Based on the comparatively unique presentation of hidradenitis suppurativa (HS) and its known psychological impacts, an international team has developed a HS-specific quality of life (QoL) measure.
Part of the rationale for developing this measure is that research into development of new treatments of HS will require measures of improvement that address patient-reported outcomes, rather than just clinical outcomes, senior author Dr. Jerry Tan told DERM.city.
The typical location of HS (on hidden parts of the body), the chronic and episodic pain and drainage of nodules and sinuses, and the social and functional effects associated with HS make more general dermatology QoL measures unsuitable for the condition, he said.
Dr. Tan is a dermatologist in practice in Windsor, Ont., and an adjunct professor in the Schulich School of Medicine and Surgery, Western University in London, Ont.
Unique condition
“We hope the measure will be used as an accurate and responsive measure for efficacy of interventions in clinical trials,” said Dr. Tan. “That includes symptoms, issues of embarrassment, socialization, self-care, and emotional responsivity.”
From a clinical perspective, Dr. Tan and his colleagues hope the new measure will practically inform doctors about what bothers patients, so that attending physicians can accurately address what is of greatest concern to their patients, he said.
Patient interviews conducted
Development of the new measure, published in the Journal of Cutaneous Medicine and Surgery (2017; 21(2):152–155), began with a literature review of HS outcomes, input from clinical experts, and HS patient concept elicitation interviews. By chance, a U.S. researcher was interviewing HS patients at the same time Dr. Tan and colleagues were planning to start concept elicitation.
“We were at a juncture, then, that serendipitously led us to meet with [paper author] Joslyn Kirby from Penn State, who had undertaken very detailed interviews with HS patients in Hershey, Pennsylvania,” said Dr. Tan. Dr. Kirby is an assistant professor in the College of Medicine, Department of Dermatology, Penn State University, Philadelphia.
There were 21 participating patients in the Penn State group. From the concept elicitation interviews, 12 themes were developed. These included: impacts of HS on daily activities; symptoms due to HS; emotional consequences; psychosocial consequences; restricted clothing choices; coping; sexual functioning; work or economic consequences; interactions with medical personnel; social support; symptoms due to treatment; and concentration issues at work or at leisure activities.
Concepts from those initial interviews and the literature review were used to generate a first version of the HS quality of life measure, HS-QoL-v1.
Pilot test of first version
“From there we went on to do phase 2, which was pilot testing with cognitive interviews,” said Dr. Tan. These interviews were conducted in patients recruited from his Windsor practice.
“We went through a couple of themes, including questions about whether [the QoL measure] was adequately thorough, whether any themes were missing, were the themes relevant, were the symptoms relevant, and were any other issues missing?”
Five specific issues were identified by the participants of the HS-QoL-v1 phase 2 cognitive interviews: a lack of knowledge of health professionals to diagnose HS; concern that a 30-day reference time frame for the questions was too short; one item on the HS QoL-v1 measure was unclear; three items on the measure were considered irrelevant; and two themes were considered missing which should be included in the measure.
The findings from phase 1 and phase 2 were used to develop a revised 53-item questionnaire, the HS-QoL-v2, which is suitable for use in patients with HS.
The HS-QoL-v2 “is currently undergoing more pilot testing and validation studies in a number of centres across the world,” Dr. Tan said. These include Penn State, and sites in Toronto, the U.K., and Singapore.
Having a diversity of test sites is intended to allow for a test population as thoroughly representative as possible, he said.
Findings from these pilots will be used to further refine the questionnaire, and to produce specialized versions. “We expect to go from 53 [questions] to probably half that for clinical trials, and then down to no more than one-quarter of that for clinical practice,” said Dr. Tan.
Having a specific QoL measure for HS should also convey to patients that doctors take HS seriously and do not lump the condition in with every other skin condition that exists, Dr. Tan said. That “we acknowledge that HS is unique and has features that are not easily transferable from other types of surveys and questionnaires.”
Dr. Tan said that it is important to see an international, collaborative project like this.
“There are multiple researchers who are doing this because they want to help patients,” he said. The HS-QoL project received no industry funding, he said, and is driven solely by the passion of the investigators trying to accomplish something they think is important.
Originally published in The Chronicle of Skin & Allergy (Sept. 2017; 23(6):1,16).