Specific Patient-Reported Impairments in Normal Endeavors (SPINE): Creating and Preliminarily Validating a Novel Lumbar Radiculopathy Survey.

Abstract

Lumbar radiculopathy is a common condition that limits patient activity. Current patient-reported outcome measures (PROMs) used to assess patients with lumbar radiculopathy ask mostly ambiguous questions and provide limited information about specific activities. There is no prior study that captures specific activity limitations in patients with lumbar radiculopathy. This information will become increasingly pertinent with advancements in objective functional outcome measurement. To create and validate a novel survey, the Specific Patient-Reported Impairments in Normal Endeavors (SPINE) survey, that captures daily activity limitations in lumbar radiculopathy patients. Phased prospective and initial validation survey study. Patients ≥ 18 years old with lumbar radiculopathy symptoms. Demographics (age, sex, body mass index), legacy PROMs (Oswestry Disability Index, Patient-Reported Outcome Measurement Information System [PROMIS] Global Physical Health, PROMIS Global Physical Health Short Form, PROMIS Global Mental Health Short Form, PROMIS Physical Function Short Form 10a, PROMIS Pain Intensity Short Form 3a, and a general pain survey), and the proposed SPINE survey. In phase one, 50 patients with lumbar radiculopathy were surveyed open-endedly to identify their most limited activities. Following phase one, responses were pooled to identify the movements with the highest prevalence and create a novel survey with 12 items. In phase two, a separate cohort of 50 patients were administered the SPINE survey and scored the prompts from 1 to 5 based on how difficult the activities are to complete. Internal consistency was calculated with Cronbach's α. External validity was assessed with Spearman correlation tests comparing the SPINE survey to well-established PROMs. Spearman tests were also used to correlate patient demographics such as age and body mass index with SPINE scores. Ceiling and floor effects were evaluated by calculating the proportion of the cohort that scored the minimum and maximum possible scores, with under 15% indicating minimal effect. From phase one, the most commonly reported symptom-limited activities in individuals with lumbar radiculopathy were used to develop the SPINE survey. These activities included: 1) sitting, 2) standing, 3) walking, 4) running, 5) bending, 6) lifting, 7) kneeling, 8) squatting, 9) sit-to-stand, 10) stand-to-sit, 11) twisting, and 12) stairs. Internal consistency of the SPINE survey was excellent (Cronbach's α = 0.93). The SPINE survey was successfully externally validated, with increasing SPINE scores associated with scores that represent worse disability in commonly used PROMs (p < 0.05). Age (Rho = 0.07, p = 0.63) and body mass index (Rho = 0.23, p = 0.13) did not influence SPINE scores. No significant floor or ceiling effects were observed, with 0% of the cohort achieving the minimum or maximum scores. Running, squatting, and kneeling were identified as the most limited movements in lumbar radiculopathy patients. This study successfully developed and preliminarily validated a novel survey to identify the specific daily activities that are most limited in lumbar radiculopathy patients. This survey can potentially help inform patient care in conjunction with established PROM instruments. These data can also influence the focus of wearable technology that can objectively measure activities.