 5 of which were subsequently rated, along with literature-based quality indicators, by an expert panel using a modified RAND appropriateness methodology. The authors discuss similarities and differences in aspects of care patients and providers value as essential for good quality. The process presented in this article may serve as a model for incorporating patient perceptions of quality into the future development of quality indicators for chronic diseases.

Practice parameter: Assessing patients in a neurology practice for risk of falls (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology.

OBJECTIVE: To develop a practice parameter for screening methods and assessments of risk for falls pertaining to patients likely to be seen in neurology practices. METHODS: Relevant literature was systematically reviewed and strength of evidence classified based on the American Academy of Neurology's criteria (Level A: established; Level B: probable; Level C: possible). RESULTS: An increased risk of falls is established among persons with diagnoses of stroke, dementia, and disorders of gait and balance (Level A) and probable among patients with Parkinson disease, peripheral neuropathy, lower extremity weakness or sensory loss, and substantial vision loss (Level B). A history of falling in the past year strongly predicts the likelihood of future falls (Level A). Screening measures have been developed to further assess risks of falls, including functional assessments that may be useful (Levels B and C). Several of these assess overlapping neurologic functions--i.e., gait, mobility, and balance--and there is insufficient evidence to assess whether they offer benefit beyond that provided by a standard neurologic examination. CONCLUSIONS: Patients with neurologic or general conditions associated with an increased risk of falling should be asked about recent falls and further examined for the presence of specific neurologic deficits that predict falls, which include gait and balance disorders; deficits of lower extremity strength, sensation, and coordination; and cognitive impairments. If substantial risks of falls are identified, appropriate interventions that are described in other evidence-based guidelines may be considered.