Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study

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

Effectiveness of antitussives, anticholinergics or honey versus usual care in adults with uncomplicated acute bronchitis: a study protocol of an open randomised clinical trial in primary care

Introduction: Despite the frequent use of therapies in acute bronchitis, the evidence of their benefit is lacking, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of three symptomatic therapies (dextromethorphan, ipratropium or honey) associated with usual care and the usual care in adults with acute bronchitis. Methods and analysis: This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 µg two puffs three times a day or honey 30 mg (a spoonful) three times a day, all taken for up to 14 days. The exclusion criteria will be pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs or admitted to a long-term residence. Sample: 668 patients. The primary outcome will be the number of days with moderate-to-severe cough. All patients will be given a paper-based symptom diary to be self-administered. A second visit will be scheduled at day 2 or 3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called 6 weeks after the baseline visit. Ethics and dissemination: The study has been approved by the Ethical Board of IDIAP Jordi Gol (reference number: AC18/002). The findings of this trial will be disseminated through research conferences and peer-review journals. Trial registration: number NCT03738917; Pre-results

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

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

Effect of effervescent paracetamol on blood pressure: a crossover randomized clinical trial

OBJECTIVE: To evaluate the effect of effervescent paracetamol on office and ambulatory blood pressure (BP) compared with noneffervescent paracetamol in hypertensive patients. DESIGN: This was a multicenter open crossover randomized clinical trial. SETTING: Primary care centers in Catalonia and the Basque Country. PARTICIPANTS: Inclusion criteria were office BP 150/95¿mmHg or less and daytime ambulatory BP 140/90¿mmHg or less, stable pharmacologic or nonpharmacologic antihypertensive treatment, and concomitant chronic osteoarticular pain. INTERVENTIONS: Baseline randomized assignment to 3-week periods of effervescent paracetamol (1¿g three times a day) first and noneffervescent paracetamol later, or inversely, during a 7-week study period. At the start and end of each treatment period, 24-h ambulatory BP monitoring was performed. MAIN OUTCOME MEASURES: Differences in 24-h SBP between baseline and end of both treatment periods. The main analyses were performed according to the intention-to-treat principle. RESULTS: In intention-to-treat analysis, 46 patients were analyzed, 21 were treated with paracetamol effervescent and noneffervescent later, and 25 followed the opposite sequence. The difference in 24-h SBP between the two treatments was 3.99¿mmHg (95% confidence interval 1.35-6.63; P¿=¿0.004), higher in the effervescent paracetamol treatment period. Similarly, the per-protocol analysis showed a difference in 24-h SBP between the two groups of 5.04¿mmHg (95% confidence interval 1.80-8.28; P¿=¿0.004), higher in the effervescent paracetamol treatment period. Self-reported pain levels did not differ between groups and did not vary by treatment period. No serious adverse events were reported in either study arm. CONCLUSION: Effervescent paracetamol tablets are responsible for a significant daytime and overall increase in ambulatory 24-h SBP. TRIAL REGISTRATION: NCT: 02514538 EudraCT: 2010-023485-53.Peer ReviewedPostprint (author's final draft

Health alliance for prudent prescribing and yield of antibiotics in a patient-centred perspective (HAPPY PATIENT): a before-and-after intervention and implementation study protocol

Background Excessive and inappropriate use of antibiotics is the most important driver of antimicrobial resistance. The aim of the HAPPY PATIENT project is to evaluate the adaptation of European Union (EU) recommendations on the prudent use of antimicrobials in human health by evaluating the impact of a multifaceted intervention targeting different categories of healthcare professionals (HCPs) on common community-acquired infectious diseases, especially respiratory and urinary tract infections. Methods/design HAPPY PATIENT was initiated in January 2021 and is planned to end in December 2023. The partners of this project include 15 organizations from 9 countries. Diverse HCPs (doctors, nurses, pharmacists, and pharmacy technicians) will be audited by the Audit Project Odense (APO) method before and after an intervention in four different settings: general practice, out of hours services, nursing homes and community pharmacies in four high antibiotic prescribing countries (France, Poland, Greece, and Spain) and one low prescribing country (Lithuania). About 25 individuals from each professional group will be recruited in each country, who will register at least 25 patients with community-acquired infections during each audit period. Shortly before the second registration participants will undertake a multifaceted intervention and will receive the results from the first registration to allow the identification of possible quality problems. At these meetings participants will receive training courses on enhancement of communication skills, dissemination of clinical guidelines with recommendations for diagnosis and treatment, posters for the waiting rooms, and leaflets for patients. The results of the second registration will be compared with those obtained in the first audit. Discussion HAPPY PATIENT is an EU-funded project aimed at contributing to the battle against antibiotic resistance through improvement of the quality of management of common community-acquired infections based on interventions by different types of HCPs. It is hypothesized that the use of multifaceted strategies combining active intervention will be effective in reducing inappropriate prescribing and dispensing of antibiotics.publishedVersio

Urinary Tract Infections in Men in Primary Care in Catalonia, Spain

Antimicrobial resistance is a major global problem that is primarily driven by the excessive and inappropriate utilization of antibiotics. Urinary tract infections (UTIs) are frequent in primary health care (PHC) and are typically treated with antibiotics. There is ample evidence on the management of this condition in women but not in men. The aim of this study was to describe the epidemiology of UTIs in men in Catalonia, Spain. We conducted a population-based observational cohort study that included male patients diagnosed with UTI within our SIDIAP and CMBD database during the period from 2012 to 2021. UTI diagnoses were grouped into five main groups (cystitis, prostatitis, orchitis and epididymitis, urethritis, and pyelonephritis). Of the 316,762 men with at least one recorded UTI episode, the majority were registered with a diagnosis of cystitis in PHC (212,958 patients). Quinolones were the most commonly recorded treatment for UTIs (between 18.3% and 38.6%, depending on the group), except for urethritis in which a combination of antibiotics (36.7%) was most frequently used. The treatment duration period was between 9 days and 18 days, except for the prostatitis group, in which treatment was extended to 21 days. Urine cultures were documented in up to 30% in the cystitis group. Pyelonephritis was the category linked to most septicemia cases (3.0%). Conclusions: This is the first study to assess UTIs in men using a large PHC database in Spain. The sociodemographic characteristics of our sample are similar to other studies in the literature. In our setting, the use of quinolones for the treatment of UTIs is the most registered, and its duration was between 9 days and 18 days, despite the fact that resistance to quinolones exceeds 20% of the strains in our area

Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study.

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

Effectiveness of antitussives, anticholinergics or honey versus usual care in adults with uncomplicated acute bronchitis : a study protocol of an open randomised clinical trial in primary care

Introduction Despite the frequent use of therapies in acute bronchitis, the evidence of their benefit is lacking, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of three symptomatic therapies (dextromethorphan, ipratropium or honey) associated with usual care and the usual care in adults with acute bronchitis. Methods and analysis This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 μg two puffs three times a day or honey 30 mg (a spoonful) three times a day, all taken for up to 14 days. The exclusion criteria will be pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs or admitted to a long-term residence. Sample: 668 patients. The primary outcome will be the number of days with moderate-to-severe cough. All patients will be given a paper-based symptom diary to be self-administered. A second visit will be scheduled at day 2 or 3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called 6 weeks after the baseline visit. Ethics and dissemination The study has been approved by the Ethical Board of IDIAP Jordi Gol (reference number: AC18/002). The findings of this trial will be disseminated through research conferences and peer-review journals. Trial registration number NCT03738917; Pre-results

Antimicrobial Agent Use for Urinary Tract Infection in Long-Term Care Facilities in Spain: Results from a Retrospective Analytical Cohort Analysis

Urinary tract infections (UTIs) are highly prevalent in long-term care facilities, constituting the most common infection in this setting. Our research focuses on analyzing clinical characteristics and antimicrobial prescriptions for UTIs in residents across nursing homes (NH) in Spain. This is a retrospective analytical cohort analysis using a multifaceted approach based on the normalization process theory to improve healthcare quality provided by nursing staff in 34 NHs in Spain. In this study, we present the results of the first audit including 719 UTI cases collected between February and April 2023, with an average age of 85.5 years and 74.5% being women. Cystitis and pyelonephritis presented distinct symptom patterns. Notably, 6% of asymptomatic bacteriuria cases were treated. The prevalence of dipstick usage was 83%, and that of urine culture was only 16%, raising concerns about overreliance, including in the 46 asymptomatic cases, leading to potential overdiagnosis and antibiotic overtreatment. Improved diagnostic criteria and personalized strategies are crucial for UTI management in NHs, emphasizing the need for personalized guidelines on the management of UTIs to mitigate indiscriminate antibiotic use in asymptomatic cases