Date of Award

January 2026

Document Type

Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Samit Shah

Abstract

Background: Ischemic heart disease (IHD) is the leading cause of death for women in the United States and across the world. Ischemia and nonobstructive coronary arteries (INOCA) affects nearly two-thirds of women with IHD and encompasses coronary microvascular disease, coronary vasospasm, and other syndromes that occur in the absence of obstructive coronary artery disease (CAD). Women with INOCA have distinct symptoms and functional impairments from other IHD forms but are under-represented in existing patient-reported outcome measures (PROM).

Methods: Based on a previous concept elicitation study of women with INOCA, we developed a novel PROM with Patient-Reported Outcomes Measurement Information System (PROMIS) items and de novo items for INOCA-specific symptoms using a 7-day recall period. The five sections of the measure consisted of symptoms (12 items), emotional health (6 items), physical function (5 items), social roles (4 items), and overall health (1 item). Semi-structured cognitive debriefing interviews were conducted with women with INOCA to assess measure validity.

Results: 20 women were included (mean age: 53.3 years [range 38-76]; race: White 70%, Hispanic 15%, Black 10%, American Indian or Alaska Native 5%). On a 5-point Likert scale, 17 participants (85%) scored the survey’s ease of completion as 5/5, while 2 participants (10%) rated it 4/5. Items in each domain were found to have high clarity and relevance, including symptom frequency (99% clarity and 92% relevance), symptom severity (97%, 92%), emotional health (100%, 89%), physical function (100%, 92%), social roles (100%, 85%), and overall health (100%, 100%). Based on participant feedback, “squeezing” was added as a descriptor for chest pain. Items that scored worse in relevance were removed, such as two emotional health items, “I felt depressed” and “I felt hopeless”, which were replaced with “I felt sad” and “I felt discouraged about the future,” respectively. Additionally, participants noted a gap in high intensity exercise items, leading to the addition of a “vigorous activities” item. Conclusion: We developed a novel PROM designed to more accurately capture the unique symptoms and functional limitations of women with INOCA. Cognitive debriefing interviews demonstrated consistent clarity and relevance, supporting potential future use for monitoring the severity of disease and response to therapies.

Comments

This thesis is restricted to Yale network users only. It will be made publicly available on 07/14/2027

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