Baseline Patient-Reported Outcomes Measurement Information System Research Articles

P103. PROMIS physical health domain scores are related to cervical deformity severity

BACKGROUND CONTEXT Computer adaptive testing is becoming increasingly common in assessing patient outcomes. The Patient Reported Outcome Measurement Information System (PROMIS) instruments of Physical Function, Pain Intensity and Pain Interference have been shown to correlate with established patient outcome metrics. There is a lack of studies investigating the relationship between PROMIS physical health domain metrics and established Ames cervical deformity (CD) radiographic classification. PURPOSE To evaluate the association of available cervical alignment components via the Ames cervical deformity classification parameters with PROMIS physical domains. STUDY DESIGN/SETTING Retrospective review of a single-center stereoradiographic database. PATIENT SAMPLE A total of 208 CD patients with complete baseline radiographic and PROMIS data. OUTCOME MEASURES PROMIS metrics [Pain Intensity (PI), Physical Function (PF), Pain Interference] and Ames CD modifiers [cSVA, TS-CL]. METHODS Surgical CD patients (C2-C7 Cobb angle >10° or C2-C7 sagittal vertical axis >4cm or TS-CL>15°) ≥18 years old with available baseline (BL) radiographic and PROMIS data were isolated in the Spine Quality Database (Quality). Patients were classified according to Ames CD modifiers for cSVA and TS-CL (non-deformed [Non], moderate deformity [Mod], severe deformity [Sev]). Descriptives and univariate analyses compared population-weighted PROMIS scores for PI, PF, and Interference across CD deformity modifiers. Conditional Tree Analysis with logistic regression sampling were performed to determine a possible threshold of PROMIS scores for which the correlation with Ames radiographic cut-offs was most significant. Reported cut off values for Mod (cSVA: 4-8cm; TS-CL: 15-20°) and Sev (cSVA: >8cm; TS-CL: >20°) disability were used. RESULTS A total of 208 pts (58.8yrs, 51%F, 29.6kg/m2, mean Charlson Comorbidity score: 1.19) met inclusion criteria. By surgical approach: 79.3% posterior, 5.7% anterior, 14.9% combined; mean levels fused: 3.7±4.2. Baseline cervical cSVA modifier by severity: 83.2% Non, 16.8% Mod. No patients met criteria for severe cSVA modifier. Baseline TS-CL modifier by severity: 18.8% Non, 22.1% Mod, 59.1% Sev. Mean PI score: 89.6±15.4, mean PF score: 11.9±13.1, mean Int score: 56.9±6.8. PI did not differ between cSVA or TS-CL modifier severity. Mod cSVA patients and Mod/Sev TS-CL modifier groups both trended towards lower PF scores and higher pain interference scores though this was not significant (P>0.05). Conditional tree analysis determined thresholds for PROMIS scores that were independent predictors of modifier severity. A PI score>96(OR: 0.658[0.303-1.430]), a PF score 57.4 (OR: 1.712[0.811-3.616]) were predictors of Mod cSVA. A PI score of >87(OR: 1.428[0.767-2.659]), a PF score 56.3 (OR:1.656[0.946-2.897]) were predictors of Sev TS-CL. CONCLUSIONS PROMIS physical health domain metrics of Pain Intensity, Physical Function, and Pain Interference were related to cervical malalignment parameters of the Ames cervical deformity classifications system. Certain baseline PROMIS thresholds can be connected to severity of cervical deformity. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Smartphone-based migraine behavioral therapy: a single-arm study with assessment of mental health predictors

Progressive muscle relaxation (PMR) is an under-utilized Level A evidence-based treatment for migraine prevention. We studied the feasibility and acceptability of smartphone application (app)-based PMR for migraine in a neurology setting, explored whether app-based PMR might reduce headache (HA) days, and examined potential predictors of app and/or PMR use. In this single-arm pilot study, adults with ICHD3 migraine, 4+ HA days/month, a smartphone, and no prior behavioral migraine therapy in the past year were asked to complete a daily HA diary and do PMR for 20 min/day for 90 days. Outcomes were: adherence to PMR (no. and duration of audio plays) and frequency of diary use. Predictors in the models were baseline demographics, HA-specific variables, baseline PROMIS (patient-reported outcomes measurement information system) depression and anxiety scores, presence of overlapping pain conditions studied and app satisfaction scores at time of enrollment. Fifty-one patients enrolled (94% female). Mean age was 39 ± 13 years. The majority (63%) had severe migraine disability at baseline (MIDAS). PMR was played 22 ± 21 days on average. Mean/session duration was 11 ± 7 min. About half (47%) of uses were 1+ time/week and 35% of uses were 2+ times/week. There was a decline in use/week. On average, high users (PMR 2+ days/week in the first month) had 4 fewer days of reported HAs in month 2 vs. month 1, whereas low PMR users (PMR < 2 days/week in the first month) had only 2 fewer HA days in month 2. PROMIS depression score was negatively associated with the log odds of using the diary at least once (vs. no activity) in a week (OR = 0.70, 95% CI = [0.55, 0.85]) and of doing the PMR at least once in a week (OR = 0.77, 95% CI = [0.68, 0.91]). PROMIS anxiety was positively associated with using the diary at least once every week (OR = 1.33, 95% CI = [1.09, 1.73]) and with doing the PMR at least once every week (OR = 1.14 [95% CI = [1.02, 1.31]). In conclusion, about half of participants used smartphone-based PMR intervention based upon a brief, initial introduction to the app. App use was associated with reduction in HA days. Higher depression scores were negatively associated with diary and PMR use, whereas higher anxiety scores were positively associated.