Adoption of Extended-Interval Dosing of Single-Agent Pembrolizumab and Comparative Effectiveness vs Standard Dosing in Time-to-Treatment Discontinuation.

Importance: Extended-interval dosing of pembrolizumab (400 mg every 6 weeks) was approved by US Food and Drug Administration (FDA) in April 2020 as an alternative to standard-interval dosing (200 mg every 3 weeks). Extended-interval dosing may enhance access, alleviate patient and health system financial toxicity, and improve patient quality of life, particularly during the COVID-19 pandemic. Neither adoption nor effectiveness of extended interval in the US has been adequately described. Objective: To describe adoption of extended-interval dosing of pembrolizumab since its FDA approval and to measure its preliminary real-world effectiveness compared with standard-interval dosing. Design, Setting, and Participants: This was a retrospective cohort study that used data from the Veterans Health Administration (VHA), a US-based, nationwide single-payer health system. Participants were veterans who were prescribed single-agent pembrolizumab within the VHA between April 1, 2020, and July 1, 2021. Patients receiving combinations of pembrolizumab and cytotoxic chemotherapy or tyrosine kinase inhibitors were excluded. A subcohort of veterans with non-small cell lung cancer (NSCLC) was also identified using claims-based codes. Exposures: Single-agent pembrolizumab at extended or standard intervals. Main Outcomes and Measures: The number and proportion of single-agent pembrolizumab prescriptions that were extended compared with standard interval. Effectiveness was described in terms of time-to-treatment discontinuation (TTD) and extended- to standard-interval pembrolizumab prescriptions were compared using Cox proportional hazards regression. Results: A total of 835 veterans (mean age [SD], 70.9 [8.7] years; 809 [96.9%] men) began single-agent pembrolizumab during the study period (all-diseases cohort), and of these, 234 (mean [SD] age, 71.6 [7.3] years; 225 [96.2%] men) had NSCLC (NSCLC cohort). Extended-interval adoption reached its steady state plateau of approximately 35% by January 2021; 65% of participants who began standard-interval single-agent pembrolizumab received only standard-interval dosing during the treatment course. In analysis consistent with the intention-to-treat principle, no differences in TTD were observed between standard- and extended-interval dosing in either the all-diseases cohort (HR, 1.00; 95% CI, 1.00-1.00) or the NSCLC cohort (HR, 1.00; 95% CI, 1.00-1.00). Conclusions and Relevance: This retrospective cohort study found that extended-interval dosing comprised a minority of single-agent pembrolizumab prescriptions despite the FDA approval and its potential health system and public health benefits. The findings support the TTD equivalence of standard- and extended-interval pembrolizumab across indications, complementing clinical pharmacology and single-arm clinical trial data in melanoma. This study provides further support for extended-interval pembrolizumab dosing.

Planning and Reporting Effective Web-Based RAND/UCLA Appropriateness Method Panels: Literature Review and Preliminary Recommendations.

BACKGROUND: The RAND/UCLA Appropriateness Method (RAM), a variant of the Delphi Method, was developed to synthesize existing evidence and elicit the clinical judgement of medical experts on the appropriate treatment of specific clinical presentations. Technological advances now allow researchers to conduct expert panels on the internet, offering a cost-effective and convenient alternative to the traditional RAM. For example, the Department of Veterans Affairs recently used a web-based RAM to validate clinical recommendations for de-intensifying routine primary care services. A substantial literature describes and tests various aspects of the traditional RAM in health research; yet we know comparatively less about how researchers implement web-based expert panels. OBJECTIVE: The objectives of this study are twofold: (1) to understand how the web-based RAM process is currently used and reported in health research and (2) to provide preliminary reporting guidance for researchers to improve the transparency and reproducibility of reporting practices. METHODS: The PubMed database was searched to identify studies published between 2009 and 2019 that used a web-based RAM to measure the appropriateness of medical care. Methodological data from each article were abstracted. The following categories were assessed: composition and characteristics of the web-based expert panels, characteristics of panel procedures, results, and panel satisfaction and engagement. RESULTS: Of the 12 studies meeting the eligibility criteria and reviewed, only 42% (5/12) implemented the full RAM process with the remaining studies opting for a partial approach. Among those studies reporting, the median number of participants at first rating was 42. While 92% (11/12) of studies involved clinicians, 50% (6/12) involved multiple stakeholder types. Our review revealed that the studies failed to report on critical aspects of the RAM process. For example, no studies reported response rates with the denominator of previous rounds, 42% (5/12) did not provide panelists with feedback between rating periods, 50% (6/12) either did not have or did not report on the panel discussion period, and 25% (3/12) did not report on quality measures to assess aspects of the panel process (eg, satisfaction with the process). CONCLUSIONS: Conducting web-based RAM panels will continue to be an appealing option for researchers seeking a safe, efficient, and democratic process of expert agreement. Our literature review uncovered inconsistent reporting frameworks and insufficient detail to evaluate study outcomes. We provide preliminary recommendations for reporting that are both timely and important for producing replicable, high-quality findings. The need for reporting standards is especially critical given that more people may prefer to participate in web-based rather than in-person panels due to the ongoing COVID-19 pandemic.

Rising use of surveillance colonoscopy and potential impacts.

OBJECTIVES: To quantify temporal changes in colonoscopy indication and assess appropriateness of surveillance use in older adults. STUDY DESIGN: Retrospective longitudinal study of national Veterans Health Administration (VHA) data of all patients who underwent outpatient colonoscopy in 2005-2014. METHODS: After validating an electronic algorithm for classifying colonoscopy indication in VHA, we examined trends in colonoscopy indication over time and across patient characteristics. RESULTS: The proportion of colonoscopies performed for postpolypectomy surveillance increased significantly during the study period, particularly among older patients with limited life expectancy, raising concern for possible overuse. CONCLUSIONS: Guidelines should make clear recommendations about when and how to discontinue postpolypectomy surveillance colonoscopy. Doing so would potentially reduce harms due to complications from low-value procedures and in turn moderate demand and thereby enhance overall procedural access for patients more likely to benefit.

Type 2 Diabetes Management, Control and Outcomes During the COVID-19 Pandemic in Older US Veterans: an Observational Study.

BACKGROUND: The COVID-19 pandemic required a change in outpatient care delivery models, including shifting from in-person to virtual visits, which may have impacted care of vulnerable patients. OBJECTIVE: To describe the changes in management, control, and outcomes in older people with type 2 diabetes (T2D) associated with the shift from in-person to virtual visits. DESIGN AND PARTICIPANTS: In veterans aged ≥ 65 years with T2D, we assessed the rates of visits (in person, virtual), A1c measurements, antidiabetic deintensification/intensification, ER visits and hospitalizations (for hypoglycemia, hyperglycemia, other causes), and A1c level, in March 2020 and April-November 2020 (pandemic period). We used negative binomial regression to assess change over time (reference: pre-pandemic period, July 2018 to February 2020), by baseline Charlson Comorbidity Index (CCI; > 2 vs. <= 2) and A1c level. KEY RESULTS: Among 740,602 veterans (mean age 74.2 [SD 6.6] years), there were 55% (95% CI 52-58%) fewer in-person visits, 821% (95% CI 793-856%) more virtual visits, 6% (95% CI 1-11%) fewer A1c measurements, and 14% (95% CI 10-17%) more treatment intensification during the pandemic, relative to baseline. Patients with CCI > 2 had a 14% (95% CI 12-16%) smaller relative increase in virtual visits than those with CCI <= 2. We observed a seasonality of A1c level and treatment modification, but no association of either with the pandemic. After a decrease at the beginning of the pandemic, there was a rebound in other-cause (but not hypo- and hyperglycemia-related) ER visits and hospitalizations from June to November 2020. CONCLUSION: Despite a shift to virtual visits and a decrease in A1c measurement during the pandemic, we observed no association with A1c level or short-term T2D-related outcomes, providing some reassurance about the adequacy of virtual visits. Further studies should assess the longer-term effects of shifting to virtual visits in different populations to help individualize care, improve efficiency, and maintain appropriate care while reducing overuse.

Applying User-Centered Design to Develop Practical Strategies that Address Overuse in Primary Care.

INTRODUCTION: Engaging patients and frontline clinicians in re-designing clinical care is essential for improving care delivery in a complex clinical environment. This study sought to assess an innovative user-centered design approach to improving clinical care quality, focusing on the use cases of de-intensifying non-beneficial care within the following areas: (1) de-intensifying diabetes treatment in high-risk patients; (2) stopping screening for carotid artery stenosis in asymptomatic patients; and (3) stopping colorectal cancer screening in average-risk, older adults. METHODS: The user-centered design approach, consisting of patient and patient-clinician charrettes (defined as intensive workshops where key stakeholders collaborate to develop creative solutions to a specific problem) and participant surveys, has been described previously. Following the charrettes, we used inductive coding to identify and categorize themes emerging from the de-intensification ideas prioritized by participants as well as facilitator notes and audio recordings from the charrettes. RESULTS: Thirty-five patients participated in the patient design charrettes, generating 134 unique de-intensification ideas and prioritizing 32, which were then distilled into six patient-generated principles of de-intensification by the study team. These principles provided a starting point for a subsequent patient-clinician charrette. In this follow-up charrette, 9 patients who had participated in an earlier patient design charrette collaborated with 7 clinicians to generate 63 potential de-intensification solutions. Six of these potential solutions were developed into multi-faceted, fully operationalized de-intensification strategies. DISCUSSION: The de-intensification strategies that patients and clinicians prioritized and operationalized during the co-design charrette process were detailed and multi-faceted. Each component of a strategy had a rationale based on feasibility, practical considerations, and ways of overcoming barriers. The charrette-based process may be a useful way to engage clinicians and patients in developing the complex and multi-faceted strategies needed to improve care delivery.

Agreement among measures examining low-value imaging for low back pain.

OBJECTIVES: To quantify the extent of patient-level agreement among 3 published measures of low-value imaging for acute low back pain (LBP). STUDY DESIGN: In this retrospective cohort study using commercial insurance claims from MarketScan, we assessed 3 published measures of low-value imaging for agreement in identifying LBP diagnoses (denominator), red-flag diagnoses (denominator exclusions), and imaging procedures (numerator). METHODS: Using a cohort of patients, aged 18 to 64 years, with a diagnosis of LBP in 2014, we assessed agreement surrounding both the overuse event (imaging procedures) and inclusion in the reference population (LBP definition and exclusion diagnoses) using percent agreement and Fleiss κ among 3 overuse measures. RESULTS: In our cohort of 1,835,620 patients with acute LBP, the 3 measures agreed 100% on the presence of acute LBP and also had excellent agreement (99%; κ = 0.98) in identifying imaging for LBP. However, there was substantial disagreement on whom to exclude for red-flag diagnoses, leading to lower agreement (75%; κ = 0.61) on whom to include in the reference population of acute LBP without red flags, among whom imaging for LBP is considered of low value. CONCLUSIONS: Our findings demonstrate the need for further consensus surrounding how to translate guideline recommendations to administrative measures that assess overuse of imaging for acute LBP, particularly with respect to defining which patients should be excluded from the measures. This finding is also important for other overuse measures that rely on exclusions.

Focus and features of prescribing indications spanning multiple chronic conditions in older adults: A narrative review.

Background: Inappropriate prescribing is frequent in older adults and associated with adverse outcomes. Prescribing indications aim to optimize prescribing, but little is known about the focus and features of prescribing indications for the most common chronic conditions in older adults. Understanding the conditions, medications, and issues addressed (e.g., patient perspective, drug-disease interaction, adverse drug event) in current prescribing indications may help to identify missing indications and develop standardized measures to improve prescribing quality. Methods: We searched Ovid/MEDLINE and EMBASE for articles published between 2015 and 2020 reporting prescribing indications for older adults. Prescribing indication included 1) prescribing "criteria," or statements that guide prescribing action, and 2) prescribing "measures," or prescribing actions observed in a population. We categorized their focus by conditions, medications and issues addressed, as well as level of evidence provided. Results: Among 16 sets of prescribing indications, we identified 748 criteria and 47 measures. The most common addressed medications were antihypertensives, analgesics/antirheumatics, and antiplatelets/anticoagulants. The most frequently addressed issues were drug-disease interaction, adverse drug event, administration, better therapeutic alternative, and (co-)prescription omission (20.8-36.1%). Age/functioning, drug-drug interaction, monitoring, and efficacy/safety ratio were found in only 9.9-16.5% of indications. Indications rarely focused on the patient perspective or issues with multiple providers. Conclusion: Most prescribing indications for chronic conditions in older patients are criteria rather than measures. Indications accounting for patient perspective and multiple providers are limited. The gaps identified in this review may help improve the development of prescribing measures for older adults and ultimately improve quality of care.

Identifying Recommendations for Stopping or Scaling Back Unnecessary Routine Services in Primary Care.

Importance: Much of health care involves established, routine use of medical services for chronic conditions or prevention. Stopping these services when the evidence changes or if the benefits no longer outweigh the risks is essential. Yet, most guidelines focus on escalating care and provide few explicit recommendations to stop or scale back (ie, deintensify) treatment and testing. Objective: To develop a systematic, transparent, and reproducible approach for identifying, specifying, and validating deintensification recommendations associated with routine adult primary care. Design, Setting, and Participants: A focused review of existing guidelines and recommendations was completed to identify and prioritize potential deintensification indications. Then, 2 modified virtual Delphi expert panels examined the synthesized evidence, suggested ways that the candidate recommendations could be improved, and assessed the validity of the recommendations using the RAND/UCLA Appropriateness Method. Twenty-five physicians from Veterans Affairs and US academic institutions with knowledge in relevant clinical areas (eg, geriatrics, primary care, women's health, cardiology, and endocrinology) served as panel members. Main Outcomes and Measures: Validity of the recommendations, defined as high-quality evidence that deintensification is likely to improve patient outcomes, evidence that intense testing and/or treatment could cause harm in some patients, absence of evidence on the benefit of continued or repeated intense treatment or testing, and evidence that deintensification is consistent with high-quality care. Results: A total of 409 individual recommendations were identified representing 178 unique opportunities to stop or scale back routine services (eg, stopping population-based screening for vitamin D deficiency and decreasing concurrent use of opioids and benzodiazepines). Thirty-seven recommendations were prioritized and forwarded to the expert panels. Panelists reviewed the evidence and suggested modifications, resulting in 44 recommendations being rated. Overall, 37 recommendations (84%) were considered to be valid, as assessed by the RAND/UCLA Appropriateness Method. Conclusions and Relevance: In this study, a total of 178 unique opportunities to deintensify routine primary care services were identified, and 37 of these were validated as high-priority deintensification recommendations. To date, this is the first study to develop a model for identifying, specifying, and validating deintensification recommendations that can be implemented and tracked in clinical practice.

Outcome Measures for Interventions to Reduce Inappropriate Chronic Drugs: A Narrative Review.

BACKGROUND: Inappropriate prescribing is a highly important problem, given the growing aging multimorbid population with associated polypharmacy. An increasing number of studies have recently developed and tested interventions to withdraw inappropriate drugs, a process called deprescribing. However, we still lack complete information on the types and prevalence of measures used to assess the success of such interventions. OBJECTIVE: To categorize and synthesize the full spectrum of measures used in intervention studies focused on reducing inappropriate prescribing of chronic drugs in adults, to standardize measurements in future studies and help researchers design studies inclusive of the important measure types. DESIGN: We searched Ovid/MEDLINE to identify intervention studies focused on deprescribing chronic drugs in adults, published between 2010 and 2019. MEASUREMENTS: We extracted data on study characteristics, intervention components, and outcome measures. We categorized and synthesized the measures using a comprehensive and systematic framework, separating measures of intended and unintended consequences. RESULTS: Most (90/93) studies used measures of appropriate prescribing, such as drug cessation or dose reduction. The following measures were used infrequently across studies: patient-reported experience, preferences, and outcome (12 (13%), 2 (2%), and 25 (27%) studies, respectively); provider-reported experience (11 (12%) studies); patient-provider interaction (4 (4%) studies); and measures of unintended consequences (24 (26%) studies). Studies varied in the type and number of measures assessed, ranging from 1 to 20 different measures by study. CONCLUSION: To ensure initiation, success, and long-term sustainability of deprescribing, it is important to assess the success of intervention studies using clinically relevant patient- and provider-centered measures. This categorized synthesis of outcome measures used in deprescribing studies may facilitate implementation of important measure types (e.g., patient-reported measures and measures of unintended consequences) in future studies. J Am Geriatr Soc 68:2390-2398, 2020.

Comparison of Payment Changes and Choosing Wisely Recommendations for Use of Low-Value Laboratory Tests in the United States and Canada.

Importance: Evidence comparing the consequences of Choosing Wisely recommendations across health systems or with the consequences of recommendations plus policy change is lacking. Objectives: To compare changes in the use of 2 low-value laboratory tests after the release of Choosing Wisely recommendations across 3 health care jurisdictions and changes associated with a related policy change. Design, Setting, and Participants: This cross-sectional study was a population-based interrupted time series of adult patients (aged 18-64 years) who had primary care visits between January 1, 2010, and June 30, 2015, or established hypothyroidism between January 1, 2012, and June 30, 2015, across 3 health care delivery jurisdictions: Ontario, Canada; the US Veterans Health Administration; and the US employer-sponsored insurance market. Data analysis was performed from March 21, 2018, to October 31, 2019. Exposures: A December 2010 payment policy change that eliminated reimbursement of vitamin D screening in Ontario, Canada, and the subsequent release of Choosing Wisely recommendations against low-value use of vitamin D tests in February 2013 and triiodothyronine tests in October 2013 in the United States and both tests in October 2014 in Canada. Main Outcomes and Measures: Relative marginal effects (RMEs) comparing low-value testing rates after the release of Choosing Wisely recommendations with rates expected based on prerelease trends and the associated change in low-value vitamin D testing after the 2010 payment policy change in Ontario, Canada. Results: Of 54 223 448 total persons, 28 504 576 (52.6%) were female, with 17 895 458 persons (33.0%) aged 18 to 34 years, 11 101 985 (20.5%) aged 35 to 44 years, and 25 226 005 (46.5%) aged 45 to 64 years. The December 2010 policy eliminating reimbursement for low-value vitamin D screening in Ontario, Canada, was associated with a 92.7% (95% CI, 92.4%-93.0%) relative reduction in such screening. Corresponding Choosing Wisely recommendations were associated with smaller reductions: 4.5% (95% CI, 2.6%-6.3%) in Ontario, 13.8% (95% CI, 11.8%-15.9%) for US Veterans Health Administration, and 14.0% (95% CI, 12.8%-15.2%) for US employer-sponsored insurance. In contrast, low-value use of triiodothyronine testing did not change significantly in Ontario, Canada (RME, 0.3%; 95% CI, -1.4% to 2.0%) or the US Veterans Health Administration (RME, 0.7%; 95% CI, -4.7% to 6.4%) and increased (RME, 3.0%; 95% CI, 1.6%-4.4%) for US employer-sponsored insurance. Conclusions and Relevance: In this study, marginal reductions in the use of 2 low-value laboratory tests were associated with the release of related Choosing Wisely recommendations but a greater reduction in low-value vitamin D screening was associated with a previous payment policy change implemented in Ontario, Canada. These findings suggest that recommendations alone may be insufficient to significantly reduce use of low-value services and that pairing recommendations with policy changes may be more effective.

Developing Strategies to Reduce Unnecessary Services in Primary Care: Protocol for User-Centered Design Charrettes.

BACKGROUND: Overtreatment and overtesting expose patients to unnecessary, wasteful, and potentially harmful care. Reducing overtreatment or overtesting that has become ingrained in current clinical practices and is being delivered on a routine basis will require solutions that incorporate a deep understanding of multiple perspectives, particularly those on the front lines of clinical care: patients and their clinicians. Design approaches are a promising and innovative way to incorporate stakeholder needs, desires, and challenges to develop solutions to complex problems. OBJECTIVE: This study aimed (1) to engage patients in a design process to develop high-level deintensification strategies for primary care (ie, strategies for scaling back or stopping routine medical services that more recent evidence reveals are not beneficial) and (2) to engage both patients and primary care providers in further co-design to develop and refine the broad deintensification strategies identified in phase 1. METHODS: We engaged stakeholders in design charrettes-intensive workshops in which key stakeholders are brought together to develop creative solutions to a specific problem-focused on deintensification of routine overuse in primary care. We conducted the study in 2 phases: a 6.5-hour design charrette with 2 different groups of patients (phase 1) and a subsequent 4-hour charrette with clinicians and a subgroup of phase 1 patients (phase 2). Both phases included surveys and educational presentations related to deintensification. Phase 1 involved several design activities (mind mapping, business origami, and empathy mapping) to help patients gain a deeper understanding of the individuals involved in deintensification. Following that, we asked participants to review hypothetical scenarios where patients, clinicians, or the broader health system context posed a barrier to deintensification and then to brainstorm solutions. The deintensification themes identified in phase 1 were used to guide phase 2. This second phase primarily involved 1 design activity (WhoDo). In this activity, patients and clinicians worked together to develop concrete actions that specific stakeholders could take to support deintensification efforts. This activity included identifying barriers to the actions and approaches to overcoming those barriers. RESULTS: A total of 35 patients participated in phase 1, and 9 patients and 7 clinicians participated in phase 2. The analysis of the deintensification strategies and survey data is currently underway. The results are expected to be submitted for publication in early 2020. CONCLUSIONS: Health care interventions are frequently developed without input from the people who are most affected. The exclusion of these stakeholders in the design process often influences and limits the impact of the intervention. This study employed design charrettes, guided by a flexible user-centered design model, to bring clinicians and patients with differing backgrounds and with different expectations together to cocreate real-world solutions to the complex issue of deintensifying medical services. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/15618.

Measures Used to Assess the Impact of Interventions to Reduce Low-Value Care: a Systematic Review.

IMPORTANCE: Studies of interventions to reduce low-value care are increasingly common. However, little is known about how the effects of such interventions are measured. OBJECTIVE: To characterize measures used to assess interventions to reduce low-value care. EVIDENCE REVIEW: We searched PubMed and Web of Science to identify studies published between 2010 and 2016 that examined the effects of interventions to reduce low-value care. We also searched ClinicalTrials.gov to identify ongoing studies. We extracted data on characteristics of studies, interventions, and measures. We then developed a framework to classify measures into the following categories: utilization (e.g., number of tests ordered), outcome (e.g., mortality), appropriateness (e.g., overuse of antibiotics), patient-reported (e.g., satisfaction), provider-reported (e.g., satisfaction), patient-provider interaction (e.g., informed decision-making elements), value, and cost. We also determined whether each measure was designed to assess unintended consequences. FINDINGS: A total of 1805 studies were identified, of which 101 published and 16 ongoing studies were included. Of published studies (N = 101), 68% included at least one measure of utilization, 41% of an outcome, 52% of appropriateness, 36% of cost, 8% patient-reported, and 3% provider-reported. Funded studies were more likely to use patient-reported measures (17% vs 0%). Of ongoing studies (registered trials) (N = 16), 69% included at least one measure of utilization, 75% of an outcome, 50% of appropriateness, 19% of cost, 50% patient-reported, 13% provider-reported, and 6% patient-provider interaction. Of published studies, 34% included at least one measure of an unintended consequence as compared to 63% of ongoing studies. CONCLUSIONS AND RELEVANCE: Most published studies focused on reductions in utilization rather than on clinically meaningful measures (e.g., improvements in appropriateness, patient-reported outcomes) or unintended consequences. Investigators should systematically incorporate more clinically meaningful measures into their study designs, and sponsors should develop standardized guidance for the evaluation of interventions to reduce low-value care.

Effects of Guideline and Formulary Changes on Statin Prescribing in the Veterans Affairs.

OBJECTIVE: To compare the effects of two sequential policy changes-the addition of a high-potency statin to the Department of Veterans Affairs (VA) formulary and the release of the American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines-on VA provider prescribing. DATA SOURCES/STUDY SETTING: Retrospective analysis of 1,100,682 VA patients, 2011-2016. STUDY DESIGN: Interrupted time-series analysis of changes in prescribing of moderate-to-high-intensity statins among high-risk patients and across high-risk subgroups. We also assessed changes in prescribing of atorvastatin and other statin drugs. We estimated marginal effects (ME) of formulary and guideline changes by comparing predicted and observed statin use. DATA COLLECTION/EXTRACTION METHODS: Data from VA Corporate Data Warehouse. PRINCIPAL FINDINGS: The use of moderate-to-high-intensity statins increased by 2 percentage points following the formulary change (ME, 2.4, 95% confidence interval [CI], 2.2 to 2.6) and less than 1 percentage point following the guideline change (ME, 0.8, 95% CI, 0.6 to 0.9). The formulary change led to approximately a 12 percentage-point increase in the use of moderate-to-high-intensity atorvastatin (ME, 11.5, 95% CI, 11.3 to 11.6). The relatively greater provider response to the formulary change occurred across all patient subgroups. CONCLUSIONS: Addition of a high-potency statin to formulary affected provider prescribing more than the ACC/AHA guidelines.

Perceived Barriers to Implementing Individual Choosing Wisely® Recommendations in Two National Surveys of Primary Care Providers.

BACKGROUND: While some research has examined general attitudes about efforts to reduce overutilization of services, such as the Choosing Wisely® (CW) initiative, little data exists regarding primary care providers' attitudes regarding individual recommendations. OBJECTIVE: We sought to identify whether particular CW recommendations were perceived by primary care providers as difficult to follow, difficult for patients to accept, or both. DESIGN: Two national surveys, one by mail to a random sample of 2000 U.S. primary care physicians in November 2013, and the second electronically to a random sample of 2500 VA primary care providers (PCPs) in October-December 2014. PARTICIPANTS: A total of 603 U.S. primary care physicians and 1173 VA primary care providers. Response rates were 34 and 48 %, respectively. MAIN MEASURES: PCP ratings of whether 12 CW recommendations for screening, testing and treatments applicable to adult primary care were difficult to follow and difficult for patients to accept; and ratings of potential barriers to reducing overutilization. KEY RESULTS: For four recommendations regarding not screening or testing in asymptomatic patients, less than 20 % of PCPs found the CW recommendations difficult to accept (range 7.2-16.6 %) or difficult for patients to follow (12.2-19.3 %). For five recommendations regarding testing or treatment for symptomatic conditions, however, there was both variation in reported difficulty to follow (9.8-32 %) and a high level of reported difficulty for patients to accept (35.7-87.1 %). The most frequently reported barriers to reducing overuse included malpractice concern, patient requests for services, lack of time for shared decision making, and the number of tests recommended by specialists. CONCLUSIONS: While PCPs found many CW recommendations easy to follow, they felt that some, especially those for symptomatic conditions, would be difficult for patients to accept. Overcoming PCPs' perceptions of patient acceptability will require approaches beyond routine physician education, feedback and financial incentives.

Rates of Deintensification of Blood Pressure and Glycemic Medication Treatment Based on Levels of Control and Life Expectancy in Older Patients With Diabetes Mellitus.

IMPORTANCE: Older patients with diabetes mellitus receiving medical treatment whose blood pressure (BP) or blood glucose level are potentially dangerously low are rarely deintensified. Given the established risks of low blood pressure and blood glucose, this is a major opportunity to decrease medication harm. OBJECTIVE: To examine the rate of BP- and blood glucose-lowering medicine deintensification among older patients with type 1 or 2 diabetes mellitus who potentially receive overtreatment. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study conducted using data from the US Veterans Health Administration. Participants included 211 667 patients older than 70 years with diabetes mellitus who were receiving active treatment (defined as BP-lowering medications other than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, or glucose-lowering medications other than metformin hydrochloride) from January 1 to December 31, 2012. Data analysis was performed December 10, 2013, to July 20, 2015. EXPOSURES: Participants were eligible for deintensification of treatment if they had low BP or a low hemoglobin A1c (HbA1c) level in their last measurement in 2012. We defined very low BP as less than 120/65 mm Hg, moderately low as systolic BP of 120 to 129 mm Hg or diastolic BP (DBP) less than 65 mm Hg, very low HbA1c as less than 6.0%, and moderately low HbA1c as 6.0% to 6.4%. All other values were not considered low. MAIN OUTCOMES AND MEASURES: Medication deintensification, defined as discontinuation or dosage decrease within 6 months after the index measurement. RESULTS: The actively treated BP cohort included 211,667 participants, more than half of whom had moderately or very low BP levels. Of 104,486 patients with BP levels that were not low, treatment in 15.1% was deintensified. Of 25,955 patients with moderately low BP levels, treatment in 16.0% was deintensified. Among 81,226 patients with very low BP levels, 18.8% underwent BP medication deintensification. Of patients with very low BP levels whose treatment was not deintensified, only 0.2% had a follow-up BP measurement that was elevated (BP ≥140/90 mm Hg). The actively treated HbA1c cohort included 179,991 participants. Of 143,305 patients with HbA1c levels that were not low, treatment in 17.5% was deintensified. Of 23,769 patients with moderately low HbA1c levels, treatment in 20.9% was deintensified. Among 12,917 patients with very low HbA1c levels, 27.0% underwent medication deintensification. Of patients with very low HbA1c levels whose treatment was not deintensified, fewer than 0.8% had a follow-up HbA1c measurement that was elevated (≥7.5%). CONCLUSIONS AND RELEVANCE: Among older patients whose treatment resulted in very low levels of HbA1c or BP, 27% or fewer underwent deintensification, representing a lost opportunity to reduce overtreatment. Low HbA1c or BP values or low life expectancy had little association with deintensification events. Practice guidelines and performance measures should place more focus on reducing overtreatment through deintensification.

Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.

OBJECTIVES: Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes. METHODS: We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling. RESULTS: Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM. DISCUSSION: Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence.

Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program.

OBJECTIVES: To determine patient characteristics associated with achieving and sustaining blood pressure (BP) targets in the Adherence and Intensification of Medications program, a program led by pharmacists trained in motivational interviewing and authorized to make BP medication changes. METHODS: We conducted a retrospective cohort study of patients with diabetes and persistent hypertension in Kaiser Permanente and the Department of Veterans Affairs. Using two-level logistic regression, baseline survey data from 458 program participants were examined to determine patient characteristics associated with (1) discharge from the program with a target BP (short-term success) and (2) maintenance of the target BP over a nine-month period (long-term success). RESULTS: In multivariable analyses, patients who screened positive for depression or had a higher baseline systolic BP were less likely to achieve short-term success (adjusted odds ratio (AOR) 0.42 [95% confidence interval (CI): 0.19-0.93], p = 0.03; AOR 0.94 [0.91-0.97], p < 0.01; respectively). Patients who reported at baseline one or more barriers to medication adherence were less likely to achieve long-term success (AOR 0.50 [0.26-0.94], p = 0.03). CONCLUSIONS: Although almost 90% of patients achieved short-term success, only 28% achieved long-term success. Baseline barriers to adherence were associated with lack of long-term success and could be the target of maintenance programs for patients who achieve short-term success.

Accounting for clinical action reduces estimates of gender disparities in lipid management for diabetic veterans.

BACKGROUND: Women with diabetes have higher low-density lipoprotein (LDL) levels than men, resulting in apparent disparities between genders on quality indicators tied to LDL thresholds. OBJECTIVE: To investigate whether gender disparities persist when accounting for clinical action with statins or cardiovascular risk. DESIGN: Retrospective cohort study. PARTICIPANTS: Veterans Health Administration patients (21,780 women and 646,429 men) aged 50-75 with diabetes. MAIN MEASURES: Threshold measure: LDL < 100 mg/dL; clinical action measure: LDL < 100 mg/dL; or LDL ≥ 100 mg/dL and the patient was prescribed a moderate or high-dose statin at the time of the test; or LDL ≥ 100 mg/dL and the patient received other appropriate clinical action within 90 days; adherence: continuous multiple interval measure of gaps in dispensed medication (CMG). KEY RESULTS: Women were much less likely to have LDL < 100 mg/dL than were men (55 % vs. 68 %). This disparity narrowed from 13 % to 6 % for passing the clinical action measure (79 % vs. 85 %). These gender differences persisted among those with ischemic heart disease (IHD). Women had a lower odds of passing the clinical action measure (odds ratio 0.68, 95 % confidence interval 0.66-0.71). Among those with IHD, the gender gap increased with age. Differences in pass rates were explained by women's higher LDL levels, but not by their slightly worse adherence (3 % higher CMG). CONCLUSIONS: Women and men veterans receive more similar quality of care for lipids in diabetes than previously indicated. Less reassuringly, the remaining gender differences appear to be as common in women at high cardiovascular risk as in those at low risk. Rather than focus on simply improving LDL levels in all women with diabetes, future efforts should ensure that patients with high cardiovascular risk are appropriately treated with statins when clinically indicated, feasible, and concordant with patient preferences.

Assessing appropriateness of lipid management among patients with diabetes mellitus: moving from target to treatment.

BACKGROUND: Performance measures that emphasize only a treat-to-target approach may motivate overtreatment with high-dose statins, potentially leading to adverse events and unnecessary costs. We developed a clinical action performance measure for lipid management in patients with diabetes mellitus that is designed to encourage appropriate treatment with moderate-dose statins while minimizing overtreatment. METHODS AND RESULTS: We examined data from July 2010 to June 2011 for 964 818 active Veterans Affairs primary care patients ≥18 years of age with diabetes mellitus. We defined 3 conditions as successfully meeting the clinical action measure for patients 50 to 75 years old: (1) having a low-density lipoprotein (LDL) <100 mg/dL, (2) taking a moderate-dose statin regardless of LDL level or measurement, or (3) receiving appropriate clinical action (starting, switching, or intensifying statin therapy) if LDL is ≥100 mg/dL. We examined possible overtreatment for patients ≥18 years of age by examining the proportion of patients without ischemic heart disease who were on a high-dose statin. We then examined variability in measure attainment across 881 facilities using 2-level hierarchical multivariable logistic models. Of 668 209 patients with diabetes mellitus who were 50 to 75 years of age, 84.6% passed the clinical action measure: 67.2% with LDL <100 mg/dL, 13.0% with LDL ≥100 mg/dL and either on a moderate-dose statin (7.5%) or with appropriate clinical action (5.5%), and 4.4% with no index LDL on at least a moderate-dose statin. Of the entire cohort ≥18 years of age, 13.7% were potentially overtreated. Facilities with higher rates of meeting the current threshold measure (LDL <100 mg/dL) had higher rates of potential overtreatment (P<0.001). CONCLUSIONS: Use of a performance measure that credits appropriate clinical action indicates that almost 85% of diabetic veterans 50 to 75 years of age are receiving appropriate dyslipidemia management. However, many patients are potentially overtreated with high-dose statins.