Symptoms and markers of symptom severity in asthma—content validity of the asthma symptom diary

Health and Quality of Life Outcomes

Maria S Mattera⁶  Robyn von Maltzahn⁴  Joseph Lin²  Ingela Wiklund⁴  Michael Schatz⁵  Mona Martin¹  Gary Globe³ 

[1] Health Research Associates, Inc., 6505 216th St SW, Mountlake Terrace 98043, WA, USA;Currently with Gilead Sciences, Inc., Foster City, CA, USA;Global Health Economics, Amgen Inc., One Amgen Center Drive MS 28-3-A, Thousand Oaks 91320, CA, USA;Evidera, Metro Building, 6th Floor, 1 Butterwick, London W6 8DL, UK;Department of Allergy, Kaiser Permanente Medical Center, 4647 Zion Ave, San Diego 92120, CA, USA;Evidera, 7101 Wisconsin Ave, Suite 600, Bethesda 20814, MD, USA

关键词: Qualitative;    Instrument development;    Patient-reported outcome;    Symptoms;    Asthma;   

Others  :  1133804
DOI  :  10.1186/s12955-015-0217-5

 received in 2014-05-20, accepted in 2015-01-28,  发布年份 2015

【 摘 要 】

Background and objectives

The American Thoracic Society/European Respiratory Society (ATS/ERS) Task Force acknowledged the multi-faceted nature of asthma in its recent definition of asthma control as a summary term capturing symptoms, reliever use, frequency/severity of exacerbations, lung function, and future risk and the Global Initiative for Asthma (GINA) defines the clinical manifestations (well established markers of asthma severity) of asthma to include symptoms, sleep disturbances, limitations of daily activity, impairment of lung function, and use of rescue medications. The objectives of this qualitative work were to identify symptoms and markers of symptom severity relevant to patients with moderate to severe asthma and to evaluate the content validity of the asthma symptom diary (ASD).

Methods

A qualitative interview study was conducted using a purposive sample of symptomatic adult and adolescent (≥12 years) subjects with asthma. Concept elicitation (CE) interviews (n = 50) were conducted to identify core asthma symptoms and symptom-related clinical markers, followed by cognitive interviews (n = 24) to ensure patient comprehension of the items, instructions and response options. CE interviews were coded using ATLAS.ti for content analysis.

Results

The study sample had a diverse range of symptom severity, level of symptom control, sociodemographic and socioeconomic status. The most frequently reported symptoms in adults were chest tightness (n = 33/34; 97.1%), wheezing (n = 31; 91.2%), coughing (n = 30; 88.2%), and shortness of breath (n = 25; 73.5%); in adolescents they were wheezing (n = 14/16; 87.5%), coughing (n = 13; 81.3%), and chest tightness (n = 11; 68.8%). Adults identified chest tightness followed by shortness of breath as their most severe symptoms; while adolescents reported coughing and chest tightness as their most severe symptoms. Sleep awakenings and limitations in day-to-day activities were frequent symptom-related clinical markers. Day-to-day variability and differences between daytime and nighttime symptom experiences reported by subjects resulted in the need for the ASD to be administered twice daily. Cognitive interviews indicated that subjects found the revised ASD items clear and easy to understand.

Conclusions

This study supports the content validity of the revised ASD, showing it to be consistent with patient experiences and ready for further psychometric testing.

【 授权许可】

   
2015 Globe et al.; licensee BioMed Central.

【 参考文献 】

• [1]American Asthma Foundation. The impact of asthma. http://www.americanasthmafoundation.org/impact-asthma. Accessed 9 July 2013.
• [2]World Health Organization (WHO). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. http://www.who.int/gard/publications/GARD%20Book%202007.pdf. Accessed 9 July 2013.
• [3]Akinbami LJ, Moorman JE, Liu X: Asthma prevalence, health care use, and mortality: United States. Natl Health Stat Report 2005, 2011:1-14.
• [4]Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. 2012. Available from: http://www.ginasthma.org/.
• [5]Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, et al.: An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med 2009, 180:59-99.
• [6]Tepper RS, Wise RS, Covar R, Irvin CG, Kercsmar CM, Kraft M, et al.: Asthma outcomes: pulmonary physiology. J Allergy Clin Immunol 2012, 129:S65-87.
• [7]Carranza Rosenzweig JR, Edwards L, Lincourt W, Dorinsky P, ZuWallack RL: The relationship between health-related quality of life, lung function and daily symptoms in patients with persistent asthma. Respir Med 2004, 98:1157-65.
• [8]Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R, et al.: Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol 2012, 129:S24-33.
• [9]Zhang J, Yu C, Holgate ST, Reiss TF: Variability and lack of predictive ability of asthma end-points in clinical trials. Eur Respir J 2002, 20:1102-9.
• [10]Shingo S, Zhang J, Reiss TF: Correlation of airway obstruction and patient-reported endpoints in clinical studies. Eur Respir J 2001, 17:220-4.
• [11]Rabe KF, Vermeire PA, Soriano JB, Maier WC: Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J 2000, 16:802-7.
• [12]Boulet LP, Phillips R, O'Byrne P, Becker A: Evaluation of asthma control by physicians and patients: comparison with current guidelines. Can Respir J 2002, 9:417-23.
• [13]Revicki D, Weiss KB: Clinical assessment of asthma symptom control: review of current assessment instruments. J Asthma 2006, 43:481-7.
• [14]Krishnan JA, Lemanske RF, Canino GJ, Elward KS, Kattan M, Matsui EC, et al.: Asthma outcomes: Symptoms. J Allergy Clin Immunol 2012, 129:S124-S35.
• [15]Food and Drug Administration (FDA): Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims Fed Regist 2009, 74:65132-3.
• [16]Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al.: Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1–eliciting concepts for a new PRO instrument. Value Health 2011, 14:967-77.
• [17]Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al.: Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2–assessing respondent understanding. Value Health 2011, 14:978-88.
• [18]Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention. http://www.ginasthma.org/local/uploads/files/GINA_Report_2014.pdf. Accessed January 2015.
• [19]Globe G, Lin S, Schatz M, Mattera MS, Feng JY, Chon Y, et al.: Psychometric performance of the Asthma Symptom Diary (ASD) in adult and adolescent subjects with persistent asthma. In ISOQOL 20th Annual Conference, Miami, Florida, USA; 2013.
• [20]Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR: Development and validation of a questionnaire to measure asthma control. Eur Respir J 1999, 14:902-7.
• [21]Juniper EF, Svensson K, Mork AC, Stahl E: Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med 2005, 99:553-8.
• [22]Busse WW, Morgan WJ, Taggart V, Togias A: Asthma outcomes workshop: overview. J Allergy Clin Immunol 2012, 129:S1-8.