Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Paul Shekelle, MD, PhD; Katherine Sherif, MD; Timothy J. Wilt, MD, MPH; Steven Weinberger, MD; Douglas K. Owens, MD, MS; for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians*
Note: Clinical practice guidelines are guides only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.
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Grant Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Potential Financial Conflicts of Interest: Stock ownership or options (other than mutual funds): S. Weinberger (GlaxoSmithKline). Grants received: V. Snow (Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Novo Nordisk, Pfizer Inc., Merck & Co. Inc., Bristol-Myers Squibb, Atlantic Philanthropies, Sanofi Pasteur).
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190. N. Independence Mall West, Philadelphia, PA 19106; e-mail, email@example.com.
Current Author Addresses: Drs. Qaseem, Snow, and Weinberger: 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Shekelle: 1776 Main Street, Santa Monica, CA 90401.
Dr. Sherif: 219 North Broad Street, 6th Floor, Philadelphia, PA 19107.
Dr. Wilt: 1 Veterans Drive (111-0), Minneapolis, MN 55417.
Dr. Owens: 117 Encina Commons, Stanford, CA 94305.
In patients with respiratory symptoms, particularly dyspnea, spirometry should be performed to diagnose airflow obstruction. Spirometry should not be used to screen for airflow obstruction in asymptomatic individuals. (Grade: strong recommendation, moderate-quality evidence.)
Treatment for stable chronic obstructive pulmonary disease (COPD) should be reserved for patients who have respiratory symptoms and FEV1 less than 60% predicted, as documented by spirometry. (Grade: strong recommendation, moderate-quality evidence.)
Clinicians should prescribe 1 of the following maintenance monotherapies for symptomatic patients with COPD and FEV1 less than 60% predicted: long-acting inhaled β-agonists, long-acting inhaled anticholinergics, or inhaled corticosteroids. (Grade: strong recommendation, high-quality evidence.)
Clinicians may consider combination inhaled therapies for symptomatic patients with COPD and FEV1 less than 60% predicted. (Grade: weak recommendation, moderate-quality evidence.)
Clinicians should prescribe oxygen therapy in patients with COPD and resting hypoxemia (Pao2 ≤55 mm Hg). (Grade: strong recommendation, moderate-quality evidence.)
Clinicians should consider prescribing pulmonary rehabilitation in symptomatic individuals with COPD who have an FEV1 less than 50% predicted. (Grade: weak recommendation, moderate-quality evidence.)
*This paper, written by Amir Qaseem, MD, PhD, MHA; Vincenza Snow, MD; Paul Shekelle, MD, PhD; Katherine Sherif, MD; Timothy J. Wilt, MD, MPH; Steven Weinberger, MD; and Douglas K. Owens, MD, MS, was developed for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians (ACP): Douglas K. Owens, MD, MS (Chair); Donald E. Casey Jr., MD, MPH, MBA; J. Thomas Cross Jr., MD, MPH; Paul Dallas, MD; Nancy C. Dolan, MD; Mary Ann Forciea, MD; Lakshmi Halasyamani, MD; Robert H. Hopkins Jr., MD; and Paul Shekelle, MD, PhD. Approved by the ACP Board of Regents on 14 July 2007.
Table 1. American College of Physicians' Clinical Practice Guidelines Grading System
Table 2. Spirometric Classifications of Chronic Obstructive Pulmonary Disease
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ACP guidelines to diagnose and treat chronic obstructive pulmonary disease (COPD), a disease of the airways and lungs that usually occurs in cigarette smokers.
Emmanuel M Bhaskar
Sri Ramachandra Medical College and Research Institute,Porur,Chennai-600116,India
November 5, 2007
Effectiveness of Immunization for patients with Chronic Obstructive Pulmonary Disease
To the Editor,
The guideline on diagnosis and management of stable chronic obstructive pulmonary disease [COPD] by Qaseem and colleagues is commendable (1).However a recommendation on immunization for patients suffering from COPD is strikingly absent.It is possible that the guideline was not meant to address this issue. But the third objective of this guideline ," What management strategies are effective for the treatment for COPD ", should include immunization for influenza and pneumococcal infection , the former being an important cause for morbidity and mortality among patients suffering from COPD (2,3). Adult immunization strategies are an important need of the hour(4).
Here, I wish to summarize two Cochrane systematic reviews on effectiveness of immunization among COPD patients.
Poole et al (5) in their review on influenza vaccine for COPD patients analysed six randomized controlled trials [RCTs] and observed a significant reduction in total number of exacerbations per vaccinated subject compared to patients who received placebo ( Weighted mean difference[WMD] -0.37 , 95% confidence interval -0.64 to -0.11 , p=0.006 ). This favourable effect was observed three to four weeks after the administration of vaccine. There was a mild and transient increase in the occurrence of local adverse reactions due to vaccine , but they are outweighed by the long term benefits of vaccination. Addition of intranasal live attenuated virus to the inactivated vaccine was of no added benefit. Further the sample size of the studies were too small to detect any effect on mortality.
Granger et al (6) in their review on injectable vaccines for preventing pneumococcal infection in patients with COPD analyzed four RCTs for outcomes like acute exacerbation, development of pneumonia,rates of hospital admissions and emergency department visits. However, a major disadvantage of this review was that only three studies had some data on outcome variables and based on that,pneumococcal vaccination had no favourable effect on patients with COPD. The authors conclude saying that there is no evidence from RCTs that pneumococcal vaccines have a significant impact on morbidity or mortality among patients with COPD. However the conclusion should be interpreted with caution , since there is absence of evidence with respect to favourable effect of pneumococcal vaccination in patients with COPD and not evidence of absence for the same.
To conclude, evidence at this point of time suggests that inactivated influenza vaccination for patients with COPD is probably beneficial and efficacy of pneumococcal vaccination for COPD patients in reducing morbidity and mortality needs further studies.
1.Amir Qaseem, Vincenza Snow, Paul Shekelle, Katherine Sherif, Timothy J. Wilt,Steven Weinberger, Douglas K. Owens, et al. Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline from the American College of Physicians . Ann Intern Med. 2007;147:633-638.
2.Nichol KL, Baken L, Nelson A. Relation between influenza vaccination and outpatient visits, hospitalization, and mortality in elderly persons with chronic lung disease.
Ann Intern Med 1999; 130:397"“403
3.Rothbart PH, Kempen BM, Sprenger MJW. Sense and nonsense of influenza vaccination in asthma and chronic obstructive pulmonary disease. American Journal of Respiratory & Critical Care Medicine 1995;151:1682"“6.
4. Gregory A.Poland, John W.Gnann, Myron J.Levin. An Update on Adult Immunizations for vaccine preventable diseases. Available at http://www.medscape.com/viewprogram/7621 (accessed on 12/9/07)
5.Poole PJ, Chacko E,Wood-Baker RWB, Cates CJ. Influenza vaccine for patients with chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD002733. DOI: 10.1002/14651858.CD002733.pub2.
6.Granger R, Walters J, Poole PJ, Lasserson TJ, Mangtani P, Cates CJ, Wood-Baker R. Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD001390. DOI: 10.1002/14651858.CD001390.pub2.
Christian Medical College and Hospital Ludhiana,India
November 7, 2007
Role of nutrition and education in the management of stable COPD
The guideline on diagnosis and management of stable chronic obstructive pulmonary disease [COPD] by Qaseem and colleagues is highly appreciable (1).However, recommendation on nutrition , education and immunization are lacking. Emmanuel M Bhaska has very well taken the role of Immunization for patients with Chronic Obstructive Pulmonary Disease .We would like to share the literature on the role of education and nutrition in the management of stable COPD Although patient education is an essential component of care for any chronic disease, assessment of the value of education in COPD may be difficult because of the relatively long time required to achieve improvements in objective measurements of lung function. Patient education alone does not improve exercise performance or lung function (2-5), but it can play a role in improving skills, ability to cope with illness, and health status (6). Patient education regarding smoking cessation has the greatest capacity to influence the natural history of COPD . Education also improves patient response to exacerbations (7, 8) . Prospective end-of-life discussions can lead to understanding of advance directives and effective therapeutic decisions at the end of life (9) . Ideally, educational messages should be incorporated into all aspects of care for COPD and may take place in many settings: consultations with physicians or other health care workers, home-care or outreach programs, and comprehensive pulmonary rehabilitation programs. Education should be tailored to the needs and environment of the individual patient, interactive, directed at improving quality of life, simple to follow, practical, and appropriate to the intellectual and social skills of the patient and the caregivers. The topics that seem most appropriate for an education program include the following: smoking cessation; basic information about COPD and pathophysiology of the disease, general approach to therapy and specific aspects of medical treatment, self- management skills, strategies to help minimize dyspnea, advice about when to seek help, self management and decision making during exacerbations, and advance directives and end-of-life issues.
Weight loss, as well as a depletion of fat-free mass (FFM), may be observed in stable COPD patients, irrespective of the degree of airflow limitation, and being underweight is associated with an increased mortality risk (10). Nutritional screening is recommended in the assessment of COPD. Simple screening can be based on measurements of BMI and weight change. Patients are considered underweight (BMI< 21 kg.m-2; age>50 yrs), normal weight (BMI 21"“25 kg.m-2), overweight (BMI 25"“30 kg.m-2) or obese (BMI â‰¥ 30 kg.m-2). Criteria to define weight loss are weight loss >10% in the past 6 months or >5% in the past month. Weight loss and particularly muscle wasting contribute significantly to morbidity, disability and handicap in COPD patients. Weight loss and loss in fat mass is primarily the result of a negative balance between dietary intake and energy expenditure, while muscle wasting is a consequence of an impaired balance between protein synthesis and protein breakdown. In advanced stages of COPD, both energy balance and protein balance are disturbed. Therefore, nutritional therapy may only be effective if combined with exercise or other anabolic stimuli (11, 12).
2 Reis AL. Response to bronchodilators. In: Clausen J, editor. Pulmonary function testing: guidelines and controversies. New York: Academic Press; 1982.
3 . Janelli LM, Scherer YK, Schmieder LE. Can a pulmonary health teaching program alter patients' ability to cope with COPD? Rehabil Nurs 1991;16:199"“202.
4 . Ashikaga T, Vacek PM, Lewis SO. Evaluation of a community-based education program for individuals with chronic obstructive pulmonary disease. J Rehabil 1980;46:23"“27.
5. Toshima MT, Kaplan RM, Ries AL. Experimental evaluation of rehabilitation in chronic obstructive pulmonary disease: short-term effects on exercise endurance and health status. Health Psychol 1990;9:237"“252.
6. Celli BR. Pulmonary rehabilitation in patients with COPD. Am J Respir Crit Care Med 1995;152:861"“864.
7. Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ 1995;152:1423"“1433.
8. Clark NM, Nothwehr F, Gong M, Evans D, Maiman LA, Hurwitz ME, Roloff D, Mellins RD. Physician-patient partnership in managing chronic illness. Acad Med 1995;70:957"“959.
9. Heffner JE, Fahy B, Hilling L, Barbieri C. Outcomes of advance directive education of pulmonary rehabilitation patients. Am J Respir Crit Care Med 1997;155:1055"“1059.
10. Schols AMWJ, Soeters PB, Dingemans AMC, Mostert R, Frantzen PJ, Wouters EF. Prevalence and characteristics of nutritional depletion in patients with stable COPD eligible for pulmonary rehabilitation. Am Rev Respir Dis 1993; 147: 1151"“1156.
11. Schols AM, Soeters PB, Mostert R, et al. Physiologic effects of nutritional support and anabolic steroids in patients with chronic obstructive pulmonary disease: A randomized controlled trial. Am J Respir Crit Care Med 1995; 152: 1248"“1274.
12. Creutzberg EL, Wouters EFM, Mostert R, et al. Efficacy of nutritional supplementation therapy in depleted patients with chronic obstructive pulmonary disease. Nutrition 2003; 19: 120"“127.
Paul A. Selecky
July 8, 2008
Clinical Practice Guideline for COPD
To the Editor:
On behalf of the joint taskforce of American College of Chest Physicians (ACCP) and American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), we wish to comment on the recommendation concerning pulmonary rehabilitation for patients with chronic obstructive pulmonary disease (COPD) that was included in the recently published Clinical Practice Guideline from the American College of Physicians (ACP).1,2 In general, we laud the ACP for publishing this important guideline highlighting the increasing prominence of COPD in the general medical community, the growing evidence base in this field, and the need for all physicians to be versed in appropriate management strategies for this often under-recognized and sub-optimally managed disease. In our view, the systematic review and recently published clinical practice guideline on pulmonary rehabilitation published by ACCP and AACVPR3,4 cast a wider net in its systematic review of the pulmonary rehabilitation literature and, as a result, graded key recommendations regarding pulmonary rehabilitation as stronger than the more narrowly focused review conducted by ACP.
In general, we agree with the statement in the ACP Guideline that "Evidence supports the use of pulmonary rehabilitation programs for patients with severe airflow obstruction, because they reduce hospitalizations and improve health status and exercise capacity." Based on the ACCP/AACVPR Guideline3,4, as well as the statement recently published by the American Thoracic Society (ATS) and European Respiratory Society (ERS)5 and the most recent Cochrane Review6, we believe that the strength of evidence supporting the use of pulmonary rehabilitation is much stronger than implied by the recommendation in the ACP Guideline. This difference in opinion about the strength of the recommendations regarding whether the "benefits do clearly outweigh risks" (strong recommendation) or the "benefits, risks and burdens are finely balanced" (weak recommendation) is due, at least in part, to the fact that the ACP review was limited primarily to clinical trials, meta-analyses and reviews that evaluated only outcomes of comprehensive pulmonary rehabilitation program interventions incorporating multiple components such as "exercise training, education, behavioral modification and outcome assessment". Although this certainly represents current state of the art treatment in pulmonary rehabilitation, it misses a wealth of evidence and clinical research justifying the treatment components in COPD that form a key basis of inclusion of such treatment modalities in pulmonary rehabilitation. For instance, in evaluating the effect of pulmonary rehabilitation on exercise tolerance, the ACP Guideline comments only on improvements in the 6-minute walk distance in the few trials of pulmonary rehabilitation that examined this particular outcome measure. This misses the large body of evidence about exercise for patients with chronic lung disease that strongly supports endurance exercise training for the lower extremities (1A Recommendation in ACCP/AACVPR Guidelines), upper extremity exercise training (important for activities of daily living, 1A Recommendation), and strength-training (1A Recommendation) and does not support routine use of inspiratory muscle training in pulmonary rehabilitation (1B Recommendation).3,4 In addition, the well established and accepted effect of pulmonary rehabilitation on health-related quality of life (HRQOL) has led to its use as a gold standard against which new measures of HRQOL are evaluated.7
In addition, we wish to emphasize a cautionary note in the ACP statement regarding the severity of patients for whom pulmonary rehabilitation may be considered. The ACP guideline states "However, the evidence is not clear for individuals with FEV1 greater than 50% predicted" and the wording of the ACP Recommendation indicates that "Clinicians should consider pulmonary rehabilitation in symptomatic individuals with COPD who have an FEV1 less than 50% predicted." While we agree that most of the patients with COPD included in the trials of pulmonary rehabilitation examined in the ACP review had moderate to severe disease with severe impairment of lung function, a key principle of rehabilitation medicine is that such treatment should be based on symptoms and disability and not on any arbitrary lung function measure. There are many symptomatic patients with FEV1 above 50% predicted who could, and do, benefit from pulmonary rehabilitation and its treatment components. We are concerned that a recommendation worded like the one in the ACP Guidelines might encourage health providers and payors to deny access to pulmonary rehabilitation for such patients. The inference from this recommendation might suggest that patients with FEV1 above 50% predicted do not benefit from pulmonary rehabilitation. There is no such evidence. In commenting on the effect of pulmonary rehabilitation on mortality, the ACP document appropriately acknowledges that "sample size and study duration were insufficient to adequately evaluate this end-point." We believe that the same principle should be applied to the use of pulmonary rehabilitation for patients with less severe disease than the arbitrary cutoff of 50% predicted FEV1. Given the modest costs and high benefits/risks ratio of pulmonary rehabilitation for such patients, we believe that rehabilitation is reasonable to recommend for appropriate patients. In the absence of evidence, much of medical treatment is based on clinical judgment and common sense. This is another example of the adage that "absence of proof is not proof of absence."
Overall, we are encouraged by the growing body of evidence supporting the use of pulmonary rehabilitation as a standard of care for patients with chronic lung disease and believe that the ACP Guideline, interpreted appropriately, will add weight to this evidence.
Alvin V. Thomas, MD, FCCP President American College of Chest Physicians
Larry Hamm, PhD, FAACVPR, FACSM President American Association of Cardiovascular and Pulmonary Rehabilitation
1. Qaseem A, Snow V, Shekelle P et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2007; 147:633-638.
2. Wilt TJ, Niewoehner D, MacDonald R et al. Management of stable chronic obstructive pulmonary disease: a systematic review for a clinical practice guideline. Ann Intern Med 2007; 147:639-653.
3. Ries AL, Bauldoff GS, Carlin BW et al. Pulmonary rehabilitation executive summary: joint American College of Chest Physicians/American Association of Cardiovascular and Pulmonary Rehabilitation evidence-based clinical practice guidelines. Chest 2007; 131(suppl)(5_suppl):1S-3S.
4. Ries AL, Bauldoff GS, Carlin BW et al. Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based clinical practice guidelines. Chest 2007; 131(suppl)(5):4S-42S.
5. American Thoracic Society, European Respiratory Society. ATS/ERS statement on pulmonary rehabilitation. Am J Respir Crit Care Med 2006; 173:1390-1413.
6. Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2006; Issue 4. Art. No.: CD003793. DOI: 10.1002/14651858.CD003793.pub2.
7. Schunemann HJ, Griffith L, Jaeschke R et al. Evaluation of the minimal important difference for the feeling thermometer and the St. George's Respiratory Questionnaire in patients with chronic airflow obstruction. J Clin Epidemiol 2003; 56:1170-1176.
Amir Qaseem, Vincenza Snow, Paul Shekelle, Katherine Sherif, Timothy J. Wilt, Steven Weinberger, et al. Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med. 2007;147:633–638. doi: 10.7326/0003-4819-147-9-200711060-00008
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