Self-Reported Training Adequacy, Experience, and Comfort Level in Performing Schizophrenia-Related Clinical Skills among Psychiatry Residents and Fellows.

OBJECTIVE: In the context of an educational program on schizophrenia for psychiatry trainees, this survey study analyzed associations between self-reported training adequacy, experience in providing patient care, and comfort level in performing schizophrenia-related clinical skills. The influence of the education on comfort level was also assessed for each skill. METHODS: Survey respondents were psychiatry residents and fellows who participated in a schizophrenia education program at an in-person workshop or through online videos recorded at the workshop. In a pre-program survey, participants reported their experience in providing schizophrenia patient care and rated their training adequacy and comfort level for performing seven clinical skills involved in diagnosing and treating schizophrenia. The post-program survey included items for reassessing comfort level in performing the skills. RESULTS: Across the seven clinical skills, the proportion of respondents (n = 79) who agreed or strongly agreed that their training was adequate ranged from 29 to 88 %. The proportion of high ratings for comfort level in skill performance ranged from 45 to 83 %. Comfort level was significantly associated with training adequacy for all seven clinical skills and with experience in providing patient care for four skills. For all skills, comfort level ratings were significantly higher after versus before the educational workshop. Commonly indicated needs for further training included education on new therapies, exposure to a broader range of patients, and opportunities for longitudinal patient management. CONCLUSIONS: Psychiatry trainees' self-reported, disease-specific training adequacy, experiences, and comfort level have unique applications for developing and evaluating graduate medical curriculum.

Continuing Medical Education Improves Gastroenterologists' Compliance with Inflammatory Bowel Disease Quality Measures.

BACKGROUND: Low rates of compliance with quality measures for inflammatory bowel disease (IBD) have been reported for US gastroenterologists. AIMS: We assessed the influence of quality improvement (QI) education on compliance with physician quality reporting system (PQRS) measures for IBD and measures related to National Quality Strategy (NQS) priorities. METHODS: Forty community-based gastroenterologists participated in the QI study; 20 were assigned to educational intervention and control groups, respectively. At baseline, randomly selected charts of patients with moderate-to-severe ulcerative colitis were retrospectively reviewed for the gastroenterologists' performance of 8 PQRS IBD measures and 4 NQS-related measures. The intervention group participated in a series of accredited continuing medical education (CME) activities focusing on QI. Follow-up chart reviews were conducted 6 months after the CME activities. Independent t tests were conducted to compare between-group differences in baseline-to-follow-up rates of documented compliance with each measure. RESULTS: The analysis included 299 baseline charts and 300 follow-up charts. The intervention group had significantly greater magnitudes of improvement than the control group for the following measures: assessment of IBD type, location, and activity (+14 %, p = 0.009); influenza vaccination (+13 %, p = 0.025); pneumococcal vaccination (+20 %, p = 0.003); testing for latent tuberculosis before anti-TNF-α therapy (+10 %, p = 0.028); assessment of hepatitis B virus status before anti-TNF-α therapy (+9 %, p = 0.010); assessment of side effects (+17 %, p = 0.048), and counseling patients about cancer risks (+13 %, p = 0.013). CONCLUSIONS: QI-focused CME improves community-based gastroenterologists' compliance with IBD quality measures and measures aligned with NQS priorities.

Strategies for Overcoming Barriers to Adopting Biosimilars and Achieving Goals of the Biologics Price Competition and Innovation Act: A Survey of Managed Care and Specialty Pharmacy Professionals.

BACKGROUND: The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care and specialty pharmacy professionals are uniquely qualified to inform initiatives to address these barriers. OBJECTIVE: To assess perceptions regarding strategies for overcoming barriers to biosimilar adoption among managed care and specialty pharmacy professionals by conducting a survey study. METHODS: Invitations to complete the online survey were emailed by the Academy of Managed Care Pharmacy (AMCP) to members and customers and to contacts sourced from a commercial database. In addition to questions on respondent demographics and perceptions of biosimilars, the survey listed 16 strategies for overcoming key barriers to biosimilar adoption. On a 5-point scale, participants rated their opinion on the likelihood that each strategy would have the potential to assist in achieving BPCIA goals. The survey also listed 6 barriers to biosimilar adoption. On a 5-point scale, participants rated their perceived difficulty in overcoming each barrier. The survey concluded with an open-text item that asked participants to list 3 additional strategies for overcoming biosimilar adoption barriers. Response frequencies were calculated to describe participants' ratings of the strategies and barriers. Statistical analyses were conducted to assess whether the ratings differed among respondents grouped by work organization. For the open-text item, we conducted qualitative content analyses to categorize strategies by stakeholder groups that might take primary implementation roles. RESULTS: A total of 300 managed care and specialty pharmacy professionals completed the survey. There was considerable variation in the preferences, policies, and practices regarding biosimilar adoption among respondents' work organizations. Responses to several survey items reflected positive attitudes about the safety and efficacy of biosimilars; for example, 84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic. Based on pooled percentages for ratings of likely and extremely likely to overcome barriers to biosimilar adoption, the highest-rated strategies were for prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of reference biologics with biosimilars (90%). The lowest-rated strategies were for requiring therapeutic drug monitoring for patients who switch to biosimilars (39%) and using quotas to incentivize providers to prescribe biosimilars (40%). For the qualitative analysis, the highest numbers of respondents' suggested strategies indicated primary implementation roles of biosimilar manufacturers (40%), the federal government (26%), and managed care organizations (15%). CONCLUSIONS: Reflecting the unique knowledge, perspectives, and practices of managed care and specialty pharmacy professionals, the study findings are relevant to informing and advancing initiatives for achieving BPCIA goals. DISCLOSURES: The survey study reported in this article was part of a continuing education program funded by an independent educational grant, which was awarded by Sandoz, a Novartis Division, to PRIME Education. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist in developing the survey and writing the manuscript. The grantor had no role in the study design, execution, analysis, or reporting. Greene and Pardo are employed by PRIME. Singh and Carden are employed by AMCP. Greene, Singh, Carden, and Pardo have no other disclosures. Lichtenstein received an honorarium from PRIME for serving as faculty for the continuing education program and has been a consultant for Pfizer, Cellceutix, and Merck.

Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration.

BACKGROUND: The introduction of anti-vascular endothelial growth factor (anti-VEGF) drugs to ophthalmology has revolutionized the treatment of neovascular age-related macular degeneration (nAMD). Despite this significant progress, gaps and challenges persist in the diagnosis of nAMD, initiation of treatment, and management of frequent intravitreal injections. Thus, nAMD remains a leading cause of blindness in the United States. OBJECTIVE: To present current knowledge, evidence, and expert perspectives on anti-VEGF therapies in nAMD to support managed care professionals and providers in decision making and collaborative strategies to overcome barriers to optimize anti-VEGF treatment outcomes among nAMD patients. SUMMARY: Three anti-VEGF therapies currently form the mainstay of treatment for nAMD, including 2 therapies approved by the FDA for treatment of nAMD (aflibercept and ranibizumab) and 1 therapy approved by the FDA for oncology indications and used off-label for treatment of nAMD (bevacizumab). In clinical trials, each of the 3 agents maintained visual acuity (VA) in approximately 90% or more of nAMD patients over 2 years. However, in long-term and real-world settings, significant gaps and challenges in diagnosis, treatment, and management pose barriers to achieving optimal outcomes for patients with nAMD. Many considerations, including individual patient characteristics, on-label versus off-label treatment, repackaging, and financial considerations, add to the complexity of nAMD decision making and management. Many factors may contribute to additional challenges leading to suboptimal long-term outcomes among nAMD patients, such as delays in diagnosis and/or treatment approval and initiation, individual patient response to different anti-VEGF therapies, lapses in physician regimentation of anti-VEGF injection and monitoring, and inadequate patient adherence to treatment and monitoring. These latter factors highlight the considerable logistical, emotional, and financial burdens of long-term, frequent intravitreal injections and the vital importance of personalized approaches to anti-VEGF treatment decision making and management for patients with nAMD. To address these challenges and reduce the number of yearly injections, studies have examined alternative dosing regimens, including extended fixed intervals, as needed, and treat-and-extend strategies in specific nAMD patient populations. New clinical evidence and insights into expert clinical practice discussed in this article can support managed care professionals in the key role they play in addressing challenges in nAMD treatment and management and optimizing patient outcomes through appropriate management of anti-VEGF treatment. DISCLOSURES: PRIME Education is an independent medical education company and has been an accredited provider of continuing education for 23 years. There is no fee for this activity as it is sponsored by PRIME through an educational grant from Regeneron. All authors contributed to the writing and reviewing of the article. Wykoff reports consultancies/research grants from Alcon Laboratories, Genentech/Roche, Clearside, and Iconic Therapeutics; consultancies/honoraria, research grants, and speaker fees from Allergan and Regeneron; research grants from Allegro, Apellis, Aura, NEI, NIH, Novartis, OHR Pharmaceuticals, Ophthotech, pSivida, Roche, Santen, SciFluor, Tyrogenex; and consultancies for Alimera Sciences, Alnylam Pharmaceuticals, Bayer, DORC, ONL Therapeutics, Thrombogenics, and Valeant. Clark reports advisory board work, consultancies, research grants, and speaker fees from Genentech/Roche and Regeneron and consultancy for Bayer. Brill reports consultancies for Aries Pharma, Avella, BaroNova, Braeburn Pharmaceuticals, Cardinal Health, Endogastric Solutions, GeneNews, Halt Medical, Lumendi, Medtronic, Monteris Medical, Natera, Phosphorus, Rebiotix, Seno Medical, UCB, Vermillion, Echosens, and HAP Innovations. Brill is a shareholder in EndoChoice, GeneNews, SonarMD, and SynerZ and reports advisory board work with Nestle Health Sciences, Indivior Pharmaceuticals, Eli Lilly, Blue Earth Diagnostics, Bayer, and AstraZeneca. Nielson reports advisory board work/consultancy and research grants for Genentech/Roche; advisory board work and research grants from Regeneron; and research grants from Alcon and Ophthotech.

Assessing Patient and Provider Perceptions of Factors Associated with Patient Engagement in Asthma Care.

RATIONALE: National quality improvement initiatives emphasize building partnerships between patients and providers by promoting patient engagement through communication, shared decision-making, and self-care skills. Efforts to promote patient engagement are especially important for people with asthma. To cultivate effective partnerships in asthma care, patients and providers may benefit from understanding each other's values and perceptions regarding treatment goals, shared decision-making, as well as barriers to optimal care and outcomes. OBJECTIVES: We conducted a survey study to assess and compare asthma patient and provider perceptions of factors that are associated with effective partnerships and patient engagement. METHODS: Surveys were administered to adult patients with poorly controlled asthma (n = 328) and their physicians (n = 40) before they participated in collaborative learning sessions held in 40 allergy and immunology practices across the United States. The surveys included items for both groups to report their asthma-related treatment goals and perceptions about information needs and knowledge, shared decision-making, and barriers to medication adherence. RESULTS: Providers rated their knowledge about different aspects of their patients' health status (on a scale from 1 = poor knowledge to 5 = excellent knowledge). The lowest percentages of ratings 4 and 5 were for knowledge about patients' financial status (29%), adherence (42%), lifestyle (46%), and workplace situation (46%). The highest percentages of ratings 4 and 5 were for knowledge about patients' exacerbation history (75%), smoking status (76%), hospitalization history (79%), and comorbidities (79%). The percentages of patients and providers, respectively, who indicated the following treatment goals as important differed significantly: preventing exacerbations (62% and 83%; P = 0.01), preventing emergency department visits (44% and 76%; P < 0.01), and improving ability to perform daily activities (69% and 48%; P < 0.01). However, there were no significant differences in percentages of provider-reported goals and goals that providers estimated their patients would indicate as important. Disconnects were also observed for perceived barriers to asthma medication adherence. CONCLUSIONS: The observed disconnects in patient and provider perceptions may inform strategies for cultivating effective partnerships and patient engagement to improve care quality and outcomes for people with asthma.

Improving Interprofessional and Coproductive Outcomes of Care for Patients with Chronic Obstructive Pulmonary Disease.

In the U.S., suboptimal care quality for patients with chronic obstructive pulmonary disease (COPD) is reflected by high rates of emergency department visits and hospital readmissions, as well as excessive costs. Moreover, a substantial proportion of COPD patients do not receive guideline-directed therapies. In quality improvement (QI) programs, these types of health care problems are commonly addressed through interventions that primarily or exclusively support physicians in aligning their practices with guidelines and clinical quality measures. However, the root causes of many deficits in health care quality are not necessarily "physician centric." Instead, they often involve suboptimal collaboration among members of interprofessional health care teams and gaps in coproductive relationships among patients and providers. We conducted a QI project to identify interprofessional and coproductive correlates of COPD care quality in the context of a continuing education program designed to advance knowledge and skill among patients, providers, and the interprofessional COPD team regarding coproductive COPD care. Participants in the program included providers in 30 primary care practices across the U.S. who, along with their own COPD patients and a separate cohort of patients from COPD advocacy groups, completed a patient-provider survey study designed to identify alignments and mismatches in coproductive perceptions and behaviors, a private survey feedback session for each practice's team, and online/mobile educational activities on COPD. In addition, more than 1,000 additional providers and 200 patients participated in just the online/mobile education. From the patient perspective, baseline measures indicated a high rate of dissatisfaction with COPD treatment plans and suboptimal coproductive interaction with members of the interprofessional health care team. Across providers, there were gaps and variation in provision of patient education, attitudes and practices regarding shared decision-making, and care coordination with pulmonary specialists. In addition, relatively low proportions of providers reported high levels of skill in various coproductive processes. The project outcomes indicated mismatches between COPD patients and providers in perceived ability to recognize COPD exacerbations, shared treatment goals, barriers to medication adherence, perceived impact of COPD on quality of life, and other aspects of COPD care. Providers demonstrated improvements in knowledge and attitudes regarding coproductive and coordinated COPD care.

Quality improvement education to improve performance on ulcerative colitis quality measures and care processes aligned with National Quality Strategy priorities.

Studies on inflammatory bowel disease (IBD) have reported suboptimal approaches to patient care. In the United States, the findings have motivated leading gastroenterology organizations to call for initiatives that support clinicians in aligning their practices with quality measures for IBD and priorities of the National Quality Strategy (NQS). We designed and implemented a quality improvement (QI) education program on ulcerative colitis in which patient charts were audited for 30 gastroenterologists before (n = 300 charts) and after (n = 290 charts) they participated in QI-focused educational activities. Charts were audited for nine measures, selected for their alignment with four NQS priorities: making care safer, ensuring patient engagement, promoting communication, and promoting effective treatment practices. Four of the measures, including guideline-directed vaccinations and assessments of disease type and activity, were part of the CMS Physician Quality Reporting System (PQRS). The other five measures involved counseling patients on various topics in ulcerative colitis management, documentation of side effects, assessment of adherence status, and simplification of dosing. The gastroenterologists also completed baseline and post-education surveys designed to assess qualitative outcomes. One of the educational interventions was a private audit feedback session conducted for each gastroenterologist. The sessions were designed to support participants in identifying measures reflecting suboptimal care quality and developing action plans for improvement. In continuous improvement cycles, follow-up interventions included QI tools and educational monographs. Across the nine chart variables, post-education improvements ranged from 0% to 48%, with a mean improvement of 15.9%. Survey findings revealed improvements in self-reported understanding of quality measures and intentions to apply them to practice, and lower rates of perceived significant barriers to high-quality care. The findings indicate the potential for QI education to support gastroenterologists in improving their performance on key measures of care quality for patients with ulcerative colitis.

Applying Quality Improvement into Systems-based Learning to Improve Diabetes Outcomes in Primary Care.

In the U.S., where the prevalence of type 2 diabetes has reached epidemic proportions, many patients with this disease are treated by primary care physicians in community-based systems, including accountable care organisations (ACOs). To address gaps in the quality of diabetes care, national quality measures have been established, including patient-centered measures adopted by the Centers for Medicare and Medicaid Services for its Shared Savings Program for ACOs. From a patient-centered perspective, high-quality diabetes care depends on effective communication between clinicians and patients, along with patient education and counseling about medications and lifestyle. We designed and implemented a quality improvement (QI) program for 30 primary care physicians treating patients with type 2 diabetes in three structurally similar but geographically diverse ACOs. Retrospective chart audits were conducted before (n = 300) and after (n = 300) each physician participated in accredited continuing medical education (CME) courses that focused on QI strategies. Randomly selected charts were audited to measurably assess essential interventions for improved outcomes in type 2 diabetes including the physicians' documentation of patient counseling and assessment of side effects, and patients' medication adherence status and changes in hemoglobin A1C (A1C) and body mass index (BMI). Paced educational interventions included a private performance improvement Internet live course conducted for each physician, small-group Internet live courses involving peer discussion, and a set of enduring materials, which were also multi-accredited for all clinicians in the physician's practice. Continual improvement cycles were guided by analysis of the baseline chart audits, quantitative survey data, and qualitative feedback offered by participants. To extend the benefit of the education, the enduring materials were offered to the interprofessional team of clinicians throughout the U.S. who did not participate in the QI program. For brevity, this article presents outcomes of the 30 primary care physicians. Baseline to post-education improvements were observed for percentages of charts with documented assessment of medication side effects (+11%) and counseling about medication risks/benefits (+28%), medication adherence (+13%), and lifestyle modifications (+8%). Improvements were also observed for documented adherence to diabetes medications (+24%) and first-to-last visit changes in A1C (-0.16%) and BMI (-2.1). The findings indicate a positive influence of QI education on primary care physicians' performance of patient-centered quality measures and patient outcomes.

Impact of Quality Improvement Educational Interventions on Documented Adherence to Quality Measures for Adults with Crohn's Disease.

BACKGROUND: In recent years, leading organizations in inflammatory bowel disease (IBD) have developed quality measures for the care of adults with Crohn's disease or ulcerative colitis. We used chart audits to assess the impact of quality improvement educational activities on documented adherence to Physician Quality Reporting System measures for IBD. METHODS: Twenty community-based gastroenterologists were recruited to participate in baseline chart audits (n = 200), a series of 4 accredited educational activities with feedback, and follow-up chart audits (n = 200). Trained abstractors reviewed randomly selected charts of adults with moderate or severe Crohn's disease. The charts were retrospectively abstracted for physicians' documented performance of the 2013 Physician Quality Reporting System IBD quality measures. We compared the physicians' baseline and posteducation rates of documented adherence with 10 of these measures. In a secondary analysis, we compared preeducation with posteducation difference scores of low-performing physicians, those whose baseline documentation rates were in the lowest quartile, and the rest of the cohort. RESULTS: At baseline, documentation of mean provider-level adherence to the 10 quality measures ranged from 3% to 98% (grand mean = 35.8%). In the overall analysis, baseline and posteducation rates of documented adherence did not differ significantly for any of the measures. However, for 4 measures, preeducation to posteducation difference scores were significantly greater among low performers than physicians in the highest 3 quartiles. CONCLUSIONS: The results of this preliminary pragmatic study indicate that quality improvement education affords the potential to improve adherence to Physician Quality Reporting System quality measures for IBD among low-performing gastroenterologists.

Influence of Continuing Medical Education on Rheumatologists' Performance on National Quality Measures for Rheumatoid Arthritis.

INTRODUCTION: In recent years researchers have reported deficits in the quality of care provided to patients with rheumatoid arthritis (RA), including low rates of performance on quality measures. We sought to determine the influence of a quality improvement (QI) continuing education program on rheumatologists' performance on national quality measures for RA, along with other measures aligned with National Quality Strategy priorities. Performance was assessed through baseline and post-education chart audits. METHODS: Twenty community-based rheumatologists across the United States were recruited to participate in the QI education program and chart audits. Charts were retrospectively audited before (n = 160 charts) and after (n = 160 charts) the rheumatologists participated in a series of accredited QI-focused educational activities that included private audit feedback, small-group webinars, and online- and mobile-accessible print and video activities. The charts were audited for patient demographics and the rheumatologists' documented performance on the 6 quality measures for RA included in the Physician Quality Reporting System (PQRS). In addition, charts were abstracted for documentation of patient counseling about medication benefits/risks and adherence, lifestyle modifications, and quality of life; assessment of RA medication side effects; and assessment of RA medication adherence. RESULTS: Mean rates of documented performance on 4 of the 6 PQRS measures for RA were significantly higher in the post-education versus baseline charts (absolute increases ranged from 9 to 24% of patient charts). In addition, after the intervention, significantly higher mean rates were observed for patient counseling about medications and quality of life, and for assessments of medication side effects and adherence (absolute increases ranged from 9 to 40% of patient charts). CONCLUSION: This pragmatic study provides preliminary evidence for the positive influence of QI-focused education in helping rheumatologists improve performance on national quality measures for RA.

Are we prepared for Affordable Care Act provisions of care coordination? Case managers' self-assessments and views on physicians' roles.

PURPOSE OF STUDY: Care coordination, traditionally the purview of the case management field, is recognized as a national priority for improving health care delivery and patient outcomes. With reforms of the Affordable Care Act (ACA) of 2010, case managers face new challenges and opportunities in providing care coordination services. The evolving roles of case managers as members of interprofessional care teams will be influenced by new policies that enable physicians to be reimbursed for care coordination. This qualitative study aimed to evaluate case managers' self-assessed readiness for ACA reforms of care coordination and their perceptions of physicians' understanding of case management and ability to lead care coordination efforts in evolving models. PRIMARY PRACTICE SETTINGS: Provisions of care coordination in the ACA affect case managers in all practice settings. The majority of this study's participants represented hospital and managed care settings. METHODOLOGY AND SAMPLE: An invitation to complete an 11-item online survey was sent by e-mail to 8,110 case managers in an opt-in database maintained by a health care continuing education company. Survey questions were designed to assess respondents' (1) self-reported levels of knowledge and preparation for ACA care coordination provisions and (2) beliefs about the readiness and abilities of physicians to administer care coordination services. In addition, demographic data and open-ended comments regarding physicians' roles in conducting care coordination were collected. Over a restricted 9-day period, 834 case managers representing various health care settings responded to the survey. RESULTS: The majority of respondents (63%) indicated that more than 50% of their day is dedicated to performing care coordination activities. However, 80% of all respondents reported being "not at all knowledgeable" or only "somewhat knowledgeable" about the new care coordination provisions in the ACA. Only 8% admitted to being "very prepared" to implement ACA changes. The majority of respondents (68%) perceive their case management departments to be at least "somewhat prepared" to implement necessary changes. Whereas 67% of respondents expect physicians to have at least a "moderate role" in implementing care coordination services, only 12% believe that physicians have more than "some" understanding of the processes of care coordination and case managers' roles. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: These qualitative study findings suggest that case managers from multiple practice settings perceive a lack of preparedness, knowledge, and understanding among themselves and physicians regarding ACA reforms that may significantly affect the delivery of care coordination services. The findings call for new initiatives in interprofessional education to address the knowledge gaps and enhance understanding of the collaborative roles among case managers and physicians.

Applications of comparative effectiveness research to case management.

PURPOSE/OBJECTIVES: This article is intended to update case managers on recent advances in comparative effectiveness research (CER) led by the Agency for Healthcare Research and Quality. The article explores potential implications and applications of CER findings to case management practice. PRIMARY PRACTICE SETTINGS: All case management settings. FINDINGS/CONCLUSIONS: An ongoing national movement to advance CER is intended to provide health care professionals with answers to questions about which diagnostic methods, therapies, devices, and services, among the available alternatives for a given disease or condition, may be most effective and safe for individual patients. IMPLICATIONS FOR CASE MANAGEMENT: Knowledge and application of CER findings may benefit case managers in their roles of improving resource utilization, controlling costs, providing stewardship, coordinating care, educating patients, and promoting treatment adherence and self-sufficiency. The findings from a 2013 study on the comparative effectiveness of outpatient case management programs have implications for improving case management models, reinforcing standards in the profession, and advancing research in the field. Continuing education on CER is important for promoting positive values and appropriate applications of its findings to case management practice.

Summary of AHRQ's Comparative Effectiveness Review of Disease-Modifying Antirheumatic Drugs for Children with Juvenile Idiopathic Arthritis.

BACKGROUND: A systematic review on the comparative effectiveness of disease-modifying antirheumatic drugs (DMARDs) used to treat children with juvenile idiopathic arthritis (JIA) was published by the Agency for Health Care Research and Quality (AHRQ) in September 2011. Studies from 198 articles included in the review addressed the benefits and harms of DMARDs compared with conventional treatments and other DMARDs used to treat JIA. The review also incorporated studies comparing various clinical tools used for diagnosing JIA and measuring disease activity. Clinical outcome measures were analyzed to determine the most effective methods to measure disease state. The lack of current research for the treatment of JIA motivated AHRQ to contract with researchers to synthesize the available information with the intent of enabling health professionals to make evidence-based practice decisions for their patients. The review alsohighlights gaps in the research and areas that need to be addressed in the future. OBJECTIVES: To (a) educate health care practitioners on the findings from AHRQ's 2011 comparative effectiveness review on DMARDs used to treat children with JIA, (b) apply review findings to make diagnosis and treatment decisions in clinical practice, and (c) recognize limitations and gaps n the current research relating to the comparative benefits and harms of DMARDs for treatment of JIA. SUMMARY: JIA is a chronic inflammatory disease affecting approximately 300,000 children and adolescents in the United States.1 Initially manifesting with inflammation, swelling, pain, and stiffness of the joints, the disease as no apparent or known cause. JIA is a clinical diagnosis based on several actors including the number of affected joints and the involvement of other tissues (e.g., the skin and lymphoid tissues), and JIA has 7 categories: systemic-onset arthritis, oligoarthritis, rheumatoid-factor positive polyarthritis, rheumatoid-factor negative polyarthritis, enthesitis-related arthritis, psoriatic arthritis, and undifferentiated arthritis.2 Complete remission and resolution of disease activity are the ultimate treatment goals; however, there is no present cure. Inhibition of inflammation, prevention of joint damage, and promotion of a high level of functioning are the immediate goals of treatment. Even with treatment, patients with JIA continue to experience disease activity, joint destruction, suboptimal function, and impaired quality of life, all of which extend into adulthood.3 JIA can be severely debilitating and places a heavy physical and psychological burden on children and families affected by the disease. Methotrexate is a nonbiologic DMARD with an unknown mechanism of action. Methotrexate has been used for so long in the treatment of JIA that it is frequently considered a part of conventional treatment; the evidence shows that methotrexate is superior to conventional treatment with NSAIDsand/or intra-articular corticosteroids. The introduction of newer biologic DMARDs has spawned optimism that treatment will increasingly lead to improved outcomes for JIA, but the evidence is insufficient to support superiority over methotrexate. There is moderate evidence to support the claim that continued treatment from 4 months to 2 years with a biologic DMARD in children who have responded to a biologic DMARD decreases the risk of a flare. However, the safety of biologic DMARDs for long-term use has not been determined and may be associated with the developmentof cancer. The association between tumor necrosis factor (TNF) alpha inhibitors and potential increased risk of lymphoma caused the U.S. Food and Drug Administration (FDA) to place boxed warning labels on biologic DMARDs including etancercept, infliximab, and adalimumab. The effectiveness of the DMARDs appears to vary among categories of JIA and the treatment history of individual patients. Except for methotrexate, there is insufficient evidence to support selection of a specific drug or drug class over another in the treatment of JIA. The AHRQ review examines the scientific literature on DMARDs used in children with JIA in an effort to synthesize what is known about the subject, and the comprehensive review identifies important research gaps in the literature that need to be addressed. Only 8 studies (in 9 publications) were rated "good quality" by the AHRQ investigators.

Summary of AHRQ's comparative effectiveness review of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers added to standard medical therapy for treating stable ischemic heart disease.

BACKGROUND: Standard therapies for the management of stable ischemic heart disease (IHD) partially reduce the risk of a future acute coronary syndrome. Among patients with chronic heart failure or previous myocardial infarction and left ventricular dysfunction, a large body of evidence supports the benefits of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-II receptor blockers (ARBs) and, in heart failure, combined therapy with these agents. In contrast, there is less certainty regarding outcomes of ACE inhibitors and ARBs for people with stable IHD who have preserved left ventricular function and no signs or symptoms of heart failure. To compile and synthesize findings derived from research on this specific population, the Agency for Healthcare Research and Quality (AHRQ) commissioned and, in October 2009, published a systematic review and meta-analysis on the benefits and harms of ACE inhibitors and ARBs. OBJECTIVES: To (a) familiarize health care professionals with AHRQ's 2009 systematic review on ACE inhibitors and ARBs for people with stable IHD and preserved left ventricular function, (b) provide commentary and encourage consideration of the clinical and managed care applications of the review findings, and (c) identify limitations to the existing research on the benefits and harms of ACE inhibitors and ARBs. SUMMARY: Six trials meeting eligibility criteria provided moderate to strong evidence that, compared with standard therapies alone, ACE inhibitors significantly lower the risks of total mortality, cardiovascular mortality, nonfatal myocardial infarction (MI), stroke, and other clinical outcomes. However, study participants on ACE inhibitors had higher incidences of withdrawals due to adverse events, including syncope, cough, and hyperkalemia. Only 1 trial (TRANSCEND) met eligibility criteria for comparing standard therapies alone versus an ARB (telmisartan). No significant differences were observed for individual clinical endpoints across groups in TRANSCEND, although the composite measure (cardiovascular mortality, nonfatal MI, and stroke) was significantly lower for telmisartan compared with placebo; like ACE inhibitors, ARB therapy increased the risk of hyperkalemia. Only 1 trial (ONTARGET) was identified that compared an ACE inhibitor (ramipril) with an ARB (telmisartan), and this trial showed that ramipril and telmisartan have similar efficacy, similar risks of harms, and therefore a similar balance of benefits to harms. ONTARGET showed that the risk reduction for all clinical endpoints was similar across the 3 treatment arms (ramipril, telmisartan, and combination therapy with ramipril and telmisartan). Combination therapy in ONTARGET was associated with a greater number of total study discontinuations, including discontinuations due to hypotension and syncope. Telmisartan compared with ramipiril had lower rates of cough and angioedema and a higher rate of hypotensive symptoms; there was no difference between ramipril and telmisartan in the rate of syncope. This summary of the AHRQ review also describes the benefits and harms of ACE inhibitors and ARBs in patients who recently had, or were scheduled to have, a revascularization procedure and in different patient subpopulations.

AHRQ's comparative effectiveness research on premixed insulin analogues for adults with type 2 diabetes: understanding and applying the systematic review findings.

BACKGROUND: Among people with type 2 diabetes who have severe pancreatic Beta-cell dysfunction, exogenous insulin treatment is essential for controlling glycemia and reducing risks of disease-related complications and mortality. Conventional human insulin preparations are limited by their slow absorption and inability to adequately match the complex basal-bolus pattern of physiologic insulin activity. The development of insulin analogues, including premixed formulations that are designed to mimic physiologic insulin activity, has advanced diabetes management and afforded patients more convenient treatment options. Until recently, however, the benefits and harms of premixed insulin analogues had not been compared with outcomes of other insulin therapies and noninsulin oral antidiabetic agents. In 2008, under the auspices of the Agency for Healthcare Research and Quality (AHRQ), a systematic comparative effectiveness review on this topic was published. OBJECTIVE: To familiarize health care professionals with the AHRQ comparative effectiveness report on premixed insulin analogues, and to offer and encourage reflections on practical applications of the systematic review findings. SUMMARY: The comparative effectiveness and safety of premixed insulin analogues vary by comparator therapies and outcomes of interest. The AHRQ systematic review indicated that premixed insulin analogues are more effective than long-acting insulin analogues in lowering postprandial glucose and hemoglobin A1c; however, in this comparison the premixed analogues were associated with higher rates of hypoglycemia and more weight gain. Similar effectiveness and safety findings were obtained through the comparison of premixed insulin analogues and noninsulin antidiabetic drugs. Many comparisons did not yield firm conclusions due to a lack of studies or weak evidence.

Updates on the treatment of essential hypertension: a summary of AHRQ's comparative effectiveness review of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and direct renin inhibitors.

BACKGROUND: In 2007, the Agency for Healthcare Research and Quality (AHRQ) published a comparative effectiveness review (CER) on the benefits and risks of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) for treating essential hypertension in adults. The main findings indicated that the 2 classes of antihypertensive medications caused similar reductions in blood pressure, although higher rates of adverse events, especially cough, were reported by patients treated with ACEIs. In addition, the 2007 review indicated no treatment related differences in lipid levels, glycemic control, or progression of kidney disease among the agents. Since 2007, 39 relevant studies have been published that compare outcomes for adults treated with ACEIs versus ARBs or a drug in one of these 2 classes versus a direct renin inhibitor (DRI). To systematically analyze findings from the new research, AHRQ commissioned and, in June 2011, published an updated comparative effectiveness review on the benefits and risks of agents that target the renin-angiotensin- aldosterone system (RAAS), specifically ACEIs, ARBs, and DRIs. OBJECTIVES: To (a) familiarize health care professionals with the methods and findings from AHRQ's 2011 comparative effectiveness review on ACEIs, ARBs, and DRIs for adults with essential hypertension; (b) provide commentary and encourage consideration of the clinical and managed care applications of the review findings; and (c) identify limitations to the existing research on the benefits and risks of ACEIs, ARBs, and DRIs. SUMMARY: Consistent with the findings from AHRQ's 2007 report, the 2011 update indicated no overall differences in blood pressure control, mortality rates, and major cardiovascular events in patients treated with ACEIs versus ARBs. With a low strength of evidence, 2 studies reported a small significantly greater blood pressure reduction for patients treated with the DRI aliskiren versus the ACEI ramipril. Studies evaluating the DRI aliskiren versus ACEIs and ARBs on mortality and morbidity outcomes were relatively short, and few deaths or cardiovascular events occurred, resulting in insufficient evidence to discern differences. A random-effects meta-analysis of 23 RCTs comparing ACEIs and ARBs found no significant difference in the proportion of patients who achieved successful blood pressure control on a single antihypertensive agent. Compared with ARBs and the DRI aliskiren, ACEIs were consistently associated with higher rates of cough. Withdrawals due to adverse events were modestly more frequent for patients receiving ACEI rather than ARBs or DRIs; this is consistent with the differential rates of cough. There was no evidence of differential effects of ACEIs, ARBs, or DRIs on the outcomes of lipids, renal outcomes, carbohydrate metabolism or diabetes, or left ventricular mass; however, there was not a high strength of evidence for any of these outcomes. Regarding the question of whether ACEIs, ARBs, or DRIs are associated with better outcomes in specific patient subgroups, the evidence was insufficient to reach firm conclusions.