The Relationship of PROMIS Pain Interference and Physical Function Scales.

Objectives: To examine the relationship between the Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference (PI) and PROMIS Physical Function (PF) scales in patients with spinal pain at a university spine center. Design: Retrospective analysis of prospectively collected patient-reported outcome data at a university spine clinic. Pearson correlation was done to examine the relationship of the PROMIS PF and PROMIS PI scores. Age, gender, and race were analyzed by subgroups on the PROMIS Physical Function and Pain Interference score. Linear regression analyzed predictive relationships. Statistical significance was set at P < 0.05. Results: A total of 1,992 participants completed an assessment, with 1,923 completing the PF CAT and 1,927 the PI CAT. Participants' mean age was 52.8 years (range = 18-94 years, SD = 6.5 years). Correlation analysis of the PROMIS PF with the PROMIS PI showed a Pearson correlation value of -0.717 (P < 0.05). There was a strong linear relationship with a high negative correlation between PF CAT and PI CAT. The PI CAT predicted PF CAT scores (ß = -0.707, P < 0.001). Conclusions: For patients with pain from spinal origin, there is a strong negative correlation between self-reported physical function and pain interference related to physical, social, and mental health. The predictive relationship of function from pain scores supports the PROMIS PI being used as an important adjunct measure of physical function in patients with spinal pain.

What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions?

BACKGROUND: As new Patient-Reported Outcomes Measurement Information System (PROMIS) instruments are incorporated into clinical practice, determining how large a change on these instruments represents a clinically relevant difference is important; the metric that describes this is the minimum clinically important difference (MCID). Prior research on MCIDs of the Neck Disability Index (NDI) and Oswestry Disability Index (ODI) has produced values ranging from 5 to 10 points, but these measures have not been presented in relation to MCID values of PROMIS instruments. QUESTIONS/PURPOSES: To establish a comprehensive repository of MCID values calculated both with distribution-based and anchor-based methods for four outcomes instruments in spine care, we asked: (1) What are the MCIDs of the PROMIS Physical Function (PF); (2) the PROMIS Pain Interference (PI); (3) the NDI; and (4) the ODI among spine patients? METHODS: We conducted a prospective study of previously tested diagnostic measures on 1945 consecutive patients with a reference standard applied. All patients aged 18 years and older visiting an orthopaedic spine clinic between October 2013 and January 2017 completed the PROMIS PF and PI, NDI, and ODI on tablet computers before their clinic visits. Patients were grouped by change level (self-report of meaningful change versus slight or no change) using an anchor question in comparison to baseline. Descriptive statistics, two anchor-based MCID values (mean change and receiver operating characteristic curve), and five distribution-based values (SD at 1/2 and 1/3 values and minimum detectable change [MDC] at 90%, 95%, and 99%) were analyzed four different times between 3 months and > 6 months of followup. A total of 1945 included patients with a wide range of spine conditions and varying treatments had a mean age of 58 years (SD = 15.5), were 51% (988 of 1945) male, 90% (1754 of 1945) self-identified as white, and 5% (94 of 1945) as Hispanic with 1% to 2% of patients refusing participation. RESULTS: The PROMIS PF mean change scores in the changed group (much worse, worse, improved, or much improved) ranged between 7 and 8 points. MCID values ranged from 3 to 23 points depending on the method of calculation with a median of 8. For the PROMIS PI, mean change scores ranged from 8 to 9 points and MCID values from 1 to 24 points with a median of 8. For the NDI, mean change scores ranged from 13 to 18 points and MCID values ranged from 6 to 43 points with a median of 18. For the ODI, mean change ranged from 17 to 19 points and MCID values ranged from 7 to 51 points with a median of 24. For each instrument, distribution-based SD yielded the smallest values, followed by anchor-based methods, with MDC yielding the largest MCID values. CONCLUSIONS: This study uses a range of methods for determining MCIDs of the PROMIS PF and PI, NDI, and ODI from anchor-based to distribution-based methods. MCIDs do not have a static value for a given outcome measure, but have a range of values and are dependent on the method calculated. The lowest MCIDs identified for the NDI and ODI are consistent with prior studies, but those at the upper range are much higher. Anchor-based methods are thought to be most relevant in the clinical setting and are more easily understood by clinicians, whereas the distribution-based MCIDs are useful in understanding population breadth. Lower MCID values may be most appropriate for screening purposes or low-risk effects, and the median or higher MCID values should be used for high-risk effects or outcomes. LEVEL OF EVIDENCE: Level I, diagnostic study.

Transthyretin amyloidosis in spinal canal stenosis: A systematic review.

We systematically review literature regarding the contribution of transthyretin amyloidosis to spinal stenosis. Amyloidosis is a protein misfolding condition that causes systemic deposition of amyloid and commonly leads to heart failure and nephropathy. A growing body of literature suggests that amyloid deposits within the ligamentum flavum are frequently associated with spinal stenosis with subsequent myelopathy. Our search identified 67 publications from the PubMed database for literature review. After evaluating the inclusion and exclusion criteria, a total of 18 articles were included in the review. Each article was evaluated for country, study type, sample size, amyloidosis subtype, spinal level, systemic symptoms, treatment, patient outcome, and conclusions. Many studies concluded that lumbar ligamentum flavum hypertrophy is more severe in patients with amyloidosis due to associated amyloid deposition. Additionally, patients with systemic amyloidosis are more likely to have recurrence of spinal stenosis. Multiple studies encourage routine screening be performed on spinal stenosis patients to target those needing cardiac surveillance. Amyloid deposition is frequently associated with spinal stenosis, and its presence may provide an earlier opportunity to diagnose or predict systemic amyloidosis. Surgeons should consider obtaining intraoperative biopsy to identify amyloidosis and inform screening postoperatively. Finally, physicians should be aware of this association and counsel patients accordingly on the risks and treatment options available for amyloidosis.

Hypoalbuminemia as a Predictor of Mortality, Disability, and Readmission in Patients Undergoing Spine Surgery: A Retrospective Analysis.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The objective of this study was to clarify the association between preoperative albumin status and mortality and morbidity in lumbar spine surgery. SUMMARY OF BACKGROUND DATA: Hypoalbuminemia is a known marker of inflammation and is associated with frailty. Hypoalbuminemia is an identified risk factor for mortality following spine surgery for metastases, yet has not been well studied among spine surgical cohorts outside of metastatic cancer. MATERIALS AND METHODS: We identified patients with preoperative serum albumin laboratory values who underwent lumbar spine surgery at a US public university health system between 2014 and 2021. Demographic, comorbidity, and mortality data were collected along with preoperative and postoperative Oswestry Disability Index (ODI) scores. Any cause readmission within 1 year of surgery was recorded. Hypoalbuminemia was defined as <3.5 g/dL in serum. We examined the Kaplan-Meier survival plots based on serum albumin. Multivariable regression models were used to identify the association between preoperative hypoalbuminemia with mortality, readmission, and ODI, while controlling for age, sex, race, ethnicity, procedure, and Charlson Comorbidity Index. RESULTS: Of 2573 patients, 79 were identified as hypoalbuminemic. Hypoalbuminemic patients had a significantly greater adjusted risk of mortality through 1 year (odds ratio=10.2; 95% CI: 3.1-33.5; P <0.001), and 7 years (hazard ratio=4.18; 95% CI: 2.29-7.65; P <0.001). Hypoalbuminemic patients had ODI scores 13.5 points higher (95% CI: 5.7-21.4; P <0.001) at baseline. Adjusted readmission rates were not different between groups through 1 year (odds ratio=1.15; 95% CI: 0.5-2.62; P =0.75) or through full surveillance (hazard ratio=0.82; 95% CI: 0.44-1.54; P =0.54). CONCLUSIONS: Preoperative hypoalbuminemia was strongly associated with postoperative mortality. Hypoalbuminemic patients did not have demonstrably worse outcomes in their functional disability beyond 6 months. Within the first 6 months following surgery, the hypoalbuminemic group improved at a similar rate to the normoalbuminemic group despite having a greater preoperative disability. However, causal inference is limited in this retrospective study.

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders.

BACKGROUND CONTEXT: The Patient-Reported Outcomes Information System (PROMIS) instruments are an important advancement in the use of PROs, but need to be evaluated with longitudinal data to determine whether they are responsive to change in specific clinical populations. PURPOSE: The purpose of this study was to assess the responsiveness of the PROMIS Physical Function (PF), PROMIS Pain Interference (PI), Neck Disability Index (NDI), and the Oswestry Disability Index (ODI). STUDY DESIGN/SETTING: This study entailed prospective data collection from consecutive patients aged 18 and older, visiting a university-based orthopaedic spine clinic between October 2013 and January 2017. PATIENT SAMPLE: A total of 763 participants in the sample had a mean age of 58 (SD = 15) years and the sample was 50.2% male and 92.8% Caucasian. OUTCOME MEASURES: The PROMIS PF and PROMIS PI Computerized Adaptive Tests along with either the NDI or ODI instruments were administered on tablet computers before clinic visits. Global rating of change questions relating to pain and function levels was also administered. METHODS: Baseline scores were compared with follow-up scores at four different time-points from 3-months to 6-months and beyond. Patient demographics, mean scores, paired-sample t tests, Standardized Response Mean (SRM), and Effect Size (ES) were analyzed to determine instrument responsiveness. This project was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number U01AR067138 and the authors have no conflicts of interest to disclose. RESULTS: The PROMIS instruments were strongly correlated with each other as well as with the NDI and ODI. Responsiveness was significant on all four instruments at every time-point assessed (paired sample t tests ranged from p < .001 to p = .049). SRM's were large and over 0.94 for every instrument at every time-point. Cohen's d ES were large and over 0.96 for all at all time-points, except for the NDI which had ES ranging from 0.74 to 0.83. This study showed large effect sizes and responsiveness of the PROMIS PF, PROMIS PI, NDI and ODI in a population of orthopaedic patients with spine pathologies. CONCLUSION: This study demonstrates strong responsiveness of the PROMIS PF and PROMIS PI in a spine clinic population.

Predicting the DRAM mZDI using the PROMIS anxiety and depression.

STUDY DESIGN: Data were collected at a university orthopedic clinic in 2012. The final sample consisted of 316 patients. Sample included new and annual follow-up adult patients for all operative and nonoperative spine care. Outcome measures consisted of the patient-reported outcome measurement information system (PROMIS) anxiety 4-item short form (SF-4), the PROMIS depression SF-4, and the distress and risk assessment method modified Zung Depression Index (mZDI). OBJECTIVE: The objective of this study was to assess whether the PROMIS anxiety 4-item short form (anxiety SF-4) or the PROMIS depression SF-4 (depression SF-4) can be used in place of the distress and risk assessment method mZDI. SUMMARY OF BACKGROUND DATA: Studies comparing the PROMIS short forms with the existing instruments are limited. In particular, there is not any published study comparing the PROMIS anxiety and depression short forms with the distress and risk assessment method mZDI. METHODS: Regression analyses were carried out to predict the mZDI total scores from the PROMIS anxiety SF-4 T scores and the PROMIS depression SF-4 T scores. Intraclass correlation coefficients were computed on the actual and predicted mZDI scores. RESULTS: All 3 instruments were highly correlated with each other. The PROMIS anxiety SF-4 and the PROMIS depression SF-4 were both able to explain a significant amount of variance in the mZDI. The intraclass correlation coefficients for the actual and predicted mZDI scores were high. The actual mZDI scores and predicted mZDI scores using either the PROMIS anxiety SF-4 or the PROMIS depression SF-4 across age and sex were similar. CONCLUSION: This study indicates that the PROMIS anxiety SF-4 scores and the depression SF-4 scores can accurately predict the mZDI scores. The PROMIS anxiety and depression short forms can be used as surrogates for the mZDI. LEVEL OF EVIDENCE: 3.