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

McMillan, Carolyn Vivienne, Speight, Jane, Relan, Anurag, Bellizzi, Luca, Haase, Gerald and Cicardi, Marco 2012, Content validity of visual analog scales to assess symptom severity of acute angioedema attacks in adults with hereditary angioedema : an interview study, Patient, vol. 5, no. 2, pp. 113-126.

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Title Content validity of visual analog scales to assess symptom severity of acute angioedema attacks in adults with hereditary angioedema : an interview study
Author(s) McMillan, Carolyn Vivienne
Speight, Jane
Relan, Anurag
Bellizzi, Luca
Haase, Gerald
Cicardi, Marco
Journal name Patient
Volume number 5
Issue number 2
Start page 113
End page 126
Total pages 14
Publisher Adis International
Place of publication Auckland, N. Z.
Publication date 2012-06-01
ISSN 1178-1653
1178-1661
Keyword(s) hereditary-angioedema
outcome-assessment-(health-care)
patient-preference
utility-measurement
Summary Background: Hereditary angioedema (HAE) is a rare, debilitating, potentially life-threatening condition characterized by recurrent acute attacks of edema of the skin, face/upper airway, and gastrointestinal and urogenital tracts. During a laryngeal attack, people with HAE may be at risk of suffocation, while other attacks are often associated with intense pain, disfigurement, disability, and/or vomiting. The intensity of some symptoms is known only to the person experiencing them. Thus, interview studies are needed to explore such experience and patient-reported outcome measures (PROMs) are required for systematic assessment of symptoms in the clinical setting and in clinical trials of treatments for acute HAE attacks.

Objective: The aim of this interview study was to assess the content validity and suitability of four visual analog scale (VAS) instruments for use in clinical studies. The VAS instruments were designed to assess symptoms at abdominal, oro-facial-pharyngeal-laryngeal, peripheral, and urogenital attack locations. This is the first known study to report qualitative data about the patient's experience of the rare disorder, HAE.

Methods: Semi-structured exploratory and cognitive debriefing interviews were conducted with 27 adults with a confirmed clinical/laboratory diagnosis of HAE (baseline plasma level of functional plasma protein C1 esterase inhibitor [C1INH] <50% of normal without evidence for acquired angioedema). There were 17 participants from the US and 10 from Italy, with mean age 42.5 (SD 14.5) years, range 18–72 years, mean HAE duration 21.3 (SD 14.1) years, range 1–45 years, 67% female, and 44% VAS-naïve. Experience of acute angioedema attacks was first explored, noting spontaneous mentions by participants of HAE symptomatology. Cognitive debriefing of the VAS instruments was undertaken to assess the suitability, comprehensibility, and relevance of the VAS items. Asymptomatic participants completed the VAS instruments relevant to their angioedema experience, reporting as if they were experiencing an acute angioedema attack at the time. Interviews were conducted in the clinic setting in the US and Italy over an 8-month period.

Results: Participants mentioned spontaneously almost all aspects of acute angioedema attacks covered by the four VAS instruments, thus providing strong support for inclusion of nearly all VAS items, with no important symptoms missing. Predominant symptoms found to be associated with acute angioedema attacks were edema and pain, and there was evidence of varying degrees of disruption to everyday activities supporting the inclusion of an overall severity item reflecting the disabling effects of HAE symptoms. VAS item wording was understood by participants.

Conclusion: This interview study explored and reported the patient experience of HAE attacks. It demonstrated the content validity of the four anatomical location HAE VAS instruments and their suitability for use in clinical trials of recombinant human C1INH (rhC1INH) treatment for ascertaining trial participants' assessments of the severity of acute angioedema symptoms.
Language eng
Field of Research 170106 Health, Clinical and Counselling Psychology
Socio Economic Objective 970117 Expanding Knowledge in Psychology and Cognitive Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2012, Adis International
Persistent URL http://hdl.handle.net/10536/DRO/DU:30047384

Document type: Journal Article
Collection: School of Psychology
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Created: Tue, 28 Aug 2012, 15:48:08 EST by Jane Moschetti

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