Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain

Abstract

There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials.

Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 2—The Patient Assessment for Low Back Pain–Impacts (PAL-I)

“…Although many instruments have been developed to assess pain from the patient perspective, a previous search revealed that none was fully compliant with the FDA guidance and none could be used for label claims. 18 In our review of existing instruments, the most common reason for failing to comply with FDA guidance was lack of patient input. Patient input is particularly important for pain assessments, as there are no measurable signs or laboratory tests to estimate or quantify pain severity, and physicians cannot easily or accurately assess the various dimensions of pain.…”

“…A survey of the LBP literature was conducted to identify impact concepts and to review currently available instruments that could be relevant to patients with cLBP. Although many instruments were identified, none was sufficient for use in labeling claims 18 based on FDA guidance. 19 Qualitative methods used to develop the PAL-I included concept elicitation (CE) interviews and cognitive interviews, and the quantitative development was based on administration of the instrument to a large sample population with cLBP.…”

“…Items to be included in the instrument were identified from expert input, a review of existing cLBP PRO instruments, 18 and CE interviews. Draft items were constructed to be at the appropriate reading level using patient-derived language and terminology.…”

“…The U.S. Food and Drug Administration (FDA) has published a guidance for drug sponsors outlining requirements for the development of PRO measures to ensure that they reliably measure the claimed concept in the patient population enrolled in the clinical trial. 19 We conducted a literature search to identify PRO instruments that could be used for a label claim for cLBP and found that most available measures were not developed in accordance with the U.S. FDA guideline, 18 particularly the requirement to demonstrate relevance to the intended patient population. This requires initial qualitative evidences, but these were not found in the published literature for the measures that were evaluated.…”

Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 1—the Patient Assessment for Low Back Pain - Symptoms (PAL-S)

“…16 , 18 We conducted a review of existing instruments that are currently used to collect patient-reported concepts of pain and pain impacts in patients with cLBP. 25 We found that none of the instruments in current use was developed in accordance with the Food and Drug Administration (FDA) PRO guidance 29 and none could be used for label claims of patient-reported improvements in clinical trials.…”