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A letter to the editor is presented in response to the article "The role of maintenance of certification programs in governance and professionalism" by Paul Teirstein and Eric J. Topol in the May 12, 2015, issue.

The US Supreme Court's most recent Term illustrates the considerable influence the Court has on the practice of reproductive health providers and their patients. Cases included the availability of mifepristone and emergency-care abortions. In addition, the Court substantially changed its deference to administrative agencies (e.g., Food and Drug Administration, Centres for Medicare & Medicaid Services, and United States Department of Homeland Security) which will affect medical practice. National organizations of physicians and reproductive health providers (e.g., American College of Obstetricians and Gynecologists, American Society for Reproductive Medicine, and the Pro-Life Obstetricians and Gynecologists) now play an active role in communicating with the Court to affect the outcome of cases., Competing Interests: Declaration of Interests S.R.S. has nothing to disclose. J.S.S. reports payment for expert testimony from Buckley, Theroux, Kline & Cooley, Inc.; travel support per UPMC Guidelines ($ 3500 annually)., (Copyright © 2024 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

During July 7-11, 2023, CDC received reports of two patients in different states with a tuberculosis (TB) diagnosis following spinal surgical procedures that used bone allografts containing live cells from the same deceased donor. An outbreak associated with a similar product manufactured by the same tissue establishment (i.e., manufacturer) occurred in 2021. Because of concern that these cases represented a second outbreak, CDC and the Food and Drug Administration worked with the tissue establishment to determine that this product was obtained from a donor different from the one implicated in the 2021 outbreak and learned that the bone allograft product was distributed to 13 health care facilities in seven states. Notifications to all seven states occurred on July 12. As of December 20, 2023, five of 36 surgical bone allograft recipients received laboratory-confirmed TB disease diagnoses; two patients died of TB. Whole-genome sequencing demonstrated close genetic relatedness between positive Mycobacterium tuberculosis cultures from surgical recipients and unused product. Although the bone product had tested negative by nucleic acid amplification testing before distribution, M. tuberculosis culture of unused product was not performed until after the outbreak was recognized. The public health response prevented up to 53 additional surgical procedures using allografts from that donor; additional measures to protect patients from tissue-transmitted M. tuberculosis are urgently needed., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Saroj Rai reports uncompensated service as the Association of Immunization Managers’ (AIM) liaison to CDC’s Advisory Committee on Immunization Practices – Chikungunya Workgroup and on the Legacy Council for AIM; and retirement stocks at Novartis Pharmaceuticals. Jeffrey M. Percak reports travel support from the County of San Diego and from the California Tuberculosis Controller’s Association for attendance at the California Tuberculosis Controller’s Association fall meeting. Lisa Y. Armitige reports support from the Texas Department of State Health Services, consulting fees (paid to institution) from the Kansas Health Department, and honoraria (forwarded to institution) from the American Academy of HIV Medicine. No other potential conflicts of interest were disclosed.

Background: Medicare patients and other stakeholders often make health care decisions that have economic consequences. Research on economic variables that patients have identified as important is referred to as patient-centered outcomes research (PCOR) and can generate evidence that informs decision-making. Medicare fee-for-service (FFS) claims are widely used for research and are a potentially valuable resource for studying some economic variables, particularly when linked to other datasets., Objective: The aim of this study was to identify and assess the characteristics of federally funded administrative and survey data sources that can be linked to Medicare claims for conducting PCOR on some economic outcomes., Research Design: A targeted internet search was conducted to identify a list of relevant data sources. A technical panel and key informant interviews were used for guidance and feedback., Results: We identified 12 survey and 6 administrative sources of linked data for Medicare FFS beneficiaries. A majority provide longitudinal data and are updated annually. All linked sources provide some data on social determinants of health and health equity-related factors. Fifteen sources capture direct medical costs (beyond Medicare FFS payments); 5 capture indirect costs (eg, lost wages from absenteeism), and 7 capture direct nonmedical costs (eg, transportation)., Conclusions: Linking Medicare FFS claims data to other federally funded data sources can facilitate research on some economic outcomes for PCOR. However, few sources capture direct nonmedical or indirect costs. Expanding linkages to include additional data sources, and reducing barriers to existing data sources, remain important objectives for increasing high-quality, patient-centered economic research., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Little is known about co-occurring tuberculosis (TB) and COVID-19 in low TB incidence settings. We obtained a cross-section of 333 persons in the United States co-diagnosed with TB and COVID-19 within 180 days and compared them to 4,433 persons with TB only in 2020 and 18,898 persons with TB during 2017‒2019. Across both comparison groups, a higher proportion of persons with TB-COVID-19 were Hispanic, were long-term care facility residents, and had diabetes. When adjusted for age, underlying conditions, and TB severity, COVID-19 co-infection was not statistically associated with death compared with TB infection only in 2020 (adjusted prevalence ratio 1.0 [95% CI 0.8‒1.4]). Among TB-COVID-19 patients, death was associated with a shorter interval between TB and COVID-19 diagnoses, older age, and being immunocompromised (non-HIV). TB-COVID-19 deaths in the United States appear to be concentrated in subgroups sharing characteristics known to increase risk for death from either disease alone.

In Dobbs v. Jackson Women's Health, the Supreme Court reversed constitutional protection for abortion. The law will affect the practice of medicine and patients. Practitioners should understand the decision. Protection for reproductive liberties has a checkered history. Much of the constitutional controversy is over the basis for reproductive rights, "substantive due process," the proposition that substantive rights arise from a procedural guarantee in the fourteenth amendment. The change in constitutional protection for abortion will play out differently among the states. Physicians should be prepared to assist patients with new rules and to participate in the public discussion of reproductive liberties., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Apologies are a means of responding to a medical error. Explanation of information related to the episode often fills a need for the patient and family to feel adequately informed. There are pros and cons related to the apology. The American College of Physicians, the American Medical Association, and the Joint Commission of the Accreditation of Health Care Organization Hospital strongly encourage practitioners to disclose when an error or complication occurs. Apologies can be admissible in the courtroom and much of this is state dependent. An apology will be an integral part of the clinician's armamentarium., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: This study examined the social cognition determinants of social distancing behavior during the COVID-19 pandemic in samples from Australia and the US guided by the health action process approach (HAPA)., Methods: Participants (Australia: N = 495, 50.1% women; US: N = 701, 48.9% women) completed HAPA social cognition constructs at an initial time-point (T1), and one week later (T2) self-reported their social distancing behavior., Results: Single-indicator structural equation models that excluded and included past behavior exhibited adequate fit with the data. Intention and action control were significant predictors of social distancing behavior in both samples, and intention predicted action and coping planning in the US sample. Self-efficacy and action control were significant predictors of intention in both samples, with attitudes predicting intention in the Australia sample and risk perceptions predicting intention in the US sample. Significant indirect effects of social cognition constructs through intentions were observed. Inclusion of past behavior attenuated model effects. Multigroup analysis revealed no differences in model fit across samples, suggesting that observed variations in the parameter estimates were relatively trivial., Conclusion: Results indicate that social distancing is a function of motivational and volitional processes. This knowledge can be used to inform messaging regarding social distancing during COVID-19 and in future pandemics., (© 2020 International Association of Applied Psychology.)

Background and Objectives: We implemented a naloxone education and distribution program in our academic health system. Despite the program, naloxone prescribing was not fully realized. This study aimed to identify the barriers to prescribing., Methods: We conducted a prospective, cross-sectional, mixed-methods study of naloxone prescribers. Participants completed a questionnaire regarding their prescribing practices, attitudes, facilitators, and barriers to prescribing naloxone. Participants were then invited for an interview to further explore these topics and elicit more in-depth explanations., Results: Sixty-four physicians and eight pharmacists completed the questionnaire (n = 72). The most commonly reported barrier to prescribing naloxone was time constraints (33%). During the interviews, 14 subthemes emerged within four themes: provider competency, provider beliefs, health care system, and patient factors/social climate., Discussion: Prescribers identified barriers to naloxone prescribing despite implementation of an institutional overdose education and naloxone distribution (OEND) program. The results were similar to those previously reported prior to initiation of such programs., Conclusion: In this study, we examined barriers and facilitators to naloxone prescribing. Although previous studies have shown that health care providers endorsed similar barriers, our study indicates that some of those barriers persist despite a concerted effort to educate and promote prescribing via an OEND. While our study is limited by a small, selective sample size the results indicate that improvements to our OEND program are warranted., Scientific Significance: Our study addressed an unexplored area of OEND research and may inform future program development. (Am J Addict 2019;00:00-00)., (© 2019 American Academy of Addiction Psychiatry.)

Background: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need., Objective: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK)., Methods: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later., Results: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106., Limitations: The optimal number of treatment sessions was not evaluated., Conclusion: Application of HP40 was well tolerated and effective in the removal of SKs., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

This study is the first to evaluate the existence and quality of patient-related cancer rehabilitation content on the websites of National Cancer Institute (NCI)-Designated Cancer Centers. In 2016, a team of cancer rehabilitation physicians (physiatrists) conducted an analysis of the patient-related rehabilitation content on the websites of all NCI-Designated Cancer Centers that provide clinical care (N = 62 of 69). The main outcome measures included qualitative rating of the ease of locating descriptions of cancer rehabilitation services on each website, followed by quantitative rating of the quality of the cancer rehabilitation descriptions found. More than 90% of NCI-Designated Cancer Centers providing clinical care did not have an easily identifiable patient-focused description of or link to cancer rehabilitation services on their website. Use of a website's search box and predetermined terms yielded an additional 13 descriptions (21%). Therefore, designers of nearly 70% of the websites evaluated overlooked an opportunity to present a description of cancer rehabilitation services. Moreover, only 8% of the websites included accurate and detailed information that referenced four core rehabilitation services (physiatry and physical, occupational and speech therapy). Further research is needed to confirm the presence of cancer rehabilitation services and evaluate access to these types of services at NCI-Designated Cancer Centers providing clinical care.

The Dissociative Symptoms Scale (DSS) was developed to assess moderately severe levels of depersonalization, derealization, gaps in awareness or memory, and dissociative reexperiencing that would be relevant to a wide range of clinical populations. Structural analyses of data from four clinical and five nonclinical samples ( N = 1,600) yielded four factors that reflected the domains of interest and showed good fit with the data. Sample scores were consistent with expectations and showed very good internal consistency and temporal stability. Analyses showed consistent evidence of convergent and divergent validity, and posttrauma elevations in scores and in patients with posttraumatic stress disorder provided additional evidence of construct validity. Item response theory analyses indicated that the items assessed moderately severe dissociative experiences. Overall, the results provide support for the reliability and validity of DSS total and subscale scores in the populations studied. Further work is needed to evaluate the performance of the DSS relative to structured interview measures and in samples of patients with other psychological disorders.

Background: We designed and implemented the Brigham and Women's Wellness Initiative (B-Well), a single-arm study to examine the feasibility of a workplace program that used individual and team-based financial incentives to increase physical activity among sedentary hospital employees., Methods: We enrolled sedentary, non-clinician employees of a tertiary medical center who self-reported low physical activity. Eligible participants formed or joined teams of three members and wore Fitbit Flex activity monitors for two pre-intervention weeks followed by 24 weeks during which they could earn monetary rewards. Participants were rewarded for increasing their moderate-to-vigorous physical activity (MVPA) by 10% from the previous week or for meeting the Centers for Disease Control and Prevention (CDC) physical activity guidelines (150 min of MVPA per week). Our primary outcome was the proportion of participants meeting weekly MVPA goals and CDC physical activity guidelines. Secondary outcomes included Fitbit-wear adherence and factors associated with meeting CDC guidelines more consistently., Results: B-Well included 292 hospital employees. Participants had a mean age of 38 years (SD 11), 83% were female, 38% were obese, and 62% were non-Hispanic White. Sixty-three percent of participants wore the Fitbit ≥4 days per week for ≥20 weeks. Two-thirds were satisfied with the B-Well program, with 79% indicating that they would participate again. Eighty-six percent met either their personal weekly goal or CDC physical activity guidelines for at least 6 out of 24 weeks, and 52% met their goals or CDC physical activity guidelines for at least 12 weeks. African Americans, non-obese subjects, and those with lower impulsivity scores reached CDC guidelines more consistently., Conclusions: Our data suggest that a financial incentives-based workplace wellness program can increase MVPA among sedentary employees. These results should be reproduced in a randomized controlled trial., Trial Registration: Clinicaltrials.gov, NCT02850094 . Registered July 27, 2016 [retrospectively registered].

Importance: Few cardiovascular outcomes trials have been conducted for obesity treatments. Withdrawal of 2 marketed drugs has resulted in controversy about the cardiovascular safety of obesity agents., Objective: To determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events (MACE, defined as cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction) compared with placebo in overweight and obese patients., Design, Setting, and Participants: Randomized, multicenter, placebo-controlled, double-blind noninferiority trial enrolling 8910 overweight or obese patients at increased cardiovascular risk from June 13, 2012, to January 21, 2013, at 266 US centers. After public release of confidential interim data by the sponsor, the academic leadership of the study recommended termination of the trial and the sponsor agreed., Interventions: An Internet-based weight management program was provided to all participants. Participants were randomized to receive placebo (n=4454) or naltrexone, 32 mg/d, and bupropion, 360 mg/d (n=4456)., Main Outcomes and Measures: Time from randomization to first confirmed occurrence of a MACE. The primary analysis planned to assess a noninferiority hazard ratio (HR) of 1.4 after 378 expected events, with a confidential interim analysis after approximately 87 events (25% interim analysis) to assess a noninferiority HR of 2.0 for consideration of regulatory approval., Results: Among the 8910 participants randomized, mean age was 61.0 years (SD, 7.3 years), 54.5% were female, 32.1% had a history of cardiovascular disease, and 85.2% had diabetes, with a median body mass index of 36.6 (interquartile range, 33.1-40.9). For the 25% interim analysis, MACE occurred in 59 placebo-treated patients (1.3%) and 35 naltrexone-bupropion-treated patients (0.8%; HR, 0.59; 95% CI, 0.39-0.90). After 50% of planned events, MACE occurred in 102 patients (2.3%) in the placebo group and 90 patients (2.0%) in the naltrexone-bupropion group (HR, 0.88; adjusted 99.7% CI, 0.57-1.34). Adverse effects were more common in the naltrexone-bupropion group, including gastrointestinal events in 14.2% vs 1.9% (P < .001) and central nervous system symptoms in 5.1% vs 1.2% (P < .001)., Conclusions and Relevance: Among overweight or obese patients at increased cardiovascular risk, based on the interim analyses performed after 25% and 50% of planned events, the upper limit of the 95% CI of the HR for MACE for naltrexone-bupropion treatment, compared with placebo, did not exceed 2.0. However, because of the unanticipated early termination of the trial, it is not possible to assess noninferiority for the prespecified upper limit of 1.4. Accordingly, the cardiovascular safety of this treatment remains uncertain and will require evaluation in a new adequately powered outcome trial., Trial Registration: clinicaltrials.gov Identifier: NCT01601704.

Background: The Choosing Wisely campaign encourages physicians to avoid low-value care. Although widely lauded, no study has examined its impact on clinical decisions made in primary care settings., Methods: We compared clinical decisions made for 5 Choosing Wisely recommendations over two 6-month time periods before and after the campaign launch and an educational intervention to promote it at 3 primary care residency clinics., Results: The rate of recommendations adherence was high (93.2%) at baseline but did significantly increase to 96.5% after the launch. These findings suggest primary care physicians respond to training and publicity in low-value care, though further research is needed., Conclusion: Given that even small decreases of physician test ordering can produce large cost savings, the Choosing Wisely project may help achieve the health care triple aim., (© Copyright 2015 by the American Board of Family Medicine.)

Objectives: Pediatric psychiatric emergencies are a nationwide crisis and have contributed to an increase in behavioral health emergency department (ED) visits. A collaborative response to this crisis was the creation of the Child & Adolescent Rapid Emergency Stabilization (CARES) program. The objective of this study is to determine how the CARES unit influenced length of stay (LOS) and costs for psychiatric patients in the pediatric ED., Methods: A retrospective review of ED patients was conducted. Children presenting 1 year before CARES, October 13, 2006, to October 13, 2007 (pre-CARES), were compared with 1 year after, October 15, 2007, to October 15, 2008 (post-CARES). The study population includes all patients presenting to the ED with psychiatric illnesses. The primary outcome is mean LOS in hours. Supplemental analyses of total charges, payments, and costs were performed., Results: There were 1719 visits before and 1867 visits after CARES, with 1190 and 1273 unique patient visits, respectively. Children in both groups had similar age, gender, and ethnicity. Pre-CARES had a mean LOS of 19.7 hours (SD, 32.6), whereas post-CARES had 10.8 hours (SD, 19.9) (P < 0.0001). Evaluating only unique visits, the difference remained highly significant. Post-CARES, compared with pre-CARES, the average charge per patient decreased by $905 (P < 0.0001), average payment decreased by $111 (P < 0.06), and average total cost decreased by $569 or 38.7% (P < 0.0001). The total cost savings the year after CARES opened was $1,019,168.55.

Medicaid reimbursements have become a key source of funding for nonprofit social service organizations operating outside the medical care sector, as well as an important tool for states seeking resources to fund social service programs within a devolving safety net. Drawing on unique survey data of more than one thousand nonprofit social service agencies in seven urban and rural communities, this article examines Medicaid funding of nonprofit social service organizations that target programs at working-age, nondisabled adults. We find that about one-quarter of nonprofit service organizations--mostly providers offering substance abuse and mental health treatment in conjunction with other services--report receiving Medicaid reimbursements, although very few are overly reliant on these funds. We also find Medicaid-funded social service nonprofits to be less accessible to residents of high-poverty neighborhoods or areas with concentrations of black or Hispanic residents than to residents of more affluent and white communities. We should expect that the role of Medicaid within the nonprofit social service sector will shift in the next few years, however, as states grapple with persistent budgetary pressures, rising Medicaid costs, and decisions to participate in the Medicaid expansion provisions contained within the 2010 Patient Protection and Affordable Care Act., (Copyright © 2014 by Duke University Press.)

Purpose: To examine parent and child characteristics associated with engagement in a coaching intervention to improve pediatric asthma care and factors associated with readiness to adopt and maintain targeted asthma management behaviors., Methods: Using methods based on the Transtheoretical Model, trained lay coaches worked with 120 parents of children with asthma promoting adoption and maintenance of asthma management strategies (behaviors). Coaches assigned stage-of-change (on continuum: pre-contemplation, contemplation, preparation, action, maintenance) for each behavior every time it was discussed. Improvement in stage-of-change was analyzed for association with characteristics of the participants (parents and children) and coaching processes., Results: Having more coach contacts was associated with earlier first contact (p<0.001), fewer attempts per successful contact (p<0.001), prior asthma hospitalization (p=0.021), more intruding events (p<0.001), and less social support (p=0.048). In univariable models, three factors were associated with forward movement at least one stage for all three behaviors: more coach contacts overall, fewer attempts per successful contact, and more discussion/staging episodes for the particular behavior. In multivariable models adjusting for characteristics of participants and coaching process, the strongest predictor of any forward stage movement for each behavior was having more contacts (p<0.05)., Conclusions: Improvement in readiness to adopt and maintain asthma management behaviors was mostly associated with factors reflecting more engagement of participants in the program. Similar coaching interventions should focus on early and frequent contacts to achieve intervention goals, recognizing that parents of children with less severe disease and who have more social support may be more difficult to engage., (Copyright © 2012 Elsevier Inc. All rights reserved.)

The model developed by Forbes (1987) of how body fat mass (FM) and fat-free mass (FFM) change during periods of weight loss or gain (Δ body weight (BW)) assumed that they change in relationship to a constant C = 10·4, where ΔFFM/ΔBW = 10·4/(10·4+FM). Forbes derived C based on aggregated, cross-sectional data from a small sample of women. The objective of the present study was to reanalyse the relationship described by Forbes and to explore whether this relationship is consistent across ethnicity and sex groups using cross-sectional data from a large sample of white and African-American men and women. Baseline data from white and African-American men and women aged 18-60 years, who participated in a clinical study at the Pennington Biomedical Research Center since 2001 and who underwent dual-energy X-ray absorptiometry scans, were available for analysis. To overcome differences in BMI distributions among the ethnicity-by-sex groups, a stratified random sample of participants was selected within each group such that numbers in each BMI category ( < 25, 25-29·9, 30-34·9, 35-39·9, 40+ kg/m2) were proportional to those within the group with the smallest sample size, yielding a sample of 1953 individuals. Linear regression models assessed the FM-FFM relationship across the four ethnicity-by-sex groups. The FM-FFM relationship varied little by ethnicity (P = 0·57) or by sex (P = 0·26). The constant describing the FM-FFM relationship was estimated to be 9·7 (95 % CI 9·0, 10·3). In conclusion, results from our large, biethnic sample of men and women found a FM-FFM relationship very close to that originally described by Forbes, absent of significant variability by ethnicity or sex.

Recent advances in genomic research have demonstrated a substantial role for genomic factors in predicting response to cancer therapies. Researchers in the fields of cancer pharmacogenomics and pharmacoepidemiology seek to understand why individuals respond differently to drug therapy, in terms of both adverse effects and treatment efficacy. To identify research priorities as well as the resources and infrastructure needed to advance these fields, the National Cancer Institute (NCI) sponsored a workshop titled "Cancer Pharmacogenomics: Setting a Research Agenda to Accelerate Translation" on July 21, 2009, in Bethesda, MD. In this commentary, we summarize and discuss five science-based recommendations and four infrastructure-based recommendations that were identified as a result of discussions held during this workshop. Key recommendations include 1) supporting the routine collection of germline and tumor biospecimens in NCI-sponsored clinical trials and in some observational and population-based studies; 2) incorporating pharmacogenomic markers into clinical trials; 3) addressing the ethical, legal, social, and biospecimen- and data-sharing implications of pharmacogenomic and pharmacoepidemiologic research; and 4) establishing partnerships across NCI, with other federal agencies, and with industry. Together, these recommendations will facilitate the discovery and validation of clinical, sociodemographic, lifestyle, and genomic markers related to cancer treatment response and adverse events, and they will improve both the speed and efficiency by which new pharmacogenomic and pharmacoepidemiologic information is translated into clinical practice.

The neurohormonal control of body weight involves a complex interplay between long-term adiposity signals (e.g., leptin), and short-term satiation signals (e.g., amylin). In diet-induced obese (DIO) rodents, amylin/leptin combination treatment led to marked, synergistic, fat-specific weight loss. To evaluate the weight-lowering effect of combined amylin/leptin agonism (with pramlintide/metreleptin) in human obesity, a 24-week, randomized, double-blind, active-drug-controlled, proof-of-concept study was conducted in obese or overweight subjects (N = 177; 63% female; 39 +/- 8 years; BMI 32.0 +/- 2.1 kg/m(2); 93.3 +/- 13.2 kg; mean +/- s.d.). After a 4-week lead-in period with pramlintide (180 microg b.i.d. for 2 weeks, 360 microg b.i.d. thereafter) and diet (40% calorie deficit), subjects achieving 2-8% weight loss were randomized 1:2:2 to 20 weeks of treatment with metreleptin (5 mg b.i.d.), pramlintide (360 microg b.i.d.), or pramlintide/metreleptin (360 microg/5 mg b.i.d.). Combination treatment with pramlintide/metreleptin led to significantly greater weight loss from enrollment to week 20 (-12.7 +/- 0.9%; least squares mean +/- s.e.) than treatment with pramlintide (-8.4 +/- 0.9%; P < 0.001) or metreleptin (-8.2 +/- 1.3%; P < 0.01) alone (evaluable, N = 93). The greater reduction in body weight was significant as early as week 4, and weight loss continued throughout the study, without evidence of a plateau. The most common adverse events with pramlintide/metreleptin were injection site events and nausea, which were mostly mild to moderate and decreased over time. These results support further development of pramlintide/metreleptin as a novel, integrated neurohormonal approach to obesity pharmacotherapy.

Objective: To describe the prevalence of time spent in sedentary behaviors (e.g., TV/video and computer use) among youth in the US., Methods: The National Health and Nutrition Examination Survey (2001-06) provided data to examine sedentary behavior across age groups (2-5, 6-11, and 12-15 years of age), ethnic groups (European [EA], African [AA], and Mexican American [MA]), and body mass index (BMI) categories (normal weight, overweight, obese)., Results: The sample included 8 707 (50.7% boys) children aged 2 to 15 years. Seventy percent of the sample was normal weight, 18.1% was overweight, and 11.5% was obese. The total proportion of young people engaged in TV/video viewing, computer use, and total screen time > or = 2 hours daily was 33.0%, 6.7%, and 47.3%, respectively. More boys (49.4%) than girls (45.0%); older (12-15 years: 56.0%) versus younger children (2-5 years: 35.3% and 6-11 years: 49.1%); AA (66.1%) versus EA (42.5%) and MA (46.1%); obese (58.5%) versus overweight (50.8%) versus normal weight (44.6%); and low and middle income (<$25 K: 51.4% and $25-45 K: 51.2%) versus high income (>$45 K: 42.6%) children spent > or = 2 hours daily in screen time., Conclusion: Nearly half (47%) of US children exceed > or = 2 hours/day of time in sedentary behavior. Further, it appears there are gender, age, ethnic, BMI-defined weight status, and income differences in exceeding > or = 2 hours/day in sedentary behavior. These results will be useful in planning targeted interventions at those populations with a higher prevalence of sedentary behavior.

Background: A study was conducted to explore the value and limitations of voluntary medical error reports and to learn about common errors in warfarin use., Methods: Voluntary reports of 8,837 inpatient errors and 820 outpatient errors in warfarin use submitted by 445 hospitals and 192 outpatient facilities participating in MEDMARX, a voluntary medication error reporting system, from 2002 to 2004, were gathered., Results: Overall, errors occurred most often during transcription/documentation (35%) and administration (30%) in hospitals, and during prescribing (31%) and dispensing (39%) in outpatient settings. Dosing errors were the most common type. In hospitals, more than 50% of reported errors were initiated by nurses, and 50% were intercepted by nurses, whereas in outpatient settings, about 50% of reported errors occurred in pharmacies and 50% were intercepted by pharmacists. About 17% of inpatient and 13% of outpatient warfarin errors resulted in changes in patient care, and 42% of inpatient and 62% of outpatient errors resulted in procedural changes. Cascade analysis and textual descriptions further located specific, correctible safety lapses., Discussion: Voluntary medical error reporting systems can, to some extent, provide meaningful and actionable information to guide patient safety improvement, but their usefulness is limited because of a lack of details, incomplete reporting, underreporting, and various reporting biases.

Objectives: To evaluate the effects of using an audiovisual animation (i.e., digital video) displayed on a personal digital assistant (PDA) for patient education in a clinical setting., Methods: Quasi-experimental study of a prospective technology intervention conducted in an outpatient infectious diseases clinic at an academic medical center. Subjects responded to questions immediately before, immediately after, and 4-6 weeks after watching a digital video on a PDA. Outcome measures include participant knowledge of disease, knowledge of medications, and knowledge of adherence behaviors; attitudes toward the video and PDA; self-reported adherence; and practicality of the intervention., Results: Fifty-one English-speaking adults who were initiating or taking medications for the treatment of HIV/AIDS participated in the study. At visit one, statistically significant improvements in knowledge of disease (p<0.005; paired t-test), knowledge of medications (p<0.005; paired t-test), and knowledge of adherence behaviors (p<0.05; ANOVA) were measured after participants watched the PDA-based video. At visit two (4-6 weeks later), statistically significant improvements in self-reported adherence to the medication regimens (p<0.005; paired t-test) were reported. Participants liked the PDA-based video and indicated that it was an appropriate medium for learning, regardless of their baseline literacy skills. The video education process was estimated to take 25 min of participant time and was viewed in both private and semi-private locations., Conclusions: Technology-assisted education using a digital video delivered via PDA is a convenient and potentially powerful way to deliver health messages. The intervention was implemented efficiently with participants of a variety of ages and educational levels, and in a range of locations within clinical environments. Additional study of this methodology is warranted.

Automated external defibrillators (AED) have been recommended for use in outpatient dialysis clinics to improve outcomes from cardiac arrest, the most common cause of death in patients with ESRD. The effectiveness of this policy is unknown. The study cohort consisted of 43,200 hemodialysis patients in the US Gambro Healthcare System from 2002 to 2005. Of these, 729 patients who sustained an in-center cardiac arrest were identified. Baseline characteristics at the time of the event were compared between patients who underwent hemodialysis in clinics with and without an AED on site. Unadjusted survival and survival adjusted for potential confounders was measured using Cox proportional hazards regression models. Unadjusted survival at 30 d was 19 versus 15% (P = 0.12) and 9.5 versus 7.8% at 1 yr (P = 0.39) in the AED-present and AED-absent groups, respectively. AED presence was not associated with outcome in unadjusted analysis (hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.78 to 1.07; P = 0.26). Univariable analysis identified age (HR 1.07 per decade; 95% CI 1.01 to 1.13), serum albumin (HR 0.91 per 0.7-mg/dl increase; 95% CI 0.82 to 1.01), and indwelling dialysis catheters (HR 1.21; 95% CI 1.02 to 1.42) as potential confounders. Medications including angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta blockers, calcium channel blockers, other BP medications, aspirin, antibiotics, and antiarrhythmics were associated with survival and considered confounders. After controlling for case mix and confounders, AED presence was not associated with outcome (HR 0.98; 95% CI 0.82 to 1.18; P = 0.83). Presence of AED in the dialysis clinic is not sufficient by itself to improve the abysmal outcome from in-clinic cardiac arrest in hemodialysis patients in the United States.

This study analyzes the results of 2 surveys sent to state insurance commissioners that focused on policies regulating conventional health insurance and managed care organizations (MCOs) during 2000. Surveys were returned by 49 states and the District of Columbia. Several states have implemented regulations mandating prescription drug coverage. In addition, some states now require health insurers and MCOs to cover the medical care associated with experimental medications and treatments. Some states have also created laws allowing beneficiaries to sue their health insurer or MCO for damages caused by denial of care. These state policies provide a rich source of data for federal policy makers to analyze as they consider new patient protection legislation and amendments to the Employee Retirement Income Security Act.

Background: Recent studies show that objective measures such as peak flow rates are strongly associated with asthma admission among adults., Objective: To identify factors associated with admission among children., Methods: We performed a prospective cohort study as part of the Multicenter Airway Research Collaboration. Patients aged 2 to 17 years who presented to the emergency department (ED) with acute asthma underwent a structured interview in the ED and another by telephone 2 weeks later. The study was performed at 44 EDs in 18 US states and 4 Canadian provinces. The decision to admit was made at the discretion of the treating physician. Univariate analysis of risk factors for admission was followed by multivariate logistic regression., Results: Of the 1178 eligible subjects, 275 (23%; 95% confidence interval, 21%-26%) were admitted or placed into ED observation units. A multivariate model that included 12 characteristics measured at presentation and during the ED stay was associated with an area under the receiver operating characteristic curve of 0.91. Demographic factors were not independently associated with admission. Severity of symptoms (odds ratio, 1.3) and intensity of therapy both before and during ED visit correlated with the likelihood of admission. Previous admission for asthma (P =.02) and recent use of inhaled corticosteroids (P =.04) also were associated with admission. Peak flows were associated with admission but were infrequently (23% overall) measured., Conclusion: Hospitalization for asthma exacerbation in children is primarily associated with clinical indicators in the ED and with historical factors such as previous asthma admission or intubation, recent use of corticosteroids, and comorbidity.

Objective: Asthma morbidity, with increasing emergency department (ED) visits, is prevalent among low-income, urban children. Follow-up care after ED visits is infrequent. We developed and evaluated an instrument that describes the parental benefits (pros) and barriers (cons) of obtaining follow-up care for interventions to promote follow-up., Methods: We enrolled a convenience sample of low-income, urban parents who brought their children to the ED for treatment of asthma. These parents rated 41 items about the pros and cons of making a follow-up visit. Principal component analysis was used to identify the underlying structure of the instrument., Results: One hundred forty-seven participants were interviewed in the ED. Principal component analysis retained 24 total items, which were identified by this sample as highly associated with deciding to take their child to a follow-up visit. Two types of pros were identified, informational and attitudinal, including "ask the doctor questions," and " children with asthma are healthier if they see their doctor regularly." Two types of cons were identified, practical and attitudinal, including "I have to find transportation," and "I don't need to see the doctor unless my child is sick." The mean total pro and con scores were 4.05 +/- 0.63 and 1.73 +/- 0.67, respectively., Conclusions: The pros and cons are not unidimensional. Even among those with infrequent follow-up, pros were endorsed more highly than cons. Programs that target these pros and cons may improve adherence to follow-up and regular care for low-income urban children.

Educational problems of African American students are examined in the context of why young, successful early elementary school students are suddenly struggling in the late elementary and middle school years. Educators need to explore the educational environment, teacher attitudes and expectations, student empowerment, and the appropriateness of the curriculum.

Background: Insurance coverage facilitates access to life-saving medications for many patients with HIV disease. Thus, the effects of insurance coverage changes, such as the gain or loss of coverage, may be important in explaining patient access and adherence to the medications used in the treatment of HIV disease., Objectives: The study's objective was to examine whether changes in health insurance coverage affect rates of prescription drug use by patients with HIV disease., Methods: Data were ascertained from adults participating in a series of up to six interviews as part of the AIDS Costs and Services Utilization Survey (ACSUS). ACSUS was an 18-month panel survey of patients in care for HIV/AIDS at 26 sites located in 10 U.S. cities. Poisson regression analyses with generalized estimating equations were conducted to determine the effects of demographic and socioeconomic variables on the acquisition rate of antiretrovirals, antipneumocystics, and antidepressants. The analytic sample consisted of 1566 respondents who provided 6518 interviews., Results: Although changes in insurance coverage were common, complete loss of insurance was reported in only 1.5% of the interviews whereas gaining insurance was reported in 3.3% of interviews. Having no coverage was associated with significantly lower rates of antiretroviral (rate ratio [RR], 0.73), antipneumocystic (RR, 0.58) and antidepressant use (RR, 0.31). Gaining insurance coverage was associated with lower antiretroviral (RR, 0.75) and antipneumocystic (RR, 0.70) use whereas losing insurance was associated with lower antiretroviral use (RR, 0.58). In multivariate analyses, these associations remained., Conclusions: Changes in health insurance coverage are associated with lower rates of drug use for some medications used by patients with HIV disease.

This study was designed to assess the ability of the Minnesota Multiphasic Personality Inventory (MMPI-2) MacAndrew Alcoholism Scale (MAC-R) to differentiate between outpatients with personality disorders with Substance-Related Disorders (SRDs) and without SRDs. MMPI-2 validity, clinical, and MAC-R scale scores were compared in an SRD Cluster B group (comprised of Narcissistic, Antisocial, Borderline, and Histrionic; n = 15), a non-SRD Cluster B group (n = 33), and a non-SRD group with personality disorders from Clusters A and C (n = 18). Results revealed that the substance-abusing Cluster B group scored significantly higher on the MAC-R ( p <.0001) as well as the Psychopathic Deviate scale ( p <.01). Dimensional analyses illustrated that MAC-R scores were related to the presence of an SRD diagnosis (rpb =.70, p <.0001) and diagnostic criteria for Antisocial Personality Disorder (r =.60, p <.0001). Stepwise regression revealed that (in order of magnitude) the presence of a substance-abuse diagnosis followed by diagnostic criteria for Antisocial and Histrionic Personality Disorders were most related to MAC-R scores (R =.78, R(2) =.60). This indicates that the MAC-R may be more related to the presence of an SRD than has been suggested, and when used in outpatient settings as MacAndrew (1965) intended, the MAC-R may be useful as a screening device for assessing SRD among outpatients with Axis II psychopathology.

Background: AIDS drug assistance programs (ADAPs) have been implemented in each state to facilitate access to medications for low-income, uninsured, and underinsured people with HIV disease. Policies for each ADAP differ, and these differences influence the access people with HIV have to medications., Objective: To compare the coverage of medications and sources of program funding for the state ADAPs., Design: A self-administered mailed survey, sent to administrators of the 50 state ADAPs and the District of Columbia ADAP in December 1998., Results: Forty-nine of the 51 ADAPs (96%) responded to the survey. Title II of the Ryan White Comprehensive AIDS Resources Emergency Act provided a large majority of the funding for the ADAPs, with a number of states also using state funds and/or Title I funds for their programs. The formularies of all ADAPs were nearly identical with respect to coverage of antiretrovirals, but differed in the number and types of other medications included. Some states limited access to medications through waiting lists, enrollment caps, and other policies. Sixteen ADAPs reported that the coverage of protease inhibitors resulted in an appropriation of state government funds to their ADAP, while eight states reported an ADAP budget shortfall. In general, ADAPs in poorer and more rural states included a fewer number of medications on their formularies., Conclusions: Access to antiretrovirals and other medications is available through state ADAPs, but may be limited in some states due to waiting lists, controls on the enrollment of new beneficiaries, and policies on the number and types of medications beneficiaries may receive.

Drug treatments for HIV infection and related opportunistic infections have had dramatic impacts on the morbidity and mortality associated with HIV disease. HIV drug therapies are essential to the survival and to improved quality of life for individuals with HIV. However, not all people with HIV disease are receiving these medications. The state AIDS drug assistance programs (ADAPs) can provide access to drug therapies for many people with HIV disease who lack adequate drug coverage. This research presents the results of a national survey that identified eligibility-related policies implemented by .48 state ADAPs during 1998 and 1999. The survey assessed the number of people receiving ADAP coverage, the percentage of ADAP beneficiaries who are women, financial and medical eligibility requirements, characteristics of the application process, any implementation of waiting lists, and any coordination of the ADAPs with other public programs.