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Jose Luis López-Campos,1,2 María Abad Arranz,1 Carmen Calero Acuña,1,2 Fernando Romero Valero,3 Ruth Ayerbe García,4 Antonio Hidalgo Molina,3 Ricardo I Aguilar Perez-Grovas,4 Francisco García Gil,5 Francisco Casas Maldonado,6 Laura Caballero Ballesteros,5 María Sánchez Palop,6 Dolores Pérez-Tejero,7 Alejandro Segado,7 Jose Calvo Bonachera,8 Bárbara Hernández Sierra,8 Adolfo Doménech,9 Macarena Arroyo Varela,9 Francisco González Vargas,10 Juan J Cruz Rueda10 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 2Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, 3Hospital Universitario Puerta del Mar, Cádiz, 4Hospital Juan Ramón Jiménez, Huelva, 5Hospital Universitario Reina Sofía, Córdoba, 6Hospital Universitario San Cecilio, Granada, 7Hospital Infanta Margarita, Cabra, Córdoba, 8Hospital Torrecárdenas, Almería, 9Hospital Regional Universitario de Málaga, 10Hospital Universitario Virgen de las Nieves, Granada, Spain Introduction: This study is an analysis of a pilot COPD clinical audit that evaluated adherence to guidelines for patients with COPD in a stable disease phase during a routine visit in specialized secondary care outpatient clinics in order to identify the variables associated with the decision to step-up or step-down pharmacological treatment.Methods: This study was a pilot clinical audit performed at hospital outpatient respiratory clinics in the region of Andalusia, Spain (eight provinces with over eight million inhabitants), in which 20% of centers in the area (catchment population 3,143,086 inhabitants) were invited to participate. Treatment changes were evaluated in terms of the number of prescribed medications and were classified as step-up, step-down, or no change. Three backward stepwise binominal multivariate logistic regression analyses were conducted to evaluate variables associated with stepping up, stepping down, and inhaled corticosteroids discontinuation.Results: The present analysis evaluated 565 clinical records (91%) of the complete audit. Of those records, 366 (64.8%) cases saw no change in pharmacological treatment, while 99patients (17.5%) had an increase in the number of drugs, 55 (9.7%) had a decrease in the number of drugs, and 45 (8.0%) noted a change to other medication for a similar therapeutic scheme. Exacerbations were the main factor in stepping up treatment, as were the symptoms themselves. In contrast, rather than symptoms, doctors used forced expiratory volume in 1second and previous treatment with long-term antibiotics or inhaled corticosteroids as the key determinants to stepping down treatment.Conclusion: The majority of doctors did not change the prescription. When changes were made, a number of related factors were noted. Future trials must evaluate whether these therapeutic changes impact clinically relevant outcomes at follow-up. Keywords: quality of care, outpatient care, treatment strategies, follow-up, respiratory diseases, airway diseases

Jose Luis López-Campos,1,2 María Abad Arranz,1 Carmen Calero Acuña,1,2 Fernando Romero Valero,3 Ruth Ayerbe García,4 Antonio Hidalgo Molina,3 Ricardo I Aguilar Perez-Grovas,4 Francisco García Gil,5 Francisco Casas Maldonado,6 Laura Caballero Ballesteros,5 María Sánchez Palop,6 Dolores Pérez-Tejero,7 Alejandro Segado,7 Jose Calvo Bonachera,8 Bárbara Hernández Sierra,8 Adolfo Doménech,9 Macarena Arroyo Varela,9 Francisco González Vargas,10 Juan J Cruz Rueda10 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 2Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, 3Hospital Universitario Puerta del Mar, Cádiz, 4Hospital Juan Ramón Jiménez, Huelva, 5Hospital Universitario Reina Sofía, Córdoba, 6Hospital Universitario San Cecilio, Granada, 7Hospital Infanta Margarita, Cabra, Córdoba, 8Hospital Torrecárdenas, Almería, 9Hospital Regional Universitario de Málaga, 10Hospital Universitario Virgen de las Nieves, Granada, Spain Introduction: This study is an analysis of a pilot COPD clinical audit that evaluated adherence to guidelines for patients with COPD in a stable disease phase during a routine visit in specialized secondary care outpatient clinics in order to identify the variables associated with the decision to step-up or step-down pharmacological treatment.Methods: This study was a pilot clinical audit performed at hospital outpatient respiratory clinics in the region of Andalusia, Spain (eight provinces with over eight million inhabitants), in which 20% of centers in the area (catchment population 3,143,086 inhabitants) were invited to participate. Treatment changes were evaluated in terms of the number of prescribed medications and were classified as step-up, step-down, or no change. Three backward stepwise binominal multivariate logistic regression analyses were conducted to evaluate variables associated with stepping up, stepping down, and inhaled corticosteroids discontinuation.Results: The present analysis evaluated 565 clinical records (91%) of the complete audit. Of those records, 366 (64.8%) cases saw no change in pharmacological treatment, while 99patients (17.5%) had an increase in the number of drugs, 55 (9.7%) had a decrease in the number of drugs, and 45 (8.0%) noted a change to other medication for a similar therapeutic scheme. Exacerbations were the main factor in stepping up treatment, as were the symptoms themselves. In contrast, rather than symptoms, doctors used forced expiratory volume in 1second and previous treatment with long-term antibiotics or inhaled corticosteroids as the key determinants to stepping down treatment.Conclusion: The majority of doctors did not change the prescription. When changes were made, a number of related factors were noted. Future trials must evaluate whether these therapeutic changes impact clinically relevant outcomes at follow-up. Keywords: quality of care, outpatient care, treatment strategies, follow-up, respiratory diseases, airway diseases

Objectives: Previous clinical audits for chronic obstructive pulmonary disease (COPD) have provided valuable information on the clinical care delivered to patients admitted to medical wards because of COPD exacerbations. However, clinical audits of COPD in an outpatient setting are scarce and no methodological guidelines are currently available. Based on our previous experience, herein we describe a clinical audit for COPD patients in specialized outpatient clinics with the overall goal of establishing a potential methodological workflow., Methods: A pilot clinical audit of COPD patients referred to respiratory outpatient clinics in the region of Andalusia, Spain (over 8 million inhabitants), was performed. The audit took place between October 2013 and September 2014, and 10 centers (20% of all public hospitals) were invited to participate. Cases with an established diagnosis of COPD based on risk factors, clinical symptoms, and a post-bronchodilator FEV1/FVC ratio of less than 0.70 were deemed eligible. The usefulness of formally scheduled regular follow-up visits was assessed. Two different databases (resources and clinical database) were constructed. Assessments were planned over a year divided by 4 three-month periods, with the goal of determining seasonal-related changes. Exacerbations and survival served as the main endpoints., Conclusions: This paper describes a methodological framework for conducting a clinical audit of COPD patients in an outpatient setting. Results from such audits can guide health information systems development and implementation in real-world settings., This study was financially supported by an unrestricted grant from Laboratorios Menarini, SA (Barcelona, Spain).