Davis Stacy, Skalicky Anne, Beaudet Amélie, Bayer Bjorn, Kleinman Leah
Janssen Global Services, LLC, Horsham, PA, 19044, USA.
Evidera, Broderick Building 615 2nd Ave, Suite 500, Seattle, WA, 98104, USA.
BMC Pulm Med. 2025 May 6;25(1):217. doi: 10.1186/s12890-025-03681-2.
The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire is a patient-reported outcome measure designed to assess pulmonary arterial hypertension (PAH) symptoms and impacts in clinical trials. It includes recall periods of 24 h for symptoms and 7 days for impacts. The PAH-SYMPACT for use in Clinical Practice (SYMPACT-CP) is an adaptation of the PAH-SYMPACT in which the recall period for symptoms has been revised to 7 days, a timeframe more appropriate for clinical practice settings. The PAH-SYMPACT was psychometrically validated previously. As such, this study focused on assessing whether patients with PAH can use the SYMPACT-CP appropriately to rate their symptoms over the 7-day range, and it explored their perspectives on the utility and feasibility of completing the questionnaire as part of routine clinical assessments.
This was a cross-sectional, noninterventional, qualitative study involving one-on-one telephone interviews with English-speaking adults (≥ 18 years) living in the US diagnosed with PAH. Participants were provided copies of the SYMPACT-CP to review, and interviews were subsequently conducted using a semi-structured guide including concept elicitation and cognitive interviewing sections. Transcripts were coded using a coding framework based on the interview guide.
Fifteen participants were interviewed (mean age, 49.9 years; n = 13 female, n = 13 White). Most (n = 12) stated that they thought about the last 7 calendar days or the "last week" when asked to interpret the 7-day recall period and all but one (n = 14) could easily remember their symptoms over this period. All 15 participants reported that it would be easy to fill out the SYMPACT-CP prior to a clinic visit with their physician or other healthcare provider (HCP), and most (n = 14) felt it would be useful in the management of their disease. Participants felt that breathing difficulties (n = 11), followed by swelling (n = 4), feeling lightheaded, dizzy, or faint (n = 3), and heart palpitations/heart fluttering (n = 3) were the most important symptoms to share with their HCPs.
The SYMPACT-CP is valid to assess symptoms and impacts of PAH in clinical practice. Compared with the PAH-SYMPACT, it provides a consistent 7-day recall period for symptoms and impacts and may improve symptom monitoring and disease management during clinical appointments.
肺动脉高压症状与影响（PAH-SYMPACT）问卷是一种患者报告结局指标，旨在评估临床试验中的肺动脉高压（PAH）症状及影响。它包括症状回顾期为24小时，影响回顾期为7天。用于临床实践的PAH-SYMPACT（SYMPACT-CP）是PAH-SYMPACT的改编版本，其中症状回顾期已修订为7天，这一时间段更适合临床实践环境。PAH-SYMPACT先前已通过心理测量学验证。因此，本研究重点评估PAH患者是否能够恰当地使用SYMPACT-CP对其7天范围内的症状进行评分，并探讨他们对将填写问卷作为常规临床评估一部分的实用性和可行性的看法。
这是一项横断面、非干预性的定性研究，涉及对居住在美国、诊断为PAH的英语成年（≥18岁）患者进行一对一电话访谈。为参与者提供SYMPACT-CP副本以供查阅，随后使用包括概念引出和认知访谈部分的半结构化指南进行访谈。使用基于访谈指南的编码框架对访谈记录进行编码。
共访谈了15名参与者（平均年龄49.9岁；13名女性，13名白人）。大多数人（12名）表示，当被要求解释7天回顾期时，他们想到的是过去7个日历日或“上周”，除一人外（14名）所有人都能轻松记住这期间的症状。所有15名参与者均报告称，在与医生或其他医疗服务提供者（HCP）进行门诊就诊前填写SYMPACT-CP很容易，大多数人（14名）认为这对他们疾病的管理有用。参与者认为呼吸困难（11名）、其次是肿胀（4名）、感到头晕、眩晕或昏厥（3名）以及心悸/心跳过速（3名）是与HCP分享的最重要症状。
SYMPACT-CP在临床实践中可有效评估PAH的症状及影响。与PAH-SYMPACT相比，它为症状及影响提供了一致的7天回顾期，并且可能改善临床预约期间的症状监测和疾病管理。
