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Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed.

Many workers are experiencing the downsides of being exposed to an overload of information and communication technology (ICT), highlighting the need for resources to cope with the resulting technostress. This article offers a novel cross-level perspective on technostress by examining how the context of the welfare state influences the relationship between income and technostress. Showing that individuals with higher income experience less technostress, this study argues that the welfare state represents an additional coping resource, in particular in the form of unemployment benefits. Since unemployment benefits insure income earners in the case of job loss, the negative effect of income on technostress should increase with higher levels of unemployment generosity. In line with these expectations, empirical results based on original survey data collected in collaboration with the OECD show that the impact of income on technostress varies across welfare state contexts. Implications for public health and policymakers are being discussed.

Background In humanitarian settings common mental disorders (depression, anxiety disorders, posttraumatic stress disorder) are highly prevalent. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, delivered by paraprofessionals that addresses common mental disorders in people in communities affected by adversity. The objectives of this study are to test effectiveness and cost-effectiveness of the locally adapted PM+ compared to Treatment as usual (TAU) in Peshawar District, Pakistan. Methods A randomised controlled trial will be conducted in 346 primary care attendees in 3 health care centres in Peshawar District, Pakistan. After informed consent, primary care attendees with high levels of psychological distress according to the General Health Questionnaire-12 (GHQ-12) and functional impairment (WHO Disability Assessment Schedule 2.0 (WHODAS)) will be assigned to PM+ (n = 173) or TAU (n = 173). At baseline, 1 week and 3 months following PM+, independent assessors will assess psychological distress with the Hospital Anxiety and Depression Scale (HADS), and functional disability with the WHODAS. Secondary outcomes are posttraumatic stress disorder (PTSD) symptoms, and client-perceived priority problems. Further, cost-effectiveness will be assessed using the Service Receipt Inventory (SRI). Discussion If proven effective, PM+ will be rolled out to other areas for further adaptation and testing in diverse humanitarian settings. Trial registration ACTRN12614001235695 . Registered 26 November 2014. Australian New Zealand Clinical Trials Registry

PurposeCancer caregiving is shown to be a burdensome experience in typical times. The purpose of this study was to describe cancer caregivers’ emotional, physical, and financial strain during the COVID-19 pandemic and compared to preCOVID-19, and explore racial and ethnic variations in caregiver strain.MethodsWe conducted a cross-sectional online survey using Lucid, LLC, incorporating quotas for race, ethnicity, gender and age. Caregivers had to be adults living in the USA and currently providing unpaid care to an adult cancer patient (i.e., during COVID-19) and prior to the pandemic. We assessed the caregivers’ emotional, physical, and financial strain and asked them to compare to preCOVID-19 caregiving. Analyses included descriptive and linear regression adjusting for sociodemographic and caregiving-related variables.ResultsA total of 285 caregivers met eligibility, and most were nonHispanic white (72.3%) and female (59.6%). Based on a scale of “1: Much lower” to “5: Much higher”, the financial, physical and emotional strain/stress experienced by caregivers compared to preCOVID-19 was, on average, 3.52 (SD: 0.82; range: 1–5) for financial strain, 3.61 (SD: 0.86; range: 1–5) for physical strain, and 3.88 (SD: 0.89; range: 1–5) for emotional stress. NonHispanic black caregivers were significantly more likely than nonHispanic white caregivers to indicate that caregiving-related financial strain was higher than preCOVID-19. Moreover, Hispanic caregivers compared to nonHispanic white caregivers reported caregiving-related emotional stress was higher than preCOVID-19.ConclusionThese findings suggest a need to be attentive to racial and ethnic variations in emotional and financial strain and provide targeted support in clinical care and via public policy during a public health crisis.

Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app. The objective of this study was to evaluate the health economy of the app for treating SUI. This deterministic cost-utility analysis, with a 1-year societal perspective, compared the app treatment with no treatment. Health economic data were collected alongside a randomized controlled trial performed in Sweden from March 2013 to October 2014. This study included 123 community-dwelling women participants of 18 years and above, with stress urinary incontinence ≥1 time per week. Participants were self-assessed with validated questionnaires and 2-day leakage diaries, and then randomized to 3 months of treatment (app group, n=62) or no treatment (controls, n=61). The app focused on pelvic floor muscle training, prescribed 3 times daily. We continuously registered treatment delivery costs. Data were collected on each participant's training time, incontinence aids, and laundry at baseline and at a 3-month follow-up. We measured quality of life with the International Consultation on Incontinence Modular Questionnaire on Lower Urinary Tract Symptoms and Quality of Life, and calculated the quality-adjusted life years (QALYs) gained. Data from the 3-month follow-up were extrapolated to 1 year for the calculations. Our main outcome was the incremental cost-effectiveness ratios compared between app and control groups. One-way and multiway sensitivity analyses were performed. The mean age of participants was 44.7 years (SD 9.4). Annual costs were €547.0 for the app group and €482.4 for the control group. Annual gains in quality-adjusted life years for app and control groups were 0.0101 and 0.0016, respectively. Compared with controls, the extra cost per quality-adjusted life year for the app group ranged from -€2425.7 to €14,870.6, which indicated greater gains in quality-adjusted life years at similar or slightly higher cost. The app for treating stress urinary incontinence is a new, cost-effective, first-line treatment with potential for increasing access to care in a sustainable way for this patient group.

Background Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. Method Patients (≥ 18 years) with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis. Discussion This RCT will provide empirical evidence of whether an individually administered stress-management programme in two steps can decrease stress as well as maintain or enhance patients’ physical activity level, quality of life and psychological well-being. Further, this RCT, with a stepped-care approach, will provide knowledge regarding the cost-effectiveness of an individually administered stress-management programme whose aim is to help and support individual patients at the right level of care. Trial registration ClinicalTrials.gov Identifier: NCT 01588262.

The percentage of missing data among economic-related items is likely to be particularly high. This study aimed at examining the amount, mechanisms, and variables associated with missingness of different family members participating in a family economic stress study. Portuguese emerging adults (N = 418) and their parents (N = 748) were required to answer objective and subjective economic items and complete measures assessing individual and family psychological functioning. Results showed that, for all participants, non-response was more likely to occur among objective economic items than among subjective ones. Children presented higher percentages of item/construct-level missingness than parents, which could reflect a reduced financial awareness on the part of these family members. Although the identification of mechanisms explaining missing data proved to be complex, family members’ missingness was associated with sociodemographic and psychological indicators, suggesting that non-answers do not occur purely by chance. Implications of these findings for further family economic stress research are discussed.

Background There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence. Methods/Design One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence–related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire–Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed. Discussion This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence. Trial registration ClinicalTrials.gov Identifier: NCT01924728 . Date of Registration: 14 August 2013.

Background Little is known of the importance of social support in the associations between psychological distress and somatic health problems and socio-economic factors among older adults living at home. The objectives of the present study were to investigate the associations of social support, somatic health problems and socio-economic factors with psychological distress. We also examined changes in the association of somatic health problems and socio-economic factors with psychological distress after adjusting for social support. Methods A random sample of 4,000 persons aged 65 years or more living at home in Oslo was drawn. Questionnaires were sent by post, and the total response was 2,387 (64%). Psychological distress was assessed using Hopkins Symptom Checklist (HSCL-10) and social support with the Oslo-3 Social Support Scale (OSS-3). A principal component analysis (PCA) included all items of social support and psychological distress. Partial correlations were used, while associations were studied by logistic regression. Results After adjusting for socio-demographics and somatic health problems, we reported a statistically significant association between psychological distress and social support: “Number of close friends”, OR 0.61; 95% CI 0.47-0.80; “Concern and interest”, OR 0.68; 95% CI 0.55-0.84. A strong association between lack of social support and psychological distress, irrespective of variables adjusted for, indicated a direct effect. The associations between psychological distress and physical impairments were somewhat reduced when adjusted for social support, particularly for hearing, whereas the associations between somatic diagnoses and psychological distress were more or less eliminated. Income was found to be an independent determinant for psychological distress. Conclusions Lack of social support and somatic health problems were associated with psychological distress in elders. Social support acted as a mediator, implying that the negative effect of somatic health problems, especially hearing, on psychological distress was mediated by low social support. We hypothesize that physical impairments reduced social support, thereby increasing psychological distress to a greater extent than the selected diagnoses. The combination of poor social support, poor somatic health and economic problems may represent a vulnerable situation with respect to the mental health of older persons. Free interventions that highlight social support should be considered in mental health promotion.

Background Internet- and mobile based stress-management interventions (iSMI) may be an effective means to address the negative consequences of occupational stress. However, available results from randomised controlled trials are conflicting. Moreover, it is yet not clear whether guided or unguided self-help iSMI provide better value for money. Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional. However, direct comparisons in randomised controlled trials are scarce and, to the best of our knowledge, the comparative (cost)-effectiveness of guided vs. unguided iSMI has not yet been studied. Hence, this study investigates the acceptability and (cost-) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress. Methods A three-armed randomised controlled trial (RCT) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition (WLC). Both active conditions are based on the same iSMI, i.e. GET.ON Stress, and differ only with regard to the guidance format. Employees with heightened levels of perceived stress (PSS ≥ 22) will be randomised to one of three conditions. Primary outcome will be comparative changes in perceived stress (PSS). Secondary outcomes include changes in self-reported depression, work-engagement, presenteeism and absenteeism. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective, including both direct medical costs and costs related to productivity losses. In addition, a cost-benefit analysis will be conducted from the employer’s perspective. Incremental net-benefit regression analyses will address the question if there are any baseline factors (i.e. subgroups of employees) associated with particularly favorable cost-effectiveness when the experimental intervention is offered. Assessments take place at baseline, 7 weeks post-treatment and 6 months after randomisation. Discussion Online-based (guided) self-help interventions could be an acceptable, effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress. This study evaluates the (cost-) effectiveness of two versions of an iSMI, minimal guided and unguided iSMI. Thus, the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs. Trial registration German Clinical Trial Registration (DRKS): DRKS00005687 .