Chandler Dale, Abramoff Benjamin, Bramson Candace, Cappelleri Joseph C, Chohan Aishwarya, Harrington Magdalena, Jamal Hiba, Lusk Jillian, Mazar Iyar, Paredes Roger, Tatlock Sophi, Ustianowski Andrew, Weinstein Edward, Mokgokong Ruth
Patient-Centered Outcomes, Adelphi Values Ltd, Bollington, UK.
University of Pennsylvania, Philadelphia, USA.
J Patient Rep Outcomes. 2025 Aug 20;9(1):105. doi: 10.1186/s41687-025-00942-w.
Post-acute sequelae of COVID-19 (PASC) or Long COVID is a post-viral complication of SARS-CoV-2 infection, causing ongoing symptoms and impaired function over a prolonged period of time. There is limited understanding of how the signs and symptoms of Long COVID/PASC affect patients' lives and how to measure them, which is essential when developing care strategies. This study aimed to develop and evaluate the content validity for a novel patient-reported outcome (PRO) instrument in Long COVID/PASC through qualitative research, which was informed by the patient experience of Long COVID/PASC and both patient and clinician input.
A review of literature and PRO instruments developed for Long COVID/PASC identified measurement gaps for the context of use (i.e., weekly assessment of signs/symptoms in clinical trial research). This informed the development of the preliminary Long COVID/PASC PRO instrument, which was tested via patient interviews (combined concept elicitation and cognitive debriefing) to align with regulatory standards, and discussions with clinical experts were conducted to provide clinical insights. The final instrument was modified based on this input to further promote its content validity.
Thirty participants were interviewed about their Long COVID/PASC experiences. Participants most frequently reported experiencing tiredness after physical activity (n = 29/30; 97%), general tiredness (n = 28/30; 93%), shortness of breath (n = 25/30; 83%), cough (n = 23/30; 77%) and muscle/body aches (n = 23/30; 77%). All participants reported that Long COVID/PASC had an impact on their health-related quality of life. Almost all (n = 27/28; 96%) sign/symptom concepts were reported in the first three sets of interviews suggesting conceptual saturation was achieved. Items, response options and the recall period of the preliminary Long COVID/PASC PRO instrument were understood as intended (≥ 90%) and relevant to most participants across both rounds (≥ 47%). Modifications were made to the instrument following patient input, resulting in the 18-item Long COVID/PASC instrument. Clinician input (n = 3) corroborated participant interview results, supporting the content validity of the Long COVID/PASC PRO instrument.
The Long COVID/PASC PRO instrument has been developed in line with regulatory standards and the qualitative evidence demonstrated strong content validity in a Long COVID/PASC population. Research to evaluate psychometric properties will provide further evidence of the instrument's measurement properties.
2019冠状病毒病急性后遗症（PASC）或“长新冠”是一种由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染引起的病毒后并发症，会在较长时间内导致持续症状和功能受损。对于“长新冠”/PASC的体征和症状如何影响患者生活以及如何进行测量，人们了解有限，而这在制定护理策略时至关重要。本研究旨在通过定性研究，开发并评估一种用于“长新冠”/PASC的新型患者报告结局（PRO）工具的内容效度，该研究以“长新冠”/PASC患者的经历以及患者和临床医生的意见为依据。
对为“长新冠”/PASC开发的文献和PRO工具进行回顾，确定了使用背景下的测量差距（即临床试验研究中对体征/症状的每周评估）。这为初步的“长新冠”/PASC PRO工具的开发提供了依据，该工具通过患者访谈（结合概念引出和认知反馈）进行测试以符合监管标准，并与临床专家进行讨论以提供临床见解。根据这些意见对最终工具进行修改，以进一步提高其内容效度。
对30名参与者进行了关于他们“长新冠”/PASC经历的访谈。参与者最常报告在体育活动后感到疲倦（n = 29/30；97%）、全身疲倦（n = 28/30；93%）、呼吸急促（n = 25/30；83%）、咳嗽（n = 23/30；77%）和肌肉/身体疼痛（n = 23/30；77%）。所有参与者均报告“长新冠”/PASC对他们的健康相关生活质量有影响。几乎所有（n = 27/28；96%）的体征/症状概念在前三轮访谈中均有报告，表明达到了概念饱和。初步的“长新冠”/PASC PRO工具的条目、回答选项和回忆期按预期被理解（≥90%），并且在两轮中与大多数参与者相关（≥47%）。根据患者意见对工具进行了修改，形成了18项的“长新冠”/PASC工具。临床医生的意见（n = 3）证实了参与者访谈结果，支持了“长新冠/PASC PRO工具的内容效度。
“长新冠”/PASC PRO工具已按照监管标准开发，定性证据表明其在长新冠/PASC人群中具有很强的内容效度。评估心理测量特性的研究将为该工具的测量特性提供进一步证据。
