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Effective Health Care Program

Chronic Obstructive Pulmonary Disease Exacerbation

Key Questions

Draft Key Questions

  • Question 1: In adult patients who have COPD, what are the benefits and harms of pharmacologic therapies for treatment of exacerbation of symptoms?
     
  • Question 2: In adult patients who have COPD, what are the benefits and harms of non-pharmacologic therapies for treatment of exacerbation of symptoms?

Draft Analytic Framework

Figure 1. Draft analytic framework for Key Question 1

Figure 1: This figure depicts the key question 1 within the context of the PICOTS described in the previous section. In general, the figure illustrates how pharmacologic treatments such as beta adrenergic agonists, anticholinergic agents, glucocorticoid therapy, antibiotics, other pharmacologic treatments and combinations of pharmacologic treatments may result in intermediate outcomes such as symptom scores, lung function (pre- and post-bronchodilator including FEV1, FVC), peak expiratory flow (PEF), quality of life, physical capacity (timed walking tests, endurance tests), duration of hospitalization, or duration of assisted ventilation and/or long-term outcomes such as resolution of exacerbation/treatment failure, relapse/recurrence, or mortality. Also, adverse events may occur at any point after the treatment is received.

Figure 2. Draft analytic framework for Key Question 2

Figure 2: This figure depicts the key question 2 within the context of the PICOTS described in the previous section. In general, the figure illustrates how non-pharmacologic treatments such as oxygen therapy, mechanical ventilation (including non-invasive or invasive ventilation), chest physiotherapy, nutritional support, other non-pharmacologic treatments, or combinations of non-pharmacologic treatments may result in intermediate outcomes such as symptom scores, lung function (pre- and post-bronchodilator including FEV1, FVC), peak expiratory flow (PEF), quality of life, physical capacity (timed walking tests, endurance tests), duration of hospitalization, or duration of assisted ventilation and/or long-term outcomes such as resolution of exacerbation/treatment failure, relapse/recurrence, or mortality. Also, adverse events may occur at any point after the treatment is received.

 

 

Background

In 2014, Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death in the United States with over 15 million people diagnosed with the condition.1 Many people suffer from this disease for years and die prematurely of it or its complications. Among patients with COPD, acute exacerbations are a leading cause of deterioration of pulmonary function and quality of life.2, 3 Unfortunately, the true incidence of COPD exacerbations is quite difficult to assess because about half of exacerbations are not reported by patients.4 COPD exacerbations are also associated with substantially higher risk for mortality. Estimates of hospital mortality rates for patients admitted with an COPD exacerbation vary from 4%–30%5 and the 3-month mortality rate after hospitalization in the UK is approximately 15%.5 COPD is also a costly disease. In developed countries, exacerbations of COPD account for the greatest burden on the health care system. In the United States in 2010, the total national medical costs attributable to COPD including exacerbations were $32.1 billion.6

Therapeutic management of COPD exacerbations range from pharmacologic agents such as short-acting/long-acting inhaled bronchodilators, systemic corticosteroids and other anti-inflammatory drugs (e.g. phosphodiesterase-4 inhibitors), and antibiotic therapy to non-pharmacologic measures such as supplemental oxygen therapy, non-invasive mechanical ventilation (NIV), home-based management, and pulmonary rehabilitation.7-9 In addition, several new pharmacologic agents with novel mechanisms of action in early stages of development may be of potential benefit to COPD patients including those in acute exacerbation.10 However, the comparative benefits and harms of these varied treatment approaches including the optimal combination or sequencing of these treatments to mitigate COPD exacerbation is unclear.

Preliminary PICOTS

Population(s)

  • Adults with acute exacerbation of COPD

Interventions

KQ 1: Pharmacologic interventions include:

  • Beta adrenergic agonists
  • Anticholinergic agents
  • Glucocorticoid therapy
  • Antibiotics
  • Others
  • Combinations of the above

KQ 2: Non-pharmacologic interventions include:

  • Oxygen therapy
  • Mechanical ventilation
    • Non-invasive ventilation
    • Invasive ventilation
  • Chest physiotherapy
  • Nutritional support
  • Others
  • Combinations of the above

Comparators

KQ 1: Pharmacologic treatments compared to each other.

KQ 2: Non-pharmacologic treatments compared to each other and to pharmacologic treatments

Outcomes

KQ 1 & 2: Intermediate outcomes

  • Symptom scores;
  • Lung function (pre- and post-bronchodilator including FEV1, FVC),
  • Peak expiratory flow (PEF);
  • Quality of Life;
  • Physical capacity (timed walking tests, endurance tests);
  • Duration of hospitalization;
  • Duration of assisted ventilation;

KQ 1 & 2: Final health outcomes

  • Resolution of exacerbation/treatment failure;
  • Relapse/recurrence;
  • Mortality;

KQ 1 & 2: Adverse effects of interventions (harms)

Timing

  • All

Setting

  • Setting (primary, specialty, hospital)

Definition of Terms

References

  1. Kochanek KD, Murphy SL, Xu J, et al. Deaths: Final Data for 2014. Natl Vital Stat Rep. 2016 Jun;65(4):1-122.  PMID: 27378572.
  2. Donaldson GC, Seemungal TA, Bhowmik A, et al. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52.  PMID: 12324669.
  3. Doll H, Miravitlles M. Health-related QOL in acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease: a review of the literature. Pharmacoeconomics. 2005;23(4):345-63.  PMID: 15853435.
  4. Seemungal TA, Donaldson GC, Bhowmik A, et al. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 May;161(5):1608-13. doi: 10.1164/ajrccm.161.5.9908022. PMID: 10806163.
  5. Patil SP, Krishnan JA, Lechtzin N, et al. In-hospital mortality following acute exacerbations of chronic obstructive pulmonary disease. Arch Intern Med. 2003 May 26;163(10):1180-6. doi: 10.1001/archinte.163.10.1180. PMID: 12767954.
  6. Ford ES, Murphy LB, Khavjou O, et al. Total and state-specific medical and absenteeism costs of COPD among adults aged >/= 18 years in the United States for 2010 and projections through 2020. Chest. 2015 Jan;147(1):31-45. doi: 10.1378/chest.14-0972. PMID: 25058738.
  7. Mackay AJ, Hurst JR. COPD exacerbations: causes, prevention, and treatment. Immunol Allergy Clin North Am. 2013 Feb;33(1):95-115. doi: 10.1016/j.iac.2012.10.006. PMID: 23337067.
  8. Calverley P. Current drug treatment, chronic and acute. Clin Chest Med. 2014 Mar;35(1):177-89. doi: 10.1016/j.ccm.2013.09.009. PMID: 24507845.
  9. Cabrini L, Landoni G, Oriani A, et al. Noninvasive ventilation and survival in acute care settings: a comprehensive systematic review and metaanalysis of randomized controlled trials. Crit Care Med. 2015 Apr;43(4):880-8. doi: 10.1097/CCM.0000000000000819. PMID: 25565461.
  10. Barjaktarevic IZ, Arredondo AF, Cooper CB. Positioning new pharmacotherapies for COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1427-42. doi: 10.2147/COPD.S83758. PMID: 26244017.