Race-ethnicity and sex differences in 1-year survival following percutaneous coronary intervention among Medicare fee-for-service beneficiaries.

RATIONALE: Existing literature describing differences in survival following percutaneous coronary intervention (PCI) by patient sex, race-ethnicity and the role of socioeconomic characteristics (SEC) is limited. AIMS AND OBJECTIVES: Evaluate differences in 1-year survival after PCI by sex and race-ethnicity, and explore the contribution of SEC to observed differences. METHODS: Using a 20% sample of Medicare claims data for beneficiaries aged 65+, we identified fee-for-service patients who received PCI from 2007 to 2015. We performed logistic regression to assess how sex and race-ethnicity relate to procedural indication, inpatient versus outpatient setting, and 1-year mortality. We evaluated whether these relationships are moderated by sequentially controlling for factors including age, comorbidities, presence of acute myocardial infarction (AMI), county SEC, medical resource availability and inpatient versus outpatient procedural status. RESULTS: We identified 300,491 PCI procedures, of which 94,863 (31.6%) were outpatient. There was a significant transition to outpatient PCI during the study period, especially for men compared with women and White patients compared with Black patients. Black patients were 3.50 percentage points (p < 0.001) and women were 3.41 percentage points (p < 0.001) more likely than White and male patients to undergo PCI at the time of AMI, which typically occurs in the inpatient setting. Controlling for age and calendar year, Black patients were 2.87 percentage points more likely than non-Hispanic White patients to die within 1 year after PCI. After controlling for Black-White differences in comorbidities, the differences in 1-year mortality decreased to 0.95 percentage points, which then became nonsignificant when further controlling for county resources and state of residence. CONCLUSION: Women were more likely to experience PCI in the setting of AMI and had less transition to outpatient care during the period. Black patients experienced higher 1-year mortality following PCI, which is explained by differences in baseline comorbidities, county medical resources, and state of residence.

Evaluation of race and ethnicity disparities in outcome studies of CYP2C19 genotype-guided antiplatelet therapy.

Dual antiplatelet therapy with a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor) and aspirin remains the standard of care for all patients undergoing percutaneous coronary intervention (PCI). It is well-established that patients carrying CYP2C19 no function alleles have impaired capacity to convert clopidogrel into its active metabolite and thus, are at higher risk of major adverse cardiovascular events (MACE). The metabolism and clinical effectiveness of prasugrel and ticagrelor are not affected by CYP2C19 genotype, and accumulating evidence from multiple randomized and observational studies demonstrates that CYP2C19 genotype-guided antiplatelet therapy following PCI improves clinical outcomes. However, most antiplatelet pharmacogenomic outcome studies to date have lacked racial and ethnic diversity. In this review, we will (1) summarize current guideline recommendations and clinical outcome evidence related to CYP2C19 genotype-guided antiplatelet therapy, (2) evaluate the presence of potential racial and ethnic disparities in the major outcome studies supporting current genotype-guided antiplatelet therapy recommendations, and (3) identify remaining knowledge gaps and future research directions necessary to advance implementation of this precision medicine strategy for dual antiplatelet therapy in diverse, real-world clinical settings.

Trends in Hospitalizations and Survival of Acute Decompensated Heart Failure in Four US Communities (2005-2014): ARIC Study Community Surveillance.

BACKGROUND: Community trends of acute decompensated heart failure (ADHF) in diverse populations may differ by race and sex. METHODS: The ARIC study (Atherosclerosis Risk in Communities) sampled heart failure-related hospitalizations (≥55 years of age) in 4 US communities from 2005 to 2014 using International Classification of Diseases, Ninth Revision, Clinical Modification codes. ADHF hospitalizations were validated by standardized physician review and computer algorithm, yielding 40 173 events after accounting for sampling design (unweighted n=8746). RESULTS: Of the ADHF hospitalizations, 50% had reduced ejection fraction, and 39% had preserved EF (HFpEF). HF with reduced ejection fraction was more common in black men and white men, whereas HFpEF was most common in white women. Average age-adjusted rates of ADHF were highest in blacks (38.1 per 1000 black men, 30.5 per 1000 black women), with rates differing by HF type and sex. ADHF rates increased over the 10 years (average annual percentage change: black women +4.3%, black men +3.7%, white women +1.9%, white men +2.6%), mostly reflecting more acute HFpEF. Age-adjusted 28-day and 1-year case fatality proportions were ≈10% and 30%, respectively, similar across race-sex groups and HF types. Only blacks showed decreased 1-year mortality over time (average annual percentage change: black women -5.4%, black men -4.6%), with rates differing by HF type (average annual percentage change: black women HFpEF -7.1%, black men HF with reduced ejection fraction -4.7%). CONCLUSIONS: Between 2005 and 2014, trends in ADHF hospitalizations increased in 4 US communities, primarily driven by acute HFpEF. Survival at 1 year was poor regardless of EF but improved over time for black women and black men.

Psychometric assessment of the processes of change scale for sun protection.

The fourteen-factor Processes of Change Scale for Sun Protection assesses behavioral and experiential strategies that underlie the process of sun protection acquisition and maintenance. Variations of this measure have been used effectively in several randomized sun protection trials, both for evaluation and as a basis for intervention. However, there are no published studies, to date, that evaluate the psychometric properties of the scale. The present study evaluated factorial invariance and scale reliability in a national sample (N = 1360) of adults involved in a Transtheoretical model tailored intervention for exercise and sun protection, at baseline. Invariance testing ranged from least to most restrictive: Configural Invariance (constraints only factor structure and zero loadings); Pattern Identity Invariance (equal factor loadings across target groups); and Strong Factorial Invariance (equal factor loadings and measurement errors). Multi-sample structural equation modeling tested the invariance of the measurement model across seven subgroups: age, education, ethnicity, gender, race, skin tone, and Stage of Change for Sun Protection. Strong factorial invariance was found across all subgroups. Internal consistency coefficient Alpha and factor rho reliability, respectively, were .83 and .80 for behavioral processes, .91 and .89 for experiential processes, and .93 and .91 for the global scale. These results provide strong empirical evidence that the scale is consistent, has internal validity and can be used in research interventions with population-based adult samples.

Fat Reduction Efforts: A 24-Month Longitudinal Comparison of a Large Sample of Maintainers, Relapsers, and Non-Changers.

This research examined dynamic transtheoretical model (TTM) constructs for dietary fat reduction. This secondary data analysis pooled three large population-based TTM-tailored school, worksite, medical, and home-based intervention studies and examined use of constructs across three groups organized by longitudinal progress (dynatypes): Maintainers, Relapsers, and Stable Non-Changers. The criteria for successful change, at the time, were that less than 30% of calories came from fat. A total of 2,718 adults met criteria for an unhealthy diet at baseline. The majority of participants were female, White, married, and middle-aged. Demographics, Stage of Change, Processes of Change, Decisional Balance, and Temptations were measured. Dynatype groups were assessed with reliable and valid scales assessing constructs at baseline and 6, 12, and 24 months. Analyses included a multivariate analysis of variance followed by a series of analyses of variance, with Tukey follow-up tests assessing differences in use of TTM constructs across the three groups at each time point. Relapsers and Maintainers were similar in their use of all TTM Processes of Change at baseline, with the exception of Self-Liberation (η(2) = 0.15, p < .001) and Reinforcement Management (η(2) = 0.01, p < .001). Although Relapsers reverted to an unhealthy diet, their overall greater use of Processes of Change suggests that their behaviors and strategy use remain better than that of the Stable Non-Changer group. Results suggest that specific cognitive and behavioral constructs may contribute differentially to intervention outcomes.

College Students' Perceptions of Professor/Instructor Bullying: Questionnaire Development and Psychometric Properties.

OBJECTIVE: This study developed and examined the psychometric properties of a newly formed measure designed to assess professor/instructor bullying, as well as teacher bullying occurring prior to college. Additionally, prevalence of instructor bullying and characteristics related to victims of instructor bullying were examined. PARTICIPANTS: Participants were 337 college students recruited in 2012 from a northeastern university. METHODS: An online questionnaire was administered to college students. A split-half, cross-validation approach was employed for measurement development. RESULTS: The measure demonstrated strong criterion validity and internal consistency. Approximately half of students reported witnessing professor/instructor bullying and 18% reported being bullied by a professor/instructor. Report of teacher bullying occurring prior to college was related to professor/instructor bullying in college, and sex was a moderating variable. CONCLUSION: College students perceive instructor bullying as occurring but may not know how to properly address it. Prevention efforts should be made by university administrators, faculty, and staff.

Gender, ethnicity and race in incarcerated and detained youth: services and policy implications for girls.

OBJECTIVE: While work has been conducted on gender differences to inform gender-specific programming, relatively little work has been done regarding racial and ethnic differences among incarcerated and detained girls in particular. This is an important gap, considering gender, race, and ethnicity may be important factors in responding to the needs of incarcerated and detained girls within the Risk-Needs-Responsivity (RNR) model. We hypothesize girls will show relatively more pathology than boys, and that White girls will show relatively more pathology as compared to girls of other groups. Implications of findings for services delivery and policy are presented. METHOD: Data were collected on N = 657 youth using structured interview and record review. Analyses included χ2 and t tests. RESULTS: As compared to boys, girls were older at first arrest yet younger during most lock-up, received poorer grades, experienced more family difficulty, and more were lesbian/bisexual. As compared to minority girls, White girls began hard drugs at a younger age, had more conduct disorder symptoms, and more frequently experienced parental difficulty and abuse. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Age-appropriate programming that addresses family difficulty and sexuality is needed for girls. As compared to White girls, reentry planning may more readily rely on family support for minority girls. Systems should consider use of actuarial methods in order to reduce bias in making placement decisions. (PsycINFO Database Record

Randomized trial outcomes of a TTM-tailored condom use and smoking intervention in urban adolescent females.

Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females were recruited and randomized within four urban family planning clinics. Participants received TTM or standard care (SC) computerized feedback and stage-targeted or SC counseling at baseline, 3, 6 and 9 months. Blinded follow-up telephone surveys were conducted at 12 and 18 months. Analyses revealed significantly more consistent condom use in the TTM compared with the SC group at 6 and 12, but not at 18 months. In baseline consistent condom users (40%), significantly less relapse was found in the TTM compared with the SC group at 6 and 12, but not at 18 months. No significant effects for smoking prevention or cessation were found, although cessation rates matched those found previously. This TTM-tailored intervention demonstrated effectiveness for increasing consistent condom use at 6 and 12 months, but not at 18 months, in urban adolescent females. This intervention, if replicated, could be disseminated to promote consistent condom use and additional health behaviors in youth at risk.

Testing demographic differences for alcohol use initiation among adolescents for the decisional balance and situational temptation prevention inventories.

Alcohol use by middle school-aged students is a public health concern because of the numerous adverse social, health and psychological outcomes. Prevention programs attempt to intervene before alcohol use begins. A tailored, computer-delivered program for the prevention of alcohol use and a series of new transtheoretical model measures were developed, including decisional balance (Pros and Cons) of alcohol use and Situational Temptations to Try Alcohol. This study investigated if there were any demographic differences on these measures in a sample of 6th grade middle school students from 20 schools (N=4151) at baseline. Three factorial analysis of variance tests were conducted to explore the impact of race (whites vs. non-whites), ethnicity (Hispanics vs. Non-Hispanics) and gender (males vs. females). A significant two-way interaction effect was found between gender and ethnicity for Pros of Alcohol Use. A significant three-way interaction effect was found between gender, race and ethnicity for Cons of Alcohol Use. Main effects were found for the three demographic factors for Situational Temptations to Try Alcohol. However, the effect sizes for the interaction effects and main effects were very small (all below η(2)=.01), suggesting that race/ethnicity and gender alone may not be highly influential factors in the Decisional Balance for the Prevention of Alcohol and Situational Temptations to Try Alcohol in adolescence. The implications for these results and alcohol use prevention among this group are discussed.

Resource use trajectories for aged medicare beneficiaries with complex coronary conditions.

OBJECTIVE: To use coronary revascularization choice to illustrate the application of a method simulating a treatment's effect on subsequent resource use. DATA SOURCES: Medicare inpatient and outpatient claims from 2002 to 2008 for patients receiving multivessel revascularization for symptomatic coronary disease in 2003-2004. STUDY DESIGN: This retrospective cohort study of 102,877 beneficiaries assessed survival, days in institutional settings, and Medicare payments for up to 6 years following receipt of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). METHODS: A three-part estimator designed to provide robust estimates of a treatment's effect in the setting of mortality and censored follow-up was used. The estimator decomposes the treatment effect into effects attributable to survival differences versus treatment-related intensity of resource use. PRINCIPAL FINDINGS: After adjustment, on average CABG recipients survived 23 days longer, spent an 11 additional days in institutional settings, and had cumulative Medicare payments that were $12,834 higher than PCI recipients. The majority of the differences in institutional days and payments were due to intensity rather than survival effects. CONCLUSIONS: In this example, the survival benefit from CABG was modest and the resource implications were substantial, although further adjustments for treatment selection are needed.

Disappearing and reappearing differences in drug-eluting stent use by race.

RATIONALE, AIMS AND OBJECTIVES: Drug-eluting coronary stents (DES) rapidly dominated the marketplace in the United States after approval in 2003, but utilization rates were initially lower among African American patients. We assess whether racial differences persisted as DES diffused into practice. METHODS: Medicare claims data were used to identify coronary stenting procedures among elderly patients with acute coronary syndromes (ACS). Regression models of the choice of DES versus bare mental stent controlled for demographics, ACS type, co-morbidities and hospital characteristics. Diffusion was assessed in the short run (2003-2004) and long run (2007), with the effect of race calculated to allow for time-varying effects. RESULTS: The sample included 381,887 Medicare beneficiaries treated with stent insertion; approximately 5% were African American. Initially (May 2003-February 2004), African American race was associated with lower DES use compared to other races (44.3% versus 46.5%, P < 0.01). Once DES usage was high in all patients (March-December 2004), differences were not significant (79.8% versus 80.3%, P = 0.45). Subsequent concerns regarding DES safety caused reductions in DES use, with African Americans having lower use than other racial groups in 2007 (63.1% versus 65.2%, P < 0.01). CONCLUSIONS: Racial disparities in DES use initially disappeared during a period of rapid diffusion and high usage rates; the reappearance of disparities in use by 2007 may reflect DES use tailored to unmeasured aspects of case mix and socio-economic status. Further work is needed to understand whether underlying differences in race reflect decisions regarding treatment appropriateness.

Stress imaging use and repeat revascularization among medicare patients with high-risk coronary artery disease.

The optimal use of stress testing after coronary revascularization remains unclear, and overuse of stress testing might increase the rates of repeat revascularization. We analyzed the association at both the patient and regional level between the use of stress testing and repeat revascularization for a cohort of Medicare beneficiaries receiving revascularization within 30 days of an admission for symptomatic coronary artery disease. The sample consisted of 219,748 Medicare beneficiaries aged >65 years who received percutaneous coronary intervention or cardiac bypass artery grafting after hospital admission for symptomatic coronary artery disease in 2003 to 2004. Medicare claims data through 2008 identified the use of stress testing and repeat revascularization. The associations between the cumulative incidence of stress testing and repeat revascularization were analyzed using linear regression analysis. Within 6 years of the initial revascularization, the cumulative incidence of events was 0.61 for stress testing and 0.23 for repeat revascularization. Most (53.1%) repeat revascularizations were preceded by a stress test. Only 10.3% of repeat revascularization procedures were preceded by myocardial infarction. The 4-year cumulative incidence of repeat revascularization and stress testing varied between the Hospital Referral Regions represented by the sample, and the positive correlation between the rates by the health referral region accounted for only a small portion of the total health referral region variation in revascularization rates. In conclusion, stress testing is commonly performed among Medicare patients after the initial revascularization, and most repeat procedures are performed for stable coronary artery disease. The variation in stress testing patterns only explained a modest fraction of the regional variation in the repeat revascularization rates.

Validation of the measures of the transtheoretical model for exercise in an adult African-American sample.

PURPOSE: African-Americans have high rates of physical inactivity-related morbidity and mortality, thus effective interventions to increase exercise are necessary. Tailored interventions show promise, but measures need validation in this population. This study validated transtheoretical model measures for exercise in an African-American sample. DESIGN: Cross-sectional measure development. SETTING: Telephone survey of individuals in North Carolina. SUBJECTS: 521 African-American adults. MEASURES: Stages of change, decisional balance (pros and cons), self-efficacy and processes of change (POC) for regular exercise. ANALYSIS: Confirmatory factor analyses tested measurement models. Multivariate analyses examined relationships between each construct and stages of change. RESULTS: For decisional balance, the two-factor uncorrelated model was the most parsimonious good-fitting model (χ(235) = 158.76; comparative fit index [CFI], .92; average absolute standardized residual [AASR], .04), and alphas were good (pros α = .85 and cons α = .74). The one-factor model for self-efficacy (α = .80) revealed an excellent fit (χ(29) = 45.51; CFI, .96; AASR, .03). For the POC subscales with good alphas (α = .62-.91), a 10-factor fully correlated model fit best (χ(2)[360] = 786.75; CFI, .91; AASR, .04). Multivariate analyses by stage of change replicated expected patterns for the pros, self-efficacy, and POC measures with medium-sized effects (η(2)  =  .05-.13). Results by stage of change did not replicate for the cons scale. CONCLUSIONS: The structures of these measures replicated with good internal and external validity, except for the cons scale, which requires additional development. Results support the use of these measures in tailored interventions to increase exercise among African-Americans.

Ticagrelor versus genotype-driven antiplatelet therapy for secondary prevention after acute coronary syndrome: a cost-effectiveness analysis.

BACKGROUND: Clopidogrel's effectiveness is likely reduced significantly for prevention of thrombotic events after acute coronary syndrome (ACS) in patients exhibiting a decreased ability to metabolize clopidogrel into its active form. A genetic mutation responsible for this reduced effectiveness is detectable by genotyping. Ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater clinical efficacy than clopidogrel in a recent secondary prevention trial. In 2011, clopidogrel will lose its patent protection and likely will be substantially less expensive than ticagrelor. OBJECTIVE: To determine the cost-effectiveness of ticagrelor compared with a genotype-driven selection of antiplatelet agents. METHODS: A hybrid decision tree/Markov model was used to estimate the 5-year medical costs (in 2009 US$) and outcomes for a cohort of ACS patients enrolled in Medicare receiving either genotype-driven or ticagrelor-only treatment. Outcomes included life years and quality-adjusted life years (QALYs) gained. Data comparing the clinical performance of ticagrelor and clopidogrel were derived from the Platelet Inhibition and Patient Outcomes trial. RESULTS: The incremental cost-effectiveness ratio (ICER) for universal ticagrelor was $10,059 per QALY compared to genotype-driven treatment, and was most sensitive to the price of ticagrelor and the hazard ratio for death for ticagrelor compared with clopidogrel. The ICER remained below $50,000 per QALY until a monthly ticagrelor price of $693 or a 0.93 hazard ratio for death for ticagrelor relative to clopidogrel. In probabilistic analyses, universal ticagrelor was below $50,000 per QALY in 97.7% of simulations. CONCLUSION: Prescribing ticagrelor universally increases quality-adjusted life years for ACS patients at a cost below a typically accepted threshold.

The contribution of hypertension to black-white differences in likelihood of coronary artery disease detected during elective angiography.

BACKGROUND: Black patients in the United States undergoing angiography for suspected coronary artery disease (CAD) have consistently been found to have less disease than whites. As the effects of hypertension are greater in blacks than whites, and hypertensive heart disease may mimic CAD and lead to catheterization, we examined the association between race and hypertension as an explanation for the disparities in angiographic CAD. METHODS: Using an academic hospital's institutional database, we studied patients undergoing first-time elective angiography from 2001 to 2008. Using multivariable logistic regression with data on patient demographics, CAD risk factors, and coronary stenoses, we compared rates of angiographic disease for blacks and whites, creating models separately for patients with and without hypertension. We then tested the significance of an interaction term between race and hypertension on angiographic findings. RESULTS: We identified 1,203 black and 2,538 white patients who underwent initial elective angiography. Black patients were less likely to have a significant stenotic lesion (≥50% stenosis in the left main artery or ≥70% stenosis elsewhere) than whites (adjusted risk ratio 0.65; 95% confidence interval (CI) 0.55-0.75). Among patients with hypertension this difference was exaggerated (adjusted risk ratio 0.60; 95% CI 0.51-0.71). However, among patients without hypertension, the risk of having a significant lesion was similar in blacks and whites (adjusted risk ratio 0.97; 95% CI 0.67-1.37). The interaction term for race and hypertension was confirmed as statistically significant. CONCLUSIONS: Among patients electively referred for angiography, hypertension, and its effects may contribute to the lower rate of CAD found in blacks compared to whites.

Acute heart failure syndromes in patients with coronary artery disease early assessment and treatment.

Acute heart failure syndromes (AHFS) have emerged as a leading public health problem worldwide, accounting for a substantial number of hospitalizations and a high utilization of resources. Although in-hospital mortality rates are relatively low, patients with AHFS have very high early after-discharge mortality and rehospitalization rates. The majority of patients admitted with AHFS have coronary artery disease (CAD), which independently has an adverse impact on prognosis. The initial in-hospital and after-discharge management of AHFS may be dependent on clinical presentation: AHFS in patients with underlying CAD or acute coronary syndromes (ACS) complicated by heart failure. In addition, the extent and severity of CAD and the presence of ischemia and/or stunned/hibernating myocardium should be assessed for optimal management. Although the overall management of AHFS with CAD may be similar to that in patients with ACS complicated by heart failure, for which specific guidelines exist, management of the former is less well defined. Prospective studies of the assessment and treatment of CAD in patients with AHFS are urgently needed.

Long-term effects of a stage-based intervention for changing exercise intentions and behavior in older adults.

PURPOSE: We examined the efficacy of an intervention tailored to the individual's stage of change for exercise adoption on exercise stage of change, physical activity, and physical function in community-dwelling older adults. DESIGN AND METHODS: We randomized participants to a print and telephone intervention or a contact comparison group. Through the use of longitudinal analyses we examined the intervention's effectiveness in promoting stage progression, altering decisional balance and the processes of change, increasing self-efficacy and physical activity, and improving physical function among older adults who completed the 24-month study (N = 966). We conducted similar analyses that excluded individuals who were in maintenance at baseline and 24 months. RESULTS: At the end of the study, there were no differences in stage progression, self-efficacy, decisional balance, the processes of change, physical activity, or physical function by intervention assignment. When the analyses excluded those participants (n = 358) who were in the maintenance stage for exercise throughout the intervention, we found that, compared with the comparison group, a greater proportion of individuals who received the exercise intervention progressed in stage by 24 months. Conversely, more individuals in the comparison group remained stable or regressed in stage compared with the intervention group. IMPLICATIONS: Results indicate that a tailored intervention is effective in increasing motivational readiness for exercise in individuals who were in stages of change other than maintenance.

Meta-analytic examination of the strong and weak principles across 48 health behaviors.

OBJECTIVE: The strong and weak principles of change state that progress from the precontemplation to the action stage of change is associated with a one standard deviation increase in the pros and a one-half standard deviation decrease in the cons of change. In this study these relationships, originally developed by Prochaska [Prochaska, J.O., 1994. Strong and weak principles for progressing from precontemplation to action on the basis of 12 problem behaviors. Health Psychology, 13, 47-51] based on an examination of 12 studies of 12 different behaviors, were re-examined using many more datasets and much more rigorous statistical methods. METHODS: The current study analyzes 120 datasets from studies conducted between 1984 and 2003 across and within 48 health behaviors, including nearly 50,000 participants from 10 countries. The datasets were primarily analyzed utilizing meta-analytic techniques. RESULTS: Despite the range of behaviors and populations, the results were remarkably consistent with the original results (pros=1.00 standard deviation, cons=0.56 standard deviation). Few potential moderators showed any impact on effect size distributions. CONCLUSIONS: This updated and enhanced examination of two important principles of behavior change is a significant contribution to the field of multiple health risk behaviors, as it clearly demonstrates the consistency of the theoretical principles across multiple behaviors, which has implications for developing multiple health risk behavior interventions.

Assessment of the pros and cons of stress management among adolescents: development and validation of a decisional balance measure.

PURPOSE: This article reports on the development of a decisional balance measure based on the transtheoretical model (TTM) for stress management among adolescents. DESIGN: Measurement development was conducted with participants of a pilot survey. SETTING: Surveys were completed in health and physical education classes. SUBJECTS: Ninth and tenth graders (N=317) completed an assessment of TTM constructs. MEASURES: The focus of this paper is the development of a decisional balance measure. ANALYSIS: A split-half cross-validation procedure was implemented. RESULTS: A brief reliable eight-item instrument was developed measuring the pros and cons of practicing stress management. A theoretically consistent pattern of pros and cons across the stages of change was obtained and indicated construct validity. Girls were more likely to practice and acknowledge benefits of stress management. CONCLUSION: This instrument will aid future work on promoting stress management practices among adolescents, particularly when using the TTM to develop interventions.

Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT).

This manuscript describes the randomized clinical trial titled Stage-Matched Intervention to Increase Dual Method Use or Project PROTECT. Project PROTECT compared two approaches to promote the use of dual methods of contraception among high-risk women. The intervention arm received tailored individualized feedback based on the Transtheoretical Model of Behavior Change using a computer-based multimedia program. The control arm received general information on contraception. The primary outcomes of this trial were 1) self-reported use of dual methods of contraception and 2) the biological outcomes of an unintended pregnancy or an incident or recurrent sexually transmitted disease. In this report, we describe the significance and background of the problem, the specific aims of the study, study organization, patient selection, randomization, outcome variables, data collection, procedures used for follow-up and testing, primary and secondary outcomes, and statistical analyses. We also describe participant characteristics and procedures used to assure patient safety and trial monitoring.