Patient experience of spontaneous intracranial hypotension (SIH): qualitative interviews for concept elicitation

Journal of Patient-Reported Outcomes

Table 4 Measuring what matters to patients with spontaneous intracranial hypotension (SIH): Recommended concepts to target with Patient-Reported Outcome Measures (PROMs) based on qualitative interviews with patients

Meaningful patient experience identified via qualitative interviews	Outcome of Interest	Existing patient-reported outcome measures (PROMs) that may be useful in measuring the outcome of interest¹
Primary Symptom - pain	Headache pain* (intensity/frequency)	Headache Impact Test (HIT-6); PROMIS Pain Intensity; Numeric Rating Scale; Pain, Enjoyment, General Activity (PEG) Scale Assessing Pain Intensity and Interference
Other symptoms - varied	List of common and uncommon symptoms associated with SIH (presence/absence)	Due to unique nature of SIH, the development of an SIH-specific symptom battery could be considered
Other symptom – fatigue	Fatigue (intensity)	PROMIS Fatigue
Other symptoms – cognitive impairment	Cognitive impairment	PROMIS Cognitive Functioning
Functioning	Pain interference*	Pain, Enjoyment, General Activity (PEG) Scale Assessing Pain Intensity and Interference
Functioning	Physical Functioning*: Impact to daily activities and limits to physical activities/exercise	PROMIS Physical Functioning
Functioning	Social Role Functioning/Participation	PROMIS Ability to Participate in Social Roles and Activities
Headache characteristics	Headache pain characteristics (frequency)²: Improve when lay down, worsen when bent over, worsen when lift heavy objects, worsen as day progresses	The development of SIH-specific items could be considered.

(1) Please note, there are currently no PROMs with validity support for use with patients with SIH. The listed measures are provided as a potential guide for clinicians and researchers, but their appropriateness is tied to any intended context of use and setting. It is generally advised that a minimal amount of cognitive testing and psychometric evaluation be conducted before measures are used with any new patient population. (2) Items could be used to differentiate between SIH headache and headache due to rebound intracranial hypertension. (3) Outcomes that are included in the National Institutes of Health HEAL Common Data Elements for studies evaluating treatment for acute and chronic pain are marked with a *