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Introduction: Evidence about the advantage of Lichtenstein’s repair, the guidelines’ recommended technique, is scarce regarding postoperative chronic inguinal pain (CPIP). The primary aim of this study was to compare CPIP in patients undergoing Lichtenstein versus other techniques. Methods: Prospective multicentric cohort study including consecutive adults undergoing elective inguinal hernia repair in Portuguese hospitals (October - December 2019). Laparoscopic and mesh-free hernia repairs were excluded. The primary outcome was postoperative pain at three months, defined as a score of ≥ 3/10 in the European Hernia Society Quality of Life score pain domain. The secondary outcome was 30-day postoperative complications. Results: Eight hundred and sixty-nine patients from 33 hospitals were included. Most were men (90.4%) and had unilateral hernias (88.6%). Overall, 53.6% (466/869) underwent Lichtenstein’s repair, and 46.4% (403/869) were treated with other techniques, of which 83.9% (338/403) were plug and patch. The overall rate of CPIP was 16.6% and 12.2% of patients had surgical complications. The unadjusted risk was similar for CPIP (OR 0.76, p = 0.166, CI 0.51 - 1.12) and postoperative complications (OR 1.06, p = 0.801, CI 0.69 - 1.60) between Lichtenstein and other techniques. After adjustment, the risk was also similar for CPIP (OR 0.83, p = 0.455, CI 0.51 - 1.34) and postoperative complications (OR 1.14, p = 0.584, CI 0.71 - 1.84). Conclusion: The Lichtenstein technique was not associated with lower CPIP and showed comparable surgical complications. Further investigation as- sessing long term outcomes is necessary to fully assess the benefits of the Lichtenstein technique regarding CPIP.

Objectives: This study aimed to compare the anthropometry and body composition of vegetarian and omnivorous adults living in Portugal, while exploring nutritional and health parameters underlying observed differences. Methods: 425 omnivorous (OMNI), lacto-ovo-vegetarian (LOV), or vegan (VEG) healthy adults were recruited. Anthropometry was measured, and bioelectrical impedance analysis was performed. Participants answered food frequency, sociodemographic, and lifestyle questionnaires. Serum iron, ferritin, and CRP were quantified by spectrophotometry, and serum B12 vitamin and homocysteine were quantified by chemiluminescent microparticle immunoassay. Results: Total protein intake significantly decreased with increasing strictness of vegetarian habits (median (P25; P75) in g/day: 98.6 (79.5; 123.1), 90.4 (65.9; 121.0), and 87.6 (59.8; 118.5) for OMNI, LOV and VEG, respectively; p = 0.020), and carbohydrate intake was the highest in LOV (median (P25; P75) in g/day: 231.5 (178.4; 287.9), 283.9 (227.3; 342.6), and 263.0 (222.0; 348.3) for OMNI, LOV and VEG, respectively; p = 0.001). VEG were the main users of B12 vitamin (93% in VEG vs. 17% in OMNI and 59% in LOV, p = 0.001), and LOV were the main users of iron supplements (29% in LOV vs. 14% in OMNI and 13% in VEG, p = 0.042), respectively. Blood levels of B12 vitamin correlated negatively with blood homocysteine (rs = −0.386, p < 0.001) and positively with % muscle mass (rs = 0.136, p = 0.005). Participants using iron supplements presented higher C-reactive protein (CRP) (p = 0.014) and they had lower % MM (p = 0.003). Finally, when compared to being OMNI, being LOV independently associated with: (a) having +4.8% (p = 0.002) of fat mass, which could be due to higher carbohydrate intake, and (b) having −2.2% (p = 0.043) of muscle mass. Our data suggest that the association between diet and muscle mass could be attenuated in VEG due to B12 supplementation and/or aggravated in LOV due to iron supplementation-associated inflammation.

Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiac disease. Recently, a connection has been observed between the presence of first-degree atrioventricular block (FDAVB) and cardiovascular outcomes, although the pathophysiology of this association remains poorly understood. Considering the period 2000-2023, we retrospectively included HCM patients at sinus rhythm at the first appointment and sought possible interactions of FDAVB (defined as PR interval >200 ms) with different clinical and imaging variables and with the occurrence of cardiovascular events, including atrial fibrillation (AF). A total of 97 patients were included, of whom 57 (58.8%) were men, with a mean age of 51±19 years, and 14 (14.4%) had FDAVB. During a median of 4.29 (P25 1.92, P75 7.67) years of follow-up, 35 cardiovascular events occurred, including 13 de novo diagnoses of AF, 8 hospitalizations due to heart failure, 8 new-onset strokes, 4 myocardial infarctions, and 2 implantations of cardio defibrillators in secondary prevention; no HCM-related death occurred. We did not find any association between outcomes and the presence of FDAVB. The role of FDAVB as a prognostic marker in HCM patients requires further investigation. We found that FDAVB patients were older, more frequently reported dyspnea, had a larger QRS duration, a higher E/e' ratio, and lower maximal left ventricle wall thickness by magnetic resonance (p

Purpose: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases. Methods: A retrospective study analyzed inpatient medication data, coded using the Anatomical Therapeutic Chemical classification system, from electronic patient records. It investigated the association between medications and clinical severity outcomes such as ICU admissions, respiratory/circulatory support needs, and hospital discharge status, including mortality (identified by ICD-10-CM/PCS codes). Multivariate analyses incorporating demographic data and comorbidities were used to adjust for potential confounders and understand the impact of medication patterns on disease progression and outcomes. Results: The analysis of 2688 hospitalized COVID-19 patients (55.3% male, average age 62.8 years) revealed a significant correlation between medication types and intensity and disease severity. Cases requiring ICU admission or ECMO support often involved blood and blood-forming organ drugs. Increased use of nervous system and genitourinary hormones was observed in nonsurvivors. Corticosteroids, like dexamethasone, were common in critically ill patients, while tocilizumab was used in ECMO cases. Medications for the alimentary tract, metabolism, and cardiovascular system, although widely prescribed, were linked to more severe cases. Invasive mechanical ventilation correlated with higher usage of systemic anti-infectives and musculoskeletal medications. Trends in co-prescribing blood-forming drugs with those for acid-related disorders, analgesics, and antibacterials were associated with intensive interventions and worse outcomes. Conclusions: The study highlights complex medication regimens in managing severe COVID-19, underscoring specific drug patterns associated with critical health outcomes. Further research is needed to explore these patterns.

Food insecurity (FI) is a critical socioeconomic and public health problem globally, particularly affecting children’s nutritional status and development. This cross-sectional study aimed to assess the prevalence of nutritional inadequacy among children and adolescents in the Cantagalo district of São Tomé and Príncipe (STP), in Central Africa. It also assessed their households’ FI situation and examined sociodemographic, anthropometric, and nutritional characteristics associated with severe FI. Data included 546 children/adolescents (51.8% males, aged 9–15 years) from the eight public basic education schools. A structured questionnaire provided sociodemographic data, while anthropometric measurements assessed nutritional status. Dietary intake data were gathered using a single 24 h dietary recall, and the adjusted prevalences of nutritional inadequacy were obtained using version 2.0 of the PC-Software for Intake Distribution Estimation (PC-SIDE®). The Household Food Insecurity Access Scale was used to assess FI, and households were classified as severely or non-severely food insecure. Multivariable binary logistic regression models adjusted for potential confounders identified factors related to FI. Children’s/adolescents’ thinness was exhibited in 34.1% of participants, and over 95% had inadequate intake of essential micronutrients, including iron. Notably, 73.7% were severely food insecure. A higher severity of FI was positively associated with a lower intake of iron and certain household head characteristics, such as being female or older, and negatively associated with having a home garden.

Human papillomavirus (HPV) is the most prevalent sexually transmitted infection among young women. Notably, more than ten years after the introduction of HPV vaccination programs in Europe, it is essential to review the real-world evidence of the incidence of anogenital warts (GWs) among women vaccinated during childhood. In this systematic review, three databases were searched for studies published between January 2008 and September 2023. Nine cohort studies were included. A total of 890,320 HPV-vaccinated women and 1,922,033 unvaccinated women were evaluated. All the studies but one investigated the 4vHPV vaccine. The incidence rate of GWs in vaccinated women ranged from 0.0 to 1650 per 100,000 person-years. The highest incidence rates were found in women vaccinated with one dose at the age of 17–19 years old and in fully vaccinated women only after 19 years of age. Similar incidence values were reported among unvaccinated women. The incidence of GWs was lower when the age at first dose was 9–11 years old. This systematic review reveals that the incidence of GWs among HPV-vaccinated women is related to the age of vaccination and the number of vaccine doses received. In the post-vaccination era, epidemiological surveillance of the incidence of GWs and their genotypes is crucial.

Background: The transmission of diseases by blood products continues to be a worldwide health problem, especially in Africa. Seroprevalence rates of the Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), Syphilis, and Coinfection in Angola are poorly documented. This study aims to identify the seroprevalence of markers with positive results for Hepatitis B, C, HIV, Syphilis, and Coinfection in blood donors. Material and methods: A retrospective study was conducted using a database of positive serological markers for these infections and coinfection in 2734 blood donors traced from 2011 to 2016 in Luanda, Angola. The Chi-Square test (χ2) or Fisher's exact test was used to evaluate serological positivity and donors’ characteristics. A p-value < 0.05 was considered statistically significant. Results: 2734 blood donors aged 18 to 64 (median age 32 ± 9) were screened from 2011 to 2016. 73.9 % of the donors were positive for one Transfusion-Transmitted Infection (TTI), and 5.9 % showed evidence of multiple infections. The overall seroprevalence rate was 50.2 % (1373) for HBV, 20 % (436) for Syphilis, 7 % (191) for HIV, 5.1 % (140) for HCV, and 5.8 % for coinfected donors. 2467 (90 %) were men, and 267 (10 %) were women. We identified 118 (5.8 %) coinfected donors. Of those, 40 (33.9 %) simultaneously presented Hepatitis B virus surface antigen (HBsAg)/Syphilis, 24 (20.3 %) HBsAg/HIV, 22 (18.6 %) HBsAg/HCV, 20 (16.9 %) HIV/Syphilis, 8 (6.8 %) HCV/Syphilis, and 4 (3.4 %) HIV/HCV. Conclusion: A high transfusion-transmissible infection prevalence was found compared to some countries in Sub-Saharan Africa. Therefore, intensifying the screening for these transfusion-transmitted infections in blood donors is critical to ensure blood safety.

Studies exploring the experience of patients receiving home respiratory therapies (HRT), such as long-term oxygen therapy (LTOT) and home mechanical ventilation (HMV), are still limited. This study focused on patients’ and carers’ experience with LTOT and HMV. An exploratory, cross-sectional qualitative study, using semi-structured focus groups, was carried out with 18 patients receiving HRT (median 71y, 78% male, 56% on both LTOT and HMV) and 6 carers (median age 67y, 67% female). Three focus groups were conducted in three regions of Portugal. Thematic analysis was performed by two independent researchers. Patients’ and carers’ experience was reflected in seven major topics, linked to specific time points and settings of the treatment: Initial symptoms/circumstances (n = 41), Prescription (n = 232), Implementation (n = 184), Carer involvement (n = 34), Quality of life impact (n = 301), Health care support/navigability (n = 173) and Suggestions (n = 14). Our findings demonstrate a general good perception of the HRT by patients and carers recognizing a significative quality of life impact improvement, while identifying specific points where improvements in healthcare are needed, particularly about navigability issues, articulation between the hospital, primary care and homecare teams, especially regardingprescriptionrenewal. This knowledge is crucial to promote a long-term HRT adherence and to optimize HRT delivery in line with patients’ experience, needs, and values. Moreover, these key points can inform the development of a specific patient-reported experience measure (PREM) for patients on HRT, which is not currently available, and foster a more integrated respiratory care model.

Cobalt (Co), copper (Cu), manganese (Mn), molybdenum (Mo), and zinc (Zn) are essential trace elements (ETEs) and important cofactors for intermediary metabolism or redox balance. These ETEs are crucial during pregnancy, their role on specific pregnancy outcomes is largely unknown. This prospective study (#NCT04010708) aimed to assess urinary levels of these ETEs in pregnancy and to evaluate their association with pregnancy outcomes. First trimester pregnant women of Porto and Lisbon provided a random spot urine sample, and sociodemographic and lifestyle data. Clinical data were obtained from clinical records. Urinary ETEs were quantified by inductively coupled plasma mass spectrometry (ICP-MS). A total of 635 mother:child pairs were included. Having urinary Zn levels above the 50th percentile (P50) was an independent risk factor for pre-eclampsia (PE) (aOR [95% CI]: 5.350 [1.044–27.423], p = 0.044). Urinary Zn levels above the P50 decreased the risk of small for gestational age (SGA) birth head circumference (aOR [95% CI]: 0.315 [0.113–0.883], p = 0.028), but it increased the risk SGA length (aOR [95% CI]: 2.531 [1.057–6.062], p = 0.037). This study may provide valuable information for public health policies related to prenatal nutrition, while informing future efforts to de-fine urinary reference intervals for ETEs in pregnant women.

Aims: Inflammation-driven endothelitis seems to be a hallmark of acute heart failure (AHF) and cardiogenic shock (CS). Endocan, a soluble proteoglycan secreted by the activated endothelium, contributes to inflammation and endothelial dysfunction, but has been scarcely explored in human AHF. We aimed to evaluate serum (S-Endocan) and urinary endocan (U-Endocan) profiles in AHF and CS patients and to correlate them with biomarkers/parameters of inflammation, endothelial activation, cardiovascular dysfunction and prognosis.Methods: Blood and spot urine were collected from patients with AHF (n = 23) or CS (n = 25) at days 1–2 (admission), 3-4 and 5-8 and from controls (blood donors, n = 22) at a single time point. S-Endocan, U-Endocan, serum IL-1β, IL-6, tumour necrosis factor-α (S-TNF-α), intercellular adhesion molecule-1 (S-ICAM-1), vascular cell adhesion molecule-1 (S-VCAM-1) and E-selectin were determined by ELISA or multiplex immunoassays. Serum C-reactive protein (S-CRP), plasma B-type natriuretic peptide (P-BNP) and high-sensitivity troponin I (P-hs-trop I), lactate, urea, creatinine and urinary proteins, as well as prognostic scores (APACHE II, SAPS II) and echocardiographic left ventricular ejection fraction (LVEF) were also evaluated.Results: Admission S-Endocan was higher in both patient groups, with CS presenting greater values than AHF (AHF and CS vs. Controls, p < 0.001; CS vs. AHF, p < 0.01). Admission U-Endocan was only higher in CS patients (p < 0.01 vs. Controls). At admission, S-VCAM-1, S-IL-6 and S-TNF-α were also higher in both patient groups but there were no differences in S-E-selectin and S-IL-1β among the groups, nor in P-BNP, S-CRP or renal function between AHF and CS. Neither endocan nor other endothelial and inflammatory markers were reduced during hospitalization (p > 0.05). S-Endocan positively correlated with S-VCAM-1, S-IL-6, S-CRP, APACHE II and SAPS II scores and was positively associated with P-BNP in multivariate analyses. Admission S-Endocan raised in line with LVEF impairment (p = 0.008 for linear trend).Conclusion: Admission endocan significantly increases across AHF spectrum. The lack of reduction in endothelial and inflammatory markers throughout hospitalization suggests a perpetuation of endothelial dysfunction and inflammation. S-Endocan appears to be a biomarker of endothelitis and a putative therapeutic target in AHF and CS, given its association with LVEF impairment and P-BNP and its positive correlation with prognostic scores.

Introduction: Children and adolescents are a relevant and increasing proportion of travelers. Injuries and infectious diseases in children are safety concerns when traveling. However, data on diseases and injuries during international travels in children are not available. The aims of this study were to analyze travel-related diseases and injuries among pediatric travelers during and after international trips, to identify risk factors for travel-associated disease, and to evaluate the compliance and effectiveness of the recommendations provided in pre-travel appointments. Material and Methods: We enrolled travelers aged under 18 years attending a pre-travel clinic, in a tertiary hospital (2017 - 2019); 223 of the 370 pediatric travelers attending the pre-travel clinic were included. The study was based on a questionnaire designed to address health and safety issues – vaccines and chemoprophylaxis, including side effects, the occurrence of disease or injury, diagnosis, treatment, and outcomes. Results: The median age at pre-travel evaluation was eight years; 39.7% of the travelers were adolescents, 52.5% were female. The participants traveled to 40 countries across four continents, with a median travel duration of 14.5 days. Asia was the most visited continent. Traveling was safe for 84.8%. From 34 travelers who had illness/injury, gastrointestinal symptoms were elicited in 41.2%. Sixteen (47.1%) travelers required an urgent medical appointment at the destination, and no one was hospitalized. Destinations in Africa and longer trips were significantly associated with a higher occurrence of disease/injury (p = 0.023 and p < 0.001, respectively). In a multivariable model, traveling to Africa was still significantly associated with travel-related disease/injury [OR = 2.736 (1.037 - 7.234)]. Conclusion: Disease/injury occurred in 15.2% of pediatric travelers. Even though 47.1% of the travelers required an urgent medical appointment, the developed conditions were not severe enough to warrant hospitalization. Travels to Africa and longer trips seem to be associated with a higher risk of disease and injury.

Introduction: Patients successfully resuscitated from cardiac arrest (CA) are admitted to the intensive care unit (ICU) for post-resuscitation care. These patients’ prognosis remains dismal, with only a minority surviving to hospital discharge. Understanding the clinical factors involved in the management of these patients is essential to improve their prognosis. Objectives: To characterize the population admitted after successful reanimation from CA, and to analyze the factors associated with their outcomes. Methods: We performed a retrospective descriptive study of patients admitted to an ICU after CA over a five-year period from January 2014 to December 2018. Demographic factors, CA characteristics, early management, mortality and neurologic outcomes were analyzed. Results: A total of 187 patients, median age 67 years, were admitted after CA, of whom 39% suffered out-of-hospital CA; 87% had an initial non-shockable rhythm and the most frequent presumed cause was cardiac (31%). In-hospital mortality was 63%. Significant neurologic dysfunction (cerebral performance category 3 or 4) was seen in 31% of survivors at hospital discharge. Non-immediate initiation of basic life support (BLS), higher Simplified Acute Physiology Score II score and longer relative duration of vasopressor support were independent predictors of in-hospital mortality, while shockable rhythms were associated with improved survival. Higher Glasgow coma scale at ICU discharge and shorter length of ICU stay were predictors of better neurologic outcome. Conclusion: This study highlights the positive prognostic impact of shockable rhythms, and confirms the importance of immediate initiation of BLS and prompt defibrillation, supporting the need for better training both outside and inside hospitals. Resumo: Introdução: Doentes ressuscitados de uma paragem cardiorrespiratória (PCR) são admitidos em Unidades de Cuidados Intensivos (UCI) para receber cuidados pós-reanimação, mas apenas uma minoria sobrevive até à alta hospitalar. Compreender os fatores clínicos envolvidos na sua abordagem é essencial para melhorar o prognóstico. Objetivos: Caracterizar a população admitida na UCI após reanimação bem-sucedida e analisar os fatores associados aos outcomes. Métodos: Realizamos um estudo retrospetivo e descritivo com doentes admitidos após PCR na UCI, de janeiro de 2014 a dezembro de 2018. Analisaram-se os fatores demográficos, caraterísticas da PCR, abordagem precoce e outcomes neurológico e de mortalidade. Resultados: Foram admitidos 187 doentes, com uma mediana de 67 anos; 39% sofreram PCR pré-hospitalar, 87% apresentavam ritmo inicial não desfibrilhável e a etiologia presumida mais frequente foi a cardíaca (31%). A mortalidade intra-hospitalar foi 63%; 31% dos sobreviventes tinha disfunção neurológica significativa à data da alta hospitalar (CPC 3 ou 4). O atraso no início do suporte básico de vida (SBV), score SAPS II mais elevado e maior duração indexada de suporte vasopressor foram preditores independentes de mortalidade intra-hospitalar. O ritmo desfibrilhável foi associado a melhoria da sobrevida. Um valor de Escala de Coma de Glasgow mais elevado na alta da UCI e menor duração de internamento na UCI foram preditores de melhor outcome neurológico. Conclusão: Este estudo salienta o impacto prognóstico do ritmo desfibrilhável e confirma a importância do início imediato de SBV e da rápida desfibrilhação, reforçando a necessidade de capacitar a população intra e extra-hospitalar.

Abstract Background In phenylketonuria (PKU), modified casein glycomacropeptide supplements (CGMP-AA) are used as an alternative to the traditional phenylalanine (Phe)-free L-amino acid supplements (L-AA). However, studies focusing on the long-term nutritional status of CGMP-AA are lacking. This retrospective study evaluated the long-term impact of CGMP-AA over a mean of 29 months in 11 patients with a mean age at CGMP-AA onset of 28 years (range 15–43) [8 females; 2 hyperphenylalaninaemia (HPA), 3 mild PKU, 3 classical PKU and 3 late-diagnosed]. Outcome measures included metabolic control, anthropometry, body composition and biochemical parameters. Results CGMP-AA, providing 66% of protein equivalent intake from protein substitute, was associated with no significant change in blood Phe with CGMP-AA compared with baseline (562 ± 289 µmol/L vs 628 ± 317 µmol/L; p = 0.065). In contrast, blood tyrosine significantly increased on CGMP-AA (52.0 ± 19.2 μmol/L vs 61.4 ± 23.8 μmol/L; p = 0.027). Conclusions Biochemical nutritional markers remained unchanged which is an encouraging finding in adults with PKU, many of whom are unable to maintain full adherence with nutritionally fortified protein substitutes. Longitudinal, prospective studies with larger sample sizes are necessary to fully understand the metabolic impact of using CGMP-AA in PKU.

Background: This systematic review and meta-analysis aims to assess composite and aggregate outcomes of observational studies in Crohn’s disease and to evaluate whether the number and type of variables included affect the frequency of the outcome. Methods: MEDLINE [via PubMed], Scopus and Web of Science were searched to identify observational studies that enrolled patients with Crohn’s disease and evaluated a composite or aggregate outcome. The proportion of patients achieving the outcome was determined and a random-effects meta-analysis was performed to evaluate how the frequency of each outcome varies according to the reporting of predefined variables. Results: From 10,257 identified records, 46 were included in the qualitative analysis and 38 in the meta-analysis. The frequency for composite and aggregate outcomes was 0.445 [95% confidence interval (CI): 0.389–0.501] and 0.140 (95% CI: 0.000–0.211), respectively. When comparing composite outcomes by number of included variables, the frequency was 0.271 (95% CI: 0.000–0.405) and 0.698 (95% CI: 0.651–0.746), for one and six variables, respectively. The frequency of the composite outcome varied according to the identity of the variables being reported. Specific pairs of predefined variables had a significant effect in the frequency of composite outcomes. Conclusion: Composite outcomes with increasing number of predefined variables show an increase in frequency. Outcomes including variables such as ‘Surgery’ and ‘Steroids’ had higher frequencies when compared with the ones that did not include these variables. These results show that the frequency of composite outcomes is dependent on the number and type of variables being reported.

Cysteinyl leukotrienes (CysLT) are potent vascular leakage-promoting agents but have been scarcely explored in human septic shock (SS). We evaluated CysLT at admission and during hospitalization and their correlation with endothelial dysfunction, inflammation, oxidative stress, the renin–angiotensin–aldosterone system, and cardiac, renal, respiratory, and hepatic parameters in SS patients. Blood and spot-urine samples were collected at days 1–2 (admission), 3–4, and 5–8 in SS patients (n = 13) and at a single time point in controls (n = 22). Urinary CysLT (u-CysLT) and isoprostanes, plasma, and urinary angiotensinogen, serum myeloperoxidase, and IL-10 were quantified by ELISA. Serum intercellular-adhesion molecule-1, vascular cell-adhesion molecule-1, E-selectin, tumor necrosis factor-α, IL-1β, and IL-6 were measured by multiplex immunoassays. Routine markers were evaluated using automated analyzers. At admission, SS patients had increased u-CysLT, endothelial activation, inflammation, oxidative stress, and plasma and urinary angiotensinogen, as well as cardiac, respiratory, hepatic, and renal injury/dysfunction. There were no changes in u-CysLT during hospitalization. Both correlation and multivariate analyses showed positive relationships of u-CysLT with endothelial activation, inflammation, oxidative stress, proteinuria, and hepatic injury/dysfunction markers. These results suggest that u-CysLT may be potential non-invasive biomarkers for monitoring the pathophysiological mechanisms underlying SS, as well as putative therapeutic targets.

Objective: Despite the effectiveness of pain medicines, nonadherence to prescribed medication remains a major problem faced by healthcare systems. The aim of present study was to perform the translation, cultural adaptation, and validation of the Intentional Non-Adherence Scale (INAS) for the European Portuguese language in a sample of chronic pain patients.Methods: A Portuguese version of the INAS scale was constructed through a process of translation, back translation, and expert’s panel evaluation. A total of 133 chronic pain patients were selected from two chronic pain clinics from tertiary hospitals in Porto, Portugal. The protocol interview included the assessment of pain beliefs (PBPI), beliefs about medicine (BMQ), medication adherence (MARS-P9), and two direct questions about adherence previously validated.Results: The internal consistency in all subscales was α = 0.902 for testing treatment; α = 0.930 for mistrust treatment; α = 0.917 for resisting treatment; and α = 0.889 for resisting illness. Exploratory and confirmatory factor analysis revealed a four-factor structure that explained 74% of the variance. The construct validity of the INAS was shown to be adequate, with the majority of the previously defined hypotheses regarding intercorrelations with other measures confirmed.Conclusion: The Portuguese version of INAS could be a valuable and available instrument for Portuguese researchers and clinicians to assess the intentional nonadherence determinants during the management of chronic pain.

We investigated oxidative stress and RAAS biomarkers, as well as their association, in chronic heart failure (CHF) patients on optimized medical therapy, stratified by disease severity or by renal function. Since vitamin D has been shown to attenuate RAAS activation and oxidative stress, we further evaluated the relationship between vitamin D, RAAS and oxidative stress in CHF patients with or without renal impairment. Sixty CHF outpatients were included and stratified by disease severity or by renal function. We quantified urinary hydrogen peroxide, plasma and urinary isoprostanes, plasma total antioxidant status, urinary angiotensinogen (intrarenal RAAS activation biomarker) and plasma angiotensinogen, plasma renin and aldosterone concentration, serum angiotensin-converting enzyme (ACE) activity, plasma angiotensin peptides, and serum total 25-hydroxyvitamin D (S-total 25(OH)D). Severe CHF patients had higher urinary isoprostanes (p = 0.002) and lower S-total 25(OH)D (p = 0.006) compared to mild-to-moderate patients, but no differences were observed for other redox or RAAS biomarkers. Patients with impaired renal function (iRF) had higher urinary angiotensinogen (p = 0.003) and lower S-total 25(OH)D (p = 0.028) compared to those with normal renal function (nRF), while no differences were observed for the remaining RAAS and redox parameters. Several positive correlations between oxidative stress and RAAS biomarkers were detected in iRF patients, while in patients with nRF these correlations were primarily inverse. In CHF-iRF patients, S-25(OD)D was inversely associated with urinary isoprostanes, which in turn were positively associated with plasma angiotensinogen and serum ACE. In conclusion, CHF patients with renal function impairment have increased intrarenal RAAS activation and lower vitamin D values and might benefit from the combination of RAAS blockers with vitamin D and/or antioxidants.

Background and Aims: Therapeutic drug monitoring (TDM) of infliximab (IFX) and anti-infliximab antibodies (ATIs) is essential for treatment optimisation in inflammatory bowel disease (IBD) patients. The aim of this study was to estimate and compare the agreement and accuracy between a new rapid test and three established enzyme-linked immunosorbent assays (ELISAs) to quantify ATIs levels, and to evaluate the impact of exogenous IFX on the performance of these assays. Methods: We analysed 200 serum samples from 57 IBD outpatients in IFX induction or maintenance therapy at six IBD centres in Portugal. ATI levels were quantified using the rapid test Quantum Blue® (QB) Anti-Infliximab (Bühlmann) and three established ELISAs: In-House, Theradiag (Lisa Tracker Anti-Infliximab), and Immundiagnostik (IDKmonitor Infliximab). ATIs were quantified in patients’ serum samples and spiked samples with exogenous IFX, based on analytical and clinical cutoffs. Qualitative agreement and accuracy were estimated by Cohen’s kappa ( k ) with 95% confidence intervals. Results: ATIs quantification with clinical cutoffs showed a slight agreement between QB rapid test and In-House [ k = 0.163 (0.051–0.276)] and Immundiagnostik [ k = 0.085 (0.000–0.177)]. Regarding IFX/ATIs status, the QB rapid test showed a substantial agreement with Theradiag [ k = 0.808 (0.729–0.888)] and a fair agreement with In-House [ k = 0.343 (0.254–0.431)] and Immundiagnostik [ k = 0.217 (0.138–0.297)]. The QB rapid test could not detect ATI-positive levels in samples with exogenous IFX at 5–300 µg/ml. Interference on ATIs detection was observed at exogenous IFX ⩾30 µg/ml for In-house and Immundiagnostik assays. Conclusion: QB rapid test is only suitable to detect ATI-positive levels in the absence of IFX.

Aims: We aimed to describe the burden of rehospitalization in patients with inflammatory bowel disease (IBD), by evaluating rehospitalization rates, charges, and risk factors over 16 years. Methods: We performed a retrospective analysis of all hospital discharges with a primary diagnosis of IBD in public hospitals between 2000 and 2015 in mainland Portugal from the Central Administration of the Health System (ACSS)’s national registry. We collected data on patient, clinical, and healthcare charges. We used survival analysis to estimate the rate and risk factors of IBD-related rehospitalization. Results: We found that 33% ( n = 15,931) of the IBD-related hospitalizations corresponded to rehospitalizations, which increased by 12% over 16 years. However, IBD rehospitalization rate per 100,000 IBD patients decreased 2.5-fold between 2003 and 2015. Mean IBD-related rehospitalization charges were €14,589/hospitalization-year in 2000 and €17,548 /hospitalization-year in 2015, with total rehospitalization charges reaching €3.1 million/year by 2015. Overall, the 30-day rate of rehospitalization was 24% for Crohn’s disease (CD) and 22.4% for ulcerative colitis (UC). Novel risk factors for rehospitalization include penetrating disease in CD patients {hazard ratio (HR) 1.34 [95% confidence interval (CI) 1.20–1.51], p

Introduction and Objectives: Aortic dilatation can develop late after tetralogy of Fallot repair. Its extension beyond the aortic root is not clearly understood. We aimed to assess the prevalence and predictors of ascending aorta dilatation to set up an imaging protocol. Methods: In this prospective study including adult patients after tetralogy of Fallot repair followed at a referral center, we assessed the aorta by cardiovascular magnetic resonance and defined ascending aorta dilatation as an observed-to-expected ratio >1.5. Results: We included 78 adults (mean age 31±10 years; 56% female), with a mean follow-up of 23±7 years since tetralogy of Fallot repair. The prevalence of ascending aorta dilatation was 11.5%. The ascending aorta was larger than the sinuses of Valsalva in 12.8% of cases. Patients with ascending aorta dilatation were older, predominantly male, with later repair and larger left ventricular mass and volumes. By multivariate analysis left ventricular mass index (LVMI) was the only factor independently associated with ascending aorta dilatation (odds ratio 1.10, 95% confidence interval 1.01-1.20, p=0.03). A cut-off value of ≥57.9 g/m2 for LVMI had 89% sensitivity and 71% specificity for ascending aorta dilatation. Conclusions: Ascending aorta assessment as part of a routine cardiovascular magnetic resonance study after tetralogy of Fallot repair is recommended to screen for future aortic complications, particularly in males and older patients, and those with later repair and larger left ventricles. LVMI assessment has potential as a screening tool for ascending aorta dilatation with future clinical implications. Resumo: Introdução e objetivos: A dilatação da aorta é uma complicação tardia após correção da tetralogia de Fallot. A sua extensão além da raiz da aorta não está bem definida. Pretendemos avaliar a prevalência e os preditores de dilatação da aorta ascendente para elaborar um protocolo imagiológico. Métodos: Estudo prospetivo com adultos operados a tetralogia de Fallot seguidos num centro de referência. Estudamos a aorta por ressonância magnética cardiovascular e definimos dilatação da aorta ascendente pelo rácio observado-esperado > 1,5. Resultados: Incluímos 78 adultos (idade média 31 ± 10 anos; 56% mulheres); seguimento médio de 23 ± 7 anos desde a cirurgia. A prevalência de dilatação da aorta ascendente foi 11,5%. A aorta ascendente era maior do que os seios de Valsalva em 12,8% dos casos. Os doentes com dilatação da aorta ascendente eram mais velhos, maioritariamente homens, operados mais tarde, com massa e volumes ventriculares esquerdos maiores. Na análise multivariada a massa ventricular esquerda indexada foi a única variável independente associada a dilatação da aorta ascendente (odds ratio 1,10; intervalo de confiança de 95% 1,01-1,20; p = 0,03). A massa ventricular esquerda indexada ≥ 57,9 g/m2 apresentou uma sensibilidade de 89% e uma especificidade de 71% para dilatação da aorta ascendente. Conclusões: Recomendamos a inclusão da aorta ascendente na avaliação por ressonância magnética da tetralogia de Fallot operada, para prevenir complicações aórticas futuras, em particular em homens, doentes mais velhos, operados mais tarde e com ventrículos esquerdos maiores. A massa ventricular esquerda indexada tem potencial para ser usada no rastreio da dilatação da aorta ascendente com implicações clínicas futuras. Keywords: Aortic dilatation, Ascending aorta, Cardiovascular magnetic resonance, Tetralogy of Fallot, Palavras-chave: Dilatação da aorta, Aorta ascendente, Ressonância magnética cardiovascular, Tetralogia de Fallot

Introduction and Aims: Intrinsic aortopathy can lead to dilatation late after tetralogy of Fallot (TOF) repair. Its extent and prevalence are not known. We aimed to assess aortic dimensions and elasticity and to find predictors of aortic dilatation. Methods: A total of 126 adults were prospectively included after TOF repair and compared to 63 gender- and age-matched controls. Transthoracic echocardiography was used to assess aortic diameters at the level of the sinuses of Valsalva and ascending aorta and aortic dilatation was defined as z-score >+2. M-mode parameters of the ascending aorta were used to calculate strain, distensibility and stiffness index. Results: TOF patients (mean age 30±9 years; 52% male) had a complete repair at a median age of five (2-49) years; mean follow-up time since repair was 23±7 years. The prevalence of aortic dilatation at the sinuses of Valsalva and ascending aorta was 29% and 24%, respectively. Compared to controls, TOF patients had a higher ascending aorta z-score, lower strain (6.4% [0.0-61.5] vs. 15.2% [0.0-45.0], p +2. Parâmetros modo M da aorta ascendente foram usados para calcular strain, distensibilidade e índice de rigidez. Resultados: Doentes com tetralogia de Fallot (idade média 30 ± 9 anos; 52% homens) foram operados com uma idade mediana de 5 (2-49) anos; tempo médio de seguimento desde a cirurgia 23 ± 7 anos. A prevalência de dilatação dos seios de Valsalva e da aorta ascendente foi 29% e 24%, respetivamente. Comparado aos controlos, os doentes com tetralogia de Fallot apresentaram maior z-score da aorta ascendente, menor strain (6,4 [0,0-61,5] versus 15,2 [0,0-45,0]%; p < 0,01) e maior índice de rigidez (7,3 [0,8-23,6] versus 3,1 [0,9-14,1]; p < 0,01). Na análise multivariada o sexo masculino associou-se significativamente à dilatação dos seios de Valsalva (odds ratio 6,3, intervalo de confiança de 95% 1,5-26,3; p = 0,01). Conclusões: Na tetralogia de Fallot operada há uma prevalência significativa de dilatação tardia da aorta, com a aorta ascendente maior e mais rígida. O sexo masculino parece influenciar a dilatação da raiz da aorta. Esta aortopatia requer um seguimento cuidadoso para evitar complicações futuras. Keywords: Aortic dilatation, Aortic elasticity, Tetralogy of Fallot, Transthoracic echocardiography, Palavras-chave: Dilatação aórtica, Elasticidade aórtica, Tetralogia de Fallot, Ecocardiografia transtorácica

Patients’ and carers’ views regarding the Portuguese model of home respiratory care were recently described, yet the complementary perspective of healthcare professionals (HCPs) is still to be investigated. Thus, this study explored HCPs experience in the management of patients needing home respiratory therapies (HRT), and their perspective about the Portuguese model. A phenomenological descriptive study, using focus groups, was carried out with 28 HCPs (median 42 y, 68% female) with distinct backgrounds (57% pulmonologists, 29% clinical physiologists, 7% physiotherapists, 7% nurses). Three focus groups were conducted in three regions of Portugal. Thematic analysis was performed by two independent researchers. HCPs have in general a positive view about the organization of the Portuguese model of home respiratory care, which was revealed in four major topics: Prescription (number of references, n = 171), Implementation and maintenance (n = 162), Carer involvement (n = 65) and Quality of healthcare (n = 247). Improvements needed were related to patients’ late referral, HRT prescription (usability of the medical electronic prescription system and renewals burden), patients’ education, access to hospital care team, lack of multidisciplinary work and articulation between hospital, primary and home care teams. This study describes the perspective of HCPs about the Portuguese model of home respiratory care and identifies specific points where improvements and reflections are needed. This knowledge may be useful to decision makers improve the current healthcare model.

Although infliximab (IFX) is an efficient therapy for ulcerative colitis (UC) patients, a considerably high rate of therapeutic failures still occurs. This study aimed at a better understanding of IFX pharmacokinetics and pharmacodynamics among clinically-asymptomatic UC patients. This was a multicentric and prospective study involving 65 UC patients in the maintenance phase of IFX therapy. There were no significant differences between patients with positive and negative clinical, endoscopic and histological outcomes concerning their IFX trough levels (TLs), area under the IFX concentration vs. time curve (AUC), clearance and antibodies to infliximab (ATI) levels. However, the need to undergo therapeutic escalation later in disease development was significantly associated with higher ATI levels (2.62 μg/mL vs. 1.15 μg/mL, p = 0.028). Moreover, and after adjusting for disease severity, the HR (hazard ratio) for therapeutic escalation was significantly decreased for patients with an ATI concentration below 3 μg/mL (HR = 0.119, p = 0.010), and increased for patients with fecal calprotectin (FC) level above 250 μg/g (HR = 9.309, p = 0.018). In clinically-stable UC patients, IFX pharmacokinetic features cannot predict therapeutic response on a short-term basis. However, high levels of ATIs or FC may be indicative of a future therapeutic escalation.

Inflammatory bowel disease (IBD) is increasingly prevalent within western societies. Its complex and chronic facets in addition to its increasing prevalence place a great economic burden on our healthcare systems. Our aim was to estimate the national prevalence of IBD through predictive models. We used prevalence data which spans the years 2003–2007 to estimate prevalence until 2030 by means of four forecasting methods. Prevalence rates are estimated to be 4–6-times higher in 2030 when compared with 2003 with an average annual percent change of 5%. IBD is poised to have a substantial impact on healthcare systems in the near future, given its rapidly increasing prevalence. Forecasting methods will allow for a proactive stance on the development of health policies that will be needed to provide high quality and cost-effective care to these patients, while ensuring the economic viability of healthcare systems.

Chronic kidney disease (CKD) is an independent risk factor for adverse cardiovascular and cerebrovascular events (MACCEs), and mortality since the earlier stages. Therefore, it is critical to identify the link between CKD and cardiovascular risk (CVR) through early and reliable biomarkers. Acknowledging that CKD and CKD progression are associated with increased sympathetic tone, which is implicated in CVR, and that renalase metabolizes catecholamines, we aimed to evaluate the relationship between renalase serum levels (RNLS) and cardiovascular and renal outcomes. The study included 40 pre-dialysis CKD patients (19F:21M) with median age of 61 (IQ 45–66) years. At baseline, we measured RNLS as well as routine biomarkers of renal and cardiovascular risk. A prospective analysis was performed to determine whether RNLS are associated with CKD progression, MACCEs, hospitalizations and all-cause mortality. At baseline, the median level of RNLS and median estimated glomerular filtration rate (eGFR) were 63.5 (IQ 48.4–82.7) µg/mL and 47 (IQ 13–119) mL/min/1.73 m2, respectively. In univariate analysis, RNLS were strongly associated with eGFR, age and Charlson Index. Over the course of a mean follow-up of 65 (47 to 70) months, 3 (7.5%) deaths, 2 (5%) fatal MACCEs, 17 (42.5%) hospital admissions occurred, and 16 (40%) patients experienced CKD progression. In univariate analysis, RNLS were associated with CKD progression (p = 0.001), hospitalizations (p = 0.001) and all-cause mortality (p = 0.022) but not with MACCEs (p = 0.094). In adjusted analysis, RNLS predicted CKD progression and hospitalizations regardless of age, Charlson comorbidity index, cardiovascular disease, hypertension, diabetes and dyslipidemia. Our results suggest that RNLS, closely related with renal function, might have a potential role as predictor of renal outcomes, hospitalizations, and mortality in pre-dialysis CKD patients.

Background: Patients with chronic kidney disease (CKD) have markedly increased rates of end stage renal disease, major adverse cardiovascular/cerebrovascular events (MACCEs), and mortality. Endothelial dysfunction (ED) is an early marker of atherosclerosis that is emerging as an increasingly important non-traditional cardiovascular risk factor in CKD. There is a lack of clinical studies examining the association between ED and both cardiovascular and renal endpoints in patients with CKD. Aims: We examined the association between reactive hyperemia index (RHI), a validated measure of endothelial function measured by peripheral arterial tonometry (PAT), with traditional cardiovascular risk factors in pre-dialysis CKD patients and prospectively evaluated the role of RHI as predictor of renal and cardiovascular outcomes in this population. Methods: One hundred and twenty pre-dialysis patients with CKD stages 1 to 5 (CKD group) and 18 healthy kidney donor candidates (control group) were recruited and had a successful RHI measurement by PAT. General demographic and clinical information including traditional cardiovascular risk factors were registered from all participants. Thereafter, patients were prospectively followed-up for a median time of 47 (IQR 19–66) months to determine associations of RHI with renal outcomes, MACCEs, hospitalizations or mortality. Results: In the CKD patient population, the mean age was 57.7 ± 15.5 years, the mean eGFR was 54.9 ± 36.7 mL/min/1.73 m2 (CKD-EPI) and 57 were males (47.5%). At baseline, in univariate analysis, RHI in the CKD group correlated positively with eGFR (r = 0.332, p < 0.0001) and correlated negatively with age (r = −0.469, p < 0.0001), Charlson index (r = −0.399, p < 0.0001), systolic blood pressure (r = −0.256, p = 0.005), and proteinuria (r = 0.211, p = 0.027). Reactive hyperemia index in the control group did not significantly differ from RHI observed in patients with CKD stages 1 to 5 (2.09 ± 0.40 vs. 2.01 ± 0.06, p = 0.493). In adjusted analysis, only age (β = −0.014, p = 0.003) remained independently associated with RHI at baseline. During follow-up, 8 patients suffered a MACCEs, 33 patients experienced renal function deterioration, 17 patients were hospitalized for medical reasons and 6 patients died. RHI at baseline was not significantly associated with CKD progression (1.94 vs. 2.02, p = 0.584), hospitalizations (1.90 vs. 2.04, p = 0.334), and all-cause mortality (1.65 vs. 2.01, p = 0.208) or MACCEs (1.77 vs. 2.01, p = 0.356), but was significantly associated with cerebrovascular events (1.27 vs. 2.02, p = 0.004) and with a composite cardiovascular outcome (MACCEs, hospital admissions and death; 1.73 vs. 2.07, p = 0.035). Conclusion: Our results suggest that RHI may be a predictor for the development of cerebrovascular events in pre-dialysis CKD patients who may benefit from more aggressive preventive measures.

Background: Patency capsule was developed to avoid small bowel video capsule endoscopy retention, namely in patients with Crohn's disease. Aims: To evaluate the predictive factors of small bowel patency in Crohn's disease patients. Patients and methods: Retrospective analysis including 151 Crohn's disease patients submitted to patency capsule (Agile® Patency Capsule) from 2011 to 2012. Patients that excreted the intact patency capsule were classified as having a patent small bowel (without patency capsule retention), other patients were considered to have negative patency of the small bowel (patency capsule retention). Results: Patients had a mean age of 41±14 years, 54% were female and 25% had been previously submitted to surgery. Stricturing disease was seen in 20% of cases and penetrating disease in 16% of cases. Left-sided colonic lesions and ileal strictures were observed at colonoscopy in 13% and 9% of patients, respectively. In our sample, 28% of patients had negative patency of the small bowel (patency capsule retention). In multivariate analysis, independent factors that were associated with negative patency of the small bowel in Crohn's disease patients were stricturing (OR 10.16, p < 0.001) and penetrating phenotypes (OR 11.73, p = 0.001), left-sided colonic lesions (OR 3.77, p = 0.038), ileal stricture (OR 9.76, p = 0.003); previous intestinal surgery was found to be protective (OR 0.16, p = 0.006). Conclusions: Stricturing or penetrating disease, ileal strictures, no previous surgery and left-sided colonic lesions were the factors associated with negative small bowel patency in Crohn's disease patients.

Background: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. Methods: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy. Results: The quantification of the spiked samples unveiled a consistent and accurate behaviour of three of the tested methods, with average percentage recoveries of 90%, 102% and 109%. Results from the clinical samples demonstrated that these three assays were also highly correlated, both concerning Spearman’s rank coefficients (range 0.890–0.947) and intraclass correlation coefficients (range 0.907–0.935). There were a few systematic deviations among them, but their impact in the clinical stratification of the patients using different cut-offs was minimal, particularly when these cut-offs were in the 3–4 µg/ml range, for which the strength of agreement (as assessed by the Kappa statistics that ranged from 0.732 to 0.902) was substantial to almost perfect. Conclusions: Our results indicate that three of the tested IFX quantification methods can be used to accurately quantify CT-P13 without any adjustments.

Background: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. Methods: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit. Results: Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman’s rank correlation coefficient = 0.843, p < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791–0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 µg/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 µg/ml was 88% both for a Mayo endoscopic score ⩽ 1 and for an FC concentration

Background and study aims Efficacy and adverse events probabilities influence decisions regarding the best options to manage patients with gastric superficial lesions. We aimed at developing a Bayesian model to individualize the prediction of outcomes after gastric endoscopic submucosal dissection (ESD). Patients and methods Data from 245 gastric ESD were collected, including patient and lesion factors. The two endpoints were curative resection and post-procedural bleeding (PPB). Logistic regression and Bayesian networks were built for each outcome; their predictive value was evaluated in-sample and validated through leave-one-out and cross-validation. Clinical decision support was enhanced by the definition of risk matrices, direct use of Bayesian inference software and by a developed online platform. Results ESD was curative in 85.3 % and PPB occurred in 7.7 % of patients. In univariate analysis, male sex, ASA status, carcinoma histology, polypoid or depressed morphology, and lesion size ≥ 20 mm were associated with non-curative resection, while ASA status, antithrombotics and lesion size ≥ 20 mm were associated with PPB. Naïve Bayesian models presented AUROCs of ~80 % in the derivation cohort and ≥ 74 % in cross-validation for both outcomes. Risk matrices were computed, showing that lesions with cancer at biopsies, ≥ 20 mm, proximal or in the middle third, and polypoid are more prone to non-curative resection. PPB risk was

INTRODUCTION:Crohn's disease (CD) is a chronic inflammatory bowel disease known to carry a high risk of disabling and many times requiring surgical interventions. This article describes a decision-tree based approach that defines the CD patients' risk or undergoing disabling events, surgical interventions and reoperations, based on clinical and demographic variables. MATERIALS AND METHODS:This multicentric study involved 1547 CD patients retrospectively enrolled and divided into two cohorts: a derivation one (80%) and a validation one (20%). Decision trees were built upon applying the CHAIRT algorithm for the selection of variables. RESULTS:Three-level decision trees were built for the risk of disabling and reoperation, whereas the risk of surgery was described in a two-level one. A receiver operating characteristic (ROC) analysis was performed, and the area under the curves (AUC) Was higher than 70% for all outcomes. The defined risk cut-off values show usefulness for the assessed outcomes: risk levels above 75% for disabling had an odds test positivity of 4.06 [3.50-4.71], whereas risk levels below 34% and 19% excluded surgery and reoperation with an odds test negativity of 0.15 [0.09-0.25] and 0.50 [0.24-1.01], respectively. Overall, patients with B2 or B3 phenotype had a higher proportion of disabling disease and surgery, while patients with later introduction of pharmacological therapeutic (1 months after initial surgery) had a higher proportion of reoperation. CONCLUSIONS:The decision-tree based approach used in this study, with demographic and clinical variables, has shown to be a valid and useful approach to depict such risks of disabling, surgery and reoperation.

Background: There is scant information on the accuracy of different assays used to measure anti-infliximab antibodies (ADAs), especially in the presence of detectable infliximab (IFX). We thus aimed to evaluate and compare three different assays for the detection of IFX and ADAs and to clarify the impact of the presence of circulating IFX on the accuracy of the ADA assays. Methods: Blood samples from 79 ulcerative colitis (UC) patients treated with infliximab were assessed for IFX levels and ADAs using three different assays: an in-house assay and two commercial kits, Immundiagnostik and Theradiag. Sera samples with ADAs and undetectable levels of IFX were spiked with exogenous IFX and analyzed for ADAs. Results: The three assays showed 81–96% agreement for the measured IFX level. However, the in-house assay and Immundiagnostik assays detected ADAs in 34 out of 79 samples, whereas Theradiag only detected ADAs in 24 samples. Samples negative for ADAs with Theradiag, but ADA-positive in both the in-house and Immundiagnostik assays, were positive for IFX or IgG4 ADAs. In spiking experiments, a low concentration of exogenous IFX (5 µg/ml) hampered ADA detection with Theradiag in sera samples with ADA levels of between 3 and 10 µg/ml. In the Immundiagnostik assay detection interference was only observed at concentrations of exogenous IFX higher than 30 µg/ml. However, in samples with high levels of ADAs (>25 µg/ml) interference was only observed at IFX concentrations higher than 100 µg/ml in all three assays. Binary (IFX/ADA) stratification of the results showed that IFX+/ADA- and IFX-/ADAs+ were less influenced by the assay results than the double-positive (IFX+/ADAs+) and double-negative (IFX-/ADAs-) combination. Conclusions: All three methodologies are equally suitable for measuring IFX levels. However, erroneous therapeutic decisions may occur when patients show double-negative (IFX-/ADAs-) or double-positive (IFX+/ADAs+) status, since agreement between assays is significantly lower in these circumstances.

Unmet needs are becoming acknowledged as better predictors of the worst prognostic outcomes than common measures of functional or cognitive decline. Their accurate assessment is a pivotal component of effective care delivery, particularly in institutionalized care where little is known about the needs of its residents, many of whom suffer from dementia and show complex needs. The aims of this study were to describe the needs of an institutionalized sample and to analyze its relationship with demographic and clinical characteristics. A cross-sectional study was conducted with a sample from three nursing homes. All residents were assessed with a comprehensive protocol that included Mini Mental State Examination (MMSE), Geriatric Depression Scale (GDS15), Neuropsychiatric Inventory (NPI) and Adults and Older Adults Functional Inventory (IAFAI). To identify needs, the Camberwell Assessment of Need for the Elderly (CANE) was used. The final sample included 175 residents with a mean age of 80.6(sd=10.1). From these, 58.7% presented cognitive deficit (MMSE) and 45.2% depressive symptoms (GDS). Statistically significant negative correlations were found between MMSE score and met(rs=-0.425), unmet(rs=-0.369) and global needs(rs=-0.565). Data also showed significant correlations between depressive symptoms and unmet(rs=0.683) and global needs(rs=0.407) and between behavioral and psychological symptoms (BPSD) and unmet (rs=0.181) and global needs (rs=0.254). Finally, significant correlations between functional impairment and met(rs=0.642), unmet(rs=0.505) and global needs(rs=0.796) were also found. These results suggest that in this sample, more unmet needs are associated with the worst outcomes measured. This is consistent with previous findings and seems to demonstrate that the needs of those institutionalized elderly remain under-diagnosed and untreated.

Background: Patient-controlled epidural analgesia with low concentrations of anesthetics is effective in reducing labor pain. The aim of this study was to assess and compare two ultra-low dose regimens of ropivacaine and sufentanil (0.1% ropivacaine plus 0.5 μg.ml-1 sufentanil vs. 0.06% ropivacaine plus 0.5 μg.ml-1 sufentanil) on the intervals between boluses and the duration of labor. Material and Methods: In this non-randomized prospective study, conducted between January and July 2010, two groups of parturients received patient-controlled epidural analgesia: Group I (n = 58; 1 mg.ml-1 ropivacaine + 0.5 μg.ml-1 sufentanil) and Group II (n = 57; 0.6 mg.ml-1 ropivacaine + 0.5 μg.ml-1 sufentanil). Rescue doses of ropivacaine at the concentration of the assigned group without sufentanil were administered as necessary. Pain, local anesthetic requirements, neuraxial blockade characteristics, labor and neonatal outcomes, and maternal satisfaction were recorded. Results: The ropivacaine dose was greater in Group I (9.5 [7.7-12.7] mg.h-1 vs. 6.1 [5.1-9.8 mg.h-1], p < 0.001). A time increase between each bolus was observed in Group I (beta = 32.61 min, 95% CI [25.39; 39.82], p < 0.001), whereas a time decrease was observed in Group II (beta = -1.40 min, 95% CI [-2.44; -0.36], p = 0.009). The duration of the second stage of labor in Group I was significantly longer than that in Group II (78 min vs. 65 min, p < 0.001). Conclusions: Parturients receiving 0.06% ropivacaine exhibited less evidence of cumulative effects and exhibited faster second stage progression than those who received 0.1% ropivacaine. Keywords: Analgesia, Obstetrical; Analgesia, Patient-Controlled; Labor Pain; Ropivacaine; Sufentanil.