A Personalized Ontology-Based Decision Support System for Complex Chronic Patients: Retrospective Observational Study.

BACKGROUND: Due to an increase in life expectancy, the prevalence of chronic diseases is also on the rise. Clinical practice guidelines (CPGs) provide recommendations for suitable interventions regarding different chronic diseases, but a deficiency in the implementation of these CPGs has been identified. The PITeS-TiiSS (Telemedicine and eHealth Innovation Platform: Information Communications Technology for Research and Information Challenges in Health Services) tool, a personalized ontology-based clinical decision support system (CDSS), aims to reduce variability, prevent errors, and consider interactions between different CPG recommendations, among other benefits. OBJECTIVE: The aim of this study is to design, develop, and validate an ontology-based CDSS that provides personalized recommendations related to drug prescription. The target population is older adult patients with chronic diseases and polypharmacy, and the goal is to reduce complications related to these types of conditions while offering integrated care. METHODS: A study scenario about atrial fibrillation and treatment with anticoagulants was selected to validate the tool. After this, a series of knowledge sources were identified, including CPGs, PROFUND index, LESS/CHRON criteria, and STOPP/START criteria, to extract the information. Modeling was carried out using an ontology, and mapping was done with Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT; International Health Terminology Standards Development Organisation). Once the CDSS was developed, validation was carried out by using a retrospective case study. RESULTS: This project was funded in January 2015 and approved by the Virgen del Rocio University Hospital ethics committee on November 24, 2015. Two different tasks were carried out to test the functioning of the tool. First, retrospective data from a real patient who met the inclusion criteria were used. Second, the analysis of an adoption model was performed through the study of the requirements and characteristics that a CDSS must meet in order to be well accepted and used by health professionals. The results are favorable and allow the proposed research to continue to the next phase. CONCLUSIONS: An ontology-based CDSS was successfully designed, developed, and validated. However, in future work, validation in a real environment should be performed to ensure the tool is usable and reliable.

A randomized clinical trial of home telemonitoring in patients with advanced heart and lung diseases.

BRIEF SUMMARY: The addition of home monitoring to an integrated care model in patients with advanced chronic heart/lung diseases decreases mortality, hospital and emergency admissions, improves functional status, HRQoL, and is cost-effective. BACKGROUND: Telemonitoring is a promising implement for medicine, but its efficacy is unknown in patients with advanced heart and lung failure (AHLF). OBJECTIVE: To determine the efficacy of a telemonitoring system added to coordinated clinical care in patients with AHLF. DESIGN: Randomized phase 3 multicenter clinical trial with parallel groups in adult patients. PARTICIPANTS: Five spanish centers including patients with AHLF at discharge or in out-patient clinics. INTERVENTION: Patients were randomly assigned to receive a remote bio-parameters telemonitoring system (TELECARE) or best usual care (UCARE). TELECARE patients were provided with devices that collected symptoms and bio-parameters, and transferred them synchronously to a call-center, with a real-time health-care response. MAIN MEASURES: Primary end point was the need of admissions/emergency room visits at 45, 90, 180 days. Secondary end points included health care requirements, mortality, functional assessment, health related quality of life (HRQoL), perceived satisfaction, and cost-efficacy. RESULTS: 510 patients were included (54.5% women, median age 76.5 years; 63.1% suffered heart failure, 13.9% lung failure, and 22.9% both conditions). Clinical and functional features were comparable in both arms. TELECARE globally needed less admissions with respect UCARE after 45 days of inclusion (35.4% vs. 46.9%, p < 0.05). This tendency was maintained in the subgroups of patients with multimorbidity (34.2% vs. 46.9%, p < 0.05), intermediate risk of mortality (36.5% vs. 51.1%, p < 0.05), and those included after hospital discharge (34.9% vs. 50.5%, p < 0.01). HRQoL significantly improved (TELECARE/UCARE EuroQol baseline of 56.2 ± 18.2/55.1 ± 19.7, p = 0.054, and 64 ± 19.9/56.3 ± 21.6; p < 0.01 at the end), and perceived satisfaction was also higher (6.77 ± 0.52 vs. 6.62 ± 0.81, p < 0.001; highest possible score = 7). A trend to mortality decrease was also observed (12.9% vs. 19.3%, p = 0.13). TELECARE was cost-efficacious (TELECARE/UCARE QALY 3.94 Euros/0.81Euros). CONCLUSIONS: The addition of a telemonitoring system to an integrated care model in patients with AHLF decreases hospital and emergency admissions, improves functional status as well as HRQoL, and is cost-efficacious.

Comorbidity and polypharmacy in chronic heart failure: a large cross-sectional study in primary care.

BACKGROUND: Comorbidity is common in heart failure, but previous prevalence estimates have been based on a limited number of conditions using mainly non-primary care data sources. AIM: To compare prevalence rates of comorbidity and polypharmacy in those with and without chronic heart failure due to left ventricular systolic dysfunction (LVSD). DESIGN AND SETTING: A cross-sectional study of 1.4 million patients in primary care in Scotland. METHOD: Data on the presence of LVSD, 31 other physical, and seven mental health comorbidities, and prescriptions were extracted from a database of 1 424 378 adults. Comorbidity prevalence was compared in patients with and without LVSD, standardised by age, sex, and deprivation. Pharmacology data were also compared between the two groups. RESULTS: There were 17 285 patients (1.2%) who had a diagnosis of LVSD. Compared with standardised controls, the LVSD group had greater comorbidity, with the biggest difference found for seven or more conditions (odds ratio [OR] 4.10; 95% confidence interval (CI] = 3.90 to 4.32). Twenty-five physical conditions and six mental health conditions were significantly more prevalent in those with LVSD relative to standardised controls. Polypharmacy was higher in the LVSD group compared with controls, with the biggest difference found for ≥11 repeat prescriptions (OR 4.81; 95% CI = 4.60 to 5.04). However, these differences in polypharmacy were attenuated after controlling for the number of morbidities, indicating that much of the additional prescribing was accounted for by multimorbidity rather than LVSD per se. CONCLUSION: Extreme comorbidity and polypharmacy is significantly more common in patients with chronic heart failure due to LVSD. The efficient management of such complexity requires the integration of general and specialist expertise.

Heart failure mortality according to acute variations in N-terminal pro B-type natriuretic peptide and cystatin C levels.

AIM: Changes in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels and cystatin C (CysC) are predictors of adverse outcomes in acute heart failure. This study assess whether NT-proBNP variations might provide independent information in addition to that obtained from CysC levels. METHODS: NT-proBNP levels were assessed in patients admitted due to acute heart failure using an observational study. Patients were classified as follows: group 1, those with a decrease in NT-proBNP levels of at least 30% from admission to 4 weeks after discharge; group 2, those with no significant changes in levels; and group 3, those who showed an increase in NT-proBNP of 30%. A multivariable Cox regression model and c-statistics were used. The primary end-point was all-cause mortality at 1-year follow-up. RESULTS: A total of 195 patients completed the follow-up. The mortality rate reached 20.5% (40 patients); 14 out of the 32 in group 3. The cumulative incidence of death, according to the change in NT-proBNP and Kaplan-Meier analysis, showed a significant increase in group 3 (log-rank P = 0.004). In the multivariable analysis, NT-proBNP variation for group 3 (hazard ratio 4.27; P <0.001) and for group 2 (hazard ratio 2.19; P = 0.043) in comparison with group 1 were independently associated with all-cause mortality, as well as anemia, hyponatremia, and admission CysC levels. Patients in group 3, and those with levels of serum CysC above the median, were also associated with slight increase in mortality. CONCLUSION: An increase of at least 30% in NT-proBNP levels after hospitalization is related to all-cause mortality in patients with acute heart failure and provides supplementary prognostic information in patients with high levels of CysC. A decrease in NT-proBNP of at least 30% is a desirable target to achieve.

Reliability of a short questionnaire for the diagnosis of severe disability in polypathological patients attended in hospital setting.

BACKGROUND: A comprehensive evaluation of polypathological patients (PP) should always include a functional evaluation. For this purpose, a modified version of the Barthel Index (BI) is the most applied questionnaire, and it consists of a 10-variable scale. The aim of this study was to develop a screening and confirmation tool to diagnose high disability with the fewest number of dimensions of the BI as possible. METHOD: This present cross-sectional observational multicentre study included PP attended in 36 Spanish hospitals that were divided into two geographical areas (Western and Eastern). The Western area was considered to be the derivation subgroup of PP, and the Eastern area was the validation subgroup. Complete disability for each item (value of 0) was assessed for the diagnosis of severe disability. Diagnostic validity indices (sensitivity, specificity, negative and positive predictive values [NPV and PPV, respectively], and negative and positive likelihood ratios [NLR and PLR, respectively]) were determined for the derivation subgroup. The dimensions with the best diagnostic validity indices were then used to evaluate the validation subgroup. RESULTS: The analysis included 1521 PP, 753 PP from the Western area and 768 PP from the Eastern area. Needing complete help for bathing showed the highest NPV and lowest NLR in the derivation/validation subgroups (NPV 96.87/95.54, NLR 0.07/0.13). Being disabled for feeding alone showed high PPV and PLR values (PPV 97.97/95.65, PLR 109.25/49.62), as did disability for transfers (PPV 98.48/97.96, PLR 143.36/107.68). In addition, complete disability for feeding and transfers had the best PPV and PLR in both subgroups (PPV 100/100, PLR X/0). CONCLUSIONS: A two-dimension mini-Barthel Index may represent a reliable diagnostic test for severe disability in PP.

[Anticoagulation in polypathological patients with atrial fibrillation]. / Anticoagulación en pacientes pluripatológicos con fibrilación auricular.

BACKGROUND AND OBJECTIVES: To determine the use of oral anticoagulants in polypathological patients with atrial fibrillation and its influence on mortality and loss of functionality. PATIENTS AND METHODS: Patients with polypathological patient criteria and atrial fibrillation were included in an observational, prospective and multicenter study. Data on demographic, clinical, functional and sociofamilial characteristics, CHADS2 score, levels of hemoglobin, albumin and creatinine, use of oral anticoagulants and survival and functional status at one year were collected. RESULTS: Five hundred and thirty-two (32.6%) of 1,632 polypathological patients had atrial fibrillation. The stroke risk was high in 505 (94.9%), moderate in 24 (4.5%) and low in 3 (0.6%) patients. Oral anticoagulants were used in 61% of patients with CHADS2 score≥2 and in 37.5% with CHADS2 score=1. Oral anticoagulants were less used in older patients, with more functional and cognitive impairment. Heart failure was associated with more use of oral anticoagulants. There was no difference by the presence of hypertension, diabetes, anemia, renal insufficiency or stroke. In multivariate analysis the use of oral anticoagulants was independently associated with lower age, lower cognitive impairment, absence of hepatic disease and with higher stroke risk. The prescription of oral anticoagulants was independently associated with more survival at one year with no influence on functional status. CONCLUSIONS: Oral anticoagulants are underused in polypathological patients with atrial fibrillation despite being associated with more survival.

Effects of renin-angiotensin blockers/inhibitors and statins on mortality and functional impairment in polypathological patients.

BACKGROUND: Frail and polypathological patients (PP) are often undertreated with evidence-based cardiovascular drugs, as their benefits are uncertain in this population. OBJECTIVES: To determine the effects of treatment with renin-angiotensin system blockers/inhibitors (ACEI/ARB), statins and/or beta-blockers on survival rates and functional decline in PP with evidence-based clinical indications for treatment with any of these drug families. METHOD: Prospective observational multicentre cohort study with a 12-month follow-up period. We selected PP with any condition of the following: chronic heart failure, coronary heart disease, chronic renal disease, cerebrovascular disease, peripheral artery disease, diabetes mellitus with any visceral involvement, hypertension, and dyslipidaemia. Clinical, functional (Barthel index), socio-familial risk data and drug prescriptions were measured at baseline. Multivariate Cox proportional hazards and logistic regression models were used to identify variables independently associated with survival and functional decline. RESULTS: The analysis included 1260 PP. The mean age was 79±9.5 years. The mortality rate was 34.5%. Statin (aHR 0.671; P=0.001), beta-blocker plus statin (aHR 0.645; P=0.007), ACEI/ARB plus statin (aHR 0.680; P=0.002), or combined ACEI/ARB plus statin plus beta-blocker (aHR 0.541; P=0.000) prescriptions were associated with longer survival times. Additionally, PP whose Barthel index was ≥60 showed a lower risk of disability progression if treated with statins (aOR=0.476; P=0.000), or their combinations, mainly with ACEI/ARB plus beta-blockers (aOR 0.563; P=0.031). CONCLUSIONS: The prescription of statins, alone or in combination with other drugs, may impact the survival and functional decline in polypathological patients. Further prospective blinded randomised assays are needed to confirm these observations.

[Reliability of different criteria in identifying end-of-life trajectory of patients with chronic medical diseases. PALIAR Project]. / Precisión de los criterios definitorios de pacientes con enfermedades médicas no neoplásicas en fase terminal. Proyecto PALIAR.

INTRODUCTION: It is a challenge to reliably identify the end-of-life trajectory in patients with advanced-stage chronic medical conditions. This makes advanced supportive care planning and transition from survival to comfort objectives more difficult in these emergent patient populations. OBJECTIVES: To evaluate the sensitivity (Se), specificity (Sp), positive predictive values (PPV) and negative (NPV), and validity index (IV) of NHO criteria for terminal medical conditions, PPI and ECOG in patients with advanced heart, lung, liver, kidney and/or neurological diseases, and to build and validate an accurate index to determine this border-line. METHODS: A multicentre prospective cohort study, with inclusion of patients with the predefined advanced medical diseases. Demographic, clinical, care, stratification and staging of disease(s), functional, analytical, NHO criteria, ECOG, PPS and PPI data collection; The end-point (death) will be assessed 180 days after inclusion. Analysis of Se, Sp, PPV, NPV, and IV of the NHO criteria, ECOG scale and PPI at 30, 60, 90, 120, 150 and 180 days. Derivation of PALIAR Index, after multivariate analysis and appropriate weighting of risk factors (beta of risk factor/lowest beta of the model), and validation in the validation cohort, and in the historical PROFUND cohort. RESULTS: The project is still ongoing, with 50 investigators from 33 hospitals throughout Spain, who have already included 1138 patients (92.5% during hospital admissions, 51.4% of them are male, with a mean age of 78.5 years). Mean inclusion chronic diseases were 1.4 per patient (44.5% of patients suffered chronic neurological diseases, 38.6% with heart failure, 34.2% with lung diseases, 12% with liver diseases, and 6.5% with renal diseases). Around 69% fulfilled the criteria of polypathological patients (mean Charlson index 3.4), and were prescribed around 8 drugs chronically. Mean Barthel index was 40 points, and 77% of them were dependent on a caregiver. Around 46% were ECOG-PS stage III or IV, and mean PPS score was 45 points. CONCLUSION: The availability of an accurate and powerful tool that could enable us to identify the end-of-life trajectory of these patients could allow us to establish specific intervention strategies for these populations. Therefore, and with these preliminary data, we believe that the PALIAR PROJECT will answer with rigour the questions and objectives of the study.