Reducing tobacco use in substance use treatment: The California tobacco free initiative.

BACKGROUND: People in substance use disorder (SUD) treatment have a smoking prevalence that is five times higher than the national average. California funded the Tobacco Free for Recovery Initiative, designed to support programs in implementing tobacco-free grounds and increasing smoking cessation services. In the first cohort of the initiative (2018-2020) client smoking prevalence decreased from 54.2% to 26.6%. The current study examined whether similar findings would be replicated with a later cohort of programs (2020-2022). METHOD: Cross-sectional survey data were collected from clients in 11 residential SUD treatment programs at baseline (n = 185) and at post intervention (n = 227). Multivariate logistic regression assessed change over time in smoking prevalence, tobacco use behaviors, and receipt of cessation services across the two timepoints. RESULTS: Client smoking prevalence decreased from 60.3 % to 40.5 % (Adjusted Odds Ratio [AOR] = 0.46, 95 % CI = 0.27, 0.78; p = 0.004). Current smokers and those who quit while in treatment reported an increase in nicotine replacement therapy (NRT)/pharmacotherapy from baseline to post intervention (31.9 % vs 45.6 %; AOR = 2.22, 95 % CI = 1.08, 4.58; p = 0.031). CONCLUSIONS: Like the first cohort, the Tobacco Free for Recovery initiative was associated with decreased client smoking prevalence and an increase in NRT/pharmacotherapy. These findings strengthen the evidence that similar initiatives may be effective in reducing smoking prevalence among people in SUD treatment.

Helping Smokers Quit: New Partners and New Strategies from the University of California, San Francisco Smoking Cessation Leadership Center.

The Smoking Cessation Leadership Center (SCLC) was established in 2003 to increase the rate of smoking cessation attempts and the likelihood those efforts would succeed. Although smoking remains the number one cause of preventable death and disability, clinicians underperform in smoking cessation. Furthermore, many clinical organizations, governmental agencies, and advocacy groups put little effort into smoking cessation. Initially targeted at increasing the efforts of primary care physicians, SCLC efforts expanded to include many other medical and non-physician disciplines, ultimately engaging 21 separate specialties. Most clinicians and their organizations are daunted by efforts required to become cessation experts. A compromise solution, Ask, Advise, Refer (to telephone quitlines), was crafted. SCLC also stimulated smoking cessation projects in governmental, not-for-profit, and industry groups, including the Veterans Administration, the Health Resources Services Administration, Los Angeles County, and the Joint Commission. SCLC helped CVS pharmacies to stop selling tobacco products and other pharmacies to increase smoking cessation efforts, provided multiple educational offerings, and distributed $6.4 million in industry-supported smoking cessation grants to 55 organizations plus $4 million in direct SCLC grants. Nevertheless, smoking still causes 540,000 annual deaths in the US. SCLC's work in the field of behavioral health is described in a companion article.

Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study.

BACKGROUND: Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. OBJECTIVE: The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. METHODS: Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. RESULTS: The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. CONCLUSIONS: We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties.

From the sidelines to the frontline: how the Substance Abuse and Mental Health Services Administration embraced smoking cessation.

Smoking is a major contributor to premature mortality among people with mental illness and substance abuse. Historically, the Substance Abuse and Mental Health Services Administration (SAMHSA) did not include smoking cessation in its mission. We describe the development of a unique partnership between SAMHSA and the University of California, San Francisco's Smoking Cessation Leadership Center. Starting with an educational summit in Virginia in 2007, it progressed to a jointly sponsored "100 Pioneers for Smoking Cessation" campaign that provided grants and technical assistance to organizations promoting cessation. By 2013, the partnership established 7 "Leadership Academies," state-level multidisciplinary collaboratives of organizations focused on cessation. This academic-public partnership increased tobacco quit attempts, improved collaboration across multiple agencies, and raised awareness about tobacco use in vulnerable populations.

Time for a paradigm shift with computerized adaptive testing of general physical function outcomes measurements.

BACKGROUND: Patient-reported outcomes (PRO) are critical to understanding the value of orthopedic treatments. We hypothesized that use of the computerized adaptive testing from a well-characterized physical function item bank would show superiority in assessing all levels of physical function compared to current standard generic physical function outcomes instruments for foot and ankle patients. METHODS: In a population of 126 foot and ankle patients we compared the psychometric properties for three PROs: the Physical Function subscale of the Medical Outcomes General Health Survey (SF-36 PF) version 2, the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computerized Adaptive Test (CAT), and the Lower Extremity (LE) CAT. A Rasch item response theory (IRT) model was applied to assess and compare the fit, dimensionality, reliability, validity, and coverage. RESULTS: The unexplained variance for the PF CAT was 3.9% and the LE CAT was 2.1%, suggesting each instrument explained a single concept. The SF-36 PF had more concerning unexplained variance of 7.6%. We found no floor or ceiling effects for the PF CAT, a minimal floor effect (1.6%) but no ceiling effect for the LE CAT, and an 11.1% floor effect and 9.5% ceiling effect for the SF-36 PF. CONCLUSION: Foot and ankle clinicians and researchers interested in measuring patient perceived functional outcomes with a generic instrument should consider using either the PF CAT or the LE CAT rather than the SF-36 PF. Further studies comparing these CATs to anatomic specific instruments are needed. LEVEL OF EVIDENCE: Level I, diagnostic study.

An FGF21-adiponectin-ceramide axis controls energy expenditure and insulin action in mice.

FGF21, a member of the fibroblast growth factor (FGF) superfamily, has recently emerged as a regulator of metabolism and energy utilization. However, the exact mechanism(s) whereby FGF21 mediates its actions have not been elucidated. There is considerable evidence that insulin resistance may arise from aberrant accumulation of intracellular lipids in insulin-responsive tissues due to lipotoxicity. In particular, the sphingolipid ceramide has been implicated in this process. Here, we show that FGF21 rapidly and robustly stimulates adiponectin secretion in rodents while diminishing accumulation of ceramides in obese animals. Importantly, adiponectin-knockout mice are refractory to changes in energy expenditure and ceramide-lowering effects evoked by FGF21 administration. Moreover, FGF21 lowers blood glucose levels and enhances insulin sensitivity in diabetic Lep(ob/ob) mice and diet-induced obese (DIO) mice only when adiponectin is functionally present. Collectively, these data suggest that FGF21 is a potent regulator of adiponectin secretion and that FGF21 critically depends on adiponectin to exert its glycemic and insulin sensitizing effects.

Boxed warning inconsistencies between drug information resources and the prescribing information.

PURPOSE: Inconsistencies in boxed warnings between drug information resources and the manufacturer's prescribing information (PI) were evaluated. METHODS: This study was a cross-sectional evaluation of boxed warnings in Black-BoxRx, DrugDex, Facts and Comparisons, Epocrates, Lexicomp, and PDR.net conducted in June 2010. New molecular entities with boxed warnings and PI that conformed to current Food and Drug Administration labeling requirements were included. Each resource was reviewed for warnings that appeared verbatim with the full boxed warning in the PI. Two drug information pharmacists independently reviewed the remaining nonverbatim boxed warnings to determine concordance with the boxed warning summary in the "highlights" section of the PI. Tests of proportions were used to examine differences among resources in the proportion of warnings concordant with the PI. Interrater reliability was assessed with the kappa statistic. RESULTS: A total of 71 drugs with unique boxed warnings were included in the evaluation. Resources revealed varying degrees of discordances with the boxed warning in the PI. The resource with the lowest number of verbatim warnings contained a significantly higher percentage of warnings with discordant information when compared with all other resources (p < 0.0001 for all paired comparisons). Interrater reliability was excellent (kappa = 0.86). CONCLUSION: Boxed warning information presented in major drug information resources may be missing key elements of the official boxed warning in the current PI. The current PI may be the most reliable approach to accessing the complete, up-to-date boxed warning for a given drug.

Systematic review of medication safety assessment methods.

PURPOSE: The accuracy, efficiency, and efficacy of four commonly recommended medication safety assessment methodologies were systematically reviewed. METHODS: Medical literature databases were systematically searched for any comparative study conducted between January 2000 and October 2009 in which at least two of the four methodologies-incident report review, direct observation, chart review, and trigger tool-were compared with one another. Any study that compared two or more methodologies for quantitative accuracy (adequacy of the assessment of medication errors and adverse drug events) efficiency (effort and cost), and efficacy and that provided numerical data was included in the analysis. RESULTS: Twenty-eight studies were included in this review. Of these, 22 compared two of the methodologies, and 6 compared three methods. Direct observation identified the greatest number of reports of drug-related problems (DRPs), while incident report review identified the fewest. However, incident report review generally showed a higher specificity compared to the other methods and most effectively captured severe DRPs. In contrast, the sensitivity of incident report review was lower when compared with trigger tool. While trigger tool was the least labor-intensive of the four methodologies, incident report review appeared to be the least expensive, but only when linked with concomitant automated reporting systems and targeted follow-up. CONCLUSION: All four medication safety assessment techniques-incident report review, chart review, direct observation, and trigger tool-have different strengths and weaknesses. Overlap between different methods in identifying DRPs is minimal. While trigger tool appeared to be the most effective and labor-efficient method, incident report review best identified high-severity DRPs.

Black box warning contraindicated comedications: concordance among three major drug interaction screening programs.

BACKGROUND: Black box warnings represent the strongest safety warning that the Food and Drug Administration can issue for a marketed prescription drug. Some black box warnings recommend against coadministration of specific medications due to an increased risk for serious, perhaps life-threatening, effects. OBJECTIVE: To determine the level of agreement in presence, clinical severity scores level of documentation ratings, and alert content among 3 leading drug interaction screening programs with regard to contraindicated comedications that are mentioned in black box warnings. METHODS: We reviewed the prescribing information for currently marketed prescription drugs with a black box warning that mentioned a contraindicated drug combination. We selected the drug interaction databases Facts & Comparisons 4.0, MICROMEDEX DRUG-REAX, and Lexi-Comp Lexi-Interact to evaluate the interactions. Discrepancies in the inclusion of interactions and level of agreement in clinical severity scores and level of documentation ratings for each interaction were assessed, using descriptive statistics, Spearman's correlation coefficient, Kendall-Stuart tau-c, and Cronbach's alpha. RESULTS: We identified 11 drugs with black box warnings that contained information on 59 unique contraindicated drug combinations, only 68% of which were covered by any source. Lexi-Comp detected the most interactions (n = 29) and DRUG-REAX the least (n = 18). Only 3 drug combinations were detected and rated as contraindicated or potentially life-threatening in all 3 databases. The severity scores and level of documentation ratings varied widely. CONCLUSIONS: There are discrepancies among major drug interaction screening programs in the inclusion, severity, and level of documentation of contraindicated drug combinations mentioned in black box warnings. Further studies could explore the implications of these inconsistencies, particularly with regard to the integration of black box warning information in clinical practice. Clinicians should consult multiple drug resources to maximize the potential for detecting a potentially severe drug interaction.

A review of three stand-alone topical thrombins for surgical hemostasis.

BACKGROUND: Topical thrombins are active hemostatic agents that can be used to minimize blood loss during surgery. Before 2007, the only topical thrombins available were derived from bovine plasma. Antibody formation to bovine thrombin and/or factor V, with subsequent risk of cross-reactivity with human factor V, and hemorrhagic complications associated with human factor-V deficiencies have been described in case reports of surgeries in which bovine thrombins were used. This risk is now included in the boxed warning section of the bovine thrombin prescribing information. In 2007 and 2008, 2 new topical thrombins from nonbovine sources received approval for use from the US Food and Drug Administration. The 3 active topical thrombins that are currently marketed are bovine plasma-derived thrombin, human plasma-derived thrombin, and human recombinant thrombin. OBJECTIVE: The purpose of this review was to evaluate the literature on the efficacy and safety of topical thrombins and discuss the pharmacoeconomic considerations associated with their use. METHODS: PubMed, EMBASE, and International Pharmaceutical Abstracts were searched for relevant papers published in English through October 10,2008, using the terms thrombin, human recombinant thrombin, bovine thrombin, plasma derived thrombin, and topical thrombin. Manufacturer-provided materials were also reviewed. Abstracts and unpublished data, as well as evaluations of sealants, adhesives, glues, and other hemostats that contain thrombin mixed with fibrinogen and other clotting factors, were excluded. RESULTS: Four randomized, double-blind studies involving the active, stand-alone topical thrombins were found. The bovine thrombin involved in these studies was the predecessor to the currently marketed, highly purified bovine formulation. No studies comparing the human products, studies involving the highly purified bovine preparation, or placebo-controlled studies involving bovine thrombin were found. In a Phase III comparison of human recombinant thrombin and bovine thrombin, the percentages of patients who achieved hemostasis within 10 minutes of topical thrombin application were 95.4% and 95.1%, respectively (95% CI, -3.7 to 5.0). The incidence of hemostasis within 10 minutes was also similar in a Phase III comparison of human plasma-derived thrombin and bovine thrombin (both, 97.4% [95% CI, 0.96 to 1.05]). In the study that compared human recombinant and bovine thrombin, the incidence of antiproduct antibody formation was 21.5% (43/200) in the bovine thrombin group and 1.5% (3/198) in the human recombinant thrombin group (P < 0.001); patients with antibodies to bovine thrombin had numerically higher incidences of bleeding or thromboembolic events than did patients without these antibodies (19% vs 13%; P value not reported). Human plasma-derived thrombin is available as a frozen sterile solution that must be thawed before application, whereas the human recombinant and bovine plasma-derived products are supplied as unrefrigerated sterile powders that must be reconstituted before use. The human thrombins are more costly than bovine thrombin on a per-vial basis. The average wholesale prices (US $, 2008) for 5000-IU vials of bovine thrombin and human recombinant thrombin were $87.85 and $103.20, respectively; the average wholesale price for a 4000- to 6000-IU vial of human plasma-derived thrombin was $96.00. CONCLUSIONS: Topical thrombins vary in the ways in which they are manufactured and their safety profiles, storage requirements, and costs. Human recombinant thrombin and human plasma-derived thrombin have each been shown to have hemostatic efficacy comparable to that of bovine thrombin. Bovine thrombin carries the risk of formation of cross-reactive antibodies to bovine thrombin, factor V, and other impurities that may be present in these formulations. Immunogenicity data for the currently marketed, highly purified bovine thrombin relative to older formulations of bovine thrombin could not be found. Whether the potential safety advantage justifies the added cost of the human products remains to be established.

Workers' compensation, return to work, and patient satisfaction after carpal tunnel decompression.

In the study reported here, we assessed satisfaction and return to work in workers' compensation (WC) patients after carpal tunnel decompression. Eighty of the 362 patients who underwent surgery met the study criteria; 42 of the 80 were found for follow-up; 40 of the 42 participated in the telephone questionnaire; 15 (38%) of the 40 received WC; and 39 (98%) of the 40 returned to work. Mean age of the 40 respondents was 47 years, and mean follow-up was 29 months. WC involvement was not related to return to work and did not affect satisfaction with overall outcome but was related to dissatisfaction with job factors and timing of return to work.