COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD.

The COPD Patient Management European Trial (COMET) investigated the efficacy and safety of a home-based COPD disease management intervention for severe COPD patients.The study was an international open-design clinical trial in COPD patients (forced expiratory volume in 1 s <50% of predicted value) randomised 1:1 to the disease management intervention or to the usual management practices at the study centre. The disease management intervention included a self-management programme, home telemonitoring, care coordination and medical management. The primary end-point was the number of unplanned all-cause hospitalisation days in the intention-to-treat (ITT) population. Secondary end-points included acute care hospitalisation days, BODE (body mass index, airflow obstruction, dyspnoea and exercise) index and exacerbations. Safety end-points included adverse events and deaths.For the 157 (disease management) and 162 (usual management) patients eligible for ITT analyses, all-cause hospitalisation days per year (mean±sd) were 17.4±35.4 and 22.6±41.8, respectively (mean difference -5.3, 95% CI -13.7 to -3.1; p=0.16). The disease management group had fewer per-protocol acute care hospitalisation days per year (p=0.047), a lower BODE index (p=0.01) and a lower mortality rate (1.9% versus 14.2%; p<0.001), with no difference in exacerbation frequency. Patient profiles and hospitalisation practices varied substantially across countries.The COMET disease management intervention did not significantly reduce unplanned all-cause hospitalisation days, but reduced acute care hospitalisation days and mortality in severe COPD patients.

Factors affecting the selection of an inhaler device for COPD and the ideal device for different patient profiles. Results of EPOCA Delphi consensus.

BACKGROUND: This study aimed to identify the relevant factors for the choice of an inhaler device by physicians and the selection of the most important characteristics of a device according to different characteristics of patients with COPD. METHOD: In this two-round Delphi survey, 96 Spanish COPD-expert pulmonologists completed an internet-based, self-administered questionnaire, which consisted of a first part with 19 items related to the prioritization of the drug or the device, the experience, ability and preference of the patient, and the experience and preferences of the healthcare professional. For each item, responses were grouped into three categories based on a 9-point Likert-type scale, calculating the response frequency and the degree of consensus. The second part included 18 items related to the inhalation devices with the aim to identify the main characteristics of a device for 8 different profiles of patients with COPD. RESULTS: Experts considered that the selection of a device was relevant when choosing the treatment for COPD patients, although 62.5% of them prioritised the selection of the drug over the device. The experience of the patient (89.6%) and his/her ability to handle the device (97.9%), together with coordination (96.9%), ability to learn (87.5%) and adherence to therapy (84.4%) were the main aspects considered in the selection of inhalation device. The panel identified Respimat® as the most adequate device for patients with either low inspiratory flow or severely impaired lung function and Spiromax® for patients with either impaired fine motor skills or older than 70 years. CONCLUSIONS: Selection of the inhalation device is recognized by specialists as a strategic therapeutic decision and should be based on the characteristics of the individual patient. Some devices may be more adequate for different patient profiles.

Comparison of trends in habitat and resource selection by the Spanish Festoon, Zerynthia rumina, and the whole butterfly community in a semiarid Mediterranean ecosystem.

Butterfly community and single species based approaches were taken to establish conservation priorities within a nature reserve in Central Spain. In this study, patch type (sclerophyllous, halophilous, or disturbed), potential herbaceous nectar availability, potential woody plant nectar availability, total nectar availability, and two approximations to plant diversity (herbaceous and woody plant diversity) were evaluated as variables that account for adult butterfly density. Butterfly communities in the reserve, which consist mostly of generalist species, were denser in relatively wet areas dominated by halophilous vegetation. Diversity did not significantly vary between ecologically different transects. Total nectar availability correlated with higher butterfly densities within both undisturbed and disturbed areas, which could be primarily explained by the lack of water typical of semiarid Mediterranean climates, where fresh, nectariferous vegetation is scarce. Woody plants were also found to be important sources of nectar and shelter. In the dryer sclerophyllous sites, adult butterfly density was best explained by herbaceous plant diversity, suggesting better quality of available resources. The endangered specialist Zerynthia rumina (L.) (Lepidoptera: Papilionidae) was only present at the sclerophyllous sites. Its density was very low in all sampled transects, excluding one relatively isolated transect with high larval hostplant density. In contrast to the community-based approach, density of Z. rumina adults is better explained by the density of its larval hostplant than by nectar availability, a trend previously described for other sedentary species. Management strategies for protecting insect-rich areas should consider the specific ecological requirements of endangered species.

Low prevalence of chewing lice (Phthiraptera) in wintering populations of the reed bunting Emberiza schoeniclus (Aves: Passeriformes: Emberizidae) in the Iberian Peninsula.

The reed bunting is a passerine bird of the Palearctic region, some subspecies suffer a decline in their populations. Four species of lice have been cited in reed bunting, but lice studies have not been carried out in the Iberian Peninsula. Between 2018 and 2020 a wintering population of the reed bunting is sampled in the center of the Iberian Peninsula through mist nets. Lice were collected directly from birds by a visual body examination. Of the 208 reed buntings sampled, only four individuals were parasitized. We find two species: Menacanthus chrysophaeus, which is the first record in Iberian lice, and Brueelia blagovescenskyi. Lice are not associated with the sex or age of the birds. The prevalence obtained is low compared to other European populations. This difference can be explained by the phenology of the subspecies, the migratory populations have a lower load of lice than sedentary populations.

Investigating edible insects as a sustainable food source: nutritional value and techno-functional and physiological properties.

This work is aimed to evaluate the nutritional composition, and the techno-functional and in vitro physiological properties of flours made using six different insect species and the sensorial feasibility of including them in bakery products. The insect flours exhibited high protein and fat contents as their main components, highlighting the presence of chitin in ant samples. The techno-functional properties showed high oil holding, swelling, and emulsifying capacities in all the analysed insect flours, whereas their bulk density, hydration properties, and foaming capacity showed average values and no gelation capacity. Moreover, these edible insect flours exhibited effective hyperglycaemia and hyperlipidaemia properties, which together with their high antioxidant capacity are associated with beneficial in vitro physiological effects. The beetle and caterpillar flours stand out in these properties, and thus were selected to make a cupcake. The sensory evaluation confirmed that the edible beetle powder can be successfully included in baked goods to provide excellent sensory properties and very high acceptance. Thus, these insect flours may be of great interest to the food industry as a healthy source of protein, exerting a positive impact on functional and sensory food properties, and with a potential role in the prevention of diseases associated with hyperglycaemia and hyperlipidaemia.

Phloem sap in Cretaceous ambers as abundant double emulsions preserving organic and inorganic residues.

Fossilized remains preserved in amber provide abundant data on the paleobiota surrounding the resin-producing plants, but relatively scarcer information about the resinous sources themselves. Here, dark pseudoinclusions in kidney-shaped amber pieces from the Early Cretaceous (Albian) amber from Spain are studied. This type of fossilized remain, abundant in Cretaceous ambers, was first interpreted as fossilized vacuole-bearing microorganisms, but later regarded as artifactual and probably secreted by the resinous trees, although their origin remained unclear. Using complementary microscopy (light, electron, confocal), spectroscopy (infrared, micro-Raman), mass spectrometry and elemental analysis techniques, we demonstrate that the pseudoinclusions correspond to droplets of phloem sap containing amber spheroids and preserving both organic and inorganic residues consistent with degraded components from the original sap. The amber pieces containing pseudoinclusions are fossilized, resin-in-sap-in-resin double emulsions, showing banding patterns with differential content of resin-in-sap emulsion droplets. Our findings represent the first time fossilized phloem sap, 105 million years old, has been recognized and characterized, and open new lines of paleontological research with taxonomic, taphonomic, physiological and ecological implications.

Cost-effectiveness of the COPD Patient Management European Trial home-based disease management program.

Purpose: Efficient management of COPD represents an international challenge. Effective management strategies within the means of limited health care budgets are urgently required. This analysis aimed to evaluate the cost-effectiveness of a home-based disease management (DM) intervention vs usual management (UM) in patients from the COPD Patient Management European Trial (COMET). Methods: Cost-effectiveness was evaluated in 319 intention-to-treat patients over 12 months in COMET. The analysis captured unplanned all-cause hospitalization days, mortality, and quality-adjusted life expectancy. Costs were evaluated from a National Health Service perspective for France, Germany, and Spain, and in a pooled analysis, and were expressed in 2015 Euros (EUR). Quality of life was assessed using the 15D health-related quality-of-life instrument and mapped to utility scores. Results: Home-based DM was associated with improved mortality and quality-adjusted life expectancy. DM and UM were associated with equivalent direct costs (DM reduced costs by EUR -37 per patient per year) in the pooled analysis. DM was associated with lower costs in France (EUR -806 per patient per year) and Spain (EUR -51 per patient per year), but higher costs in Germany (EUR 391 per patient per year). Evaluation of cost per death avoided and cost per quality-adjusted life year (QALY) gained showed that DM was dominant (more QALYs and cost saving) in France and Spain, and cost-effective in Germany vs UM. Nonparametric bootstrapping analysis, assuming a willingness-to-pay threshold of EUR 20,000 per QALY gained, indicated that the probability of home-based DM being cost-effective vs UM was 87.7% in France, 81.5% in Spain, and 75.9% in Germany. Conclusion: Home-based DM improved clinical outcomes at equivalent cost vs UM in France and Spain, and in the pooled analysis. DM was cost-effective in Germany with an incremental cost-effectiveness ratio of EUR 2,541 per QALY gained. The COMET home-based DM intervention could represent an attractive alternative to UM for European health care payers.

[Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. / Satisfacción y preferencia del paciente asmático por los dispositivos de inhalación. Aplicación del FSI-10.

BACKGROUND AND OBJECTIVE: Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma, and it has been suggested that allowing patients to choose their own inhalers would resolve this problem. The FSI-10 (Feeling of Satisfaction with Inhaler) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids: Turbuhaler, Accuhaler, and Novolizer. PATIENTS AND METHODS: We performed a multicenter, prospective, observational study in 112 stable asthmatic patients (64 women; mean [SD] age, 37 [22] years) treated on a regular basis with inhaled corticosteroids. The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned. The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used. Once the protocol was completed, patients stated their preference for the different devices used. RESULTS: The FSI-10 was easily understood and rapidly completed, and it exhibited acceptable measurement properties. Factor analysis showed that the measure was unidimensional. Although acceptance of all 3 devices assessed was reasonable, the FSI-10 questionnaire detected significant differences between them: Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions. This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study. However, the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer, even though the Turbuhaler had also usually been used by those patients prior to the study. CONCLUSIONS: The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices. It is easy to understand and complete, and able to identify differences in patient satisfaction with the different inhalers.

External validation of the recommendations of the multidisciplinary consensus about inhaled therapies.

UNLABELLED: The understanding of physicians and the skill of patients in the use of inhalers continues to be inadequate. OBJECTIVE: The external validation, by an expert panel, of practical clinical recommendations that had been developed in order to improve the knowledge and understanding of correct inhaled therapy use. METHODS: After a bibliographic review about inhaled therapies, 40 clinical recommendations were proposed. A two-round modified Delphi consensus was used to compare the opinions of a panel of 59 experts about the recommendations, which were grouped into 8 areas: general aspects (4), inhaled drugs (9), pressurized metered-dose and spacer inhalers (6), powder inhalers (4), nebulizers (3), devices for mechanical ventilation (3), inhalers for children (5) and issues related with compliance and education (6). RESULTS: After the first round of the consensus panel, 35 of the 40 recommendations analyzed were accepted. At the end of round 2, agreement was reached in 39 (97.5%). In 8 (20%), the consensus was unanimous (100%). Item 14 was deleted from the recommendations as consensus was not reached. CONCLUSIONS: The external validation by experts in inhaled therapy found a high level of agreement with the clinical recommendations proposed. This consensus provides a tool that could contribute to the improved use of inhalers in our country in the future.

Physicians' knowledge of inhaler devices and inhalation techniques remains poor in Spain.

BACKGROUND: Studies in many countries in the 1990s revealed deficiencies in physicians' knowledge about inhalation therapy. In an attempt to remedy this situation, Spanish scientific societies implemented a variety of educational strategies. The objective of the present study was to assess changes in attitudes and knowledge about inhalers and inhalation techniques in a sizable sample of physicians. METHODS: An 11-question multiple choice test was developed and administered throughout Spain to practicing physicians from specialties that frequently prescribe inhaler devices. The survey collected demographic characteristics (four items), preferences (two items), and issues related to knowledge (three items) and education (two items) about devices and inhalation techniques. Completion of the questionnaire was voluntary, individual, and anonymous. RESULTS: A total of 1514 respondents completed the questionnaire. Dry powder inhalers (DPI) were preferred by 61.2% physicians, but only 46.1% identified "inhale deeply and forcefully" as the most significant step in the inhalation maneuver using these devices. Only 27.7% stated that they always checked the patient's inhalation technique when prescribing a new inhaler. A composite variable, general inhaled therapy knowledge, which pooled the correct answers related to knowledge, revealed that only 14.2% physicians had an adequate knowledge of inhaled therapy. Multivariate analysis showed that this knowledge was lowest among internal medicine and primary care physicians. CONCLUSIONS: Prescribers' knowledge of inhalers and inhalation techniques remains poor in Spain. The causes should be identified in further research to allow effective educational strategies to be developed. Specific educational policies should be addressed to general practitioners.

Consensus document on the overlap phenotype COPD-asthma in COPD.

INTRODUCTION: Although asthma and COPD are different pathologies, many patients share characteristics from both entities. These cases can have different evolutions and responses to treatment. Nevertheless, the evidence available is limited, and it is necessary to evaluate whether they represent a differential phenotype and provide recommendations about diagnosis and treatment, in addition to identifying possible gaps in our understanding of asthma and COPD. METHODS: A nation-wide consensus of experts in COPD in two stages: 1) during an initial meeting, the topics to be dealt with were established and a first draft of statements was elaborated with a structured "brainstorming" method; 2) consensus was reached with two rounds of e-mails, using a Likert-type scale. RESULTS: Consensus was reached about the existence of a differential clinical phenotype known as"Overlap Phenotype COPD-Asthma", whose diagnosis is made when 2 major criteria and 2 minor criteria are met. The major criteria include very positive bronchodilator test (increase in FEV(1) ≥ 15% and ≥ 400ml), eosinophilia in sputum and personal history of asthma. Minor criteria include high total IgE, personal history of atopy and positive bronchodilator test (increase in FEV(1) ≥ 12% and ≥ 200ml) on two or more occasions. The early use of individually-adjusted inhaled corticosteroids is recommended, and caution must be taken with their abrupt withdrawal. Meanwhile, in severe cases the use of triple therapy should be evaluated. Finally, there is an obvious lack of specific studies about the natural history and the treatment of these patients. CONCLUSIONS: It is necessary to expand our knowledge about this phenotype in order to establish adequate guidelines and recommendations for its diagnosis and treatment.

Can cumulative tobacco consumption, FTND score, and carbon monoxide concentration in expired air be predictors of chronic obstructive pulmonary disease?

Between 15% and 20% of smokers develop chronic obstructive pulmonary disease (COPD). The aim of the present study was to determine which characteristics of smoking, particularly the Fagerström Test for Nicotine Dependence (FTND) score, were associated with the risk of developing COPD. Data from the IBERPOC epidemiological study were analyzed. IBERPOC was a multicenter epidemiological study including 4035 individuals aged 40-69 years, 1023 (25%) of whom were active smokers. We analyzed the association between smoking characteristics--such as the cumulative consumption of tobacco, FTND score, and expired-air carbon monoxide levels--and the diagnosis of COPD. Among the smokers, 153 (15%) were diagnosed with COPD. A cumulative tobacco consumption of more than 30 pack-years (OR=4.24, 95% CI=2.83-6.36) and the FTND score (OR=1.11, 95% CI=1.02-1.21, for each point increase) were significantly associated with the diagnosis of COPD in the model obtained by logistic regression analysis with the full sample of smokers. Cumulative consumption of tobacco was associated with the diagnosis of COPD. For each point increase in the FTND score, the probability of a smoker developing COPD increased by 11%.