Xpert Bladder Cancer Monitor for the Early Detection of Non-Muscle Invasive Bladder Cancer Recurrences: Could Cystoscopy Be Substituted?

Biomarker; Bladder cancer; SurveillanceBiomarcador; Cáncer de vejiga; VigilanciaBiomarcador; Càncer de bufeta; VigilànciaXBM was prospectively assessed in spontaneous urine collected just before flexible cystoscopy and washing cytology carried out within the first 2 years follow-up of 337 patients with NMIBC. Recurrences were pathologically confirmed in 49 patients (14.5%), 22 of them being high-risk (6.5%). The XBM sensitivity for detecting any type of recurrence was 69.4% and 63.6% in the cases of high-risk NMIBC. Negative predictive value (NPV) for XBM was 93% for all recurrences and 96.2% for high-risk recurrences. XBM could have avoided 213 invasive controls but missed the detection of 15 recurrences (30.6%)-8 of them of high-risk (36.4%). XBM false positive elevations were detected in 90 patients (26.7%), whereas 10 patients with the invasive method had a false positive result (3%), p <0.001. However, early detection of recurrences during the first year's follow-up after an XBM false positive result was observed in 18 patients (20%). On the other hand, 19 recurrences were detected during this period among the rest of the patients (7.7%)-p = 0.003, and odds ratio (OR) 3.0 (95% CI 1.5-6.0). Regarding one-year follow-up recurrences, 10% were high-risk recurrences in the XBM false positive group and 3.2% in the rest of the patients-p = 0.021, and OR 3.3 (95% CI 1.2-8.9). Additionally, 11.3% of the patients without false positive results developed a recurrence, p = 0.897, for any recurrence, being 10% and 5.2%, respectively, and high-risk and low-risk recurrences, p = 0.506. After searching for the best XBM cutoff for detecting the 38 high-risk initial recurrences and the early high-risk recurrences after a one-year follow-up, a linear discriminant analysis (LDA) of 0.13 could have avoided 11.3% of cystoscopies and bladder wash cytologies, as this cutoff missed only 1 high-risk recurrence (2.6%). More extensive and well-designed studies will confirm if XBM can improve the surveillance of NMIBC

Effectiveness of community-based integrated care in frail COPD patients: a randomised controlled trial

Background: Chronic obstructive pulmonary disease (COPD) generates a high burden on health care, and hospital admissions represent a substantial proportion of the overall costs of the disease. Integrated care (IC) has shown efficacy to reduce hospitalisations in COPD patients at a pilot level. Deployment strategies for IC services require assessment of effectiveness at the health care system level. Aims: The aim of this study was to explore the effectiveness of a community-based IC service in preventing hospitalisations and emergency department (ED) visits in stable frail COPD patients. Methods: From April to December 2005, 155 frail community-dwelling COPD patients were randomly allocated either to IC (n=76, age 73 (8) years, forced expiratory volume during the first second, FEV1 41(19) % predicted) or usual care (n=84, age 75(9) years, FEV1 44 (20) % predicted) and followed up for 12 months. The IC intervention consisted of the following: (a) patient’s empowerment for self-management; (b) an individualised care plan; (c) access to a call centre; and (d) coordination between the levels of care. Thereafter, hospital admissions, ED visits and mortality were monitored for 6 years. Results: IC enhanced self-management (P=0.02), reduced anxiety–depression (P=0.001) and improved health-related quality of life (P=0.02). IC reduced both ED visits (P=0.02) and mortality (P=0.03) but not hospital admission. No differences between the two groups were seen after 6 years. Conclusion: The intervention improved clinical outcomes including survival and decreased the ED visits, but it did not reduce hospital admissions. The study facilitated the identification of two key requirements for adoption of IC services in the community: appropriate risk stratification of patients, and preparation of the community-based work force

The Star Formation History of the Local Group dwarf galaxy Leo I

We present a quantitative analysis of the star formation history (SFH) of the Local Group dSph galaxy Leo I, from the information in its HST [(V-I),I] color-magnitude diagram (CMD). The method we use is based in comparing, via synthetic CMDs, the expected distribution of stars in the CMD for different evolutionary scenarios, with the observed distribution. We consider the SFH to be composed by the SFR(t), the Z(t), the IMF, and a function $\beta(f,q)$, controlling the fraction $f$ and mass ratio distribution $q$ of binary stars. The comparison between the observed CMD and the model CMDs is done through chi-square minimization of the differences in the number of stars in a set of regions of the CMD. Our solution for the SFH of Leo I defines a minimum of chi-square in a well defined position of the parameter space, and the derived SFR(t) is robust, in the sense that its main characteristics are unchanged for different combinations of the remaining parameters. However, only a narrow range of assumptions for Z(t), IMF and $\beta(f,q)$ result in a good agreement between the data and the models, namely: Z=0.0004, a Kroupa et al. (1993) IMF or slightly steeper, and a relatively large fraction of binary stars. Most star formation activity (70% to 80%) occurred between 7 and 1 Gyr ago. At 1 Gyr ago, it abruptly dropped to a negligible value, but seems to have been active until at least ~ 300 Myr ago. Our results don't unambiguously answer the question of whether Leo I began forming stars around 15 Gyr ago, but it appears that the amount of this star formation, if existing at all, would be small.Comment: 25 pages + 14 figures. Accepted by The Astronomical Journa

Prospective cohort study for assessment of integrated care with a triple aim approach: hospital at home as use case

Background: Applicability of comprehensive assessment of integrated care services in real world settings is an unmet need. To this end, a Triple Aim evaluation of Hospital at Home (HaH), as use case, was done. As ancillary aim, we explored use of the approach for monitoring the impact of adoption of integrated care at health system level in Catalonia (Spain). Methods: Prospective cohort study over one year period, 2017-2018, comparing hospital avoidance (HaH-HA) with conventional hospitalization (UC) using propensity score matching. Participants were after the first episode directly admitted to HaH-HA or the corresponding control group. Triple Aim assessment using multiple criteria decision analysis (MCDA) was done. Moreover, applicability of a Triple Aim approach at health system level was explored using registry data. Results: HaH-HA depicted lower: i) Emergency Room Department (ER) visits (p < .001), ii) Unplanned re-admissions (p = .012); and iii) costs (p < .001) than UC. The weighted aggregation of the standardized values of each of the eight outcomes, weighted by the opinions of the stakeholder groups considered in the MCDA: i) enjoyment of life; ii) resilience; iii) physical functioning; iv) continuity of care; v) psychological wellbeing; (vi) social relationships & participation; (vii) person-centeredness; and (viii) costs, indicated better performance of HaH-HA than UC (p < .05). Actionable factors for Triple Aim assessment of the health system with a population-health approach were identified. Conclusions: We confirmed health value generation of HaH-HA. The study identified actionable factors to enhance applicability of Triple Aim assessment at health system level for monitoring the impact of adoption of integrated care. Registration: ClinicalTrials.gov (26/04/2017; NCT03130283). Keywords: Chronic care, Health Delivery Assessment, Health Services Research, Hospital at Home, Implementation Science, Multiple Criteria Decision Analysis, Triple Ai

Exploratory study of an oral screening dysplasia program for HIV-infected men who have sex with men

Dysplasia; Screening; HIV-infectedDisplasia; Cribado; Infectado por el VIHDisplàsia; Cribratge; Infectat pel VIHBackground: HIV-infected men who have sex with men (MSM) are at high risk to develop human papilloma virus (HPV)-related oropharyngeal cancer. The aim of our study was to assess the usefulness of a pilot oral dysplasia screening program and its correlation with an anal dysplasia screening program. Methods: This was a prospective study with HIV-infected MSM. Oral and anal screenings were performed based on HPV determination, liquid cytology, direct and microscopy oral examinations, high-resolution anoscopy and biopsies, if necessary. Results: A total of 103 patients were included. The mean age of the patients was 44.6 years, 55.3% were smokers, and 57.3% had a history of previous anal high-grade squamous intraepithelial lesions (HSILs). The prevalence of oral HPV infections was 14% (9% HPV-high risk), the prevalence of abnormal cytology was 25.2%, and in 4.8% of the patients, oral examinations showed suspicious HSILs. Oral microscopy did not detect additional lesions that visual inspection. Five oral biopsies were performed and the results were normal. No risk factors for oral HPV infections were identified. The prevalence of anal HPV infections was 88.3% (76.7% HPV-high risk), 52.9% of the patients had altered cytology, and in 45.6% anoscopy showed changes suggestive of HSILs. Seventy-two anal biopsies were performed, detecting 25 cases of HSILs (24.3%). A poor correlation was observed between oral and anal HPV infections (κ = 0.037). Conclusions: The prevalence of oral HPV infections, abnormal cytology and lesions in HIV-infected MSM was low, and their correlation with anal HPV-related lesions was slight. These results confirm the current barriers to oral dysplasia screening techniques.Study funded by program MISP of MSD (Merck HPV Investigator Study Program). MISP project code 58237

Evaluation of integrated care services in Catalonia:population-based and service-based real-life deployment protocols

BackgroundComprehensive assessment of integrated care deployment constitutes a major challenge to ensure quality, sustainability and transferability of both healthcare policies and services in the transition toward a coordinated service delivery scenario. To this end, the manuscript articulates four different protocols aiming at assessing large-scale implementation of integrated care, which are being developed within the umbrella of the regional project Nextcare (2016-2019), undertaken to foster innovation in technologically-supported services for chronic multimorbid patients in Catalonia (ES) (7.5M inhabitants).Whereas one of the assessment protocols is designed to evaluate population-based deployment of care coordination at regional level during the period 2011-2017, the other three are service-based protocols addressing: i) Home hospitalization; ii) Prehabilitation for major surgery; and, iii) Community-based interventions for frail elderly chronic patients. All three services have demonstrated efficacy and potential for health value generation. They reflect different implementation maturity levels. While full coverage of the entire urban health district of Barcelona-Esquerra (520k inhabitants) is the main aim of home hospitalization, demonstration of sustainability at Hospital Clinic of Barcelona constitutes the core goal of the prehabilitation service. Likewise, full coverage of integrated care services addressed to frail chronic patients is aimed at the city of Badalona (216k inhabitants).MethodsThe population-based analysis, as well as the three service-based protocols, follow observational and experimental study designs using a non-randomized intervention group (integrated care) compared with a control group (usual care) with a propensity score matching method. Evaluation of cost-effectiveness of the interventions using a Quadruple aim approach is a central outcome in all protocols. Moreover, multi-criteria decision analysis is explored as an innovative method for health delivery assessment. The following additional dimensions will also be addressed: i) Determinants of sustainability and scalability of the services; ii) Assessment of the technological support; iii) Enhanced health risk assessment; and, iv) Factors modulating service transferability.DiscussionThe current study offers a unique opportunity to undertake a comprehensive assessment of integrated care fostering deployment of services at regional level. The study outcomes will contribute refining service workflows, improving health risk assessment and generating recommendations for service selection.Trials registrationNCT03130283 (date released 04/06/2018), NCT03768050 (date released 12/05/2018), NCT03767387 (date released 12/05/2018).</p

Grupo español de cirugía torácica asistida por videoimagen: método, auditoría y resultados iniciales de una cohorte nacional prospectiva de pacientes tratados con resecciones anatómicas del pulmón

Introduction: our study sought to know the current implementation of video-assisted thoracoscopic surgery (VATS) for anatomical lung resections in Spain. We present our initial results and describe the auditing systems developed by the Spanish VATS Group (GEVATS). Methods: we conducted a prospective multicentre cohort study that included patients receiving anatomical lung resections between 12/20/2016 and 03/20/2018. The main quality controls consisted of determining the recruitment rate of each centre and the accuracy of the perioperative data collected based on six key variables. The implications of a low recruitment rate were analysed for '90-day mortality' and 'Grade IIIb-V complications'. Results: the series was composed of 3533 cases (1917 VATS; 54.3%) across 33 departments. The centres' median recruitment rate was 99% (25-75th:76-100%), with an overall recruitment rate of 83% and a data accuracy of 98%. We were unable to demonstrate a significant association between the recruitment rate and the risk of morbidity/mortality, but a trend was found in the unadjusted analysis for those centres with recruitment rates lower than 80% (centres with 95-100% rates as reference): grade IIIb-V OR=0.61 (p=0.081), 90-day mortality OR=0.46 (p=0.051). Conclusions: more than half of the anatomical lung resections in Spain are performed via VATS. According to our results, the centre's recruitment rate and its potential implications due to selection bias, should deserve further attention by the main voluntary multicentre studies of our speciality. The high representativeness as well as the reliability of the GEVATS data constitute a fundamental point of departure for this nationwide cohort

Case-Control Analysis of the Impact of Anemia on Quality of Life in Patients with Cancer: A Qca Study Analysis

The impact of anemia on the quality of life (QoL) in cancer patients has been studied previously; however, the cut-off point used to define anemia differed among studies, thus providing inconsistent results. Therefore, we analysed the clinical impact of anemia on QoL using the same cut-off point for hemoglobin level to define anemia as that used in ESMO clinical practice guidelines. This post-hoc analysis aimed to determine the impact of anemia on QoL in cancer patients through the European Organization for Research and Treatment of Cancer Quality of life questionnaire version 3.0 (EORTC QLQ-C30) and Euro QoL 5-dimension 3-level (EQ-5D-3L) questionnaire. We found that cancer patients with anemia had significantly worse QoL in clinical terms. In addition, anemic patients had more pronounced symptoms than those in non-anemic patients. Anemia is a common condition in cancer patients and is associated with a wide variety of symptoms that impair quality of life (QoL). However, exactly how anemia affects QoL in cancer patients is unclear because of the inconsistencies in its definition in previous reports. We aimed to examine the clinical impact of anemia on the QoL of cancer patients using specific questionnaires. We performed a post-hoc analysis of a multicenter, prospective, case-control study. We included patients with cancer with (cases) or without (controls) anemia. Participants completed the European Organization for Research and Treatment of Cancer Quality of Life questionnaire version 3.0 (EORTC QLQ-C30) and Euro QoL 5-dimension 3-level (EQ-5D-3L) questionnaire. Statistically significant and clinically relevant differences in the global health status were examined. From 2015 to 2018, 365 patients were included (90 cases and 275 controls). We found minimally important differences in global health status according to the EORTC QLQ-C30 questionnaire (case vs. controls: 45.6 vs. 58%, respectively; mean difference: -12.4, p < 0.001). Regarding symptoms, cancer patients with anemia had more pronounced symptoms in six out of nine scales in comparison with those without anemia. In conclusion, cancer patients with anemia had a worse QoL both clinically and statistically

Genetically predicted telomere length and Alzheimer’s disease endophenotypes: a Mendelian randomization study

Telomere length (TL) is associated with biological aging, consequently influencing the risk of age-related diseases such as Alzheimer's disease (AD). We aimed to evaluate the potential causal role of TL in AD endophenotypes (i.e., cognitive performance, N = 2233; brain age and AD-related signatures, N = 1134; and cerebrospinal fluid biomarkers (CSF) of AD and neurodegeneration, N = 304) through a Mendelian randomization (MR) analysis. Our analysis was conducted in the context of the ALFA (ALzheimer and FAmilies) study, a population of cognitively healthy individuals at risk of AD. A total of 20 single nucleotide polymorphisms associated with TL were used to determine the effect of TL on AD endophenotypes. Analyses were adjusted by age, sex, and years of education. Stratified analyses by APOE-epsilon 4 status and polygenic risk score of AD were conducted. MR analysis revealed significant associations between genetically predicted longer TL and lower levels of CSF A beta and higher levels of CSF NfL only in APOE-epsilon 4 non-carriers. Moreover, inheriting longer TL was associated with greater cortical thickness in age and AD-related brain signatures and lower levels of CSF p-tau among individuals at a high genetic predisposition to AD. Further observational analyses are warranted to better understand these associations

integrated care for complex chronic patients

Background: In 2006, 35% - 40% of the population in the EU aged > 65 years reported a longstanding health problem and one in four currently receives medical long-term treatment. In Catalonia, data from the 2011-2015 health plan reported that about 30% of the general population has at least one chronic disorder. It is widely accepted that this increasingly important group of the population may suffer frequent unexpected hospital admissions or emergency room visits because of clinical or social circumstances triggering adverse outcomes. Accordingly, the Complex Chronic Patient (CCP) is defined as a patient with at least one+ chronic diseases, comorbidities, frail (due to social, economic and/or clinical factors), usually elderly, and who consumes a very high level of health resources. Although CCPs comprise about 5% of the general population, their health care needs consume an estimated 40% plus of all hospital admissions. Methods: CONNECARE (H2020-PHC-2015-689802) aims to develop and evaluate a new organizational model to enable integrated care of CCPs, supported by technological solutions following an adaptive case management approach. From the CCP's perspective, different healthcare professionals are central to patients' care: the general practitioners, specialist doctors, other hospital staff, and social workers. Moreover, the carers, unpaid relatives or friends, who typically deliver the majority of care that CCPs require, are indispensable. The CONNECARE integrated care organizational model will facilitate collaboration and communication among healthcare professionals, patients and their carers through integrated technological solutions in which the patients play a central role. CONNECARE will also support and empower patients for self-management, by providing them recommendations and suggestions according to continuous monitoring of their activities. CONNECARE will be deployed in three regions: Catalonia (Spain), Israel, and Groningen (the Netherlands). Results: The CONNECARE integrated care solution is built upon the experience of on-going large-scale deployment programs in each of the participating sites and the inclusion of the main stakeholders in the process (healthcare professionals, patients, carers, insurance companies, and policy makers). Therefore, a co-design methodology has been established to capture the feed-back of all actors in the integrated care process. Three clinical studies have been defined for field-testing the CONNECARE solution that will then be performed and evaluated (October 2016 to March 2019) in the three regions: community-based management of CCP, and integrated management of patients undergoing surgical procedures with a specific use case for pre-habilitation of high risk candidates for complex abdominal surgical procedures –which will only be performed and evaluated in Barcelona. The purposes of the clinical studies are: (i) assessing health value generation of the CONNECARE solution; (ii) enabling its refinement and fine tuning during the last six-month period; and (iii) generating guidelines for transferability of CONNECARE achievements to other sites. Conclusions: The ambition of CONNECARE is to co-design, develop, deploy, and evaluate a novel integrated care services model supported by a smart and adaptive case management system for better care coordination and self-management of CCPs. Pragmatic clinical trials will be held in the three sites to assess the health value generation of the CONNECARE solution. Guidelines for the transferability of CONNECARE achievements to other sites will be developed. This will save European healthcare organizations huge sums whilst improving patient outcomes