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1.
Article in English | MEDLINE | ID: mdl-29201388

ABSTRACT

BACKGROUND: Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes. METHODS: Prior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group. RESULTS: We identified 135 eligible patients. Eighty-two consented to the trial randomizing patients to usual care (n = 41) or PtDA intervention (n = 41). Feasibility outcome results were (1) referral rate at approximately 20/month, (2) recruitment rate 61%, and (3) successful delivery of PtDA and study management. Pre-consultation, PtDA patients scored lower on the DCS scale (mean, standard deviation [SD] 27.3 (18.4) compared to usual care, 49.4 (18.6); the between-group difference in means [95% confidence interval (CI)] was - 22.1[- 30.23, - 13.97]. A difference remained post-implantation 21.2 (11.7), PtDA intervention 29.9 (13.3), and usual care - 8.7 [- 14.61, - 2.86]. SURE test results supported DCS differences. The PtDA group scored higher on the ICD-related knowledge questions, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care. The mean [SD] number of correct knowledge responses out of 5 was 3.33(1.19) in the PtDA group and 2.62 (1.16) in usual care pre-implant. Concordance between values and decision choice found a strong association between predicted and actual ICD implant status in the intervention group. CONCLUSION: Our results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes. TRIAL REGISTRATION: NCT01876173.

2.
BMC Womens Health ; 17(1): 11, 2017 02 07.
Article in English | MEDLINE | ID: mdl-28173855

ABSTRACT

BACKGROUND: Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality among women. Women with CVD experience a greater burden of psychosocial distress than men, and practice guidelines promote screening in cardiac patients, especially women. The objectives herein were to describe the burden of psychosocial distress, extent of screening, forms of treatment, and whether receipt of treatment was related to psychosocial distress symptom severity at follow-up, among women. METHODS: Within a multi-center trial of women randomized to cardiac rehabilitation models, consenting participants were asked to complete surveys upon consent and 6 months later. Clinical data were extracted from charts. This study presents a secondary analysis of the surveys, including investigator-generated items assessing screening and treatment, the Beck Depression Inventory-II, the Hospital Anxiety and Depression Scale, and Patient Health Questionnaire-2. RESULTS: Of the 128 (67.0%) participants with valid baseline and follow-up survey results, 48 (40.3%) self-reported that they recalled being screened, and of these, 10 (21.3%) recalled discussing the results with a health care professional. Fifty-six (43.8%) retained participants had elevated symptoms of psychosocial distress at baseline, of which 25 (44.6%) were receiving treatment. Regression analyses showed that treatment of psychosocial distress was not significantly associated with follow-up depressive symptoms, but was significantly associated with greater follow-up anxiety. CONCLUSIONS: Findings reiterate the great burden of psychosocial distress among women with CVD. Less than half of patients with elevated symptoms were treated, and the treatment approaches appeared to insufficiently achieve symptom relief.


Subject(s)
Anxiety/therapy , Cardiac Rehabilitation/psychology , Cost of Illness , Depression/therapy , Mass Screening/methods , Aged , Anxiety/psychology , Depression/psychology , Female , Humans , Mass Screening/standards , Middle Aged , Ontario , Prospective Studies , Stress, Psychological/complications , Stress, Psychological/etiology , Surveys and Questionnaires
3.
Can J Cardiol ; 32(8): 956-62, 2016 08.
Article in English | MEDLINE | ID: mdl-26850727

ABSTRACT

BACKGROUND: Cardiac rehabilitation (CR) is associated with significantly lower mortality and improved psychosocial well-being. However, women are less likely to participate than men. This trial tested whether participation in women-only CR results in better health behaviours and psychosocial outcomes than do other models. METHODS: Cardiac Rehabilitation for her Heart Event Recovery (CR4HER) was a single-blind randomized trial with 3 parallel arms. Low-risk cardiac patients were recruited from 6 sites in Ontario. Consenting participants completed surveys assessing health behaviours (physical activity, diet, medication adherence, smoking) and psychosocial well-being (social support, quality of life, depressive symptoms) and wore pedometers for 7 days. After intake assessment, eligible participants were randomized to mixed-sex, women-only, or home-based CR. Participants were mailed follow-up surveys and pedometers 6 months later. RESULTS: One hundred sixty-nine patients were randomized, and 116 (68.6%) were retained. Self-reported physical activity increased among women in mixed-sex and women-only CR groups (per protocol and as treated, P < 0.05). Diet improved among women in women-only CR groups (as treated, P < 0.05). Quality of life improved among women in mixed-sex (per protocol and as treated, P < 0.05) and women-only CR groups (per protocol, P < 0.05; as treated, P < 0.01). After testing, women in the mixed-sex CR group had higher anxiety symptoms than did those in the women-only group (per protocol, P = 0.017), and those in the mixed-sex CR group had higher depressive symptoms than did those in the women-only group (as treated, P = 0.001). Analyses adjusted for confounding variables revealed no significant differences in any outcome by model. Post hoc equivalency tests were computed on a per-protocol basis, and all outcomes were equivalent by model. CONCLUSIONS: Behavioural and psychosocial outcomes were largely equivalent regardless of model; however, women-only programs may confer an advantage for anxiety and depressive symptoms.


Subject(s)
Cardiac Rehabilitation , Health Behavior , Mental Health , Women's Health , Aged , Anxiety/therapy , Depression/therapy , Diet , Exercise , Female , Humans , Male , Middle Aged , Quality of Life , Single-Blind Method
4.
Mayo Clin Proc ; 91(2): 140-8, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26682921

ABSTRACT

OBJECTIVE: To compare program adherence and functional capacity between women referred to supervised mixed-sex, supervised women-only, or home-based cardiac rehabilitation (CR). PATIENTS AND METHODS: Cardiac Rehabilitation for Heart Event Recovery (CR4HER) was a single-blind, 3 parallel-arm, pragmatic randomized controlled trial. The study took place between November 1, 2009, and July 31, 2013. Low-risk patients with coronary artery disease were recruited from 6 hospitals in Ontario, Canada. Consenting participants completed a preprogram survey, and clinical data were extracted from charts. Participants were referred to CR at 1 of 3 sites. After intake assessment, including a graded exercise stress test, eligible patients were randomized to supervised mixed-sex, supervised women-only, or home-based CR. Six months later, CR adherence and exit assessment data were ascertained. RESULTS: Of the 264 consenting patients, 169 (64.0%) were eligible and randomized. Twenty-seven (16.0%) did not attend, and 43 (25.4%) attended a different model. Program adherence was moderate overall (54.46%±35.14%). Analysis of variance revealed no significant differences based on per-protocol analysis (P=.63), but as-treated, home-based participants attended significantly more than did women-only participants (P<.05). Overall, there was a significant increase in functional capacity preprogram to postprogram (P<.001). Although there were no significant differences in functional capacity by model at CR exit based on per-protocol analysis, there was a significant difference on an as-treated basis, which sustained adjustment. Women attending mixed-sex CR attained significantly higher post-CR functional capacity than did women attending home-based programs (P<.05). CONCLUSION: Offering women alternative program models may not promote greater CR adherence or functional capacity; however, replication is warranted. Other proven strategies such as action planning and self-monitoring should be applied. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01019135.


Subject(s)
Coronary Artery Disease/rehabilitation , Exercise Therapy/methods , Patient Compliance , Activities of Daily Living , Coronary Artery Disease/diagnosis , Coronary Artery Disease/physiopathology , Exercise Test/methods , Exercise Tolerance/physiology , Female , Home Care Services, Hospital-Based/standards , Humans , Middle Aged , Needs Assessment , Treatment Outcome
5.
Med Decis Making ; 35(8): 959-66, 2015 11.
Article in English | MEDLINE | ID: mdl-26246516

ABSTRACT

BACKGROUND: Patient decision aids (PtDAs) supplement advice from health care professionals by communicating the absolute risk or benefit of treatment options (i.e., X/100). As such, PtDAs have been amenable to binary outcomes only. We aimed to develop and test the validity of the Conversion to Risk Estimates through Application of Normal Theory (CREATE) method for estimating absolute risk based on continuous outcome data. METHODS: CREATE is designed to derive an estimate of the proportion of those who experience a clinically relevant degree of change (CRDoC). We used a 2-stage validation process using real and simulated change score data, respectively. First, using raw data from published intervention trials, we calculated the proportion of patients with a CRDoC and compared that with our CREATE-derived estimate using chi-square tests of association. Second, 200,000 simulated distributions of change scores were generated with widely varying distribution characteristics. Actual and CREATE-derived estimates were compared for each simulated distribution, and relative differences were summarized graphically. RESULTS: The absolute difference between the estimated and actual CRDoC did not exceed 5% for any of the samples based on real data. Applying the CREATE method to 200,000 simulated scenarios demonstrated that the CREATE method should be avoided for outcomes where the underlying distribution can be reasonably assumed to have high levels of skew or kurtosis. CONCLUSION: Our results suggest that standard statistical theory can be used to estimate continuous outcomes in absolute terms with reasonable accuracy for use in PtDAs; caution is advised if outcome summary statistics are assumed to have been derived from highly skewed distributions.


Subject(s)
Decision Support Techniques , Risk Assessment/methods , Treatment Outcome , Cardiovascular Diseases/therapy , Choice Behavior , Computer Simulation , Humans , Meta-Analysis as Topic , Randomized Controlled Trials as Topic
6.
J Nurs Meas ; 23(1): 179-200, 2015.
Article in English | MEDLINE | ID: mdl-25985503

ABSTRACT

BACKGROUND AND PURPOSE: Vascular access site (VAS) bruising is common following invasive cardiac procedures. The extent of VAS bruising is underreported because of the lack of reliable measurement methods. This study examined the reliability of linear measurement and planimetry to measure VAS bruise size. METHODS: There were 40 participants with VAS bruising after invasive cardiac procedures who completed VAS bruise measurement. Participants, a principal investigator, and a research assistant completed measurements independently. Inter-rater reliability was determined using intraclass correlation coefficient (ICC), 2-way random effects model. RESULTS: The ICC for linear measurement and planimetry was high (.929 and .914 respectively). Both methods were reliable measures of VAS bruise size. CONCLUSIONS: Linear measurement or planimetry can be used with confidence to measure VAS bruising in clinical and research contexts.


Subject(s)
Catheters, Indwelling/adverse effects , Contusions/etiology , Contusions/pathology , Cardiac Catheterization/adverse effects , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Reproducibility of Results
8.
Rehabil Psychol ; 60(1): 59-66, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25602362

ABSTRACT

OBJECTIVE: Little is known regarding the social-cognitive correlates of physical activity (PA) during and after cardiac rehabilitation (CR) in a female sample. The objective of the current study was to identify distinct trajectories for task self-efficacy, barrier self-efficacy, and outcome expectations and examine their association with PA. METHOD: A total of 203 women with cardiovascular disease completed a survey that included the self-efficacy, outcome-expectation, and PA measures at the beginning and end of CR, and 6 and 12 months after completing CR. RESULTS: Latent class growth analyses showed that multiple trajectories existed for task self-efficacy, barrier self-efficacy, and outcome expectations. Dual trajectory analyses showed that women in less favorable task self-efficacy, barrier self-efficacy, and outcome-expectation trajectories had a greater probability of being in an inactive PA trajectory. CONCLUSION/IMPLICATIONS: Women in trajectories with higher task and barrier self-efficacy and outcome expectations are more likely to be active, whereas the opposite is true for women with lower efficacy and outcome expectancies. As such, it is critical that health-care practitioners incorporate strategies into their CR programs or professional practice after CR to increase women's confidence in engaging in PA, overcome barriers to engage in PA, and promote positive outcomes related to PA to increase their PA levels.


Subject(s)
Attitude to Health , Cardiac Rehabilitation , Cardiovascular Diseases/psychology , Exercise/psychology , Self Efficacy , Women/psychology , Female , Follow-Up Studies , Humans , Middle Aged , Treatment Outcome
9.
Eur J Prev Cardiol ; 22(12): 1513-22, 2015 Dec.
Article in English | MEDLINE | ID: mdl-25452626

ABSTRACT

BACKGROUND: Although cardiac rehabilitation (CR) is effective, women often report programs do not meet their needs. Innovative models have been developed that may better suit women. The objectives of the study were to describe: (1) adherence to CR model allocation; (2) satisfaction by model attended; and (3) CR preferences. DESIGN AND METHODS: Tertiary objectives from a randomized controlled trial of female patients randomized to mixed-sex, women-only, or home-based CR were tested. Patients were recruited from six hospitals. Consenting participants were asked to complete a survey and undertook a CR intake assessment. Eligible patients were randomized. Participants were mailed a follow-up survey six months later. Adherence to model allocation was ascertained from CR charts. RESULTS: Overall 169 (18.6%) patients were randomized, of which 116 (68.6%) completed the post-test survey. Forty-five (26.6%) participants did not receive the allocated model, with those referred to home-based CR least likely to attend the allocated model (n = 25; 45.4%). Semi-structured interviews revealed participants also often switched from women-only to mixed-sex CR due to time conflicts. Satisfaction was high across all models (mean = 4.23 ± 1.16/5; p = 0.85) but participants in the women-only program felt significantly more comfortable in their workout attire (p = 0.003) and perceived the environment as less competitive (p = 0.02). Patients equally preferred mixed-sex (n = 44, 41.9%) and women-only (n = 44, 41.9%) CR, over home-based (n = 17, 16.2%), with patients preferring the model they attended. CONCLUSION: Females were highly satisfied regardless of CR model attended but preferred supervised programs most. Patient preference and session timing should be considered in program model allocation decisions.


Subject(s)
Health Knowledge, Attitudes, Practice , Heart Diseases/rehabilitation , Patient Compliance , Patient Preference , Women's Health Services/organization & administration , Women's Health , Aged , Clothing , Competitive Behavior , Environment , Female , Heart Diseases/diagnosis , Heart Diseases/physiopathology , Heart Diseases/psychology , Humans , Male , Middle Aged , Models, Organizational , Ontario , Perception , Sex Factors , Single-Blind Method , Surveys and Questionnaires , Time Factors , Treatment Outcome
10.
Eur J Cardiovasc Nurs ; 14(1): 79-89, 2015 Feb.
Article in English | MEDLINE | ID: mdl-24399843

ABSTRACT

AIMS: The purpose of this study was to conduct a systematic review answering the following questions: (a) what specific activities do caregivers (CGs) contribute to patients' self-care in heart failure (HF)?; and (b) how mature (or developed) is the science of the CG contribution to self-care? METHODS: MEDLINE, EMBASE, Cumulative Index of Nursing and Allied Health Literature (CINAHL), the Cochrane Library and ClinicalTrials.gov were searched using the terms heart failure and caregiv* as well as the keywords 'careers', 'family members' and 'lay persons' for studies published between 1948 and September 2012. Inclusion criteria for studies were: informal CGs of adult HF patients-either as dependent/independent variable in quantitative studies or participant in qualitative studies; English language. Exclusion criteria for studies were: formal CGs; pediatric, adult congenital, or devices or transplant CGs; mixed diagnosis; non-empiric reports or reports publishing duplicate results. Each study was abstracted and confirmed by two authors. After CG activities were identified and theoretically categorized, an analysis across studies was conducted. RESULTS: Forty papers were reviewed from a pool of 283 papers. CGs contribute substantively to HF patients' self-care characterized from concrete (weighing the patient) to interpersonal (providing understanding). Only two studies attempted to quantify the impact of CGs' activities on patients' self-care reporting a positive impact. Our analysis provides evidence for a rapidly developing science that is based largely on observational research. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: To our knowledge, this is the first systematic review to examine CGs' contributions in depth. Informal caregivers play a major role in HF self-care. Longitudinal research is needed to examine the impact of CGs' contributions on patient self-care outcomes.


Subject(s)
Caregivers/organization & administration , Heart Failure/nursing , Self Care/methods , Chronic Disease , Female , Heart Failure/diagnosis , Humans , Long-Term Care/organization & administration , Male , Prognosis , Quality Control , Severity of Illness Index , Treatment Outcome
12.
Res Theory Nurs Pract ; 28(1): 71-86, 2014.
Article in English | MEDLINE | ID: mdl-24772608

ABSTRACT

Over the last two decades, the number of patients receiving implantable cardiac defibrillators (ICDs) for the prevention of sudden cardiac death has grown significantly. This growth is largely the result of broadened indication for ICD use because of the success of trials demonstrating efficacy. Early ICD indication centered on secondary prevention, which then advanced to primary prevention in high-risk patients. Nurses delivering care to these patients not only manage this complex technology but also patients' uncertainty about their survival and related psychosocial adjustment to receiving an ICD. To inform practice, theoretical models such as Mishel's (1988) uncertainty in illness model provide insight into such acute phases of illness. This article proposes expansion of the uncertainty in illness model to advance knowledge in this field for nurses caring for patients with ICD.


Subject(s)
Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Uncertainty , Humans
13.
BMC Cardiovasc Disord ; 14: 14, 2014 Feb 01.
Article in English | MEDLINE | ID: mdl-24483947

ABSTRACT

BACKGROUND: Chronic stable angina (CSA) has a major negative impact on health-related quality of life (HRQL) including poor general health status, psychological distress, and inability to self-manage. METHODS: We used meta-analysis to assess the effectiveness of self-management interventions for improving stable angina symptoms, HRQL and psychological well-being. Nine trials, involving 1,282 participants in total, were included. We used standard inverse-variance random-effects meta-analysis to combine the trials. Heterogeneity between trials was evaluated using chi-square tests for the tau-squared statistic and quantified using the I2 statistic. RESULTS: There was significant improvement in the frequency of angina symptoms (Seattle Angina Questionnaire [SAQ], symptom diary) across trials, standardized mean difference (SMD): 0.30 (95% Confidence interval [CI] 0.14, 0.47), as well as reduction in the use of sublingual (SL) nitrates, SMD: -0.49 (95% CI -0.77, -0.20). Significant improvements for physical limitation (SAQ), SMD: 0.38 (95% CI 0.20, 0.55) and depression scores (Hospital Anxiety and Depression Scale), SMD: -1.38 (95% CI -2.46, -0.30) were also found. The impact of SM on anxiety was uncertain due to statistical heterogeneity across trials for this outcome, I2 = 98%. SM did not improve other HRQL dimensions including angina stability, disease perception, and treatment satisfaction. CONCLUSIONS: SM interventions significantly improve angina frequency and physical limitation; they also decrease the use of SL nitrates and improve depression in some cases. Further work is needed to make definitive conclusions about the impact of SM on cardiac-specific anxiety.


Subject(s)
Angina, Stable/therapy , Quality of Life , Self Care , Angina, Stable/complications , Angina, Stable/diagnosis , Angina, Stable/psychology , Anxiety/etiology , Anxiety/prevention & control , Chi-Square Distribution , Depression/etiology , Depression/prevention & control , Humans , Mental Health , Surveys and Questionnaires , Treatment Outcome
14.
Trials ; 14: 346, 2013 Oct 22.
Article in English | MEDLINE | ID: mdl-24148851

ABSTRACT

BACKGROUND: Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. METHODS/DESIGN: A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. DISCUSSION: Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01876173.


Subject(s)
Arrhythmias, Cardiac/therapy , Death, Sudden, Cardiac/prevention & control , Decision Support Techniques , Defibrillators, Implantable , Electric Countershock/instrumentation , Patient Selection , Primary Prevention/instrumentation , Research Design , Arrhythmias, Cardiac/complications , Arrhythmias, Cardiac/diagnosis , Clinical Protocols , Death, Sudden, Cardiac/etiology , Delphi Technique , Feasibility Studies , Humans , Ontario , Patient Participation , Physician-Patient Relations , Pilot Projects , Predictive Value of Tests , Professional-Family Relations , Risk Assessment , Risk Factors
15.
Biomed Res Int ; 2013: 121030, 2013.
Article in English | MEDLINE | ID: mdl-24151580

ABSTRACT

BACKGROUND: Physical activity is associated with reduced mortality and morbidity. Cardiac rehabilitation (CR) is an effective intervention for patients with cardiovascular disease (CVD). Unfortunately, women are less likely to engage in, or sustain, regular physical activity. Objectives were to (1) describe women's guidelines-based levels of physical activity during and after CR and (2) determine the physical activity trajectories of women from entry to CR to one year after CR. METHODS AND RESULTS: A prospective, longitudinal study of 203 women with CVD enrolled in a 6-month CR program. Physical activity was measured using the Godin Leisure Time Exercise Questionnaire (LSI), focusing on moderate-strenuous activity. Data were analyzed using latent class growth analysis (LCGA) and logistic regression. Mean scores on the LSI showed women to be "active" at all follow-up points. LCGA revealed a two-class model, respectively, called "inactive relapsers" and "moderately active relapsers." Predictors of the "moderately active relapsers" class were employment status and diagnosis of myocardial infarction. CONCLUSIONS: Women achieved the recommended physical activity levels by the end of CR and sustained them until one year after CR. LCGA allowed us to determine the class trajectories associated with moderate-strenuous activity and, from these, to identify implications for targeted intervention.


Subject(s)
Exercise , Myocardial Infarction/pathology , Myocardial Infarction/rehabilitation , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Middle Aged , Myocardial Infarction/mortality , Prospective Studies
16.
Health Expect ; 16(1): 69-79, 2013 Mar.
Article in English | MEDLINE | ID: mdl-21645190

ABSTRACT

BACKGROUND: Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patients' decision-making process (DMP) of whether or not to accept an ICD has not been explored. We asked patients about their decision making when offered an ICD. DESIGN/SETTING: A grounded theory methodology was employed. Patients were recruited from three ICD centres. Those who received an ICD underwent interviews the first month after implant. Declining patients had interviews at their convenience. In-depth analysis of transcripts was completed. Identified themes were placed along process pathways in a DMP model and tested. FINDINGS: Forty-four patients consented to participate (25% women). Thirty-four accepted an ICD and 10 (23%) declined. Ages ranged from 26 to 87 (mean = 65; SD = 12.5). Participants were retired (65%), had ischaemic heart disease (64%) and some post-secondary education (52%). The DMP was triggered when patient's risk for SCD was communicated. The physician's recommendation and a new awareness SCD risk were motivators to accept the ICD. Patient's decision-making approaches fell along a continuum, from active and engaged to passive and indifferent. Patient's approaches were influenced most by the following: (i) trust; (ii) social influences and (iii) health state. CONCLUSIONS: Health-care providers need to recognize the DMP pathways in which ICD candidacy and SCD risk are understood. The factors that influence a patient's decision warrant discussion pre-implant. It is imperative that patients comprehend the meaning of ICD candidacy to make an informed decision. Participants did not recall alternatives to receiving ICD therapy.


Subject(s)
Death, Sudden, Cardiac/prevention & control , Decision Making , Defibrillators, Implantable/psychology , Patient Acceptance of Health Care/psychology , Patient Preference/psychology , Adult , Aged , Aged, 80 and over , Defibrillators, Implantable/statistics & numerical data , Female , Health Status , Humans , Interviews as Topic , Male , Middle Aged , Risk Factors , Trust
17.
Can J Cardiol ; 28(4): 502-7, 2012.
Article in English | MEDLINE | ID: mdl-22425267

ABSTRACT

BACKGROUND: Ventricular arrhythmia is a significant cause of sudden death. Implantable cardioverter-defibrillators (ICDs) offer at-risk patients a prophylactic treatment option. This prophylaxis is largely responsible for growth in utilization of ICDs. Identification of factors that may impact device-specific quality of life (QOL) is warranted. The influence of preimplant patient variables on postimplant device-specific QOL is unknown. The study aimed to determine whether preimplant psychosocial, generic health-related quality of life (HRQOL), personality disposition, or demographic factors predicted early postimplant device-specific QOL. METHODS: A prospective cohort study design was employed in 70 adults receiving an ICD for primary prevention. Preimplant, we measured generic HRQOL, personality disposition, depressive symptoms, age, and sex. The primary outcome was 3-month ICD device-specific QOL as measured by the Florida Patient Acceptance Scale (FPAS). We applied hierarchical multivariate regression analysis. RESULTS: Mean age was 64.8 ± 9.4 years; 12.9% were women. Most had ischemic heart disease (77%) and a heart failure history (54.3%). Preimplant prevalence of elevated depressive symptoms was 30%. Three months post implant, the mean adjusted FPAS score was 76.8 ± 12.98. Of the variance in FPAS scores, 37% was explained by the independent variables. Younger age and poor preimplant mental HRQOL contributed most to lower FPAS scores. CONCLUSIONS: Patient support and psychosocial interventions should target younger ICD candidates and those reporting poor preimplant mental HRQOL; these patients may be at risk for poor postimplant device-specific QOL.


Subject(s)
Defibrillators, Implantable/psychology , Quality of Life/psychology , Ventricular Fibrillation/prevention & control , Ventricular Fibrillation/psychology , Age Factors , Aged , Character , Cohort Studies , Depressive Disorder/psychology , Female , Heart Failure/complications , Heart Failure/psychology , Humans , Male , Middle Aged , Multivariate Analysis , Myocardial Ischemia/complications , Myocardial Ischemia/psychology , Ontario , Patient Acceptance of Health Care/psychology , Prospective Studies , Socioeconomic Factors , Treatment Outcome
18.
Can J Cardiol ; 28(2 Suppl): S20-41, 2012.
Article in English | MEDLINE | ID: mdl-22424281

ABSTRACT

Refractory angina (RFA) is a debilitating disease characterized by cardiac pain resistant to conventional treatments for coronary artery disease including nitrates, calcium-channel and ß-adrenoceptor blockade, vasculoprotective agents, percutaneous coronary interventions, and coronary artery bypass grafting. The mortality rate of patients living with RFA is not known but is thought to be in the range of approximately 3%. These individuals suffer severely impaired health-related quality of life with recurrent and sustained pain, poor general health status, psychological distress, impaired role functioning, and activity restriction. Effective care for RFA sufferers in Canada is critically underdeveloped. These guidelines are predicated upon a 2009 Canadian Cardiovascular Society (CCS) Position Statement which identified that underlying the problem of RFA management is the lack of a formalized, coordinated, interprofessional strategy between the cardiovascular and pain science/clinical communities. The guidelines are therefore a joint initiative of the CCS and the Canadian Pain Society (CPS) and make practice recommendations about treatment options for RFA that are based on the best available evidence. Concluding summary recommendations are also made, giving direction to future clinical practice and research on RFA management in Canada.


Subject(s)
Angina Pectoris , Cardiovascular Agents/therapeutic use , Disease Management , Myocardial Revascularization , Pain, Intractable , Self Care/methods , Activities of Daily Living , Angina Pectoris/diagnosis , Angina Pectoris/etiology , Angina Pectoris/physiopathology , Angina Pectoris/therapy , Canada , Humans , Meta-Analysis as Topic , Myocardial Revascularization/adverse effects , Myocardial Revascularization/methods , Outcome and Process Assessment, Health Care , Pain, Intractable/complications , Pain, Intractable/physiopathology , Patient Care Team/organization & administration , Quality Indicators, Health Care , Safety Management/standards , Secondary Prevention , Sickness Impact Profile , Societies, Medical , Stress, Psychological/etiology
19.
Can J Cardiol ; 28(2 Suppl): S42-9, 2012.
Article in English | MEDLINE | ID: mdl-22424283

ABSTRACT

New data suggest that persistent chest pain, despite normal coronary angiography, is less benign than previously thought. It has long been recognized that cardiac syndrome X (CSX) is associated with significant suffering, disability, and health care costs, but the biggest shift in thinking comes in terms of long-term risk. It is now recognized that the prognosis is not benign and that a significant proportion of patients are at increased cardiovascular disease risk. Of major debate is the question of whether the mechanisms that explain this chest pain are cardiac vs noncardiac. The most current definition of CSX is the triad of angina, ischemia, and normal coronary arteries, which is associated with an increased cardiovascular risk. This paper provides a review of CSX, epidemiology of the problem, proposed explanatory mechanisms, and important next steps in research. Central to this review is the proposition that new insights into CSX will be fostered by both clinical and scientific collaboration between cardiovascular and pain scientists.


Subject(s)
Disease Management , Interdisciplinary Communication , Microvascular Angina , Microvessels , Myocardial Ischemia , Postmenopause/metabolism , Canada/epidemiology , Chest Pain/metabolism , Chest Pain/physiopathology , Coronary Angiography/methods , Coronary Vessels/metabolism , Coronary Vessels/physiopathology , Cost of Illness , Female , Humans , Microvascular Angina/diagnosis , Microvascular Angina/epidemiology , Microvascular Angina/etiology , Microvascular Angina/physiopathology , Microvascular Angina/therapy , Microvessels/metabolism , Microvessels/physiopathology , Myocardial Ischemia/complications , Myocardial Ischemia/metabolism , Myocardial Ischemia/physiopathology , Prognosis , Research , Risk Factors , Stress, Psychological/etiology , Time
20.
Can J Cardiol ; 28(2 Suppl): S60-9, 2012.
Article in English | MEDLINE | ID: mdl-22424285

ABSTRACT

BACKGROUND: The purpose of this study was to identify factors that predispose individuals to nonischemic chest pain following successful percutaneous coronary intervention (PCI). METHODS: We prospectively followed, for 6 months, a cohort of 110 patients who underwent PCI. We determined baseline factors associated with post PCI pain via nonlinear mixed model regression; a binomial distribution with logit link was used. RESULTS: The mean age of participants (n = 110) was 64 (SD ± 11.19), 69% were male. The majority had 1 coronary vessel dilated (88%) and a single stent placement (67%). During follow-up, chest pain was prevalent in 54% (95% confidence interval [CI], 44.8-63.7) and 45% (95% CI, 36.0-54.8) of patients, at 3 and 6 months respectively. Less than half of those with chest pain were evaluated for ischemia. Of those evaluated, tests were negative for the majority; 74% and 61% at 3 and 6 months respectively. Higher baseline depression (odds ratio 1.50; 95% CI, 1.13-1.99) scores (Hospital Anxiety Depression Scale) were significantly associated with nonischemic chest pain during follow-up. CONCLUSION: Higher baseline depression scores were found to be significant risk factors for chest pain of nonischemic origin following successful PCI. A larger study is needed to confirm the predictive value of this and other factors that may contribute to this elusive pain problem. Further research is also required to develop pain management strategies for patients whose chest pain persists in the absence of discernible ischemic causes.


Subject(s)
Angioplasty, Balloon, Coronary/adverse effects , Chest Pain , Coronary Artery Disease/therapy , Myocardial Ischemia , Pain Measurement/methods , Postoperative Complications , Aged , Chest Pain/epidemiology , Chest Pain/etiology , Chest Pain/physiopathology , Confidence Intervals , Coronary Artery Disease/pathology , Coronary Vessels/pathology , Female , Humans , Male , Middle Aged , Myocardial Ischemia/complications , Myocardial Ischemia/epidemiology , Myocardial Ischemia/physiopathology , Ontario/epidemiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prevalence , Prospective Studies , Referral and Consultation/statistics & numerical data , Risk Factors , Severity of Illness Index , Stents
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