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Background: Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy are not effective for many smokers, and in many cases, the amount of nicotine provided is much less than when a smoker is smoking their usual number of cigarettes. The proposed study will test if titrating the dose of the nicotine patch (up to 84 mg) will improve quitting success compared to those receiving a 21-mg nicotine patch with increasing doses of placebo patch.Methods: This is a multicenter, pragmatic, two-arm, placebo-controlled, block randomized controlled trial. We will recruit participants who smoke at least 10 cigarettes daily and are interested in making a quit attempt. After 2 weeks of usual treatment with a 21-mg patch, participants who fail to quit smoking (target n = 400) will be randomized to receive escalating doses of a nicotine patch vs matching placebo patches for an additional 10 weeks or up to a maximum dose of 84 mg per day. Those who stop smoking during the first 2 weeks of usual treatment will continue with 21 mg patch treatment for 10 weeks and will form an additional comparison arm. In addition to the medication, participants will receive brief behavioral counseling at each study visit. The primary outcome will be biochemically confirmed continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9 to 12).Discussion: Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings. Given the evidence that quitting smoking at any age diminishes the risk of tobacco-related morbidity and mortality, even small increases in absolute quit rates can have a substantial population-level impact on reducing smoking-related disease, mortality rates, and associated healthcare costs.Trial Registration: ClinicalTrials.gov, NCT03000387 . Registered on 22 December 2016. [ABSTRACT FROM AUTHOR]

Background: Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR).Methods: A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures.Results: The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups.Conclusions: Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.Trial Registration: ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011. [ABSTRACT FROM AUTHOR]

Background: The rapid pace of modern life requires working-age women to juggle occupational, family, and social demands. Despite the large numbers of working-age women in developed countries and the proven benefits of regular moderate-to-vigorous intensity aerobic physical activity (MVPA) in chronic disease prevention, few women meet current physical activity (PA) recommendations of 150 min of MVPA per week. It is important that appropriate and effective behavioral interventions targeting PA are identified and developed to improve the MVPA levels of working-age women. As women worldwide embrace modern technologies, e-health innovations may provide opportune and convenient methods of implementing programs and strategies to target PA in an effort to improve MVPA levels and cardiometabolic health. Previous reviews on this topic have been limited; none have focused on working-age women from developed countries who exhibit inappropriately low PA levels. It remains unknown as to which e-health interventions are most effective at increasing MVPA levels in this population. The purpose of this systematic review is to examine the effectiveness of e-health interventions in raising MVPA levels among working-age women in developed countries and to examine the effectiveness of these interventions in improving the health of women. Methods: Eight electronic databases will be searched to identify all prospective cohort and experimental studies examining the impact of e-health interventions for increasing MVPA levels among working-age women (mean age 18-65 years) in developed countries. Gray literature including theses, dissertations, and government reports will also be examined. Study quality will be assessed using a modified Downs and Black checklist, and risk of bias will be assessed within and across all included studies using the Cochrane's risk of bias tool and Grades of Recommendation, Assessment, Development and Evaluation approach. A quantitative synthesis in the form of meta-analyses for measures of MVPA and health outcomes will be conducted where possible. Discussion: This review will determine the effectiveness of e-health interventions in raising MVPA levels in working-age women in developed countries. It will form a contemporary, rigorously developed, and reliable research base for policy makers and stakeholders; and inform and influence the development and implementation of effective e-health interventions designed to increase MVPA levels and improve health outcomes in this population. [ABSTRACT FROM AUTHOR]

Introduction: Despite greater need, rural inhabitants and individuals of low socioeconomic status (SES) are less likely to undertake cardiac rehabilitation (CR). This study examined barriers to enrollment and participation in CR among these under-represented groups. Method: Cardiac inpatients from 11 hospitals across Ontario were approached to participate in a larger study. Rurality was assessed by asking participants whether they lived within a 30-minute drive-time from the nearest hospital, with those >30 minutes considered “rural.” Participants completed a sociodemographic survey, which included the MacArthur Scale of Subjective Social Status. One year later, they were mailed a survey which assessed CR utilization and included the Cardiac Rehabilitation Barriers Scale. In this cross-sectional study, CR utilization and barriers were compared by rurality and SES. Results: Of the 1809 (80.4%) retained, there were 215 (11.9%) rural participants, and the mean subjective SES was 6.37 ± 1.76. The mean CRBS score was 2.03 ± 0.73. Rural inhabitants reported attending significantly fewer CR sessions (p < .05), and greater CR barriers overall compared to urban inhabitants (p < .01). Patients of lower subjective SES were significantly less likely to be referred, enroll, and participate in CR, and reported significantly greater barriers to CR compared to their high SES counterparts (p < .01). Prominent barriers for both groups included distance, cost, and transportation problems. These relationships sustained adjustment, and a significant relationship between having undergone coronary artery bypass graft surgery and lower barriers was also identified. Conclusions: The results confirm that rural inhabitants and patients of low SES experience greater barriers to CR utilization when compared to their urban, high SES counterparts. It is time to implement known strategies to overcome these barriers, to achieve equitable and greater use of CR. [ABSTRACT FROM AUTHOR]

Background: Despite the evidence of benefit, cardiac rehabilitation (CR) remains highly underutilized. The present study examined the effect of two inpatient and one outpatient strategy on CR utilization: allied healthcare provider completion of referral (a policy that had been endorsed and approved by the cardiac program leadership in advance; PRE-APPROVED); CR intake appointment booked before hospital discharge (PRE-BOOKED); and early outpatient education provided at the CR program shortly after inpatient discharge (EARLY ED). In this prospective observational study, 2,635 stable cardiac inpatients from 11 Ontario hospitals completed a sociodemographic survey, and clinical data were extracted from charts. One year later, participants were a mailed survey that assessed CR use. Participating inpatient units and CR programs to which patients were referred were coded to reflect whether each of the strategies was used (yes/no). The effect of each strategy on participants' CR referral and enrollment was examined using generalized estimating equations. Results: A total of 1,809 participants completed the post-test survey. Adjusted analyses revealed that the implementation of one of the inpatient strategies was significantly related to greater referral and enrollment (PRE-APPROVED: OR = 1.96, 95%CI = 1.26 to 3.05, and OR = 2.91, 95%CI = 2.20 to 3.85, respectively). EARLY ED also resulted in significantly greater enrollment (OR = 4.85, 95%CI = 2.96 to 7.95). Conclusions: These readily-implementable strategies could significantly increase access to and enrollment in CR for the cardiac population. The impact of these strategies on wait times warrants exploration. [ABSTRACT FROM AUTHOR]

Background: The rapid pace of modern life requires working-age women to juggle occupational, family and social demands. This modern lifestyle has been shown to have a detrimental effect on health, often associated with increased smoking and alcohol consumption, depression and cardiovascular disease risk factors. Despite the proven benefits of regular moderate-to-vigorous intensity physical activity (MVPA), few are meeting the current physical activity (PA) recommendations of 150 min of MVPA/week. It is important that appropriate and effective behavioural interventions targeting PA are developed and identified to improve the MVPA levels of working-age women. As these women spend a substantial proportion of their waking hours at work, workplaces may be an opportune, efficient and relatively controlled setting to implement programmes and strategies to target PA in an effort to improve MVPA levels and impact cardiometabolic health. The purposes of this systematic review are to compare the effectiveness of individual-level workplace interventions for increasing MVPA levels in working-age women in high-income/developed countries and examine the effectiveness of these interventions for improving the known beneficial health sequelae of MVPA., Methods/design: Eight electronic databases will be searched to identify all prospective cohort and experimental studies that examine the impact of individual-level workplace interventions for increasing MVPA levels among working-age (mean age 18-65 years) women from high-income/developed countries. Grey literature including theses, dissertations and government reports will also be included. Study quality will be assessed using a modified Downs and Black checklist, and risk of bias will be assessed within and across all included studies using the Cochrane's risk of bias tool and Grades of Recommendation, Assessment, Development and Evaluation approach. Meta-analyses will be conducted where possible among studies with sufficient homogeneity., Discussion: This review will determine the effectiveness of individual-level workplace interventions for increasing MVPA levels in working-age women in high-income/developed countries, and form a current, rigorous and reliable research base for policy makers and stakeholders to support the development and implementation of effective workplace interventions that increase MVPA levels in this population., Systematic Review Registration: PROSPERO CRD42014009704.

Background: The majority of North American adult females do not meet current physical activity recommendations (150 min of moderate-to-vigorous intensity physical activity (MVPA) per week accrued in ≥10 min bouts) ultimately placing themselves at increased risk of morbidity and mortality. Working-age females face particular challenges in meeting physical activity recommendations as they have multiple demands, including occupational, family and social demands. To develop effective interventions to increase MVPA among working-age females, it is necessary to identify and understand the strongest modifiable determinants influencing these behaviours. Therefore, the objective of this systematic review is to examine the available evidence to identify intrapersonal, social and environmental determinants of MVPA among working-age females., Methods/design: Six electronic databases will be searched to identify all prospective cohort studies that report on intrapersonal, social and/or environmental determinants of MVPA in working-age females. Grey literature sources including theses, published conference abstracts and websites from relevant organizations will also be included. Articles that report on intrapersonal (e.g. health status, self-efficacy, socio-economic status (SES), stress, depression), social environmental (e.g. crime, safety, area SES, social support, climate and capital, policies), and environmental (e.g. weather, workplace, home, neighbourhood, recreation environment, active transportation) determinants of MVPA in a working-age (mean age 18-65 years) female population will be included. Risk of bias will be assessed within and across all included studies using the Tool to Assess Risk of Bias in Cohort Studies and the Grades of Recommendation, Assessment, Development and Evaluation approach. Harvest plots will be used to synthesize results across all determinants, and meta-analyses will be conducted where possible among studies with sufficient homogeneity., Discussion: This review will provide a comprehensive examination of evidence in this field and will serve to highlight gaps for future research on the determinants of MVPA in working-age females and ultimately inform intervention design., Systematic Review Registration Prospero: CRD42014009750.

Background: Adults spend the majority of their time being sedentary, and evidence suggests that those who spend more of their day engaged in sedentary activities (TV viewing, sitting, screen-based activities) are at increased risk for morbidity and mortality, regardless of whether they exercise regularly. In order to develop effective interventions to reduce sedentary time, it is necessary to identify and understand the strongest modifiable factors of these behaviours. Therefore, the objective of this systematic review is to examine the available evidence in order to identify individual, social, environmental and policy correlates and determinants of sedentary behaviours (TV time, sitting time, screen time) and total sedentary time among adults., Methods/design: Six electronic databases will be searched to identify all studies that report on individual, social and/or environmental correlates and determinants of sedentary behaviours and total sedentary time in adults. Grey literature sources including theses, published conference abstracts and websites from relevant organizations will also be included. Articles that report on modifiable individual (e.g. health behaviours and status, self-efficacy, socio-economic status), social (e.g. crime, safety, social support, climate and capital), environmental (e.g. weather, workplace, home, neighbourhood, recreation environment, transportation environment) and policy correlates and determinants (based on study design) of sedentary behaviours in an adult population (mean age ≥18 years) will be included. Study quality and risk of bias will be assessed within and across all included studies. Harvest plots will be used to synthesize results across all correlates, and meta-analyses will be conducted where possible among studies with sufficient homogeneity., Discussion: This review will provide a comprehensive examination of evidence in the field and will serve to highlight gaps for future research on the determinants of sedentary behaviours and inform intervention design., Systematic Review Registration: PROSPERO CRD42014009814.

Background: Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge. The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial., Methods: Breast cancer patients in Edmonton, Vancouver, and Ottawa, Canada receiving chemotherapy (N = 301) were randomized to a standard dose of 25-30 minutes of aerobic exercise (STAN), a higher dose of 50-60 minutes of aerobic exercise (HIGH), or a higher dose of 50-60 minutes of combined aerobic and resistance exercise (COMB). Predictors included demographic, medical, fitness, and quality of life variables. Exercise adherence was measured as the percentage of supervised exercise sessions completed., Results: Overall adherence to the supervised exercise sessions was 73% (SD = 24%). In a multivariate regression model, six independent predictors explained 26.4% (p < 0.001) of the variance in exercise adherence. Higher exercise adherence was achieved by breast cancer patients in Vancouver (p < 0.001), with fewer endocrine symptoms (p = 0.009), randomized to STAN (p = 0.009), with fewer exercise limitations (p = 0.009), receiving shorter chemotherapy protocols (p = 0.015), and with higher VO2peak (p = 0.017). Disease stage (p for interaction = 0.015) and body mass index (p for interaction = 0.030) interacted with group assignment to predict adherence. For disease stage, patients with stage I/IIa disease adhered equally well to all three exercise interventions whereas patients with stage IIb/III disease adhered better to the STAN intervention than the two higher dose exercise interventions. For body mass index, healthy weight patients adhered equally well to all three exercise interventions whereas overweight patients adhered best to STAN and worst to COMB; and obese patients adhered best to STAN and worst to HIGH., Conclusions: Determinants of exercise adherence in breast cancer patients receiving chemotherapy are multidisciplinary and may vary by the exercise prescription.

Background: While it is recommended that records are kept between primary care providers (PCPs) and specialists during patient transitions from hospital to community care, this communication is not currently standardized. We aimed to assess the transmission of cardiac rehabilitation (CR) program intake transition records to PCPs and to explore PCPs' needs in communication with CR programs and for intake transition record content., Method: 144 PCPs of consenting enrollees from 8 regional and urban Ontario CR programs participated in this cross-sectional study. Intake transition records were tracked from the CR program to the PCP's office. Sixty-six PCPs participated in structured telephone interviews., Results: Sixty-eight (47.6%) PCPs received a CR intake transition record. Fifty-eight (87.9%) PCPs desired intake transition records, with most wanting it transmitted via fax (n = 52, 78.8%). On a 5-point Likert scale, PCPs strongly agreed that the CR transition record met their needs for providing patient care (4.32 ± 0.61), with 48 (76.2%) reporting that it improved their management of patients' cardiac risk. PCPs rated the following elements as most important to include in an intake transition record: clinical status (4.67 ± 0.64), exercise test results (4.61 ± 0.52), and the proposed patient care plan (4.59 ± 0.71)., Conclusions: Less than half of intake transition records are reaching PCPs, revealing a large gap in continuity of patient care. PCP responses should be used to develop an evidence-based intake transition record, and procedures should be implemented to ensure high-quality transitional care.

Background: The Ottawa Model of Smoking Cessation (OMSC) is a hospital-based smoking cessation program that is expanding across Canada. While the short-term effectiveness of hospital cessation programs has been documented, less is known about long-term sustainability. The purpose of this exploratory study was to understand how hospitals using the OMSC were addressing sustainability and determine if there were critical factors or issues that should be addressed as the program expanded., Methods: Six hospitals that differed on OMSC program activities (identify and document smokers, advise quitting, provide medication, and offer follow-up) were intentionally selected, and two key informants per hospital were interviewed using a semi-structured interview guide. Key informants were asked to reflect on the initial decision to implement the OMSC, the current implementation process, and perceived sustainability of the program. Qualitative analysis of the interview transcripts was conducted and themes related to problem definition, stakeholder influence, and program features emerged., Results: Sustainability was operationalized as higher performance of OMSC activities than at baseline. Factors identified in the literature as important for sustainability, such as program design, differences in implementation, organizational characteristics, and the community environment did not explain differences in program sustainability. Instead, key informants identified factors that reflected the interaction between how the health problem was defined by stakeholders, how priorities and concerns were addressed, features of the program itself, and fit within the hospital context and resources as being influential to the sustainability of the program., Conclusions: Applying a sustainability model to a hospital smoking cessation program allowed for an examination of how decisions made during implementation may impact sustainability. Examining these factors during implementation may provide insight into issues affecting program sustainability, and foster development of a sustainability plan. Based on this study, we suggest that sustainability plans should focus on enhancing interactions between the health problem, program features, and stakeholder influence.

Background: Patient preference for group assignment may affect outcomes in unblinded trials but few studies have attempted to understand such preferences. The purpose of the present study was to examine factors associated with breast cancer patients' preference for two types of exercise training during chemotherapy., Methods: Breast cancer patients (N = 242) completed a battery of tests including a questionnaire that assessed patient preference and the theory of planned behavior (TPB) prior to being randomized to usual care, resistance exercise training (RET), or aerobic exercise training (AET)., Results: 99 (40.9%) participants preferred RET, 88 (36.4%) preferred AET, and 55 (22.7%) reported no preference. Past exercisers (p = 0.023), smokers (p = 0.004), and aerobically fitter participants (p = 0.005) were more likely to prefer RET. As hypothesized, participants that preferred AET had more favorable TPB beliefs about AET whereas participants that preferred RET had more favorable TPB beliefs about RET. In multivariate modeling, patient preference for RET versus AET was explained (R2 = .46; p < 0.001) by the difference in motivation for RET versus AET (beta = .56; p < 0.001), smoking status (beta = .13; p = 0.007), and aerobic fitness (beta = .12; p = 0.018). Motivational difference between RET versus AET, in turn, was explained (R2 = .48; p < 0.001) by differences in instrumental attitude (beta = .27; p < 0.001), affective attitude (beta = .25; p < 0.001), and perceived behavioral control (beta = .24; p < 0.001)., Conclusion: Breast cancer patients' preference for RET versus AET during chemotherapy was predicted largely by a difference in motivation for each type of exercise which, in turn, was based on differences in their beliefs about the anticipated benefits, enjoyment, and difficulty of performing each type of exercise during chemotherapy. These findings may help explain patient preference effects in unblinded behavioral trials., Trial Registration: ClinicalTrials.gov Identifier NCT00115713.