Measuring in-hospital quality multidimensionally by integrating patients', kin's and healthcare professionals' perspectives: development and validation of the FlaQuM-Quickscan.

BACKGROUND: Measuring quality is essential to drive improvement initiatives in hospitals. An instrument that measures healthcare quality multidimensionally and integrates patients', kin's and professionals' perspectives is lacking. We aimed to develop and validate an instrument to measure healthcare quality multidimensionally from a multistakeholder perspective. METHODS: A multi-method approach started by establishing content and face validity, followed by a multi-centre study in 17 Flemish (Belgian) hospitals to assess construct validity through confirmatory factor analysis, criterion validity through determining Pearson's correlations and reliability through Cronbach's alpha measurement. The instrument FlaQuM-Quickscan measures 'Healthcare quality for patients and kin' (part 1) and 'Healthcare quality for professionals' (part 2). This bipartite instrument mirrors 15 quality items and 3 general items (the overall quality score, recommendation score and intention-to-stay score). A process evaluation was organised to identify effective strategies in instrument distribution by conducting semi-structured interviews with quality managers. RESULTS: By involving experts in the development of quality items and through pilot testing by a multi-stakeholder group, the content and face validity of instrument items was ensured. In total, 13,615 respondents (5,891 Patients/kin and 7,724 Professionals) completed the FlaQuM-Quickscan. Confirmatory factor analyses showed good to very good fit and correlations supported the associations between the quality items and general items for both instrument parts. Cronbach's alphas supported the internal consistency. The process evaluation revealed that supportive technical structures and approaching respondents individually were effective strategies to distribute the instrument. CONCLUSIONS: The FlaQuM-Quickscan is a valid instrument to measure healthcare quality experiences multidimensionally from an integrated multistakeholder perspective. This new instrument offers unique and detailed data to design sustainable quality management systems in hospitals. Based on these data, hospital management and policymakers can set quality priorities for patients', kin's and professionals' care. Future research should investigate the transferability to other healthcare systems and examine between-stakeholders and between-hospitals variation.

Effect of aflibercept plus FOLFIRI and potential efficacy biomarkers in patients with metastatic colorectal cancer: the POLAF trial.

BACKGROUND: Aflibercept is an antiangiogenic drug against metastatic colorectal cancer (mCRC) combined with 5-fluorouracil/leucovorin/irinotecan (FOLFIRI); however, no antiangiogenic biomarker has yet been validated. We assessed aflibercept plus FOLFIRI, investigating the biomarker role of baseline vascular endothelial growth factor A (VEGF-A) and angiotensin-converting enzyme (ACE). METHODS: Phase II trial in oxaliplatin-treated mCRC patients who received aflibercept plus FOLFIRI. The reported 135 ng/mL ACE cut-off was used and ROC analysis was performed to assess the optimal VEGF-A cut-off for progression-free survival (PFS). Overall survival (OS), time to progression (TTP), time to treatment failure (TTF), overall response rate (ORR) and disease control rate (DCR) were also assessed. RESULTS: In total, 101 patients were followed for a median of 12 (6-17) months. The 1941 pg/mL VEGF-A was an optimal cut-off, with a longer median PFS when VEGF-A was <1941 versus ≥1941 pg/mL (9 versus 4 months). Patients with VEGF-A < 1941 pg/mL showed longer median OS (19 versus 8 months), TTP (9 versus 4 months) and TTF (8 versus 4 months), along with higher ORR (26% versus 9%) and DCR (81% versus 55%). No differences were identified according to ACE levels. CONCLUSIONS: This study supports aflibercept plus FOLFIRI benefits, suggesting VEGF-A as a potential biomarker to predict better outcomes.

Quality of Colonoscopy Is Associated With Adenoma Detection and Postcolonoscopy Colorectal Cancer Prevention in Lynch Syndrome.

BACKGROUND & AIMS: Colonoscopy reduces colorectal cancer (CRC) incidence and mortality in Lynch syndrome (LS) carriers. However, a high incidence of postcolonoscopy CRC (PCCRC) has been reported. Colonoscopy is highly dependent on endoscopist skill and is subject to quality variability. We aimed to evaluate the impact of key colonoscopy quality indicators on adenoma detection and prevention of PCCRC in LS. METHODS: We conducted a multicenter study focused on LS carriers without previous CRC undergoing colonoscopy surveillance (n = 893). Incident colorectal neoplasia during surveillance and quality indicators of all colonoscopies were analyzed. We performed an emulated target trial comparing the results from the first and second surveillance colonoscopies to assess the effect of colonoscopy quality indicators on adenoma detection and PCCRC incidence. Risk analyses were conducted using a multivariable logistic regression model. RESULTS: The 10-year cumulative incidence of adenoma and PCCRC was 60.6% (95% CI, 55.5%-65.2%) and 7.9% (95% CI, 5.2%-10.6%), respectively. Adequate bowel preparation (odds ratio [OR], 2.07; 95% CI, 1.06-4.3), complete colonoscopies (20% vs 0%; P = .01), and pan-chromoendoscopy use (OR, 2.14; 95% CI, 1.15-3.95) were associated with significant improvement in adenoma detection. PCCRC risk was significantly lower when colonoscopies were performed during a time interval of less than every 3 years (OR, 0.35; 95% CI, 0.14-0.97). We observed a consistent but not significant reduction in PCCRC risk for a previous complete examination (OR, 0.16; 95% CI, 0.03-1.28), adequate bowel preparation (OR, 0.64; 95% CI, 0.17-3.24), or previous use of high-definition colonoscopy (OR, 0.37; 95% CI, 0.02-2.33). CONCLUSIONS: Complete colonoscopies with adequate bowel preparation and chromoendoscopy use are associated with improved adenoma detection, while surveillance intervals of less than 3 years are associated with a reduction of PCCRC incidence. In LS, high-quality colonoscopy surveillance is of utmost importance for CRC prevention.

Cornerstones of a sustainable national quality policy: A qualitative study based on international expert opinions.

BACKGROUND: National initiatives launched to improve the quality of care have grown exponentially over the last decade. Public reporting, accreditation and governmental inspection form the basis for quality in Flemish (Belgian) hospitals. Due to the lack of evidence for these national initiatives and the questions concerning their sustainability, our research aims to identify cornerstones of a sustainable national quality policy for acute-care hospitals based on international expert opinion. METHODS: A qualitative study was conducted using in-depth semi-structured interviews with 12 renowned international quality and patient safety experts selected by purposive sampling. Interviews focussed on participants' perspectives and their recommendations for a future, sustainable quality policy. Inductive analysis was carried out with themes being generated from the data using the constant comparison method. RESULTS: Three major and five minor themes were identified and integrated into a framework as a basis for national quality policies. Quality culture, minimum requirements for quality education and quality control as well as continuous learning and improvement act as cornerstones of this framework. CONCLUSIONS: Complementary to the current national policy, this study demonstrated the need for profound attention to quality cultures in acute-care hospitals. Policymakers need to provide a control system and minimum requirements for quality education for all healthcare workers. A model for continuous learning and improvement with data feedback loops has to be installed in each hospital to obtain a sustainable quality system. This framework can inspire policymakers to further develop bottom-up initiatives in co-governance with all relevant stakeholders adapted to individual hospitals' context.

Prospective Study Comparing Clinicians' and Cancer Patients' Estimates of Risk of Relapse and Toxicity with Adjuvant Chemotherapy.

The aim of this study was to compare physicians' and patients' estimates of risk of relapse and toxicity. A prospective, cross-sectional, multicenter study including 735 patients with cancer and 29 oncologists. Physicians' appraisals of risk of relapse with and without chemotherapy (27.5% and 43.1%) and risk of severe toxicity (12.2%) were more realistic than those of patients (34.6%, 78.5%, and 57.4%, respectively). The greater the risk of recurrence and risk of toxicity estimated, the less physicians expressed satisfaction with SDM. Estimations of risk of relapse and toxicity are important in diagnostic and therapeutic decision-making and can help patients face their situation.

External validity of docetaxel triplet trials in advanced gastric cancer: are there patients who still benefit?

BACKGROUND: The purpose of our study was to develop an online calculator to estimate the effect of docetaxel triplets (DPF) in first line of advanced gastric cancer (AGC), and to assess the external validity of docetaxel trials in individual patients. METHODS: The study includes patients with HER2(-) AGC treated with platin and fluoropyrimidine (PF) or with DPF in first line. Treatment effect and interactions were assessed using Bayesian accelerated failure time models. RESULT: The series comprises 1376 patients; 238 treated with DPF and 1138 with PF between 2008 and 2019. DPF was associated with increased progression-free survival (PFS) and overall survival (OS) with time ratio (TR) 1.27 (95% credible interval [CrI], 1.15-1.40), and TR 1.19 (95% CrI, 1.09-1.27), respectively. Serious adverse events were more common with DPF, particularly hematological effects (32% vs 22%). Younger participants received greater DPF dose density without achieving greater disease control, while severe toxicity was likewise higher. DPF yielded superior OS in Lauren intestinal (TR 1.27, 95% CrI, 1.08-1.11) vs diffuse subtype (TR 1.17, 95% CrI, 1.09-1.24) and the probability of increasing OS > 15% was 90% vs 67% in each subtype, respectively. The effect dwindles over time, which can be attributed to pathological changes and clinical practice changes. CONCLUSION: Our study confirms the effect of DPF is highly dependent on several clinical-pathological variables, with discreet and gradually declining benefit over platinum doublets in later years, at the expense of increased toxicity. These results may help to underpin the idea that external validity of AGC trials should be revised regularly.

Prognostic Nomogram and Patterns of Use of FOLFIRI-Aflibercept in Advanced Colorectal Cancer: A Real-World Data Analysis.

INTRODUCTION: The VELOUR study evaluated the efficacy and safety of adding aflibercept to FOLFIRI (fluorouracil, leucovorin, irinotecan) in second-line therapy for metastatic colorectal cancer (mCRC). However, a nomogram that can stratify patients according to prognosis is unavailable, and the frequency and effect of the pragmatic use of modified schedules in actual practice remains unknown. METHOD: The sample consists of 250 patients with mCRC treated with aflibercept and irinotecan-based chemotherapy at nine Spanish academic centers between January 2013 and September 2015. The result of a Cox proportional hazards model regression for overall survival (OS), adjusted for covariates available in daily practice, was represented as a nomogram and web-based calculator. Harrell's c-index was used to assess discrimination. RESULTS: The prognostic nomogram for OS includes six variables: Eastern Cooperative Oncology Group performance status, tumor location, number of metastatic sites, mutational status, better response to previous treatment(s), and carcinoembryonic antigen. The model is well calibrated and has acceptable discriminatory capacity (optimism-corrected c-index, 0.723; 95% confidence interval [CI], 0.666-0.778). Median OS was 6.1 months (95% CI, 5.1-8.8), 12.4 months (95% CI, 9.36-14.8), and 22.9 months (95% CI, 16.6-not reached) for high-, intermediate-, and low-risk groups, respectively. Age, comorbidity, or use of modified FOLFIRI regimens did not affect prognosis in this series. Grade 3-4 adverse events were less common following modified schedules. The admission rate because of toxicity was higher in ≥65 years (9.7% vs. 19.6%; odds ratio, 2.26; p = .029). CONCLUSION: We have developed and internally validated a prognostic model for use in individuals with colorectal cancer initiating therapy with FOLFIRI-aflibercept to predict both OS and the effect of pragmatic modifications of the classic regime on efficacy and safety. This can aid in decision making and in designing future trials. IMPLICATIONS FOR PRACTICE: In this study, the authors developed and conducted the internal validation of a prognostic nomogram that makes it possible to stratify patients who are eligible for second-line FOLFIRI-aflibercept based on their probability of survival. This model was developed in a multicenter sample from nine Spanish hospitals. Furthermore, to increase the study's validity, the practical use of aflibercept in this setting was investigated, including doses or pragmatic modifications. The results suggest that the modified schedules often used in this daily clinical practice-based patient population are associated with less severe toxicity without apparent detriment to survival endpoints. It is believed that these data complement the information provided by the VELOUR trial and are relevant for the oncologist in treating colon cancer in the second-line setting.

Biopsychosocial and clinical characteristics in patients with resected breast and colon cancer at the beginning and end of adjuvant treatment.

BACKGROUND: The aim of this study was to analyze biopsychosocial factors affecting how patients cope with cancer and adjuvant treatment and to appraise psychological distress, coping, perceived social support, quality of life and SDM before and after adjuvant treatment in breast cancer patients compared to colon cancer patients. METHODS: NEOcoping is a national, multicenter, cross-sectional, prospective study. The sample comprised 266 patients with colon cancer and 231 with breast cancer. The instruments used were the Brief Symptom Inventory (BSI), Mini-Mental Adjustment to Cancer (Mini-MAC), Multidimensional Scale of Perceived Social Support (MSPSS), Shared Decision-Making Questionnaire-Patient (SDM-Q-9) and Physician's (SDM-Q-Doc), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). RESULTS: Breast cancer patients reacted worse to the diagnosis of cancer with more symptoms of anxiety, depression, and somatization, and were less satisfied with their involvement than those with colon cancer (p = 0.003). Participants with colon cancer were older and had more physical symptoms and functional limitations at the beginning of adjuvant treatment, while there were scarcely any differences between the two groups at the end of adjuvancy, at which time both groups suffered greater psychological and physical effects and scored lower on coping strategies, except for anxious preoccupation. CONCLUSIONS: Breast cancer patients need more information and involvement of the oncologist in shared decision-making, as well as and more medical and psychological support when beginning adjuvant treatment. Both breast and colon cancer patients may require additional psychological care at the end of adjuvancy.

[Self-help groups and patient participation: current results and projects in the Belgian region of Flanders]. / Selbsthilfe und Patientenbeteiligung: aktuelle Ergebnisse und Projekte in der belgischen Region Flandern.

In 2018, around 1500 self-help groups existed in the Belgian region of Flanders, dealing with almost 200 different diseases or problems. Most have existed for 25 to 35 years, with new initiatives added annually. The first part of this article describes the development of self-help groups and patient participation in Flanders. The second part discusses the legal framework for the participation of patient associations at the micro-, meso-, and macrolevel. The third section describes two current practical examples of patient participation in the health system: the "self-help-friendly hospital" and "the integration of experts by experience in hospitals" with initial interim results. Finally, we discuss development and growth opportunities, as well as needs of self-help groups and patient associations and their support agencies and umbrella associations. More support for self-help groups and increased recognition of their achievements can promote structural forms of cooperation with the professional health system and boost patient participation.

European Regulatory Developments for Orally Inhaled and Nasal Drug Products.

Orally inhaled and nasal drug products (OINDP) are regulated in Europe via national (country) legislation and guidelines and/or legislation established in the European Union and resulting guidelines developed by the European Medicines Agency (EMA). Recent movement in EMA guidance and European Commission legislation implies potential significant changes in OINDP regulation. The UK exiting the European Union ("Brexit") has also raised a number of questions related to OINDP development and regulation in the region. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) European outreach working group provides and overview and analysis of the current state of European regulatory activity for OINDP (International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) 2018).

Lauren subtypes of advanced gastric cancer influence survival and response to chemotherapy: real-world data from the AGAMENON National Cancer Registry.

BACKGROUND: The choice of chemotherapy in HER2-negative gastric cancer is based on centre's preferences and adverse effects profile. No schedule is currently accepted as standard, nor are there any factors to predict response, other than HER2 status. We seek to evaluate whether Lauren type influences the efficacy of various chemotherapies and on patient overall survival (OS). METHODS: We have conducted a multicenter study in 31 hospitals. The eligibility criteria include diagnosis of stomach or gastroesophageal junction adenocarcinoma, HER2 negativity, and chemotherapy containing 2-3 drugs. Cox proportional hazards regression adjusted for confounding factors, with tests of 'treatment-by-histology' interaction, was used to estimate treatment effect. RESULTS: Our registry contains 1303 tumours analysable for OS end points and 730 evaluable for overall response rate (ORR). A decrease in ORR was detected in the presence of a diffuse component: odds ratio 0.719 (95% confidence interval (CI), 0.525-0.987), P=0.039. Anthracycline- or docetaxel-containing schedules increased ORR only in the intestinal type. The diffuse type displayed increased mortality with hazard ratio (HR) of 1.201 (95% CI, 1.054-1.368), P=0.0056. Patients receiving chemotherapy with docetaxel exhibited increased OS limited to the intestinal type: HR 0.65 (95% CI, 0.49-0.87), P=0.024, with no increment in OS for the subset having a diffuse component. With respect to progression-free survival (PFS), a significant interaction was seen in the effect of docetaxel-containing schedules, with better PFS limited to the intestinal type subgroup, in the comparison against any other schedule: HR 0.65 (95% CI, 0.50-0.85), P=0.015, and against anthracycline-based regimens: HR 0.64 (95% CI, 0.46-0.88), P=0.046. CONCLUSIONS: As a conclusion, in this registry, Lauren classification tumour subtypes predicted survival and responded differently to chemotherapy. Future clinical trials should stratify effect estimations based on histology.

A nomogram for predicting complications in patients with solid tumours and seemingly stable febrile neutropenia.

BACKGROUND: We sought to develop and externally validate a nomogram and web-based calculator to individually predict the development of serious complications in seemingly stable adult patients with solid tumours and episodes of febrile neutropenia (FN). PATIENTS AND METHODS: The data from the FINITE study (n=1133) and University of Salamanca Hospital (USH) FN registry (n=296) were used to develop and validate this tool. The main eligibility criterion was the presence of apparent clinical stability, defined as events without acute organ dysfunction, abnormal vital signs, or major infections. Discriminatory ability was measured as the concordance index and stratification into risk groups. RESULTS: The rate of infection-related complications in the FINITE and USH series was 13.4% and 18.6%, respectively. The nomogram used the following covariates: Eastern Cooperative Group (ECOG) Performance Status ⩾2, chronic obstructive pulmonary disease, chronic cardiovascular disease, mucositis of grade ⩾2 (National Cancer Institute Common Toxicity Criteria), monocytes <200/mm(3), and stress-induced hyperglycaemia. The nomogram predictions appeared to be well calibrated in both data sets (Hosmer-Lemeshow test, P>0.1). The concordance index was 0.855 and 0.831 in each series. Risk group stratification revealed a significant distinction in the proportion of complications. With a ⩾116-point cutoff, the nomogram yielded the following prognostic indices in the USH registry validation series: 66% sensitivity, 83% specificity, 3.88 positive likelihood ratio, 48% positive predictive value, and 91% negative predictive value. CONCLUSIONS: We have developed and externally validated a nomogram and web calculator to predict serious complications that can potentially impact decision-making in patients with seemingly stable FN.

Association between adherence to the mediterranean diet, physical activity, and sleep apnea-hypopnea syndrome (SAHS) in a middle-aged population with cardiovascular risk: Insights from the ILERVAS cohort.

INTRODUCTION: Sleep Apnea-Hypopnea Syndrome (SAHS) is a common sleep disorder influenced by factors like age, gender, and obesity. The Mediterranean Diet (MedDiet) and physical activity have shown health benefits in lung diseases, but their effects on SAHS remain underexplored. METHODS: In a cross-sectional analysis of 678 middle-aged individuals with low-to-moderate cardiovascular risk from the ILERVAS cohort, we assessed adherence to the MedDiet and physical activity levels using validated tools. Sleep parameters, SAHS severity, and excessive daytime sleepiness were evaluated through non-attended cardiorespiratory polygraphy and the Epworth Sleepiness Scale. Multinomial logistic regression models were employed to assess the relationship between MedDiet adherence, physical activity, and SAHS severity. RESULTS: The prevalence of severe, moderate, and mild SAHS was 15.5%, 23.2% and 36.1%, respectively. We found no significant associations between adherence to the MedDiet, physical activity levels, and the presence or severity of SAHS. However, we noted a significant interaction between MedDiet and physical activity with minimum SpO2 values (p = 0.049). Notably, consuming more than one serving of red meat per day was independently associated with a higher risk of moderate SAHS [OR = 2.65 (1.29-5.44), p = 0.008]. CONCLUSION: Individually, MedDiet adherence and physical activity did not show independent correlations with SAHS. However, when considered together, a minimal but significant effect on minimum SpO2 was observed. Additionally, red meat consumption was associated with a moderate risk of SAHS. Further research is necessary to comprehend the intricate connections between lifestyle factors and sleep-breathing disorders, with a focus on personalized approaches for high-risk populations.

Influence of nonalcoholic fatty liver disease severity on carotid adventitial vasa vasorum.

Introduction: Nonalcoholic fatty liver disease (NAFLD) affects a quarter of the world's population and encompasses a spectrum of liver conditions, from non-alcoholic steatohepatitis (NASH) to inflammation and fibrosis. In addition, NAFLD also links to extrahepatic conditions like diabetes or obesity. However, it remains unclear if NAFLD independently correlates with the onset and progression of atherosclerosis. Material and methods: This cross-sectional study aimed to explore the relationship between NAFLD severity, assessed via liver biopsy, and early atherosclerosis using adventitial vasa vasorum (VV) density. It included 44 patients with obesity (33 with steatosis, 11 with NASH) undergoing bariatric surgery. Results: Results revealed no significant differences in adventitial VV density between steatosis and NASH groups, neither in the mean values [0.759 ± 0.104 vs. 0.780 ± 0.043, P=0.702] nor left-right sides. Similarly, carotid intima-media thickness (cIMT) did not vary between these groups. Additionally, no linear correlation existed between VV density and cIMT. Only gender showed an association with VV density. Conclusion: These findings suggest that NASH severity doesn't independently drive early atherosclerosis or affects cIMT. Gender might play a role in early atherosclerotic disease in NAFLD, impacting VV density and cIMT. This highlights the need to consider other risk factors when evaluating cardiovascular risk in NAFLD patients.

Validation of the CoVID-TE model as a tool to predict thrombosis, bleeding, and mortality in the oncology patient with Sars-Cov-2 infection: a study by the SEOM cancer and thrombosis group.

PURPOSE: The CoVID-TE model was developed with the aim of predicting venous thrombotic events (VTE) in cancer patients with Sars-Cov-2 infection. Moreover, it was capable of predicting hemorrhage and mortality 30 days following infection diagnosis. The model is pending validation. METHODS/PATIENTS: Multicenter retrospective study (10 centers). Adult patients with active oncologic disease/ antineoplastic therapy with Sars-Cov-2 infection hospitalized between March 1, 2020 and March 1. 2022 were recruited. The primary endpoint was to study the association between the risk categories of the CoVID-TE model and the occurrence of thrombosis using the Chi-Square test. Secondary endpoints were to demonstrate the association between these categories and the occurrence of post-diagnostic Sars-Cov-2 bleeding/ death events. The Kaplan-Meier method was also used to compare mortality by stratification. RESULTS: 263 patients were enrolled. 59.3% were men with a median age of 67 years. 73.8% had stage IV disease and lung cancer was the most prevalent tumor (24%). A total of 86.7% had an ECOG 0-2 and 77.9% were receiving active antineoplastic therapy. After a median follow-up of 6.83 months, the incidence of VTE, bleeding, and death 90 days after Sars-Cov-2 diagnosis in the low-risk group was 3.9% (95% CI 1.9-7.9), 4.5% (95% CI 2.3-8.6), and 52.5% (95% CI 45.2-59.7), respectively. For the high-risk group it was 6% (95% CI 2.6-13.2), 9.6% (95% CI 5.0-17.9), and 58.0% (95% CI 45.3-66.1). The Chi-square test for trends detected no statistically significant association between these variables (p > 0.05). Median survival in the low-risk group was 10.15 months (95% CI 3.84-16.46), while in the high-risk group it was 3.68 months (95% CI 0.0-7.79). The differences detected were not statistically significant (p = 0.375). CONCLUSIONS: The data from our series does not validate of the CoVID-TE as a model to predict thrombosis, hemorrhage, or mortality in cancer patients with Sars-Cov-2 infection.

Is there a preferred platinum and fluoropyrimidine regimen for advanced HER2-negative esophagogastric adenocarcinoma? Insights from 1293 patients in AGAMENON-SEOM registry.

BACKGROUND: The optimal chemotherapy backbone for HER2-negative advanced esophagogastric cancer, either in combination with targeted therapies or as a comparator in clinical trials, is uncertain. The subtle yet crucial differences in platinum-based regimens' safety and synergy with combination treatments need consideration. METHODS: We analyzed cases from the AGAMENON-SEOM Spanish registry of HER2-negative advanced esophagogastric adenocarcinoma treated with platinum and fluoropyrimidine from 2008 to 2021. This study focused exclusively on patients receiving one of the four regimens: FOLFOX (5-FU and oxaliplatin), CAPOX (capecitabine and oxaliplatin), CP (capecitabine and cisplatin) and FP (5-FU and cisplatin). The aim was to determine the most effective and tolerable platinum and fluoropyrimidine-based chemotherapy regimen and to identify any prognostic factors. RESULTS: Among 1293 patients, 36% received either FOLFOX (n = 468) or CAPOX (n = 466), 20% CP (n = 252), and 8% FP (n = 107). FOLFOX significantly increased PFS (progression free survival) compared to CP, with a hazard ratio of 0.73 (95% CI 0.58-0.92, p = 0.009). The duration of treatment was similar across all groups. Survival outcomes among regimens were similar, but analysis revealed worse ECOG-PS (Eastern Cooperative Oncology Group-Performance Status), > 2 metastatic sites, bone metastases, hypoalbuminemia, higher NLR (neutrophil-to-lymphocyte ratio), and CP regimen as predictors of poor PFS. Fatigue was common in all treatments, with the highest incidence in FOLFOX (77%), followed by FP (72%), CAPOX (68%), and CP (60%). Other notable toxicities included neuropathy (FOLFOX 69%, CAPOX 62%), neutropenia (FOLFOX 52%, FP 55%), hand-foot syndrome in CP (46%), and thromboembolic events (FP 12%, CP 11%). CONCLUSIONS: FOLFOX shown better PFS than CP. Adverse effects varied: neuropathy was more common with oxaliplatin, while thromboembolism was more frequent with cisplatin.

Sustainable quality management in hospitals: The experiences of healthcare quality managers.

BACKGROUND: Quality management systems are essential in hospitals, but evidence shows a real literature gap on the sustainable implementation of quality. PURPOSE: This study aimed to explore and identify enablers towards sustainable quality management in hospitals. Research design and Study Sample: Interviews were conducted with 23 healthcare quality managers from 20 hospitals. Data collection and/or Analysis: Data collection and analysis were conducted simultaneously by using the Qualitative Analysis Guide of Leuven and following the COREQ Guidelines. Thematic analysis from interview transcripts was performed in NVivo 12. RESULTS: The results reveal two categories: (1) quality in the organisation's DNA and (2) quality in the professional's DNA. The first category consists of: bottom-up and top-down management, the organisation-wide integration of quality and an organisational culture shift. The second one consists of: quality awareness, understanding the added value, the encouragement and engagement, the accountability and ownership for quality. Moving towards sustainable quality management systems in hospitals requires a good interaction between a bottom-up approach and leadership to ensure continuous support from healthcare stakeholders. CONCLUSIONS: This study contributes to existing conceptual and theoretical foundations with practical insights into sustainable quality management. The findings can guide quality departments and hospital management to regain professionals' commitment to quality and to establish a sustainable quality management system.

Low adherence to the Mediterranean diet is associated with increased prevalence and number of atherosclerotic plaques in the ILERVAS cohort.

BACKGROUND AND AIMS: Current research on the association between dietary patterns and subclinical atherosclerotic disease (SAD) is still limited, and published results are inconsistent and often consist of small population sizes. We aimed to evaluate the association between the Mediterranean diet (MDiet) and SAD in a large cohort of Mediterranean individuals. METHODS: This was a cross-sectional study that included 8116 subjects from the ILERVAS cohort. The presence of atherosclerotic plaques (AP) was assessed by ultrasound examination. Adherence to the MDiet was assessed using the 14-item Mediterranean Diet Adherence Score (MEDAS). Inclusion criteria were subjects with at least one cardiovascular risk factor. Exclusion criteria were a clinical history of diabetes, chronic kidney disease, or a prior cardiovascular event. Bivariable and multivariable models were performed. RESULTS: Compared with subjects without SAD, participants with SAD were older and had a higher frequency of smoking habit, hypertension, dyslipidemia, HbA1c and waist circumference. The adjusted multivariable analysis showed that a higher MEDAS was associated with a lower risk of AP (incidence rate ratios [IRR] 0.97, 95% CI [0.96-0.98]; p<0.001). Furthermore, moderate or high adherence to the MDiet was associated with a lower number of AP compared with a low MDiet adherence (IRR 0.90, 95% CI [0.87-0.94]; p<0.001). In both models, female sex was associated with a lower risk of AP. CONCLUSIONS: Our findings point to a potentially protective role of MDiet for SAD in a Mediterranean population with low-to-moderate cardiovascular risk. Further research is needed to establish a causal relationship between both variables.

What do patients and oncologists think about the evaluation and management of cancer-related anorexia-cachexia? The Quasar_SEOM study.

INTRODUCTION: Cancer patients often suffer from malnutrition and early detection and raising awareness of nutritional issues is crucial in this population. METHODS: The Spanish Oncology Society (SEOM) conducted the Quasar_SEOM study to investigate the current impact of the Anorexia-Cachexia Syndrome (ACS). The study employed questionnaires and the Delphi method to gather input from both cancer patients and oncologists on key issues related to early detection and treatment of ACS. A total of 134 patients and 34 medical oncologists were surveyed about their experiences with ACS. The Delphi methodology was used to evaluate oncologists' perspectives of ACS management, ultimately leading to a consensus on the most critical issues. RESULTS: Despite widespread acknowledgement of malnutrition in cancer as a significant issue by 94% of oncologists, the study revealed deficiencies in knowledge and protocol implementation. A mere 65% of physicians reported being trained to identify and treat these patients, with 53% failing to address ACS in a timely manner, 30% not monitoring weight, and 59% not adhering to any clinical guidelines. The lack of experience was identified as the primary hindrance to the use of orexigens in 18% of cases. Furthermore, patients reported concerns and a perception of inadequate attention to malnutrition-related issues from their physicians. CONCLUSION: The results of this study point to a gap in the care of this syndrome and a need to improve education and follow-up of cancer patients with anorexia-cachexia.