Research methods challenges: A case study of preparedness in The Bahamas.

Disaster research is essential for developing more robust and contextualised policies. It is, therefore, no surprise that multilateral organisations like the United Nations and the World Bank have called for enhanced disaster-related frameworks, legislation and policies in developing countries using quality data. However, internal and external researchers and practitioners often face significant challenges collecting data in these nations because of a range of problems including, but not limited to, incomplete sampling frames, inadequate infrastructure or unstable governments. This reality leads one to question: is the cart coming before the horse? This study explored individual and household (IH) preparedness in The Bahamas - a small island developing state in the Caribbean. An online survey was used, and 629 Bahamians opted to participate. However, the researchers faced many barriers to collecting representative data. This case study, therefore, discusses the range of methodological challenges faced by the researchers and their impact on this study. Contribution: This article substantially contributes to the disaster literature by exploring the challenges associated with conducting IH preparedness research in The Bahamas. This article also reminds practitioners and academics of the issues associated with collecting data in developing nations and its implications for policy enhancement and development. Furthermore, the authors present various recommendations ranging from enhanced funding to recognising the need for methodological innovation to support continuous research in countries like The Bahamas.

Patterns of blunt and cigar use in the United States, 2015-2019.

Background: The use of cigars for blunts (i.e., cannabis rolled in cigar paper) is well-documented; proportions of cigar and blunt use and associated characteristics are less studied. Methods: Pooled data from the 2015-2019 National Survey on Drug Use and Health (NSDUH) were analyzed in 2023. Respondents aged 12+ who reported past 30-day cigar use were categorized into three mutually exclusive use categories: (1) exclusively cigars, (2) exclusively blunts, and (3) both cigars and blunts. We examined associations between cigar-blunt use category and sociodemographic characteristics. Results: Among people 12 and older who reported past 30-day cigar use, 48.6% (95% CI=47.6-49.6) reported exclusive cigar use; 44.3% (95% CI=43.3-45.3) reported exclusive blunt use; and 7.2% (95% CI=6.8-7.6) reported cigars and blunts. The prevalence differed by age, with exclusively blunts most prevalent among youth (72.5% [95% CI=70.7-74.3]) and young adults (62.4% [95% CI=61.4-63.5]), and exclusively cigars most prevalent among adults 26+ (61.2% [95% CI=59.8-62.5]). Exclusive blunt users smoked more days in the past month (17.5; 95% CI=16.8-18.2), compared to 13.8 days (95% CI=13.2-14.4) for cigar and blunt users, and 7.7 days (95% CI=7.5-8.0) for exclusive cigar users. There were significant differences in characteristics, with exclusive blunt use more prevalent among female (41.6%; 95% CI=40.3-42.9) and Hispanic (18.2%; 95% CI=17.3-19.2) participants. Conclusions: Exclusive blunt use was the most prevalent pattern of past-30-day cigar use among youth and young adults. Those who use cigars as blunts smoke more cigars per month, suggesting this may be an important group for additional education and policy efforts.

National Trends in Sales and Price for Commercial Tobacco and Nicotine Products, 2018-2022.

This cross-sectional study explores recent trends in sales and price of tobacco and nicotine products in the US.

Cigarette smoking behaviors and nicotine dependence at the intersection of sexual identity and sex in the United States: Findings from the National Survey on Drug Use and Health.

INTRODUCTION: Cigarette smoking is disproportionately high among lesbian, gay, and bisexual (LGB) adults. Yet, collapsing these identities into a monolith can disguise important within group disparities (e.g., lesbian/gay versus bisexual female). The purpose of this study is to report recent national prevalence estimates and trends of cigarette smoking behaviors and nicotine dependence by sexual identity and sex. METHODS: Data were from the 2015-2019 National Survey on Drug Use and Health (n = 210,392; adults 18+), a nationally representative, repeated cross-sectional study of substance use and mental health in the U.S. We examined bivariate and multivariable associations between sexual identity and cigarette smoking measures (i.e., former smoking, lifetime smoking, current smoking, current daily smoking, nicotine dependence) by sex. We also examined linear time trends in current and former smoking. Covariates included age, race/ethnicity, education, annual household income, and survey year. RESULTS: Bisexual women had the highest unadjusted prevalence of current smoking (31 %) and lowest of former smoking (25 %). LGB females and males had higher adjusted prevalence of current smoking, daily smoking, and nicotine dependence than heterosexual adults. Bisexual females and gay and bisexual males had lower adjusted prevalence of former smoking (adjusted prevalence ratio range: 0.78-0.85) than heterosexual counterparts. DISCUSSION: This is the first study to identify disproportionately low prevalence of former smoking among bisexual females. Paired with findings of high prevalence of current cigarette smoking and nicotine dependence, these data suggest that tobacco control interventions targeted toward bisexual females are urgently needed to reduce the burden of cigarette smoking among these individuals.

The Impact of Modest Price Increases and Single Cigar Restrictions on Youth Cigar Use.

INTRODUCTION: In 2011, Boston restricted cigar sales to packages of at least 4 cigars unless sold at a minimum of $2.50 per cigar. Nearly 200 localities in Massachusetts have since adopted policies establishing minimum pack quantities of 2-5 or minimum prices of $2.50-5.00 per cigar. The objective of this study was to examine the impact of these policies on youth cigar use. METHODS: Biennial data from 1999 to 2019 were obtained from the Massachusetts Youth Risk Behavior Survey and analyzed in 2023. Final analytic samples included 15,674 youth for the Boston analyses and 35,674 youth for the statewide analyses. For Boston, change in use was examined from prepolicy (1999-2011) to postpolicy (2012-2019). For statewide analyses, the percentage of the state covered by a policy was estimated. Multivariable logistic regressions examined the impact of cigar policies on cigar and cigarette use. Analyses were adjusted for sociodemographic characteristics and stratified by sex and race. RESULTS: Policy enactment was associated with significant decreases in the odds of cigar use in Boston (AOR: 0.28; 95% CI: 0.17-0.47) and statewide (AOR: 0.98; 95% CI: 0.98-0.99), with similar findings for cigarette use. Results were consistent among males and females statewide but only among males in Boston. By race statewide and in Boston, odds of cigar use decreased significantly among White, Black, and Hispanic youth, but not youth of other races. CONCLUSIONS: These findings indicate small increases in the quantity and price of cigar packs could discourage young people from purchasing and using cigars, providing significant benefits for local tobacco control efforts.

Longitudinal analysis of cigar use patterns among US youth and adults, 2013-2019.

BACKGROUND: Cigars are available in a range of pack quantities, which contrasts regulations requiring cigarettes to be sold in packs of 20 or greater. Smaller packages may be associated with increases in initiation while larger packs may lead consumers to smoke more. The purpose of this study was to inform pack quantity regulations by examining whether usual cigar pack quantity purchased was associated with use, initiation, and discontinuation among youth and adults for four cigar types: premium cigars, large cigars, cigarillos, and filtered cigars. METHODS: We analyzed waves 1-5 (2013-2019) of the adult and waves 2-5 (2014-2019) of the youth Population Assessment of Tobacco and Health (PATH) Study. Samples included those responding to the item on pack quantity and providing data at all waves (adults: premium cigars [N = 536], large cigars [N = 1,272], cigarillos [N = 3,504], filtered cigars [N = 1,281]; youth: premium cigars [N = 55], large cigars [N = 217], cigarillos [N = 1514], filtered cigars [N = 266]). Generalized estimating equation models examined the population-averaged effects of pack quantity on cigar use, initiation, and discontinuation. RESULTS: Adult pack quantity was positively associated with the days used per month for premium cigars (b: 0.23, 95% CI: 0.11, 0.34), large cigars (b: 0.17, 95% CI: 0.08, 0.25), cigarillos (b: 0.12, 95% CI: 0.003, 0.24), and filtered cigars (b: 0.07, 95% CI: 0.04, 0.10), and positively associated with amount smoked per day for all cigar types. Youth pack quantity was positively associated with days used per month for premium cigars (b: 0.88, 95% CI: 0.33, 1.43), large cigars (b: 0.79, 95% CI: 0.43, 1.15), and cigarillos (b: 0.17, 95% CI: 0.01, 0.34). Adult initiation was associated with pack quantity for filtered cigars (b: -2.22, 95% CI: -4.29, -0.13), as those who initiated purchased smaller pack quantities compared to those who did not initiate that wave. Pack quantity was not associated with discontinuation for adults or youth. CONCLUSIONS: Cigar use increased as usual pack quantity purchased increased across cigar types for youth and adults. Small increases in pack quantity (e.g., one additional cigar) are likely to result in consuming less than one additional day per month, though larger increases (e.g., 10 additional cigars per pack) may result in greater use.

Examining Cigar Pack Quantity Purchases by Cigar Type in the United States Between 2014 and 2017.

INTRODUCTION: We examined whether the proportion of cigar pack quantity usually purchased differed between 2014 and 2017 in the United States. METHODS: Data are from waves 1 and 4 of the Population Assessment of Tobacco and Health Study. The proportions of pack quantity purchases between waves for premium cigars, large cigars, cigarillos, and filtered cigars for 10-pack quantities (singles, 2-packs, 3-packs, 4-packs, 5-packs, 6-9-packs, 10-packs, 11--19-packs, 20-packs, ≥21 packs) were compared using Z-tests. We used multivariable linear regressions to examine factors associated with pack quantity. RESULTS: For premium cigars, most adults purchased singles, with 84.4% in 2014 and 88.7% in 2017. For large cigars, single purchases increased from 46.2% to 62.7% (p < .00001). Two-packs also increased, 3.1% to 10.2% (p < .00001), while 5-packs, 6-9 packs, 10-19-packs, and 20-packs decreased. For cigarillos, singles purchases increased from 51.9% to 57.5% (p = .0002). Two-packs also increased, 8.8% to 19.6% (p < .00001), while 3-packs, 4-packs, 5-packs, and 20-packs decreased. For filtered cigars, the most prevalent pack quantity shifted from 20-packs in 2014 (62.6%) to singles in 2017 (36.7%). Singles, 2-packs, 3-4-packs, and 5-packs increased while 11-19-packs, 20-packs, and ≥21 packs decreased. Days used were positively associated with pack quantity purchase for all cigar types in 2017, while the price was positively associated with premium cigar purchase. CONCLUSIONS: Between 2014 and 2017, the proportion of consumers who purchased singles remained at over 80% for premium cigars and increased for other cigars. Continued monitoring of use behaviors, including pack quantities by cigar type, is needed as the market and policy landscapes continue shifting. IMPLICATIONS: Single cigar purchases are prominent across cigar types. Five-packs and 20-packs were the second most common pack quantities across cigar types, with relatively low proportions for other pack quantities. These findings suggest adults consuming premium cigars consistently prefer singles, a pattern that was found across cigar types. However, when considering purchases made online, premium cigars are widely purchased in larger pack quantities. Age and race were associated with purchase for some cigar types at some years, days used were associated with the purchase quantity in 2017 for all cigar types, and price was positively associated across time periods for only premium cigar purchases. Thus, the factors associated with cigar pack quantity purchase remain unclear. As the cigar policy landscape shifts, continued monitoring of the purchase behaviors by cigar type will be important to better inform future cigar policies.

Preliminary Efficacy of a Multi-Behavioral Zoom-Based Peer Health Coaching Intervention in Young Adults: A Stepped Wedge Randomized Controlled Trial.

The purpose of this study was to test the preliminary efficacy of a Zoom-based peer coaching intervention on health and risk behaviors in young adults. A convenience sample of young adults was recruited from one U.S. university (N = 89; 73.0 percent female). Participants were randomized to one of two coaching session sequences within the framework of a stepped wedge randomized controlled trial. One experimental sequence received a control condition and a single coaching session, and the second sequence received two sessions. The intervention was a 1-hour program delivered by peer health coaches in a one-on-one setting on Zoom. The program consisted of a behavior image screen, a consultation, and goal planning. Behavioral assessments were completed after each condition. Mixed-effects models were employed to test for behavior differences after coaching sessions compared with the control condition (no coaching session) adjusting for baseline scores. Participants reported significantly higher levels of vigorous physical activity (b = 750 metabolic equivalent of task minutes, p < 0.001), a lower frequency of e-cigarette use (b = -2.1 days; p < 0.001), and a lower risk of e-cigarette susceptibility after two sessions (relative risk = 0.04, p = 0.05), and higher odds of using stress reduction techniques after one session (odds ratio = 1.4, p = 0.04). A nonsignificant trend was observed for longer weekday sleep (b = 0.4 h/night, p = 0.11) after two coaching sessions. The Zoom-based peer health coaching intervention may be an efficient way to improve vigorous physical activity, lower e-cigarette use and susceptibility, and facilitate the use of stress reduction techniques in young adults. The results observed from this preliminary study warrants further investigation using powered effectiveness trials.

Bidirectional associations of physical activity, sleep, and self-reported mental health in young adults participating in an online wellness intervention during the COVID-19 pandemic.

Purpose: The purpose of this study was to examine the bidirectional associations of physical activity (PA), sleep, and mental health in young adults participating in an online wellness intervention from October 2021 to April 2022. Methods: Participants were a sample of undergraduate students from one US university (N = 89; 28.0% freshman; 73.0% female). The intervention was a 1-h health coaching session that was delivered either once or twice by peer health coaches on Zoom during COVID-19. The number of coaching sessions was determined by random allocation of participants to experimental groups. Lifestyle and mental health assessments were collected at two separate assessment timepoints after each session. PA was assessed using the International Physical Activity Questionnaire-Short Form. Weekday and weekend sleep were assessed by two one-item questionnaires and mental health was calculated from five items. Cross-lagged panel models (CLPMs) examined the crude bidirectional associations of PA, sleep, and mental health across four-time waves (i.e., T1 through T4). To control for individual unit effects and time-invariant covariates, linear dynamic panel-data estimation using maximum likelihood and structural equation modeling (ML-SEM) was also employed. Results: ML-SEMs showed that mental health predicted future weekday sleep (ß = 0.46, p < 0.001) and weekend sleep predicted future mental health (ß = 0.11, p = 0.028). Although CLPMs showed significant associations between T2 PA and T3 mental health (ß = 0.27, p = 0.002), no associations were observed when unit effects and time-invariant covariates were accounted for. Conclusion: Self-reported mental health was a positive predictor of weekday sleep and weekend sleep positively predicted mental health during the online wellness intervention.

The impact of cigar pack size and pricing policies on youth and adult cigar use in the US.

BACKGROUND: Over 250 US localities have adopted cigar pack quantity and price policies. No empirical studies exist on their impact on tobacco use. METHODS: A quasi-experimental design was used to assess the impact of cigar policies on cigar and cigarette use among (1) Minnesota youth (n=569,528, triennially 2007-2019); (2) New York youth (n=111,236, annually 2000-2020), (3) New York adults (n=62,295, annually 2003-2019), and (4) District of Columbia (DC) adults (n=5027, annually 2015-2019). We estimated the county-level policy coverage for 15 local policies in Minnesota. Differences-in-differences approach was used to compare the policy in NYC with the rest of the state (no policy). We examined changes in DC use before and after policy implementation. Analyses adjust for sociodemographic characteristics. RESULTS: In Minnesota, youth in counties with a greater proportion of the population covered by a policy had lower odds of cigar use (AOR: 0.51; 95% CI: 0.38-0.69). Similarly, adult cigar use in DC declined following policy enactment (AOR: 0.65; 95% CI: 0.46-0.93). Cigarette use also decreased in both Minnesota and DC following policy enactment. However, in New York, the NYC policy did not have a significant impact on cigar use among youth (AOR: 0.95; 95% CI: 0.47-1.93) or adults (AOR: 1.98; 95% CI: 0.85-1.37) in NYC compared to the rest of the state. The only significant effect in NYC was reduced odds for adult cigarette use (AOR: 0.79; 95% CI: 0.68-0.92). CONCLUSIONS: Findings suggest regulating cigar packaging could decrease cigar consumption without increasing cigarette consumption, but effects may differ across jurisdictions.

Current State of Clinical Trials and Regulatory Approvals with Fibroblast Activation Protein Targeting Interventions.

In this article, the authors review the current state of fibroblast activation protein (FAP)-targeted interventions utilizing available data from clinicaltrials.gov. Thirty-seven records were reviewed and demonstrated interventions with imaging studies comprising the largest portion of the active studies in progress, followed by therapeutic studies using non-radioligand and radioligand therapy. The efforts are in early stages of clinical development; however the field is gaining significant momentum. Completion of existing clincial studies and entrance of new products into the clincial trial phase will shed important light on the clinical utility of these interventions and shape future clinical development efforts.

Loopholes for Underage Access in E-Cigarette Delivery Sales Laws, United States, 2022.

Objectives. To comprehensively catalog and review state e-cigarette delivery sales laws as well as capture their scope and dimensions. Methods. We conducted an in-depth review to determine whether states had at least 1 form of e-cigarette delivery sales law. We coded laws for 5 key policy domains: (1) delivery terminology used in laws, (2) age verification requirements, (3) packaging label requirements, (4) permit or registration requirements, and (5) fines and penalties for violations. Results. Overall, 34 states had e-cigarette delivery sales laws with varying scopes and dimensions. In 27 states, these laws required at least 1 form of age verification requirements. We identified mandatory packaging labels in 12 states, and 7 states where permits were required. There were considerable differences among states on the scale of fines and penalties for violations. Conclusions. Our findings reveal extensive heterogeneity in e-cigarette delivery sales laws among states, particularly regarding the scope and dimensions of these laws. Public Health Implications. The mapping of e-cigarette delivery sales policies showed several potential loopholes that may diminish their effectiveness. (Am J Public Health. 2023;113(5):568-576. https://doi.org/10.2105/AJPH.2023.307228).

E-cigarette preemption laws: Limiting local communities from protecting youth.

E-cigarette use is prevalent among youth in the United States. Historically, local communities have been a catalyst for adopting evidence-based tobacco control policies. However, some states have ceiling preemption laws that prevent more stringent statutes from being enacted at the city or county level and inhibit tobacco control efforts. The current study documents state preemption laws regarding e-cigarette advertising, licensure, indoor clean air, and youth access. We conducted a systematic synthesis of state statutes to identify states with e-cigarette preemption laws. Data were collected on four policy categories being preempted: advertising, licensure, clean indoor air, and youth access. Laws were compiled, and the content was verified using the Westlaw legal database. In the US, 25 states preempt stricter local e-cigarette regulations in 55 laws. Of these states, 19 preempt advertising regulations, 11 preempt licensure requirements, four preempt ordinances for indoor clean air, and 21 preempt youth access. A broad range of terms was employed to describe preemption, yet few states explicitly used the term "preempt." E-cigarette ceiling preemption laws inhibit public health progress and prevent local authorities from addressing the popularity of e-cigarettes among adolescents.States without preemption laws should be encouraged to adopt language that expressly saves local authority.

Correlates of Anticipated Responses to Cigar Price Increase Among U.S. Adults Who Smoke Cigars.

We examined the prevalence and correlates of anticipated responses to hypothetical cigar price increases. Data are from a 2021 representative sample of U.S. adults who reported past-30-day cigar use (n = 454; mean age = 39.8 years). Weighted multivariable logistic regressions assessed the correlates of behavior change responses. If cigar price increased, 77.2% intend to pay more, 44.7% intend to reduce use, and 39.9%, 37.7%, and 17.1% intend to use other tobacco, cannabis, and cheaper cigars, respectively. Those who smoked cigarillos (vs. other cigars) had higher odds of intending to pay more (adjusted odds ratio [AOR] = 2.73; 95% confidence interval [CI] = [1.41, 5.29]) and use other tobacco (AOR = 2.35; 95%CI = [1.26, 4.36]). Those who smoked within 5 min of waking (vs. >60 min) had higher odds of intending to use cheaper cigars (AOR = 5.19, 95%CI = [1.38, 19.46]). Almost half of U.S. adults who report past-30-day cigar use may reduce cigar smoking in response to price increases, though behavioral response may depend on cigar type smoked and tobacco dependence.

Price, convenience, the buying experience, and other motivations for purchasing tobacco and e-cigarettes online.

INTRODUCTION: Consumers have shifted to online purchases for many products, including tobacco and e-cigarettes. These shifts have occurred alongside internet tobacco purchasing restrictions being proposed and enacted across the US. The aim of this study was to identify motivations for and against purchasing tobacco and e-cigarettes online, to better understand potential impacts or loopholes. METHODS: We surveyed 463 US adults who reported ever purchasing tobacco or e-cigarettes in April 2021, using Amazon's Mechanical Turk. Participants who reported purchasing tobacco or e-cigarettes online were asked to describe their reasons for doing so. Those who reported never purchasing online were asked to describe their reasons. Responses were triple-coded and thematically analyzed. RESULTS: Most respondents (n=330; 71.3%) had purchased tobacco or e-cigarettes online. We identified 14 reasons for purchasing tobacco or e-cigarettes online across four themes: price (cheaper online, discounts, bulk purchases, avoiding taxes), product characteristics (availability, quality), buying experience (convenience, time, COVID-19 concerns, avoiding shame, discretion, avoiding salespersons, reading reviews), and curiosity. We identified 13 reasons for not purchasing tobacco or e-cigarette products online across seven themes: buying experience (convenience, time, discretion, seeing the product), concerns (legality, safety, quality), consumption, price, supporting local, unaware, and uninterested. CONCLUSIONS: Both online and offline purchasers stated price and convenience motivated their choice to purchase tobacco or e-cigarettes online. Though few participants mentioned purchasing illicit products, concerns about legality and quality of online purchases were raised, and there was some awareness that online purchases attracted lower taxation.

A synthesis of local cigar pack policies in the US.

Communities have adopted cigar pack policies to eliminate inexpensive, small packs from being sold and reduce youth use. Still, it is unclear how widespread these policies are and whether they differ based on specific policy components. This study identified and measured local cigar pack size and price policies in the US. We used a systematic 14-step process to identify, obtain, and code local cigar pack policies, including pack size and pricing. Between January and July 2021, we identified 299 local cigar pack policies in the US. Policies were (1) identified through municipal code review and requests to state tobacco control representatives, (2) obtained online or from municipality representatives, and (3) double-coded for minimum pack size, minimum price, adopted/effective/enforcement dates, cigar definitions, differences in pack size/price by cigar type, price adjustments, whether the price is before discounts, policy exclusions, and enforcement. We identified 259 municipalities with cigar pack policies, 40 of which amended the pack size or price requirements after initial adoption, resulting in 299 policies. Policies specified eight different pack size requirements ranging from 2 to 25; most prevalent were minimums of 2 (n = 116, 39.2%) and 4 (n = 67, 22.6%). Minimum prices ranged from $0.35 to $10.00 per cigar. Exclusions included cigars priced above a specified amount (n = 225, 76.0%; $2.01-$10.00) and cigars sold at adult-only or tobacco retailers (n = 45, 15.2%). This is the first comprehensive synthesis of cigar pack size and price policies within the US. Policies vary widely both between and within states.

Changes in college students' health behaviors and substance use after a brief wellness intervention during COVID-19.

College students exhibit low levels of physical activity, high levels of sedentary behavior, poor dietary behaviors, sleep problems, high stress, and increased substance use. On-campus resources offering programs to improve college students' health have been limited during the pandemic. The purpose of this study was to test a brief intervention to improve multiple health behaviors among United States college students. The intervention was a single arm repeated measures study conducted over 12 weeks, utilizing the Behavior Image Model. The intervention involved three components: a survey, a 25-minute wellness specialist consult with a peer health coach, and a 15-minute goal planning session. Follow-up measures were completed at 2-, 6-, and 12-weeks post session to assess changes in wellness behaviors. Linear mixed effects models for repeated measures were used to analyze the association between intervention implementation on within-subject changes in physical activity, sedentary behavior, diet, general health, emotional wellness, and substance use. A total of 121 participants enrolled in the study and 90 (74.4%) completed the health coach session (71% female). At first follow-up, statistically significant increases were observed in vigorous physical activity days/week (coef. = 0.5,95%CI: 0.2,0.9), moderate physical activity days/week (coef. = 0.7, 95%CI: 0.2,1.1), general health (coef. = 4.8,95%CI: 2.1, 7.5), and emotional wellness (coef. = 8.6,95%CI: 5.8, 11.3). Statistically significant decreases in cannabis use (coef. = -2.3,95%CI:-4.1, -0.5) and alcohol consumption (coef. = -2.5,95%CI: -3.7,-1.3) were observed. Many of these changes were sustained at second and third follow-up. This brief wellness intervention shows promise to positively influence multiple health behaviors in college students.

Providing evidence from practice: Evaluating 4.5 years of implementing diabetes education support program in carbohydrate management.

OBJECTIVE: To evaluate personal and economical outcomes of CarbSmart, a 3-hour person-centered, theory-based program implemented throughout Australia, targeting optimal dietary carbohydrate management. METHODS: More than 500 CarbSmart programs were implemented over 4.5 years. Pre-, post-, (N = 4656) and 3-month follow-up assessments (N = 188) of knowledge, empowerment, confidence, and patient activation were collected from people with diabetes. Participant satisfaction and potential annual cost-savings were calculated. FINDINGS: Repeated measures ANCOVAs showed large improvements pre- to post-program in all outcome variables (d = 0.80-1.68), which were maintained at 3-month follow-up in a sub-sample. Participant satisfaction was high (Net Promoter Score = 72.3). Potential annual cost-savings nation-wide were estimated at US$512million. CONCLUSION: This paper provides evidence that CarbSmart is effective in improving behavioral indicators of self-management outcomes in Australians living with diabetes. PRACTICE IMPLICATIONS: CarbSmart has the potential to prevent diabetes-related complications. However, not engaging people living with diabetes with lower levels of patient activation at baseline was recognized as a future opportunity to improve the impact of our service. Strategies are needed to engage people with lower activation levels to improve outcomes in vulnerable and at-risk populations. FUNDING: The development of CarbSmart was funded by Diabetes WA, the national implementation of CarbSmart by the National Diabetes Services Scheme, an initiative of the Australian Government.

A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY).

PURPOSE: Prostate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer. MATERIALS AND METHODS: Two patient populations underwent 18F-DCFPyL-positron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the 18F-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated. RESULTS: A total of 385 patients were enrolled. In cohort A (252 evaluable patients), 18F-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively. CONCLUSIONS: The primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that 18F-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of 18F-DCFPyL-positron emission tomography/computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.