Diagnosis and Staging of Chronic Obstructive Pulmonary Disease by PCPs

and consumption of fish, unprocessed poultry, or unprocessed red meat.

Researchers recommended a modified diet for patients with IBD that limits consumption of processed meat, whether alone or in combination with medication use.

PARENTS MAY HAVE ANXIETY, DEPRESSION YEARS INTO CHILD’S IBD

Parents of children with inflammatory bowel diseases (IBD) were found to have increased symptoms of distress, continuing over the course of their child’s disease, according to research presented at the AIBD 2021 Annual Meeting.

Previous research has identified a pattern of elevated symptoms of depression and anxiety among parents of children with IBD. This study aimed to better assess how these symptoms change over the disease course of IBD.

Investigators from Children’s Hospital of Pittsburgh in the United States recruited parents (N=155) of children with IBD aged 2 to 17 years for this cross-sectional study. Stratified by diagnosis time (<6 months vs >1 year), parental distress was assessed using the Patient Reported Outcomes Measurement Information System Short Form v1.0Anxiety (PROMIS-ANX), Patient Health Questionnaire-8 (PHQ-8), and Impact of Event Scale Revised (IESR).The parents’ children were recently diagnosed (n=52) or had established IBD (n=103).

Clinically elevated PROMIS-ANX scores were observed among 52% of the newly diagnosed cohort. There was no significant change in PROMIS-ANX scores during the transition from newly diagnosed to established disease (mean, 3.77 vs 3.74; P =.220).

Depression scores were clinically elevated among 45% of the parents of newly diagnosed children. Similar to anxiety, the transition to established disease did not affect depression scores (mean, 1.426 vs 1.346; P =.266).

For IES-R, parents of children who were recently diagnosed were more distressed compared with the parents of children with established disease (mean, 2.03 vs 1.62; P =.017).

Additional stratification of parents with children diagnosed <3 months (n=37) and >5 years (n=41) previously found no difference between cohorts for PROMIS-ANX (P =.371) or PHQ-8 (P =.605) scores but a significant change in IES-R scores (P =.0478).

This study found that parents of children with IBD had clinically elevated anxiety and depression scores. There did not appear to be a temporal pattern to their anxiety or depression and scores remain elevated even years after their child’s diagnosis. For distress measured by IES-R scores, there did appear to be a temporal pattern with a reduction in concordance with time since diagnosis. Additional studies are needed to assess potential interventions to mitigate the negative impact on parents.

USTEKINUMAB THERAPY LINKED TO HIGHER RATES OF CD REMISSION

Ustekinumab treatment was associated with a high rate of remission among patients with Crohn disease (CD) who had previously failed to respond to antitumor necrosis factor (TNF) therapy, according to data from a real-world study presented at the AIBD 2021 Annual Meeting.

Ustekinumab, a monoclonal antibody against the interleukin (IL)-12/23 subunit p40, was approved for the treatment of moderate to severe CD and ulcerative colitis. Researchers from the University of Massachusetts Medical School retrospectively reviewed patient records in a cohort of 34 patients with CD who had failed at least 1 anti-TNF treatment before induction with ustekinumab; 59% of patients were women and 50% had fistulizing disease.

Clinical remission was achieved by 70.5% of patients. Among those in remission, 29% were also taking concomitant steroids or immunomodulators at the time of remission. This relatively high remission rate also was found among the subgroup of patients with fistulizing CD (70%).

Among patients with data on C-reactive protein levels (70%), the average level prior to ustekinumab induction was 2.4, which trended downward to 1.98 (95% CI, -0.064 to 1.08; P =.079) after starting therapy. Among the patients with fecal calprotectin data (18%), mean fecal calprotectin levels prior to ustekinumab induction were 386. Like C-reactive protein, fecal calprotectin also trended downward after ustekinumab exposure (mean, 175; 95% CI, -106.25 to 528.46; P =.148).

This study found that ustekinumab was associated with a high rate of remission, even for patients with fistulizing CD, among a difficult to treat population who had prior failed anti-TNF therapy. ■

The proportion of patients with fistulizing disease who achieved remission was 70%.

Using the GOLD standards for COPD staging will identify high-risk patients, improve delivery of care, and reduce health care costs.

© KOLDUNOV / GETTY IMAGES

COPD is misdiagnosed in up to 40% of patients.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide and follows cancer as the fourth-leading cause of death in the United States (N=156,979 deaths annually).¹ The direct costs for COPD admissions in the United States are approximately $50 billion annually.² The percentage of US adults who have ever been diagnosed with COPD (including emphysema and chronic bronchitis) is 4.6%,1 and the prevalence is 2-fold higher in rural areas of the country than in large metropolitan areas (8.2% vs 4.7%; Figure 1).3,4 In the United States, COPD is mainly diagnosed and managed in the primary care setting; however, misdiagnosis rates range from 10% to 40%.5 The primary goal of COPD management is to effectively manage symptoms and improve quality of life. Understanding and implementing the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standards will guide providers in diagnosing and staging patients with COPD accurately and selecting appropriate prescriptive therapy.6 Using the GOLD standards for COPD will help clinicians more effectively identify high-risk patients, improve delivery of care, and reduce exorbitant spending of health care dollars.

Pulmonary Function Tests

Diagnosis of COPD should be considered in any patient presenting with dyspnea, chronic cough or sputum production, history of recurrent lower respiratory tract infections or low birth weight,

and/or a history of exposure to COPD risk factors (eg, genetic factors or congenital/developmental abnormalities; tobacco smoking; exposure to occupational dusts, vapors, fumes, gases, or other chemicals; exposure to smoke from home cooking/heating fuels).

After completion of a thorough patient assessment, pulmonary function tests (PFTs) should be ordered for patients with suspected COPD.7 Spirometry is the preferred tool for detecting airflow limitation and diagnosing COPD.6,7 Spirometry performed in a primary care clinic is as reliable as that performed in a pulmonary function laboratory as long as the clinician is skilled with calibration of the machine, administration of the test, and interpretation of the results.6,7 Many hospitals complete outpatient PFTs in the respiratory department, and clinicians must be proficient in interpreting the results.

Key components of spirometric assessment are as follows6: • Forced expiratory volume (FEV1): the amount of air exhaled in the first second of expiration • Forced vital capacity (FVC): volume of air forcibly exhaled from the point of maximal inspiration • FEV1/FVC: ratio of these 2 measurements expressed as a fraction

A postbronchodilator FEV1/FVC <0.7 confirms airflow limitation and COPD diagnosis in patients with appropriate symptoms and exposures to noxious stimuli. Suggested bronchodilator doses include 400 µg short-acting β2-agonist, 160 µg short-acting anticholinergic, or both agents combined. Timing of FEV1 measurement is based on which agent is used: at 10 to 15 minutes after a short-acting β2-agonist or 30 to 45 minutes after a short-acting anticholinergic or combination of both agents. These measurements should be compared with reference volumes based on age, height, sex, and race.6 Additional spirometry tips provided in the GOLD report include recording long enough for a volume plateau to be reached, which may be more than 15 seconds in a patient with severe disease. Practitioners should use the largest of the individual FEV1 and FVC measurements taken from any of 3 technically satisfactory curves, with the curves varying no more than 5% or 150 mL, whichever is the greater value. The FEV1/FVC ratio should be derived from the technically acceptable curve that has the largest sum of FEV1 and FVC.6 The GOLD report provides guidance on assessing the level of airflow limitation, impact of COPD on patient’s health status, and risk for future exacerbations. The FEV1 will guide clinicians in determining GOLD stage of disease severity (Table 1).

Symptom Assessment

Previously, a measure of breathlessness such as the Modified British Medical Research Council (mMRC) dyspnea scale was used as the sole assessment of symptom severity.6 The revised GOLD assessment scheme includes use of spirometry to assess severity of airflow limitation; assessment of either dyspnea via the mMRC or symptoms using the COPD Assessment Test (CAT); and history of moderate and severe exacerbations, including prior hospitalizations (Figure 2, page 8).6

TABLE 1. GOLD Classification of Airflow Limitation Severity in COPDa

Gold Classification Airflow Limitation Severity FEV1 Measurement

GOLD 1 Mild FEV1 ≥80% predicted

GOLD 2 Moderate 50% ≤FEV1 <80% predicted

GOLD 3 Severe 30% ≤FEV1 <50% predicted

GOLD 4 Very severe FEV1 <30% predicted

COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in the first second of expiration. aIn patients with postbronchodilator FEV1/FVC <0.7. Adapted from Global Initiative for Chronic Obstructive Lung Disease.6

Model-Based COPD Prevalence by County, United States, 2018

Percent (%): ■ 3.5-7.0 ■ 7.1-8.9 ■ 9.0-10.9 ■ 11.0-13.4 ■ 13.5-19.7

Reprinted from the CDC.4

FIGURE 1. Model-based county-level prevalence estimates of COPD among adults in the United States during 2018. Counties with the highest model-based COPD prevalence estimates were clustered along the Ohio and lower Mississippi Rivers.

Assessment of Airflow Limitation

GOLD Grade FEV1 (% Predicted)

1 ≥80

2 50-79

3 30-49

4 <30

Exacerbation History

≥2 or ≥1 leading to hospitalization

0 or 1 not leading to hospitalization

CAT, COPD Assessment Test; ICS, inhaled corticosteroid; LABA, long-acting β agonist; LAMA, long-acting muscarinic antagonist; mMRC, Modified British Medical Research Council dyspnea scale. Adapted from Global Initiative for Chronic Obstructive Lung Disease.6

FIGURE 2. GOLD assessment tool for COPD.

Assessment of Symptoms/ Risks for Exacerbations

Group C LAMA

Group D LAMA or LAMA + LABA or ICS + LABA

Group A Bronchodilator

Group B LABA or LAMA

mMRC 0-1 CAT <10 mMRC ≥2 CAT ≥10

Modified British Medical Research Council Dyspnea Scale

The mMRC dyspnea scale is a concise, patient-centered tool that measures the level of dyspnea when walking or exercising. Patients with scores of 0 to 1 are in group A or C, and patients with scores of 2 to 5 are in group B or D (Table 2).5,8

COPD Assessment Test

The CAT is an easily administered, 8-item health questionnaire that assesses dyspnea and activity limitations to calculate a score that captures symptom burden and impact of COPD on activities of daily living.9 Results range from a score of 0 to 40, and 10 is a cutoff for consideration of regular treatment for symptoms, including breathlessness.6 This information also can improve communication between the patient and the health care team when assessing the impact of symptoms beyond dyspnea on activities of daily living.6,10

COPD Classification Group Guides Treatment

Initiation of pharmacotherapy for COPD is based on the ABCD assessment scheme in the GOLD report (Figure 2).6 Patients in group A should be prescribed a long- or shortacting bronchodilator. Patients in group B should be prescribed a long-acting muscarinic antagonist (LAMA) or a long-acting β agonist (LABA); there is no evidence to recommend one class over the other, and the choice should

TABLE 2. Modified British Medical Research Council Scale

mMRC Grade Degree of Breathlessness

0 I only get breathless with strenuous exercise

1 I get breathless when walking fast on flat ground or walking up a slight hill

2 I walk slower than people my age on flat ground because of breathlessness or I have to stop to breathe when walking at my own pace on flat ground

3 I stop for breath after walking approximately 100 yd or after a few minutes walking on flat ground

4 I am too breathless to leave the house or I am breathless when getting dressed or undressed

Adapted from Fletcher CM.8

be dependent upon the patient’s perception of symptom relief. If a patient in group B continues to have symptoms, a combination LAMA plus LABA may be used as control therapy. A LAMA is the choice for initial therapy among patients in groups C and D. Group D patients may be more symptomatic and may benefit from combination therapy with a LAMA plus LABA (for persons with CAT ≥20) or a LABA plus inhaled corticosteroid (ICS) (for persons with blood eosinophil counts ≥300 cells/µL). If the patient is experiencing persistent breathlessness or is exercise-intolerant, combination treatment should be used.

If there is no improvement with dual therapy, treatment should be changed to triple therapy with LAMA, LABA, and ICS. If patients on triple therapy still have exacerbations, treatment options are to add roflumilast, add a macrolide, or stop ICSs if the patient reports lack of efficacy or adverse effects (eg, pneumonia).

Nonpharmacologic Management of COPD

Smoking cessation and physical activity are recommended for all patients with COPD.6 For patients in groups B, C, and D, pulmonary rehabilitation is also recommended. The GOLD report has added COVID-19 vaccination to its list of recommended vaccines, which also includes influenza, pneumococcal, and pertussis vaccinations.

Long-term oxygen therapy is recommended for stable patients with: • Partial pressure arterial oxygen (PaO2) ≤55 mm Hg or arterial oxygen saturation (SaO2) ≤88% with or without hypercapnia confirmed twice over 3 weeks; or • PaO2 55 mm Hg to 60 mm Hg or SaO2 88% in patients with pulmonary hypertension, peripheral edema suggesting congestive cardiac failure, or polycythemia.

COVID-19 and COPD

The GOLD report recommends COVID-19 testing for patients with COPD who present with new or worsening respiratory symptoms, fever, or other COVID-19 symptoms.6 Patients should continue taking ICSs, long-acting bronchodilators, roflumilast, chronic macrolides, systemic steroids, and antibiotics as indicated during the pandemic.6

Summary

Most patients with COPD have not undergone appropriate PFTs or are receiving inadequate mediations according to their GOLD class.12 The estimated $50 billion spent annually on COPD therapy cost could be decreased by improving diagnosis and staging of this disease and implementing appropriate therapy.2 Using the GOLD standards to classify COPD stage and prescribe the correct pharmaceutical management may reduce daily symptoms, reduce hospital admissions, and improve quality of life. ■

Shannon Harris, DNP, FNP-BC, CCRN, is an assistant professor at the University of South Alabama College of Nursing and a nurse practitioner at Diagnostic Medical Clinic, both in Mobile, Alabama. Lori Prewitt Moore, DNP, FNP-BC, RN, CHSE, is an assistant professor at the University of South Alabama College of Nursing.

References

1. Centers for Disease Control and Prevention. Chronic obstructive pulmonary disease (COPD) includes: Chronic bronchitis and emphysema. Updated September 13, 2021. Accessed December 9, 2021. 2. Press VG, Konetzka RT, White SR. Insights about the economic impact of chronic obstructive pulmonary disease readmissions post implementation of the hospital readmission reduction program. Curr Opin Pulm Med. 2018;24(2):138-146. 3. Croft JB, Wheaton AG, Liu Y, et al. Urban-rural county and state differences in chronic obstructive pulmonary disease - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018;67(7):205-211. 4. Centers for Disease Control and Prevention. Data and statistics: COPD death rates in the United States. Updated June 14, 2021. Accessed December 13, 2021. 5. Ragaišiene˙ G, Kibarskyte˙ R, Gauronskaite˙ R, et al. Diagnosing COPD in primary care: what has real life practice got to do with guidelines? Multidiscip Respir Med. 2019;14:28. 6. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, 2022 Report. Accessed December 10, 2021. 7. Graham BL, Steenbruggen I, Miller MR, et al. Standardization of spirometry 2019 update. An official American Thoracic Society and European Respiratory Society technical statement. Am J Respir Crit Care Med. 2019; 200(8):e70-e88. 8. Fletcher CM. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on Aetiology of Chronic Bronchitis (MRC breathlessness score). BMJ. 1960;2:1662. 9. Gil HI, Zo S, Jones PW, et al. Clinical characteristics of COPD patients according to COPD assessment test (CAT) score level: cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2021;16:1509-1517. 10. Munari AB, Gulart AA, Dos Santos K, Venâncio RS, Karloh M, Mayer AF. Modified Medical Research Council dyspnea scale in GOLD classification better reflects physical activities of daily living. Respir Care. 2018;63(1):77-85. 11. Halpin DMG, Criner GJ, Papi A, et al. Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. The 2020 GOLD Science Committee report on COVID-19 and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2021;203(1):24-36. 12. Rohde J, Joseph A, Tambedou B, et al. Reducing 30-day all-cause acute exacerbation of chronic obstructive pulmonary disease readmission rate with a multidisciplinary quality improvement project. Cureus. 2021: 13(11): e19917.