PROMIS Physical Health Research Articles

Mid-term outcomes of a kinematically designed cruciate retaining total knee arthroplasty.

Advances in implant material and design have allowed for improvements in total knee arthroplasty (TKA) outcomes. A cruciate retaining (CR) TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament. Limited research exists that has examined clinical outcomes or patient reported outcome measures (PROMs) of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant. It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores. To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design. A retrospective, multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System (JOURNEY™ II CR; Smith and Nephew, Inc., Memphis, TN) at an urban, academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon. Patient demographics, surgical information, clinical outcomes, and PROMs data were collected via query of electronic medical records. The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) and Patient-Reported Outcomes Measurement Information System (PROMIS®) scores. The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests. Of the 255 patients, 65.5% were female, 43.8% were White, and patients had an average age of 60.6 years. Primary osteoarthritis (96.9%) was the most common primary diagnosis. The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home (92.5%). There were 18 emergency department (ED) visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%, including a 2.4% orthopedic-related ED visit rate and a 4.7% non-orthopedic-related ED visit rate. There were three (1.2%) hospital readmissions within 90 d postoperatively. With a mean time to latest follow-up of 3.3 years, four patients (1.6%) required revision, two for arthrofibrosis, one for aseptic femoral loosening, and one for peri-prosthetic joint infection. There were significant improvements in KOOS JR, PROMIS Pain Intensity, PROMIS Pain Interference, PROMIS Mobility, and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores. The evaluated implant is an effective, novel design offering excellent outcomes and low complication rates. At a mean follow up of 3.3 years, four patients required revisions, three aseptic and one septic, resulting in an overall implant survival rate of 98.4% and an aseptic survival rate of 98.8%. The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.

Achievement of One-Year MCID Varies with Preoperative Function of Patients Undergoing Total Hip Arthroplasty

AbstractThe minimum clinically important difference (MCID) of an orthopaedic outcome measure is commonly used to assess treatment success including for patients undergoing total hip arthroplasty (THA). Various patient factors may contribute to MCID values in patients undergoing THA. The purpose of this study was to calculate the 1-year MCID for the Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) based on patient factors and evaluate if there were any differences between each cohort's MCID.A patient-reported outcome measure (PROM) database was reviewed for patients undergoing THA from 2017 to 2018. Patients were included that underwent primary THA and completed baseline and 1-year follow-up for Patient-Reported Outcome Measurement Information System 10-item global health form (PROMIS10) and HOOS-JR surveys. MCID was calculated using the distribution method and an anchor-based method that used the PROMIS10 Physical Health item. Differences in MCID were assessed between patient cohorts stratified by preoperative characteristics.For the 523 patients that underwent THA, the average 1-year HOOS-JR MCID values were 33.9 ± 16.3 (men), 37.0 ± 13.9 (women), 38.1 ± 17.1 (diagnosis of mental health), and 35.0 ± 14.6 (no diagnosis). MCID values were not significantly different between groups according to sex (p = 0.186) or mental health status (p = 0.302). MCID value did not correlate with body mass index (β = –0.126). MCID achievement had a notable inverse relationship with preoperative HOOS-JR.This study demonstrated that preoperative function of patients undergoing THA affects the ability to achieve HOOS-JR 1-year MCID. Future investigation is necessary to clarify which patient factors may affect MCID.

Fusion Rates in Tibiotalocalcaneal Arthrodesis with Tantalum Coated Metal Cup Augmentation

Category: Ankle Arthritis; Ankle Introduction/Purpose: Tantalum coated metal spacers (TCMS) have recently been utilized to fill and provide structure to large bony defects in the hindfoot. TCMS have a porous structure and elastic modulus similar to cancellous bone, increasing resistance to collapse, as well as osteoconductive properties that allow for bony ingrowth. At this time, there is still a paucity of literature assessing the use and outcomes of TCMS in foot and ankle surgery, more specifically as bridging structures for large bony defects when performing tibiotalocalcaneal (TTC) arthrodesis. This study serves to assess clinical outcomes and fusion rates of patients who underwent TTC arthrodesis utilizing intramedullary nailing with tantalum coated metal cup augmentation for large bony defects. Methods: We retrospectively reviewed the charts of 20 patients who underwent TTC fusion with TCMS augmentation at our local tertiary care center between 2015-2021. The CT scans at the six-month post-operative window were reviewed by one orthopaedic surgeon to determine the presence of bony fusion, which was defined as having at least 50% fusion mass. From the initial cohort, we collected the following modified foot function index scores for 13 patients: PROMIS Physical Health (0-20), PROMIS Mental health (0-20), Foot Function Index (0-170), Activity Limitation Scale (0-30), Pain Scale (0-50) and Disability Scale (0-90). Results: The mean age of our cohort was 53.9 (± 12.9) with a mean CCI of 1.54 (± 1.127) and mean follow up of 451.5 days (± 353.3). Mean modified foot function index scores included: PROMIS Physical Health 12.15 (± 3.34), PROMIS Mental health 12.23 (± 4.82), Foot Function Index 91.08 (± 47.59), Activity Limitation Scale 15.00 (± 10.42), Pain Scale 25.00 (± 14.77) and Disability Scale 51.00 (± 25.06). The post-operative complication rate was 30.8% in which 3 patients required a revision surgery via nail dynamization and one patient required a below knee amputation due to an infected nonunion of the TTC arthrodesis. The overall fusion rate at the 6-month postoperative visit was 69.2%. Conclusion: Unlike prior studies, we were able to obtain 6-month post-operative CT scans to delineate successful fusions with a larger number of patients (n=13). Given the paucity of literature looking at TCMS augmented fusions in foot and ankle surgery, our data will contribute to our understanding and efficaciousness of this relatively new use of TCMS in foot and ankle surgery. Further studies are needed to evaluate the efficacy of TCMS augmented fusions as a viable surgical approach as well an alternative to standard nail dynamizations with structural grafts.

Obesity and Ankle Fractures: Are Outcomes and Complications Really Worse?

Category: Ankle; Trauma Introduction/Purpose: Existing literature has established that obese patients have nearly double the risk of sustaining an ankle fracture when compared to a non-obese population. However, few studies have investigated obesity’s effect on fracture complications and patient reported outcomes (PROs) when patients are stratified by fracture type. Furthermore, as the average body mass index (BMI) of our population steadily rises, it becomes prudent to investigate variations in complications rates and patient reported outcomes in various stages of obesity. The aim of this study is to identify trends in complication rates and patient reported outcome scores among patients of different BMI before and after dividing by fracture complexity. Methods: We retrospectively assessed clinical and surgical data from 595 patients who underwent ankle fracture surgery at a single institution between 2017 and 2021 for surgical related complications. All patients had a minimum of 18 months follow up (mean-42.2 [18.2-71.4] months). PROMIS Physical Health and Visual Analog Scale pain scores surveys were available only for patients receiving surgery after November 2019. We aggregated survey data for timepoints between three months and two years post-operatively to assess only patients with meaningful clinical data in regard to their recovery. Patients were divided based on BMI and fracture type. BMI subgroups were classified as: Non-obese (18.5-24.9 kg/m2, n=88), Overweight/Obese I (25-34.9 kg/m2, n=314), Obese II/III (≥35 kg/m2, n=192). Fracture subgroups were divided into two groups: Simple (Unimalleolar types) and complex (Bimalleolar and Trimalleolar variants). Data analysis was performed using Chi-Square and T-Tests with statistical significance set at an alpha (α) of ≤ 0.05. Results: We observed a whole cohort complication rate of (15.3%, n=91/594). Complication rates when stratified by BMI were: Non-obese (12.3%, n=9), Overweight/Obese class I (19.4%, n=61), Obese class II/III (10.3%, n=20). Complication rates for Overweight/Obese I patients were significantly higher when compared to Non-obese patients (p=0.044, OR=2.11). However, there was no significant difference when comparing Non-obese to Class II/III (p=0.972). We observed no significant differences in complications when performing a sub analysis on specific fracture types, regardless of BMI group. Pain scores were significantly higher in both Overweight/Obese I and Obese II/III groups when compared to Non-Obese patients (p= < 0.001, p=0.015). Physical health scores were significantly lower only in the Obese II/III group when compared to Non-Obese patients (p=0.011). Conclusion: Our results indicate that patients who are Overweight/Obese I have a significantly higher risk of complication when compared to patients of normal BMI. Surprisingly, our cohort demonstrated nearly equivalent risk between Obese II/III and Non- obese patient groups. Patient reported outcome data shows different trends with worse pain scores and lower physical health outcomes in the Obese II/III group. These findings add to the growing debate surrounding obesity’s effect on ankle fracture complication rates as well as patient reported outcomes and suggest that increased BMI cannot be viewed purely as a one-to-one relationship with negative outcomes.

Adapting natural language processing and sentiment analysis methods for an intervention in older adults: Positive perceptions of health and technology.

Older adults frequently participate in behavior change studies, yet it is not clear how to quantify a potential relationship between their perception of the intervention and its efficacy. We assessed the relationship between participant sentiment toward the intervention from follow-up interviews with physical activity and questionnaires for the perception of health. Sentiment was calculated using the transcripts of exit interviews through a bag of words approach defined as the sum of positive and negative words in 28 older adults with obesity (body mass index ≥30kg/m2). Mean age was 73 years (82% female), and 54% lost ≥5% weight loss. Through linear regression we describe a significant association between positive sentiment about the intervention and weight loss; positive sentiment on technology and change in PROMIS-10 physical health and reduced physical activity time, while controlling for sex and age. This analysis demonstrates that sentiment analysis and natural language processing in program review identified an association between perception and topics with clinical outcomes.

Abstract PD8-05: Effectiveness of Electroacupuncture Versus Auricular Acupuncture in Reducing Pain and Improving Quality of Life in Breast Cancer Survivors with Chronic Musculoskeletal Pain

Abstract Introduction: Chronic musculoskeletal pain is common and debilitating among breast cancer survivors. Recently, the Personalized Electroacupuncture (EA) versus Auricular Acupuncture (AA) Comparative Effectiveness (PEACE) trial demonstrated that both acupuncture methods reduced pain more than usual care (UC) in cancer survivors. However, the comparative effectiveness between EA and AA among breast cancer survivors is unknown. Here, we report the results of subgroup analysis of breast cancer survivors enrolled in the PEACE trial. Methods: PEACE is a three-arm, parallel, single center randomized trial investigating the effectiveness of EA and AA versus UC for chronic musculoskeletal pain in 360 cancer survivors. Patients in both EA and AA received ten weekly treatments. Patients in UC could receive ten EA treatments after week 12. The primary endpoint was the change in mean Brief Pain Inventory (BPI) pain intensity from baseline to week 12; change from baseline to week 24 and change in quality of life were secondary endpoints. We analyzed the subset of 46% of trial participants with a primary diagnosis of breast cancer. We conducted constrained linear mixed model analyses, which constrained all arms to have a common pre-randomization baseline mean. Model-based mean estimates at weeks 12 and 24 were compared between arms using model contrasts. Results: Among 165 breast cancer survivors, the baseline mean pain severity was 5.35 (95% Confidence Interval [CI]: 5.04, 5.66). At week 12, the BPI pain severity score was 2.69 (2.26. 3.13) in EA, 3.60 (3.17, 4.02) in AA, and 5.06 (4.47, 5.65) in UC. At week 24, the mean BPI pain severity was 2.84 (95% CI: 2.40, 3.28) in EA and 3.67 (95% CI: 3.23, 4.10) in AA. EA reduced pain severity significantly more than AA at both week 12, (-0.90 [-1.45, -0.36], p=0.001) and week 24 (-0.82, [-1.38, -0.27], p=0.004). There were no differences between EA and AA in improvements in PROMIS physical health or mental health component scores, but both EA and AA significantly improved both PROMIS scores at week 12 compared to UC. Mild toxicities were reported, more patients dropped out of the AA arm due to ear pain. Conclusions: EA was more effective than AA at reducing pain severity, but both similarly improved physical and mental health scores. Breast cancer survivors with chronic musculoskeletal pain may consider EA before AA. Citation Format: Ting Bao, W. Iris Zhi, Raymond Baser, Qing Li, Jun Mao. Effectiveness of Electroacupuncture Versus Auricular Acupuncture in Reducing Pain and Improving Quality of Life in Breast Cancer Survivors with Chronic Musculoskeletal Pain [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD8-05.

0479 Prescribing Patterns for Hypnotic Medication Among Adults Seeking CBTI Treatment: A Preliminary Report from the RESTING Study

Abstract Introduction Use of prescription hypnotic medications is common among adults with chronic insomnia; however, little is known about prescribing patterns for hypnotic medication in middle-to-older age adults with insomnia disorder who seek to engage in cognitive behavioral therapy for insomnia (CBTI). Methods Participants were 235 adults aged 50 or older with insomnia disorder (mean age 63.1y [SD 7.7y], 73.6% women) enrolled in the ongoing Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING). At screening, participants provided information about prescribed medications for sleep, insomnia severity (Insomnia Severity Index), daytime sleepiness (Epworth Sleepiness Scale), chronotype (Composite Morningness Questionnaire), depression (Geriatric Depression Scale) and physical and mental health (PROMIS Global-10, Physical and Mental Health Subscales). Results Of the 235 participants, 95 (40.4%) reported taking at least one medication prescribed to improve sleep. 26.5% were prescribed multiple medications (polypharmacy). Non-benzodiazepine receptor agonists (non-BzRAs) were the most common (prescribed to 51.6% of medication-using sample), followed by benzodiazepines (Bzs; 35.8%) and trazodone (20.0%). 25.2% of participants took a variety of other prescription medications at lower frequencies.Comparing patient characteristics for patients prescribed non-BzRAs, Bzs, and trazodone monotherapies, as well as polypharmacy, there were no significant differences in age, gender, insomnia severity or any other clinical characteristics, outside of modest associations within the PROMIS physical health scale (F[3,81]=2.78, p=.046); participants prescribed trazodone as monotherapy had significantly higher scores (better physical functioning) than participants prescribed non-BzRAs. Bzs were more likely to be prescribed as part of polypharmacy (52.9% of patients prescribed Bz) in the total medication using sample compared to those taking non-BzRAs (34.7%) or trazodone (36.8%; p<.001). Conclusion In this study, a high percentage of adults with insomnia seeking CBTI were also taking medications prescribed for sleep, including medications that are associated with increased risk (benzodiazepines, polypharmacy) or are not FDA-approved for insomnia (trazodone). Increasing prescriber knowledge about CBTI may promote adherence to the American Geriatric Society Beers Criteria for potentially inappropriate medication use in older adults. More research on how prescription patterns may differ among provider specialties could help target educational efforts to increase utilization of CBTI. Support (If Any) 1R01AG057500

High complication rates following revision first metatarsophalangeal joint arthrodesis: a retrospective analysis of 79 cases.

The most common indications for revision of first metatarsophalangeal joint (MTPJ) arthrodesis are symptomatic failures of prior arthrodesis, failed hallux valgus correction, and failed MTPJ arthroplasty implants. However, the outcomes of revision MTPJ arthrodesis have rarely been studied. The purpose of this study was to compare the clinical, radiographic, and patient-reported outcomes of revision MTPJ arthrodesis following different primary procedures. A retrospective review of revision MTPJ arthrodesis cases between January 2015 and December 2019 was performed. The radiographic results, patient-reported outcomes, and rates of complications, subsequent revisions, and nonunions, were analyzed and compared preoperatively and postoperatively. A multivariate analysis was utilized to determine risk factors for complications and reoperations. This study yielded a total of 79 cases of revision MTPJ arthrodesis. The mean follow-up time was 365days (SD ± 295). The overall complication rate was 40.5%, of which the overall nonunion rate was 19.0%. Seven cases (8.9%) required further revision surgery. The multivariate analysis revealed that Diabetes mellitus was associated with significantly higher overall complication rates (p = 0.016), and nonunion was associated with "in-situ" joint preparation techniques (p = 0.042). Visual Analog Scale (VAS) significantly improved postoperatively (p < 0.001); However, PROMIS-10 physical health and PROMIS-10 mental health did not change significantly during the study period. Treatment of MTPJ surgery failures is a clinical challenge in orthopedic surgery. In our study, revision of first MTPJ surgery resulted in higher nonunion rates and overall complication rates compared to typical outcomes from primary MTPJ arthrodesis. Diabetes, Tobacco use, and "in-situ" joint preparation technique were found to be independent risk factors for complications and reoperations. III-Retrospective Cohort Study.

Interpreting the Hip Osteoarthritis Outcome Score Joint Replacement: Minimum clinically important difference values vary over time within the same patient population

Introduction Total hip arthroplasty (THA) results in outstanding outcomes and long-term implant survivorship, but there continues to be a need for tools to identify surgical candidates and assist with shared decision-making. This study aims to determine the Hip Osteoarthritis Outcome Score Joint Replacement (HOOS JR) Minimum Clinical Important Difference (MCID) at two time intervals and to evaluate different methods for calculating the HOOS JR MCID for patients undergoing THA. Methods A patient reported outcome measure (PROM) database was prospectively queried at a single outpatient ambulatory surgery center for patients treated with THA between 2017 and 2018. All patients completed PROM surveys at preoperative baseline, 3-month, and 1-year follow-up. MCID was calculated at two different intervals, baseline to 3-months and baseline to 1-year, using anchoring and distribution-based methods. Anchor-based calculations were anchored to the Patient-Reported Outcomes Measure Information System (PROMIS10) quality-of-life and physical health instruments. Results 514 patients were statistically analyzed. Average HOOS JR scores were 52.5, 79.3, and 86.1 at preoperative baseline, 3-month follow-up and 1-year follow-up, respectively. The HOOS JR MCID determined by the PROMIS10 physical health anchoring method was 30.1 and 35.5 for the 3-month and 1-year time intervals. The HOOS JR MCID determined by the PROMIS10 quality-of-life anchoring method was 31.1 and 34.8 for the 3-month and 1-year time intervals. The distribution method MCID was 8.2 for the 3-month interval and 8.4 for the 1-year interval. Conclusions MCID values vary by time and by calculation method. THA patients may require individualized and time-point specific MCID formulas to better guide clinical decision-making.

Interpreting the Knee Osteoarthritis Outcome Score Joint Replacement: Minimum clinically important difference values vary over time within the same patient population

Introduction Total knee arthroplasty (TKA) is the preferred treatment for end-stage osteoarthritis. Minimal clinical important difference (MCID) quantifies if a patient achieves a successful outcome following TKA. This study aims to determine the MCID for Knee Injury Osteoarthritis Outcome Score Joint Replacement (KOOS JR) at two designated time intervals and to compare methodologies for calculating MCID. Methods Patient-Reported Outcome Measures (PROM) were prospectively evaluated for 956 patients undergoing TKA between 2017 and 2018 at a single health care system. Patients who completed baseline, 3-month and 1-year post-operative PROM surveys at clinical follow-up were included in the study. MCID was calculated from baseline to 3-months and baseline to 1-year using anchoring and distribution-based methods. Results Average KOOS JR scores at baseline, 3-month, and 1-year follow-up were 51.7 ± 11.7, 69.2 ± 12.0, and 76.3 ± 14.5. The KOOS JR MCID determined by the PROMIS10 physical health anchoring method was 21.5 ± 14.9 and 27.9 ± 16.0 for the 3-month and 1-year intervals. The KOOS JR MCID determined by the PROMIS10 quality-of-life anchoring method was 21.2 ± 14.9 and 28.9 ± 15.8 for the 3-month and 1-year intervals. The MCID calculated by the distribution method was 7.4 and 8.2 for the 3-month and 1-year intervals. Conclusion KOOS JR MCID varies as a function of time and is variable within the same population depending on MCID calculation methodology. Improved strategy for calculating or standardizing MCID is required to better guide use of KOOS JR and other PROMs in clinical decision-making.

PROMIS-10 scores at six months post-baseline among breast and gynecologic oncology patients participating in a text-based symptom monitoring program with patient navigation.

e19173 Background: Unreported symptoms during cancer treatment can lead to poorer patient care and quality of life. eHealth technologies enable effective means to track patients’ health in real time to provide assistance in meeting patients’ needs and facilitating symptom management. Methods: Gynecologic (endometrial and ovarian) and breast oncology patients were enrolled in a quality improvement program post-surgically to respond to 12-monthly, text-based symptom surveys assessing fatigue, sleep quality, pain, and depression (PHQ-9). At baseline, 6 and 12 months, patients also completed the PROMIS-10 to assess their physical and mental health functioning. All patient responses were captured in REDCap and monitored by program staff, with patients’ oncologists receiving monthly feedback for patient follow-up. Patient navigators were also engaged for patients needing assistance with non-medical concerns. We provide the interim results of this program on PROMIS-10 scores from baseline to 6 months. Results: 198 breast and 120 gynecologic oncology patients (ovarian [n = 70] and endometrial [n = 50]) were enrolled. Multiple regression examined the impact of demographic (age, race, education), clinical (stage, chemotherapy, radiation), and monitoring program variables (# of monthly surveys completed, navigation services [yes/no]) on PROMIS-10 physical and mental health subscale scores at 6 months, adjusting for baseline PROMIS scores. For the breast patients, the only significant predictor of worse PROMIS physical health scores was a cancer stage of 4 vs 1 (p = 0.049), whereas a higher number of symptom surveys completed was associated with worse mental health functioning (p = 0.033). For the gynecologic oncology patients, worse PROMIS physical health scores were only associated with higher age (p = 0.037), but higher PROMIS mental health was also associated with higher age (p = 0.029) and borderline significantly associated with not using navigation services (p = 0.07). Conclusions: These results indicate that greater adherence in completing monthly symptom surveys and using navigation services were more likely to be associated with patients reporting lower mental health. PROMIS physical health scores, however, were not significantly associated with adherence to monthly surveys or navigation services. These interim results suggest that monitoring programs, such as this, may assist in identifying and treating patients with lower mental health functioning during treatment.

309. Patient reported allergies: a marker of preoperative pain and disability in elective spine surgery

BACKGROUND CONTEXT Previous literature has demonstrated mixed results regarding the correlation between patient reported allergies and their pain, function, and satisfaction scores with elective spine surgery. A better understanding of the correlation is important for preoperative risk factor assessment and management. PURPOSE The objective of this study was to investigate the correlation between patient reported allergies and preoperative Oswestry Disability Index (ODI), Neck Disability Index (NDI) and Patient-Reported Outcomes Measurement System (PROMIS) scores. STUDY DESIGN/SETTING Retrospective review at a single institution from May 2017-October 2018. PATIENT SAMPLE All patients undergoing elective cervical, thoracolumbar, and lumbar spine surgery at a single institution who had completed preoperative ODI, NDI, and PROMIS questionnaires. OUTCOME MEASURES The PROMIS, ODI and NDI scores were utilized. METHODS All patients undergoing elective cervical, lumbar procedures between May 2017 and October 2018 were included. Baseline demographic information was recorded, as well as all reported allergies or adverse reactions. PROMIS scores, ODI and NDI were recorded. Hierarchical multiple linear regressions were used to assess the relationship between total number of allergies and the preoperative pain and function scores. RESULTS A total of 570 patients were included (476 lumbar, 94 cervical). The mean number of allergies reported was 1.89 ± 2.32. The mean preoperative ODI and NDI scores were 46.39 ±17.67, and 43.47 ±16.51, respectively. The mean preoperative PROMIS Physical Health and PROMIS Mental Health scores were 37.21±6.54 and 43.89 ±9.26, respectively. Hierarchical multiple linear regression showed that total number of reported allergies shared a statistically significant negative relationship with all of the following scores: ODI (B = 0.83,p=.02), NDI (B = 1.45, p=.02), PROMIS Physical Health (B = -0.29, p=.013), PROMIS Mental Health (B = -0.38, p=.024). CONCLUSIONS Patient reported allergies share a statistically significant negative relationship with preoperative pain and function scores; as patients have increasing total number of allergies, the ODI/NDI scores become worse (increase), and the PROMIS scores become worse (decrease). FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. Previous literature has demonstrated mixed results regarding the correlation between patient reported allergies and their pain, function, and satisfaction scores with elective spine surgery. A better understanding of the correlation is important for preoperative risk factor assessment and management. The objective of this study was to investigate the correlation between patient reported allergies and preoperative Oswestry Disability Index (ODI), Neck Disability Index (NDI) and Patient-Reported Outcomes Measurement System (PROMIS) scores. Retrospective review at a single institution from May 2017-October 2018. All patients undergoing elective cervical, thoracolumbar, and lumbar spine surgery at a single institution who had completed preoperative ODI, NDI, and PROMIS questionnaires. The PROMIS, ODI and NDI scores were utilized. All patients undergoing elective cervical, lumbar procedures between May 2017 and October 2018 were included. Baseline demographic information was recorded, as well as all reported allergies or adverse reactions. PROMIS scores, ODI and NDI were recorded. Hierarchical multiple linear regressions were used to assess the relationship between total number of allergies and the preoperative pain and function scores. A total of 570 patients were included (476 lumbar, 94 cervical). The mean number of allergies reported was 1.89 ± 2.32. The mean preoperative ODI and NDI scores were 46.39 ±17.67, and 43.47 ±16.51, respectively. The mean preoperative PROMIS Physical Health and PROMIS Mental Health scores were 37.21±6.54 and 43.89 ±9.26, respectively. Hierarchical multiple linear regression showed that total number of reported allergies shared a statistically significant negative relationship with all of the following scores: ODI (B = 0.83,p=.02), NDI (B = 1.45, p=.02), PROMIS Physical Health (B = -0.29, p=.013), PROMIS Mental Health (B = -0.38, p=.024). Patient reported allergies share a statistically significant negative relationship with preoperative pain and function scores; as patients have increasing total number of allergies, the ODI/NDI scores become worse (increase), and the PROMIS scores become worse (decrease).

Patient-Reported Allergies, a Marker of Preoperative Pain and Disability in Elective Spine Surgery.

Study Design:Retrospective review.Objective:Previous literature demonstrates mixed results regarding the relationship between patient-reported allergies and pain, function, and satisfaction scores. The objective of this study was to investigate the correlation between patient-reported allergies and preoperative Oswestry Disability Index (ODI), Neck Disability Index (NDI), and Patient-Reported Outcomes Measurement System (PROMIS) scores.Methods:All patients undergoing elective cervical, lumbar procedures between May 2017 and October 2018 were included. Baseline demographic information was recorded, as well as all reported allergies or adverse reactions. Preoperative PROMIS, ODI, and NDI scores were recorded. Hierarchical multiple linear regressions were used to assess the relationship between total number of allergies and the preoperative pain and function scores.Results:A total of 570 patients were included (476 lumbar, 94 cervical). The mean number of allergies reported was 1.89 ± 2.32. The mean preoperative ODI and NDI scores were 46.39 ± 17.67 and 43.47 ± 16.51, respectively. The mean preoperative PROMIS Physical Health and PROMIS Mental Health scores were 37.21 ± 6.54 and 43.89 ± 9.26, respectively. Hierarchical multiple linear regression showed that total number of reported allergies shared a statistically significant negative relationship with all of the following scores: ODI (B = 0.83, P = .02), NDI (B = 1.45, P = .02), PROMIS Physical Health (B = −0.29, P = .013), and PROMIS Mental Health (B = −0.38, P = .024).Conclusions:Patient-reported allergies share a statistically significant negative relationship with preoperative pain and function scores; as patients have increasing total number of allergies, the ODI/NDI scores become worse (increase) and the PROMIS scores become worse (decrease).

Abstract 119: Final Patient-Level Results From the Michigan Stroke Transitions Trial (MISTT): A Randomized Clinical Trial to Improve Stroke Transitions

Background: Navigating the transition after returning home following a stroke can be associated with substantial psychosocial and health-related challenges. The Michigan Stroke Transitions Trial (MISTT) tested the efficacy of a social work case management (SWCM) program and access to an online information and support resource (MISTT Website) to improve outcomes in acute stroke patients who returned home. Methods: MISTT was a randomized, pragmatic, open, 3-group parallel designed trial conducted in 3 Michigan hospitals. Eligible subjects were acute stroke patients who returned home either directly or within 4 weeks of being discharged to a rehab facility. A total of 265 patients were randomized to one of 3 groups: 1) usual care, 2) SWCM program only, or 3) SWCM plus MISTT Website access. Interventions concluded after 90-days. Primary outcomes including Quality-of-Life (PROMIS Global-10 physical- and mental-health subscales) and the Patient Activation Measure (PAM) were collected by telephone at 7- and 90-days. The change in outcomes (90-day minus 7-day) between the three treatment groups was assessed using a differences-in-differences (D-in-D) analysis. Results: The mean age of the 265 randomized subjects was 66 years, 49% were female, 21% non-white, 14% had hemorrhagic stroke, 56% were discharged to a rehab facility. Following the intervention there were statistically significant treatment group differences in PROMIS physical-health (p=0.003) and PAM (p=0.042), but not PROMIS mental-health (p=0.56). Mean change in physical-health scores for group-3 (SWCM+Website) was significantly higher than both group-1 (Usual Care) (difference= 3.4; 95%CI=1.41, 5.33; p&lt;0.001) and group-2 (SWCM) (difference= 2.4; 95%CI=0.46, 4.34; p=0.02). The mean change in PAM scores for group-3 was significantly higher than group-2 (6.7; 95%CI=1.26, 12.08; p=0.02) and marginally higher than group-1 (5.0; 95%CI=-0.47, 10.52; p=0.07). Conclusion: An intervention that combined social worker-led case management with access to online stroke-related information produced greater gains in patient-reported physical health and activation compared to usual care or case management alone. [ClinicalTrials.gov: NCT02653170].

Assessment of Disease-Specific and General Patient-Reported Outcome Measures of Hearing Health.

Objective To assess disease-specific (Inner EAR) and general (Patient-Reported Outcomes Measurement Information System [PROMIS]) health status in patients reporting hearing loss and whether there is enough correlation between scales such that the general instrument alone could suffice. Study Design Correlation analysis of prospective cohort data. Setting Tertiary care academic medical center. Methods Adults presenting with a chief complaint of hearing loss completed the Inner EAR scale and the PROMIS instrument. Summary statistics, including means, percentiles, and measures of variance, were calculated. The Spearman ρ statistic was used to test the null hypothesis that there were no correlations between the Inner EAR composite or global score and PROMIS scores. Results The mean Inner EAR composite score was 35.6, while the global item had a mean score of 4.8. Mean PROMIS-10 scores were 16.0 for physical health and 15.3 for mental health. The global item and social item had mean scores of 3.6 and 3.8, respectively. Inner EAR composite scores were significantly correlated with the PROMIS mental health summary scores (Spearman ρ = 0.3, P = .0066) and the PROMIS social item score (Spearman ρ = 0.4, P = .0005). The Inner EAR global item was moderately correlated with the PROMIS social item score (Spearman ρ = 0.3, P = .0118), while there was no significant correlation between the Inner EAR global item and the PROMIS physical health, mental health, or global item scores. Conclusions Inner EAR and a subset of PROMIS scores have weak to moderate correlations. Disease-specific assessment still confers independent value.

Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus.

To assess the feasibility, validity, and reliability of the Patient Reported Outcomes Measurement Information System Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE). SLE outpatients completed PROMIS10, Medical Outcomes Study Short Form-36 (SF-36), LupusQoL-US, and selected PROMIS computerized adaptive tests (CAT) at routine visits at an SLE Center of Excellence. Construct validity was evaluated by correlating PROMIS10 physical and mental health scores with PROMIS CAT, legacy instruments, and physician-derived measures of disease activity and damage. Test-retest reliability was determined among subjects reporting stable SLE activity at 2 assessments 1 week apart using intraclass correlation coefficients (ICC). A diverse cohort of 204 out of 238 patients with SLE (86%) completed survey instruments. PROMIS10 physical health scores strongly correlated with physical function, pain, and social health domains in PROMIS CAT, SF-36, and LupusQoL, while mental health scores strongly correlated with PROMIS depression CAT, SF-36, and LupusQoL mental health domains (Spearman correlations ≥ 0.70). Active arthritis, comorbid fibromyalgia (FM), and anxiety were associated with worse PROMIS10 scores, but sociodemographic factors and physician-assessed flare status were not. Test-retest reliability for PROMIS10 physical and mental health scores was high (ICC ≥ 0.85). PROMIS10 required < 2 minutes to complete. PROMIS10 is valid and reliable, and can efficiently screen for impaired physical function, pain, and emotional distress in outpatients with SLE. With strong correlations to LupusQoL and SF-36 but significantly reduced responder burden, PROMIS10 is a promising tool for measuring patient-reported outcomes in routine SLE clinical care and value-based healthcare initiatives.