Composer-Visual Cohort Analysis of Patient Outcomes.

OBJECTIVE: Visual cohort analysis utilizing electronic health record data has become an important tool in clinical assessment of patient outcomes. In this article, we introduce Composer, a visual analysis tool for orthopedic surgeons to compare changes in physical functions of a patient cohort following various spinal procedures. The goal of our project is to help researchers analyze outcomes of procedures and facilitate informed decision-making about treatment options between patient and clinician. METHODS: In collaboration with orthopedic surgeons and researchers, we defined domain-specific user requirements to inform the design. We developed the tool in an iterative process with our collaborators to develop and refine functionality. With Composer, analysts can dynamically define a patient cohort using demographic information, clinical parameters, and events in patient medical histories and then analyze patient-reported outcome scores for the cohort over time, as well as compare it to other cohorts. Using Composer's current iteration, we provide a usage scenario for use of the tool in a clinical setting. CONCLUSION: We have developed a prototype cohort analysis tool to help clinicians assess patient treatment options by analyzing prior cases with similar characteristics. Although Composer was designed using patient data specific to orthopedic research, we believe the tool is generalizable to other healthcare domains. A long-term goal for Composer is to develop the application into a shared decision-making tool that allows translation of comparison and analysis from a clinician-facing interface into visual representations to communicate treatment options to patients.

Physical function computer adaptive test outcomes in diabetic lumbar spine surgical patients.

BACKGROUND CONTEXT: Diabetes is a highly prevalent comorbid condition among patients undergoing spine surgery. Several studies have used legacy patient-reported outcome measures to implicate diabetes as a predictor of increased disability, pain, and decreased physical function and quality of life following spine surgery. The effect of diabetes on postoperative physical function has not yet been studied using the PROMIS Physical Function Computer Adaptive Test (PF CAT). PURPOSE: To understand the effect of diabetes on physical function outcomes among patients undergoing lumbar spine surgery, as reported by the PF CAT. STUDY DESIGN/SETTING: A retrospective cohort study was performed at a single university-based spine clinic. PATIENT SAMPLE: Patients who underwent lumbar spine surgery between October 1, 2013 and April 26, 2018 with both PF CAT and Oswestry Disability Index (ODI) scores available for review. OUTCOME MEASURES: PROMIS PF CAT. Secondary measures of disability included the ODI. METHODS: PF CAT and ODI questionnaires were administered to patients via electronic tablets. Data from these questionnaires were collected prospectively, and retrieved from a university database. Wilcox tests, Exact Wilcox tests, linear regression models, and descriptive analytics were applied. RESULTS: Patients meeting inclusion criteria included 233 nondiabetic patients and 65 diabetic patients. Mean PF CAT scores among diabetics were lower than those of nondiabetics at all time-points from preoperative through 12 months postoperative, with significance found at both 6 months (p=.035) and 12 months (p=.039) postoperative. Mean ODI scores among diabetics were significantly higher than those of nondiabetics at 3 months (p=.018) and 12 months (p=.027) postoperative. By 12 months postoperative, a smaller proportion of diabetics reached PF CAT and ODI minimum clinically important difference thresholds when compared to nondiabetics. CONCLUSIONS: Diabetes is associated with lower PF CAT scores up to one year following lumbar spine surgery. However, many of these patients achieve meaningful improvement in physical function during this time. The PF CAT is consistent with legacy outcome measures in assessing outcomes in diabetic patients undergoing lumbar spine surgery, with an added benefit of decreased patient burden.

Oswestry Disability Index: a psychometric analysis with 1,610 patients.

BACKGROUND: One-fourth of the adult US population has or will experience back pain and has undergone one of a myriad of treatments. Understanding the outcomes of these many treatments from pharmacologic to surgical, from manipulation to modality, allows for a better understanding and value-driven decision making. Patient-reported outcome measures are the current standard and include general and disease-specific measures. The Oswestry Disability Index (ODI) is the most commonly used disease-specific patient-reported outcome tool to measure functional disability related to back pain. Few studies have evaluated its psychometric properties in a large patient sample using a modern tool such as the Rasch analysis model. This study aims to identify the benefits and deficiencies of the ODI as an outcome tool for assessing patients with back pain. PURPOSE: This study aimed to investigate the psychometric properties, performance, and applicability of the ODI in patients with back pain who visited a university-based outpatient clinic. STUDY DESIGN: This study used a secondary analysis-assessment of diagnostic tool on consecutive patients. PATIENT SAMPLE: The sample comprised 1,610 patients visiting an academic spine center. OUTCOME MEASURES: The ODI was the outcome measure. METHODS: Detailed Rasch analysis of the ODI was performed. Standard descriptive statistics were also assessed. RESULTS: The ODI performed well overall. It demonstrated suboptimal unidimensionality (ie, unexplained variance after accounting for the first dimension) of 8.3%. Person reliability was good, at 0.85, and item reliability was excellent, at 1.00. The overall item fit for the ODI was good with an outfit mean square of 1.02. The ODI had a floor effect of 29.9% and ceiling effect of 3.9%. The raw score to measure correlation of the ODI was excellent, at 0.944. CONCLUSIONS: The ODI performed relatively well overall, with some problematic findings. It had good person and item reliability, although it did not demonstrate strong evidence of unidimensionality. The ODI has moderately poor coverage, with a very large floor effect and small ceiling effect, which could present a challenge in interpreting results of scores at the end of the spectrum.

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.

Challenging the norm: further psychometric investigation of the neck disability index.

BACKGROUND CONTEXT: The neck disability index (NDI) was the first patient-reported outcome (PRO) instrument specific to patients with neck pain, and it remains one of the most widely used PROs for the neck population. The NDI is an appealing measure as it is a short and well-known PRO measure. Currently, there are conflicting data on the performance and applicability of the NDI in patients undergoing either operative or nonoperative treatment for neck-related conditions. PURPOSE: This study investigates the psychometric properties, performance, and applicability of the NDI in the spine patient population. STUDY DESIGN: A total of 865 patients visiting a university-based spine clinic with neck complaints, with or without radiating upper extremity pain, numbness, or weakness were enrolled in the study. Visit types included new and follow-up visits to both operative and nonoperative treatments. Questionnaires were administered electronically on a tablet computer, and all patients answered all 10 questions of the NDI. METHODS: Standard descriptive statistics were performed to describe the demographic characteristics of the patients. Rasch modeling was applied to examine the psychometric properties of the NDI. RESULTS: The NDI demonstrated insufficient unidimensionality (ie, unexplained variance after accounting for the first dimension=9.4%). Person reliability was 0.85 and item reliability was 1.00 for the NDI. The overall item fit for the NDI was good with an outfit mean square of 1.03. The NDI had a floor effect of 35.5% and ceiling effect of 4.6%. The raw score to measure correlation of the NDI was 0.019. CONCLUSIONS: Although the NDI had good person and item reliability, it did not demonstrate strong evidence of unidimensionality. The NDI exhibited a very large floor effect. Because of the poor raw score to measure correlation, the sum score should not be used in interpretation of findings. Despite great investment by physicians and other stakeholders in the NDI, this evaluation and previous research have demonstrated that the NDI needs further investigation and refinement.

Clinical predictors of psychological distress in patients presenting for evaluation of a spinal disorder.

BACKGROUND CONTEXT: Psychological distress has been shown to adversely affect the treatment outcomes of many spinal disorders. Most physicians do not routinely use psychological screening questionnaires. Additionally, physicians have not performed well when assessing patients for psychological distress while using clinical impression alone. PURPOSE: The purpose of our study was to evaluate the clinical factors that most accurately predict the presence of psychological distress in patients presenting for the evaluation of a spinal disorder. STUDY DESIGN: This is a retrospective study. PATIENT SAMPLE: Three hundred eighty-eight consecutive patients presented for an initial evaluation of a spinal disorder at a tertiary spine clinic. OUTCOME MEASURES: Oswestry disability index (ODI), visual analog scale (VAS), and distress risk assessment method (DRAM). METHODS: Three hundred eighty-eight consecutive patients presenting for the evaluation of a spinal disorder with a completed DRAM, ODI, and VAS were evaluated. The DRAM was used to classify the patients' level of psychological distress. Clinical variables such as history of depression, use of antidepressants, use of other psychotropic medications, history of surgery, and history of chronic pain syndromes along with ODI and VAS scores were used to develop a model to predict a patient's level of psychological distress. RESULTS: Our model was highly accurate (92%), sensitive (92%), and specific (95%) in predicting a patient's level of psychological distress. If patients' VAS is 4 or 5, their ODI is less than 45, and they are not on any psychotropic medications, they likely will fall into the normal group. Patients with a VAS greater than 7, currently taking antidepressants or other psychotropic medications, an ODI greater than 58, and a history of surgery are likely to fall into the higher distressed categories of distressed depressive or distressed somatic. CONCLUSIONS: A patient's clinical history, ODI, and VAS scores can predict their level of psychological distress. In general, patients with higher VAS pain scores, higher ODI scores (>58), and those taking an antidepressant or another psychotropic medication were likely to have high levels of psychological distress. The predictive clinical factors noted in this study are readily available to most physicians treating spinal disorders and may be helpful in improving their ability to detect patients with psychological distress, counseling them on realistic outcomes, and possibly improve their treatment outcomes.

Psychometric properties of the PROMIS physical function item bank in patients with spinal disorders.

STUDY DESIGN: Patient-reported outcomes provide vital information when assessing effectiveness of clinical care. Yet, most patient-reported outcome instruments are limited by lack of validation and reliability to measure PF adequately. As part of the Patient-Reported Outcomes Measurement Information System (PROMIS), a PF item bank consisting of 124 items has been developed. OBJECTIVE: There is validation evidence for the PROMIS PF item bank in the general orthopedic patient population in general, but has yet to be validated in the patient with spinal disorders. This study aims to evaluate the psychometric properties of the PROMIS PF item bank specifically for patients presenting with spine-related complaints. SUMMARY OF BACKGROUND DATA: Data were collected from adult patients visiting a university spine clinic for back and neck problems. All patients older than 18 years were eligible to participate. A total of 438 patients (49% male) were enrolled in this prospective study. Patients were 18- to 89-year old and presented with back problems (n = 286) and neck problems (n = 152). All patients were administered a 131 item questionnaire. METHODS: Conventional descriptive statistics such as means, standard deviations, and proportions were conducted to examine patient characteristics. A Rasch model was used to examine the psychometric properties of the instrument including dimensionality, floor/ceiling effects, reliabilities, and item bias. RESULTS: Results showed that a single PF dimension was supported by the data (i.e., unexplained variance was 2.9%). The instrument had 1.7% ceiling effect and 0.2% floor effect. Item reliability was 1.00 and person reliability was 0.99. We found evidence of item response bias associated with sex, age, and education in some items. CONCLUSION: The PROMIS PF item bank adequately addressed outcomes of patients with spinal disorders as reliabilities were excellent, minimal ceiling/floor effect existed, and item bias was limited. Future effort should be focused on eliminating, rescaling, or modifying those items that had item bias. LEVEL OF EVIDENCE: 2.

Scoliosis research society-22 results in 3052 healthy adolescents aged 10 to 19 years.

STUDY DESIGN: Cross-sectional survey. OBJECTIVE: The purpose of our study was to evaluate a large population of adolescents from a broad mix of racial/ethnic backgrounds and age groups to better establish baseline normative values for the Scoliosis Research Society-22 (SRS-22). SUMMARY OF BACKGROUND DATA: The SRS-22 instrument was developed to assess treatment outcomes in patients with adolescent idiopathic scoliosis. To accurately assess real changes in outcome measures, the SRS-22 must be able to differentiate patients with and without adolescent idiopathic scoliosis. METHODS: The SRS-22 was administered to 3052 healthy adolescents, 51% female and 49% male, with a mean age of 14.6 years (range, 10-19 yr). We grouped the children into 3 age groups for analysis: 10 to 12 years (362), 13 to 15 years (1487), and 16 to 19 years (1203). Racial/ethnic groups included: Caucasian, 62%; African American, 14%; Hispanic, 9%; Asian, 6%; Native American, 5%; and Pacific Islander, 4%. SRS-22 scores were analyzed to establish normative values for each group. RESULTS: Mean SRS-22 scores were: activity, (4.31 ± 0.54); pain, (4.44 ± 0.67); image, (4.41 ± 0.64); mental, (3.96 ± 0.81); and total, (4.26 ± 0.54). Females had lower scores in the mental domain (3.90) than males (4.04) (P < 0.001). The scores of children aged 10 through 12 years were higher in the domains of activity (P = 0.000), pain (P < 0.001), and mental (P < 0.001) than those of children aged 13 through 15 years and 16 through 19 years. The 13- to 15-year group had significantly higher scores than the 16- to 19-year group (P < 0.001) in each of the same categories. Regarding race/ethnicity, Caucasians tended to report higher scores in most domains than other race/ethnic groups. Hispanics scored lower in all domains than the non-Hispanic group. CONCLUSION: Age, sex, and race had a significant impact on SRS-22 scores in a large group of healthy adolescents. In general, scores lowered as age increased from 10 to 19 years, Caucasians scored higher in function, pain, and image than other racial groups, and Hispanics scored lower than non-Hispanics in all domains. These factors should be considered when evaluating SRS-22 scores.