PROMs for Systemic Lupus Erythematosus

Abstract

Patients with active Systemic Lupus Erythematosus (SLE) experience a large variation of symptoms and manifestations. The symptoms and manifestations of SLE impact the patients’ health-related quality of life (HRQoL). Many of the patients’ SLE symptoms are not always adequately captured by objective clinical outcome measures or laboratory assessments alone. Therefore in addition to well-established clinical outcome measures used in clinical practice, the patient perspective should be captured through patient reported outcome measures (PROMs). Key concepts/domains derived from a recently developed conceptual model published by Holloway et al. (Qual Life Outcomes. 2014;12:116) are the basis for the recommendations of PROMs. Recommendations for PROMs to apply in clinical practice are based on the face and content validity as well as psychometric properties of each of the PROMs. In the conceptual model, fatigue, pain, and emotional well-being/depression were identified as key domains impacting the lives of patients with SLE. Appropriate PROMs to use in clinical practice capturing the key domains are the Functional Assessment of Chronic Illness Therapy—Fatigue scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF), and Hospital Anxiety and Depression Scale (HADS). In addition the generic HRQoL measure Short Form (36 item) Health Survey version 2 (SF-36v2) and the disease-specific HRQoL measure LupusQoL can be applied in clinical practice. It might be favorable in standard clinical practice to consider including one cohesive PROM for the assessment of patient reported key symptoms and impacts in SLE, however, further research and validation studies are needed. PROMs capturing key symptoms of SLE such as fatigue, pain, and HRQoL supplement objective clinical outcome measures and laboratory assessments providing clinicians with a valuable patient perspective on the impact of SLE.

Appendices

Appendix 1: FACIT-Fatigue is presented with permission from the copyright holder. Potential users

Potential users should go to http://www.facit.org/FACITOrg and contact copyright holder for permission before using FACIT-Fatigue in studies and clinical practice.

FACIT Fatigue Scale (Version 4)

Below is a list of statements that other people with your illness have said are important. Please circle or mark one number per line to indicate your response as it applies to the past 7 days.

		Not at all	A little bit	Some-what	Quite a bit	Very much
HI7	I feel fatigued	0	1	2	3	4
HI12	I feel weak all over	0	1	2	3	4
An1	I feel listless (washed out)	0	1	2	3	4
An2	I feel tired	0	1	2	3	4
An3	I have trouble starting things because I am tired	0	1	2	3	4
An4	I have trouble finishing things because I am tired	0	1	2	3	4
An5	I have energy	0	1	2	3	4
An7	I am able to do my usual activities	0	1	2	3	4
An8	I need to sleep during the day	0	1	2	3	4
An12	I am too tired to eat	0	1	2	3	4
An14	I need help doing my usual activities	0	1	2	3	4
An15	I am frustrated by being too tired to do the things I want to do	0	1	2	3	4
An16	I have to limit my social activity because I am tired	0	1	2	3	4

Appendix 2: Brief Pain Inventory—Short Form

BPI-SF is presented with permission from the copyright holder. Potential users should go to www.mdanderson.org/departments/prg and contact copyright holder for permission before using BPI-SF in studies and clinical practice.

Appendix 3: LupusQoL

LupusQoL is presented with permission from the copyright holders. Anyone running a commercially funded study must obtain a license for the LupusQoL and pay the license fee. Use is free for noncommercially funded studies but copyright holders requires that researchers contact the licensors for permission before using to ensure that researchers use the professionally developed and validated translations only.

Potential users should go to www.lupusqol.com for more information on using LupusQoL in studies and clinical practice.

Appendix 4: Multidimensional Questionnaire for Patient Reported Outcome Measures—SLE