A call for action to include psychosocial management into holistic, integrated care for patients with atrial fibrillation.

Contemporary management of atrial fibrillation (AF) has become increasingly complex. Therefore, strong efforts have been made during the past decade to develop models for structured, integrated care for patients with AF. These have also been incorporated in international guidelines for the management of patients with AF. However, implementation of integrated care approaches in daily clinical practice is scarce and far from optimal, and it may require a re-thinking of the structure of the healthcare system. The reasons for the poor implementation are many, from limited time and economic resources to deficits in postgraduate education of healthcare professionals, lack of involvement of patients in how integrated care should be designed, and fragmentation of the healthcare system. Moreover, patients' psychological challenges, which not only impact patients' adherence to treatment but, if untreated, increase their risk of morbidity, mortality, and poor quality of life, are not given sufficient attention. It is time to start a necessary discussion of what integrated care should be, what it should contain, and what is necessary to implement it in daily clinical practice.

Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Social Disconnectedness in Individuals with Cardiovascular Disease: Associations with Health Literacy and Treatment Burden.

BACKGROUND: Knowledge is limited on associations between social disconnectedness (i.e. loneliness and social isolation), health literacy and perceived treatment burden in individuals with cardiovascular disease (CVD). However, understanding these associations may be important for clinical practice. METHODS: This study used cross-sectional self-reported data from the 2017 Danish health and morbidity survey entitled 'How are you?', investigating the associations of loneliness and social isolation with low health literacy and high treatment burden in individuals with CVD (n = 2521; mean age = 65.7 years). RESULTS: Logistic regression analysis showed that loneliness and social isolation were associated with low health literacy in terms of difficulties in 'understanding health information' (loneliness: adjusted odds ratio (AOR) = 1.32, 95% confidence intervals (CI) [1.16, 1.50]; social isolation: AOR = 1.47, 95% CI [1.24, 1.73]) and 'engaging with healthcare providers' (loneliness: AOR = 1.53, 95% CI [1.37, 1.70]; social isolation: AOR = 1.21, 95% CI [1.06, 1.40]) and associated with high treatment burden (loneliness: AOR = 1.49, 95% CI [1.35, 1.65]; social isolation: AOR = 1.20, 95% CI [1.06, 1.37]). CONCLUSIONS: Our findings show that loneliness and social isolation coexisted with low health literacy and high treatment burden in individuals with CVD. These findings are critical as socially disconnected individuals experience more health issues. Low health literacy and a high treatment burden may potentially exacerbate these issues.

Does targeted positioning of the left ventricular pacing lead towards the latest local electrical activation in cardiac resynchronization therapy reduce the incidence of death or hospitalization for heart failure?

BACKGROUND: Cardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement. METHODS: The DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1,000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a nonapical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and nonplanned HF hospitalization. Patients are followed for a minimum of 2 years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024. CONCLUSIONS: The DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or nonplanned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. GOV IDENTIFIER: NCT03280862.

Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

AIMS: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. METHODS AND RESULTS: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. CONCLUSION: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.

Return to work: does cardiac rehabilitation make a difference? Danish nationwide register-based study.

AIM: to assess whether participation in cardiac rehabilitation affects the probability of returning to work after ischaemic heart disease. METHODS: the study population consisted of 24,509 patients (18-70 years of age) discharged from an inpatient admission at a Danish hospital during 2014-2018 and who were working before their admission. Only patients with a percutaneous coronary intervention or coronary artery bypass grafting surgery procedure and ICD-10 codes I20-I25 as their main diagnosis or ICD-10 codes I21, I240, I248 or I249 as secondary diagnosis during an emergency admission were included. Exposure was defined as participation in cardiac rehabilitation (N = 15,742), and binary indicator of being at work in the last week of a given month were used as primary outcomes. Coarsened exact matching (CEM) of exposed and unexposed patients was used to reduce selection bias. Logistic regression models were applied on the matched population (N = 15,762). RESULTS: Less deprived and less comorbid patients were more likely to receive cardiac rehabilitation. CEM succeeded in arriving at a population where this selection was reduced and in this population we found that patients who received cardiac rehabilitation had a lower probability of returning to work after 3 months (OR 0.81, 95%CI: 0.77-0.84), a higher but insignificant probability after 6 (OR 1.02, 95%CI: 0.97-1.08), and a higher probability after 9 (OR 1.08, 95%CI: 1.02-1.15) and 12 months (OR 1.20, 95%CI: 1.13-1.28). CONCLUSIONS: Deprived and comorbid patients have lower use of cardiac rehabilitation. In a matched population where this bias is reduced, cardiac rehabilitation will increase the probability of returning to work.

Effects of screening for anxiety and depression in patients with ischaemic heart disease - a nationwide Danish register study.

AIM: To investigate the effect of screening for anxiety and depression (AD) in patients with ischaemic heart disease (IHD) on the likelihood of receiving treatment for AD. METHODS: We used a nationwide dataset of all Danish patients with an incident IHD diagnosis in the period 2015-2018 (N = 80,701) of which 20,461 (25%) were exposed to screening for AD as part of cardiac rehabilitation. A binary composite indicator for the use of any AD treatment (prescriptions of AD drugs, general practitioner (GP) counselling or referral to a psychologist), was modelled as the dependent variable. The probability of receiving AD treatment was estimated using linear probability and instrumental variable regression models. RESULTS: Exposure to AD screening was lower for patients with low income (change in probability -0.67, 95% CI -0.76; -0.59), low education (change in probability -0.16, 95% CI -0.20; -0.13), and a high comorbidity burden (change in probability -0.09, 95% CI -0.10; -0.07). Screened patients had a lower conditional probability of AD treatment (change in probability -0.0061, p < 0.001) than non-screened patients. The patient's GP also had an impact on the probability of being referred for AD treatment. Using an instrumental variable approach did not affect the results. CONCLUSIONS: Screening for AD was subject to selection at the patient level; patients at lower risk of AD had a higher probability of being screened. Hence, extending systematic screening to cover a larger population may not achieve a noticeable increase in the uptake of AD treatment if it is not supported by appropriate measures to reduce reverse selection into screening.

Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial.

AIMS: Remote patient monitoring (RPM) systems offer a promising alternative to conventional In-Clinic check-ups, hereby reducing unnecessary clinic visits. Especially with the rise of the COVID-19 pandemic, this reduction is of paramount importance. Regarding the association between RPM and clinical outcomes, findings of previous studies have been inconsistent. The aim of this study is to elucidate the effect of partly substituting In-Clinic visits by RPM on clinical outcomes in implantable cardioverter-defibrillator (ICD) patients. METHODS AND RESULTS: The study included 595 heart failure patients (LVEF ≤35%; NYHA Class II/III) implanted with an ICD compatible with the Boston Scientific LATITUDE™ system. Participants were randomized to RPM plus an annual In-Clinic visit or 3-6 months In-Clinic check-ups alone. The investigated endpoints after 2 years of follow-up included a composite of all-cause mortality and cardiac hospitalization, mortality and cardiac hospitalization as independent endpoints and ICD therapy. The incidence of mortality and hospitalization did not differ significantly as independent, nor as composite endpoint between the RPM and In-Clinic group (all Ps <0.05). The results were similar regarding ICD therapy, except for appropriate ICD therapy (odds ratio 0.50; 95% confidence interval 0.26-0.98; P = 0.04). Exploratory subgroup analyses indicated that the effect of RPM differs between patients with specific characteristics, i.e. ≥60 years and permanent atrial fibrillation (all Ps < 0.05). CONCLUSION: RPM is non-inferior to conventional In-Clinic visits regarding clinical outcomes. Routine In-Clinic follow-up may partly be substituted by RPM without jeopardizing safety and efficiency, and thus reducing unnecessary In-Clinic visits. CLINICALTRIALS.GOV IDENTIFIER: NCT01691586.

Perceptions of person-centred care in two large university hospitals: A cross-sectional survey among healthcare professionals.

BACKGROUND: Patient-centred care (PCC) including collaborative practices is the core component of modern health care. Despite this, it has proven difficult to implement. AIMS: To examine (1) healthcare professionals' (HCPs') perception of whether they perceive a PCC culture, their attitudes towards involving patients in decisions and their experiences of barriers for PCC; and (2) variables that may contribute to explain differences in perceived person-centred culture. METHODS: A questionnaire survey of HCPs from 27 different departments from two university hospitals in Denmark. HCPs were eligible if they held a profession as physician, Registered Nurse, nurse assistant, physiotherapist, occupational therapist, dietician, midwife or psychologist and excluded if they reported not being involved in patient treatment and care. The questionnaire consisted of four items from the Context Assessment Index (CAI). The remaining items were purpose-designed. RESULTS: In total 1140 (24% response rate) HCPs completed the questionnaire and were included in the analyses. Most of the HCPs perceived a culture of PCC (e.g. 91% agreed or agreed to a high degree that patients were provided with opportunities to participate in decisions). Most HCPs also held positive attitudes towards involving patients in decisions. Time and prioritisation from the management were perceived as barriers for PCC, and many HCPs also believed that involving patients in decisions could be difficult for the patients. The HCPs who were least involved in treatment and care, and working in the acute setting or in surgery, were least likely to perceive a PCC culture. HCPs with the longest or shortest educations, and HCPs working primarily with outpatients or with planned inpatients, were most likely to perceive a person-centred culture. CONCLUSION: The HCPs generally perceived a culture of PCC and held positive attitudes towards involving patients in decisions. To further promote PCC, time and prioritisation must be invested at an organisational level.

Psychometric evaluation of the implantable cardioverter defibrillator body image concerns questionnaire (ICD-BICQ).

BACKGROUND: Patients receiving an implantable cardioverter defibrillator (ICD) generally adapt well to living with their device, but we know little about the prevalence of patients' body image concerns (BICs) postimplant. METHODS: The objectives were to evaluate the psychometric properties of the ICD-body image concerns questionnaire (BICQ), find a cut-off indicating BICs and determine the prevalence of BICs. Construct validity was determined using the Kaiser-Meyer-Olkin test, Scree-plot and explorative factor analysis. Internal consistency was examined via Cronbach's alpha. Correlations to other validated questionnaires, a weighted and simple scale and a cut-off indicating BICs was evaluated. RESULTS: In total, 331 patients completed the 39-item ICD-BICQ together with: Type D Scale (DS14), Generalized Anxiety Disorder scale (GAD-7), Patient Health Questionnaire (PHQ-9), and Florida Patient Acceptance Survey. Five patients were excluded due to reoperations, leaving 326 patients in the analyses. Results revealed a one-factor structure with 32 items and Cronbach's alpha at .948. A cut-off at 36 points displayed the 20% patients with the highest score of BICs. The prevalence was 29.8% in women and 18.4% in men. CONCLUSION: The psychometric evaluation of the 32-item ICD-BICQ showed acceptable construct validity and internal reliability. We recommend a cut-off score at 36 points to identify patients at risk of having BICs. The prevalence of BICs indicated that both men and women are at risk of having BICs. The ICD-BICQ can be used in clinical practice to help healthcare professionals to identify patients at risk of BICs and as to evaluate BICs when implementing new operation techniques.

Hybrid Systematic Review and Network Meta-Analysis of Randomized Controlled Trials of Interventions for Depressive Symptoms in Patients With Coronary Artery Disease.

OBJECTIVE: Depression is common in patients with coronary artery disease (CAD) and is associated with poor outcomes. Although different treatments are available, it is unclear which are best or most acceptable to patients, so we conducted a network meta-analysis of evidence from randomized controlled trials (RCTs) of different depression treatments to ascertain relative efficacy. METHODS: We searched for systematic reviews of RCTs of depression treatments in CAD and updated these with a comprehensive search for recent individual RCTs. RCTs comparing depression treatments (pharmacological, psychotherapeutic, combined pharmacological/psychotherapeutic, exercise, collaborative care) were included. Primary outcomes were acceptability (dropout rate) and change in depressive symptoms 8 week after treatment commencement. Change in 26-week depression and mortality were secondary outcomes. Frequentist, random-effects network meta-analysis was used to synthesize the evidence, and evidence quality was evaluated following Grading of Recommendations, Assessment, Development and Evaluations recommendations. RESULTS: Thirty-three RCTs (7240 participants) provided analyzable data. All treatments were equally acceptable. At 8 weeks, combination therapy (1 study), exercise (1 study), and antidepressants (10 studies) yielded the strongest effects versus comparators. At 26 weeks, antidepressants were consistently effective, but psychotherapy was only effective versus usual care. There were no differences in treatment groups for mortality. Grading of Recommendations, Assessment, Development and Evaluations ratings ranged from very low to low. CONCLUSIONS: Overall, the evidence was limited and biased. Although all treatments for post-CAD depression were equally acceptable, antidepressants have the most robust evidence base and should be the first-line treatment. Combinations of antidepressants and psychotherapy, along with exercise, could be more effective than antidepressants alone but require further rigorous, multiarm intervention trials.Systematic Review Registration: CRD42018108293 (International Prospective Register of Systematic Reviews).

Loneliness, Social Isolation, and Chronic Disease Outcomes.

BACKGROUND: Research suggests that loneliness and social isolation (SI) are serious public health concerns. However, our knowledge of the associations of loneliness and SI with specific chronic diseases is limited. PURPOSE: The present prospective cohort study investigated (a) the longitudinal associations of loneliness and SI with four chronic diseases (cardiovascular disease [CVD], chronic obstructive pulmonary disease [COPD], diabetes mellitus Type 2 [T2D], and cancer), (b) the synergistic association of loneliness and SI with chronic disease, and (c) baseline psychological and behavioral explanatory factors. METHODS: Self-reported data from the 2013 Danish "How are you?" survey (N = 24,687) were combined with individual-level data from the National Danish Patient Registry on diagnoses in a 5 year follow-up period (2013-2018). RESULTS: Cox proportional hazard regression analyses showed that loneliness and SI were independently associated with CVD (loneliness: adjusted hazard ratio (AHR) = 1.20, 95% confidence interval [CI; 1.03, 1.40]; SI: AHR = 1.23, 95% CI [1.04, 146]) and T2D (loneliness: AHR =1.90, 95% CI [1.42, 2.55]; SI: AHR = 1.59, 95% CI [1.15, 2.21]). No significant associations were found between loneliness or SI and COPD and cancer, respectively. Likewise, loneliness and SI did not demonstrate a synergistic effect on chronic disease. Multiple mediation analysis indicated that loneliness and SI had an indirect effect on CVD and T2D through both baseline psychological and behavioral factors. CONCLUSION: Loneliness and SI were independently associated with a diagnosis of CVD and T2D within a 5 year follow-up period. The associations of loneliness and SI with CVD and T2D were fully explained by baseline psychological and behavioral factors.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol.

BACKGROUND: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. METHODS: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. DISCUSSION: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as "one package" to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

Facilitating participation in cardiovascular preventive initiatives among people with diabetes: a qualitative study.

BACKGROUND: Type 2 diabetes (T2D) is associated with a significantly increased risk of cardiovascular disease (CVD). The DIAbetic CArdioVAscular Screening and intervention trial (DIACAVAS) was designed to clarify whether advanced imaging for subclinical atherosclerosis combined with medical treatment is an effective strategy to develop individualised treatment algorithms for Danish men and women with T2D aged 40-60. But in the DIACAVAS pilot study, the uptake was only 41%. Consequently, we explored how people experienced living with T2D to understand how to improve the uptake in initiatives targeting the prevention of CVD. METHODS: We used semi-structured interviews to obtain information on how the respondents experienced having T2D. For supplementary information, we used structured interviews on e.g. socioeconomic factors. From April to October 2019, 17 participants aged 40-60 years were recruited from general practices and diabetes outpatient clinics in Denmark. Several levels of analysis were involved consistent with inductive content analysis. RESULTS: The participants' experiences of living with T2D fell along two continuums, from an emotional to a cognitive expression and from reactive to proactive disease management. This led to identification of four archetypal characteristics: (I) powerlessness, (II) empowerment, (III) health literacy, and (IV) self-efficacy. These characteristics indicated the importance of using different approaches to facilitate participation in cardiovascular preventive initiatives. Additionally, findings inspired us to develop a model for facilitating participation in future preventive initiatives. CONCLUSION: Encouraging people with T2D to participate in cardiovascular preventive initiatives may necessitate a tailored invitation strategy. We propose a model for an invitational process that takes into consideration invitees' characteristics, including powerlessness, empowerment, health literacy and self-efficacy. This model may enhance participation in such initiatives. However, participation is a general concern, not only in relation to cardiovascular prevention. Our proposed model may be applicable in preventive services for people with T2D in general.

Anger and long-term mortality and ventricular arrhythmias in patients with a first-time implantable cardioverter-defibrillator: data from the MIDAS study.

AIMS: Psychosocial factors increase risk for incident heart disease and poor prognosis. In patients with an implantable cardioverter-defibrillator (ICD), negative emotions have been associated with increased mortality risk, although the association with ventricular arrhythmias (VAs) is less consistent. Anger has been linked to incident ICD shocks, but no prospective study has examined the association of anger (state and trait) with mortality or VAs in the ICD population. In a consecutively recruited cohort of first-time ICD patients, we examined the association of state and trait anger with 7-year mortality risk and time to first VA. METHODS AND RESULTS: A consecutive cohort of patients implanted with a first-time ICD (n = 388; 80% men) between 2003 and 2010 completed the State-Trait Anger Scale and were followed for 7 years. Outcomes were mortality and time to first appropriate ICD therapy. State anger at the time of implant was associated with increased mortality risk in adjusted analyses, with a 1-point increase in score on the state anger measures associated with a 5% [hazard ratio 1.05; 95% confidence interval 1.01-1.09; P = 0.015] increased 7-year mortality risk. We found no statistically significant differences in mortality risk for trait anger, nor an effect for state or trait anger on time to first treated VA (all ps > 0.05). CONCLUSION: This is the first study to examine the association of state and trait anger with long-term clinical outcomes in ICD patients. Evaluating anger reduction strategies in newly implanted ICD patients, such as self-regulation or mindfulness techniques, may be warranted for reducing mortality risk.

Anxiety and depression symptoms in Danish patients with an implantable cardioverter-defibrillator: prevalence and association with indication and sex up to 2 years of follow-up (data from the national DEFIB-WOMEN study).

AIMS: To investigate (i) the prevalence of anxiety and depression and (ii) the association between indication for implantable cardioverter-defibrillator (ICD) implantation and sex in relation to anxiety and depression up to 24 months' follow-up. METHODS AND RESULTS: Patients with a first-time ICD, participating in the national, multi-centre, prospective DEFIB-WOMEN study (n = 1496; 18% women) completed the Hospital Anxiety and Depression Scale at baseline, 3, 6, 12, and 24 months. Data were analysed using linear mixed modelling for longitudinal data. Patients with a secondary prophylactic indication (SPI) had higher mean anxiety scores than patients with a primary prophylactic indication (PPI) at baseline, 3, and 12 months and higher mean depression scores at all-time points, except at 24 months. Women had higher mean anxiety scores as compared to men at all-time points; however, only higher mean depression scores at baseline. Overall, women with SPI had higher anxiety and depression symptom scores than men with SPI. Symptoms decreased over time in both women and men. From baseline to follow-up, the prevalence of anxiety (score ≥8) was highest in patients with SPI (13.3-20.2%) as compared to patients with PPI (range 10.0-14.7%). The prevalence of depression was stable over the follow-up period in both groups (range 8.5-11.1%). CONCLUSION: Patients with a SPI reported higher anxiety and depression scores as compared to patients with PPI. Women reported higher anxiety scores than men, but only higher depression scores at baseline. Women with SPI reported the highest anxiety and depression scores overall.

Development and content validation of a questionnaire measuring patient empowerment in cancer follow-up.

PURPOSE: The aim of this study was to develop and ensure the content validity of a new patient-reported outcome measure, the Cancer Patient Empowerment Questionnaire (CPEQ), to measure the level of, desire for, and enablement of empowerment among cancer patients in follow-up. METHODS: An iterative process based on: (i) empowerment theories by Zimmerman and Tengland, (ii) a systematic review of questionnaires measuring empowerment or related concepts among cancer patients, (iii) qualitative data from 18 semi-structured interviews with Danish cancer patients in follow-up, (iv) input from a group of eight cancer patients involved as co-researchers and from an expert steering group, and (v) cognitive interviews with 15 cancer patients in follow-up. RESULTS: The items for the CPEQ were developed and revised and 12 versions of the questionnaire were evaluated. The final version consists of 67 items, covering three different dimensions of empowerment: (A) empowerment outcomes consisting of three components: (A1) the intrapersonal-, (A2) interactional-, and (A3) behavioral component, (B) empowerment facilitators (enablement), and (C) the value of empowerment. CONCLUSIONS: This study documents the theoretical and empirical basis for the development of the CPEQ and its content validity. The CPEQ provides a tool for researchers to assess the level of, desire for, and enablement of empowerment among cancer patients. The next steps will be to use the CPEQ in a nationwide study of empowerment in cancer follow-up and subsequently shorten the CPEQ based on psychometric methods in order to make it more relevant in clinical studies.

What to expect after open heart valve surgery? Changes in health-related quality of life.

PURPOSE: To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. METHODS: A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. RESULTS: Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. CONCLUSIONS: This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

Sociodemographic Representativeness in a Nationwide Web-Based Survey of the View of Men on Involvement in Health Care Decision-Making: Cross-Sectional Questionnaire Study.

BACKGROUND: Being able to generalize research findings to a broader population outside of the study sample is an important goal in surveys on the internet. We conducted a nationwide, cross-sectional, web-based survey with vignettes illustrating different levels of patient involvement to investigate men's preferences regarding participation in health care decision-making. Following randomization into vignette variants, we distributed the survey among men aged 45 to 70 years through the state-authorized digital mailbox provided by the Danish authorities for secure communication with citizens. OBJECTIVE: This study aimed to investigate the sociodemographic representativeness of our sample of men obtained in a nationwide web-based survey using the digital mailbox. METHODS: Response rate estimates were established, and comparisons were made between responders and nonresponders in terms of age profiles (eg, average age) and municipality-level information on sociodemographic characteristics. RESULTS: Among 22,288 men invited during two waves, a total of 6756 (30.31%) participants responded to the survey. In adjusted analyses, responders' characteristics mostly resembled those of nonresponders. Response rates, however, were significantly higher in older men (odds ratio [OR] 2.83 for responses among those aged 65-70 years compared with those aged 45-49 years, 95% CI 2.58-3.11; P<.001) and in rural areas (OR 1.10 compared with urban areas, 95% CI 1.03-1.18; P=.005). Furthermore, response rates appeared lower in areas with a higher tax base (OR 0.89 in the highest tertile, 95% CI 0.81-0.98; P=.02). CONCLUSIONS: Overall, the general population of men aged 45 to 70 years was represented very well by the responders to our web-based survey. However, the imbalances identified highlight the importance of supplementing survey findings with studies of the representativeness of other characteristics of the sample like trait and preference features, so that proper statistical corrections can be made in upcoming analyses of survey responses whenever needed.

Men's view on participation in decisions about prostate-specific antigen (PSA) screening: patient and public involvement in development of a survey.

BACKGROUND: Prostate-Specific Antigen (PSA) screening for early detection of prostate cancer (PCa) may prevent some cancer deaths, but also may miss some cancers or lead to unnecessary and potentially harmful treatment. Therefore, involving patients in decision-making about PSA screening is recommended. However, we know little about the attitude of men regarding participation in decisions about PSA screening and how to assess such attitudes. The purpose of this paper is to describe patient and public participation in the development of a national, web-based case vignette survey for studying men's view on participation in decision-making about PSA screening. METHODS: The project group developed a first draft plan for the survey, its vignettes and choice of measurements. This included multiple vignette variants representing various levels of patient participation in decision-making about PSA screening with different outcomes. Additionally, it included questions on respondents' satisfaction with imagined courses of health care, their propensity to initiate a malpractice complaint, their own health care experiences, socio-demography, personality, and preferences for control regarding health care decision-making. Following feedback from a workshop with academic peers on the draft plan, a group of 30 adult men was engaged to help develop case vignette versions and questionnaire items by providing feedback on structure, comprehension, response patterns, and time required to complete the survey. Furthermore, a panel of three patients with PCa experience was assembled to assist development through a separate review-and-feedback process. RESULTS: Based on reviews of survey drafts, the large group made further suggestions about construction of the survey (e.g. clarification and modification of case vignette versions, deletion of items and adjustment of wording, instructions to guide respondents, replacement of technical terms, and optimization of sequence of survey elements). The patient panel ensured fine-tuning of vignette versions and questionnaire items and helped review the internet version of the survey. CONCLUSIONS: Patient and public involvement during various phases of the survey development helped modify and refine survey structure and content. The survey exemplifies a way to measure health care users' satisfaction with imagined courses of health care and wish to complain, taking into account their characteristics.