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Background: Patient reported outcome measures (PROMs) such as health status (HS) and quality of life (QOL) are frequently used interchangeably while they represent different outcomes. Whether a discrepancy exists in patients with intermittent claudication (IC) in changes over time between HS and QOL is unclear. This study aimed to investigate the strength and the direction of the association between HS and QOL over time in patients with IC that underwent supervised exercise therapy (SET).Material and methods: Patients were part of the ELECT multi-center prospective cohort study. One goal of this study was to obtain data on HS and QOL at different time intervals of patients with IC that underwent SET. HS (VascuQOL-6) and QOL (WHOQOL-BREF) were completed at baseline, 3 months, and 6 months follow up. Pearson's correlation coefficients and the associated common variances (R2) were calculated to measure the strength and the direction of the association between HS and QOL in changes between baseline and follow-up moments.Results: In total, 177 patients were included in data analyses. Only changes in physical QOL and overall QOL had a small correlation with changes over time in HS, at both 3- and 6 months follow up (respectively R2=.14; P < 0.001 and R2 = 0.12; P < 0.001 for physical QOL and R2 = 0.18; P < 0.001 and R2 = 0.13; P < 0.001 for overall QOL).Conclusions:This study showed that HS and QOL provide different outcomes in patients with IC that underwent SET. Future studies should be aware of these differences before PROMs are being incorporated as an outcome measure in clinical studies.

Background: Longitudinal studies including parental distress when examining adverse health outcomes in adolescents with type 1 diabetes are lacking. This study examined whether parental depression and anxiety predict adolescent emotional distress and glycated hemoglobin A1c (HbA1c) 1 year later and whether a relation between parental distress and HbA1c is mediated by the level of parental involvement in diabetes care and by treatment behaviors.Methods: Longitudinal path modeling was applied to data from 154 adolescents and parents from diabetes centers participating in the Longitudinal study of Emotional problems in Adolescents with type 1 diabetes and their Parents/caregivers (Diabetes LEAP). At baseline and 1-year follow-up, participants completed measures of depression and anxiety. HbA1c was extracted from medical charts. Responsibility and treatment behavior questionnaires were completed by adolescents at baseline.Results: Baseline parental depressive and anxiety symptoms were not associated with 1-year adolescent depressive symptoms, anxiety symptoms, and HbA1c. Responsibility division and treatment behaviors did not mediate associations between parental emotional distress and 1-year HbA1c.Conclusions: Parental depressive and anxiety symptoms did not predict adolescent health outcomes 1 year later. Future studies may determine whether the link is present in case of mood/anxiety disorders or severe diabetes-specific distress, or whether adolescents are resilient in the face of parental distress.Impact: Adolescents with T1D are a vulnerable group in terms of psychological and health outcomes. Whether parental emotional distress (i.e., depressive and anxiety symptoms) is prospectively associated with adolescent emotional distress and/or HbA1c has been understudied. Our results show that parental distress was not related to adolescent distress or HbA1c 1 year later. Responsibility division and treatment behaviors did not mediate associations between parental emotional distress and 1-year HbA1c. Future studies could determine whether these links are present in case of mood/anxiety disorders or severe diabetes-specific distress, or whether adolescents are resilient in the face of parental distress.

Background: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI.Methods: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means.Results: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain.Conclusions: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

Background The course and different characteristics of acute and posttraumatic stress disorder (ASD, PTSD) in trauma populations are unclear. Objective The aims were to identify longitudinal trajectories of PTSD, to establish a risk profile for ASD and PTSD based on patients’ sociodemographic, clinical, and psychological characteristics, and to study the effect of ASD and dissociation on PTSD during 12 months after trauma. Method Patients completed questionnaires after inclusion and at 3, 6, 9, and 12 months afterwards. Trajectories were identified using repeated measures latent class analysis (RMLCA). The risk profile was based on a ranking of importance of each characteristic using Cohen’s d effect sizes and odds ratios. The impact of ASD and dissociation on PTSD was examined using logistic regression analyses. Results Altogether, 267 patients were included. The mean age was 54.0 (SD = 16.1) and 62% were men. The prevalence rate of ASD was approximately 21.7% at baseline, and 36.1% of trauma patients exhibited PTSD at 12 months after injury. Five trajectories were identified: (1) no PTSD symptoms, (2) mild, (3) moderate, (4) subclinical, and (5) severe PTSD symptoms. These trajectories seemed to remain stable over time. Compared with patients in other trajectories, patients with ASD and (subclinical) PTSD were younger and scored higher on anxiety, depressive symptoms, neuroticism, and trait anxiety. Regarding dissociation symptoms, inability to recall memories about the event was significantly more present than an altered sense of reality, (105 (40.7%) versus 56 (21.7%), p = .031), although that symptom had the strongest likelihood for PTSD. Patients with dissociation were significantly at risk for PTSD than patients without dissociation (OR = 4.82; 95%CI: 1.91–12.25). Conclusions Psychological factors characterized ASD and trajectories of PTSD during 12 months post-trauma. Healthcare providers who are aware of these findings could early identify patients at risk for ASD and PTSD and refer them for patient-centred interventions., HIGHLIGHTS Longitudinal trajectories of posttraumatic stress disorder (PTSD) after physical trauma were evaluated.A risk profile for ASD and PTSD was subsequently determined.Overall, only psychological characteristics determined ASD and PTSD.No clinical characteristics were found.

Background: Revascularization is the cornerstone in the treatment of patients with critical limb-threatening ischemia (CLTI). However, the 2-year mortality rate is up to 50% in these patients. Therefore, the clinical benefit of revascularization needs to be considered carefully. The question emerges if there are changes in quality of life (QoL) and health status (HS) in the end-of-life phase of CLTI in older patients.Methods: Patients with CLTI and of an age of 70 years or older were included in a prospective observational cohort study. Treatment consisted of endovascular revascularization, surgical revascularization, or conservative therapy. The follow-up period was 2 years. Within this follow-up period, patients completed the following questionnaires at six specified time intervals: the WHOQOL-BREF and the SF-12. Patients who died within 2 years after inclusion were analyzed. Final scores were defined as the last measurement at end of follow-up or death.Results: Eighty two patients (42.1%) died during the 24-month follow-up. QoL and HS before death did not decrease with treatment (option: endovascular intervention, surgical revascularization, or conservative therapy).Conclusions: Older patients with CLTI and a life expectancy less than 2 years had no differences in QoL and HS before death compared to their previous measurement. Except for the mental HS domain, no differences in the percentage of patients showing significant individual change in QoL and HS were found between the treatments. For clinicians, it is important to use patient-reported outcome measure when discussing treatment for older frail patients with CLTI in a shared decision-making process.

Background: Consequences of sarcoidosis are wide ranging, and the symptom burden has a great impact on patients’ quality of life (QoL). However, the QoL of couples living with sarcoidosis has not yet been studied. Objectives: Our aim was to assess the QoL of couples living with sarcoidosis and to evaluate whether living with a partner with sarcoidosis influences the partner’s QoL. Furthermore, we aimed to assess whether nonspecific symptoms (fatigue, cognitive failure, small fiber neuropathy (SFN)-related symptoms, depressive symptoms, and state/trait anxiety) predict QoL of partners as well as sarcoidosis patients. Method: Sarcoidosis outpatients, recruited at Maastricht University Medical Centre (n = 443), and their partners (n = 208) completed several questionnaires, including the World Health Organization QoL - BREF, Fatigue Assessment Scale, SFN screening list, and cognitive failure questionnaire. Results: QoL of the partners as well as the sarcoidosis patients was reduced compared with healthy controls, especially regarding the physical health domain. All nonspecific symptoms studied, as well as perceived social support, predicted one or more QoL domains in the sarcoidosis patients, but these factors did not predict the QoL of their partners. Conclusions: The QoL of partners of sarcoidosis patients was reduced, although to a lesser extent than that of the patients. Although the nonspecific symptoms and perceived social support were related to the patients’ QoL, this was not the case for the partners. In the management of sarcoidosis, it is important to focus not only on the patients but also on their partners.

Background and Objectives Prevalent Post-traumatic Stress Disorder (PTSD) negatively affected individuals during the COVID-19 pandemic. Using network analyses, this study explored the construct of PTSD symptoms during the COVID-19 pandemic in China to identify similarities and differences in PTSD symptom network connectivity between the general Chinese population and individuals reporting PTSD. Methods We conducted an online survey recruiting 2858 Chinese adults. PTSD symptoms were measured using the PCL-5 and PTSD was determined according to the DSM-5 criteria. Results In the general population, self-destructive/reckless behaviours were on average the most strongly connected to other PTSD symptoms in the network. The five strongest positive connections were found between 1) avoidance of thoughts and avoidance of reminders, 2) concentration difficulties and sleep disturbance, 3) negative beliefs and negative trauma-related emotions, 4) irritability/anger and self-destructive/reckless behaviours, and 5) hypervigilance and exaggerated startle responses. Besides, negative connections were found between intrusive thoughts and trauma-related amnesia and between intrusive thoughts and self-destructive/reckless behaviours. Among individuals reporting PTSD, symptoms such as flashbacks and self-destructive/reckless behaviours were on average most strongly connected to other PTSD symptoms in the network. The five strongest positive connections were found between 1) concentration difficulty and sleep disturbance, 2) intrusive thoughts and emotional cue reactivity, 3) negative beliefs and negative trauma-related emotions, 4) irritability/anger and self-destructive/reckless behaviour, and 5) detachment and restricted affect. In addition, a negative connection was found between intrusive thoughts and self-destructive/reckless behaviours. Conclusion Our results indicate similarly positive connections between concentration difficulty and sleep disturbance, negative beliefs and negative trauma-related emotions, and irritability/anger and self-destructive/reckless behaviours in the general and PTSD-reported populations. We argue that self-destructive/reckless behaviours are a core symptom of COVID-19 related PTSD, worthy of more attention in future psychiatric programmers., HIGHLIGHTS The most central symptom for the general group was self-destructive/reckless behaviours and for the PTSD subgroup was flashbacks.Results matched the hybrid model of PTSD and were important for prevention and intervention for PTSD related to COVID-19.

Chloé ML Peters,1 Paul Lodder,2,3 Jolanda de Vries,2,4 Stijn L Steunenberg,1 Eelco J Veen,1 Hans GW de Groot,1 Gwan H Ho,1 Lijckle van der Laan1,5 1Department of Surgery, Amphia Hospital, Breda, The Netherlands; 2Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; 3Department of Methodology and Statistics, Tilburg University, Tilburg, The Netherlands; 4Department of Medical Psychology, Elisabeth-TweeSteden Hospital Tilburg University, Tilburg, The Netherlands; 5Department of Cardiovascular Science, UZ Leuven - University Hospitals, Leuven, BelgiumCorrespondence: Lijckle van der LaanAmphia Hospital, Molengracht 21, Breda, CK 4818, the NetherlandsTel +31 76 595 5000Email lvanderlaan@amphia.nlPurpose: In elderly patients with chronic limb-threatening ischemia (CLTI), there is little scientific understanding of the long-term changes of quality of life (QoL) and health status (HS) after treatment. The primary goal of this study was to provide long-term QoL and HS results for elderly CLTI patients after therapy. Treatments consisted of endovascular revascularization, surgical revascularization, or conservative treatment. Furthermore, the aim of this study was to identify the distinctive trajectories of QoL and HS.Patients and Methods: CLTI patients aged ≥ 70 years were included in a prospective observational cohort study with a two-year follow-up. The WHOQOL-BREF was used to asses QoL. The 12-Item Short Form Health Survey was used to measure HS. The QoL and HS scores were compared to the scores in the general elderly Dutch population. Latent class trajectory analysis was used.Results: A total of 195 patients were included in this study. After two years, in all treatment groups patients showed significantly higher physical QoL score compared to baseline and there was no significant difference with the corresponding values in the elderly Dutch population. In the latent class trajectory analysis, there were no overlapping risk factors for poorer QoL or HS.Conclusion: This study shows that QoL levels in surviving elderly CLTI patients in the long-term do not differ from the corresponding values for elderly in the general population. There were no disparities in sociodemographic, clinical and treatment characteristics associated with poorer QoL and HS. This study was carried out to encourage further analysis of the influence of biopsychosocial characteristics on QoL and HS in elderly CLTI patients.Keywords: quality of life, health status, peripheral arterial disease, frail elderly, chronic limb-threatening ischemia

ObjectiveUnhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time.MethodsCardiac patients (n = 150; mean age = 61.97 +/- 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the "Do CHANGE 2" or "care as usual" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis.ResultsLinear mixed-model analysis showed significant intervention effects for life-style behavior (F-interaction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible.ConclusionsThe personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit.Trial registration: https//clinicaltrials.gov/ct2/show/NCT03178305

Introduction: Revascularization is the cornerstone of the treatment of critical limb ischemia (CLI), but the number of elderly frail patients increase. Revascularization is not always possible in these patients and conservative therapy seems to be an option. The goals of this study are to analyze the 1-year quality of life (QoL) results and mortality rates of elderly patients with CLI and to investigate if conservative treatment could be an acceptable treatment option. Methods: Patients with CLI ≥70 years old were included in a prospective observational cohort study in 2 hospitals in the Netherlands between 2012 and 2016 and were divided over 3 treatment modalities: endovascular therapy, surgical revascularization, and conservative treatment. The World Health Organization Quality of Life (WHOQoL-Bref) instrument, a generic QoL assessment tool that includes components of physical, psychological, social relationships and environment, was used to evaluate QoL at baseline, 6 months, and 1 year. Results: In total, 195 patients (56% male, 33% Rutherford 4, mean age of 80) were included. Physical QoL significantly increased after surgical (10.4 vs 14.9, P < .001), endovascular (10.9 vs 13.7, P < .001), and conservative therapy (11.6 vs 13.2, P = .01) at 1 year. One-year mortality was relatively low after surgery (10%) compared to endovascular (40%) and conservative therapy (37%). Conclusion: The results of this study could not be used to designate the superior treatment used in elderly patients with CLI. Conservative treatment could be an acceptable treatment option in selected patients with CLI unfit for revascularization. Treatment of choice in elderly patients with CLI is based on multiple factors and should be individualized in a shared decision-making process.

BACKGROUND: Knowledge of the level of healthcare utilization (HCU) and the predictors of high HCU use in patients with an implantable cardioverter defibrillator (ICD) is lacking. We examined the level of HCU and predictors associated with increased HCU in first-time ICD patients, using a prospective study design.METHODS: ICD patients (N = 201) completed a set of questionnaires at baseline, 3-, 6-, and 12 months after inclusion. A hierarchical multiple linear regression with 3 models was performed to examine predictors of HCU.RESULTS: HCU was highest between baseline and 3 months post-implantation and gradually decreased during 12 months follow-up. During the first year post implantation, only depression (β = 0.342, p = 0.002) was a significant predictor. Between baseline and 3 months follow-up, younger age (β = -.220, p < .01), NYHA class III/IV (β = .705, p = .01), and secondary indication (β = .148, p = .05) were independent predictors for increased HCU. Between 3 and 6 months follow-up, younger age (β = -.151, p = .05) and depression (β = .370, p < .001) predicted increased HCU. Between 6 and 12 months only depression (β = 0.355, p = 0.001) remained a significant predictor.CONCLUSIONS: Depression was an important predictor of increased HCU in ICD patients in the first year post implantation, particularly after 3 months post implantation. Identifying patients who need additional care and provide this on time might better meet patients' needs and lower future healthcare utilization. This article is protected by copyright. All rights reserved.

ObjectivesA patient-oriented appraisal of treatment has become extremely important, particularly in elderly patients with critical limb ischaemia (CLI). Quality of life (QoL) is an important patient-reported outcome in vascular surgery. Frequently, the physical domain of QoL questionnaires represents an ‘objective’ evaluation of performing activities, which is expected to be impaired after major limb amputation. However, an objective appraisal of physical function is an assessment of health status (HS) and not of QoL. Little is known about the subjective appraisal of physical health (QoL). The goal of this study was to evaluate, prospectively, QoL in relation to HS in elderly CLI patients undergoing major limb amputation.MethodsPatients suffering from CLI aged 70 years or older were included in a prospective observational cohort study with a follow-up period of 1 year. Patients were divided according to having had an amputation or not. The World Health Organization Quality Of Life-BREF (WHOQOL-BREF) was used to asses QoL. The 12-Item Short Form Health Survey (SF-12) was used to measure HS. These self-reported questionnaires were completed five times during follow-up.ResultsTwo-hundred patients were included of whom 46 underwent a major limb amputation within one year. Amputees had a statistically significant improvement of their physical QoL after six months (14.0 vs. 9.0 (95% CI -7.84;-1.45),p = 0.005) and after a one-year follow-up (14.0 vs. 9.0 (95% CI -9.58;-1.46),p = 0.008). They did not however show any statistically significant difference in HS. For non-amputees, both physical QoL and HS improved. An instant statistically significant improvement of the physical QoL appeared 1 week after inclusion (12.0 vs. 10.9 (95% CI -1.57;-0.63),pConclusionsThere is a clear difference between patients' functioning (HS) and the patients' appraisal of functioning (QoL). In elderly CLI patients, this study clearly suggests a discrepancy between the physical QoL (WHOQOL-BREF) and HS (SF-12) measurements in vascular amputees. This raises the question, which outcome measurement is the most relevant for elderly CLI patients. Individual treatment goals should be kept in mind when assessing the HS or QoL outcome of patients undergoing hospital care. With respect to shared decision making, distinctive and subjective QoL questionnaires, like the WHOQOL-BREF, provide a very important outcome measurement and should be used in future research.

PurposePrevious research reported conflicting findings regarding the association of sociodemographic and clinical variables with expectations for surgical outcomes. The current study aimed to identify and characterize different subgroups of osteoarthritis patients with respect to amount and level of expectations, and to examine factors that are associated with expectations.MethodsHip and knee patients (n = 287) completed a questionnaire 1 week post consultation. Linear regression analyses were performed to examine whether sociodemographic (e.g., age, sex) and clinical factors (e.g., pain, function) were associated with expectations. Latent class analysis (LCA) was used to identify different subgroups and the step 3 method was conducted to assess subgroup characteristics. ResultsMean age of patients was 70 years (SD = 8) and 57% of patients was female. Most improvement was expected in walking ability and pain relief. Higher expectations were associated with younger age, male sex, and functional disability. Both hip and knee patients could be classified into three subgroups. These subgroups differed significantly on pain and other symptoms, and functional disability. ConclusionBoth hip and knee patients reported pain and other osteoarthritis symptoms and functional disability and consequently had high expectations in these areas for treatment outcomes. Higher expectations were characterized by more pain, more symptoms and more functional disability. These insights could guide physicians in the discussion of expectations during consultation.

Background Identification of patient-related factors associated with Health-Related Quality of Life (HRQoL) and Quality of Life (QoL) at the start of treatment may identify patients who are prone to a decrease in HRQoL and/or QoL resulting from chemotherapy. Identification of these factors may offer opportunities to enhance patient care during treatment by adapting communication strategies and directing medical and psychological interventions. The aim was to examine the association of sociodemographic factors, personality traits, and depressive symptoms with HRQoL and QoL in patients with advanced-stage lung cancer at the start of chemotherapy. Methods Patients (n = 151) completed the State-Trait Anxiety Inventory (trait anxiety subscale), the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI), the Center for Epidemiologic Studies Depression (CES-D), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Simple linear regression analyses were performed to select HRQoL and QoL associated factors (a P ≤ 0.10 was used to prevent non-identification of important factors) followed by multiple linear regression analyses (P ≤ 0.05). Results In the multiple regression analyses, CES-D score (β = − 0.63 to − 0.53; P-values P-values P-values P = 0.02, Environment: β = − 0.39; P = 0.007) and conscientiousness (Physical health: β = 0.20; P-value Conclusions Higher scores on depressive symptoms and ECOG performance status were related to lower HRQoL and QoL in patients with advanced-stage non-small cell lung cancer. Supportive care interventions aimed at improvement of depressive symptoms and performance score may facilitate an increase of HRQoL and/or QoL during treatment.

ObjectiveIn research on Type D personality, its subcomponents negative affectivity (NA) and social inhibition (SI) are hypothesized to have a synergistic effect on various medical and psychosocial outcomes. As some methods to analyze Type D personality have been criticized, this study investigated whether these methods adequately detect a Type D effect.MethodWe used a simulation and two empirical illustrations to investigate each method's performance (bias, power and false positives) in detecting the Type D effect.ResultsOur simulation showed that the two most commonly used methods to assess the Type D effect (subgroup methods) were primarily picking up the presence of NA or SI main effects, indicating that these methods might falsely suggest synergistic Type D effects. Moreover, these methods failed to detect the combined presence of the NA and SI main effects, resulting in significant Type D effects when only one of the NA/SI main effects was present. The method that best detected Type D effects modeled the continuous NA/SI main effects and their statistical interaction in a regression analysis. Reanalysis of two empirical Type D personality datasets confirmed the patterns found in our simulation.ConclusionThis study showed that Type D effects should be modeled with a continuous interaction approach. Other approaches showed either more bias, more false positive findings or lower power. We recommend against using subgroup approaches to operationalize Type D personality, as these methods are biased, regardless of whether the Type D effect is synergistic or additive in nature.

Purpose: In lung cancer, the preservation of well-being is warranted given the limited prognosis. Chemotherapy may negatively influence health-related quality of life (HRQoL) due to adverse events. However, patients' judgement about this negative impact is not well understood. We examined the relationship between expectations, feelings about side effects, and satisfaction with therapy and (HR)QoL in advanced-stage thoracic cancer and investigated which of these factors has the highest impact on (HR)QoL.Methods: Sixty-nine patients completed the Cancer Therapy Satisfaction Questionnaire (CTSQ), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Multiple regression analyses were performed to investigate the relation of the CTSQ domains (i.e., expectations of therapy, feelings about side effects, satisfaction with therapy) with (HR)QoL and simple regression analyses to identify the factors of the CTSQ domain that was most often associated with (HR)QoL.Results: Feelings about side effects were associated with the (HR)QoL domain/scale scores (i.e., WHOQOL-BREF domains: β = 0.36 to 0.58; EORTC QLQ-C30 scales: β = 0.33 to 0.61) except social relationships of the WHOQOL-BREF. Low-grade adverse events were related to feelings about side effects (β = - 0.326; P = 0.007).Conclusions: Patients experiencing negative feelings about side effects have worse (HR)QoL. Additional care should be provided to prevent low-grade adverse events.

Background Psychological factors are associated with an increased risk of developing ischemic heart disease ( IHD ). Women more often report psychological factors, and sex and gender differences are present in IHD . In this meta‐analysis we examine the risks of psychological factors for IHD incidence in women and men. We hypothesize that a broad range of psychological factors are related to a higher risk for incident IHD , with a higher risk for women. Methods and Results PubMed, EMBASE , and Psyc INFO were searched for studies assessing the risk between psychological factors and incident IHD . Psychological factors included depression, anxiety or panic disorder, social support, hostility, anger, personality (type D), type A behavior pattern, posttraumatic stress disorder, and psychological distress. In the primary analyses, 62 studies (77 separate reports) that included 2 145 679 women and 3 119 879 men and reported confounder‐adjusted hazard ratios or relative risks were included. Pooled effect confounder‐adjusted estimates from random‐effects models showed that psychological factors (all combined) were associated with incident IHD in women (hazard ratio: 1.22; 95% CI , 1.14–1.30) and men (hazard ratio: 1.25; 95% CI , 1.19–1.31). No sex and gender differences were found for these pooled effect estimates ( P =0.547). Conclusions Psychological factors are associated with incident IHD in both women and men, but no significant differences were observed between women and men. IHD is predominantly being studied as obstructive coronary artery disease, which is more prevalent in men. Data are needed on psychological predictors and other manifestations of IHD such as coronary microvascular disease, which is more common in women.

Background:Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure.Mehods:VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. NewOVCFs and further vertebral height loss were assessed at 3, 6, and 12 months.Results:After a median follow-up of 12 months (interquartile range (IQR) = 12-12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (χ2(1) = 0.83, p = 0.36, OR = .71, 95%CI = 0.33-1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (χ2(1) = 28.85, p Conclusions:The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protectsagainst progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs.

Background: In patients with critical limb ischemia, an association is assumed between depression and worse outcome for morbidity, such as major limb amputation. After major amputation, anxiety and depression are common. We aimed to determine the association of depressive and anxiety symptoms in the elderly with critical limb ischemia, especially after major limb amputation.Methods: Patients with critical limb ischemia aged >= 70 years were included in this prospective observational cohort study between January 2012 and February 2016 in 2 Dutch hospitals. After a multidisciplinary vascular conference, patients were divided into 4 treatment groups: endovascular revascularization, surgical revascularization, conservative therapy, and primary major amputation. In a 1-year follow-up period, depression and anxiety were measured 4 times using the Dutch versions of the Center for Epidemiological Studies Depression Scale and the State-Trait Anxiety Inventory.Results: One Hundred eighty-seven patients were included. Within 1 year, 44 patients underwent a major limb amputation. Lower amputation-free survival did not differ significantly for patients with versus without greater anxiety (X-2 [1] = 0.689, P = 0.407) and also not for patients with versus without more depressive symptoms (X-2 [1] = 0.614, P = 0.433). For both groups, there were no significant changes in anxiety scores over time. After a median follow-up time of 336.5 days and 365 days, depressive symptoms significantly decreased in amputees, respectively, 8.5 vs. 4.5 (95% CI 1.76-7.48, P = 0.002) and 8.5 vs. 4.3 (95% CI 0.61-9.82, P = 0.027) when compared to the baseline measurement. Similarly, nonamputees had significantly lower overall score for depressive symptoms after a median follow-up time of 365 days (10.1 vs. 4.1, 95% CI 4.49 to 6.90, P Conclusions: In the opinion of the medical health care provider, amputation is a severe and unwanted end phase of critical limb ischemia. However, depressive symptoms seem to decrease over time and anxiety symptoms do not seem to be affected in patients after major limb amputation. In addition, patients with greater trait anxiety or more depressive symptoms at baseline did not have significantly higher amputation rates. These findings are similar to the course of depressive and anxiety symptoms for the elderly patients without major limb amputation.

ObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.Main outcome measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up.ResultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.ConclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures.

BackgroundTo determine the psychometric properties and minimal clinically important differences (MCIDs) of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) in advanced stage lung cancer patients.MethodsPatients (n = 153) completed the WHOQOL-BREF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Confirmatory factor analysis (CFA) was performed and reliability and construct validity determined. MCIDs were estimated with two distribution-based methods (0.5 standard deviation (SD) and 1 standard error of measurement (1 SEM)).ResultsCFA confirmed WHOQOL-BREF domain structure. All domains demonstrated good internal consistency (α > 0.70), except Social Relationships (α = 0.57). Nineteen of the 24 WHOQOL-BREF items had correlations of ≥ 0.40 with their intended domain. Four items had higher correlations with a domain other than their intended domain. Moderate to strong correlations were observed for corresponding domains of the two questionnaires, except for the social domains (r = 0.07). For 0.5 SD, MCIDs ranged from 0.88 to 1.55, and for 1 SEM MCIDs ranged from 1.76 to 2.72.ConclusionsThe WHOQOL-BREF has satisfactory psychometric properties in patients with advanced stage lung cancer, whereas the observed MCIDs provide a method for interpretation of scores.

Background: Revascularization to relieve ischemic pain and prevent limb loss is the cornerstone of critical limb ischemia (CLI) treatment; however, not all elderly patients are deemed fit for revascularization. Patient-related outcome measurements are important in these patients. Quality of life (QoL) results regarding the effect of endovascular, surgical, and conservative treatment on the QoL in the elderly are scarce in the current literature. The goal of this study was to explore the outcomes of the different treatment modalities in elderly patients suffering from CLI, with a specific focus on QoL.Methods: A total of 195 CLI patients >= 70 years were prospectively included between January 2012 and February 2016 and divided into 6 groups (endovascular revascularization, surgical revascularization, and conservative treatment). Two age groups (70-79 and >80 years) were analyzed. Follow-up was performed at 5-7 days, 6 weeks, and 6 months. World Health Organization Quality of Life-BREF questionnaire was used to determine QoL. The Vasculare Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity score was noted. QoL was used as the primary end point, with mortality and limb salvage as the secondary end points.Results: Six-month mortality was significantly lower in surgically treated patients aged 70-79 years (4%) as compared with endovascular (24%, P = 0.001) or conservative treatment (25%, P = 0.02). There was no significant difference in 6-month mortality in patients >80 years among endovascularly (38%), surgically (15%), and conservatively treated patients (27%). QoL significantly increased at all follow-up moments in surgically treated patients between 70 and 79 years and at 6 months in endovascularly treated patients. Conservatively treated patients did not improve their QoL in this age group. All patients aged >80 years, including conservatively treated patients, showed significantly improved QoL results at 6 months.Conclusions: Elderly patients judged fit for surgery may benefit the most from surgical revascularization, reporting low mortality rates, low adverse events and significantly gained QoL in multiple domains. However, all 3 treatment modalities have significantly increased physical health at 6 months. Conservative therapy seems to be an acceptable treatment option in patients unfit for revascularization with gained physical health at 6 months.