Outcomes of community-acquired pneumonia using the Pneumonia Severity Index versus the CURB-65 in routine practice of emergency departments.

Background: The Pneumonia Severity Index (PSI) and the CURB-65 score assess disease severity in patients with community-acquired pneumonia (CAP). We compared the clinical performance of both prognostic scores according to clinical outcomes and admission rates. Methods: A nationwide retrospective cohort study was conducted using claims data from adult CAP patients presenting to the emergency department (ED) in 2018 and 2019. Dutch hospitals were divided into three categories: "CURB-65 hospitals" (n=25), "PSI hospitals" (n=19) and hospitals using both ("no-consensus hospitals", n=15). Main outcomes were hospital admission rates, intensive care unit admissions, length of hospital stay, delayed admissions, readmissions and all-cause 30-day mortality. Multilevel logistic and Poisson regression analysis were used to adjust for potential confounders. Findings: Of 50 984 included CAP patients, 21 157 were treated in CURB-65 hospitals, 17 279 in PSI hospitals and 12 548 in no-consensus hospitals. The 30-day mortality was significantly lower in CURB-65 hospitals versus PSI hospitals (8.6% and 9.7%, adjusted odds ratio (aOR) 0.89, 95% CI: 0.83-0.96, p=0.003). Other clinical outcomes were similar between CURB-65 hospitals and PSI hospitals. No-consensus hospitals had higher admission rates compared to the CURB-65 and PSI hospitals combined (78.4% and 81.5%, aOR 0.78, 95% CI: 0.62-0.99). Interpretation: In this study, using the CURB-65 in CAP patients at the ED is associated with similar and possibly even better clinical outcomes compared to using the PSI. After confirmation in prospective studies, the CURB-65 may be recommended over the use of the PSI since it is associated with lower 30-day mortality and is more user-friendly.

Can the Use of Health Insurance Claim Data Benefit the Risk-Based Supervision of General Practitioner Practices? An Exploratory Study in the Netherlands.

BACKGROUND: The Dutch Health and Youth Care Inspectorate has organized a study investigating whether there are benefits to using claim data in the risk-based supervision of general practitioner (GP) practices. METHODS: We identified and selected signals of risks based on interviews with experts. Next, we selected 3 indicators that could be measured in the claim database. These were: the expected and actual costs of the GP practice; the percentage of reserve antibiotics prescribed; and the percentage of patients undergoing an emergency admission during the weekend. We corrected the scores of the GP practices based on their casemix and identified practices with the most unfavorable scores, 'red flags,' in 2015, or the trend between 2013-2015. Finally, we analysed the data of GP practices already identified as delivering substandard care by the Health and Youth Care Inspectorate and calculated the sensitivity and specificity of using the indicators to identify poor performing GP practices. RESULTS: By combining the 3 indicators, we identified 1 GP practice with 3 red flags and 24 GP practices with 2 red flags. The a priori chance of identifying a GP practice that shows substandard care is 0.3%. Using the indicators, this improved to 1.0%. The sensitivity was 26.7%, the specificity was 92.8%. CONCLUSION: The Dutch Health and Youth Care Inspectorate might use claim data to calculate indicators on costs, the prescribing of reserve antibiotics and emergency admissions during the weekend, when setting priorities for its visits to GP practices. Visiting more GP practices by the Health and Youth Care Inspectorate, and identifying substandard care, is necessary to validate the use of these indicators.

Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial.

OBJECTIVE: To determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects. DESIGN: Hypothesis-blinded, three-armed randomised controlled trial SETTING AND PARTICIPANTS: 303 statin users with stable CVD enrolled in a cohort INTERVENTION: Participants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com). OUTCOME: Primary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th- 75th percentile). RESULTS: Decisional conflict differed between the intervention arms: median control 27 (20-43), iAR-group 22 (11-30; p-value vs control 0.001) and iLE-group 25 (10-31; p-value vs control 0.021). No differences in secondary outcomes were observed. CONCLUSION: In patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making. TRIAL REGISTRATION: NTR6227/NL6080.

How do studies assess the preventability of readmissions? A systematic review with narrative synthesis.

BACKGROUND: A large number of articles examined the preventability rate of readmissions, but comparison and interpretability of these preventability rates is complicated due to the large heterogeneity of methods that were used. To compare (the implications of) the different methods used to assess the preventability of readmissions by means of medical record review. METHODS: A literature search was conducted in PUBMED and EMBASE using "readmission" and "avoidability" or "preventability" as key terms. A consensus-based narrative data synthesis was performed to compare and discuss the different methods. RESULTS: Abstracts of 2504 unique citations were screened resulting in 48 full text articles which were included in the final analysis. Synthesis led to the identification of a set of important variables on which the studies differed considerably (type of readmissions, sources of information, definition of preventability, cause classification and reviewer process). In 69% of the studies the cause classification and preventability assessment were integrated; meaning specific causes were predefined as preventable or not preventable. The reviewers were most often medical specialist (67%), and 27% of the studies added interview as a source of information. CONCLUSION: A consensus-based standardised approach to assess preventability of readmission is warranted to reduce the unwanted bias in preventability rates. Patient-related and integrated care related factors are potentially underreported in readmission studies.

How Health Care Professionals Evaluate a Digital Intervention to Improve Medication Adherence: Qualitative Exploratory Study.

BACKGROUND: Medication nonadherence poses a serious and a hard-to-tackle problem for many chronic diseases. Electronic health (eHealth) apps that foster patient engagement and shared decision making (SDM) may be a novel approach to improve medication adherence. OBJECTIVE: The aim of this study was to investigate the perspective of health care professionals regarding a newly developed digital app aimed to improve medication adherence. Familial hypercholesterolemia (FH) was chosen as a case example. METHODS: A Web-based prototype of the eHealth app-MIK-was codesigned with patients and health care professionals. After user tests with patients, we performed semistructured interviews and user tests with 12 physicians from 6 different hospitals to examine how the functionalities offered by MIK could assist physicians in their consultation and how they could be integrated into daily clinical practice. Qualitative thematic analysis was used to identify themes that covered the physicians' evaluations. RESULTS: On the basis of the interview data, 3 themes were identified, which were (1) perceived impact on patient-physician collaboration; (2) perceived impact on the patient's understanding and self-management regarding medication adherence; and (3) perceived impact on clinical decisions and workflow. CONCLUSIONS: The eHealth app MIK seems to have the potential to improve the consultation between the patient and the physician in terms of collaboration and patient engagement. The impact of eHealth apps based on the concept of SDM for improving medication-taking behavior and clinical outcomes is yet to be evaluated. Insights will be useful for further development of eHealth apps aimed at improving self-management by means of patient engagement and SDM.

Design and reliability of a specific instrument to evaluate patient safety for patients with acute myocardial infarction treated in a predefined care track: a retrospective patient record review study in a single tertiary hospital in the Netherlands.

OBJECTIVE: Numerous studies have shown that a substantial number of patients suffer from adverse events (AEs) as a result of hospital care. However, specific data on AEs in acute cardiac care are scarce. The current manuscript describes the development and validation of a specific instrument to evaluate patient safety of a predefined care track for patients with acute myocardial infarction (AMI). DESIGN: Retrospective patient record review study. SETTING AND PARTICIPANTS: A total of 879 hospital admissions treated in a tertiary care centre for an AMI (age 64±12 years, 71% male). MAIN OUTCOME MEASURE: In the first phase, the medical records of patients with AMI warranting coronary angiography or coronary intervention were analysed for process deviations. In the second phase, the medical records of these patients were checked for any harm that had occurred which was caused by the healthcare provider or the healthcare organisation (AE) and whether the harm that occurred was preventable. RESULTS: Of all 879 patients included in the analysis, 40% (n=354) had 1 or more process deviation. Of these 354 patients, 116 (33%) had an AE. Patients with AE experienced more process deviations compared with patients without AE (2±1.7 vs 1.5±0.9 process deviations per patient, p=0.005). Inter-rater reliability in assessing a causal relation of healthcare with the origin of an AE showed a κ of 0.67 (95% CI 0.51 to 0.83). CONCLUSIONS: This study shows that it is possible to develop a reliable method, which can objectively assess process deviations and the occurrence of AEs in a specified population. This method could be a starting point for developing an electronic tracking system for continuous monitoring in strictly predefined care tracks.

Antidepressant use and risk for mortality in 121,252 heart failure patients with or without a diagnosis of clinical depression.

BACKGROUND: Depression is a risk factor for mortality in patients with heart failure (HF), however, treating depression with antidepressant therapy does not seem to improve survival. We examined the prevalence of antidepressant use in HF patients, the correlates of antidepressant use subsequent to hospital discharge and the relation between antidepressant use, clinical depression and mortality in patients with HF. METHODS: 121,252 HF patients surviving first hospitalization were stratified by antidepressant use and a diagnosis of clinical depression. RESULTS: In total, 15.6% (19,348) received antidepressants at baseline, of which 86.7% (16,780) had no diagnosis of clinical depression. Female gender, older age, higher socio-economic status, more comorbidities, increased use of statins, spironolactone and aspirin, lower use of beta-blockers and ACE-inhibitors, greater HF severity and a diagnosis of clinical depression were independently associated with antidepressant use. Patients using no antidepressants with clinical depression and patients using antidepressants, with or without clinical depression, had a significantly higher risk for all-cause mortality (HR, 1.25; 95% CI, 1.15-1.36; HR, 1.24; 95% CI, 1.22-1.27; HR, 1.21; 95% CI, 1.16-1.27, respectively) and CV-mortality (HR: 1.17; 95% CI, 1.14-1.20, P<.001; HR: 1.20; 95% CI, 1.08-1.34, P<.001; HR: 1.21; 95% CI, 1.12-1.29, P<.001, respectively) as compared to patients not using antidepressants without depression in adjusted analysis. CONCLUSION: Patients with HF taking antidepressants had an increased risk for all-cause and CV-mortality, irrespectively of having clinical depression. These results highlight the importance of further examining the antidepressant prescription pattern in patients with HF, as this may be crucial in understanding the antidepressant effects on cardiac function and mortality.

Health Status and Psychological Distress in Patients with Non-compaction Cardiomyopathy: The Role of Burden Related to Symptoms and Genetic Vulnerability.

BACKGROUND: Non-compaction cardiomyopathy (NCCM) is a cardiomyopathy characterized by left ventricular tribeculae and deep intertrabecular recesses. Because of its genetic underpinnings and physical disease burden, noncompaction cardiomyopathy is expected to be associated with a lower health status and increase in pscyhological distress. PURPOSE: This study determined the health status and psychological distress in NCCM patients. We also examined the potential contribution of genetic predisposition and cardiac symptoms to health status and distress in NCCM, by comparing NCCM patients with (1) patients with familial hypercholesterolemia (FH) and (2) patients with acquired dilated cardiomyopathy (DCM). METHODS: Patients were recruited from the Erasmus Medical Center, Rotterdam, The Netherlands. Using a case-control design, NCCM patients (N = 45, mean age 46.7 ± 15.1 years, 38 % male) were compared with 43 FH patients and 42 DCM patients. Outcome measures were health status (Short Form Health Survey-12), anxiety (Generalized Anxiety Disorder 7-item scale) and depression (Patient Health Questionnaire 9-item scale). RESULTS: NCCM patients showed significantly worse health status (Physical Component Score F(1,84) = 9.58, P = .003; Mental Component Score F(1,84) = 16.65, P < .001), anxiety (F(1,85) = 9.63, P = .003) and depression scores (F(1,82) = 5.4, P = .023) compared to FH patients, also after adjusting age, sex, comorbidity, educational level and time since diagnosis. However, NCCM patients did not differ from DCM patients (Physical Component Score F(1,82) = 2,61, P = .11; Mental Component Score F(1,82) = .55, P = .46), anxiety (F(1,82) = 1.16, P = .28) and depression scores (F(1,82) = 1,95, P = .17). CONCLUSION: Cardiac symptoms are likely to play a role in the observed poor health status and elevated levels of anxiety and depressive symptoms in NCCM, whereas the burden of having a genetic condition may contribute less to these health status and psychological measures.

A comparison of the health status and psychological distress of partners of patients with a left ventricular assist device versus an implantable cardioverter defibrillator: a preliminary study.

OBJECTIVE: To examine if the caregiving for patients with a left ventricular assist device (LVAD) is related to a poorer health status and more distress compared to patients with an implantable cardioverter defibrillator (ICD). BACKGROUND: Partners distress may influence patient outcomes and is therefore an important aspect in the care of LVAD and ICD patients. METHODS: Multi-center prospective observational study with 6 months follow-up of 33 LVAD partners (27% men; mean age = 54 ± 10 years) and 414 ICD partners (22% men; mean age = 60 ± 12 years). RESULTS: LVAD partners reported better physical (F = 10.71, p = .001) but poorer mental health status (F = 14.82, p < .001) and higher depression scores compared to ICD partners (F = 3.68, p = .05) at 6 months follow-up, also in adjusted analyses. There was no significant difference between groups on anxiety. CONCLUSION: Caregivers of LVAD patients show higher distress levels compared to caregivers of ICD patients. LVAD partners may have a need for support beyond what is offered currently in clinical practice.

Psychological distress in patients with a left ventricular assist device and their partners: an exploratory study.

BACKGROUND: Left ventricular assist device (LVAD) therapy is increasingly used in patients with advanced heart failure, and may have a significant psychological impact on both patients and their partners. Hence, we examined the distress levels of LVAD patients and their partners. METHODS: Anxiety, depression and post-traumatic stress disorder (PTSD) were assessed at 3-4 weeks after implantation, and at 3 and 6 months follow-up in 33 LVAD patients (73% men; mean age=54±10 years) and 33 partners (27% men; mean age=54±11 years). RESULTS: The prevalence of anxiety in LVAD partners was significantly higher compared to LVAD patients at baseline (48% vs. 23%, p=0.03) and 3 months follow-up (44% vs. 15%, p=0.02), but not at 6 months follow-up (p=0.43). No differences were found for depression and PTSD (ps>0.05). Scores between the LVAD patients and partners showed only a significant correlation at baseline between the anxiety, depression and PTSD score of the patient and the depression score of the partner (r anx=0.40, p=0.04; rdep=.40, p=0.04; r PSTD=0.46, p=0.05). Multivariable analyses showed no significant association between the role (patient vs. partner) and anxiety, depression and PTSD over time after correction for age, gender and clinical covariates. However, after correction for Type D personality and the use of psychotropic medication the LVAD partners showed significantly higher anxiety (F=6.95, p=0.01) and depression (F=3.94, p=0.04) scores over time compared to LVAD patients. CONCLUSION: LVAD partners had significantly higher levels of anxiety than LVAD patients. Emotional distress of LVAD partners should gain more attention, as partners are an essential source of support for LVAD patients.

Association between brain natriuretic peptide, markers of inflammation and the objective and subjective response to cardiac resynchronization therapy.

INTRODUCTION: Studies suggest that cardiac resynchronization therapy (CRT) can induce a decrease in brain natriuretic peptide (BNP) and systemic inflammation, which may be associated with CRT-response. However, the evidence is inconclusive. We examined levels of BNP and inflammatory markers from pre-CRT implantation to 14months follow-up in CRT-responders and nonresponders, defined by two response criteria. METHODS: We studied 105 heart failure patients implanted with a CRT-defibrillator (68% men; age=65.4±10.1years). The objective CRT-response was defined as a reduction of ⩾15% in left ventricular end systolic volume; subjective CRT-response was defined as an improvement of ⩾10 points in patient-reported health status assessed with the Kansas City Cardiomyopathy Questionnaire. Plasma BNP and markers of inflammation (CRP, IL-6, TNFα, sTNFr1 and sTNFr2) were measured at three time points. RESULTS: Pre-implantation concentrations of TNFα were significantly lower for subjective responders compared to nonresponders (p=.05), but there was no difference in BNP and the other inflammatory markers at baseline. Objective CRT-response was significantly associated with lower BNP levels over time (F=27.31, p<.001), and subjective CRT-response with lower TNFα levels (F=5.67, p=.019). CONCLUSION: Objective and subjective response to CRT was associated with lower levels of BNP and TNFα, respectively, but not with other markers of inflammation. This indicates that response to CRT is not automatically related to a stronger overall decrease in inflammation. Large-scale studies are warranted that further examine the relation between the clinical effects of CRT on inflammatory markers, as the latter have been associated with poor prognosis in heart failure.

Predictors of changes in health status between and within patients 12 months post left ventricular assist device implantation.

BACKGROUND: Improving patient-reported outcomes (e.g. health status) has become an important goal in left ventricular assist device (LVAD) therapy, in addition to reducing mortality and morbidity. We examined predictors of changes in health status scores between and within patients 12 months post LVAD implantation. METHODS: Health status [Kansas City Cardiomyopathy Questionnaire (KCCQ); Short-Form 12 (SF-12)] were assessed at 3-4 weeks after implantation, and at 3, 6 and 12 months follow up in 54 LVAD patients (74% men; mean age 54 ± 9 years). RESULTS: Patients experienced significant improvements in health status between baseline and 3 months follow-up as assessed by the KCCQ (clinical summary score: F = 33.49, P < 0.001; overall summary score: F = 31.13, P < 0.001) and the SF-12 (physical component score: F = 31.59, P < 0.001; mental component score: F = 21.77, P < 0.001), but not between 3 months and 12 months follow-up (P > 0.05 for all). Higher scores on anxiety and depression over time, older age, lower ejection fraction, and more co-morbidity were associated with poorer health status scores on one or both of the KCCQ and SF-12 subscales. The majority of the between-patient variance of the mental component summary scores (82.6%), but not the KCCQ overall summary score (41.9%), KCCQ clinical summary score (36.2%) and physical component summary scores (23.2%), was explained by the sociodemographic, clinical and psychological factors. CONCLUSION: The majority of LVAD patients show a significant improvement in health status after LVAD implantation. However, there are large differences in individual health status score trajectories which are only partly explained by measures of disease severity pre-LVAD, co-morbidity and psychological stress.

Depressive symptoms in outpatients with heart failure: importance of inflammatory biomarkers, disease severity and personality.

OBJECTIVE: Depressive symptoms are highly prevalent in heart failure (HF) patients, however the underlying etiology of depression in HF patients remains yet unclear. Hence, the goal is to examine the relative importance of inflammation, disease severity and personality as predictors of depression in HF patients. DESIGN: Depressive symptoms (Hospital Anxiety and Depression Scale, depression subscale) were assessed at baseline and one-year follow-up in 268 HF patients (75.6% men; mean age = 66.7 ± 8.7). Markers of inflammation (TNFα, sTNFr1, sTNFr2, IL-6 and IL-10), disease severity (e.g. New York Heart Association (NYHA) classification) and personality (Type D personality, loneliness) were assessed at baseline. RESULTS: At baseline, NYHA class, body mass index, educational level, Type D personality and loneliness were significantly associated with depression. Higher NYHA class (B = 2.25; SE = .83), higher educational level (B = 1.41; SE = .48), Type D personality (B = 2.56; SE = .60) and loneliness (B = .19; SE = .05) were also independently associated with higher depression levels at one-year follow-up (all p-values < .005). Inflammation, brain natriuretic peptide and left ventricular ejection fraction were not related to depression over time. CONCLUSIONS: Personality factors, but not inflammation, were independent concomitants of depressive symptoms in patients with HF. Gaining more insight into the etiology of depression in HF patients is important in order to identify potential targets for novel interventions.

Positive affect dimensions and their association with inflammatory biomarkers in patients with chronic heart failure.

BACKGROUND: In cardiac patients positive affect has found to be associated with improved clinical outcomes, with reduced inflammation being one of the potential mechanisms responsible. METHODS: Positive affect was assessed using The Global Mood Scale (GMS), Positive and Negative Affect Schedule (PANAS), and Hospital Anxiety and Depression Scale (HADS) in patient with chronic heart failure (N=210; 67 ± 9 years, 79% men). Markers of inflammation (TNFα, sTNFr1, sTNFr2, IL-6 and CRP) were measured and averaged at three consecutive time points. RESULTS: The positive affect dimensions of the GMS and PANAS were significantly associated with lower averaged levels of sTNFr2, TNFα and IL-6 (p<.1), even after adjustment for clinical and lifestyle confounders. Positive affect of the HADS was significantly associated with lower averaged levels of hsCRP (p<.1), but was no longer significant after correction for lifestyle confounders and depressive symptoms. CONCLUSION: Positive affect is associated with reduced inflammation in patients with heart failure.

Psychological vulnerability, ventricular tachyarrhythmias and mortality in implantable cardioverter defibrillator patients: is there a link?

Implantable cardioverter defibrillator (ICD) therapy is the first-line treatment for the prevention of sudden cardiac death. Despite the demonstrated survival benefits of the ICD, predicting which patients will die from a ventricular tachyarrhythmia remains a major challenge. So far, psychological factors have not been considered as potential risk markers that might enhance the prediction of sudden cardiac death. This article evaluates the evidence for a link between psychological vulnerability, ventricular tachyarrhythmias and mortality and the pathways that might explain such a link. This review demonstrates that there is cumulative evidence supporting a link between psychological vulnerability and risk of ventricular tachyarrhythmias and mortality in ICD patients independent of disease severity and other biomedical risk factors. It may be premature to include psychological factors in risk algorithms, but information on the psychological profile of the patient may help to optimize the management and care of these patients in clinical practice.

Association between psychological measures and brain natriuretic peptide in heart failure patients.

OBJECTIVE: Brain natriuretic peptide (BNP) is a promising marker for heart failure diagnosis and prognosis. Although psychological factors also influence heart failure (HF) prognosis, this might be attributed to confounding by BNP. Our aim was to examine the association between multiple psychological markers using a prospective study design with repeated N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements. DESIGN: The sample comprised 94 outpatients with systolic HF (80% men; mean age =62.2 ± 9.3). The psychological markers (i.e., anxiety, depression, and Type D personality), assessed with the Hospital Anxiety and Depression Scale (HADS), the Beck Depression Inventory (BDI), and the Type D Scale (DS14) were assessed only at baseline. Plasma NT-proBNP levels were measured at baseline and at 9 months. RESULTS: The prevalence of anxiety, depression, and Type D personality at baseline was 23.4% (HADS-A), 17.0% (HADS-D), 46.6% (BDI), and 21.3% (DS14), respectively. At baseline, none of the psychological risk markers were associated with NT-proBNP levels (all p >.05). In the subset of patients with scores on psychological risk markers both at baseline and at 9 months, there were no association between anxiety (p =0.44), depression (HADS-D: p =0.90; BDI: p =0.85), and Type D (p =0.63) with NT-proBNP levels using ANOVA for repeated measures. CONCLUSIONS: Our findings indicate that measures frequently used in HF to assess psychological risk markers are unconfounded by NT-proBNP. Futher studies are warranted to replicate these findings and examine whether psychological risk markers are independent predictors of prognosis in HF or an artifact that may be attributed to other biological or behavioral mechanisms.

Patient-reported outcomes in left ventricular assist device therapy: a systematic review and recommendations for clinical research and practice.

BACKGROUND: Technological advancements of left ventricular assist devices (LVAD) have created today's potential for extending the lives of patients with end-stage heart failure. Few studies have examined the effect of LVAD therapy on patient-reported outcomes (PROs), such as health status, quality of life, and anxiety/depression, despite poor PROs predicting mortality and rehospitalization in patients with heart failure. In this systematic review, we provide an overview of available evidence on the impact of LVAD therapy on PROs and discuss recommendations for clinical research and practice. METHODS AND RESULTS: A systematic literature search identified 16 quantitative studies with a sample size ≥10 (mean±SD age=50.1±12.6 years) that examined the impact of LVAD therapy on PROs using a quantitative approach. Initial evidence suggests an improvement in health status, anxiety, and depression in the first few months after LVAD implantation. However, PRO scores of patients receiving LVAD therapy are still lower for physical, social, and emotional functioning compared with transplant recipients. These studies had several methodological shortcomings, including the use of relatively small sample sizes, and only a paucity of studies focused on anxiety and depression. CONCLUSIONS: There is a paucity of studies on the patient perspective of LVAD therapy. To advance the field of LVAD research and to optimize the care of an increasingly growing population of patients receiving LVAD therapy, more well-designed large-scale studies are needed to further elucidate the impact of LVAD therapy on PROs.

Gender disparities in psychological distress and quality of life among patients with an implantable cardioverter defibrillator.

A subset of patients with an implantable cardioverter defibrillator (ICD) reports psychological distress and poor quality of life (QoL). Gender is one of the factors that has been proposed to explain individual differences in these outcomes. In this viewpoint, we (1) review the evidence for gender disparities in psychological distress and QoL in ICD patients by means of a systematic review, and (2) provide recommendations for future research and clinical implications. A systematic search of the literature identified 18 studies with a sample size ≥ 100 that examined gender disparities in anxiety/depression and QoL in ICD patients (mean prevalence of women = 21%; mean age = 62 years). Our review shows that there is insufficient evidence to conclude that gender per se is a major autonomous predictor for disparities in psychological distress and QoL in ICD patients. Women had a higher prevalence of anxiety and poorer QoL in some studies, but there was no statistically significant gender effect in relation to 80% (26/32) of the outcomes reported in the 18 studies. Studies are warranted that are designed a priori and sufficiently powered to examine gender disparities in distress and QoL outcomes in order to establish the exact gender-specific effect. Due to a need to explore the complexity of this issue further, at this time, caution is warranted with respect to the clinical implications.