J Bras Pneumol.

2018;44(2):84-84 CONTINUING EDUCATION:

http://dx.doi.org/10.1590/S1806-37562018000000088 SCIENTIFIC METHODOLOGY

Inclusion and exclusion criteria in research

studies: definitions and why they matter
Cecilia Maria Patino1,2,a, Juliana Carvalho Ferreira1,3,b

PRACTICAL SCENARIO a study but also evaluate how those decisions will impact
the external validity of the results of the study. Common
A cross-sectional multicenter study evaluated self-
errors regarding inclusion and exclusion criteria include
reported adherence to inhaled therapies among patients
the following: using the same variable to define both
with COPD in Latin America.(1) Inclusion and exclusion
inclusion and exclusion criteria (for example, in a study
criteria for the study are shown in Chart 1. The authors
including only men, listing being a female as an exclusion
found that self-reported adherence was low in 20% of the
criterion); selecting variables as inclusion criteria that are
patients, intermediate in 29%, and high in 51%; and that
not related to answering the research question; and not
poor adherence was associated with more exacerbations
describing key variables in the inclusion criteria that are
in the past year, a lower smoking history, and a lower
needed to make a statement about the external validity
level of education. The authors concluded that suboptimal
of the study results.
adherence to inhaled therapies among COPD patients was
common and that interventions to improve adherence IMPACT OF THE INCLUSION AND
are warranted. EXCLUSION CRITERIA ON THE EXTERNAL
VALIDITY OF THE STUDY
BACKGROUND
In our example, the investigators described the inclusion
Establishing inclusion and exclusion criteria for study criteria related to demographic characteristics (age ≥
participants is a standard, required practice when designing 40 years of age and male or female gender), clinical
high-quality research protocols. Inclusion criteria are characteristics (diagnosis of COPD, stable disease,
defined as the key features of the target population that the outpatient, and current or former smoker); and exclusion
investigators will use to answer their research question.(2) criteria related to comorbidities that could bias the results
Typical inclusion criteria include demographic, clinical, and (sleep apnea, other chronic respiratory diseases, and
geographic characteristics. In contrast, exclusion criteria acute or chronic conditions that could limit the ability
are defined as features of the potential study participants of the patient to participate in the study). On the basis
who meet the inclusion criteria but present with additional of these inclusion and exclusion criteria, we can make a
characteristics that could interfere with the success of the judgment regarding their impact on the external validity
study or increase their risk for an unfavorable outcome. of the results. Making those judgments requires in-depth
Common exclusion criteria include characteristics of knowledge of the area of research, as well as of in what
eligible individuals that make them highly likely to be lost direction each criterion could affect the external validity of
to follow-up, miss scheduled appointments to collect data, the study. As an example, the authors excluded patients
provide inaccurate data, have comorbidities that could bias with comorbidities, and it is therefore possible that the
the results of the study, or increase their risk for adverse levels of nonadherence reported would not be generalizable
events (most relevant in studies testing interventions). to COPD patients with comorbidities, who most likely
It is very important that investigators not only define the would show higher levels of nonadherence due to their
appropriate inclusion and exclusion criteria when designing more complex medication regimens.

Chart 1. Inclusion and exclusion criteria for a cross-sectional multicenter study of patients with COPD in Latin America.(1)
Inclusion criteria Exclusion criteria
• Adults ≥40 years of age • Diagnosis of sleep apnea or any other chronic respiratory
• Diagnosis of COPD at least for 1 year disease
• At least one spirometry in the last year with a post- • Any acute or chronic condition that would limit the ability
bronchodilator FEV1/FVC < 0.70 of the patient to participate in the study
• Current or former smokers (> 10 pack-years) • Refusal to give informed consent
• Stable disease (no recent exacerbation)

REFERENCES
1. Montes de Oca M, Menezes A, Wehrmeister FC, Lopez Varela MV, pone.0186777
Casas A, Ugalde L, et al. Adherence to inhaled therapies of COPD 2. Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB.
patients from seven Latin American countries: The LASSYC study. Designing Clinical Research. 3rd ed, Philadelphia, PA: Lippincott
PLoS One. 2017;12(11):e0186777. https://doi.org/10.1371/journal. Williams & Wilkins; 2007.
1. Methods in Epidemiologic, Clinical, and Operations Research–MECOR–program, American Thoracic Society/Asociación Latinoamericana del Tórax,
Montevideo, Uruguay.
2. Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
3. Divisão de Pneumologia, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo (SP) Brasil.
a. http://orcid.org/0000-0001-5742-2157; b. http://orcid.org/0000-0001-6548-1384

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