Content validity of visual analog scales to assess symptom severity of acute angioedema attacks in adults with hereditary angioedema: An interview study

Patient

Volumn 5, Issue 2, 2012, Pages 113-126

  McMillan, Carolyn Vivienne ^a   Speight, Jane ^a,b,c   Relan, Anurag ^d   Bellizzi, Luca ^e   Haase, Gerald ^f   Cicardi, Marco ^g  

^a AHP Research   (United Kingdom)

^b THE AUSTRALIAN CENTRE FOR BEHAVIOURAL RESEARCH IN DIABETES   (Australia)

^c DEAKIN UNIVERSITY   (Australia)

^d Pharming Group NV   (United States)

^e Sintesi Research Srl   (Italy)

^f Gordon and Levine Consultancy Services Ltd   (United Kingdom)

^g UNIVERSITY OF MILAN   (Italy)

Author keywords

Hereditary angioedema; Outcome assessment (health care); Patient preference; Utility measurement

Indexed keywords

ADL DISABILITY; ADULT; AGED; ANGIONEUROTIC EDEMA; ARTICLE; BLOATING; BREATHING; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; FEMALE; HUMAN; HUNGER; INTERVIEW; MALE; MICTURITION; NAUSEA; PAIN; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; SPEECH; SWALLOWING; SWELLING; SYMPTOMATOLOGY; VALIDITY; VISUAL ANALOG SCALE;

ADOLESCENT; ADULT; AGED; ANGIOEDEMAS, HEREDITARY; FEMALE; HUMANS; INTERVIEWS AS TOPIC; MALE; MIDDLE AGED; PAIN MEASUREMENT; PATIENT PREFERENCE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84860198173     PISSN: 11781653     EISSN: 11781661     Source Type: Journal    
DOI: 10.2165/11597490-000000000-00000     Document Type: Article

References (26)

1. Agostoni A, ygoren-Pursun E, Binkley KE, et al. Hereditary and acquired angioedema: problems and progress - proceedings of the Third C1 Esterase Inhibitor Deficiency Workshop and beyond. J Allergy Clin Immunol 2004 Sep; 114 Suppl. 3: S51-131 (Pubitemid 39200689)
2. Davis III AE. The pathogenesis of hereditary angioedema. Transfus Apher Sci 2003 Dec; 29 (3): 195-203
3. Zuraw BL. Clinical practice: hereditary angioedema. N Engl J Med 2008 Sep 4; 359 (10): 1027-36
4. Gompels MM, Lock RJ, Abinun M, et al. C1 inhibitor deficiency: consensus document. Clin Exp Immunol 2005 Mar; 139 (3): 379-94 (Pubitemid 40333248)
5. Lumry WR, Castaldo AJ, VernonMK, et al. The humanistic burden of hereditary angioedema: impact on health-related quality of life, productivity, and depression. Allergy Asthma Proc 2010 Sep; 31 (5): 407-14
6. Myles PS, Urquhart N. The linearity of the visual analogue scale in patients with severe acute pain. Anaesth IntensiveCare 2005 Feb; 33 (1): 54-8 (Pubitemid 40287596)
7. Stadler M, Schlander M, Braeckman M, et al. A cost-utility and cost-effectiveness analysis of an acute pain service. J Clin Anesth 2004 May; 16 (3): 159-67 (Pubitemid 38813262)
8. Gerlinger C, Schumacher U, Faustmann T, et al. Defining a minimal clinically important difference for endometriosisassociated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes 2010 Nov 24; 8 (1): 138
9. Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J 2001 May; 18 (3): 205-7
10. Cicardi M, Banerji A, Bracho F, et al. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med 2010 Aug 5; 363 (6): 532-41
11. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry. Patientreported outcome measures - use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79
12. Zuraw B, Cicardi M, Levy RJ, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol 2010 Oct; 126 (4): 821-7
13. Vernon MK, Rentz AM, Wyrwich KW, et al. Psychometric validation of two patient-reported outcome measures to assess symptom severity and changes in symptoms in hereditary angioedema. Qual Life Res 2009 Sep; 18 (7): 929-39
14. Guyatt GH, Feeny DH, Patrick DL. Measuring healthrelated quality of life. Ann Intern Med 1993; 118: 622-9
15. Bowling A. Measuring health: a review of quality of life measurement scales. 3rd ed. New York (NY): Open University Press, 2005
16. Willis G. Cognitive interviewing: a tool for improving questionnaire design. Thousand Oaks (CA): Sage Publications, 2005
17. Rothman M, Burke L, Erickson P, et al. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value in Health 2010; 12 (8): 1075-83
18. Joffe H, Yardley L. Content and thematic analysis. In: Marks DF, Yardley L, editors. Research methods for clinical and health psychology. London: Sage, 2004: 56-68
19. Craig TJ, Levy RJ, Wasserman RL, et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol 2009 Oct; 124 (4): 801-8
20. Bouillet L, Longhurst H, Boccon-Gibod I, et al. Disease expression in women with hereditary angioedema. Am J Obstet Gynecol 2008 Nov; 199 (5): 484
21. Bork K, Meng G, Staubach P, et al. Hereditary angioedema: new findings concerning symptoms, affected organs, and course. Am J Med 2006 Mar; 119 (3): 267-74 (Pubitemid 43255068)
22. Speight J, Reaney M, Barnard KD. The use of hypothetical scenarios and importance weightings when measuring the impact of diabetes on quality of life: a response to Brose et al. Diabet Med 2010; 26 (10): 1077-9
23. Pramming S, Thorsteinsson B, Bendtson I, et al. Symptomatic hypoglycaemia in 411 type 1 diabetic patients. Diabet Med 1991 Apr; 8 (3): 217-22
24. Gallagher EJ, Bijur PE, Latimer C, et al. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med 2002 Jul; 20 (4): 287-90 (Pubitemid 34701069)
25. Todd KH, Funk KG, Funk JP, et al. Clinical significance of reported changes in pain severity. Ann Emerg Med 1996 Apr; 27 (4): 485-9 (Pubitemid 26103814)
26. Food and Drug Administration. Firazyr (icatibant) injection for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years of age and older: briefing document [report no. NDA 022-150]. 2011 [online]. Available from URL: Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM 260020.pdf [Accessed 2011 Jul 5]