Health-care organization characteristics in cancer care delivery: an integrated conceptual framework with content validation.

Context can influence cancer-related outcomes. For example, health-care organization characteristics, including ownership, leadership, and culture, can affect care access, communication, and patient outcomes. Health-care organization characteristics and other contextual factors can also influence whether and how clinical discoveries reduce cancer incidence, morbidity, and mortality. Importantly, policy, market, and technology changes are transforming health-care organization design, culture, and operations across the cancer continuum. Consequently, research is essential to examine when, for whom, and how organizational characteristics influence person-level, organization-level, and population-level cancer outcomes. Understanding organizational characteristics-the structures, processes, and other features of entities involved in health care delivery-and their dynamics is an important yet understudied area of care delivery research across the cancer continuum. Research incorporating organizational characteristics is critical to address health inequities, test care delivery models, adapt interventions, and strengthen implementation. The field lacks conceptual grounding, however, to help researchers identify germane organizational characteristics. We propose a framework identifying organizational characteristics relevant for cancer care delivery research based on conceptual work in health services, organizational behavior, and management science and refined using a systematic review and key informant input. The proposed framework is a tool for organizing existing research and enhancing future cancer care delivery research. Following a 2012 Journal of the National Cancer Institute monograph, this work complements National Cancer Institute efforts to stimulate research addressing the relationship between cancer outcomes and contextual factors at the patient, provider, team, delivery organization, community, and health policy levels.

Breastfeeding Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children: A Systematic Review.

BACKGROUND: The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) promotes and supports breastfeeding for low-income women and children. A prior review reported negative associations of WIC with breastfeeding outcomes. WIC food package changes in 2009 increased breastfeeding support. OBJECTIVE: The objectives of this systematic review were to 1) evaluate evidence on WIC participation and breastfeeding outcomes and 2) evaluate breastfeeding outcomes of WIC participants before versus after the 2009 food package. DATA SOURCES: PubMed, Embase®, CINAHL, ERIC, SCOPUS, PsycINFO, and the Cochrane Central Register of Controlled Trials for papers published January 2009 to April 2022. ELIGIBILITY CRITERIA: Included studies compared breastfeeding outcomes (initiation, duration, exclusivity, early introduction of solid foods) of WIC participants with WIC-eligible nonparticipants, or among WIC participants before versus after the 2009 package change. STUDY APPRAISAL METHODS: Two independent reviewers evaluated each study and assessed risk of bias using EHPHP assessment. RESULTS: From 13 observational studies we found: 1) moderate strength of evidence (SOE) of no difference in initiation associated with WIC participation; 2) insufficient evidence regarding WIC participation and breastfeeding duration or exclusivity; 3) low SOE that the 2009 food package change is associated with greater breastfeeding exclusivity; 4) low SOE that WIC breastfeeding support services are positively associated with initiation and duration. LIMITATIONS: Only observational studies, with substantial risk of bias and heterogeneity in outcomes and exposures. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: WIC participation is not associated with a difference in breastfeeding initiation compared to WIC-eligible nonparticipants, but the 2009 food package change may have improved breastfeeding exclusivity among WIC participants and receipt of breastfeeding support services may have improved breastfeeding initiation and duration.

Maternal, Infant, and Child Health Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children : A Systematic Review.

BACKGROUND: The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is intended to improve maternal and child health outcomes. In 2009, the WIC food package changed to better align with national nutrition recommendations. PURPOSE: To determine whether WIC participation was associated with improved maternal, neonatal-birth, and infant-child health outcomes or differences in outcomes by subgroups and WIC enrollment duration. DATA SOURCES: Search (January 2009 to April 2022) included PubMed, Embase, CINAHL, ERIC, Scopus, PsycInfo, and the Cochrane Central Register of Controlled Trials. STUDY SELECTION: Included studies had a comparator of WIC-eligible nonparticipants or comparison before and after the 2009 food package change. DATA EXTRACTION: Paired team members independently screened articles for inclusion and evaluated risk of bias. DATA SYNTHESIS: We identified 20 observational studies. We found: moderate strength of evidence (SOE) that maternal WIC participation during pregnancy is likely associated with lower risk for preterm birth, low birthweight infants, and infant mortality; low SOE that maternal WIC participation may be associated with a lower likelihood of inadequate gestational weight gain, as well as increased well-child visits and childhood immunizations; and low SOE that child WIC participation may be associated with increased childhood immunizations. We found low SOE for differences in some outcomes by race and ethnicity but insufficient evidence for differences by WIC enrollment duration. We found insufficient evidence related to maternal morbidity and mortality outcomes. LIMITATION: Data are from observational studies with high potential for selection bias related to the choice to participate in WIC, and participation status was self-reported in most studies. CONCLUSION: Participation in WIC was likely associated with improved birth outcomes and lower infant mortality, and also may be associated with increased child preventive service receipt. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42020222452).

STRENGTHENING OUR VOICE IN PUBLIC POLICY ON MEDICAL EDUCATION.

Medical education is in the eye of public policy makers more than ever before. Many forces contribute to the interest of policy makers in medical education, including public awareness of how policies can affect access to and quality of clinical care. Governmental legislatures are getting more involved in medical education policy, with less acceptance of the profession's autonomy. Professional societies are not positioned to respond optimally to governmental involvement in medical education policy due to limited resources, poor coordination, and competing concerns. To urge leaders in medicine to strengthen their voice in public policy on medical education, I review educational issues that have recently received attention in the policy arena, and what professional societies have focused on. I highlight strengths and weaknesses of how professional societies have addressed public policy on medical education, and suggest opportunities for strengthening the voice of the medical community.

Implementation of a comprehensive program to improve coordination of care in an urban academic health care system.

Purpose Academic healthcare systems face great challenges in coordinating services across a continuum of care that spans hospital, community providers, home and chronic care facilities. The Johns Hopkins Community Health Partnership (J-CHiP) was created to improve coordination of acute, sub-acute and ambulatory care for patients, and improve the health of high-risk patients in surrounding neighborhoods. The paper aims to discuss this issue. Design/methodology/approach J-CHiP targeted adults admitted to the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center, patients discharged to participating skilled nursing facilities (SNFs), and high-risk Medicare and Medicaid patients receiving primary care in eight nearby outpatient sites. The primary drivers of the program were redesigned acute care delivery, seamless transitions of care and deployment of community care teams. Findings Acute care interventions included risk screening, multidisciplinary care planning, pharmacist-driven medication management, patient/family education, communication with next provider and care coordination protocols for common conditions. Transition interventions included post-discharge health plans, hand-offs and follow-up with primary care providers, Transition Guides, a patient access line and collaboration with SNFs. Community interventions involved forming multidisciplinary care coordination teams, integrated behavioral care and new partnerships with community-based organizations. Originality/value This paper offers a detailed description of the design and implementation of a complex program to improve care coordination for high-risk patients in an urban setting. The case studies feature findings from each intervention that promoted patient engagement, strengthened collaboration with community-based organizations and improved coordination of care.

Association of a Care Coordination Model With Health Care Costs and Utilization: The Johns Hopkins Community Health Partnership (J-CHiP).

Importance: The Johns Hopkins Community Health Partnership was created to improve care coordination across the continuum in East Baltimore, Maryland. Objective: To determine whether the Johns Hopkins Community Health Partnership (J-CHiP) was associated with improved outcomes and lower spending. Design, Setting, and Participants: Nonrandomized acute care intervention (ACI) and community intervention (CI) Medicare and Medicaid participants were analyzed in a quality improvement study using difference-in-differences designs with propensity score-weighted and matched comparison groups. The study spanned 2012 to 2016 and took place in acute care hospitals, primary care clinics, skilled nursing facilities, and community-based organizations. The ACI analysis compared outcomes of participants in Medicare and Medicaid during their 90-day postacute episode with those of a propensity score-weighted preintervention group at Johns Hopkins Community Health Partnership hospitals and a concurrent comparison group drawn from similar Maryland hospitals. The CI analysis compared changes in outcomes of Medicare and Medicaid participants with those of a propensity score-matched comparison group of local residents. Interventions: The ACI bundle aimed to improve transition planning following discharge. The CI included enhanced care coordination and integrated behavioral support from local primary care sites in collaboration with community-based organizations. Main Outcomes and Measures: Utilization measures of hospital admissions, 30-day readmissions, and emergency department visits; quality of care measures of potentially avoidable hospitalizations, practitioner follow-up visits; and total cost of care (TCOC) for Medicare and Medicaid participants. Results: The CI group had 2154 Medicare beneficiaries (1320 [61.3%] female; mean age, 69.3 years) and 2532 Medicaid beneficiaries (1483 [67.3%] female; mean age, 55.1 years). For the CI group's Medicaid participants, aggregate TCOC reduction was $24.4 million, and reductions of hospitalizations, emergency department visits, 30-day readmissions, and avoidable hospitalizations were 33, 51, 36, and 7 per 1000 beneficiaries, respectively. The ACI group had 26 144 beneficiary-episodes for Medicare (13 726 [52.5%] female patients; mean patient age, 68.4 years) and 13 921 beneficiary-episodes for Medicaid (7392 [53.1%] female patients; mean patient age, 52.2 years). For the ACI group's Medicare participants, there was a significant reduction in aggregate TCOC of $29.2 million with increases in 90-day hospitalizations and 30-day readmissions of 11 and 14 per 1000 beneficiary-episodes, respectively, and reduction in practitioner follow-up visits of 41 and 29 per 1000 beneficiary-episodes for 7-day and 30-day visits, respectively. For the ACI group's Medicaid participants, there was a significant reduction in aggregate TCOC of $59.8 million and the 90-day emergency department visit rate decreased by 133 per 1000 episodes, but hospitalizations increased by 49 per 1000 episodes and practitioner follow-up visits decreased by 70 and 182 per 1000 episodes for 7-day and 30-day visits, respectively. In total, the CI and ACI were associated with $113.3 million in cost savings. Conclusions and Relevance: A care coordination model consisting of complementary bundled interventions in an urban academic environment was associated with lower spending and improved health outcomes.

How we developed the GIM clinician-educator mentoring and scholarship program to assist faculty with promotion and scholarly work.

Clinician Educators' (CEs) focus on patient care and teaching, yet many academic institutions require dissemination of scholarly work for advancement. This can be difficult for CEs. Our division developed the Clinician-Educator Mentoring and Scholarship Program (CEMSP) in an effort to assist CEs with scholarship, national reputation, recognition, promotion and job satisfaction. The key components are salary-supported director and co-director who coordinate the program and serve as overall mentors and link CEs and senior faculty, and a full-time Senior Research Coordinator to assist with all aspects of scholarship, a close relationship with the General Internal Medicine (GIM) Methods Core provides advanced statistical support. Funding for the program comes from GIM divisional resources. Perceived value was evaluated by assessing the number of manuscripts published, survey of faculty regarding usage and opinion of CEMSP, and a review of faculty promotions. Although impossible to attribute the contributions of an individual component, a program specifically aimed at helping GIM CE faculty publish scholarly projects, increase participation in national organizations and focus on career progression can have a positive impact.

Challenges in implementing The Institute of Medicine systematic review standards.

In 2011, The Institute of Medicine (IOM) identified a set of methodological standards to improve the validity, trustworthiness, and usefulness of systematic reviews. These standards, based on a mix of theoretical principles, empiric evidence, and commonly considered best practices, set a high bar for authors of systematic reviews.Based on over 15 years of experience conducting systematic reviews, the Agency for Healthcare Research and Quality Evidence-based Practice Center (EPC) program has examined the EPC's adherence and agreement with the IOM standards. Even such a large program, with infrastructure and resource support, found challenges in implementing all of the IOM standards. We summarize some of the challenges in implementing the IOM standards as a whole and suggest some considerations for individual or smaller research groups needing to prioritize which standards to adhere to, yet still achieve the highest quality and utility possible for their systematic reviews.

Policy implications for optimizing advanced practice registered nurse use nationally.

This article examines the potential benefits of enhanced use of advanced practice registered nurses (APRNs) given health care workforce projections that predict an inadequate supply of certain types of providers. The conclusions of a systematic review comparing the effectiveness of care provided by APRNs with that of physicians alone or teams without APRNs indicate the viability of this approach. Allowing APRNs to assume roles that take full advantage of their educational preparation could mitigate the shortage of primary care physicians and improve care processes. The development of health care policy should be guided by patient-centric evidence rather than how care has been delivered in the past.

Impact of tobacco control interventions on smoking initiation, cessation, and prevalence: a systematic review.

BACKGROUND: Policymakers need estimates of the impact of tobacco control (TC) policies to set priorities and targets for reducing tobacco use. We systematically reviewed the independent effects of TC policies on smoking behavior. METHODS: We searched MEDLINE (through January 2012) and EMBASE and other databases through February 2009, looking for studies published after 1989 in any language that assessed the effects of each TC intervention on smoking prevalence, initiation, cessation, or price participation elasticity. Paired reviewers extracted data from studies that isolated the impact of a single TC intervention. FINDINGS: We included 84 studies. The strength of evidence quantifying the independent effect on smoking prevalence was high for increasing tobacco prices and moderate for smoking bans in public places and antitobacco mass media campaigns. Limited direct evidence was available to quantify the effects of health warning labels and bans on advertising and sponsorship. Studies were too heterogeneous to pool effect estimates. INTERPRETATIONS: We found evidence of an independent effect for several TC policies on smoking prevalence. However, we could not derive precise estimates of the effects across different settings because of variability in the characteristics of the intervention, level of policy enforcement, and underlying tobacco control environment.

Advanced practice nurse outcomes 1990-2008: a systematic review.

Advanced practice registered nurses have assumed an increasing role as providers in the health care system, particularly for underserved populations. The aim of this systematic review was to answer the following question: Compared to other providers (physicians or teams without APRNs) are APRN patient outcomes of care similar? This systematic review of published literature between 1990 and 2008 on care provided by APRNs indicates patient outcomes of care provided by nurse practitioners and certified nurse midwives in collaboration with physicians are similar to and in some ways better than care provided by physicians alone for the populations and in the settings included. Use of clinical nurse specialists in acute care settings can reduce length of stay and cost of care for hospitalized patients. These results extend what is known about APRN outcomes from previous reviews by assessing all types of APRNs over a span of 18 years, using a systematic process with intentionally broad inclusion of outcomes, patient populations, and settings. The results indicate APRNs provide effective and high-quality patient care, have an important role in improving the quality of patient care in the United States, and could help to address concerns about whether care provided by APRNs can safely augment the physician supply to support reform efforts aimed at expanding access to care.

The impact of working part-time on measures of academic productivity among general internists.

BACKGROUND: There is increased interest in part-time (PT) positions at academic medical centers (AMCs). Faculty and institutional leaders may have concerns about the potential for academic advancement among PT faculty. Our objective was to determine the impact of working PT on measures of academic productivity. METHODS: A cross-sectional survey was mailed to PT and full-time (FT) physicians in U.S. divisions of general internal medicine. Outcome measures included publications and funding. We used multivariate analysis to identify factors associated with academic productivity. RESULTS: The response rate was 63% (176 of 279); 91% of respondents were women (160 of 176). Compared with FT faculty, PT faculty were more often clinicians (Cs) or clinician-educators (CEs) (78% vs. 96%, p < 0.001), were less likely to be fellowship trained (44% vs. 23%, p < 0.001), and reported less academic support, including administrative assistance (84% vs. 67%, p = 0.008), mentoring (71% vs. 54%, p = 0.02), and research support (43% vs. 25%, p = 0.01). PT faculty spent a greater percentage of their time in patient care (55% vs. 45%, p = 0.01) and teaching (32% vs. 23%, p = 0.01) and less time in research activities (5% vs. 15%, p = 0.01) compared with FT faculty. Among Cs and CEs, FT faculty reported more publications (median 2, interquartile range [IQR 5] vs. median 0, IQR 1, p < 0.001) and funding (odds ratio [OR] 2.85, 95% confidence internal [CI] 1.36-5.98). Multivariate analyses showed that fellowship training, mentors, academic support, and number of total years worked were associated with publications and acquisition of funding. There were no associations between working PT and publications or funding. CONCLUSIONS: PT faculty report fewer publications and grants. This may be related to insufficient training and academic support. AMCs wanting to facilitate the success of their PT faculty may need to expand the support available to them.

Medication utilization and annual health care costs in patients with type 2 diabetes mellitus before and after bariatric surgery.

OBJECTIVE: To examine the relationship of bariatric surgery with the use of diabetes medications and with total health care costs in patients with type 2 diabetes mellitus. DESIGN: We studied 2235 adults with type 2 diabetes and commercial health insurance who underwent bariatric surgery in the United States during a 4-year period from January 1, 2002, through December 31, 2005. We used administrative claims data to measure the use of diabetes medications at specified time intervals before and after surgery and total median health care costs per year. SETTING: Seven states in the Blue Cross/Blue Shield Obesity Care Collaborative. PATIENTS: Two thousand two hundred thirty-five patients with type 2 diabetes mellitus who underwent bariatric surgery. RESULTS: Surgery was associated with elimination of diabetes medication therapy in 1669 of 2235 patients (74.7%) at 6 months, 1489 of 1847 (80.6%) at 1 year, and 906 of 1072 (84.5%) at 2 years after surgery. Reduction of use was observed in all classes of diabetes medications. The median cost of the surgical procedure and hospitalization was $29,959. In the 3 years following surgery, total annual health care costs per person increased by 9.7% ($616) in year 1 but then decreased by 34.2% ($2179) in year 2 and by 70.5% ($4498) in year 3 compared with a preoperative annual cost of $6376 observed from 1 to 2 years before surgery. CONCLUSIONS: Bariatric surgery is associated with reductions in the use of medication and in overall health care costs in patients with type 2 diabetes. Health insurance should cover bariatric surgery because of its health and cost benefits.

A cost-effectiveness analysis of three treatments for age-related macular degeneration.

PURPOSE: The purpose of this study was to evaluate the cost effectiveness of pegaptanib sodium and ranibizumab injections compared with photodynamic therapy (PDT) with verteporfin for the treatment of choroidal neovascularization secondary to age-related macular degeneration. METHODS: The analyses were performed using outcomes data from the pivotal trials for each treatment and the medicare reimbursable costs for each treatment and associated medical procedures. A multistate transition model with 3-month cycles was created to compare incremental medical costs associated with pegaptanib or ranibizumab versus PDT for patients with starting vision of 20/40, 20/80, and 20/200 Snellen equivalent. RESULTS: Two-year medical treatment costs ranged from $3,100 to $54,100 depending on treatment and lesion type. Photodynamic therapy was less costly and more effective than pegaptanib for predominantly classic and minimally classic lesions. Ranibizumab was not only more effective but also more costly than PDT for all lesion types. CONCLUSION: Compared with PDT, pegaptanib is inferior in both cost and effectiveness, whereas ranibizumab has a greater effectiveness. Because ranibizumab does not meet 1 of the common thresholds for being considered cost effective (<$50,000 per quality-adjusted life year), there is rationale to seek other therapies that are more cost effective.

A systematic review of barriers and interventions to improve appropriate use of therapies for sickle cell disease.

Clinical experts have expressed concern about underutilization of sickle cell disease (SCD) therapies, including hydroxyurea, prophylactic antibiotics, iron chelation, bone marrow transplantation, pain management during vaso-occlusive crisis, and receipt of routine ambulatory health care. We synthesized studies that identified barriers to and interventions to improve appropriate use of these therapies. Of the 48 studies included in our review, 35 identified therapeutic barriers or facilitators, and 13 evaluated interventions to improve use of therapies. Consistently identified barriers to appropriate pain management were negative provider attitudes and lack of provider knowledge. Four of 9 pain management interventions improved direct measures of pain management quality, while 5 improved indirect measures. One intervention improved receipt of routine ambulatory care. We concluded that interventions to improve pain management in SCD can be effective and should address providers' negative attitudes and knowledge and that more intervention studies are needed to improve receipt of recommended SCD therapies.

Therapeutic management, delivery, and postpartum risk assessment and screening in gestational diabetes.

OBJECTIVES: We focused on four questions: What are the risks and benefits of an oral diabetes agent (i.e., glyburide), as compared to all types of insulin, for gestational diabetes? What is the evidence that elective labor induction, cesarean delivery, or timing of induction is associated with benefits or harm to the mother and neonate? What risk factors are associated with the development of type 2 diabetes after gestational diabetes? What are the performance characteristics of diagnostic tests for type 2 diabetes in women with gestational diabetes? DATA SOURCES: We searched electronic databases for studies published through January 2007. Additional articles were identified by searching the table of contents of 13 journals for relevant citations from August 2006 to January 2007 and reviewing the references in eligible articles and selected review articles. REVIEW METHODS: Paired investigators reviewed abstracts and full articles. We included studies that were written in English, reported on human subjects, contained original data, and evaluated women with appropriately diagnosed gestational diabetes. Paired reviewers performed serial abstraction of data from each eligible study. Study quality was assessed independently by each reviewer. RESULTS: The search identified 45 relevant articles. The evidence indicated that: Maternal glucose levels do not differ substantially in those treated with insulin versus insulin analogues or oral agents. Average infant birth weight may be lower in mothers treated with insulin than with glyburide. Induction at 38 weeks may reduce the macrosomia rate, with no increase in cesarean delivery rates. Anthropometric measures, fasting blood glucose (FBG), and 2-hour glucose value are the strongest risk factors associated with development of type 2 diabetes. FBG had high specificity, but variable sensitivity, when compared to the 75-gm oral glucose tolerance test (OGTT) in the diagnosis of type 2 diabetes after delivery. CONCLUSIONS: The evidence suggests that benefits and a low likelihood of harm are associated with the treatment of gestational diabetes with an oral diabetes agent or insulin. The effect of induction or elective cesarean on outcomes is unclear. The evidence is consistent that anthropometry identifies women at risk of developing subsequent type 2 diabetes; however, no evidence suggested the FBG out-performs the 75-gm OGTT in diagnosing type 2 diabetes after delivery.

The reported validity and reliability of methods for evaluating continuing medical education: a systematic review.

PURPOSE: To appraise the reported validity and reliability of evaluation methods used in high-quality trials of continuing medical education (CME). METHOD: The authors conducted a systematic review (1981 to February 2006) by hand-searching key journals and searching electronic databases. Eligible articles studied CME effectiveness using randomized controlled trials or historic/concurrent comparison designs, were conducted in the United States or Canada, were written in English, and involved at least 15 physicians. Sequential double review was conducted for data abstraction, using a traditional approach to validity and reliability. RESULTS: Of 136 eligible articles, 47 (34.6%) reported the validity or reliability of at least one evaluation method, for a total of 62 methods; 31 methods were drawn from previous sources. The most common targeted outcome was practice behavior (21 methods). Validity was reported for 31 evaluation methods, including content (16), concurrent criterion (8), predictive criterion (1), and construct (5) validity. Reliability was reported for 44 evaluation methods, including internal consistency (20), interrater (16), intrarater (2), equivalence (4), and test-retest (5) reliability. When reported, statistical tests yielded modest evidence of validity and reliability. Translated to the contemporary classification approach, our data indicate that reporting about internal structure validity exceeded reporting about other categories of validity evidence. CONCLUSIONS: The evidence for CME effectiveness is limited by weaknesses in the reported validity and reliability of evaluation methods. Educators should devote more attention to the development and reporting of high-quality CME evaluation methods and to emerging guidelines for establishing the validity of CME evaluation methods.

Diffusion into use of exenatide for glucose control in diabetes mellitus: a retrospective cohort study of a new therapy.

BACKGROUND: Exenatide was approved by the US Food and Drug Administration (FDA) in April 2005 as adjunctive therapy to metformin or a sulfonylurea for the treatment of type 2 diabetes mellitus (DM). OBJECTIVE: We evaluated whether use of exenatide soon after its approval was consistent with the FDA- approved indications. METHODS: We assembled a retrospective cohort of patients with DM using data from a population of employed persons and their dependents, including pharmacy claims and claims for inpatient and outpatient services, provided by i3 Innovus. The data set included patients aged between 18 and 64 years with a diagnosis of DM or a claim for a DM drug from June 1, 2004, to December 31, 2005. Laboratory data were available for a subgroup of patients tested at specific commercial laboratories from June 1, 2003, to December 31, 2005. In addition, we requested data for patients with a diagnosis of obesity, regardless of a diagnosis of DM, to assess early off-label use of this medication. Patients were categorized by DM medication use and by their first fill date for exenatide, and their clinical characteristics were described. Early use was defined as filling a prescription for exenatide in the first 3 months after its approval. For descriptive purposes, we reported the means and percentages for the variables described. RESULTS: The study included data for 206,345 individuals (mean age, 51.3 years), of whom 54.0% were male. Starting in June 2005, prescriptions for exenatide were filled by 3225 (1.6%) individuals. Fifty-three percent of early users were women. Among those who filled a prescription for exenatide, 21.9% were obese, compared with 10.9% to 15.1% of those filling prescriptions for other DM medications. The proportion of patients filling a prescription for exenatide who had not received a prescription for any other DM medication in the preceding year was 14%, suggesting that exenatide was their initial therapy. A prescription for a thiazolidinedione was filled by 29.9% of patients within 60 days of filling a prescription for exenatide. CONCLUSIONS: Soon after its approval, exenatide was frequently used as monotherapy or in combination with a thiazolidinedione, neither of which is an FDA- approved indication. The observation that those filling a prescription for exenatide had a higher prevalence of obesity than those receiving prescriptions for other therapies may reflect awareness of the weight-lowering effects of exenatide.

Applying justice in clinical trials for diverse populations.

BACKGROUND: Considerable attention has focused on increasing clinical trial participation for members of "underrepresented groups". However, doing so involves clarifying how to meet the demands of justice, or fairness, which provides the ethical mandate to enhance broad trial representation. PURPOSE: To examine the ethical principle of justice as it applies to recruiting diverse populations to clinical trials representation. METHODS: In this paper, we analyse the conceptual and practical challenges in applying the principle of justice to clinical trials representation. RESULTS: Different facets of justice include demands for both fair outcomes and fair processes. Including both of these facets in clinical trials policy should not only promote access to trials, but also help to provide a framework to improve fairness in representation in clinical trials. Efforts to evaluate recruitment of representation should include outcome and process measures. LIMITATIONS: The suggestions offered based on this conceptual analysis need to be tested empirically. CONCLUSIONS: Those involved in the design, conduct and oversight of clinical trials should consider all of the facets of justice when assessing representation in clinical trials and attempt to balance fair access to trials with a fair process that may require protection from being unduly pressured to participate.

Systematic review: the value of the periodic health evaluation.

BACKGROUND: The periodic health evaluation (PHE) has been a fundamental part of medical practice for decades despite a lack of consensus on its value. PURPOSE: To synthesize the evidence on benefits and harms of the PHE. DATA SOURCES: Electronic searches of such databases as MEDLINE and the Cochrane Library, review of reference lists, and hand- searching of journals through September 2006. STUDY SELECTION: Studies (English-language only) assessing the delivery of preventive services, clinical outcomes, and costs among patients receiving the PHE versus those receiving usual care. DATA EXTRACTION: Study design and settings, descriptions of the PHE, and clinical outcomes associated with the PHE. DATA SYNTHESIS: The best available evidence assessing benefits or harms of the PHE consisted of 21 studies published from 1973 to 2004. The PHE had a consistently beneficial association with patient receipt of gynecologic examinations and Papanicolaou smears, cholesterol screening, and fecal occult blood testing. The PHE also had a beneficial effect on patient "worry" in 1 randomized, controlled trial but had mixed effects on other clinical outcomes and costs. LIMITATIONS: Descriptions of the PHE and outcomes were heterogeneous. Some trials were performed before U.S. Preventive Services Task Force guidelines were disseminated, limiting their applicability to modern practice. CONCLUSIONS: Evidence suggests that the PHE improves delivery of some recommended preventive services and may lessen patient worry. Although additional research is needed to clarify the long-term benefits, harms, and costs of receiving the PHE, evidence of benefits in this study justifies implementation of the PHE in clinical practice.