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Background European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries. Methods A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test–retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL. Discussion The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe. Trial registration ClinicalTrials.gov Identifier: NCT05947903, 2023–06-28.

Anorexia nervosa (AN) is an eating disorder that most frequently afflicts females in adolescence. In these subjects, cardiovascular complications are the main cause of morbidity and mortality. Aim of this review is to analyze the hemodynamic, pro-arrhythmic and structural changes occurring during all phases of this illness, including re-feeding. A systematic literature search was performed on studies in the MEDLINE database, from its inception until September 2017, with PUBMED interface focusing on AN and cardiovascular disease. This review demonstrated that the most common cardiac abnormalities in AN are bradycardia and QT interval prolongation, which may occasionally degenerate into ventricular arrhythmias such as Torsades des Pointes or ventricular fibrillation. As these arrhythmias may be the substrate of sudden cardiac death (SCD), they require cardiac monitoring in hospital. In addition, reduced cardiac mass, with smaller volumes and decreased cardiac output, may be found. Furthermore, mitral prolapse and a mild pericardial effusion may occur, the latter due to protein deficiency and low levels of thyroid hormone. In anorectic patients, some cases of hypercholesterolemia may be present; however, conclusive evidence that AN is an atherogenic condition is still lacking, although a few cases of myocardial infarction have been reported. Finally, refeeding syndrome (RFS), which occurs during the first days of refeeding, may engender a critically increased risk of acute, life-threatening cardiac complications.

Myostatin (Mstn) is a skeletal muscle growth inhibitor involved in metabolic disorders and heart fibrosis. In this study we sought to verify whether Mstn is also operative in atherosclerosis of abdominal aorta. In human specimens, Mstn expression was almost absent in normal vessels, became detectable in the media of non-progressive lesions and increased with the severity of the damage. In progressive atherosclerotic lesions, Mstn was present in the media, neointima, plaque shoulder and in infiltrating macrophages. Mstn co-localized with α-smooth muscle actin (α-SMA) staining and with some CD45+ cells, indicating Mstn expression in VSMCs and bloodstream-derived leukocytes. In vitro , Mstn was tested in VSMCs and monocytes. In A7r5 VSMCs, Mstn downregulated proliferation and Smoothelin mRNA, induced cytoskeletal rearrangement, increased migratory rate and MCP-1/CCR2 expression. In monocytes (THP-1 cells and human monocytes), Mstn acted as a chemoattractant and increased the MCP-1-dependent chemotaxis, F-actin, α-SMA, MCP-1 and CCR2 expression; in turn, MCP-1 increased Mstn mRNA. Mstn induced JNK phosphorylation both in VSMCs and monocytes. Our results indicate that Mstn is overexpressed in abdominal aortic wall deterioration, affects VSMCs and monocyte biology and sustains a chronic inflammatory milieu. These findings propose to consider Mstn as a new playmaker in atherosclerosis progression.

PurposeExplore clinical factors associated with higher pain intensity and future pain in patients with bone metastases to identify patients who can benefit from closer follow-up or pain-modifying interventions.MethodsThis is a secondary analysis of 606 patients with bone metastases included in a multicenter longitudinal study. The dependent variables were “average pain” and “worst pain” in the last 24 h (0–10 NRS). Twenty independent variables with potential association to pain intensity were selected based on previous literature. Cross-sectional analyses were performed with multiple linear regression to explore factors associated with pain intensity at baseline. Longitudinal data were analyzed with a generalized equation models to explore current factors associated with pain intensity at the next visit in 1 month.ResultsCurrent pain intensity (p < 0.001), sleep disturbances (p 0.01 and 0.006), drowsiness (p 0.003 and 0.033) and male gender (p 0.045 and 0.001) were associated with higher average and worst pain intensity in 1 month. In addition, breakthrough pain was related to higher worst pain intensity (p 0.003) in 1 month. The same variables were also associated with higher average pain intensity at baseline.ConclusionHigher current pain intensity, sleep disturbances, drowsiness, male gender, and breakthrough pain are factors associated with higher pain intensity in patients with bone metastases at the next follow-up in 1 month. These factors should be assessed in clinical practice and may aid clinicians in identifying patients that can benefit from closer follow-up or interventions to prevent lack of future pain control.Trial registration in clinicaltrials.govNCT01362816.

This study aims to propose an initial development of the FACT-Liver Transplant (FACT-LT) scale to assess the major physical and emotional concerns of patients before and after Orthotopic Liver transplant (OLT) due to acute and chronic liver failure and hepatocellular carcinoma. The FACT-LT was developed in two phases. In Phase I, items were generated: 1) through interviews with 10 OLT experts and 15 candidates for or recipients of both oncological and non-oncological OLT which identified relevant topics; 2) from the FACIT item bank. In Phase II, a questionnaire to assess item frequency, applicability, and comprehension was administered to 20 OLT experts and, to assess item difficulty, embarrassment and content irrelevance, to 30 transplant recipients or candidate patients (15 oncological, 15 non-oncological). In Phase I, 44 items were formulated/reviewed, and 30 items were maintained. All the healthcare professionals interviewed rejected the recommendation to develop two different modules for cancer and non-cancer patients. In Phase II, the majority of the experts and patients expressed an overall satisfaction with the questionnaire, indicating that the items were relevant, comprehensible and not embarrassing (range 75% - 99%). The first version of the FACT-LT includes 28 items defining four QOL domains: 5 items relating to Physical Well-Being, 8 to Functional Well-Being, 13 to Emotional Well-Being, and 2 to Social/Family Well-Being. The preliminary results obtained were promising; however further studies are needed, in order to proceed with a FACT-LT validation process.

We examined the contribution of arterial wave reflection to early abnormalities in left ventricular relaxation, whether this association was modified by gender or hypertension and the role of reflected wave timing and amplitude. We studied a cohort of normotensive and untreated essential hypertensive Taiwanese participants (675 men, 601 women, mean age 52 years). Doppler flow and applanation tonometry were performed to assess carotid–femoral pulse wave velocity (PWV) and augmentation index (AI). Diastolic parameters including the ratio between the peak velocity of early and late diastolic mitral inflow (E/A), E-deceleration time and left atrial (LA) diameter were measured by echocardiography. In multivariate models predicting E/A, women were more likely to have lower E/A than men ( β =−0.08, P <0.001). AI was significantly associated with lower E/A in both men ( β =−0.09, P =0.005) and women ( β =−0.12, P <0.001) independent of PWV. Inclusion of AI in the overall model reduced the gender difference in E/A by 61% and rendered it nonsignificant. There was a significant interaction between AI and hypertension ( P =0.02). The inverse association between AI and E/A was significant only in normotensive men and women, and only for the amplitude but not timing of the reflected wave. In conclusion, the contribution of wave reflection to left ventricular diastolic dysfunction was independent of arterial stiffness, more pronounced in normotensive individuals and explained a significant portion of the gender difference in diastolic function.

Objective The first instruments developed to evaluate specific logotherapeutic dimensions were the Purpose In Life (PIL) and the Seeking Of Noetic Goals (SONG) tests, designed to reflect Frankl's concepts of, respectively, meaning in life attainment and will to meaning. This study aims to perform the Italian cultural adaptation and the psychometric validation of the PIL and SONG questionnaires. Methods We administered the PIL and SONG, culturally adapted into the Italian language, to 266 cancer patients. The psychometric validation appraised construct validity, internal consistency, test–retest reliability, known-group validity, and convergent validity of the two questionnaires with respect to one another. Results The factorial analysis indicates that the original single-factor solution can be maintained for both instruments (proportion of variance explained by the first factor 77% and 71% for the PIL and SONG, respectively). The results show excellent internal consistency (Cronbach's alpha of 0.91 for the PIL and 0.90 for the SONG) and test-retest reliability (intraclass correlation coefficient of 0.92 for the PIL and 0.81 for the SONG). As expected, males, believers, patients nearer to the diagnosis, and patients not undergoing psychological therapy have higher PIL and lower SONG scores, while expectations for age were not confirmed. The average level for the PIL was 107.3, while for the SONG, it was 66.1, and a negative correlation (−0.47) between PIL and SONG scores indicates good convergent validity of the two instruments. Conclusion Italian versions of the PIL and SONG are adequate and reliable self-report instruments for evaluating purpose in life and the motivation to find purpose for cancer patient populations.

Background: In clinical practice the major role of opioid drugs is the management of malignant and nonmalignant pain. The primary aim of this study is to evaluate the trend in sales of four opioid analgesic drugs (codeine, tramadol, morphine, fentanyl), from wholesalers to community pharmacies, as an indicator of opioid consumption in nine European countries in 2001, 2002 and 2003. Secondary aims are to compare: (a) the amount of each drug purchased by different countries in 2003; (b) the average price for each drug in the different countries in 2003; and (c) the total expenditure for each opioid from 2001 to 2003. Methods: Data from the Statistical Report on drugs purchased by pharmacies was supplied by IMS Health, an internationally accepted information provider for the pharmaceutical and health care industries. Finding: In the period 2001-2003, while the percentage increase of purchases of fentanyl and tramadol was considerable, that of morphine was the lowest in most of the nine countries. The largest consumer of codeine was the UK and of tramadol was Belgium. The consumption of morphine was the lowest reported in all the countries together and was three times lower than that of transdermal fentanyl. There was a high variability in the costs of the opioids among the different countries. In 2003, the total expenditure on fentanyl reached the total expenditure on tramadol, followed by codeine. Morphine presents the lowest expenditure in all nine countries and over all three years. Interpretation: These results open up many questions. What factors influence opioid purchasing and costs in these European countries? It would be interesting to have the answers from those people who know the actual situation in the individual countries.

Palliative care (PC) services and patients differ across countries. Data on PC delivery paired with medical and self-reported data are seldom reported. Aims were to describe (1) PC organisation and services in participating centres and (2) characteristics of patients in PC programmes. This was an international prospective multicentre study with a single web-based survey on PC organisation, services and academics and patients' self-reported symptoms collected at baseline and monthly thereafter, with concurrent registrations of medical data by healthcare providers. Participants were patients ≥18 enrolled in a PC programme. 30 centres in 12 countries participated; 24 hospitals, 4 hospices, 1 nursing home, 1 home-care service. 22 centres (73%) had PC in-house teams and inpatient and outpatient services. 20 centres (67%) had integral chemotherapy/radiotherapy services, and most (28/30) had access to general medical or oncology inpatient units. Physicians or nurses were present 24 hours/7 days in 50% and 60% of centres, respectively. 50 centres (50%) had professorships, and 12 centres (40%) had full-time/part-time research staff. Data were available on 1698 patients: 50% females; median age 66 (range 21-97); median Karnofsky score 70 (10-100); 1409 patients (83%) had metastatic/disseminated disease; tiredness and pain in the past 24 hours were most prominent. During follow-up, 1060 patients (62%) died; 450 (44%) <3 months from inclusion and 701 (68%) within 6 months. ANOVA and χ tests showed that hospice/nursing home patients were significantly older, had poorer performance status and had shorter survival compared with hospital-patients (p<.0.001). There is a wide variation in PC services and patients across Europe. Detailed characterisation is the first step in improving PC services and research. ClinicalTrials.gov Identifier: NCT01362816.

Background Polymyalgia rheumatica (PMR) is an inflammatory disorder of the elderly, characterized by pain and stiffness in the shoulder and pelvic girdles. It can be isolated or associated with giant cell arteritis (GCA). Similar to other inflammatory rheumatic disorders, PMR is associated with an increased cardiovascular risk, which may result in aortic aneurysms and dissections. Objectives to investigate the relationship between inflammatory involvement of the ascending aorta and its possible dilatation. Methods 24 PMR patients (19 females), of whom 4 had also giant cell arteritis, underwent standardized history and clinical examination, including cardiovascular risk factors (CRFs), and transthoracic echocardiography. 20/24 patients underwent also simultaneous FDG-Positron Emission/Computed Tomography (PET/CT). Patients were compared with 24 controls, without inflammatory conditions, matched for age, sex and CRFs (family history of early cardiovascular events, hypertension, dyslipidemia, diabetes mellitus, smoking, alcohol, obesity and a sedentary lifestyle). The echocardiographic parameters were evaluated according to the American Society of Echocardiography recommendations. FDG uptake in joint and vascular regions was semi-quantitatively scored relative to liver uptake as 0=no uptake present, 1=lower than liver uptake, 2=similar to liver uptake, 3=higher than liver uptake. All the values were further subdivided into “positive” (scores 2 and 3) and “negative” (scores 0 and 1). Results patients and controls did not differ for age, gender, and cardiovascular risk factors. Ten patients (50%) showed vasculitis of the thoracic aorta at PET/CT scan. Echocardiographic results are summarized in table 1. Aortic regurgitation was significantly more frequent and the mean regurgitation grade of the aortic valve was significantly greater in patients than in controls. Patients with vasculitis tended to have more regurgitation (p=0.07). Left atrium diameter, left ventricular end-diastolic diameter and inter-ventricular septum thickness were significantly higher in controls than in PMR patients (p=0.005, p=0.014, and p=0.0036, respectively). Within the PMR group, no correlation was found between echocardiographic changes and demographic data, PMR variables, and type of treatment. TABLE 1. Echocardiographic findings of the study population. AAO: abdominal aorta; AsAO: ascending aorta; AOArch: Aortic Arch; LA: left atrium; PAPS: pulmonary artery systolic pressure; LVEDD: left ventricular end-diastolic dimension; LVESD: left ventricular end-systolic dimension; IVST: interventricular septum thickness; PWD: posterior wall thickness; LVEF: left ventricular ejection fraction. Conclusions PMR patients showed more frequent and more severe aortic valve regurgitation than matched controls. Aortic regurgitation could be due to an initial inflammatory annular dilatation, because no significant deterioration of the valve leaflets was observed. Controls showed increased heart volumes, a fact that could be ascribed to their being referred to the cardiologist. In conclusion, our results suggest that PMR patients may show early signs of aortic dilatation at the annular level. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3255