Epidemiological, Clinical, Patient-Reported and Economic Burden of Inflammatory Bowel Disease (Ulcerative colitis and Crohn's disease) in Spain: A Systematic Review.

INTRODUCTION: This study describes the epidemiological, clinical, patient-reported and economic burden of inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), in Spain. METHODS: A systematic review was performed of observational studies reporting the epidemiological, clinical, patient-reported and economic burden of IBD in the Spanish population, from 2011 to 2021. Original articles and conference abstracts published in English or Spanish were eligible. RESULTS: A total of 45 publications were included in the review. The incidence of IBD in adults ranged from 9.6 to 44.3 per 100,000 inhabitants (4.6 to 18.5 for CD and 3.4 to 26.5 for UC). The incidence increased between 1.5- and twofold from 2000 to 2016 (regionally). Up to 6.0% (CD) and 3.0% (UC) IBD-associated mortality was reported. Disease onset predominantly occurs between 30 and 40 years (more delayed for UC than CD). Most frequently reported gastrointestinal manifestations are rectal bleeding in UC and weight loss in CD. Extraintestinal manifestations (EIM) have been described in up to 47.4% of patients with CD and 48.1% of patients with UC. Psychiatric comorbidities were frequently reported in both CD and UC (depression up to 20% and anxiety up to 11%). Reduced health-related quality of life (HRQoL) compared to the general population was reported. Significant symptomatology was associated with high levels of anxiety, depression, stress and lower HRQoL. Main healthcare resources reported were emergency department visits (24.0%), hospitalization (14.7%), surgery (up to 11%) and use of biologics (up to 60%), especially in CD. Direct and indirect annual costs per patient with UC were €1754.1 and €399.3, respectively. CONCLUSION: Patients with CD and UC present a high disease burden which negatively impacts their HRQoL, leading to elevated use of resources.

Validation of a Loop-Mediated Isothermal Amplification Assay for Rapid Diagnosis of Invasive Pneumococcal Disease.

Current molecular PCR-based techniques used for detecting Streptococcus pneumoniae, the causative pathogen of invasive pneumococcal disease (IPD), are accurate but have a run time of several hours. We aimed to develop and validate a novel real-time loop mediated amplification (LAMP) assay for rapid detection of pneumococcus in normally sterile samples with accuracy comparable to a gold standard real-time PCR. Conserved regions of lytA were used for the design of the LAMP test. Analytical validation included assessment of linearity, limit of detection (LOD), intra-assay and inter-assay precision and analytical specificity, which was evaluated by using reference strain S. pneumoniae R6 and a quality control panel. Clinical performance was assessed on all samples collected from children with suspicion of IPD attended in Hospital Sant Joan de Deu (Barcelona, Spain) during the period April-September 2015. Fresh samples were analyzed after DNA extraction. The following values of analytical parameters were determined: linearity within the range 108-104 copies/mL; limit of detection, 5·103 copies/mL; intra- and inter-assay precision measured by mean coefficient of variance, 3.61 and 6.59%; analytical specificity, 9/9 pathogens similar to S. pneumoniae and 14/14 strains of different S. pneumoniae serotypes correctly identified as negative and positive results, respectively. Diagnostic sensitivity and specificity values were 100.0 and 99.3%. Median time of DNA amplification was 15 min. The new LAMP assay showed to have similar accuracy as PCR while being 5-fold faster and could become a useful diagnostic tool for early diagnosis of IPD.

Cross-sectional study about the use of telemedicine for type 2 diabetes mellitus management in Spain: patient's perspective. The EnREDa2 Study.

OBJECTIVES: The usefulness of telemedicine (TM) in type 2 diabetes mellitus (T2DM) has been discussed in recent years. The aim of this study is to describe patients' perceptions about TM and to identify preferences on TM resources, in Spain. DESIGN: An observational, cross-sectional study was conducted using a structured questionnaire. PARTICIPANTS: 1036 patients with T2DM accepted to participate in the study (response rate: 68%). RESULTS: Blood glucose values were recorded by 85.9% of the patients while data such as lifestyle habits were only recorded by 14.4% of the patients. Previous experience in TM was reported by 9.8% of the patients, out of which 70.5% were satisfied with its service and 73.5% considered that the use of TM had optimised their T2DM management. However, most of these patients noted aspects to be improved such as user-friendliness (81.4%), interaction with the medical team (78.4%) and time required for recording/transferring data (78.4%). Experienced patients had better perception about TM usefulness than naïve patients for all listed aspects (p<0.05). Among naïve patients, 38.2% expressed their willingness to participate in TM programmes, but only 4.7% were invited to do so. Patients considered that physicians' (77.5%) and pharmacists' (75.5%) encouragement can boost the use of TM. CONCLUSIONS: In Spain, nearly 10% of patients with T2DM have experience with TM and it is well accepted, especially one based on glucometers. Nevertheless, in order to promote TM use, easier and time-saving programmes for patient-physician interaction should be optimised.

Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project.

OBJECTIVE: To define a standard set of outcomes and the most appropriate instruments to measure them for managing newly diagnosed patients with multiple myeloma (MM). METHODS: A literature review and five discussion groups facilitated the design of two-round Delphi questionnaire. Delphi panellists (haematologists, hospital pharmacists and patients) were identified by the scientific committee, the Spanish Program of Haematology Treatments Foundation, the Spanish Society of Hospital Pharmacies and the Spanish Community of Patients with MM. Panellist's perception about outcomes' suitability and feasibility of use was assessed on a seven-point Likert scale. Consensus was reached when at least 75% of the respondents reached agreement or disagreement. A scientific committee led the project. RESULTS: Fifty-one and 45 panellists participated in the first and second Delphi rounds, respectively. Consensus was reached to use overall survival, progression-free survival, minimal residual disease and treatment response to assess survival and disease control. Panellists agreed to measure health-related quality of life, pain, performance status, fatigue, psychosocial status, symptoms, self-perception on body image, sexuality and preferences/satisfaction. However, panellist did not reach consensus about the feasibility of assessing in routine practice psychosocial status, symptoms, self-perception on body image and sexuality. Consensus was reached to collect patient-reported outcomes through the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core questionnaire 30 (C30), three items from EORTC-QLQ-Multiple Myeloma (MY20) and EORTC-QLQ-Breast Cancer (BR23), pain Visual Analogue Scale, Morisky-Green and ad hoc questions about patients' preferences/satisfaction. CONCLUSIONS: A consensual standard set of outcomes for managing newly diagnosed patients with MM has been defined. The feasibility of its implementation in routine practice will be assessed in a future pilot study.

Molecular isothermal techniques for combating infectious diseases: towards low-cost point-of-care diagnostics.

Nucleic acid amplification techniques such as PCR have facilitated rapid and accurate diagnosis in central laboratories over the past years. PCR-based amplifications require high-precision instruments to perform thermal cycling reactions. Such equipment is bulky, expensive and complex to operate. Progressive advances in isothermal amplification chemistries, microfluidics and detectors miniaturisation are paving the way for the introduction and use of compact 'sample in-results out' diagnostic devices. However, this paradigm shift towards decentralised testing poses diverse technological, economic and organizational challenges both in industrialized and developing countries. This review describes the landscape of molecular isothermal diagnostic techniques for infectious diseases, their characteristics, current state of development, and available products, with a focus on new directions towards point-of-care applications.