A Digital Health Intervention to Lower Cardiovascular Risk: A Randomized Clinical Trial.

IMPORTANCE: South Asian individuals have a high burden of premature myocardial infarction (MI). OBJECTIVES: To test whether a digital health intervention (DHI) designed to change diet and physical activity improves MI risk among a South Asian population. DESIGN, SETTING, AND PARTICIPANTS: This single-blind, community-based, randomized clinical trial with 1-year follow-up was performed among South Asian men and women 30 years or older and living in Ontario and British Columbia who were free of cardiovascular disease. Data analysis was by intention to treat. Data were collected from June 3, 2012, to October 27, 2013. Final follow-up was completed on December 2, 2014, and data were analyzed from April 2, 2015, to February 29, 2016. INTERVENTIONS: Participants were randomized 1:1 to the DHI or control condition. The goal-setting DHI used emails or text messages and focused on improving diet and physical activity that was tailored to the participant's self-reported stage of change. MAIN OUTCOMES AND MEASURES: The change in an MI risk score from baseline to 1 year was the primary outcome. Secondary outcomes included the change in each objectively measured component of the MI risk score (ie, blood pressure, waist to hip ratio, hemoglobin A1c level, and the ratio of apolipoprotein B to apolipoprotein A). Genetic risk for MI was determined by counting the 9p21 risk alleles; results were provided to each participant at baseline. RESULTS: A total of 343 South Asian men and women (178 men [51.9%]; mean [SD] age, 50.6 [11.4] years) who were free of cardiovascular disease were randomized to the control condition (n = 174) or the DHI (n = 169). The mean (SD) MI risk score was 13.3 (6.6) at baseline. No significant difference was found in the change in MI score after 1 year between the DHI and control groups (-0.27; 95% CI, -1.12 to 0.58; P = .53) after adjusting for baseline scores, and no difference was found in the fully adjusted model (-0.39; 95% CI, -1.24 to 0.45; P = .36). No association between knowledge of the genetic risk status at baseline and the change in MI risk score was found (0.19; 95% CI, -0.40 to 0.78; P = .53). CONCLUSIONS AND RELEVANCE: Among South Asian individuals, a DHI was not associated with a reduction in MI risk score after 12 months and was not influenced by knowledge of genetic risk status. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01841398.

Post-traumatic growth among cardiac outpatients: degree comparison with other chronic illness samples and correlates.

This study evaluated the sociodemographic, clinical and behavioral correlates of post-traumatic growth (PTG) in coronary artery disease (CAD) patients, and the degree of PTG compared to other patient groups. Using a prospective design, 1497 CAD outpatients completed a survey assessing potential PTG correlates. A total of 1268 responded to a nine-month follow-up survey assessing PTG. Significant PTG correlates were being younger, non-white, having lower income, functional status, and depressive symptoms, greater social support, and positive illness perceptions. The degree of PTG was equivalent to that of cardiac patients in other countries, but was lower than that of breast cancer and multiple sclerosis patients.

Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic.

BACKGROUND: In clinical and research practice linked to prostate cancer treatment, frequent monitoring of patient health-related quality of life (HRQOL) is essential. Practical and analytic limitations of paper questionnaire data capture may be overcome with the use of self-administered personal digital assistant (PDA) data collection. The objective of this study was to assess the reliability, validity, and feasibility of using PDA in place of paper versions of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) in a prostate cancer clinic setting. METHODS: 152 participants were randomly assigned to one of three conditions: 1) paper followed by PDA survey; 2) PDA followed by paper survey; or 3) PDA followed by PDA survey. Evaluation included an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference and difficulty/ease of using PDA). RESULTS: Internal consistency was similar for both PDA and paper applications. Test-retest reliability was confirmed for PDA repeated administration. Data from paper and PDA questionnaires were strongly correlated. Lower missed item rates were found in PDA administration. 82.8% of participants preferred using the PDA or had no preference. Mean difficulty/ease ratings indicated that participants found the PDA easy to use. Age did not significantly correlate with preference or difficulty. CONCLUSION: The results confirm the adaptability of the IPSS, IIEF-5, and the PORPUS to PDA administration. Similarly, the findings of this study support the feasibility of using PDA technology for HRQOL serial data capture in the prostate cancer patient population.

Responsiveness of disease-specific and generic utility instruments in prostate cancer patients.

BACKGROUND: Preferences (utilities) for health outcomes have an important role in decisions about prostate cancer screening and treatment. The responsiveness of utility instruments has not been evaluated. SUBJECTS: Prostate cancer outpatients from the Princess Margaret Hospital, Toronto (n = 248) were allocated into three cohorts: N - newly diagnosed and treated; M - metastatic disease; O - all others. MEASURES: We measured quality of life at 3 points within 12 months using 3 disease-specific utility instruments (Patient Oriented Prostate Utility Scales), 3 generic utility instruments (Health Utilities Index, EQ-5D, Quality of Well-Being Scale), and 3 profile scales (PORPUS-P profile, Prostate Cancer Index, QLQ-C-30). Responsiveness was assessed using measures of internal responsiveness (standardized effect size, standardized response mean) and external responsiveness (receiver operator curve analysis, mixed model regression). RESULTS: Cohort N patients showed post-treatment declines followed by improvement in global health and functional status. Disease specific instruments detected moderate (0.4-1.3) decrements followed by small increments (0.1-0.4) in standardized effect size and standardized response mean. Most instruments detected change using external responsiveness measures (all cohorts). CONCLUSIONS: Disease-specific utility instruments appeared to be more responsive than generic instruments. Use of generic instruments should be supplemented with a responsive disease-specific instrument, particularly for applications in early prostate cancer.

Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial.

PURPOSE: To determine whether a stress management (SM) program could improve cessation rates when added to usual care (UC) among women attempting to quit smoking. DESIGN: Randomized controlled trial conducted during a 12-month period. SETTING: Smoking cessation clinics located within two tertiary care centers in Ottawa, Ontario. SUBJECTS: A total of 332 women smokers 19 years or older who smoked 10 or more cigarettes per day were recruited via advertisements. INTERVENTION. Either UC (physician advice and nicotine replacement therapy) or UC plus an eight-session group SM training program (coping skills development relevant to smoking-specific and generic stressors). MEASURES: Point prevalence abstinence 2 and 12 months after study intake. A secondary outcome of interest was change in perceived stress during the intervention period. RESULTS: On an intent-to-treat basis, the addition of SM to UC had no incremental effect on 2- or 12-month abstinence rates. Abstinence rates at 2 months were 26.2% vs. 31.7% in the UC and SM groups, respectively (p = .59). At 12 months, the rates were 18.5% vs. 20.7% (p = .86). When quit rates were compared including only participants who demonstrated adequate adherence to the intervention protocol, there was a significant difference between the UC and SM groups at 2 months (34.9% vs. 48.7%; adjusted odds ratio, 1.88; 95% confidence interval, 1.04-3.42; p = .04) but not at 12 months (23.0% vs. 28.2%; adjusted odds ratio, 1.24; 95% confidence interval, .64-2.41; p = .53). There was a significant reduction in perceived stress from preintervention to postintervention; however, this decrease was not moderated by group assignment. CONCLUSION: The addition of SM in our setting neither increased abstinence rates nor reduced perceived stress over and above UC in women motivated to quit smoking. Poor attendance at the SM intervention undermined its effectiveness.

Reliability and validity of the PORPUS, a combined psychometric and utility-based quality-of-life instrument for prostate cancer.

BACKGROUND: Although utility-based quality-of-life instruments are often used in economic evaluations and psychometric instruments in treatment evaluations, these are complementary approaches to assessing outcomes. In this study we developed and tested these two forms of quality-of-life instruments, both based on a single, validated, health classification system. OBJECTIVES: To assess the measurement properties (reliability and validity) of two newly developed psychometric and utility-based instruments for assessing outcomes associated with prostate cancer. METHODS: 141 men with cancer of the prostate (CaP), treated with radical prostatectomy, radiation therapy, hormonal therapy, and/or chemotherapy were assessed with both instruments and other standard psychometric and utility-based instruments. RESULTS: Analyses indicate the test instruments are reliable and valid. Full-scale correlations between the instruments and standard instruments indicate validity, as do correlations of key subscales, and an evaluation of linear associations with the UCLA-Prostate Cancer Symptom Scales. CONCLUSION: Evidence from this study supports the reliability and construct validity of the tested instruments. Prostate cancer outcomes can now be assessed by a combination of psychometric and utility-based methods, allowing a ready comparison of derived outcomes.

Prospective examination of anxiety persistence and its relationship to cardiac symptoms and recurrent cardiac events.

BACKGROUND: The current study builds on previous research demonstrating a link between anxiety and inhospital recurrent ischemic and arrhythmic events, by examining the effects of persistent anxiety on recurrent events 1 year later. METHODS: 913 patients with unstable angina (UA) and myocardial infarction (MI) from 12 coronary care units were recruited, and follow-up data were collected at 6 and 12 months after the event. Measures included cardiac symptomatology, healthcare utilization, the anxiety subscale of the Primary Care Evaluation of Mental Disorders , the phobic anxiety subscale of the Middlesex Hospital Questionnaire, and the Beck Depression Inventory. RESULTS: Over one third of participants with UA and MI experienced elevated anxiety at the time of the ischemic event, and these symptoms persisted for 1 year in 50% of anxious participants. Although participants with anxiety reported more atypical cardiac symptomatology, the prevalence of typical cardiac symptoms such as chest pain did not differ based on anxiety. After controlling for the severity of the coronary event, family income, sex, diabetes, and smoking, the following variables were significantly predictive of self-reported recurrent cardiac events at 6 months or 1 year: older age, family history of cardiovascular disease, greater depressive symptomatology at baseline, and anxiety at 6 months. Only 38% of anxious patients were asked about such symptoms, indicating underutilization of effective psychotherapeutic treatment. CONCLUSIONS: Over and above the effects of depressive symptomatology (among other confounding variables), nonphobic anxiety appears to have a negative effect on self-reported outcome following an ischemic coronary event. Anxiety symptomatology is underrecognized and undertreated, and examination of effects of treatment on secondary prevention must be pursued.

Patient and community preferences for outcomes in prostate cancer: implications for clinical policy.

BACKGROUND: Preferences, or utilities, for health outcomes are central in prostate cancer decision-making. Utilities can be elicited directly from patients using standard techniques, or indirectly, using questionnaires that incorporate preference weights from community members. OBJECTIVES: To evaluate directly elicited and indirectly elicited (questionnaire-derived, community-weighted) utilities for prostate cancer outcomes and the effects of sexual, urinary, and bowel dysfunction on them. MATERIALS AND METHODS: Utilities for the current health of 141 prostate cancer patients, recruited from ambulatory clinics, were elicited directly with the Patient Oriented Prostate Utility Scale, rating scale (PORPUS-U(RS)) and standard gamble (PORPUS-U(SG)) subscales. Patients completed the Health Utilities Index (HUI) and Quality of Well Being Scale (QWB), utility instruments incorporating community preferences, and the UCLA Prostate Cancer Index. RESULTS: Patients' treatments included radical prostatectomy (18%), radiation (60%), and hormonal (42%). Mean utility scores for current health were 0.65 (QWB), 0.79 (PORPUS-U(RS)), 0.80 (HUI), 0.86 (PORPUS-U(SG)). Utility decrements for dysfunction were small (0.08-0.14 [sexual], 0.06 to 0.13 [urinary], and 0.01 to 0.13 [bowel]), and even smaller when adjusted for concomitant changes in other quality of life (QOL) domains. CONCLUSIONS: Patients' directly elicited utilities for their own health were higher than community-derived utilities obtained from HUI and QWB administration to the same patients. HUI scores of these patients were similar to those of age-matched Canadian men. Sexual, urinary, and bowel problems were common but had less impact on overall QOL than reported in previous utility studies. These results weaken the argument that prostate cancer screening and treatment should be limited because of severe and debilitative side effects.