Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study.

BACKGROUND: Tobacco use is the leading cause of preventable morbidity and mortality. Existing evidence-based treatments are underutilized and have seen little recent innovation. The success of personal biofeedback interventions in other disease states portends a similar opportunity in smoking cessation. The Pivot Breath Sensor is a personal interactive FDA-cleared (over-the-counter) device that measures carbon monoxide (CO) in exhaled breath, enabling users to link their smoking behavior and CO values, and track their progress in reducing or quitting smoking. OBJECTIVE: The objective of this study is to assess the Pivot Breath Sensor in people who smoke cigarettes, evaluating changes in attitudes toward quitting smoking, changes in smoking behavior, and use experience. METHODS: US adults (18-80 years of age, ≥10 cigarettes per day [CPD]) were recruited online for this remote 12-week study. Participants completed a screening call, informed consent, and baseline questionnaire, and then were mailed their sensor. Participants were asked to submit 4 or more breath samples per day and complete questionnaires at 1-4, 8, and 12 weeks. Outcomes included attitudes toward quitting smoking (Stage of Change, success to quit, and perceived difficulty of quitting), smoking behavior (quit attempts, CPD reduction, and 7-, 30-day point prevalence abstinence [PPA]), and use experience (impact and learning). RESULTS: Participants comprised 234 smokers, mean age 39.9 (SD 11.3) years, 52.6% (123/234) female, mean CPD 20.3 (SD 8.0). The 4- and 12-week questionnaires were completed by 92.3% (216/234) and 91.9% (215/234) of participants, respectively. Concerning attitude outcomes, at baseline, 15.4% (36/234) were seriously thinking of quitting in the next 30 days, increasing to 38.9% (84/216) at 4 weeks and 47.9% (103/215) at 12 weeks (both P<.001). At 12 weeks, motivation to quit was increased in 39.1% (84/215), unchanged in 54.9% (118/215), and decreased in 6.0% (13/215; P<.001). Additional attitudes toward quitting improved from baseline to 12 weeks: success to quit 3.3 versus 5.0 (P<.001) and difficulty of quitting 2.8 versus 4.3 (P<.001). Regarding smoking behavior, at 4 weeks, 28.2% (66/234) had made 1 or more quit attempts (≥1 day of abstinence), increasing to 48.3% (113/234) at 12 weeks. At 4 weeks, 23.1% (54/234) had reduced CPD by 50% or more, increasing to 38.5% (90/234) at 12 weeks. At 12 weeks, CPD decreased by 41.1% from baseline (P<.001), and 7- and 30-day PPA were 12.0% (28/234) and 6.0% (14/234), respectively. Concerning use experience, 75.3% (171/227) reported the sensor increased their motivation to quit. More than 90% (>196/214) indicated the sensor taught them about their CO levels and smoking behavior, and 73.1% (166/227) reported that seeing their CO values made them want to quit smoking. CONCLUSIONS: Use of the Pivot Breath Sensor resulted in a significant increase in motivation to quit, a reduction in CPD, and favorable quit attempt rates. These outcomes confer increased likelihood of quitting smoking. Accordingly, the results support a role for biofeedback via personal CO breath sampling in smoking cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04133064; https://clinicaltrials.gov/ct2/show/NCT04133064.

Patients Who Undergo Colectomy for Pediatric Ulcerative Colitis at Low-Volume Hospitals Have More Complications.

BACKGROUND & AIMS: Adults with ulcerative colitis (UC) who undergo colectomy at high-volume centers have better outcomes and fewer complications than those at low-volume centers. We aimed to evaluate the hospital volume of total abdominal colectomy (TAC) for pediatric patients with UC and explore time trends in the proportion of colectomies performed at high-volume centers. We then evaluated the association between hospital colectomy volume and complications. METHODS: We performed a cross-sectional analysis of pediatric patients (age, ≤18 y) hospitalized for UC using the Kids' Inpatient Database, a nationally representative database of pediatric hospitalizations. We identified UC hospitalizations with a procedural code (International Classification of Diseases, 9th or 10th revision) for TAC from 1997 through 2016. We defined complications using diagnosis codes adapted from published algorithms. We defined high-volume as hospitals that performed 10 or more TACs annually. We used multivariate statistics to evaluate the association between hospital volume and in-hospital complications. RESULTS: A total of 1453 hospitalizations of children with UC included a TAC (2306 colectomies nationwide). A total of 766 hospitals performed 1 or more annual colectomies and only 36 (4.7%) were high-volume hospitals, accounting for 21% of colectomies. The proportion of colectomies at high-volume hospitals decreased over time. The absolute risk of complication was 16% at high-volume centers compared with 22% at low-volume centers (adjusted odds ratio, 0.7; 95% CI, 0.5-0.9). The effect of annual TAC volume on complication risk was not statistically significant for nonemergent admissions. CONCLUSIONS: Pediatric patients with UC who undergo colectomy at high-volume centers have fewer complications. However, only a small proportion of pediatric colectomies (<5%) are performed at high-volume centers.

Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study.

BACKGROUND: Cigarette smoking is the leading cause of preventable morbidity and mortality, excess health care expenditure, and lost work productivity. Otherwise effective evidence-based treatments have had limited success owing to challenges with access, engagement, and scale. Pivot is a comprehensive digital smoking cessation program that incorporates a Food and Drug Administration-cleared carbon monoxide breath sensor, smartphone app, and text-based human coaching. OBJECTIVE: This initial evaluation of Pivot aimed to assess participant engagement, changes in attitudes toward quitting, and changes in smoking behavior. METHODS: US cigarette smokers aged 18 to 65 years who smoked ≥5 cigarettes per day (CPD) were recruited online. Participants completed a screening call, electronic informed consent, registration, and onboarding before beginning Pivot. Pivot includes 5 sequential stages (Explore, Build, Mobilize, Quit, and Secure), taking 14.5 to 18.5 weeks to complete. Data were collected via app and online questionnaires. Outcomes included engagement and retention (ie, weeks of active engagement and Pivot stage progression); attitudes toward quitting (ie, quit readiness, quit confidence, and expected difficulty maintaining quit); and smoking behavior (ie, quit attempts, cigarette reduction, and abstinence (7- and 30-day point prevalence abstinence [PPA]). RESULTS: A total of 319 participants completed onboarding (intention-to-treat [ITT] sample); 272/319 participants (85.3%) completed the end-of-Pivot questionnaire (study completer sample). Most (212/319, 66.5%) were not ready to quit in the next 30 days at baseline. On average, participants actively engaged in the program for a mean 12.4 (SD 7.1) weeks. Pivot stage completion rates were Explore: 88.7% (283/319), Build: 57.4% (183/319), Mobilize: 43.6% (139/319), Quit: 41.1% (131/319), and Secure: 39.5% (126/319). Repeated measures linear mixed model analyses demonstrated positive changes in attitudes from baseline to Mobilize (pre-Quit): increased confidence to quit (4.2 to 7.4, P<.001) and decreased expected difficulty maintaining quit (3.1 to 6.8, P<.001). The quit attempt rate (ie, those making ≥1 quit attempt lasting ≥1 day) was 79.4% (216/272, completer). At the end of Pivot, 7-day PPA rates were 32.0% (102/319, ITT) and 37.5% (102/272, completer); 30-day PPA rates were 27.6% (88/319, ITT) and 32.4% (88/272, completer). Moreover, 30-day PPA rates were comparable among those ready and not ready to quit in the next 30 days at baseline. Of those not achieving abstinence, 25.9% (44/170, completer) achieved ≥50% reduction in CPD by study end. CONCLUSIONS: This study evaluated Pivot's initial performance with comparable quit rates among those ready and not ready to quit in the next 30 days at entry. The present data, considered with the program's accessibility, innovation, evidence-based foundation, and design for all smokers, suggest Pivot has the potential to address limitations of reach and scale and thereby advance smoking cessation efforts. TRIAL REGISTRATION: ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643 (Archived by WebCite at http://www.webcitation.org/75TiNe6BE).

Utilization of healthcare resources by U.S. children and adults with inflammatory bowel disease.

BACKGROUND: The inflammatory bowel diseases (IBDs) Crohn's disease (CD) and ulcerative colitis (UC) affect over 1 million people in the United States, yet little is known about healthcare utilization by affected individuals. The objectives were to describe the healthcare utilization associated with IBD in an insured U.S. population and to determine how sociodemographic factors impact healthcare utilization in this population. METHODS: Using an administrative database comprised of 87 health plans, we ascertained cases of CD and UC using an administrative definition. We identified inpatient, office-based, emergency (ED), and endoscopy services occurring between 2003-2004 in IBD patients and matched controls. For each case, excess utilization was determined by subtracting the mean number of control visits from the number of case visits. Multivariate logistic and linear regressions were used to identify the sociodemographic factors associated with excess utilization. RESULTS: We identified 9056 CD patients and 10,364 UC patients. The mean number of annual excess hospitalizations, ED visits, and office visits per 100 patients for CD were 21.7, 20.1, and 493, respectively. These values for UC were 13.3, 10.3, and 364, respectively. In general, utilization was higher in CD compared with UC, and in younger patients compared with older patients. Utilization also varied by gender, geographical region, and insurance type (Medicaid versus commercial). CONCLUSIONS: In the U.S., patients with IBD consume substantial healthcare resources. Resource utilization varies by patient age and disease type, and to a lesser extent, gender, geographical region, and insurance type. These findings may be used to inform health policy.

High case volumes and surgical fellowships are associated with improved outcomes for bariatric surgery patients: a justification of current credentialing initiatives for practice and training.

BACKGROUND: Recent years have seen the establishment of bariatric surgery credentialing processes, center-of-excellence programs, and fellowship training positions. The effects of center-of-excellence status and of the presence of training programs have not previously been examined. The objective of this study was to examine the effects of case volume, center-of-excellence status, and training programs on early outcomes of bariatric surgery. STUDY DESIGN: Data were obtained from the Nationwide Inpatient Sample from 1998 to 2006. Quantification of patient comorbidities was made using the Charlson Index. Using logistic regression modeling, annual case volumes were analyzed for an association with each institution's center-of-excellence status and training program status. Risk-adjusted outcomes measures were calculated for these hospital-level parameters. RESULTS: Data from 102,069 bariatric operations were obtained. Adjusting for comorbidities, greater bariatric case volume was associated with improvements in the incidence of total complications (odds ratio [OR] 0.99937 for each single case increase, p = 0.01), in-hospital mortality (OR 0.99717, p < 0.01), and most other complications. Hospitals with a Fellowship Council-affiliated gastrointestinal surgery training program were associated with risk-adjusted improvements in rates of splenectomy (OR 0.2853, p < 0.001) and bacterial pneumonias (OR 0.65898, p = 0.02). Center-of-excellence status, irrespective of the accrediting entity, had minimal independent association with outcomes. A surgical residency program had a varying association with outcomes. CONCLUSIONS: The hypothesized positive volume-outcomes relationship of bariatric surgery is shown without arbitrarily categorizing hospitals to case volume groups, by analysis of volume as a continuous variable. Institutions with a dedicated fellowship training program have also been shown, in part, to be associated with improved outcomes. The concept of volume-dependent center-of-excellence programs is supported, although no independent association with the credentialing process is noted.

Race, healthcare access and physician trust among prostate cancer patients.

OBJECTIVE: To study the effect of healthcare access and other characteristics on physician trust among black and white prostate cancer patients. METHODS: A three-timepoint follow-up telephone survey after cancer diagnosis was conducted. This study analyzed data on 474 patients and their 1,320 interviews over three time periods. RESULTS: Among other subpopulations, black patients who delayed seeking care had physician trust levels that were far lower than that of both Caucasians as well as that of the black patients overall. Black patients had greater variability in their levels of physician trust compared to their white counterparts. CONCLUSIONS: Both race and access are important in explaining overall lower levels and greater variability in physician trust among black prostate cancer patients. Access barriers among black patients may spill over to the clinical encounter in the form of less physician trust, potentially contributing to racial disparities in treatment received and subsequent outcomes. Policy efforts to address the racial disparities in prostate cancer should prioritize improving healthcare access among minority groups.

The impact of socioeconomic factors on patient preparation for bariatric surgery.

BACKGROUND: Socioeconomic factors (SEF) influence bariatric surgery access and outcomes perhaps because of variations in patient knowledge and behaviors. This study examines the associations between income, formal education, race, health insurance, employment status, and patient self-educational and behavioral activities prior to bariatric surgery. METHODS: From March 2005 through January 2006, we surveyed 127 individuals who contacted our office seeking bariatric surgery. Study participants were asked to report their income, formal education, health insurance, employment status, height, weight, and standard demographic data. The type and number of self-educational resources utilized were elicited; a description of current eating and exercise behaviors was obtained; and an objective assessment (OA) of knowledge of the risks of both obesity and bariatric procedures was completed. RESULTS: The most valuable self-educational resource cited by respondents was the internet (41.2%) and was unaffected by SEF. Individuals who were employed, privately insured, white, and earning>or=$20,000/year reported using a greater number of self-educational resources than their peers, while subjects who were privately insured, had higher formal educational levels, and earned>or=$20,000/year demonstrated greater proficiency on the OA instrument. Engagement in healthy eating and exercise behaviors was unaffected by any SEF. On multivariate analysis, higher income was the sole significant factor directly related to the number of educational resources utilized and proficiency on OA. CONCLUSION: Obese patients from lower-income households may benefit from additional preoperative education. All individuals, regardless of socioeconomic factors, must be encouraged to implement healthy eating and exercise behaviors preoperatively.

Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults.

BACKGROUND & AIMS: Data regarding the health care costs of inflammatory bowel disease (IBD) in the United States are limited. The objectives of this study were to estimate the direct costs of Crohn's disease (CD) and ulcerative colitis (UC) in the United States, describe the distribution of costs among inpatient, outpatient, and pharmaceutical services, and identify sociodemographic factors influencing these costs. METHODS: We extracted medical and pharmacy claims from an administrative database containing insurance claims from 87 health plans in 33 states, occurring between 2003 and 2004. We identified cases of CD and UC using an administrative definition. For each case, we selected up to 3 non-IBD controls. Claims were classified as inpatient, outpatient, or pharmaceutical according to Current Procedural Terminology codes or National Drug Codes. Costs were based on the paid amount of each claim. IBD-attributable costs were estimated by subtracting costs for non-IBD patients from those for patients with IBD. Logistic regression was used to identify the sociodemographic factors affecting these costs. RESULTS: We identified 9056 patients with CD and 10,364 patients with UC. Mean annual costs for CD and UC were $8265 and $5066, respectively. For CD, 31% of costs were attributable to hospitalization, 33% to outpatient care, and 35% to pharmaceutical claims. The corresponding distribution for UC was 38%, 35%, and 27%, respectively. Costs were significantly higher for children younger than 20 years compared with adults, but this did not vary substantially by sex or region. CONCLUSIONS: This study demonstrates a substantial economic burden of IBD and can be used to inform health policy.

Assessment of serum proteomics to detect large colon adenomas.

A noninvasive blood test that could reliably detect early colorectal cancer or large adenomas would provide an important advance in colon cancer screening. The purpose of this study was to determine whether a serum proteomics assay could discriminate between persons with and without a large (> or =1 cm) colon adenoma. To avoid problems of "bias" that have affected many studies about molecular markers for diagnosis, specimens were obtained from a previously conducted study of colorectal cancer etiology in which bloods had been collected before the presence or absence of neoplasm had been determined by colonoscopy, helping to assure that biases related to differences in sample collection and handling would be avoided. Mass spectra of 65 unblinded serum samples were acquired using a nanoelectrospray ionization source on a QSTAR-XL mass spectrometer. Classification patterns were developed using the ProteomeQuest algorithm, performing measurements twice on each specimen, and then applied to a blinded validation set of 70 specimens. After removing 33 specimens that had discordant results, the "test group" comprised 37 specimens that had never been used in training. Although in the primary analysis, no discrimination was found, a single post hoc analysis, done after hemolyzed specimens had been removed, showed a sensitivity of 78%, a specificity of 53%, and an accuracy of 63% (95% confidence interval, 53-72%). The results of this study, although preliminary, suggest that further study of serum proteomics, in a larger number of appropriate specimens, could be useful. They also highlight the importance of understanding sources of "noise" and "bias" in studies of proteomics assays.

Intrinsic and extrinsic motivations for healthful dietary change in African Americans.

OBJECTIVE: To describe associations of intrinsic and extrinsic motivations for dietary change with participant characteristics and current diet among African Americans. METHODS: Cross-sectional survey of 658 African American adults in North Carolina provided information on intrinsic (self-image and health concerns) and extrinsic (social influence) motivation scales, participant characteristics, and diet. RESULTS: Most respondents considered it important to change their diet for health reasons; fewer were motivated by self-image or social influence. Motivation scales were significantly associated with demographic, behavioral, and psychosocial characteristics and fat, but not fruit/vegetable consumption, after adjustment for covariates (P<0.05). CONCLUSION: Tailoring on intrinsic and extrinsic motives may improve the effectiveness of dietary interventions in African Americans.

Comparison of three methods of measuring dietary fat consumption by African-American adults.

OBJECTIVE: To determine dietary fat consumption by African-American adults using three methods that capture different domains of fat consumption and assess the degree of agreement between the three instruments. DESIGN/SUBJECTS: Data were self-reported from a population-based cross-sectional survey of 658 African Americans, aged 18 to 70 years, in North Carolina using an 11-page questionnaire. Fat consumption was based on a household inventory of high-fat and low-fat foods, fat-related dietary behaviors, and total and saturated fat intakes. Demographic, behavioral, and diet-related psychosocial factors were also assessed. STATISTICAL ANALYSES: Descriptive statistics were computed. Linear regression and Pearson's correlations examined the degree of agreement between the three dietary fat assessment methods. Linear regression was also used to assess associations of participant characteristics with fat consumption. RESULTS: The participant mean age was 43.9+/-11.6 years, 41% were men, 37% were college graduates, and 75% were overweight/obese. High proportions of respondents had high-fat foods in their homes (78% had full-fat salad dressing and butter/margarine), whereas fewer had reduced-fat food items (only 19% had 1% or skim milk). Similarly, few respondents practiced healthful fat-related dietary behaviors; for example, 48% did not take the skin off chicken. There was good concordance among the three measures of fat consumption; for example, among those with more high-fat foods in the home, adjusted total and saturated fat intakes were 39.6 g and 14.9 g (compared to 24.1 g and 9.2 g, respectively, for those with none/few high-fat foods), P<0.0001. Pearson's correlation coefficients among the three methods ranged from 0.18 to 0.58 (P<0.0001). CONCLUSIONS: There was good agreement among three instruments capturing different domains of dietary fat consumption by African Americans. The household food inventory is a brief and practical measure that may be a useful alternative dietary assessment tool in this population.

Associations of psychosocial factors with fruit and vegetable intake among African-Americans.

OBJECTIVE: To examine associations of various psychosocial factors with fruit and vegetable intake in African-American adults. METHODS: A cross-sectional survey of a population-based sample of 658 African-Americans, aged 18-70 years, in North Carolina. Information was collected on diet-related psychosocial (predisposing, reinforcing and enabling) factors based on the PRECEDE (Predisposing, Reinforcing, and Enabling Constructs in Educational Diagnosis and Evaluation) planning framework; demographic, lifestyle and behavioural characteristics, and fruit and vegetable intake. RESULTS: The mean participant age was 43.9 years (standard deviation 11.6), 57% were female and 76% were overweight/obese. Participants expressed healthy beliefs regarding many of, but not all, the psychosocial factors. For example, although half of the respondents believed it is important to eat a diet high in fruits/vegetables, only 26% knew that >or=5 daily servings are recommended. The strongest associations of the psychosocial factors with fruit/vegetable intake were for predisposing factors (e.g. belief in the importance of a high fruit/vegetable diet and knowledge of fruit/vegetable recommendations) and one reinforcing factor (social support), with differences between the healthiest and least healthy responses of 0.5-1.0 servings per day. There was evidence of effect modification by gender in associations between psychosocial factors and fruit/vegetable consumption (e.g. self-efficacy was only significant in women), with higher intakes and generally healthier responses to the psychosocial variables in women than men. CONCLUSIONS: Interventions to increase fruit/vegetable intake in African-Americans may be more effective if they focus primarily on predisposing factors, such as knowledge, self-efficacy and attitudes, but not to the exclusion of reinforcing and enabling factors. The psychosocial factors that are targeted may also need to be somewhat different for African-American men and women.

Food nutrition label use is associated with demographic, behavioral, and psychosocial factors and dietary intake among African Americans in North Carolina.

OBJECTIVE: Reading nutrition labels on food packages may improve food choices and enable healthful dietary practices. This report describes the prevalence of nutrition label use and its association with demographic, behavioral, and psychological factors and diet among African-American adults. DESIGN/SUBJECTS: Self-reported data from a population-based cross-sectional survey of 658 African Americans, aged 20 to 70 years, in North Carolina. An 11-page questionnaire assessed nutrition label use, fruit and vegetable consumption, total and saturated fat intakes, fat-related dietary behaviors, diet-related psychosocial factors, and demographic and behavioral characteristics. STATISTICAL ANALYSIS: Chi2 tests and logistic regression analyses examined associations of demographic, psychosocial, and behavioral factors with nutrition label use. Linear regression was used to estimate the variation in diet explained by label use. RESULTS: The mean age of participants was 43.9+/-11.6 years, 41% were men, 37% were college graduates, and 75% were overweight/obese. Seventy-eight percent of respondents read nutrition labels when they purchased packaged foods. Nutrition label use was significantly higher among participants who were women, older, educated beyond high school, and obese (P <.05). After adjusting for demographic characteristics, the strongest psychosocial predictors of nutrition label use were healthful eating self-efficacy, strong belief in a diet-cancer relationship, and trying to lose weight. Usual/often label users had higher fruit and vegetable consumption and lower fat intakes (P <.001), and nutrition labels explained 2% to 17% of the variance in dietary intake. CONCLUSIONS: Nutrition information on packaged foods appears to be a useful way to conduct point-of-purchase nutrition education among African Americans in North Carolina. Most respondents used food labels at least sometimes, but only about half usually or often did so. Efforts should be made to determine how all consumers could use nutrition labels effectively.

Eating at fast-food restaurants is associated with dietary intake, demographic, psychosocial and behavioural factors among African Americans in North Carolina.

OBJECTIVE: To examine associations of the frequency of eating at fast-food restaurants with demographic, behavioural and psychosocial factors and dietary intake in African American adults. METHODS: Self-reported data from a population-based cross-sectional survey of 658 African Americans, aged 20-70 years, in North Carolina. An 11-page questionnaire assessed eating at fast-food restaurants, demographic, behavioural and diet-related psychosocial factors, and dietary intake (fruit, vegetable, total fat and saturated fat intakes, and fat-related dietary behaviours). RESULTS: The participants were aged 43.9+/-11.6 years (mean+/-standard deviation), 41% were male, 37% were college graduates and 75% were overweight or obese. Seventy-six per cent reported eating at fast-food restaurants during the previous 3 months: 4% usually, 22% often and 50% sometimes. Frequency of eating at fast-food restaurants was positively associated with total fat and saturated fat intakes and fat-related dietary behaviours (P<0.0001) and inversely associated with vegetable intake (P<0.05). For example, mean daily fat intake was 39.0 g for usually/often respondents and 28.3 g for those reporting rare/never eating at fast-food restaurants. Participants who reported usual/often eating at fast-food restaurants were younger, never married, obese, physically inactive and multivitamin non-users (all P<0.01). Frequency of eating at fast-food restaurants was positively associated with fair/poor self-rated health, weak belief in a diet-cancer relationship, low self-efficacy for healthy eating, weight dissatisfaction, and perceived difficulties of preparing healthy meals and ordering healthy foods in restaurants (all P<0.05). Frequency of eating at fast-food restaurants did not differ significantly by sex, education, smoking, ability to purchase healthy foods or knowledge of the Food Guide Pyramid. CONCLUSIONS: Eating at fast-food restaurants is associated with higher fat and lower vegetable intakes in African Americans. Interventions to reduce fast-food consumption and obesity in African Americans should consider demographic and behavioural characteristics and address attitudes about diet-disease relationships and convenience barriers to healthy eating.