Development and validation of a specific questionnaire to assess health-related quality of life in patients with home enteral nutrition: NutriQoL® development

Introduction: Home enteral nutrition (HEN) is indicated in patients with a functional gastrointestinal tract but who are unable to meet their nutritional requirements with normally consumed foodstuffs. HEN allows patients to remain in their social and family environment, thus reducing complications and costs associated with hospital admission, while increasing health-related quality of life (HRQoL). HRQoL in patients with HEN is mainly evaluated by generic instruments, which are not sensitive enough to identify certain specific patient-related outcomes of HEN. Objective: To develop a specific instrument to measure HRQoL in patients receiving HEN whose results allow interpretation regardless of the underlying disease and nutritional support administration route: the NutriQoL (R) questionnaire. Materials and methods: The development of the NutriQoL entailed a literature review, focus groups with experts, semistructured interviews with patients, an assessment of face validity and feasibility, and Rasch analysis conducted on data from a sample of 141 patients and 24 caregivers. Results: Of the 52 items initially proposed on the basis of the literature review, expert focus group, and semi-structured interviews with patients and caregivers, 17 items were finally selected through the development process to make up the final version of the NutriQoL, as well as a visual analog scale for global HRQoL scoring. The selected items were evaluated as adequate for frequency, importance, and clarity. Furthermore, they have been shown to be independent of the underlying condition and HEN administration route. Conclusion: A new instrument for measuring the HRQoL of patients with HEN in Spain has been developed, whose results are independent of the underlying condition and administration route. The next step will be the validation of the questionnaire to ensure that the instrument is valid, reliable, and sensitive to health status changes in patients, to be used periodically in usual clinical practice

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Home parenteral nutrition: a consensus document of experts from Andalucia and Extremadura

Home parenteral nutrition (HPN) is a technique that has allowed the survival in the community of those patients with serious diseases resulting in an intestinal failure that made their nutrition impossible by other methods. It is indicated if there is a documented intestinal failure (understood by the reduction of the intestinal function to the minimum to the point that intravenous supplementation is required to maintain health and/or growth) with impossibility for oral or enteral exclusive nutrition, provided that there is the possibility of managing the patient at home and that there is no short-term survival expectancy. It requires taking into account the patient's quality of life, family environment and the capacity of the patient and/or their caregivers to be trained for HPN therapy.In low prevalence health topics, as intestinal failure, where the available scientific evidence is of poor quality, consensus documents add value in decision-making. Furthermore, HPN is a complex process and, although there is extensive experience in its application and even clinical practice guidelines, in daily practice there are uncertainties about its suitability, usefulness, rational use and associated costs. For this reason, this document of consensus has been carried out, using the GRADE method. With this document we intend to define our position with regard to the current use of HPN in our country and answer several controversial questions related to this treatment

The NutriQoL (R) questionnaire for assessing health-related quality of life (HRQoL) in patients with home enteral nutrition (HEN): validation and first results

Introduction: Health-related quality of life (HRQoL) provides a global view of the state of health of a patient receiving home enteral nutrition (HEN).Objective: To evaluate the HRQoL of patients receiving HEN using the NutriQoL (R) questionnaire, a specific instrument regardless of the underlying disease and route of administration.Materials and methods: Observational, prospective and multicentre study conducted in the context of the validation and assessment of the NutriQoL (R) questionnaire's psychometric properties.Results: One-hundred-and-forty individuals [disease: cancer (58.6%), malabsorption and other (27.1%), neurological (13.6%); HEN: supplement (61.4%), sole source of nutrition (35.7%); administration route: oral (54.3%), ostomy (31.4%), nasoenteric tube (12.1%)] participated. NutriQoL (R) was reliable [ICC: 0.88 (95% CI: 0.80-0.93); Cronbach's alpha: 0.77 (1st visit) and 0.83 (2nd visit)], valid (significant Rho), lowly sensitive to changes (effect size 0.23), can be completed by either patients or caregivers (ICC: 0.82). The mean HRQoL (SD) with NutriQoL (R) was 14.98 (14.86), EQ-5D tariff: 53(0.25), EQ-5D VAS: 54.15(20.64) and COOP/WONCA charts: 23.32(5.66). HRQoL with NutriQoL (R) was better (

Digital skills of Valencian university students

[EN] With the outbreak of the COVID-19 pandemic, higher education changed overnight from face-to-face to e-learning. The tech shortcomings during the lock-down period were expected to affect students from the most disadvantaged stdents in a more negative way. The aim is to detect the strengths and weaknesses of Valencian university students in relation to the e-learning modality. A sample of 18,295 students from the five public Valencian universities, answered a four-sections online form: equipment, connection, experience and attitude. Results show that the Valencian university student community, in general, has sufficient equipment to follow e-learning, nontheless 2% do not have any computer, not even in shared use. Three out of four have a broadband conection, but 0.7% of the participants cannot afford Internet access. 50% self-assess as a medium-low competence, two points in a a five-level scale. Opinions reveal a strong preference for face-to-face teaching, although e-learning advantages are positively valued.Dirección General para la Lucha contra la Brecha Digital - Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital - Valencian GovermentLloret-Irles, D.; Segura-Heras, JV.; Nogués-Pedregal, AM.; Saumell-Castelló, C.; Akita-Udrea, M. (2022). Digital skills of Valencian university students. En 8th International Conference on Higher Education Advances (HEAd'22). Editorial Universitat Politècnica de València. 207-213. https://doi.org/10.4995/HEAd22.2022.1455820721

Reliability and Responsiveness of NutriQoL® Questionnaire

Introduction NutriQoL® (Nestlé Health Science, Vevay, Switzerland) is a questionnaire developed to assess the health-related quality-of-life (HRQoL) of patients with home enteral nutrition (HEN) irrespective of their underlying condition and route of administration. The aim of this work is assessing the questionnaire’s reliability and responsiveness to change. Methods Two cohorts of patients with HEN and their primary caregivers were enrolled to assess reliability and responsiveness, respectively. All participants had to be 18 years of age or older, without mental deterioration (≤3 or 4 errors in the Pfeiffer’s test) and with sufficient functional status (>40 points on Karnovsky’s performance status scale). When the patients’ ability to respond to the questionnaire was impaired due to underlying disease, their caregivers answered on their behalf. NutriQoL was administered in two and three visits to reliability and responsiveness cohorts, respectively. Test–retest reliability and internal consistency were assessed by the intra-class correlation coefficient (ICC) and the Cronbach’s α, respectively. Responsiveness was evaluated by standardized effect size and standardized response mean between basal visit and third visit. Finally, the minimal clinically important difference (MCID) was estimated. Results A total of 54 and 86 participants were recruited to the reliability and responsiveness cohort, respectively. Thirty-five caregivers were selected to assess the inter-observer reliability. ICC values confirmed the good reproducibility level (ICC >0.75) of the questionnaire in both “physical functioning and activities of daily living” and “social life” domains and total score. The assessment of internal consistency in both domains of the questionnaire showed good internal consistency in visit 2. ICC showed the excellent agreement level between caregiver and patient in the global NutriQoL score. Finally, patients classified as having a minimal change in their health reported a mean (standard deviation) MCID in NutriQoL score of 0.63 (11.51). Conclusion NutriQoL is a reliable and unique instrument to measure the HRQoL in HEN patients. NutriQoL detects changes in the health status of the patient. Nevertheless, further research is needed to determine the full extent of the questionnaire responsiveness.Sponsorship and article processing charges for this study were funded by Nestlé Health Science, Barcelona, Spain. Medical writing assistance for this study was provided by Outcomes’10, Castellón de la Plana, Spain, and funded by Nestlé Health Science, Barcelona, Spain. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published

Development and validation of a specific questionnaire to assess health-related quality of life in patients with home enteral nutrition: NutriQoL® development

Introduction: Home enteral nutrition (HEN) is indicated in patients with a functional gastrointestinal tract but who are unable to meet their nutritional requirements with normally consumed foodstuffs. HEN allows patients to remain in their social and family environment, thus reducing complications and costs associated with hospital admission, while increasing health-related quality of life (HRQoL). HRQoL in patients with HEN is mainly evaluated by generic instruments, which are not sensitive enough to identify certain specific patient-related outcomes of HEN. Objective: To develop a specific instrument to measure HRQoL in patients receiving HEN whose results allow interpretation regardless of the underlying disease and nutritional support administration route: the NutriQoL (R) questionnaire. Materials and methods: The development of the NutriQoL entailed a literature review, focus groups with experts, semistructured interviews with patients, an assessment of face validity and feasibility, and Rasch analysis conducted on data from a sample of 141 patients and 24 caregivers. Results: Of the 52 items initially proposed on the basis of the literature review, expert focus group, and semi-structured interviews with patients and caregivers, 17 items were finally selected through the development process to make up the final version of the NutriQoL, as well as a visual analog scale for global HRQoL scoring. The selected items were evaluated as adequate for frequency, importance, and clarity. Furthermore, they have been shown to be independent of the underlying condition and HEN administration route. Conclusion: A new instrument for measuring the HRQoL of patients with HEN in Spain has been developed, whose results are independent of the underlying condition and administration route. The next step will be the validation of the questionnaire to ensure that the instrument is valid, reliable, and sensitive to health status changes in patients, to be used periodically in usual clinical practice