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Critical Appraisal of Clinical Practice Guidelines Targeting Chronic Obstructive Pulmonary Disease
Yves Lacasse, MD, MSc;
Ivone Ferreira, MD;
Dina Brooks, PhD;
Toni Newman, BSc;
Roger S. Goldstein, MB, ChB
Arch Intern Med. 2001;161:69-74.
ABSTRACT
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Background Chronic obstructive pulmonary disease (COPD) is so prevalent that the
endorsement of management strategies by professional organizations issuing
clinical practice guidelines (CPGs) will likely influence the clinical and
financial resources allocated to this condition.
Objectives To examine the content of and to critically appraise the CPGs targeting
COPD.
Methods We identified, through a MEDLINE search (from January 1990 to May 1999)
and contacts with experts and professional organizations, the CPGs for the
overall management of COPD. We assessed the guidelines according to an index
of quality measuring 3 dimensions: the rigor of development, the context and
content, and the extent to which the dissemination and implementation have
been addressed. The recommendations were also examined and compared.
Results Of the 15 CPGs we included, none was based on a systematic review of
the literature. Two were independently reviewed before their release, 1 included
strategies for dissemination and implementation, and 1 estimated the economic
implications associated with its recommendations. The recommendations were
often difficult to interpret (reviewers' agreement:  median, 0.41).
When unanimity existed regarding the benefits of a given management modality
(such as respiratory rehabilitation), discrepancies were often identified
in the application of the recommendation.
Conclusions The methodological quality of CPGs targeting COPD is limited, and there
are disparities among many of their recommendations. Despite there being several
CPGs worldwide, there is a need for an evidence-based summary of the literature
to serve as a resource for those who provide health care to individuals with
COPD.
INTRODUCTION
CHRONIC obstructive pulmonary disease (COPD) is widely prevalent in
developed and developing countries.1 From the
National Health Interview Survey conducted in the United States in 1993,2 the prevalence of COPD approximated 5%. A Canadian
health survey reflected that, in 1994-1995, 6% of the population aged 55 years
and older acknowledged the diagnosis of COPD having been made by a health
professional.3 Similarly, European studies4 have indicated that 4% to 6% of the adult population
has clinically relevant COPD. As COPD is so prevalent, treatment approaches
recommended by professional organizations are likely to affect the attitudes
and behaviors of health care professionals and the use of health care resources
associated with its management.
Representative examples that have clinical and financial implications
include the use of ipratropium bromide vs ß2-agonists, the
indications for inhaled corticosteroids and oral theophylline, the benefit
of oxygen therapy for transient nocturnal or exercise desaturation, and the
use of noninvasive ventilation in end-stage disease.
Several organizations have developed practice guidelines to assist clinicians
in making decisions about the management of COPD. Practice
guidelines are defined as "systematically developed statements to assist
practitioner and patient decisions about appropriate health care for specific
clinical circumstances."5(p1) They are intended
to improve the process of health care and health outcomes, to decrease practice
variation, and to optimize resources use.6
Despite the previously described intentions, it is sometimes unclear whether
such guidelines do actually influence patient outcomes.7
Poor scientific quality ("validity") of the practice guidelines or the lack
of a cogent implementation strategy may contribute to their failure to influence
outcomes.7 Primary criteria defining the validity
of a clinical practice guideline (CPG) include whether an explicit, sensible
process was used to identify, select, and combine the evidence supporting
its recommendations. It is also necessary for the important management options
and outcomes to be clearly specified.8
CRITICAL APPRAISAL OF COPD PRACTICE GUIDELINES ISSUED BY PROFESSIONAL
ORGANIZATIONS
We recently appraised CPGs for the management of COPD published by professional
organizations to compare them and to explore potential sources of discrepancy
among their recommendations.
We searched MEDLINE (from January 1990 to May 1999) for CPGs related
to the overall management of COPD using the core strategies of: (1) lung diseases,
obstructive; and (2) guideline—publication type or guideline*—text
word. We also contacted content experts and professional organizations to
retrieve documents not listed in MEDLINE. We selected only the guidelines
targeting the comprehensive management of COPD and excluded guidelines that
addressed specific components of the disease, such as respiratory rehabilitation
or home oxygen use. We excluded reports that were secondary publications of
practice guidelines, individual overviews, original investigations, editorials,
and letters to the editor. Practice guidelines published in other languages
(French, Norwegian, German, Spanish, and Polish) were translated into English.
We selected, from the 12 instruments that measure the scientific quality
of practice guidelines,9 the one instrument
that provided data supporting its validity and reliability (the "Appraisal
Instrument for Clinical Guidelines" developed by Cluzeau et al10).
This instrument had satisfactory internal reliability and was able to differentiate
the components of guideline development that contributed to the overall guideline
quality. It measures 3 methodological dimensions: (1) the rigor of development,
(2) the context and content, and (3) the extent to which dissemination and
implementation have been addressed during development. Four reviewers (Y.L.,
I.F., D.B., and R.S.G.) used this instrument to independently appraise the
COPD practice guidelines.
Three reviewers (Y.L., I.F., and D.B.) also examined the guidelines
for specific components relating to the management of COPD, including the
following: (1) the initial assessment of the patients, (2) smoking cessation,
(3) vaccination, (4) pharmacological management, (5) oxygen therapy, (6) rehabilitation,
(7) surgical therapy, (8) management of acute exacerbations, and (9)  1-antitrypsin replacement therapy. These components were classified
as "recommended," "not recommended," "mentioned without any firm recommendation,"
or "not mentioned at all." For inhaled bronchodilators, we noted the priority
ranking that was attached to their use in the initial bronchodilator prescription.
Where the guidelines agreed on a management approach, we examined their recommendations
regarding its application. Agreement among the reviewers for the methodological
quality score and the strength of recommendations was measured using
statistics. Once all the reviewers had appraised the content and quality of
the guidelines, they shared the results of their assessment. Whenever disagreement
was identified among the reviewers, it was resolved following a discussion
involving all of them.
We identified 15 CPGs published between August 1992 and May 1999.11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25
Seven12, 14, 16, 18, 20, 21, 24
of the 15 guidelines were published in languages other than English. When
we applied the appraisal instrument to these guidelines, we noted many limitations
in their scientific validity.
Rigor of Development
None of the guidelines met the primary criteria of validity, ie, none
were truly evidence-based. In only 1 guideline did the authors mention that
they conducted MEDLINE searches to retrieve relevant literature; however,
neither the search strategy nor the study selection criteria were detailed.
One guideline included an explicit statement about how the background evidence
was synthesized and categorized. Sources of external funding for guideline
development were clearly identified by 7 of the 15 professional organizations.
In only 1 of them did the authors clearly mention that the "sponsorship did
not influence the activities of the group." Mention of an independent review
(other than a possible review related to their being published in peer-reviewed
journals) was included in 6 guidelines. None of the guidelines was pilot tested,
and only 1 included a date for reviewing or updating. A trend in the improvement
of guidelines development methods over time was not clearly apparent. With
few exceptions, there was no clear indication that local and cultural influences
had modulated any of the organizations' recommendations.
Context and Content
The objectives of the guidelines were stated in 10 documents. All provided
a clinical definition of COPD that would clearly identify the population to
which the guidelines were meant to apply. Only 1 of the guidelines included
an estimate of the expenditures likely to be associated with the recommended
management.
Dissemination and Implementation
Two guidelines suggested possible methods for implementation.
Table 1 summarizes our observation
relating to the content of the 15 practice guidelines. Clarity of the recommendations
was often lacking. This was reflected by the moderate level of agreement among
the 3 reviewers on the recommendations attached to each management component
( median, 0.41; interquartile range, 0.21-0.85). Disagreement often
stemmed from trying to interpret phrases such as "may be used" or "can be
considered." All the guidelines recommended smoking cessation, and almost
all recommended influenza vaccination. Recommendations for vaccination against
pneumococcus varied. Other areas of controversy included the preferential
use of ß2-agonists vs anticholinergic agents as first-line
bronchodilators, the indication for mucolytics, the role of inhaled corticosteroids,
and the prescription of oxygen therapy for patients with transient desaturation
during sleep or exercise. Lung volume reduction surgery for emphysema was
an especially good example of a management strategy that has been widely accepted
by some despite considerable debate regarding its indications and effectiveness
(in the absence of a single randomized controlled trial). Guidelines issued
after the publication of the report26 that
relaunched interest in this intervention also varied in their recommendations,
with 4 supporting it, 3 not mentioning it at all, and 5 being equivocal.
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Table 1. Content of Practice Guidelines Related to the Overall Management
of COPD*
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When unanimity existed regarding a particular recommendation, we often
identified discrepancies in its application. For example, regarding respiratory
rehabilitation, the recommendations ranged from no application rule at all
to specific recommendations based on the measurement of PCO2 or
the response to a trial of oral glucocorticoids (Table 2).
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Table 2. Indications of Respiratory Rehabilitation (Including Exercise
Training) According to 15 National Practice Guidelines on the Management of
COPD*
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LIMITATIONS OF THE GUIDELINES
The methodological quality of CPGs that address the comprehensive management
of COPD is limited. This conclusion is in support of the observation by Shaneyfelt
et al27 that during the past decade, guidelines
published in peer-reviewed medical literature have not always adhered to methodological
standards. The selection, evaluation, and synthesis of the scientific evidence
are the items being most in need of improvement. It is likely that the discrepancies
among the practice guidelines have arisen from different interpretations of
the medical literature. Given the frequency with which guidelines were developed
by "experts" who relied heavily on their knowledge or opinions of published
work rather than a systematic review of the literature,28
the guidelines likely reflected individual enthusiasm and biases. These may
not necessarily be synonymous with current knowledge based on available evidence.
Inevitably, discrepancies will arise based on different interpretations of
the medical literature, as was identified by Antman et al29
in a comparison of the results of meta-analyses of randomized controlled trials
for the treatment of myocardial infarction and by the recommendations of clinical
experts.
Criteria defining the quality of a CPG are yet to be fully validated.
Guidelines' developers themselves may not agree on the methods perceived by
others to be optimal. Also, the "optimal methods" may be too onerous to be
implemented even by professional organizations.30
We selected the Appraisal Instrument for Clinical Guidelines developed by
Cluzeau et al10 to measure the scientific quality
of the guidelines because it is the only instrument for which data supporting
its validity were available. In the absence of a gold standard of guideline
quality, the validity of this instrument was determined by the authors' finding
of (1) significant correlations between the scores obtained from the instrument
and their global assessment of a selection of 60 guidelines; and (2) higher
scores for national guidelines than for local guidelines, a result that met
their a priori prediction. The items included in the instrument we used in
this study and the criteria selected by Shaneyfelt et al27
are similar and encompass those that would be important to most guideline
users.30 Among these criteria, the generation
of evidence-based recommendations is perceived as an important initial step
in the guideline development process31 and
should become a primary criterion of guideline quality.
The interest in evidence-based practice guidelines is not restricted
to methodologists. Grol et al32 recently found
that family practitioners were most likely to comply with clear, evidence-based
recommendations, whereas vague, controversial recommendations, especially
those requiring a change in existing practice, were less likely to be followed.
When reviewing information on disease management, clinicians preferred brief
summaries of the major recommendations with a synopsis of the underlying evidence
for the expected benefits and risks.33
CHALLENGES IN DEVELOPING GUIDELINES
The development of evidence-based guidelines presents several major
challenges. A systematic review of the literature is time-consuming and expensive,
a task expanded by the inclusion of several components of management in a
single document. Existing systematic reviews and meta-analyses will often
obviate the need or reduce it to updating.31
If more than 1 systematic review has been published, conflicting interpretations
may emerge. There may be insufficient well-designed trials to guide clinical
practice, in which case professional judgment and group consensus can fill
gaps of knowledge provided that major assumptions or areas of uncertainty
are acknowledged.34 This involves a summary
of the evidence available, including its susceptibility to bias. An example
of such a classification scheme is found in Table 3. An organization may support lung volume reduction surgery
in its guidelines despite the absence of a single randomized controlled trial.
The decision may be based on the results of encouraging case series and the
availability of financial and human resources. However, such a recommendation
should also detail the level of evidence attached to it (in this case, level
3 at best). Another organization might consider the evidence insufficient
to include lung volume reduction surgery in its guidelines. In both cases,
the decision would be based on the evidence available at the time of the guideline
publication.
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Table 3. Levels of Scientific Evidence About Therapeutic Interventions*
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For the 26 components of the management of COPD summarized in Table 1, we observed several differences
in recommendations for which there is most often neither a "right" nor a "wrong"
answer. Some of the differences may stem from the evolution, from 1992 to
1999, of the scientific knowledge regarding the effectiveness of several interventions.
We submit that the only misleading recommendations are those for which strong
data establishing the lack of efficacy are available.
Finally, even well-conducted systematic reviews are insufficient for
guidelines until they are interpreted in the context of local factors, such
as patient preferences and the health care setting in which the recommendations
are being made.35 Thus, although respiratory
rehabilitation improves important domains of the quality of life of patients
with COPD, practice guidelines must consider that less than 2% of the population
with COPD per annum has access to such programs.36
The British Thoracic Society provided an interesting example of such a situation
in stating that "although some patients undoubtedly benefit from rehabilitation,
facilities are limited and, until more UK data are available, firm recommendations
as to who should be treated cannot be made."22(pS13)
It is our view that the compilation (and regular update) of systematic
reviews that address the management of COPD is highly desirable. Improved
access to medical databases, either through the Cochrane Collaboration (an
international initiative designed to prepare, maintain, and disseminate systematic
reviews on health care37) or by peer-reviewed
medical information on the Internet, may be instrumental in improving the
quality of CPGs. This effort is to avoid the situation in which firm recommendations
are issued years after the evidence is available.38
Such a resource document would provide professional organizations in the developed
and developing world with the evidence to create their own guidelines in the
context of available health care resources, attitudes, and beliefs by the
physicians and patients. It would also be a valuable teaching instrument for
physicians and nonphysician health professionals.
For patient care to be influenced, guidelines must be disseminated and
implemented by those in practice. Their impact can then be evaluated. The
lack of uniformity of the recommendations for many components of the management
of COPD complicates the dissemination and implementation of comprehensive
guidelines. At present, local implementation of guidelines for specific components
of the management of COPD, such as the indications for home oxygen use or
respiratory rehabilitation, would appear more promising.
MEDICOLEGAL CONSIDERATIONS
The possibility that CPGs might be used to establish the "prevailing
standard of care" and, by implication, to determine what is appropriate practice
is of concern. Until now, in jurisdictions such as Canada and the United Kingdom,
minimum acceptable standards of care have been determined from responsible
customary practice, not from guidelines.39, 40
In these countries, discrepancies between guidelines on COPD likely reflect
the widespread variations in practice. It is, therefore, unlikely that such
guidelines will influence the legal standard of care.39
We should nevertheless be mindful of the potential of guidelines to affect
the clinical and financial resources allocated to the disease. In the United
States, in a study41 of 259 malpractice claims
between 1990 and 1992, CPGs were more often used for inculpatory purposes
than for exculpatory purposes. In France, mandatory medical practice guidelines
were introduced in 1994 as a way of containing costs and standardizing patient
care. Physicians who do not comply with several CPGs (including guidelines
targeting asthma and long-term oxygen therapy for chronic respiratory tract
insufficiency) can be fined.42 Whether practice
guidelines are used within a medicolegal context or as a teaching and resource
instrument for those who provide or fund health care, they should meet the
criterion of scientific quality.28
CONCLUSIONS
The purpose of this communication is not to endorse any particular management
strategy for COPD, but rather to highlight that existing guidelines are not
evidence-based. They vary in their recommendations for specific interventions
and likely reflect the biases of selective experience rather than scientific
knowledge. Practitioners, policy makers, and patients would benefit from an
evidence-based resource document that summarized the literature and identified
the gaps in our knowledge and the discrepancies between evidence and clinical
practice. In addition to integrating evidence of effectiveness with local
availability, guidelines should also address approaches to their implementation
and an evaluation of the impact of their recommendations on COPD.
AUTHOR INFORMATION
Accepted for publication July 28, 2000.
This study was supported by Glaxo Wellcome (Canada) Inc, Mississauga,
Ontario, which was not otherwise involved in the preparation of the manuscript.
From the Centre de Pneumologie de L'Hôpital Laval, Ste-Foy, Québec
(Dr Lacasse); the Departments of Medicine (Drs Ferreira and Goldstein) and
Physical Therapy (Drs Brooks and Goldstein), University of Toronto, Toronto,
Ontario; and the Department of Surgery, McMaster University, Hamilton, Ontario
(Ms Newman).
Corresponding author: Yves Lacasse, MD, MSc, Centre de Pneumologie
L'Hôpital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5
(e-mail: Yves.Lacasse{at}med.ulaval.ca).
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