Reliability, Validity, and Responsiveness of the DEG, a Three-Item Dyspnea Measure

Duc M Ha, Lubin R Deng, Allison V Lange, Jeffrey J Swigris, David B Bekelman, Duc M Ha, Lubin R Deng, Allison V Lange, Jeffrey J Swigris, David B Bekelman

Abstract

Background: Dyspnea is a common and debilitating symptom that affects many different patient populations. Dyspnea measures should assess multiple domains.

Objective: To evaluate the reliability, validity, and responsiveness of an ultra-brief, multi-dimensional dyspnea measure.

Design: We adapted the DEG from the PEG, a valid 3-item pain measure, to assess average dyspnea intensity (D), interference with enjoyment of life (E), and dyspnea burden with general activity (G).

Participants: We used data from a multi-site randomized clinical trial among outpatients with heart failure.

Main measures: We evaluated reliability (Cronbach's alpha), concurrent validity with the Memorial-Symptom-Assessment-Scale (MSAS) shortness-of-breath distress-orbothersome item and 7-item Generalized-Anxiety-Disorder (GAD-7) scale, knowngroups validity with New-York-Heart-Association-Functional-Classification (NYHA) 1-2 or 3-4 and presence or absence of comorbid chronic obstructive pulmonary disease (COPD), responsiveness with the MSAS item as an anchor, and calculated a minimal clinically important difference (MCID) using distribution methods.

Key results: Among 312 participants, the DEG was reliable (Cronbach's alpha 0.92). The mean (standard deviation) DEG score was 5.26 (2.36) (range 0-10) points. DEG scores correlated strongly with the MSAS shortness of breath distress-or-bothersome item (r=0.66) and moderately with GAD-7 categories (ρ=0.36). DEG scores were statistically significantly lower among patients with NYHA 1-2 compared to 3-4 [mean difference (standard error): 1.22 (0.27) points, p<0.01], and those without compared to with comorbid COPD [0.87 (0.27) points, p<0.01]. The DEG was highly sensitive to change, with MCID of 0.59-1.34 points, or 11-25% change.

Conclusions: The novel, ultra-brief DEG measure is reliable, valid, and highly responsive. Future studies should evaluate the DEG's sensitivity to interventions, use anchor-based methods to triangulate MCID estimates, and determine its prognostic usefulness among patients with chronic cardiopulmonary and other diseases.

Keywords: Patient-reported outcome measure; cardiopulmonary disease; chronic obstructive pulmonary disease; dyspnea; heart failure; psychometrics.

Conflict of interest statement

The authors declare no competing interests.

© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

Figures

Figure 1
Figure 1
Dyspnea, enjoyment of life, general activity (DEG) measure.
Figure 2
Figure 2
Distribution of DEG scores. DEG = dyspnea, enjoyment of life, general activity measure.
Figure 3
Figure 3
Concurrent validity of the DEG. A With the MSAS shortness-of-breath distress-or-bothersome item (r= 0.66,p< 0.01); B with GAD-7 anxiety levels (ρ= 0.36,p< 0.01). DEG = dyspnea, enjoyment of life, general activity measure; GAD-7 = 7-item Generalized Anxiety Disorder Scale; MSAS = Memorial Symptom Assessment Scale.
Figure 4
Figure 4
Known-group validity of the DEG. A By NYHA classification [mean difference (standard error) = 1.22 (0.27) points, p < 0.01]; B by presence or absence of COPD [mean difference (standard error) = 0.87 (0.27) points, p < 0.01]. COPD = chronic obstructive pulmonary disease; DEG = Dyspnea, Enjoyment of life, General activity measure; NYHA = New York Heart Association.

References

    1. Parshall MB, Schwartzstein RM, Adams L, et al. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012;185(4):435–452. doi: 10.1164/rccm.201111-2042ST.
    1. Laviolette L, Laveneziana P, Faculty ERSRS Dyspnoea: a multidimensional and multidisciplinary approach. Eur Respir J. 2014;43(6):1750–1762. doi: 10.1183/09031936.00092613.
    1. Banzett RB, Moosavi SH. Measuring dyspnoea: new multidimensional instruments to match our 21st century understanding. Eur Respir J. 2017;49(3):1602473. doi: 10.1183/13993003.02473-2016.
    1. Massart A, Hunt DP. Management of Refractory Breathlessness: a Review for General Internists. J Gen Intern Med. 2021;36(4):1035–1040. doi: 10.1007/s11606-020-06439-0.
    1. Hendriks SA, Smalbrugge M, Galindo-Garre F, Hertogh CM, van der Steen JT. From admission to death: prevalence and course of pain, agitation, and shortness of breath, and treatment of these symptoms in nursing home residents with dementia. J Am Med Dir Assoc. 2015;16(6):475–481. doi: 10.1016/j.jamda.2014.12.016.
    1. Ho SF, O'Mahony MS, Steward JA, Breay P, Buchalter M, Burr ML. Dyspnoea and quality of life in older people at home. Age Ageing. 2001;30(2):155–159. doi: 10.1093/ageing/30.2.155.
    1. McKenzie E, Zhang L, Chan S, et al. Symptom correlates of dyspnea in advanced cancer patients using the Edmonton Symptom Assessment System. Support Care Cancer: Off J Multinatl Assoc Support Care Cancer. 2020;28(1):87–98. doi: 10.1007/s00520-019-04787-0.
    1. Ramalho SHR, Santos M, Claggett B, et al. Association of Undifferentiated Dyspnea in Late Life With Cardiovascular and Noncardiovascular Dysfunction: A Cross-sectional Analysis From the ARIC Study. JAMA Netw Open. 2019;2(6):e195321. doi: 10.1001/jamanetworkopen.2019.5321.
    1. Reuben DB, Mor V. Dyspnea in terminally ill cancer patients. Chest. 1986;89(2):234–236. doi: 10.1378/chest.89.2.234.
    1. Smith AK, Currow DC, Abernethy AP, et al. Prevalence and Outcomes of Breathlessness in Older Adults: A National Population Study. J Am Geriatr Soc. 2016;64(10):2035–2041. doi: 10.1111/jgs.14313.
    1. Edmonds P, Karlsen S, Khan S, Addington-Hall J. A comparison of the palliative care needs of patients dying from chronic respiratory diseases and lung cancer. Palliat Med. 2001;15(4):287–295. doi: 10.1191/026921601678320278.
    1. Berraho M, Nejjari C, El Rhazi K, et al. Dyspnea: a strong independent factor for long-term mortality in the elderly. J Nutr Health Aging. 2013;17(10):908–912. doi: 10.1007/s12603-013-0347-6.
    1. Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002;121(5):1434–1440. doi: 10.1378/chest.121.5.1434.
    1. Abidov A, Rozanski A, Hachamovitch R, et al. Prognostic significance of dyspnea in patients referred for cardiac stress testing. N Engl J Med. 2005;353(18):1889–1898. doi: 10.1056/NEJMoa042741.
    1. Byng D, Lutter JI, Wacker ME, et al. Determinants of healthcare utilization and costs in COPD patients: first longitudinal results from the German COPD cohort COSYCONET. Int J Chron Obstruct Pulmon Dis. 2019;14:1423–1439. doi: 10.2147/COPD.S201899.
    1. Budhwar N, Syed Z. Chronic Dyspnea: Diagnosis and Evaluation. Am Fam Physician. 2020;101(9):542–548.
    1. Jones PW, Beeh KM, Chapman KR, Decramer M, Mahler DA, Wedzicha JA. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med. 2014;189(3):250–255. doi: 10.1164/rccm.201310-1863PP.
    1. Pang PS, Cleland JG, Teerlink JR, et al. A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach. Eur Heart J. 2008;29(6):816–824. doi: 10.1093/eurheartj/ehn048.
    1. Cotes JE, Chinn DJ. MRC questionnaire (MRCQ) on respiratory symptoms. Occup Med. 2007;57(5):388–388. doi: 10.1093/occmed/kqm051.
    1. Banzett RB, O'Donnell CR, Guilfoyle TE, et al. Multidimensional Dyspnea Profile: an instrument for clinical and laboratory research. Eur Respir J. 2015;45(6):1681–1691. doi: 10.1183/09031936.00038914.
    1. Tan JY, Yorke J, Harle A, et al. Assessment of Breathlessness in Lung Cancer: Psychometric Properties of the Dyspnea-12 Questionnaire. J Pain Symptom Manag. 2017;53(2):208–215. doi: 10.1016/j.jpainsymman.2016.08.009.
    1. Egleston BL, Miller SM, Meropol NJ. The impact of misclassification due to survey response fatigue on estimation and identifiability of treatment effects. Stat Med. 2011;30(30):3560–3572. doi: 10.1002/sim.4377.
    1. Bekelman DB, Allen LA, McBryde CF, et al. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial. JAMA Intern Med. 2018;178(4):511–519. doi: 10.1001/jamainternmed.2017.8667.
    1. Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24(6):733–738. doi: 10.1007/s11606-009-0981-1.
    1. Bekelman DB, Allen LA, Peterson J, et al. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial. Contemp Clin Trials. 2016;51:1–7. doi: 10.1016/j.cct.2016.09.002.
    1. Boateng GO, Neilands TB, Frongillo EA, Melgar-Quiñonez HR, Young SL. Best Practices for Developing and Validating Scales for Health, Social, and Behavioral Research: A Primer. Front Public Health. 2018;6:149. doi: 10.3389/fpubh.2018.00149.
    1. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34–42. doi: 10.1016/j.jclinepi.2006.03.012.
    1. Portenoy RK, Thaler HT, Kornblith AB, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer (Oxford, England: 1990). 1994;30A(9):1326–1336. doi: 10.1016/0959-8049(94)90182-1.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297–334. doi: 10.1007/BF02310555.
    1. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–109. doi: 10.1016/j.jclinepi.2007.03.012.
    1. Kean J, Monahan PO, Kroenke K, et al. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016;54(4):414–21. doi: 10.1097/MLR.0000000000000497.
    1. Beaton DE, Hogg-Johnson S, Bombardier C. Evaluating changes in health status: reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders. J Clin Epidemiol. 1997;50(1):79–93. doi: 10.1016/S0895-4356(96)00296-X.
    1. Chen CX, Kroenke K, Stump TE, et al. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018;159(4):775–782. doi: 10.1097/j.pain.0000000000001121.
    1. Kroenke K, Baye F, Lourens SG. Comparative Responsiveness and Minimally Important Difference of Common Anxiety Measures. Med Care. 2019;57(11):890–897. doi: 10.1097/MLR.0000000000001185.
    1. Kupper N, Bonhof C, Westerhuis B, Widdershoven J, Denollet J. Determinants of Dyspnea in Chronic Heart Failure. J Card Fail. 2016;22(3):201–209. doi: 10.1016/j.cardfail.2015.09.016.
    1. Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012;126(4):501–506. doi: 10.1161/CIRCULATIONAHA.112.125435.
    1. Zhou H, Della PR, Roberts P, Goh L, Dhaliwal SS. Utility of models to predict 28-day or 30-day unplanned hospital readmissions: an updated systematic review. BMJ Open. 2016;6(6):e011060. doi: 10.1136/bmjopen-2016-011060.
    1. Hegendörfer E, Doukhopelnikoff A, Degryse JM. Validity and reliability of the Multidimensional Dyspnoea Profile in older adults. ERJ Open Res. 2021;7(2):10.1183/23120541.00606-2020.
    1. Elliott-Button HL, Johnson MJ, Nwulu U, Clark J. Identification and Assessment of Breathlessness in Clinical Practice: A Systematic Review and Narrative Synthesis. J Pain Symptom Manag. 2020;59(3):724–733.e19. doi: 10.1016/j.jpainsymman.2019.10.014.
    1. Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988;93(3):580–586. doi: 10.1378/chest.93.3.580.
    1. Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991;7(2):6–9. doi: 10.1177/082585979100700202.
    1. Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92–98.
    1. Hajiro T, Nishimura K, Tsukino M, Ikeda A, Koyama H, Izumi T. Analysis of clinical methods used to evaluate dyspnea in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;158(4):1185–1189. doi: 10.1164/ajrccm.158.4.9802091.
    1. Johnson MJ, Oxberry SG, Cleland JG, Clark AL. Measurement of breathlessness in clinical trials in patients with chronic heart failure: the need for a standardized approach: a systematic review. Eur J Heart Fail. 2010;12(2):137–147. doi: 10.1093/eurjhf/hfp194.
    1. Lewthwaite H, Jensen D, Ekström M. How to Assess Breathlessness in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2021;16:1581–1598. doi: 10.2147/COPD.S277523.
    1. Hodgev V, Kostianev S, Marinov B. University of Cincinnati Dyspnea Questionnaire for Evaluation of Dyspnoea during physical and speech activities in patients with chronic obstructive pulmonary disease: a validation analysis. Clin Physiol Funct Imaging. 2003;23(5):269–274. doi: 10.1046/j.1475-097X.2003.00506.x.
    1. Wilcox TK, Chen WH, Howard KA, et al. Item selection, reliability and validity of the Shortness of Breath with Daily Activities (SOBDA) questionnaire: a new outcome measure for evaluating dyspnea in chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2013;11:196–7525. doi: 10.1186/1477-7525-11-196.
    1. Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. Validation of a new dyspnea measure: the UCSD Shortness of Breath Questionnaire. University of California, San Diego. Chest. 1998;113(3):619–624. doi: 10.1378/chest.113.3.619.
    1. Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991;85(Suppl B):25–31. doi: 10.1016/S0954-6111(06)80166-6.
    1. Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 1987;42(10):773–778. doi: 10.1136/thx.42.10.773.
    1. Tsai CL, Hodder RV, Page JH, Cydulka RK, Rowe BH, Camargo CA., Jr The short-form chronic respiratory disease questionnaire was a valid, reliable, and responsive quality-of-life instrument in acute exacerbations of chronic obstructive pulmonary disease. J Clin Epidemiol. 2008;61(5):489–497. doi: 10.1016/j.jclinepi.2007.07.003.
    1. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline LN. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34(3):648–654. doi: 10.1183/09031936.00102509.
    1. Selim AJ, Ren XS, Fincke G, Rogers W, Lee A, Kazis L. A symptom-based measure of the severity of chronic lung disease: results from the Veterans Health Study. Chest. 1997;111(6):1607–1614. doi: 10.1378/chest.111.6.1607.
    1. Guyatt GH, Nogradi S, Halcrow S, Singer J, Sullivan MJ, Fallen EL. Development and testing of a new measure of health status for clinical trials in heart failure. J Gen Intern Med. 1989;4(2):101–107. doi: 10.1007/BF02602348.
    1. Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer (Oxford, England: 1990). 1994;30A(5):635–642. doi: 10.1016/0959-8049(94)90535-5.
    1. Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010;65(1):21–26. doi: 10.1136/thx.2009.118521.
    1. Yorke J, Swigris J, Russell AM, et al. Dyspnea-12 is a valid and reliable measure of breathlessness in patients with interstitial lung disease. Chest. 2011;139(1):159–164. doi: 10.1378/chest.10-0693.
    1. Meek PM, Banzett R, Parsall MB, Gracely RH, Schwartzstein RM, Lansing R. Reliability and validity of the multidimensional dyspnea profile. Chest. 2012;141(6):1546–1553. doi: 10.1378/chest.11-1087.
    1. Williams MT, John D, Frith P. Comparison of the Dyspnoea-12 and Multidimensional Dyspnoea Profile in people with COPD. Eur Respir J. 2017;49(3):1600773. doi: 10.1183/13993003.00773-2016.
    1. Mahler DA, Buhl R, Lawrence D, McBryan D. Efficacy and safety of indacaterol and tiotropium in COPD patients according to dyspnoea severity. Pulm Pharmacol Ther. 2013;26(3):348–355. doi: 10.1016/j.pupt.2013.02.006.

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