Antibiotic resistance is a global health concern. Although numerous strategies have tried to reduce inadequate antibiotic prescribing, antibiotics are still prescribed in 60% of acute lower respiratory tract infections (ALRTIs) cases in Catalonia (Spain). This study aims to explore service users’ experiences of ALRTIs, the quality and access to healthcare services, and health education. Selective purposive sampling was carried out, based on a prior definition of participant characteristics. These were sex, age, ethnicity, date of the last ALRTI, number of ALRTIs in the last year, and treatments received. Participants with a previous diagnosis of ALRTIs were recruited from three primary health care centres in Barcelona and one in Tarragona. Twenty-nine interviews were conducted between April and June 2019. A content thematic analysis was performed. Three themes were identified: 1) risk perceptions and help-seeking; 2) treatment preferences and antibiotic use; and 3) relationship dynamics and communication with healthcare professionals. Accounts of service users’ sense of autonomy towards their health and power dynamics within the healthcare system were apparent. Supporting service users to become reliable, subjective and agentic experts of their health and bodies could help them to voice their healthcare agendas. Power structures embedded within healthcare, political and economic institutions should be challenged so that healthcare services can be co-developed (with service users) and based on service users’ autonomy and horizontal relationships. Special consideration should be paid to the intersection of social vulnerabilities. A concordance approach to prescribing could be key to improve the responsible use of antibiotics and to contribute to the prevention of AMR in primary healthcare. The marketisation of health, and the increased demands of private healthcare in Spain due to the financial pressures on public healthcare as a consequence of the financial crisis of 2008 and the COVID-19 pandemic, are a risk for promoting adequate antibiotic prescribing and use. Trial registration The ISAAC-CAT study has been registered in the NCT registry, ID: NCT03931577.
Background The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable. Objectives To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. Methods and analysis Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast. Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registration ClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.
BackgroundDespite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres.Methods/designA cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out.DiscussionThe ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines.Trial registrationClinicalTrials.gov, NCT03931577.
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