Study: The Burden of Obstructive Lung Disease
Initiative (BOLD): Rationale and Design.
Study Publication: COPD: Journal of Chronic
Obstructive Pulmonary Disease, June 2005.
Review Authors: A. Sonia Buist, William M. Vollmer,
Sean D. Sullivan, Kevin B. Weiss, Todd A. Lee, Ana M. B.
Menezes, Robert O. Crapo, Robert L. Jensen and Peter G. J
Burney
"Quantifying COPD prevalence worldwide is needed to
document COPD’s effect on disability, health care costs, and
impaired quality of life and to inform governments and health
planners. As an adjunct to data obtained from population-based
studies, and for countries where a fully powered prevalence
survey cannot be done, modeling of COPD prevalence and its
economic burdens can help estimate potential health care needs
and costs. For comparability, standardized methods for
prevalence surveys are needed that can be used in countries at
all levels of economic development".
"The Burden of Obstructive Lung Disease (BOLD) Initiative
has developed a set of methods for estimating COPD prevalence
and a model for assessing its economic impact, and piloted
these methods in China and Turkey. The methods were revised to
reflect the findings in the pilot studies, and BOLD is now
making the standardized methods available worldwide"
"The BOLD Operations Center provides training, materials,
quality control, and data analysis. BOLD’s standardized
methods will provide a uniform way to compare COPD burden
within and between countries, and where differences are found,
to explore explanations for these differences".
Spirometry (Excerpts): "The single most important
outcome measure obtained as part of the BOLD protocol is
spirometry before and after administration of 200 mg (2 puffs)
of albuterol / salbutamol. The use of a bronchodilator is
important because present diagnostic criteria for COPD
recommend the use of post-bronchodilator values for the
diagnosis and classification of severity (2). Although
standardized methods for performing spirometry are available
and widely used, no single standard is universally applied in
practice".
"Proper training and ongoing quality control are essential
to obtaining consistently high quality measurements over time.
The methods developed for BOLD meet or exceed the ATS
standards for acceptable equipment and technique".
"The BOLD methods were developed assuming that testing will
often be done in the field, i.e., not in a climate-controlled
pulmonary function laboratory. The primary spirometry
measurements to be used for analysis include the FEV1, the
FVC, and the FEV6, allowing comparison of FEV1/FVC and
FEV1/FEV6 as measures of airflow limitation".
"The FEV6 has been demonstrated as a viable surrogate for
the FVC and has important advantages—it requires only 6
seconds of exhalation time and has about 25% less variability
than the FVC. In epidemiologic studies, there are significant
advantages to requiring only 6 seconds of maximal exhalation,
such as less coaching time, less chance of dizziness, and less
physical discomfort to participants than a complete
exhalation".
"To optimize quality control in the BOLD study, sites are
required to use the ndd EasyOneTM Spirometer, which was
chosen because it provides a high degree of accuracy,
robustness, portability, and ease of storage. It can be used
easily in the field and where there is no electric power
available—it operates on batteries and requires no calibration
with a 3-liter syringe. The ndd spirometer has been approved
by the BOLD pulmonary function reading center as meeting
predetermined performance criteria relating to reliability of
measurement, suitability for field use, and ease of access to
data".
