Long-term effect of α1-antitrypsin augmentation therapy on the decline of FEV1 in deficient patients: an analysis of the AIR database

Lung structure and function; COPD and smokingEstructura y función pulmonar; EPOC y tabaquismoEstructura i funció pulmonar; MPOC i tabaquismeBackground Patients with ZZ (Glu342Lys) α-1-antitrypsin deficiency (ZZ-AATD) who received augmentation therapy with α-1-antitrypsin (AAT) in randomised controlled trials over 2–3 years failed to show a significant reduction of the annual decline of forced expiratory volume in 1 s (FEV1). Methods To compare the trajectory of FEV1 change during 4 or more years in ZZ-AATD patients with emphysema receiving or not receiving intravenous augmentation therapy, a retrospective analysis of FEV1 values entered in the Alpha-1 International Registry (AIR) of ZZ-AATD patients from five different European countries (Germany, UK, Spain, Italy and the Netherlands) was performed. The post-bronchodilator FEV1 % predicted values for baseline and follow-up over time from patients were analysed using linear mixed effects models. Results Data of 374 patients were analysed: 246 untreated and 128 treated with intravenous AAT augmentation therapy. The mean±sd follow-up duration of the untreated group was 8.60±3.34 years and 8.59±2.62 years for the treated group. The mixed effects model analysis showed a mean FEV1 decline of −0.931% predicted per year (95% CI −1.144 to −0.718) in the untreated group and a decline of −1.016% predicted per year (95% CI −1.319 to −0.7145) in the treated group. The likelihood ratio test showed no difference between the two groups (p=0.71). Conclusion In our study population, we could not detect a significant difference in the annual decline of FEV1 by AAT augmentation treatment over a mean period of 8.6 years. Other approaches are needed to validate any benefit of augmentation therapy.This study was supported by Stichting AIR

Long-term effect of α1-antitrypsin augmentation therapy on the decline of FEV1 in deficient patients : an analysis of the AIR database

Background Patients with ZZ (Glu342Lys) α-1-antitrypsin deficiency (ZZ-AATD) who received augmentation therapy with α-1-antitrypsin (AAT) in randomised controlled trials over 2–3 years failed to show a significant reduction of the annual decline of forced expiratory volume in 1 s (FEV1). Methods To compare the trajectory of FEV1 change during 4 or more years in ZZ-AATD patients with emphysema receiving or not receiving intravenous augmentation therapy, a retrospective analysis of FEV1 values entered in the Alpha-1 International Registry (AIR) of ZZ-AATD patients from five different European countries (Germany, UK, Spain, Italy and the Netherlands) was performed. The post bronchodilator FEV1 % predicted values for baseline and follow-up over time from patients were analysed using linear mixed effects models. Results Data of 374 patients were analysed: 246 untreated and 128 treated with intravenous AAT augmentation therapy. The mean±SD follow-up duration of the untreated group was 8.60±3.34 years and 8.59±2.62 years for the treated group. The mixed effects model analysis showed a mean FEV1 decline of −0.931% predicted per year (95% CI −1.144 to −0.718) in the untreated group and a decline of −1.016% predicted per year (95% CI −1.319 to −0.7145) in the treated group. The likelihood ratio test showed no difference between the two groups ( p=0.71). Conclusion In our study population, we could not detect a significant difference in the annual decline of FEV1 by AAT augmentation treatment over a mean period of 8.6 years. Other approaches are needed to validate any benefit of augmentation therapy

Online Guide for Electronic Health Evaluation Approaches: Systematic Scoping Review and Concept Mapping Study

BACKGROUND: Despite the increase in use and high expectations of digital health solutions, scientific evidence about the effectiveness of electronic health (eHealth) and other aspects such as usability and accuracy is lagging behind. eHealth solutions are complex interventions, which require a wide array of evaluation approaches that are capable of answering the many different questions that arise during the consecutive study phases of eHealth development and implementation. However, evaluators seem to struggle in choosing suitable evaluation approaches in relation to a specific study phase. OBJECTIVE: The objective of this project was to provide a structured overview of the existing eHealth evaluation approaches, with the aim of assisting eHealth evaluators in selecting a suitable approach for evaluating their eHealth solution at a specific evaluation study phase. METHODS: Three consecutive steps were followed. Step 1 was a systematic scoping review, summarizing existing eHealth evaluation approaches. Step 2 was a concept mapping study asking eHealth researchers about approaches for evaluating eHealth. In step 3, the results of step 1 and 2 were used to develop an "eHealth evaluation cycle" and subsequently compose the online "eHealth methodology guide." RESULTS: The scoping review yielded 57 articles describing 50 unique evaluation approaches. The concept mapping study questioned 43 eHealth researchers, resulting in 48 unique approaches. After removing duplicates, 75 unique evaluation approaches remained. Thereafter, an "eHealth evaluation cycle" was developed, consisting of six evaluation study phases: conceptual and planning, design, development and usability, pilot (feasibility), effectiveness (impact), uptake (implementation), and all phases. Finally, the "eHealth methodology guide" was composed by assigning the 75 evaluation approaches to the specific study phases of the "eHealth evaluation cycle." CONCLUSIONS: Seventy-five unique evaluation approaches were found in the literature and suggested by eHealth researchers, which served as content for the online "eHealth methodology guide." By assisting evaluators in selecting a suitable evaluation approach in relation to a specific study phase of the "eHealth evaluation cycle," the guide aims to enhance the quality, safety, and successful long-term implementation of novel eHealth solutions

SERIES:eHealth in primary care. Part 2: Exploring the ethical implications of its application in primary care practice

Background: eHealth promises to increase self-management and personalised medicine and improve cost-effectiveness in primary care. Paired with these promises are ethical implications, as eHealth will affect patients' and primary care professionals' (PCPs) experiences, values, norms, and relationships.Objectives: We argue what ethical implications related to the impact of eHealth on four vital aspects of primary care could (and should) be anticipated.Discussion: (1) EHealth influences dealing with predictive and diagnostic uncertainty. Machine-learning based clinical decision support systems offer (seemingly) objective, quantified, and personalised outcomes. However, they also introduce new loci of uncertainty and subjectivity. The decision-making process becomes opaque, and algorithms can be invalid, biased, or even discriminatory. This has implications for professional responsibilities and judgments, justice, autonomy, and trust. (2) EHealth affects the roles and responsibilities of patients because it can stimulate self-management and autonomy. However, autonomy can also be compromised, e.g. in cases of persuasive technologies and eHealth can increase existing health disparities. (3) The delegation of tasks to a network of technologies and stakeholders requires attention for responsibility gaps and new responsibilities. (4) The triangulate relationship: patient-eHealth-PCP requires a reconsideration of the role of human interaction and 'humanness' in primary care as well as of shaping Shared Decision Making.Conclusion: Our analysis is an essential first step towards setting up a dedicated ethics research agenda that should be examined in parallel to the development and implementation of eHealth. The ultimate goal is to inspire the development of practice-specific ethical recommendations

SERIES: eHealth in primary care. Part 1: Concepts, conditions and challenges.

Primary care is challenged to provide high quality, accessible and affordable care for an increasingly ageing, complex, and multimorbid population. To counter these challenges, primary care professionals need to take up new and innovative practices, including eHealth. eHealth applications hold the promise to overcome some difficulties encountered in the care of people with complex medical and social needs in primary care. However, many unanswered questions regarding (cost) effectiveness, integration with healthcare, and acceptability to patients, caregivers, and professionals remain to be elucidated. What conditions need to be met? What challenges need to be overcome? What downsides must be dealt with? This first paper in a series on eHealth in primary care introduces basic concepts and examines opportunities for the uptake of eHealth in primary care. We illustrate that although the potential of eHealth in primary care is high, several conditions need to be met to ensure that safe and high-quality eHealth is developed for and implemented in primary care. eHealth research needs to be optimized; ensuring evidence-based eHealth is available. Blended care, i.e. combining face-to-face care with remote options, personalized to the individual patient should be considered. Stakeholders need to be involved in the development and implementation of eHealth via co-creation processes, and design should be mindful of vulnerable groups and eHealth illiteracy. Furthermore, a global perspective on eHealth should be adopted, and eHealth ethics, patients' safety and privacy considered.Published versio

LA PRESA DE AYAGAURES EN CONSTRUCCIÓN [Material gráfico]

Copia digital. Madrid : Ministerio de Educación, Cultura y Deporte. Subdirección General de Coordinación Bibliotecaria, 201

SERIES: eHealth in primary care. Part 3: eHealth education in primary care

Background: Education is essential to the integration of eHealth into primary care, but eHealth is not yet embedded in medical education. Objectives: In this opinion article, we aim to support organisers of Continuing Professional Development (CPD) and teachers delivering medical vocational training by providing recommendations for eHealth education. First, we describe what is required to help primary care professionals and trainees learn about eHealth. Second, we elaborate on how eHealth education might be provided. Discussion: We consider four essential topics. First, an understanding of existing evidence-based eHealth applications and conditions for successful development and implementation. Second, required digital competencies of providers and patients. Third, how eHealth changes patient-provider and provider-provider relationships and finally, understanding the handling of digital data. Educational activities to address these topics include eLearning, blended learning, courses, simulation exercises, real-life practice, supervision and reflection, role modelling and community of practice learning. More specifically, a CanMEDS framework aimed at defining curriculum learning goals can support eHealth education by

Effecten van het gebruik van het eHealth-platform e-Vita voor COPD-patiënten op domeinen van de ziektespecifieke kwaliteit van leven

Samenvatting Achtergrond: Een integrale behandeling inclusief zelfmanagement bij chronisch obstructieve longziekte (COPD) leidt tot betere klinische resultaten. eHealth kan zorgen voor meer betrokkenheid bij patiënten waardoor ze in staat zijn een gezondere levensstijl aan te nemen en vast te houden. Desondanks is er geen eenduidig bewijs van de impact van eHealth op de kwaliteit van leven (quality of life (QoL)). Doel: Het primaire doel van de e-Vita COPD-studie was om te onderzoeken wat de effecten zijn van het gebruik van eeneHealth-platform voor patiënten op de verschillende domeinen van ziektespecifieke kwaliteit van leven van COPD-patiënten (CCQ). Methoden: We hebben de impact beoordeeld van het gebruik van een eHealth-platform op de klinische COPD-vragenlijst (CCQ). Deze vragenlijst omvatte subschalen van symptomen, functionele en mentale toestand. Een design met onderbroken tijdreeksen (interrupted time series (ITS)) is gebruikt om CCQ-gegevens op verschillende tijdstippen te verzamelen. Er is gebruik gemaakt van multilevel lineaire regressieanalyse om de CCQ-trends vóór en na de interventie te vergelijken. Resultaten: Van de 742 uitgenodigde COPD-patiënten hebben er 244 het document voor ‘informed consent’ ondertekend. In de analyses hebben we uitsluitend patiënten opgenomen die daadwerkelijk gebruik hebben gemaakt van het eHealthplatform (n=123). De afname van CCQ-symptomen was 0,20% vóór de interventie en 0,27% na de interventie; dit was een statistisch significant verschil (P=0,027). De daling van CCQ-mentale toestand was 0,97% vóór de interventie en na de interventie was er sprake van een stijging van 0,017%; dit verschil was statistisch significant (P=0,01). Er werd geen significant verschil vastgesteld in het verloop van CCQ (P=0,12) en CCQ-functionele toestand (P=0,11) vóór en na de interventie. Conclusie: Het e-Vita eHealth-platform had een gunstig effect op de CCQ-symptomen van COPD-patiënten, maar niet op de functionele status. De CCQ-mentale toestand bleef stabiel na de interventie, maar dit was een verslechtering in vergelijking met de verbeterende situatie voorafgaand aan de start van het eHealth-platform. Deze studie laat dus zien dat patiënten na de introductie van het COPD-platform minder symptomen ervaarden, maar dat hun mentale toestand tegelijkertijd licht verslechterde. Zorgprofessionals moeten zich ervan bewust zijn dat, ondanks de verbetering van symptomen, er een lichte toename van angst en depressie kan optreden na invoering van een eHealth-interventie

Physical activity in the morning and afternoon is lower in patients with chronic obstructive pulmonary disease with morning symptoms

Abstract Background Patients with chronic obstructive pulmonary disease (COPD) experience symptoms that vary over the day. Symptoms at the start of the day might influence physical activity during the rest of the day. Therefore, physical activity during the course of the day was studied in patients with low and high morning symptom scores. Methods This cross-sectional observational study included patients with moderate to very severe COPD. Morning symptoms were evaluated with the PRO-morning COPD Symptoms Questionnaire (range 0–60); the median score was used to create two groups (low and high morning symptom scores). Physical activity was examined with an accelerometer. Activity parameters during the night, morning, afternoon and evening were compared between patients with low and high morning symptom scores using independent t-tests or Mann-Whitney U tests. Results Seventy nine patients were included. Patients were aged (mean ± SD) 65.6 ± 8.8 years with a mean forced expiratory volume in 1 s of 55 ± 17%predicted. Patients with low morning symptom scores (score < 17.0) took more steps in the afternoon (p = 0.015) and morning (p = 0.030). There were no significant differences during the evening and night. Conclusion Patients with high morning symptom scores took significantly fewer steps in the morning and afternoon than those with low morning symptom scores. Prospective studies are needed to prove causality between morning symptoms and physical activity during different parts of the day

Effects of use of an eHealth platform e-Vita for COPD patients on disease specific quality of life domains

Abstract Background: Integrated disease management with self-management for Chronic Obstructive Pulmonary Disease (COPD) is effective to improve clinical outcomes. eHealth can improve patients’ involvement to be able to accept and maintain a healthier lifestyle. Eventhough there is mixed evidence of the impact of eHealth on quality of life (QoL) in different settings. Aim: The primary aim of the e-Vita-COPD-study was to investigate the effect of use of eHealth patient platforms on disease specific QoL of COPD patients. Methods: We evaluated the impact of an eHealth platform on disease specific QoL measured with the clinical COPD questionnaire (CCQ), including subscales of symptoms, functional state and mental state. Interrupted time series (ITS) design was used to collect CCQ data at multiple time points. Multilevel linear regression modelling was used to compare trends in CCQ before and after the intervention. Results: Of 742 invited COPD patients, 244 signed informed consent. For the analyses, we only included patients who actually used the eHealth platform (n = 123). The decrease of CCQ-symptoms was 0.20% before the intervention and 0.27% after the intervention; this difference in slopes was statistically significant (P = 0.027). The decrease of CCQ-mental was 0.97% before the intervention and after the intervention there was an increase of 0.017%; this difference was statistically significant (P = 0.01). No significant difference was found in the slopes of CCQ (P = 0.12) and CCQ-function (P = 0.11) before and after the intervention. Conclusion: The e-Vita eHealth platform had a potential beneficial impact on the CCQ-symptoms of COPD patients, but not on functional state. The CCQ-mental state remained stable after the intervention, but this was a deterioration compared to the improving situation before the start of the eHealth platform. Therefore, health care providers should be aware that, although symptoms improve, there might be a slight increase in anxiety and depression after introducing an eHealth intervention to support self-management. Trial registration: Our study is registered in the Dutch Trial Register (national registration of clinical trails, mandatory for publication) with number NTR4098 and can be found at http://www.trialregister.nl/trial/3936