Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment.

Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.

Evaluating Teaching Effectiveness of Medical Humanities in an Integrated Clerkship Program by a Novel Prospective Propensity Score Matching Framework.

BACKGROUND: This study aims to rigorously compare the effectiveness of the educational programs of a new integrated clinical clerkship in medicine (3 months) and surgery (3 months) at a cancer center with the conventional subspecialty-based rotations at a tertiary teaching hospital, by this prospective, pre-post comparative method. METHODS: Between 2013-2016, we compared 69 students who had selected the integrated clerkship that emphasized clinical competency and medical humanities training with 138 matched peers who had completed conventional clerkships during the same period. Outcome measures for medical humanities included empathy, patient-centeredness, and other values and skills related to holistic health care professionalism by introducing prospective propensity score matching (PSM). RESULTS: At baseline, no significant between-group differences existed. At the completion of the core clerkships, students receiving the integrative clerkship had significantly higher scores on the Patient-Practitioner Orientation Scale (PPOS) and the Professionalism Climate in Clinical Teaching Environment (PCI), and similar Jefferson Scale of Physician Empathy Student Version (JSPE) scores, as compared with the comparison group. We also found that the students in this program did not perform worse than those in the traditional internship group in the comprehensive and formative OSCE medical clinical skills test. CONCLUSIONS: Our study develops an empirical basis for rigorous evaluation to design medical education to improve the medical humanities values and skills of interns. Features of the new integrated clerkship program that we developed include substantial participation by the students in patient-centered in-hospital culture, as well as reflection, discussion, and feedback on actual clinical cases.

Impact of dietary intake of sodium and potassium on short-term blood pressure variability.

BACKGROUND: Dietary Approaches to Stop Hypertension (DASH)-Sodium trial showed that dietary sodium and potassium affect blood pressure (BP). We aimed to investigate whether dietary sodium and potassium affect short-term BP variability (BPV) in addition to BP. METHODS: A total of 343 participants from the DASH-Sodium trial (age 48.4 ±â€Š9.7, 42.5% men) and 323 individuals from the Jackson Heart Study (JHS) (age 56.7 ±â€Š11.2, 30.7% men) with satisfactory ambulatory BP monitoring records and 24-h urine collection were included. Average real variability (ARV) was calculated as a measure of short-term BPV. RESULTS: By estimating dietary intake from urinary excretion, we observed that higher urinary sodium-to-potassium ratio was significantly associated with higher diastolic ARV in both studies. Among the DASH-Sodium trial, potassium-rich DASH diet alone had insignificant effect on both systolic (-0.1 ±â€Š1.7 mmHg, P = 0.343) or diastolic ARV (-0.2 ±â€Š1.5 mmHg, P = 0.164), whereas combined DASH diet and low sodium intake significantly reduced both systolic (8.5 ±â€Š1.6 vs. 8.9 ±â€Š1.7 mmHg, P = 0.032) and diastolic ARV (7.5 ±â€Š1.5 vs. 7.8 ±â€Š1.6 mmHg, P = 0.025) as compared with control diet and high sodium intake. As the reduction of systolic ARV was majorly derived from the change of mean SBP, diastolic ARV was significantly determined by urinary sodium-to-potassium ratio (ß coefficient ±â€Šstandard error: 0.012 ±â€Š0.004; P = 0.006) after adjusting for age, sex, smoking, mean DBP, BMI, and race. CONCLUSION: Dietary sodium and potassium can jointly modulate short-term BPV in addition to BP. Combined DASH diet and low sodium intake may reduce systolic and diastolic ARV via different mechanisms.

Prognostic Utility of Morning Blood Pressure Surge for 20-Year All-Cause and Cardiovascular Mortalities: Results of a Community-Based Study.

BACKGROUND: Morning blood pressure (BP) surge (MS), defined by the MS amplitude, is an independent prognostic factor of cardiovascular outcomes in some, but not all, populations. METHOD AND RESULTS: We enrolled 2020 participants (1029 men; aged 30-79 years) with 24-hour ambulatory BP data. During a median 19.7-year follow-up, 607 deaths (182 by cardiovascular causes) were confirmed from the National Death Registry. The amplitude of sleep-trough MS (STMS) was derived from the difference between morning systolic BP (SBP) and lowest nighttime SBP. The rate of STMS was derived as the slope of linear regression of sequential SBP measures on time intervals within the STMS period. Thresholds for high STMS amplitude and rate were determined by the 95th percentiles (43.7 mm Hg and 11.3 mm Hg/h, respectively). Multivariable Cox models, adjusting for age, sex, body mass index, smoking, alcohol, low-density lipoprotein cholesterol, 24-hour SBP, night:day SBP ratio, and antihypertensive treatment, revealed that a high STMS rate (hazard ratio, 1.666; 95% confidence interval, 1.185-2.341), but not STMS amplitude (hazard ratio, 1.245; 95% confidence interval, 0.984-1.843), was significantly associated with a greater mortality risk. Similarly, STMS rate (hazard ratio, 2.608; 95% confidence interval, 1.554-4.375), but not STMS amplitude, was significantly associated with the risk of cardiovascular mortality (hazard ratio, 0.966; 95% confidence interval, 0.535-1.747). Moreover, the prognostic values of STMS rate were comparable in subjects with or without morning and nocturnal hypertension (P>0.05 for interaction for all). In simulation studies, STMS rate was less susceptible to measurement errors of the sleep-trough SBP than STMS amplitude. CONCLUSIONS: STMS rate could independently help identify subjects with an increased cardiovascular risk.