Publications by authors named "Ioanna Tsiligianni"

134 Publications

Comparison of rhinitis treatments using MASK-air® data and considering the Minimal Important Difference.

Allergy 2022 May 14. Epub 2022 May 14.

UCIBIO, REQUINTE, Faculty of Pharmacy and Competence Center on Active and Healthy Ageing of University of Porto (Porto4Ageing), Portugal.

Background: Different treatments exist for allergic rhinitis (AR), including pharmacotherapy and allergen immunotherapy (AIT), but they have not been compared using direct patient data (i.e., "real-world data").

Objective: To compare AR pharmacological treatments on (i) daily symptoms, (ii) frequency of use in co-medication, (iii) visual analogue scale (VAS) on allergy symptom control considering the minimal important difference (MID) and (iv) the effect of AIT.

Methods: We assessed the MASK-air® app data (May 2015 - December 2020) by users self-reporting AR (16-90 years). We compared eight AR medication schemes on reported VAS of allergy symptoms, clustering data by patient, and controlling for confounding factors. We compared (i) allergy symptoms between patients with and without AIT and (ii) different drug classes used in comedication.

Results: We analysed 269,837 days from 10,860 users. Most days (52.7%) involved medication use. Median VAS levels were significantly higher in co-medication than in monotherapy (including the fixed combination azelastine-fluticasone) schemes. In adjusted models, azelastine-fluticasone was associated with lower average VAS global allergy symptoms than all other medication schemes, while the contrary was observed for oral corticosteroids. AIT was associated with a decrease in allergy symptoms in some medication schemes. A difference larger than the MID compared to no treatment was observed for oral steroids. Azelastine-fluticasone was the drug class with the lowest chances of being used in co-medication (adjusted OR=0.75; 95%CI=0.71-0.80).

Conclusions: Median VAS levels were higher in co-medication than in monotherapy. Patients with more severe symptoms report a higher treatment, which is currently not reflected in guidelines.
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http://dx.doi.org/10.1111/all.15371DOI Listing
May 2022

Beliefs, Perceptions, and Behaviors Regarding Chronic Respiratory Diseases of Roma in Crete, Greece: A Qualitative FRESH AIR Study.

Front Public Health 2022 15;10:812700. Epub 2022 Apr 15.

Clinic of Social and Family Medicine, School of Medicine, University of Crete, Heraklion, Greece.

Background: The global burden of chronic respiratory diseases (CRDs) disproportionally affects Roma populations. Health interventions addressing CRD among Roma or other vulnerable groups often fail to be effective, as their implementation strategy misaligns with the local context. To design context-driven strategies, we studied CRD-related beliefs, perceptions, and behaviors among a Greek Roma population, focussing on asthma and COPD.

Methods: For this qualitative study in Crete, Greece, we used a Rapid Assessment Process. We conducted interviews and focus groups with purposively selected Roma community members (CMs), key informants (KIs) and healthcare professionals (HPs) serving the population. Data were triangulated using observations of households and clinical consultations. Key themes were identified using Thematic Content Analysis. The Health Belief Model, the Explanatory Model of Illness, and the Theory of Planned Behavior that are complementary is some aspects, guided our methodology with the several variables from them to be integrated to better understand CRD risk preventative behavior.

Results: We conducted six focus groups, seven interviews and 13 observations among 15 CMs, four KIs, and three HPs. Five themes emerged: (1) Poor CRD-awareness (smoking and household air pollution were perceived as harmful, but almost exclusively associated with acute rather than chronic symptoms); (2) Low perceived susceptibility to CRD (and CMs tended to ignore respiratory symptoms); (3) High risk exposure (smoking was common, and air pollution was perceived inevitable due to financial constraints); (4) Healthcare seeking (healthcare was sought only for persistent, severe symptoms, daily needs were a priority); (5) Perceived barriers/facilitators to care (health illiteracy, perceived discrimination and financial constraints were main barriers; established trust the main facilitator).

Conclusion: These five themes highlight that strategies to tackle CRD in the studied Roma setting require a multilevel approach: bridging awareness gaps at the population level, providing resources to enhance the adoption of healthy behaviors, and fighting discrimination at the societal level, whilst establishing trusted relationships at the local level. Similar methodologies to address local context may strengthen the implementation of effective interventions for similarly vulnerable and/or low-resource populations.
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http://dx.doi.org/10.3389/fpubh.2022.812700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9051233PMC
May 2022

Allergen immunotherapy in MASK-air users in real-life: Results of a Bayesian mixed-effects model.

Clin Transl Allergy 2022 Mar;12(3):e12128

Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.

Background: Evidence regarding the effectiveness of allergen immunotherapy (AIT) on allergic rhinitis has been provided mostly by randomised controlled trials, with little data from real-life studies.

Objective: To compare the reported control of allergic rhinitis symptoms in three groups of users of the MASK-air app: those receiving sublingual AIT (SLIT), those receiving subcutaneous AIT (SCIT), and those receiving no AIT.

Methods: We assessed the MASK-air data of European users with self-reported grass pollen allergy, comparing the data reported by patients receiving SLIT, SCIT and no AIT. Outcome variables included the daily impact of allergy symptoms globally and on work (measured by visual analogue scales-VASs), and a combined symptom-medication score (CSMS). We applied Bayesian mixed-effects models, with clustering by patient, country and pollen season.

Results: We analysed a total of 42,756 days from 1,093 grass allergy patients, including 18,479 days of users under AIT. Compared to no AIT, SCIT was associated with similar VAS levels and CSMS. Compared to no AIT, SLIT-tablet was associated with lower values of VAS global allergy symptoms (average difference = 7.5 units out of 100; 95% credible interval [95%CrI] = -12.1;-2.8), lower VAS Work (average difference = 5.0; 95%CrI = -8.5;-1.5), and a lower CSMS (average difference = 3.7; 95%CrI = -9.3;2.2). When compared to SCIT, SLIT-tablet was associated with lower VAS global allergy symptoms (average difference = 10.2; 95%CrI = -17.2;-2.8), lower VAS Work (average difference = 7.8; 95%CrI = -15.1;0.2), and a lower CSMS (average difference = 9.3; 95%CrI = -18.5;0.2).

Conclusion: In patients with grass pollen allergy, SLIT-tablet, when compared to no AIT and to SCIT, is associated with lower reported symptom severity. Future longitudinal studies following internationally-harmonised standards for performing and reporting real-world data in AIT are needed to better understand its 'real-world' effectiveness.
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http://dx.doi.org/10.1002/clt2.12128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8967259PMC
March 2022

Vitamin D levels in primary care patients: correlations with clinical, seasonal, and quality-of-life parameters.

Fam Pract 2022 Mar 23. Epub 2022 Mar 23.

Department of Social Medicine, Faculty of Medicine, University of Crete, Heraklion, Greece.

Background: The prevalence of vitamin D deficiency varies across countries and few data exist in the adult population in Greece.

Objectives: To assess vitamin D levels in unselected patients from primary care and to investigate possible correlations with clinical, seasonal, and quality-of-life parameters.

Methods: In this cross-sectional study, 389 consecutive patients were included. They were grouped according to vitamin D status as vitamin D deficient (<20 ng/mL) and vitamin D sufficient groups (≥20 ng/mL). Demographic, Epworth Sleepiness Scale (ESS), Athens Insomnia Scale (AIS), Beck Depression Inventory (BDI), and Fatigue Severity Scale (FSS) scores were measured and compared between groups.

Results: Vitamin D deficiency (<20 ng/mL) was observed in 50.4% of the cohort. Female gender (76% vs 66%, P = 0.026), obesity (42% vs 26%, P = 0.005), and hypertension (55% vs 43%, P = 0.023) were higher in the vitamin D deficiency group compared with the group without deficiency. After multiparametric adjustments (for age, gender, obesity, comorbidities, and seasonality), hypertension (odds ratio [OR] = 2.338, 95% confidence interval [CI] = 1.257-4.349, P = 0.007), excessive daytime sleepiness (ESS >10; OR = 3.345, 95% CI = 1.124-9.948, P = 0.029), depressive symptoms (BDI >10; OR = 3.769, 95% CI = 0.984-14.443, P = 0.04), and fatigue (FSS >36; OR = 7.157, 95% CI = 0.855-59.877, P = 0.04) showed significant independent associations with vitamin D deficiency in specific subgroups of patients.

Conclusion: A large proportion of patients in primary care had vitamin D deficiency, independently associated with hypertension, sleepiness, depressive symptoms, and fatigue. Further research is needed in order to determine the role of vitamin D in these patients.
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http://dx.doi.org/10.1093/fampra/cmac012DOI Listing
March 2022

Behavioural patterns in allergic rhinitis medication in Europe: A study using MASK-air real-world data.

Allergy 2022 Mar 8. Epub 2022 Mar 8.

Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.

Background: Co-medication is common among patients with allergic rhinitis (AR), but its dimension and patterns are unknown. This is particularly relevant since AR is understood differently across European countries, as reflected by rhinitis-related search patterns in Google Trends. This study aims to assess AR co-medication and its regional patterns in Europe, using real-world data.

Methods: We analysed 2015-2020 MASK-air European data. We compared days under no medication, monotherapy and co-medication using the visual analogue scale (VAS) levels for overall allergic symptoms ('VAS Global Symptoms') and impact of AR on work. We assessed the monthly use of different medication schemes, performing separate analyses by region (defined geographically or by Google Trends patterns). We estimated the average number of different drugs reported per patient within 1 year.

Results: We analysed 222,024 days (13,122 users), including 63,887 days (28.8%) under monotherapy and 38,315 (17.3%) under co-medication. The median 'VAS Global Symptoms' was 7 for no medication days, 14 for monotherapy and 21 for co-medication (p < .001). Medication use peaked during the spring, with similar patterns across different European regions (defined geographically or by Google Trends). Oral H -antihistamines were the most common medication in single and co-medication. Each patient reported using an annual average of 2.7 drugs, with 80% reporting two or more.

Conclusions: Allergic rhinitis medication patterns are similar across European regions. One third of treatment days involved co-medication. These findings suggest that patients treat themselves according to their symptoms (irrespective of how they understand AR) and that co-medication use is driven by symptom severity.
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http://dx.doi.org/10.1111/all.15275DOI Listing
March 2022

Family Medicine at the Forefront: Lessons Learnt From the COVID-19 Vaccine Rollout in Crete, Greece.

Front Public Health 2022;10:815825. Epub 2022 Jan 31.

Clinic of Social and Family Medicine, Faculty of Medicine, University of Crete, Heraklion, Greece.

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http://dx.doi.org/10.3389/fpubh.2022.815825DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8841835PMC
February 2022

Prioritising primary care respiratory research needs: results from the 2020 International Primary Care Respiratory Group (IPCRG) global e-Delphi exercise.

NPJ Prim Care Respir Med 2022 01 28;32(1). Epub 2022 Jan 28.

Paediatrics-Pulmonary Medicine, University of Colorado, Boulder, USA.

Respiratory diseases remain a significant cause of global morbidity and mortality and primary care plays a central role in their prevention, diagnosis and management. An e-Delphi process was employed to identify and prioritise the current respiratory research needs of primary care health professionals worldwide. One hundred and twelve community-based physicians, nurses and other healthcare professionals from 27 high-, middle- and low-income countries suggested 608 initial research questions, reduced after evidence review by 27 academic experts to 176 questions covering diagnosis, management, monitoring, self-management and prognosis of asthma, COPD and other respiratory conditions (including infections, lung cancer, tobacco control, sleep apnoea). Forty-nine questions reached 80% consensus for importance. Cross-cutting themes identified were: a need for more effective training of primary care clinicians; evidence and guidelines specifically relevant to primary care, adaption for local and low-resource settings; empowerment of patients to improve self-management; and the role of the multidisciplinary healthcare team.
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http://dx.doi.org/10.1038/s41533-021-00266-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8799668PMC
January 2022

Mapping low-resource contexts to prepare for lung health interventions in four countries (FRESH AIR): a mixed-method study.

Lancet Glob Health 2022 01;10(1):e63-e76

Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands; Amsterdam Institute for Social Science Research, University of Amsterdam, Amsterdam, Netherlands; The Children's Institute, University of Cape Town, Cape Town, South Africa.

Background: Effectiveness of health programmes can be undermined when the implementation misaligns with local beliefs and behaviours. To design context-driven implementation strategies, we explored beliefs and behaviours regarding chronic respiratory disease (CRD) in diverse low-resource settings.

Methods: This observational mixed-method study was conducted in Africa (Uganda), Asia (Kyrgyzstan and Vietnam) and Europe (rural Greece and a Roma camp). We systematically mapped beliefs and behaviours using the SETTING-tool. Multiple qualitative methods among purposively selected community members, health-care professionals, and key informants were triangulated with a quantitative survey among a representative group of community members and health-care professionals. We used thematic analysis and descriptive statistics.

Findings: We included qualitative data from 340 informants (77 interviews, 45 focus group discussions, 83 observations of community members' households and health-care professionals' consultations) and quantitative data from 1037 community members and 204 health-care professionals. We identified three key themes across the settings; namely, (1) perceived CRD identity (community members in all settings except the rural Greek strongly attributed long-lasting respiratory symptoms to infection, predominantly tuberculosis); (2) beliefs about causes (682 [65·8%] of 1037 community members strongly agreed that tobacco smoking causes symptoms, this number was 198 [19·1%] for household air pollution; typical perceived causes ranged from witchcraft [Uganda] to a hot-cold disbalance [Vietnam]); and (3) norms and social structures (eg, real men smoke [Kyrgyzstan and Vietnam]).

Interpretation: When designing context-driven implementation strategies for CRD-related interventions across these global settings, three consistent themes should be addressed, each with common and context-specific beliefs and behaviours. Context-driven strategies can reduce the risk of implementation failure, thereby optimising resource use to benefit health outcomes.

Funding: European Commission Horizon 2020.

Translations: For the Greek, Russian and Vietnamese translations of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S2214-109X(21)00456-3DOI Listing
January 2022

Managing asthma in primary healthcare.

Minerva Med 2021 Oct;112(5):582-604

International Primary Care Respiratory Group, Edinburgh, UK.

Asthma brings considerable challenges for family doctors because of its variety of shapes, different levels of severity, a wide age range, and the fact that in the last decades clinicians are able to offer much better treatment options with a better level of disease control and a higher quality of life. The objectives of the current review article are to provide an up-to-date review by primary care respiratory leaders from different countries of the most significant challenges regarding asthma diagnosis and management, the importance of team work and the problems in recognizing and dealing with difficult-to-manage and severe asthma in primary care. The article provides a short review of the main challenges faced by family physicians and other primary health care professionals in supporting their patients in the management of asthma, such as asthma diagnosis, promoting access to spirometry, the importance of a multiprofessional team for the management of asthma, how to organize an asthma review, the promotion of patient autonomy and shared decision-making, improving the use of inhalers, the importance of the personalized asthma action plan, dealing with difficult-to-manage and severe asthma in primary care and choosing when, where and how to refer patients with severe asthma. The article also discusses the development of an integrated approach to asthma care in the community and the promotion of Asthma Right Care.
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http://dx.doi.org/10.23736/S0026-4806.21.07277-3DOI Listing
October 2021

European Network to Advance Best Practices and Technology on Medication Adherence: Mission Statement.

Front Pharmacol 2021 11;12:748702. Epub 2021 Oct 11.

Department of Pharmacy, Faculty of Pharmacy, Uppsala University, Uppsala, Sweden.

Medication non-adherence is associated with almost 200,000 deaths annually and €80-125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.
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http://dx.doi.org/10.3389/fphar.2021.748702DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8544003PMC
October 2021

Under-Vaccination in Adults: Qualitative Insights Into Perceived Barriers Reported by Vaccine Supporters, Undecided and Refuters.

J Prim Prev 2021 Dec 17;42(6):625-640. Epub 2021 Oct 17.

Research Committee of Greek Association of General Practitioners, 54625, Thessaloniki, Greece.

Although vaccination is one of the most cost-effective ways of preventing disease, vaccine hesitancy has been included among the ten threats of global health. Addressing low adult vaccination rates requires an adequate understanding of people's views. We explored perceived barriers to immunization among under-vaccinated adults to identify potential differences among vaccine supporters, refuters, and those who are undecided. We conducted a multi-center, mixed-methods study at 23 primary care practices in Greece. Each day, we asked three new randomly-selected adult healthcare users who attended the practice over the course of 30 consecutive working days. We used thematic content analysis to analyze their written answers to open-ended questions that addressed reasons for not getting vaccinated. Out of 1571 participants, two-thirds reported they were under-vaccinated as adults, thus accounting for three out of five of the supporters and the vast majority of the undecided and refuters. "Concerns/fears," a "perception of low susceptibility to disease due to good health status," the "absence of healthcare professional's recommendation," and "previous negative experiences" were four themes common to all three groups. Additional barriers reported by supporters and the undecided included "knowledge gaps about the necessity of adult vaccination," "negligence," and lack of "accessibility." Among refuters, additional themes identified were "mistrust in pharmaceutical companies" and "disbelief in vaccine effectiveness." In conclusion, under-vaccination is common, not only among refuters or the undecided, but also among supporters of adult vaccination. We found similarities and differences in under-vaccinated adults' perceived barriers, depending on their individual perspectives. Physicians and public health services should take into consideration the impact of the wide range of attitudes and beliefs in their effort to address the underlying barriers to vaccination compliance as they attempt to increase vaccination coverage in adults.
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http://dx.doi.org/10.1007/s10935-021-00650-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8520579PMC
December 2021

Strategies for the prevention, diagnosis and treatment of COPD in low- and middle- income countries: the importance of primary care.

Expert Rev Respir Med 2021 12 12;15(12):1563-1577. Epub 2021 Oct 12.

University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (Griac), Groningen, The Netherlands.

Introduction: Low- and middle-income countries (LMICs) bear a high proportion of the global morbidity and mortality caused by COPD. Increased exposure to risk factors throughout life (e.g. malnutrition, indoor and outdoor air pollution, and smoking) is associated with higher COPD prevalence in LMICs and the lack of treatment availability increases avoidable harm.

Areas Covered: This review covers the epidemiology and burden of COPD in LMICs, and challenges and recommendations related to health-care systems, prevention, diagnosis, and treatment. Main challenges are related to under-resourced health-care systems (such as limited availability of spirometry, rehabilitation, and medicines). Lack of policy and practical local guidelines on COPD diagnosis and management further contribute to the low diagnostic and treatment rates. In the absence of, or limited number of respiratory specialists, primary care practitioners (general practitioners, nurses, pharmacists, physiotherapists, and community health workers) play an even more pivotal role in COPD management in LMICs.

Expert Opinion: Raising awareness on COPD, educating health-care workers, patients, and communities on cost-effective preventive measures as well as improving availability, affordability and proper use of diagnostic and pharmacological and non-pharmacologic treatment in primary care are the key interventions needed to improve COPD prevention, diagnosis, and care in LMICs.
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http://dx.doi.org/10.1080/17476348.2021.1985762DOI Listing
December 2021

Impact of PIF, Inhalation Technique and Medication Adherence on Health Status and Exacerbations in COPD: Protocol of a Real-World Observational Study (PIFotal COPD Study).

Pulm Ther 2021 Dec 17;7(2):591-606. Epub 2021 Sep 17.

General Practitioners Research Institute, Professor Enno Dirk Wiersmastraat 5, 9713 GH, Groningen, The Netherlands.

Introduction: Dry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy.

Methods And Analysis: This cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model.

Ethics: The study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants.

Trial Registration Number: ClinicalTrials.gov: NCT04532853.
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http://dx.doi.org/10.1007/s41030-021-00172-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445793PMC
December 2021

Evaluation of Obstructive Sleep Apnea in Female Patients in Primary Care: Time for Improvement?

Med Princ Pract 2021 26;30(6):508-514. Epub 2021 Aug 26.

Department of Thoracic Medicine, Sleep Disorders Center, University of Crete, Heraklion, Greece.

Obstructive sleep apnea (OSA) has historically been regarded as a male disease. However, there are a number of significant gender-related differences in the symptoms, diagnosis, and consequences of OSA, which seems to be more severe in male than in female patients, although this sex difference decreases with increasing age. Female patients with OSA tend to present nonspecific symptoms, such as insomnia, depressive symptoms, fatigue, morning headache, and nightmares, often resulting in underdiagnosis and undertreatment compared to male patients. Understanding these differences in women is essential for early identification and referral of patients for diagnosis and treatment of OSA.
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http://dx.doi.org/10.1159/000518932DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740168PMC
March 2022

Clinical characteristics and outcomes of polypharmacy in chronic obstructive pulmonary disease patients: A cross-sectional study from Crete, Greece.

Clin Respir J 2021 Dec 23;15(12):1310-1319. Epub 2021 Aug 23.

Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Crete, Greece.

Objectives: Polypharmacy and multimorbidity in chronic obstructive pulmonary disease (COPD) are highly prevalent, with potential associations with worse COPD outcomes. The aim of this study was to identify the clinical characteristics and outcomes of polypharmacy, investigate the relationship of polypharmacy with health status and exacerbations and assess the prevalence of inappropriate medication (PIM), risk of adverse drug reactions (ADRs) and drug-to-drug interactions in COPD patients.

Methods: A total of 245 COPD patients were enrolled from primary care in Crete, Greece. Patients completed a questionnaire and the COPD Assessment Test (CAT). Multimorbidity was defined as having two or more comorbidities and polypharmacy was defined as taking five or more drugs per day.

Results: Most of COPD patients (77.0%) and the majority (83.6%) of elderly (≥65 years) had multimorbidity, while polypharmacy was evident in 55.2% of all patients and 62.4% in elderly. After adjustments for age, gender and pack-years, polypharmacy was associated with CAT ≥ 10, multimorbidity, several cardiometabolic diseases, cancer and depression-anxiety and prostate disorders (all p values > 0.05). PIMs were found in 9.6% of subjects aged ≥65 years and were mainly mental health medication. Due to coadministration of medications, 22.3% of the population were at cumulative risk for falls, 17% for constipation and 12.8% for cardiovascular events. Finally, 15 pairs of drug-to-drug interactions were identified in 11.5% of patients.

Conclusion: Our data suggest that polypharmacy is highly prevalent and associated with worse health status and prescription risks in COPD patients. These findings potentially introduce an additional challenge on effective management of these patients.
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http://dx.doi.org/10.1111/crj.13434DOI Listing
December 2021

High Use of SABAs is Associated with Higher Exacerbation Rate in Dutch Patients with Asthma.

J Asthma Allergy 2021 12;14:851-861. Epub 2021 Jul 12.

General Practitioners Research Institute, Groningen, the Netherlands.

Purpose: Many patients with asthma still have insufficient disease control, despite the availability of effective treatment options. A substantial proportion of patients appear to rely more on short-acting beta-agonist (SABA) rather than on anti-inflammatory maintenance treatment. The aim of this study was to describe differences in indicators of asthma symptoms and exacerbations among patients using more or less SABA than the guideline-recommended threshold of <3 times/week.

Patients And Methods: Data from Dutch respondents in the European REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey were used in this post hoc analysis. The survey included asthma patients aged 18-50 years with at least two prescriptions for their asthma in the past two years. SABA use was categorized into two groups: <3 (low-SABA users) or ≥3 (high-SABA users) times in the last week.

Results: Of the 736 asthma patients, 21% did not use SABA and 19% used SABA 1 to 2 times (all low SABA users) and 60% used SABA ≥3 times (high SABA users) in the last week. The majority of high and low SABA users also reported using an ICS-containing treatment. Significant differences were found for all indicators related to exacerbations (p<0.001): high SABA users more frequently used antibiotics and oral steroids, more frequently visited the emergency departments or needed an overnight hospital stay. Indicators of asthma symptoms were not significantly different between both groups.

Conclusion: The majority of a Dutch asthmatic population reported high SABA use and had frequent moderate/severe exacerbations. More effective interventions are needed to change healthcare providers' and patients' behaviours to improve care and reduce SABA (over)use.
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http://dx.doi.org/10.2147/JAA.S292943DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285233PMC
July 2021

Obstructive sleep apnea as an additive or even synergistic risk factor for cardiovascular disease in patients with type 2 Diabetes: A call for action in primary care?

Diabetes Res Clin Pract 2021 Aug 6;178:108940. Epub 2021 Jul 6.

Department of Social Medicine, Faculty of Medicine, University of Crete, Greece.

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http://dx.doi.org/10.1016/j.diabres.2021.108940DOI Listing
August 2021

Management of asthma in childhood: study protocol of a systematic evidence update by the Paediatric Asthma in Real Life (PeARL) Think Tank.

BMJ Open 2021 07 2;11(7):e048338. Epub 2021 Jul 2.

Department of Paediatrics, University of Turku, Turku, Finland.

Introduction: Clinical recommendations for childhood asthma are often based on data extrapolated from studies conducted in adults, despite significant differences in mechanisms and response to treatments. The Paediatric Asthma in Real Life (PeARL) Think Tank aspires to develop recommendations based on the best available evidence from studies in children. An overview of systematic reviews (SRs) on paediatric asthma maintenance management and an SR of treatments for acute asthma attacks in children, requiring an emergency presentation with/without hospital admission will be conducted.

Methods And Analysis: Standard methodology recommended by Cochrane will be followed. Maintenance pharmacotherapy of childhood asthma will be evaluated in an overview of SRs published after 2005 and including clinical trials or real-life studies. For evaluating pharmacotherapy of acute asthma attacks leading to an emergency presentation with/without hospital admission, we opted to conduct de novo synthesis in the absence of adequate up-to-date published SRs. For the SR of acute asthma pharmacotherapy, we will consider eligible SRs, clinical trials or real-life studies without time restrictions. Our evidence updates will be based on broad searches of Pubmed/Medline and the Cochrane Library. We will use A MeaSurement Tool to Assess systematic Reviews, V.2, Cochrane risk of bias 2 and REal Life EVidence AssessmeNt Tool to evaluate the methodological quality of SRs, controlled clinical trials and real-life studies, respectively.Next, we will further assess interventions for acute severe asthma attacks with positive clinical results in meta-analyses. We will include both controlled clinical trials and observational studies and will assess their quality using the previously mentioned tools. We will employ random effect models for conducting meta-analyses, and Grading of Recommendations Assessment, Development and Evaluation methodology to assess certainty in the body of evidence.

Ethics And Dissemination: Ethics approval is not required for SRs. Our findings will be published in peer reviewed journals and will inform clinical recommendations being developed by the PeARL Think Tank.

Prospero Registration Numbers: CRD42020132990, CRD42020171624.
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http://dx.doi.org/10.1136/bmjopen-2020-048338DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256789PMC
July 2021

A Cross-Sectional Survey on Medication Management Practices for Noncommunicable Diseases in Europe During the Second Wave of the COVID-19 Pandemic.

Front Pharmacol 2021 7;12:685696. Epub 2021 Jun 7.

Medication Adherence Research Centre, Department of Family Medicine, Medical University of Lodz, Lodz, Poland.

Maintaining healthcare for noncommunicable diseases (NCDs) is particularly important during the COVID-19 pandemic; however, diversion of resources to acute care, and physical distancing restrictions markedly affected management of NCDs. We aimed to assess the medication management practices in place for NCDs during the second wave of the COVID-19 pandemic across European countries. In December 2020, the European Network to Advance Best practices & technoLogy on medication adherencE (ENABLE) conducted a cross-sectional, web-based survey in 38 European and one non-European countries. Besides descriptive statistics of responses, nonparametric tests and generalized linear models were used to evaluate the impact on available NCD services of the number of COVID-19 cases and deaths per 100,000 inhabitants, and gross domestic product (GDP) per capita. Fifty-three collaborators from 39 countries completed the survey. In 35 (90%) countries face-to-face primary-care, and out-patient consultations were reduced during the COVID-19 pandemic. The mean ± SD number of available forms of teleconsultation services in the public healthcare system was 3 ± 1.3. Electronic prescriptions were available in 36 (92%) countries. Online ordering and home delivery of prescription medication (avoiding pharmacy visits) were available in 18 (46%) and 26 (67%) countries, respectively. In 20 (51%) countries our respondents were unaware of any national guidelines regarding maintaining medication availability for NCDs, nor advice for patients on how to ensure access to medication and adherence during the pandemic. Our results point to an urgent need for a paradigm shift in NCD-related healthcare services to assure the maintenance of chronic pharmacological treatments during COVID-19 outbreaks, as well as possible future disasters.
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http://dx.doi.org/10.3389/fphar.2021.685696DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216671PMC
June 2021

Towards Rational Prescription of Common Inhaler Medication in the Multimorbid COPD Patient.

Int J Chron Obstruct Pulmon Dis 2021;16:1315-1327. Epub 2021 May 11.

Department of Pneumology, ISPPC, CHU Charleroi, Charleroi, Belgium.

COPD is a chronic disease, typically accompanied by multiple comorbid conditions. The need to apply several, and sometimes conflicting, disease-specific treatment guidelines, complicates the management of individual patients. Moreover, national and international recommendations evolve rapidly but provide limited guidance on the integrated approach in the multimorbid patient. Particularly bothersome is the fact that the presence of comorbidities may deteriorate the course of COPD, and inversely COPD may affect the outcome of the comorbid diseases. In addition, some effects of commonly prescribed COPD inhaler medications, including beta-agonists, long-acting antimuscarinics and especially inhaled corticosteroids, mimic or worsen COPD-related comorbidities. Therefore, the authors combined their perspectives to formulate advice that may help physicians to improve COPD patient care in daily practice when comorbidities are present. Diabetes, atrial fibrillation, osteoporosis/fractures, infections (pneumonia and tuberculosis) and asthma were identified as areas where practicing clinicians should give special attention to the risk-benefit ratio of the inhaled medication. Overall, the presence of multimorbidity in a COPD patient should act as a signal to carefully reconsider the treatment choices.
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http://dx.doi.org/10.2147/COPD.S298345DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127323PMC
July 2021

Management of anaphylaxis due to COVID-19 vaccines in the elderly.

Allergy 2021 10;76(10):2952-2964

Regional Ministry of Health of Andalusia, Seville, Spain.

Older adults, especially men and/or those with diabetes, hypertension, and/or obesity, are prone to severe COVID-19. In some countries, older adults, particularly those residing in nursing homes, have been prioritized to receive COVID-19 vaccines due to high risk of death. In very rare instances, the COVID-19 vaccines can induce anaphylaxis, and the management of anaphylaxis in older people should be considered carefully. An ARIA-EAACI-EuGMS (Allergic Rhinitis and its Impact on Asthma, European Academy of Allergy and Clinical Immunology, and European Geriatric Medicine Society) Working Group has proposed some recommendations for older adults receiving the COVID-19 vaccines. Anaphylaxis to COVID-19 vaccines is extremely rare (from 1 per 100,000 to 5 per million injections). Symptoms are similar in younger and older adults but they tend to be more severe in the older patients. Adrenaline is the mainstay treatment and should be readily available. A flowchart is proposed to manage anaphylaxis in the older patients.
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http://dx.doi.org/10.1111/all.14838DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251336PMC
October 2021

Differentiation of COVID-19 signs and symptoms from allergic rhinitis and common cold: An ARIA-EAACI-GA LEN consensus.

Allergy 2021 08 14;76(8):2354-2366. Epub 2021 May 14.

Division of Allergy, Department of Pediatric Medicine, The Bambino Gesù Children's Research Hospital Holy see, IRCCS, Rome, Italy.

Background: Although there are many asymptomatic patients, one of the problems of COVID-19 is early recognition of the disease. COVID-19 symptoms are polymorphic and may include upper respiratory symptoms. However, COVID-19 symptoms may be mistaken with the common cold or allergic rhinitis. An ARIA-EAACI study group attempted to differentiate upper respiratory symptoms between the three diseases.

Methods: A modified Delphi process was used. The ARIA members who were seeing COVID-19 patients were asked to fill in a questionnaire on the upper airway symptoms of COVID-19, common cold and allergic rhinitis.

Results: Among the 192 ARIA members who were invited to respond to the questionnaire, 89 responded and 87 questionnaires were analysed. The consensus was then reported. A two-way ANOVA revealed significant differences in the symptom intensity between the three diseases (p < .001).

Conclusions: This modified Delphi approach enabled the differentiation of upper respiratory symptoms between COVID-19, the common cold and allergic rhinitis. An electronic algorithm will be devised using the questionnaire.
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http://dx.doi.org/10.1111/all.14815DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250633PMC
August 2021

Artificial Intelligence/Machine Learning in Respiratory Medicine and Potential Role in Asthma and COPD Diagnosis.

J Allergy Clin Immunol Pract 2021 06 19;9(6):2255-2261. Epub 2021 Feb 19.

Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Artificial intelligence (AI) and machine learning, a subset of AI, are increasingly used in medicine. AI excels at performing well-defined tasks, such as image recognition; for example, classifying skin biopsy lesions, determining diabetic retinopathy severity, and detecting brain tumors. This article provides an overview of the use of AI in medicine and particularly in respiratory medicine, where it is used to evaluate lung cancer images, diagnose fibrotic lung disease, and more recently is being developed to aid the interpretation of pulmonary function tests and the diagnosis of a range of obstructive and restrictive lung diseases. The development and validation of AI algorithms requires large volumes of well-structured data, and the algorithms must work with variable levels of data quality. It is important that clinicians understand how AI can function in the context of heterogeneous conditions such as asthma and chronic obstructive pulmonary disease where diagnostic criteria overlap, how AI use fits into everyday clinical practice, and how issues of patient safety should be addressed. AI has a clear role in providing support for doctors in the clinical workplace, but its relatively recent introduction means that confidence in its use still has to be fully established. Overall, AI is expected to play a key role in aiding clinicians in the diagnosis and management of respiratory diseases in the future, and it will be exciting to see the benefits that arise for patients and doctors from its use in everyday clinical practice.
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http://dx.doi.org/10.1016/j.jaip.2021.02.014DOI Listing
June 2021

Understanding what people think and feel about adult vaccinations and the associated barriers in Greece: Development and validation of the attitude towards adult vaccination (ATAVAC) scale.

Health Soc Care Community 2021 05 17;29(3):818-828. Epub 2021 Feb 17.

Research Committee of Greek Association of General Practitioners, Thessaloniki, Greece.

Despite the unequivocal value of vaccination in reducing the global burden of infectious diseases, the anti-vaccination movement thrives. The vast majority of the existing validated tools explore attitudes regarding vaccination in children. The aim of our study was to develop and validate a scale assessing attitudes towards adult immunisation. This national cross-sectional study included adult healthcare users who visited 23 Greek Primary Healthcare Units. The development of the scale was the result of literature review, semi-structured interviews and pilot testing of its preliminary versions. The initial version contained 15 items measuring respondents' attitudes on a 6-point Likert scale. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales; confirmatory factor analysis was used in the second sample to assess goodness of fit. Moreover, concurrent validity, internal consistency reliability, test-retest reliability and ceiling and floor effects were explored. The total sample consisted of 1,571 individuals. Overall 'Cronbach's alpha' (0.821) indicated good internal consistency. The initial exploratory factor analysis resulted in a three-factor model. The subsequent confirmatory factor analysis indicated that an 11-item version of the scale provided the best fit of the model to the data (RMSEA = 0.050, SRMR = 0.053, TLI = 0.937, CFI = 0.955, AIC = 24,999.949). All subscales ('value of adult vaccination', 'safety concerns' and 'perceived barriers') demonstrated strong concurrent associations with participants' attitudes and behaviour regarding vaccination (p < .001). No ceiling or floor effects were noted for any of the subscales (0.13%, 2.61% and 0.51%; 0.13%, 0.57% and 0.45% respectively). The 11-item ATAVAC scale proved to be a reliable and valid tool, suitable for assessing attitudes towards adult vaccination.
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http://dx.doi.org/10.1111/hsc.13317DOI Listing
May 2021

A systematic approach to context-mapping to prepare for health interventions: development and validation of the SETTING-tool in four countries.

BMJ Glob Health 2021 01;6(1)

Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.

Effectiveness of health interventions can be substantially impaired by implementation failure. Context-driven implementation strategies are critical for successful implementation. However, there is no practical, evidence-based guidance on how to map the context in order to design context-driven strategies. Therefore, this practice paper describes the development and validation of a systematic context-mapping tool. The tool was cocreated with local end-users through a multistage approach. As proof of concept, the tool was used to map beliefs and behaviour related to chronic respiratory disease within the FRESH AIR project in Uganda, Kyrgyzstan, Vietnam and Greece. Feasibility and acceptability were evaluated using the modified Conceptual Framework for Implementation Fidelity. Effectiveness was assessed by the degree to which context-driven adjustments were made to implementation strategies of FRESH AIR health interventions. The resulting Setting-Exploration-Treasure-Trail-to-Inform-implementatioN-strateGies (SETTING-tool) consisted of six steps: (1) Coset study priorities with local stakeholders, (2) Combine a qualitative rapid assessment with a quantitative survey (a mixed-method design), (3) Use context-sensitive materials, (4) Collect data involving community researchers, (5) Analyse pragmatically and/or in-depth to ensure timely communication of findings and (6) Continuously disseminate findings to relevant stakeholders. Use of the tool proved highly feasible, acceptable and effective in each setting. To conclude, the SETTING-tool is validated to systematically map local contexts for (lung) health interventions in diverse low-resource settings. It can support policy-makers, non-governmental organisations and health workers in the design of context-driven implementation strategies. This can reduce the risk of implementation failure and the waste of resource potential. Ultimately, this could improve health outcomes.
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http://dx.doi.org/10.1136/bmjgh-2020-003221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7805378PMC
January 2021

GINA 2020: Potential Impacts, Opportunities, and Challenges for Primary Care.

J Allergy Clin Immunol Pract 2021 04 26;9(4):1516-1519. Epub 2020 Dec 26.

Quality Use of Respiratory Medicines Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia. Electronic address:

In 2019, it was reported that changes to asthma management reported in the Global Initiative for Asthma (GINA) "…might be considered the most fundamental changes in asthma management in 30 years." These changes refer to the recommendation that the treatment of asthma in adolescents and adults would no longer include short-acting ß-agonist (SABA) only, but that people with asthma should receive either symptom-driven inhaled corticosteroids (ICS)-containing treatment (mild asthma) or daily ICS-containing treatment. The fundamental reason for this shift was driven by concerns about the risks and consequences associated with SABA-only treatment, the need to improve the day-to-day management of asthma symptoms to prevent exacerbations and emergent evidence. These recommendations have subsequently been reinforced and characterized in GINA 2020, and it is reasonable to say that they are significant, not only in terms of an asthma management framework but also as a management approach in practice. This opinion article specifically focuses on opportunities and challenges associated with the implementation of GINA 2020 in primary care practice that need to be recognized and addressed if the shift in asthma treatment paradigm is to be successfully implemented into day-to-day practice.
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http://dx.doi.org/10.1016/j.jaip.2020.12.035DOI Listing
April 2021
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