Table 3.

Summary of Patient-Reported Outcome Instruments of Health-Related Quality of Life to Be Considered for Use in Clinical Trials in AL Amyloidosis

	SF-36v2 Health Survey	PROMIS-29 Profile v2.1
Characteristic of Outcome Measure
Objective	No (patient perception)	No (patient perception)
Clinically Relevant	Yes (as mapped to conceptual model) Select domains predict mortality and healthcare resource utilization; associated with B-type natriuretic peptide (BNP) and hematologic response	Yes (as mapped to conceptual model) Select domains predict mortality and N-terminal pro B-type natriuretic peptide (NT-proBNP) response
Potential Limitations	Does not include coverage of specific aspects of social functioning and mental health that may be important to patients. Does not evaluate sleep.	Does not include coverage of aspects of social functioning and mental health that may be important to patients. Does not have broad coverage of physical functioning, daily activities, and general health.
PRO Instrument Characteristics
Item content	36 items across 8 domains: Physical Functioning (PF), General Health (GH), Role Limitations due to Physical Health (RP), Bodily Pain (BP), Social Functioning (SF), Role Limitations due to Emotional Health (RE), Vitality (VT), Mental Health (MH), and 1 Health Transition item (HT)	28 items across 7 domains: Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and 1 Pain Intensity item
Recall period	Standard recall: Over the past 4 weeks Acute recall: Over the past week No specific recall period for physical function	Over the past 7 days No specific recall period for physical function
Response options	Each item has between 3 and 5 response options	Each item has 5 response options
Scoring	Scores for each domain; 2 summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS) Norm-based scoring, relative to average score of the US general population (mean = 50, standard deviation = 10) Score range (when using norm-based scoring) varies by domain Higher scores indicate better functioning/well-being	Scores for each domain Domains scored relative to the average score of US general population (mean = 50, standard deviation = 10) Score range varies according to domain (raw sum from 4 to 20) Higher scores indicate more of the concept being measured
Time to complete	5–10 minutes	Information not provided by developers
Modes of administration	Paper and pencil, electronic	Paper and pencil, electronic
Available translations	At least 188 (for standard recall)	At least 47