While studies support the notion that MSC therapy has a positive effect on OA patients, there is limited high quality evidence and long-term follow-up. The present study summarizes the specifics of high level evidence studies and identifies a lack of consistency, including a diversity of MSC preparations, and thus a lack of reproducibility amongst these articles' methods.

3.

OBJECTIVEThe Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly popular due to computer adaptive testing methodology. This study aims to validate the association between PROMIS and legacy outcome metrics and compare PROMIS to legacy metrics in terms of ceiling and floor effects and questionnaire burden.METHODSA retrospective review of an outcomes database was performed at a single institution from December 2016 to April 2017. Inclusion criteria were age > 18 years and a chief complaint of back pain or neck pain. The PROMIS computer adaptive testing Pain Interference, Physical Function (PF), and Pain Intensity domains; Oswestry Disability Index (ODI); Neck Disability Index (NDI); and visual analog scale (VAS) back, VAS leg, VAS neck, and VAS arm were completed in random order. PROMIS was compared to legacy metrics in terms of the average number of questions needed to complete each questionnaire and the score distributions in the lower and higher bounds of scores.RESULTSA total of 494 patients with back pain and 130 patients with neck pain were included. For back pain, ODI showed a strong correlation with PROMIS-PF (R = −0.749, p < 0.001), Pain Intensity (R = 0.709, p < 0.001), and Pain Interference (R = 0.790, p < 0.001) domains. Additionally, the PROMIS Pain Intensity domain correlated to both VAS back and neck pain (R = 0.642, p < 0.001 for both). PROMIS-PF took significantly fewer questions to complete compared to the ODI (4.123 vs 9.906, p < 0.001). When assessing for instrument sensitivity, neither survey presented a significant ceiling and floor effect in the back pain population (ODI: 0.40% and 2.63%; PROMIS-PF: 0.60% and 1.41%). In the neck pain cohort, NDI showed a strong correlation with PROMIS-PF (R = 0.771, p < 0.001). Additionally, PROMIS Pain Intensity correlated to VAS neck (R = 0.642, p < 0.001). The mean number of questions required to complete the questionnaire was much lower for PROMIS-PF compared to NDI (4.417 vs 10, p < 0.001). There were no significant differences found in terms of ceiling and floor effects for neck complaints (NDI: 2.3% and 6.92%; PROMIS-PF: 0.00% and 5.38%) or back complaints (ODI: 0.40% and 2.63%; PROMIS-PF: 1.41% and 0.60%).CONCLUSIONSPROMIS correlates strongly with traditional disability measures in patients with back pain and neck pain. For both back and neck pain, the PROMIS-PF required patients to answer significantly fewer questions to achieve similar granularity. There were no significant differences in ceiling and floor effects for NDI or ODI when compared with the PROMIS-PF instrument.

Study Design. Retrospective cohort study. Objective. To evaluate the ability of patient reported outcome measurement information system (PROMIS) assessments to capture disability related to cervical sagittal alignment and secondarily to compare these findings to legacy outcome measures. Summary of Background Data. PROMIS is a validated patient-reported outcome metric that is increasing in popularity due to its speed of administration relative to legacy metrics. The ability of PROMIS to capture disability from sagittal alignment and baseline health status in patients with neck pain has not been investigated. Methods. Patients presenting with a chief complaint of neck pain from December 2016 to July 2017 were included. Demographics and comorbidities were retrospectively collected. All patients prospectively completed the neck disability index (NDI), EQ-5D, visual analog scale (VAS) neck, VAS arm, PROMIS physical function, PROMIS pain intensity, and PROMIS pain interference metrics. Cervical sagittal alignment parameters were measured on standing X-rays. The correlations between outcome measures, health status indexes, psychiatric diagnoses, and sagittal alignment were analyzed. Results. Two hundred twenty-six patients were included. The sample was 58.4% female with a mean age of 55.1 years. In patients with neck pain, PROMIS physical function correlated strongly with the NDI (r = −0.763, P < 0.01), EQ-5D (r = 0.616, P < 0.01), VAS neck pain (−0.466, P < 0.01), and VAS arm pain (r = −0.388, P < 0.01). One hundred seventy-seven patients (69.96%) were included in the radiographic analysis. 20.3% of the radiographic cohort had cervical deformity and in this group, less cervical lordosis correlated with PROMIS pain intensity and EQ-5D but not NDI. In patients without cervical deformity, no outcome metric was found to correlate significantly with cervical alignment parameters. Conclusion. PROMIS domains correlated strongly with legacy outcome metrics. For the whole cohort, sagittal alignment was not correlated with outcomes. In patients with sagittal cervical deformity, worsening alignment correlated with PROMIS pain intensity and EQ-5D but not NDI. Level of Evidence: 3

Study Design: This was a single-center retrospective review. Objectives: To explore how age and gender affect PROMIS scores compared with traditional health-related quality of life (HRQL) in spine patients. Methods: Patients presenting with a primary complaint of back pain (BP) or neck pain (NP) were included. Legacy HRQLs were Oswestry Disability Index (ODI), Neck Disability Index (NDI), and Visual Analogue Scale (VAS). PROMIS Physical Function (PF), Pain Intensity (Int), and Pain Interference (Inf) were also administered to patients in a clinical setting. Patients were grouped by chief complaint, age (18-44, 45-64, 65+ years) and gender. Two parallel analyses were conducted to identify the effects of age and gender on patient-reported outcomes. Age groups were compared after propensity-score matching by VAS-pain and gender. Separately, genders were compared after propensity-score matching by age and VAS-pain. Results: A total of 484 BP and 128 NP patients were matched into gender cohorts (n = 201 in each BP group, 46 in each NP group). Among BP patients, female patients demonstrated worse disability by ODI (44.15 vs 38.45, P = .005); PROMIS-PF did not differ by gender. Among NP patients, neither legacy HRQLs nor PROMIS differed by gender when controlling for NP and age. BP and NP patients were matched into age cohorts (n = 135 in each BP group and n = 14 in each BP group). Among BP patients, ANOVA revealed differences between groups when controlling for BP and gender: ODI ( P < .001), PROMIS-PF ( P = .018), PROMIS-Int ( P < .001) PROMIS-Inf ( P < .001). Among NP patients, matched age groups differed significantly in terms of NDI ( P = .032) and PROMIS-PF ( P = .022) but not PROMIS-Int or PROMIS-Inf. Conclusions: Age and gender confound traditional HRQLs as well as PROMIS domains. However, PROMIS offers age and gender-specific scores, which traditional HRQLs lack.

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