Exploring the feasibility of using very short answer questions (VSAQs) in team-based learning (TBL).

BACKGROUND: Team-based learning (TBL) currently relies on single best answer questions (SBAQs) to provide immediate feedback. Very short answer questions (VSAQs) are a reliable and discriminatory alternative that encourage learners to use more authentic clinical reasoning strategies compared to SBAQs. However, the challenge of marking VSAQs has limited their integration into TBL; we therefore explored the feasibility of VSAQs within a TBL session. METHODS: An online platform was developed to allow immediate marking of VSAQs during the TBL sessions. As part of the readiness assurance process, students completed VSAQs and SBAQs, which were marked in real time. RESULTS: Instructors were able to mark all VSAQs during the individual readiness assurance test (iRAT), which facilitated the provision of immediate feedback during the team readiness assurance test (tRAT). The mean time to mark five VSAQs was 422 seconds (SD 73 seconds). For VSAQs, the number of attempts to reach the correct answer ranged from 1 to 38, compared to 1 to 4 for SBAQs. In total, 71.6% of students agreed that using VSAQs in TBL helped to emphasise group discussions. DISCUSSION: The wide range of attempts at, and students' perspectives of VSAQs are suggestive of their positive impact on student discussion during TBL. We demonstrate how new technology allows VSAQs to be feasibly integrated into TBL with the potential to enrich group discussions.

Performance assessment: Consensus statement and recommendations from the 2020 Ottawa Conference.

INTRODUCTION: In 2011 the Consensus Statement on Performance Assessment was published in Medical Teacher. That paper was commissioned by AMEE (Association for Medical Education in Europe) as part of the series of Consensus Statements following the 2010 Ottawa Conference. In 2019, it was recommended that a working group be reconvened to review and consider developments in performance assessment since the 2011 publication. METHODS: Following review of the original recommendations in the 2011 paper and shifts in the field across the past 10 years, the group identified areas of consensus and yet to be resolved issues for performance assessment. RESULTS AND DISCUSSION: This paper addresses developments in performance assessment since 2011, reiterates relevant aspects of the 2011 paper, and summarises contemporary best practice recommendations for OSCEs and WBAs, fit-for-purpose methods for performance assessment in the health professions.

Managing the COVID-19 risk: the practicalities of delivering high stakes OSCEs during a pandemic.

This article was migrated. The article was marked as recommended. The impact of the COVID-19 pandemic on the teaching and assessment of clinical skills continues to pose significant challenges for healthcare education providers worldwide. In March 2020 Duke-National University of Singapore (Duke-NUS) Medical School demonstrated how to design and implement clinical skills examinations (OSCEs) in the early phase of COVID-19. As governing bodies continue to revise restrictions to help 'flatten the curve', educational institutions have to undertake a rapid review of assessment practices and adapt to this ever-changing environment. This case study describes the risk-assessments and challenges faced when delivering high stakes OSCEs during the COVID-19 pandemic. We also describe successful mitigation strategies implemented to combat these risks, and how we also embraced and leveraged technology in a very creative way despite the restrictions and constrained environment. We describe and share practical guidance that may be of help or interest to healthcare education providers across all disciplines on how to effectively deliver clinical and procedural skills examinations that are authentic, valid and comply with the strict national COVID-19 restrictions implemented during this time.

How cognitive engagement fluctuates during a team-based learning session and how it predicts academic achievement.

The objective of the paper is to report findings of two studies that attempted to find answers to the following questions: (1) What are the levels of cognitive engagement in TBL? (2) Are there differences between students who were more exposed to TBL than students who were less exposed to TBL? (3) To which extent does cognitive engagement fluctuate as a function of the different activities involved in TBL? And (4) How do cognitive engagement scores collected over time correlate with each other and with academic achievement? The studies were conducted with Year-1 and -2 medical students enrolled in a TBL curriculum (N = 175, 62 female). In both studies, six measurements of cognitive engagement were taken during the distinct TBL activities (preparation phase, individual/team readiness assurance test, burning questions, and application exercises). Data were analysed by means of one-way repeated-measures ANOVAs and path modelling. The results of the repeated-measures ANOVA revealed that cognitive engagement systematically fluctuated as a function of the distinct TBL activities. In addition, Year-1 students reported significantly higher levels of cognitive engagement compared to Year-2 students. Finally, cognitive engagement was a significant predictor of performance (ß = .35). The studies presented in this paper are a first attempt to relate the different activities undertaken in TBL with the extent to which they arouse cognitive engagement with the task at hand. Implications of these findings for TBL are discussed.

Data Driven Quality Improvement of Health Professions Education: Design and Development of CLUE - An Interactive Curriculum Data Visualization Tool.

Curriculum Mapping and dynamic visualization is quickly becoming an integral aspect of quality improvement in support of innovations which drive curriculum quality assurance processes in medical education. CLUE (Curriculum Explorer) a highly interactive, engaging and independent platform was developed to support curriculum transparency, enhance student engagement, and enable granular search and display. Reflecting a design based approach to meet the needs of the school's varied stakeholders, CLUE employs an iterative and reflective approach to drive the evolution of its platform, as it seeks to accommodate the ever-changing needs of our stakeholders in the fast pace world of medicine and medical education today. CLUE exists independent of institutional systems and in this way, is uniquely positioned to deliver a data driven quality improvement resource, easily adaptable for use by any member of our health care professions.

Symptomatic males and female carriers in a large Caucasian kindred with XIAP deficiency.

PURPOSE: X-linked inhibitor of apoptosis (XIAP) deficiency caused by mutations in BIRC4 was originally described in male patients with X-linked lymphoproliferative syndrome type 2 (XLP2). Recent observations have highlighted a critical role of XIAP for the regulation of NOD2 signaling and are probably the molecular basis for increasingly recognized further immune dysregulatory symptoms of XIAP deficient patients, such as inflammatory bowel disease (IBD). We describe a large Caucasian family in which IBD and erythema nodosum (EN) also manifested in female carriers of XIAP mutations. METHODS: Clinical data and laboratory findings including flow cytometric analysis of XIAP protein expression and sequencing of the BIRC4 gene. NOD2 signaling was investigated by determination of TNFα production in monocytes upon L18-MDP stimulation in vitro. RESULTS: The BIRC4 nonsense mutation p.P225SfsX226 was identified as the genetic cause of XIAP deficiency in our family. Surprisingly, clinical symptoms were not restricted to male patients, but also occurred in several female carriers. The most severely affected carrier demonstrated random X-inactivation, leading to a significant expression of mutated XIAP protein in monocytes, and consequently to impaired NOD2 responses in vitro. CONCLUSION: Our report provides further evidence that clinical symptoms of XIAP deficiency are not restricted to male patients. Random X-inactivation may be associated with EN and mild IBD also in female carriers of BIRC4 mutations. Analysis of the X-inactivation pattern reflected by XIAP protein expression can identify such carriers and the analysis of NOD2 signaling by flow cytometry can confirm the functional significance. XIAP expression patterns should be investigated in female patients with a family history of EN and/or IBD.

Medicare claims can be used to identify US hospitals with higher rates of surgical site infection following vascular surgery.

BACKGROUND: Surgical site infections (SSIs) following vascular surgery have high morbidity and costs, and are increasingly tracked as hospital quality measures. OBJECTIVE: To assess the ability of Medicare claims to identify US hospitals with high SSI rates after vascular surgery. RESEARCH DESIGN: Using claims from fee-for-service Medicare enrollees of age 65 years and older who underwent vascular surgery from 2005 to 2008, we derived hospital rankings using previously validated codes suggestive of SSI, with individual-level adjustment for age, sex, and comorbidities. We then obtained medical records for validation of SSI from hospitals ranked in the best and worst deciles of performance, and used logistic regression to calculate the risk-adjusted odds of developing an SSI in worst-decile versus best-decile hospitals. RESULTS: Among 203,023 Medicare patients who underwent vascular surgery at 2512 US hospitals, a patient undergoing surgery in a hospital ranked in the worst-performing decile based on claims had 2.5 times higher odds of developing a chart-confirmed SSI relative to a patient with the same age, sex, and comorbidities in a hospital ranked in the best-performing decile (95% confidence interval, 2.0-3.1). SSI confirmation among patients with claims suggesting infection was similar across deciles, and we found similar findings in analyses limited to deep and organ/space SSIs. We report on diagnosis codes with high sensitivity for identifying deep and organ/space SSI, with one-to-one mapping to ICD-10-CM codes. CONCLUSIONS: Claims-based surveillance offers a standardized and objective methodology that can be used to improve SSI surveillance and to validate hospitals' publicly reported data.

WLS retrograde transport to the endoplasmic reticulum during Wnt secretion.

Wnts are transported to the cell surface by the integral membrane protein WLS (also known as Wntless, Evi, and GPR177). Previous studies of WLS trafficking have emphasized WLS movement from the Golgi to the plasma membrane (PM) and then back to the Golgi via retromer-mediated endocytic recycling. We find that endogenous WLS binds Wnts in the endoplasmic reticulum (ER), cycles to the PM, and then returns to the ER through the Golgi. We identify an ER-targeting sequence at the carboxyl terminus of native WLS that is critical for ER retrograde recycling and contributes to Wnt secretory function. Golgi-to-ER recycling of WLS requires the COPI regulator ARF as well as ERGIC2, an ER-Golgi intermediate compartment protein that is also required for the retrograde trafficking of the KDEL receptor and certain toxins. ERGIC2 is required for efficient Wnt secretion. ER retrieval is an integral part of the WLS transport cycle.

FGFR1 signaling stimulates proliferation of human mesenchymal stem cells by inhibiting the cyclin-dependent kinase inhibitors p21(Waf1) and p27(Kip1).

Signaling through fibroblast growth factor receptor one (FGFR1) is a known inducer of proliferation in both embryonic and human adult mesenchymal stem cells (hMSCs) and positively regulates maintenance of stem cell viability. Leveraging the mitogenic potential of FGF2/FGFR1 signaling in stem cells for therapeutic applications necessitates a mechanistic understanding of how this receptor stimulates cell cycle progression. Using small interfering RNA (siRNA) depletion, antibody-inhibition, and small molecule inhibition, we establish that FGFR1 activity is rate limiting for self-renewal of hMSCs. We show that FGFR1 promotes stem cell proliferation through multiple mechanisms that unite to antagonize cyclin-dependent kinase (CDK) inhibitors. FGFR1 not only stimulates c-Myc to suppress transcription of the CDK inhibitors p21(Waf1) and p27(Kip1), thus promoting cell cycle progression but also increases the activity of protein kinase B (AKT) and the level of S-phase kinase-associated protein 2 (Skp2), resulting in the nuclear exclusion and reduction of p21(Waf1). The in vivo importance of FGFR1 signaling for the control of proliferation in mesenchymal progenitor populations is underscored by defects in ventral mesoderm formation during development upon inhibition of its signaling. Collectively, these studies demonstrate that FGFR1 signaling mediates the continuation of MSC growth and establishes a receptor target for enhancing the expansion of mesenchymal progenitors while maintaining their multilineage potential.

Impact of emerging health insurance arrangements on diabetes outcomes and disparities: rationale and study design.

Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre-post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes quality of care, outcomes, and disparities. We will use a 13-year rolling sample (2001-2013) of members of an HDHP and members of a control group. To reduce selection bias, we will limit participants to those whose employers mandate a single health insurance type. The study will measure rates of monthly hemoglobin A1c, lipid, and albuminuria testing; availability of blood glucose test strips; and rates of retinal examinations, high-severity emergency department visits, and preventable hospitalizations. Results could be used to design health plan features that promote high-quality care and better outcomes among people who have diabetes.

Use of Medicare claims to identify US hospitals with a high rate of surgical site infection after hip arthroplasty.

OBJECTIVE: To assess the ability of Medicare claims to identify US hospitals with high rates of surgical site infection (SSI) after hip arthroplasty. DESIGN: Retrospective cohort study. SETTING: Acute care US hospitals. PARTICIPANTS: Fee-for-service Medicare patients 65 years of age and older who underwent hip arthroplasty in US hospitals from 2005 through 2007. METHODS: Hospital rankings were derived from claims codes suggestive of SSI, adjusted for age, sex, and comorbidities, while using generalized linear mixed models to account for hospital volume. Medical records were obtained for validation of infection on a random sample of patients from hospitals ranked in the best and worst deciles of performance. We then calculated the risk-adjusted odds of developing a chart-confirmed SSI after hip arthroplasty in hospitals ranked by claims into worst- versus best-performing deciles. RESULTS: Among 524,892 eligible Medicare patients who underwent hip arthroplasty at 3,296 US hospitals, a patient who underwent surgery in a hospital ranked in the worst-performing decile based on claims-based evidence of SSI had 2.9-fold higher odds of developing a chart-confirmed SSI relative to a patient with the same age, sex, and comorbidities in a hospital ranked in the best-performing decile (95% confidence interval, 2.2-3.7). CONCLUSIONS: Medicare claims successfully distinguished between hospitals with high and low SSI rates following hip arthroplasty. These claims can identify potential outlier hospitals that merit further evaluation. This strategy can also be used to validate the completeness of public reporting of SSI.

Developmental expression of the fermitin/kindlin gene family in Xenopus laevis embryos.

Fermitin genes are highly conserved and encode cytocortex proteins that mediate integrin signalling. Fermitin 1 (Kindlin1) is implicated in Kindler syndrome, a human skin blistering disorder. We report the isolation of the three Fermitin orthologs from Xenopus laevis embryos and describe their developmental expression patterns. Fermitin 1 is expressed in the skin, otic and olfactory placodes, pharyngeal arches, pronephric duct, and heart. Fermitin 2 is restricted to the somites and neural crest. Fermitin 3 is expressed in the notochord, central nervous system, cement gland, ventral blood islands, vitelline veins, and myeloid cells. Our findings are consistent with the view that Fermitin 1 is generally expressed in the skin, Fermitin 2 in muscle, and Fermitin 3 in hematopoietic lineages. Moreover, we describe novel sites of Fermitin gene expression that extend our knowledge of this family. Our data provide a basis for further functional analysis of the Fermitin family in Xenopus laevis.

Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis.

CONTEXT: Rheumatoid arthritis (RA) and psoriasis have been linked with insulin resistance and diabetes mellitus (DM). Prior investigations suggest that systemic immunosuppressive drugs may improve insulin resistance and reduce the risk of DM. OBJECTIVE: To compare the risk of newly recorded DM among participants diagnosed with RA or psoriasis based on use of a variety of disease-modifying antirheumatic drugs (DMARDs). DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study among 121,280 patients with a diagnosis of either RA or psoriasis on at least 2 visits. The analyses were conducted in the context of 2 large health insurance programs, 1 in Canada and 1 in the United States, using administrative data. The mean follow-up was 5.8 months and began with the first prescription for a DMARD after study eligibility was met. Drug regimens were categorized into 4 mutually exclusive groups: (1) tumor necrosis factor (TNF) inhibitors with or without other DMARDs; (2) methotrexate without TNF inhibitors or hydroxychloroquine; (3) hydroxychloroquine without TNF inhibitors or methotrexate; or (4) other nonbiologic DMARDs without TNF inhibitors, methotrexate, or hydroxychloroquine (reference exposure). MAIN OUTCOME MEASURE: Newly recorded DM as evidenced by a new diagnosis of DM with use of a DM-specific medication. RESULTS: The study cohort consisted of 13,905 participants with 22,493 treatment episodes starting 1 of the categories of DMARD regimens between January 1996 and June 2008. New diabetes cases and respective incidence rates per 1000 person-years were: other nonbiologic DMARDs (55 cases among 3993 treatment episodes; rate, 50.2; 95% confidence interval [CI], 47.3-53.2); TNF inhibitors (80 cases among 4623 treatment episodes; rate, 19.7; 95% CI, 19.1-20.3); methotrexate (82 cases among 8195 treatment episodes; rate, 23.8; 95% CI, 23.0-24.6); and hydroxychloroquine (50 cases among 5682 treatment episodes; rate, 22.2; 95% CI, 21.3-23.1). The multivariate adjusted hazard ratios for DM were 0.62 (95% CI, 0.42-0.91) for TNF inhibitors, 0.77 (95% CI, 0.53-1.13) for methotrexate, and 0.54 (95% CI, 0.36-0.80) for hydroxychloroquine compared with other nonbiologic DMARDS. CONCLUSION: Among patients with RA or psoriasis, the adjusted risk of DM was lower for individuals starting a TNF inhibitor or hydroxychloroquine compared with initiation of other nonbiologic DMARDs.

Identification of hospitalizations for intentional self-harm when E-codes are incompletely recorded.

CONTEXT: Suicidal behavior has gained attention as an adverse outcome of prescription drug use. Hospitalizations for intentional self-harm, including suicide, can be identified in administrative claims databases using external cause of injury codes (E-codes). However, rates of E-code completeness in US government and commercial claims databases are low due to issues with hospital billing software. OBJECTIVE: To develop an algorithm to identify intentional self-harm hospitalizations using recorded injury and psychiatric diagnosis codes in the absence of E-code reporting. METHODS: We sampled hospitalizations with an injury diagnosis (ICD-9 800-995) from two databases with high rates of E-coding completeness: 1999-2001 British Columbia, Canada data and the 2004 US Nationwide Inpatient Sample. Our gold standard for intentional self-harm was a diagnosis of E950-E958. We constructed algorithms to identify these hospitalizations using information on type of injury and presence of specific psychiatric diagnoses. RESULTS: The algorithm that identified intentional self-harm hospitalizations with high sensitivity and specificity was a diagnosis of poisoning, toxic effects, open wound to elbow, wrist, or forearm, or asphyxiation; plus a diagnosis of depression, mania, personality disorder, psychotic disorder, or adjustment reaction. This had a sensitivity of 63%, specificity of 99% and positive predictive value (PPV) of 86% in the Canadian database. Values in the US data were 74, 98, and 73%. PPV was highest (80%) in patients under 25 and lowest those over 65 (44%). CONCLUSIONS: The proposed algorithm may be useful for researchers attempting to study intentional self-harm in claims databases with incomplete E-code reporting, especially among younger populations.

WLS-dependent secretion of WNT3A requires Ser209 acylation and vacuolar acidification.

Wnt proteins are secreted post-translationally modified proteins that signal locally to regulate development and proliferation. The production of bioactive Wnts requires a number of dedicated factors in the secreting cell whose coordinated functions are not fully understood. A screen for small molecules identified inhibitors of vacuolar acidification as potent inhibitors of Wnt secretion. Inhibition of the V-ATPase or disruption of vacuolar pH gradients by diverse drugs potently inhibited Wnt/ß-catenin signaling both in cultured human cells and in vivo, and impaired Wnt-regulated convergent extension movements in Xenopus embryos. WNT secretion requires its binding to the carrier protein wntless (WLS); we find that WLS is ER-resident in human cells and WNT3A binding to WLS requires PORCN-dependent lipid modification of WNT3A at serine 209. Inhibition of vacuolar acidification results in accumulation of the WNT3A-WLS complex both in cells and at the plasma membrane. Modeling predictions suggest that WLS has a lipid-binding ß-barrel that is similar to the lipocalin-family fold. We propose that WLS binds Wnts in part through a lipid-binding domain, and that vacuolar acidification is required to release palmitoylated WNT3A from WLS in secretory vesicles, possibly to facilitate transfer of WNT3A to a soluble carrier protein.

Risk of diabetes among patients with rheumatoid arthritis, psoriatic arthritis and psoriasis.

OBJECTIVE: To examine the risk of diabetes mellitus (DM) among subjects with rheumatoid arthritis (RA), psoriatic arthritis or psoriasis (PsA/PsO), compared with non-rheumatic controls. METHODS: Study cohorts were assembled using linked healthcare utilisation data from British Columbia. All people with at least two diagnoses of RA or PsA/PsO were included and compared with a cohort of people without any known rheumatic disease. The outcome of interest was a diagnosis of new-onset DM, as defined by initiation of an antidiabetic drug. Incidence rates (IRs) per 1000 person-years and IR ratios were calculated and Cox regression models were constructed to determine the hazard ratio (HR) for diabetes by age, gender, systemic immunosuppressive drug and glucocorticoid use. RESULTS: The study cohort comprised 48 718 subjects with RA, 40 346 with PsA/PsO and 442 033 without any rheumatic disease. The IR for DM among subjects with RA was 8.6 per 1000 person-years (95% CI 8.5 to 8.7), PsA/PsO 8.2 (95% CI 8.1 to 8.3) and for non-rheumatic controls 5.8 (95% CI 5.8 to 5.8). The adjusted HR for RA compared with non-rheumatic controls was 1.5 (95% CI 1.4 to 1.5) and 1.4 (95% CI 1.3 to 1.5) for PsA/PsO. CONCLUSIONS: RA and PsA/PsO appear to be associated with an increased risk of DM. The ability of potent antirheumatic treatments to reverse this trend warrants study.

Impact of drug cost sharing on service use and adverse clinical outcomes in elderly receiving antidepressants.

BACKGROUND: Depression imposes enormous burdens on the elderly. Despite this, rates of initiation of and adherence to recommended pharmacotherapy are frequently low in this population. Although initiatives such as the Medicare Modernization Act (MMA) have improved seniors' access to antidepressants, there are concerns that the patient cost-sharing incorporated in the MMA may have unintended consequences if it reduces essential drug use. Age-related pharmacokinetic and pharmacodynamic changes could make seniors particularly vulnerable to antidepressant regimens used inappropriately to save costs, increasing their risks of morbidity, hospitalizations, and nursing home placements. Two sequential large-scale "natural experiments'' in British Columbia provide a unique opportunity to evaluate the effect of cost sharing on outcomes and mental health service use among seniors. In January 2002 the province introduced a CAD 25 copay (CAD10 for low-income seniors). In May 2003 this copay policy was replaced by a second policy consisting of an income-based deductible, 25% coinsurance once the deductible was met, and full coverage once an out-of-pocket ceiling was met. The transition between the two policies is analogous to what many U.S. seniors experience when they transition from private insurance requiring copays to Medicare Part D requiring deductibles and coinsurance. AIMS: To evaluate whether declines in antidepressant initiation after the introduction of two drug cost-sharing policies in British Columbia were associated with increased use of physician services, hospitalizations, and nursing home admissions among all British Columbia residents aged 65+. METHODS: Records of physician service use, inpatient hospitalizations, and residential care admissions were obtained from administrative databases. Population-level patterns over time were plotted, and effects of implementing the cost-sharing policies examined in segmented linear regression models. RESULTS: Neither policy affected the rates of visits to physicians or psychiatrists for depression, hospitalizations with a depression diagnosis, or long-term care admissions. DISCUSSION: The cost-sharing policies studied may have contained non-essential antidepressant use without substantially increasing mental health service utilization. However, it is possible that the policies had effects that we were unable to detect, such as increasing rates of visits to social workers or psychologists or forcing patients to reduce other spending. Further, the sequential implementation of the policy changes, makes it difficult to estimate the effect of a direct change from full coverage to a coinsurance/income-based deductible policy. IMPLICATIONS FOR HEALTH POLICIES: It may be possible to design policies to contain non-essential antidepressant use without substantially increasing other service utilization or adverse events. However, because undertreatment remains a serious problem among depressed elderly, well-designed prescription drug policies should be coupled with interventions to address under-treatment.

An evaluation of the relationship between the implementation of a newly designed prescription drug label at Target pharmacies and health outcomes.

BACKGROUND: Medication errors represent a major public health concern, and inadequate prescription drug labels have been identified as a root cause of errors. A new prescription medication labeling system was implemented by Target pharmacies in May 2005 and aimed to improve health outcomes. OBJECTIVES: To evaluate whether the new Target label influenced patient health services utilization. SUBJECTS: Derived from 2 large health plans. RESEARCH DESIGN AND MEASURES: Using administrative claims, we identified patients with 1 of 9 chronic diseases who filled prescriptions at Target pharmacies and a matched sample who filled prescriptions at other community pharmacies. We stratified our cohort into new and prevalent medication users and evaluated the impact of the Target label on outpatient, emergency department and inpatient health services use. We used linear regression and segmented linear regression to evaluate the new-user and prevalent-user analyses, respectively. RESULTS: Our sample included 23,745 Target pharmacy users and 162,369 matched non-Target pharmacy users. In the new-user analysis, we found no significant change in rates of both outpatient (event rate ratio: 0.53; 95% CI: 0.15-1.86) and inpatient and emergency department (Event rate ratio: 0.88; 95% CI: 0.62-1.24) health services utilization in Target users after implementation when compared with non-Target users. Similarly, in the prevalent user analysis, we found no change in the level or slope of outpatient or emergency/inpatient services in Target users after implementation of the new label when compared with non-Target users. CONCLUSIONS: We found no statistically significant change in health services use attributable to the implementation of the new prescription drug label at Target pharmacies. These findings highlight the challenge of influencing health outcomes with interventions to improve health literacy.

A cohort study of thiazolidinediones and fractures in older adults with diabetes.

CONTEXT: Thiazolidenediones (TZDs) are selective ligands of peroxisome-proliferator-activated receptor-gamma and have been shown to reduce bone mineral density. Recent results from several randomized controlled trials find an increased risk of fracture with TZDs compared with other oral antidiabetic agents. OBJECTIVE: The aim of the study was to determine the association between TZD use and fracture risk among older adults with diabetes. DESIGN: We conducted a cohort study. PARTICIPANTS: Medicare beneficiaries with at least one diagnosis of diabetes initiating monotherapy for an oral hypoglycemic agent participated in the study. MAIN OUTCOME: We measured the incidence of fracture within the cohort. RESULTS: Among the 20,964 patients with diabetes eligible for this study, 686 (3.3%) experienced a fracture during the median follow-up of approximately 10 months. Although not statistically significant, patients using only a TZD were more likely to experience a fracture than those using metformin (adjusted relative risk, 1.31; 95% confidence interval, 0.98-1.77; P = 0.071) or a sulfonylurea (adjusted relative risk, 1.21; 95% confidence interval, 0.94-1.55; P = 0.12). Each individual TZD was associated with an increased risk, with confidence intervals overlapping unity, compared with both metformin and sulfonylureas. The adjusted risk of any fracture associated with TZD use compared with metformin was elevated for non-insulin-using patients, women and men. If TZD use is associated with fractures, the number needed for one excess fracture when comparing TZD users to sulfonylurea users was 200, and the number was 111 when comparing TZDs with metformin. CONCLUSIONS: As has been found with other analyses, our data suggest that TZDs may be associated with an increased risk of fractures compared with oral sulfonylureas and metformin.

Can improved prescription medication labeling influence adherence to chronic medications? An evaluation of the Target pharmacy label.

BACKGROUND: Prescription medication labels contain valuable health information, and better labels may enhance patient adherence to chronic medications. A new prescription medication labeling system was implemented by Target pharmacies in May 2005 and aimed to improve readability and understanding. OBJECTIVE: We evaluated whether the new Target label influenced patient medication adherence. DESIGN AND PATIENTS: Using claims from two large health plans, we identified patients with one of nine chronic diseases who filled prescriptions at Target pharmacies and a matched sample who filled prescriptions at other community pharmacies. MEASUREMENTS: We stratified our cohort into new and prevalent medication users and evaluated the impact of the Target label on medication adherence. We used linear regression and segmented linear regression to evaluate the new-user and prevalent-user analyses, respectively. RESULTS: Our sample included 23,745 Target users and 162,368 matched non-Target pharmacy users. We found no significant change in adherence between new users of medications at Target or other community pharmacies (p = 0.644) after implementing the new label. In prevalent users, we found a 0.0069 percent reduction in level of adherence (95% CI -0.0138-0.0; p < 0.001) and a 0.0007 percent increase in the slope in Target users (the monthly rate of change of adherence) after implementation of the new label (95% CI 0.0001-0.0013; p = 0.001). CONCLUSIONS: We found no changes in adherence of chronic medication in new users, and small and likely clinically unimportant changes in prevalent users after implementation of the new label. While adherence may not be improved with better labeling, evaluation of the effect of labeling on safety and adverse effects is needed.