Martin Mona L, Stassek Larissa, Blum Steven I, Joshi Ashish V, Jones David
Health Research Associates, Inc., 6505 216th St. SW, Suite 105, Mountlake Terrace, WA, 98043, USA.
, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.
J Patient Rep Outcomes. 2019 Jan 15;3(1):2. doi: 10.1186/s41687-018-0090-1.
To conduct qualitative interviews to evaluate and refine the Itch Diary (ID) and weekly version of the PBC-40 in patients with itching associated with primary biliary cholangitis (PBC).
Twenty adults with self-reported PBC diagnoses and recent/ongoing itching of at least moderate intensity participated in face-to-face qualitative combined concept elicitation (CE) interviews and cognitive interviews after completing the morning and evening versions of the ID and weekly version of the PBC-40. These questionnaires were evaluated to confirm saturation of concepts of interest and cognitively test the English language versions of the measures in patients with PBC in the US and Canada. Transcripts were organized into descriptions of PBC-related symptoms and symptom-related impacts using a structured coding framework. Two waves of interviews were conducted; revisions made after wave 1 were further tested in wave 2.
Interview results confirmed the relevance of concepts presented in the PBC-40 and ID to patients' experiences. Saturation of concept was achieved. Itching-related signs and symptoms (46%) were the most commonly expressed symptom concept in the CE interviews followed by energy-related (14%) and additional signs/symptoms (13%). Several changes to the ID were made in response to cognitive interview results. Changes to the PBC-40 included adaptations from British to North American English, and the appropriateness of a 7-day recall period was confirmed.
Relevance of the symptom and impact concepts in the ID to measure PBC-related itch were confirmed. Adaptation of the PBC-40 to a weekly recall period and for North American English was successful.
进行定性访谈，以评估和完善原发性胆汁性胆管炎（PBC）患者的瘙痒日记（ID）和PBC-40的每周版本。
20名自我报告患有PBC诊断且近期/正在经历至少中度强度瘙痒的成年人，在完成ID的早晚版本和PBC-40的每周版本后，参加了面对面的定性联合概念激发（CE）访谈和认知访谈。对这些问卷进行评估，以确认感兴趣概念的饱和度，并在美国和加拿大的PBC患者中对这些测量方法的英语版本进行认知测试。使用结构化编码框架将访谈记录整理成与PBC相关症状和症状相关影响的描述。进行了两轮访谈；第一轮后做出的修订在第二轮中进一步测试。
访谈结果证实了PBC-40和ID中呈现的概念与患者经历的相关性。实现了概念的饱和度。在CE访谈中，与瘙痒相关的体征和症状（46%）是最常表达的症状概念，其次是与能量相关的（14%）和其他体征/症状（13%）。根据认知访谈结果对ID进行了几处修改。对PBC-40的修改包括从英式英语改编为北美英语，并确认了7天回忆期的适宜性。
证实了ID中症状和影响概念与测量PBC相关瘙痒的相关性。PBC- 的适应每周回忆期和北美英语改编成功。40
