G Model
ARTICLE IN PRESS
Arch Bronconeumol. 2015;xxx(xx):xxx–xxx
www.archbronconeumol.org
Special article
ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical
Practice Guidelines: Questions and Answers夽
María Montes de Oca,a,∗ María Victorina López Varela,b Agustín Acuña,c Eduardo Schiavi,d
María Alejandra Rey,b José Jardim,e Alejandro Casas,f Antonio Tokumoto,g Carlos A. Torres Duque,f
Alejandra Ramírez-Venegas,h Gabriel García,i Roberto Stirbulov,j Aquiles Camelier,k Miguel Bergna,l
Mark Cohen,m Santiago Guzmán,n Efraín Sánchezc
a
Hospital Universitario de Caracas, Universidad Central de Venezuela, Caracas, Venezuela
b
Universidad de la República, Hospital Maciel, Montevideo, Uruguay
c
Hospital Universitario de Caracas, Universidad Central de Venezuela, y Centro Médico Docente La Trinidad, Caracas, Venezuela
d
Hospital de Rehabilitación Respiratoria “María Ferrer”, Buenos Aires, Argentina
e
Universidade Federal de São Paulo, São Paulo, Brazil
f
Fundación Neumológica Colombiana, Bogotá, Colombia
g
Hospital Central Fuerza Aérea del Perú, Lima, Peru
h
Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
i
Hospital Rodolfo Rossi, La Plata, Argentina
j
Facultad de Ciencias Médicas, Santa Casa de San Pablo, São Paulo, Brazil
k
Universidade Federal da Bahia e Escola Bahiana de Medicina, Salvador, Brazil
l
Hospital Dr. Antonio Cetrángolo, Vicente López, Buenos Aires, Argentina
m
Hospital Centro Médico, Guatemala, Guatemala
n
Hospital José Gregorio Hernández, Caracas, Venezuela
a r t i c l e i n f o a b s t r a c t
Article history: ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence
Received 30 June 2014 related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals
Accepted 17 November 2014 the existence of risk factors for COPD other than tobacco, as well as gender differences in disease pre-
Available online xxx
sentation. It shows the benefit of screening in an at-risk population, and the predictive value use of
multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function
Keywords: and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more
Clinical practice guideline
effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy.
Chronic obstructive pulmonary disease
(COPD)
LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with
LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vacci-
nation in all patients and anti-pneumococcal vaccination in patients < 65 years of age and/or with severe
airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The
use of systemic corticosteroids and antibiotics is justified in exacerbations requiring hospitalization and
in some patients managed in an outpatient setting.
© 2014 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.
Guía de práctica clínica de la enfermedad pulmonar obstructiva crónica (EPOC)
ALAT-2014: Preguntas y respuestas
r e s u m e n
Palabras clave: La guía de práctica clínica de enfermedad pulmonar obstructiva crónica (EPOC) ALAT 2014 fue elaborada
Enfermedad pulmonar obstructiva crónica contestando preguntas clínicas en formato PICO a través del análisis de evidencias sobre factores de
(EPOC) riesgo, búsqueda de casos, evaluación pronóstica, tratamiento y exacerbaciones. La evidencia indica que
Guía de práctica clínica
existen factores de riesgo diferentes al tabaco, diferencias según el género, soporta la búsqueda activa
夽 Please cite this article as: Montes de Oca M, López Varela MV, Acuña A, Schiavi E, Rey MA, Jardim J, et al. Guía de práctica clínica de la enfermedad pulmonar obstructiva
crónica (EPOC) ALAT-2014: Preguntas y respuestas. Arch Bronconeumol. 2015. http://dx.doi.org/10.1016/j.arbres.2014.11.017
∗ Corresponding author.
E-mail address: (M. Montes de Oca).
1579-2129/© 2014 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.
ARBR-1100; No. of Pages 14
, G Model
ARTICLE IN PRESS
2 M. Montes de Oca et al. / Arch Bronconeumol. 2015;xxx(xx):xxx–xxx
de casos en población de riesgo y el valor predictivo de los índices multidimensionales. En la EPOC estable
se encuentran similares beneficios de la monoterapia broncodilatadora (LAMA o LABA) sobre la disnea,
función pulmonar o calidad de vida, y mayor efectividad del LAMA para prevenir exacerbaciones. La doble
terapia broncodilatadora tiene mayores beneficios comparada con la monoterapia. La eficacia de la terapia
con LAMA y la combinación LABA/CI es similar, con mayor riesgo de neumonía con la combinación LABA/CI.
Existe limitada información sobre la eficacia y la seguridad de la triple terapia. La evidencia soporta el
uso de vacunación contra la influenza en todos los pacientes y contra neumococo en <65 años y/o con
obstrucción grave. Los antibióticos profilácticos pueden disminuir la frecuencia de exacerbaciones en
pacientes de riesgo. Está justificado el uso de corticosteroides sistémicos y antibióticos en exacerbaciones
que requieren tratamiento intrahospitalario y en algunas de tratamiento ambulatorio.
© 2014 SEPAR. Publicado por Elsevier España, S.L.U. Todos los derechos reservados.
Introduction appropriate answer to the clinical question. Whenever this was
not possible, intermediate (observational) or low level (open-label,
The ALAT-2014 guidelines on chronic obstructive pulmonary case series or consensus) studies were selected. The recommended
disease (COPD) are the result of a collaborative project. These rec- algorithmic selection method was used primarily for therapeutic
ommendations contain regional information and clinical practice questions.2 The results of RCTs included in a systematic review
guideline (CPG) tools to improve the effectiveness, efficiency are not described separately, unless they address a highly relevant
and safety of routine treatment decisions related to COPD aspect that merits additional observations (for example, secondary
patients. outcomes). Studies published in Spanish, Portuguese and English
This document presents the methodology of the CPG and the were considered for inclusion. The end date of the search was Octo-
development of the PICO format questions formulated in each ber 2013.
chapter. The complete version of the CPG is available online.
Critical Analysis and Formulating Recommendations
Methodology
The critical appraisal of the studies selected was performed
Working Group and Design of Clinical Questions according to the recommendations and templates developed by
the CASPE network (www.redcaspe.org). For this purpose, the ACCP
The working group was formed of members of the 2011 Expert grading system was used to classify recommendations as strongor
Consensus Group, along with other experts in drafting and/or eval- weak according to the balance of benefits, risks, burdens, and
uating CPGs who were invited to join the project. The group was possibly cost. The quality of evidence was classified as high, inter-
divided into 5 teams to address the following topics: mediate or low, according to the study design, the consistency of
the results, and the ability of the evidence to clearly answer PICO
• Methodology questions. This system was chosen because it is simple, transparent,
• Epidemiology and definition explicit and consistent with the existing methodological approach
• Diagnosis to developing evidence-based CPGs.3
• Treatment of stable COPD A group of external reviewers with experience in COPD was
• Exacerbation formed. This group is detailed in the ***“authors and contributors”
section. The final version of these guidelines has been reviewed and
The task of these teams was to draw up the clinical questions approved by all the authors.
contained in the guideline.
The questions were formulated in PICO or PECO format: Patient, PICO Questions
(Problem or Population), Intervention or Exposure, Comparison and
Outcome.1 The CPG uses PICO questions to address evidence and contro-
Two metasearch engines were used for the literature search: versies relating to risk factors, screening, prognostic evaluation,
Tripdatabase and PubMed. The first was used to establish the treatment of stable COPD, prevention and treatment of exacerba-
hierarchy for the introductory information in each chapter, and to tions.
answer the PICO questions; MeSH was used to search PubMed
to compare and supplement the search for PICO questions. Table 1
shows the keywords used in the Tripdatabase search and the Risk Factors
MeSH terms. The number and type of relevant studies retrieved
for each question, shown in Table 2, were evaluated by at least The importance of risk factors other than smoking in COPD and
3 experts, and only those with a Critical Appraisal Skills Program the influence of patient gender on the disease are still controversial.
España (CASPE) score of ≥70% were selected. To update the 1. Question: Are there inhaled substances, other than tobacco
content of each chapter, priority was given to existing guidelines, smoke, that constitute a risk factor in the development of
secondary evidence, extensive primary clinical trials and studies COPD?
retrieved from Tripdatabase following a keyword-based search
strategy. Justification
Eligibility Criteria Although smoking is the main risk factor for COPD, a signifi-
cant number of cases cannot be attributed to this exposure. Other
The studies retrieved for PICO questions were prioritized risk factors (exposure to biomass smoke, occupational exposure to
according to the highest level of evidence (randomized controlled dusts and gases, and outdoor air pollution) have been linked to the
trials [RCTs], meta-analyses and systematic reviews) and the most pathogenesis of COPD.4
ARTICLE IN PRESS
Arch Bronconeumol. 2015;xxx(xx):xxx–xxx
www.archbronconeumol.org
Special article
ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical
Practice Guidelines: Questions and Answers夽
María Montes de Oca,a,∗ María Victorina López Varela,b Agustín Acuña,c Eduardo Schiavi,d
María Alejandra Rey,b José Jardim,e Alejandro Casas,f Antonio Tokumoto,g Carlos A. Torres Duque,f
Alejandra Ramírez-Venegas,h Gabriel García,i Roberto Stirbulov,j Aquiles Camelier,k Miguel Bergna,l
Mark Cohen,m Santiago Guzmán,n Efraín Sánchezc
a
Hospital Universitario de Caracas, Universidad Central de Venezuela, Caracas, Venezuela
b
Universidad de la República, Hospital Maciel, Montevideo, Uruguay
c
Hospital Universitario de Caracas, Universidad Central de Venezuela, y Centro Médico Docente La Trinidad, Caracas, Venezuela
d
Hospital de Rehabilitación Respiratoria “María Ferrer”, Buenos Aires, Argentina
e
Universidade Federal de São Paulo, São Paulo, Brazil
f
Fundación Neumológica Colombiana, Bogotá, Colombia
g
Hospital Central Fuerza Aérea del Perú, Lima, Peru
h
Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
i
Hospital Rodolfo Rossi, La Plata, Argentina
j
Facultad de Ciencias Médicas, Santa Casa de San Pablo, São Paulo, Brazil
k
Universidade Federal da Bahia e Escola Bahiana de Medicina, Salvador, Brazil
l
Hospital Dr. Antonio Cetrángolo, Vicente López, Buenos Aires, Argentina
m
Hospital Centro Médico, Guatemala, Guatemala
n
Hospital José Gregorio Hernández, Caracas, Venezuela
a r t i c l e i n f o a b s t r a c t
Article history: ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence
Received 30 June 2014 related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals
Accepted 17 November 2014 the existence of risk factors for COPD other than tobacco, as well as gender differences in disease pre-
Available online xxx
sentation. It shows the benefit of screening in an at-risk population, and the predictive value use of
multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function
Keywords: and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more
Clinical practice guideline
effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy.
Chronic obstructive pulmonary disease
(COPD)
LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with
LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vacci-
nation in all patients and anti-pneumococcal vaccination in patients < 65 years of age and/or with severe
airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The
use of systemic corticosteroids and antibiotics is justified in exacerbations requiring hospitalization and
in some patients managed in an outpatient setting.
© 2014 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.
Guía de práctica clínica de la enfermedad pulmonar obstructiva crónica (EPOC)
ALAT-2014: Preguntas y respuestas
r e s u m e n
Palabras clave: La guía de práctica clínica de enfermedad pulmonar obstructiva crónica (EPOC) ALAT 2014 fue elaborada
Enfermedad pulmonar obstructiva crónica contestando preguntas clínicas en formato PICO a través del análisis de evidencias sobre factores de
(EPOC) riesgo, búsqueda de casos, evaluación pronóstica, tratamiento y exacerbaciones. La evidencia indica que
Guía de práctica clínica
existen factores de riesgo diferentes al tabaco, diferencias según el género, soporta la búsqueda activa
夽 Please cite this article as: Montes de Oca M, López Varela MV, Acuña A, Schiavi E, Rey MA, Jardim J, et al. Guía de práctica clínica de la enfermedad pulmonar obstructiva
crónica (EPOC) ALAT-2014: Preguntas y respuestas. Arch Bronconeumol. 2015. http://dx.doi.org/10.1016/j.arbres.2014.11.017
∗ Corresponding author.
E-mail address: (M. Montes de Oca).
1579-2129/© 2014 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.
ARBR-1100; No. of Pages 14
, G Model
ARTICLE IN PRESS
2 M. Montes de Oca et al. / Arch Bronconeumol. 2015;xxx(xx):xxx–xxx
de casos en población de riesgo y el valor predictivo de los índices multidimensionales. En la EPOC estable
se encuentran similares beneficios de la monoterapia broncodilatadora (LAMA o LABA) sobre la disnea,
función pulmonar o calidad de vida, y mayor efectividad del LAMA para prevenir exacerbaciones. La doble
terapia broncodilatadora tiene mayores beneficios comparada con la monoterapia. La eficacia de la terapia
con LAMA y la combinación LABA/CI es similar, con mayor riesgo de neumonía con la combinación LABA/CI.
Existe limitada información sobre la eficacia y la seguridad de la triple terapia. La evidencia soporta el
uso de vacunación contra la influenza en todos los pacientes y contra neumococo en <65 años y/o con
obstrucción grave. Los antibióticos profilácticos pueden disminuir la frecuencia de exacerbaciones en
pacientes de riesgo. Está justificado el uso de corticosteroides sistémicos y antibióticos en exacerbaciones
que requieren tratamiento intrahospitalario y en algunas de tratamiento ambulatorio.
© 2014 SEPAR. Publicado por Elsevier España, S.L.U. Todos los derechos reservados.
Introduction appropriate answer to the clinical question. Whenever this was
not possible, intermediate (observational) or low level (open-label,
The ALAT-2014 guidelines on chronic obstructive pulmonary case series or consensus) studies were selected. The recommended
disease (COPD) are the result of a collaborative project. These rec- algorithmic selection method was used primarily for therapeutic
ommendations contain regional information and clinical practice questions.2 The results of RCTs included in a systematic review
guideline (CPG) tools to improve the effectiveness, efficiency are not described separately, unless they address a highly relevant
and safety of routine treatment decisions related to COPD aspect that merits additional observations (for example, secondary
patients. outcomes). Studies published in Spanish, Portuguese and English
This document presents the methodology of the CPG and the were considered for inclusion. The end date of the search was Octo-
development of the PICO format questions formulated in each ber 2013.
chapter. The complete version of the CPG is available online.
Critical Analysis and Formulating Recommendations
Methodology
The critical appraisal of the studies selected was performed
Working Group and Design of Clinical Questions according to the recommendations and templates developed by
the CASPE network (www.redcaspe.org). For this purpose, the ACCP
The working group was formed of members of the 2011 Expert grading system was used to classify recommendations as strongor
Consensus Group, along with other experts in drafting and/or eval- weak according to the balance of benefits, risks, burdens, and
uating CPGs who were invited to join the project. The group was possibly cost. The quality of evidence was classified as high, inter-
divided into 5 teams to address the following topics: mediate or low, according to the study design, the consistency of
the results, and the ability of the evidence to clearly answer PICO
• Methodology questions. This system was chosen because it is simple, transparent,
• Epidemiology and definition explicit and consistent with the existing methodological approach
• Diagnosis to developing evidence-based CPGs.3
• Treatment of stable COPD A group of external reviewers with experience in COPD was
• Exacerbation formed. This group is detailed in the ***“authors and contributors”
section. The final version of these guidelines has been reviewed and
The task of these teams was to draw up the clinical questions approved by all the authors.
contained in the guideline.
The questions were formulated in PICO or PECO format: Patient, PICO Questions
(Problem or Population), Intervention or Exposure, Comparison and
Outcome.1 The CPG uses PICO questions to address evidence and contro-
Two metasearch engines were used for the literature search: versies relating to risk factors, screening, prognostic evaluation,
Tripdatabase and PubMed. The first was used to establish the treatment of stable COPD, prevention and treatment of exacerba-
hierarchy for the introductory information in each chapter, and to tions.
answer the PICO questions; MeSH was used to search PubMed
to compare and supplement the search for PICO questions. Table 1
shows the keywords used in the Tripdatabase search and the Risk Factors
MeSH terms. The number and type of relevant studies retrieved
for each question, shown in Table 2, were evaluated by at least The importance of risk factors other than smoking in COPD and
3 experts, and only those with a Critical Appraisal Skills Program the influence of patient gender on the disease are still controversial.
España (CASPE) score of ≥70% were selected. To update the 1. Question: Are there inhaled substances, other than tobacco
content of each chapter, priority was given to existing guidelines, smoke, that constitute a risk factor in the development of
secondary evidence, extensive primary clinical trials and studies COPD?
retrieved from Tripdatabase following a keyword-based search
strategy. Justification
Eligibility Criteria Although smoking is the main risk factor for COPD, a signifi-
cant number of cases cannot be attributed to this exposure. Other
The studies retrieved for PICO questions were prioritized risk factors (exposure to biomass smoke, occupational exposure to
according to the highest level of evidence (randomized controlled dusts and gases, and outdoor air pollution) have been linked to the
trials [RCTs], meta-analyses and systematic reviews) and the most pathogenesis of COPD.4
