Preoperative spinal education for lumbar spinal stenosis: A feasibility study.

INTRODUCTION: Lumbar spinal stenosis (LSS) is a leading cause of chronic musculoskeletal pain among older adults. A common and costly intervention for the treatment of LSS is lumbar decompression with or without fusion (LSS surgery), which has mixed outcomes among patients. Prehabilitation is a strategy designed to optimize the consistency of positive surgical outcomes and promote patient self-efficacy, while attempting to mitigate postoperative complications. No efforts have investigated the prehabilitation strategies specifically for patients undergoing LSS surgery. OBJECTIVE: To determine the feasibility of delivery and acceptability by participants of a novel prehabilitation intervention for patients undergoing LSS surgery. DESIGN: Feasibility study. SETTING: Outpatient orthopedic clinic at an academic medical center. PARTICIPANTS: Patients at least 50 years of age, who were scheduled for LSS surgery between October 2020 and October 2021. INTERVENTION: PreOperative Spinal Education for Lumbar Spinal Stenosis (POSE-LSS), is a novel multimodal, education-focused, time-efficient prehabilitation program for patients undergoing LSS surgery. Participants received the following: (1) Educational booklet and video; (2) In-person physical therapy (PT) session; and (3) Telemedicine visit with a physiatrist. MAIN OUTCOME MEASURE(S): The primary outcomes of interest were feasibility and acceptability of intervention by participants. Key potential surgical outcomes were length of stay and discharge disposition. RESULTS: POSE-LSS was completed by all eligible participants enrolled (n = 15) indicating feasibility and acceptability. Potential effectiveness measures including length of stay and discharge disposition were positively associated with the POSE-LSS intervention. CONCLUSIONS: This study demonstrates that a novel prehabilitation intervention is feasible, acceptable, and appears positively associated with important short-term measures of postoperative recovery that may impact the trajectory of patient care following LSS surgery.

AM-PAC Mobility Score <13 Predicts Development of Ileus Following Adult Spinal Deformity Surgery.

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine whether the Activity Measure for Post-Acute Care (AM-PAC) "6-Clicks" score is associated with the development of postoperative ileus. SUMMARY OF BACKGROUND DATA: Adult spinal deformity (ASD) surgery has a high complication rate. One common complication is postoperative ileus, and poor postoperative mobility has been implicated as a modifiable risk factor for this condition. METHODS: Eighty-five ASD surgeries in which ≥5 levels were fused were identified in a single institution database. A physical therapist/physiatrist collected patients' daily postoperative AM-PAC scores, for which we assessed first, last, and daily changes. We used multivariable linear regression to determine the marginal effect of ileus on continuous AM-PAC scores; threshold linear regression with Bayesian information criterion to identify a threshold AM-PAC score associated with ileus; and multivariable logistic regression to determine the utility of the score thresholds when controlling for confounding variables. RESULTS: Ten of 85 patients (12%) developed ileus. The mean day of developing ileus was postoperative day 3.3±2.35. The mean first and last AM-PAC scores were 16 and 18, respectively. On bivariate analysis, the mean first AM-PAC score was lower in patients with ileus than in those without (13 vs. 16; P<0.01). Ileus was associated with a first AM-PAC score of 3 points lower (Coef. -2.96; P<0.01) than that of patients without ileus. Patients with an AM-PAC score<13 had 8 times greater odds of developing ileus (P=0.023). Neither the last AM-PAC score nor the daily change in AM-PAC score was associated with ileus. CONCLUSIONS: In our institutional cohort, a first AM-PAC score of <13, corresponding to an inability to walk or stand for more than 1 minute, was associated with the development of ileus. Early identification of patients who cannot walk or stand after surgery can help determine which patients would benefit from prophylactic management. LEVEL OF EVIDENCE: Level-III.

Trends in Telerehabilitation Utilization in the United States 2020-2021.

OBJECTIVE: To examine telerehabilitation utilization in the United States (US) during the first 2 years of the pandemic. DESIGN: We performed a retrospective analysis of outpatient insurance claims from the IBM MarketScan Commercial Claims and Encounters Database to identify the number and proportion of patients using telerehabilitation from 2020 to 2021. Telerehabilitation was identified based on the presence of specific code modifiers and place of service. SETTING: Retrospective claims analysis. PARTICIPANTS: Individuals living in the United States with employer-sponsored insurance plans using outpatient physical or occupational therapy (PT/OT) (N=2,007,524). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Number and proportion of outpatient PT/OT visits completed via telerehabilitation. RESULTS: We identified 21,026,608 PT/OT visits among 2,007,524 patients. Overall, 49,974 (2.5%) patients received ≥1 telerehabilitation visit during the specified timeframe. We observed trends in utilization over time, with utilization peaking in April 2020 when 10.9% of all PT/OT visits were conducted by telerehabilitation. We also observed geographic trends with lower rates of utilization identified in rural areas. State-by-state utilization rates ranged from 10.4% (California) to 0.3% (Wyoming). CONCLUSION: Telerehabilitation may be underutilized as a means of improving access to PT/OT, especially in rural areas of the country. Further research is needed to examine contributing factors to low observed utilization rates, such as provider and patient perceptions of telerehabilitation.

Impact of Controlled Versus Uncontrolled mFI-5 Frailty on Perioperative Complications After Adult Spinal Deformity Surgery.

STUDY DESIGN: Retrospective review. OBJECTIVES: We substratified the mFI-5 frailty index to reflect controlled and uncontrolled conditions and assess their relationship to perioperative complications. SUMMARY OF BACKGROUND DATA: Risk assessment before adult spinal deformity (ASD) surgery is critical because the surgery is highly invasive with a high complication rate. Although frailty is associated with risk of surgical complications, current frailty measures do not differentiate between controlled and uncontrolled conditions. METHODS: Frailty was calculated using the mFI-5 index for 170 ASD patients with fusion of ≥5 levels. Uncontrolled frailty was defined as blood pressure >140/90 mm Hg, HbA1C >7% or postprandial glucose >180 mg/dL, or recent chronic obstructive pulmonary disease (COPD) exacerbation, while on medication. Patients were divided into nonfrailty, controlled frailty, and uncontrolled frailty cohorts. The primary outcome measure was perioperative major and wound complications. Bivariate analysis was performed. Multivariable analysis assessed the relationship between frailty and perioperative complications. RESULTS: The cohorts included 97 nonfrail, 54 controlled frail, and 19 uncontrolled frail patients. Compared with nonfrail patients, patients with uncontrolled frailty were more likely to have age older than 60 years (84% vs. 24%), hyperlipidemia (42% vs. 20%), and Oswestry Disability Index (ODI) score >42 (84% vs. 52%) (P<0.05 for all). Controlled frailty was associated with those older than 60 years (41% vs. 24%) and hyperlipidemia (52% vs. 20%) (P<0.05 for all). On multivariable regression analysis controlling for hyperlipidemia, functional independence, motor weakness, ODI>42, and age older than 60 years, patients with uncontrolled frailty had greater odds of major complications (OR 4.24, P=0.03) and wound complications (OR 9.47, P=0.046) compared with nonfrail patients. Controlled frailty was not associated with increased risk of perioperative complications (P>0.05 for all). CONCLUSIONS: Although patients with uncontrolled frailty had higher risk of perioperative complications compared with nonfrail patients, patients with controlled frailty did not, suggesting the importance of controlling modifiable risk factors before surgery. LEVEL OF EVIDENCE: 3.

Measuring Value in Spine Care Using the PROMIS-Preference Scoring System.

BACKGROUND: A transition to value-based care requires a thorough understanding of the costs and impacts of various interventions on patients' overall health utility. The Patient-Reported Outcomes Measurement Information System (PROMIS) has gained popularity and is frequently used to assess physical, mental, and social health domains in clinical and research settings. To assess health utility, the PROMIS-Preference (PROPr) score, a societal preference-based measure, has been proposed to produce a single estimate of health utility. We determined the psychometric properties (validity and responsiveness) of the PROPr score as a health state utility measure in patients undergoing spine surgery. We hypothesized that PROPr score would be lower in the presence of comorbid conditions and lower socioeconomic status and in those with more severe pain-related disability and would be responsive to changes in health status following spine surgery. METHODS: In this prospective cohort study, 904 adults presented for cervical (n = 359) and/or lumbar (n = 622) conditions, and 624 underwent surgery, from August 2019 through January 2022. To assess concurrent validity, we correlated the PROPr score with Neck Disability Index (NDI)/Oswestry Disability Index (ODI) values. To assess known-groups validity, we regressed the PROPr score on participant age, sex, pain-related disability, and social determinants of health. To assess responsiveness, we used an anchor-based approach, evaluating change from preoperatively to 6 and 12 months postoperatively anchored by the Patient Global Impression of Change. A p level of <0.05 was considered significant. RESULTS: The median overall preoperative PROPr score was 0.20 (interquartile range [IQR], 0.10 to 0.32; range, -0.02 to 0.95). The PROPr score was associated with higher educational attainment (p = 0.01), higher household income (p < 0.001), and a greater number of comorbid conditions (p = 0.04). The median PROPr score decreased (worse health utility) with greater disability (NDI, 0.44 [none] to 0.09 [severe/complete], p < 0.001; ODI, 0.57 [none] to 0.08 [severe/complete], p < 0.001). The change in the median PROPr score differed in participants who rated their postoperative health as improved (0.17) compared with little or no change (0.04; p < 0.001) or worse (-0.06; p = 0.025) at 6 months and in those who rated their health as improved (0.15) compared with little or no change (0.02; p < 0.001) or worse (-0.05; p = 0.043) at 12 months. CONCLUSIONS: The PROPr score is a valid and responsive preference-based assessment of health utility for patients undergoing spine surgery. It can be calculated from PROMIS outcome data. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

Predicting major complications and discharge disposition after adult spinal deformity surgery.

BACKGROUND CONTEXT: Several spine-specific comorbidity indices are available to help risk-stratify patients before they undergo invasive spine procedures. Studies of patients with adult spinal deformity (ASD) typically use the Charlson Comorbidity Index (CCI), which is not specific to spine patients. PURPOSE: To compare the CCI with the Seattle Spine Score (SSS), the Adult Spinal Deformity-Comorbidity Score (ASD-CS), and the Modified 5-Item Frailty Index (mFI-5) and identify which tool more accurately predicted major perioperative complications and discharge disposition after ASD surgery. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: Patients with ASD who underwent spinal arthrodesis of at least four levels at a single institution. OUTCOME MEASURES: Self-reported measures include SSS, ASD-CS, and mFI-5. Functional measures include the CCI. METHODS: We retrospectively reviewed records of 164 patients with ASD who underwent spinal arthrodesis of ≥ four levels from January 2008 to February 2018 at our U.S. academic tertiary care center and who had available Oswestry Disability Index values. To assess the predictive ability of the comorbidity indices, we created five multivariable logistic regression models, with the presence of major complications and discharge disposition (home or inpatient rehabilitation) as the primary outcome variables. The base model used validated demographic and surgical factors that were predictors of complications and outcomes in those with ASD and within the broader spinal literature. The other four models used the base model along with one of the four indices. The predictive ability of each model was compared using goodness-of-fit testing, with higher pseudo-R2 values and lower Akaike information criteria (AIC) values indicating better model fit. RESULTS: Thirty-one patients (19%) experienced major perioperative complications, and 68 (42%) were discharged to inpatient rehabilitation facilities (vs home). The model using the SSS had the highest pseudo-R2 value and lowest AIC value for both major complications and discharge disposition. The mFI-5 had a similar predictive ability. The models using the CCI and ASD-CS were weaker predictors. CONCLUSIONS: Compared with the CCI and the ASD-CS, the SSS and the mFI-5 were strong predictors of major complications and discharge disposition after ASD surgery. These results suggest that the SSS and the mFI-5 are preferable to the CCI for clinical risk stratification and outcomes research in patients undergoing ASD surgery.

Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain.

OBJECTIVE: The coronavirus disease-2019 pandemic has facilitated the emergence of telerehabilitation, but it is unclear which patients are most likely to respond to physical therapy provided this way. The purpose of this study was to examine the relationship between individual patient factors and substantial clinical benefit from telerehabilitation among a cohort of patients with chronic low back pain (LBP). METHODS: This is a secondary analysis of data collected during a prospective longitudinal cohort study. Patients with chronic LBP (N = 98) were provided with a standardized physical therapy protocol adapted for telerehabilitation. We examined the relationship between patient factors and substantial clinical benefit with telerehabilitation, defined as a ≥50% improvement in disability at 10 weeks, measured using the Oswestry Disability Index. RESULTS: Sixteen (16.3%) patients reported a substantial clinical benefit from telerehabilitation. Patients reporting substantial clinical benefit from telerehabilitation had lower initial pain intensity, lower psychosocial risk per the STarT Back Screening Tool, higher levels of pain self-efficacy, and reported higher therapeutic alliance with their physical therapist compared to other patients. CONCLUSION: Patients with lower psychosocial risk and higher pain-self efficacy experienced substantial clinical benefit from telerehabilitation for chronic LBP more often than other patients in our cohort. Therapeutic alliance was higher among patients who experienced a substantial clinical benefit compared to those who did not. IMPACT: This study indicates that psychosocial factors play an important role in the outcomes of patients receiving telerehabilitation for chronic LBP. Baseline psychosocial screening may serve as a method for identifying patients likely to benefit from this approach.

Gender diversity at spine surgery academic conferences: a 15-year investigation.

BACKGROUND CONTEXT: Enhancing gender diversity at academic conferences is critical for advancing women's representation and career trajectories in spine surgery. PURPOSE: To discover trends in women's representation at major spine conferences over a 15-year period. STUDY DESIGN/SETTING: Conference records from the 2007-2021 annual meetings of the Congress of Neurological Surgeons, North American Spine Society, and Scoliosis Research Society (SRS). PATIENT SAMPLE: Authors of spine-related presentations. OUTCOME MEASURES: Authorship by gender. METHODS: Retrospective bibliometric analysis with univariate and multivariate modeling to identify trends and predictors of gender diversity. RESULTS: Among 8,948 presentations, 750 (8.4%) had female first authors and 618 (6.9%) had female senior authors. There was no change in rates of female first authorship (p=.41) or senior authorship (p=.88) over time. The strongest predictors of female first authorship were having a female senior author (OR 7.32, p<.001), and delivering presentations at SRS (OR 1.95, p=.001). Factors negatively associated with female first authorship included poster format (OR 0.82, p=.039) and conference location in the United States/Canada (OR 0.76, p=.045). Similar trends were encountered for senior authorship. Productivity per senior author was similar between genders (p=.160); whereas a gender gap in productivity per first author during 2007 to 2011 (p=.020) equalized by 2017 to 2021 (p=.300). Among the 10 most productive authors of each gender, male authors delivered more presentations, but all authors shared similar format, content, and location. CONCLUSIONS: Women's representation in spine-related presentations did not increase at three major conferences over a 15-year period. Our findings regarding the positive effects of female mentorship, and international or virtual venues merit further investigation to address the gender gap. The upstream pipeline of recruiting women into academic spine surgery also needs to be addressed.

Abnormal Postoperative PROMIS Scores are Associated with Patient Satisfaction in Adult Spinal Deformity and Degenerative Spine Patients.

STUDY DESIGN: Retrospective review. OBJECTIVES: To evaluate 1) patient satisfaction after adult spine surgery; 2) associations between number of abnormal PROMIS domain scores and postoperative satisfaction; and 3) associations between normalization of a patient's worst preoperative PROMIS domain score and postoperative satisfaction. SUMMARY OF BACKGROUND DATA: Although "legacy" patient-reported outcome measures correlate with patient satisfaction after adult spine surgery, it is unclear whether PROMIS scores do. METHODS: We included 1119 patients treated operatively for degenerative spine disease (DSD) or adult spinal deformity (ASD) from 2014-2019 at our tertiary hospital who completed questionnaires preoperatively and at ≥1 postoperative timepoints up to 2 years. Postoperative satisfaction was measured in ASD patients using items 21 and 22 from the SRS 22-revised questionnaire and in DSD patients using the NASS Patient Satisfaction Index. "Worst" preoperative PROMIS domain was that with the greatest clinically negative deviation from the mean. "Normalization" was a postoperative score within 1 standard deviation of the general population mean. Multivariate logistic regression identified factors associated with satisfaction. RESULTS: Satisfaction was reported by 88% of DSD and 86% of ASD patients at initial postoperative follow-up; this proportion did not change during the first year after surgery. We observed an inverse relationship between postoperative satisfaction and number of abnormal PROMIS domains at all postoperative timepoints beyond 6 weeks. Only among ASD patients was normalization of the worst preoperative PROMIS domain associated with greater odds of satisfaction at all timepoints up to 1 year. CONCLUSION: The proportion of DSD and ASD patients satisfied postoperatively did not change from 6 weeks to 1 year. Normalizing the worst preoperative PROMIS domain and minimizing the number of abnormal postoperative PROMIS scores may reduce the number of dissatisfied patients. PROMIS data can guide perioperative patient management to improve satisfaction. LEVEL OF EVIDENCE: 3.

Association of Neighborhood Socioeconomic Deprivation With Utilization and Costs of Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: A retrospective analysis. OBJECTIVE: The aim of our study was to analyze the association of Area Deprivation Index (ADI) with the utilization and costs of elective anterior cervical discectomy and fusion (ACDF) surgery. SUMMARY OF BACKGROUND DATA: ADI, a comprehensive neighborhood-level measure of socioeconomic disadvantage, has been shown to be associated with worse perioperative outcomes in a variety of surgical settings. MATERIALS AND METHODS: The Maryland Health Services Cost Review Commission Database was queried to identify patients who underwent primary elective ACDF between 2013 and 2020 in the state. Patients were stratified into tertiles by ADI, from least disadvantaged (ADI1) to most disadvantaged (ADI3). The primary endpoints were ACDF utilization rates per 100,000 adults and episode-of-care total costs. Univariable and multivariable regression analyses were performed. RESULTS: A total of 13,362 patients (4984 inpatient and 8378 outpatient) underwent primary ACDF during the study period. In our study, there were 2,401 (17.97%) patients residing in ADI1 neighborhoods (least deprived), 5974 (44.71%) in ADI2, and 4987 (37.32%) in ADI3 (most deprived). Factors associated with increased surgical utilization were increasing ADI, outpatient surgical setting, non-Hispanic ethnicity, current tobacco use, and diagnoses of obesity and gastroesophageal reflux disease. Factors associated with lower surgical utilization were: non-white race, rurality, Medicare/Medicaid insurance status, and diagnoses of cervical disk herniation or myelopathy. Factors associated with higher costs of care were increasing ADI, older age, Black/African American race, Medicare or Medicaid insurance, former tobacco use, and diagnoses of ischemic heart disease and cervical myelopathy. Factors associated with lower costs of care were outpatient surgical setting, female sex, and diagnoses of gastroesophageal reflux disease and cervical disk herniation. CONCLUSIONS: Neighborhood socioeconomic deprivation is associated with increased episode-of-care costs in patients undergoing ACDF surgery. Interestingly, we found greater utilization of ACDF surgery among patients with higher ADI. LEVEL OF EVIDENCE: 3.

The Statistical Fragility of Trials Comparing Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion: A Meta Analysis.

STUDY DESIGN: Meta-analysis. OBJECTIVE: Assess the robustness of randomized controlled trials (RCTs) that compared cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative cervical pathology by using fragility indices. SUMMARY OF BACKGROUND DATA: RCTs comparing these surgical approaches have shown that CDA may be equivalent or even superior to ACDF due to better preservation of normal spinal kinematics. METHODS: RCTs reporting clinical outcomes after CDA versus ACDF for degenerative cervical disc disease were evaluated. Data for outcome measures were classified as continuous or dichotomous. Continuous outcomes included: Neck Disability Index (NDI), overall pain, neck pain, radicular arm pain, and modified Japanese Orthopaedic Association (mJOA) scores. Dichotomous outcomes included: any adjacent segment disease (ASD), superior-level ASD, and inferior-level ASD. The fragility index (FI) and continuous FI (CFI) were determined for dichotomous and continuous outcomes, respectively. The corresponding fragility quotient (FQ) and continuous FQ (CFQ) were calculated by dividing FI/CFI by sample size. RESULTS: Twenty-five studies (78 outcome events) were included. Thirteen dichotomous events had a median FI of 7 (IQR: 3-10) and the median FQ was 0.043 (IQR: 0.035-0.066). Sixty-five continuous events had a median CFI of 14 (IQR: 9-22) and median CFQ of 0.145 (IQR: 0.074-0.188). This indicates that, on average, altering the outcome of 4.3 patients out of 100 for the dichotomous outcomes, and 14.5 out of 100 for continuous outcomes, would reverse trial significance. Of the 13 dichotomous events that included lost to follow-up data, 8 (61.5%) represented ≥7 patients lost. Of the 65 continuous events reporting lost to follow-up data, 22 (33.8%) represented ≥14 patients lost. CONCLUSION: RCTs comparing ACDF and CDA have fair to moderate statistical robustness and do not suffer from statistical fragility.

Pain Self-Efficacy (PSEQ) score of <22 is associated with daily opioid use, back pain, disability, and PROMIS scores in patients presenting for spine surgery.

BACKGROUND CONTEXT: Pain self-efficacy, or the belief that one can carry out activities despite pain, has been shown to be associated with back and neck pain severity. However, the literature correlating psychosocial factors to opioid use, barriers to proper opioid use, and Patient-Reported Outcome Measurement Information System (PROMIS) scores is sparse. PURPOSE: The primary aim of this study was to determine whether pain self-efficacy is associated with daily opioid use in patients presenting for spine surgery. The secondary aim was to determine whether there exists a threshold self-efficacy score that is predictive of daily preoperative opioid use and subsequently to correlate this threshold score with opioid beliefs, disability, resilience, patient activation, and PROMIS scores. PATIENT SAMPLE: Five hundred seventy-eight elective spine surgery patients (286 females; mean age of 55 years) from a single institution were included in this study. STUDY DESIGN/SETTING: Retrospective review of prospectively collected data. OUTCOME MEASURES: PROMIS scores, daily opioid use, opioid beliefs, disability, patient activation, resilience. METHODS: Elective spine surgery patients at a single institution completed questionnaires preoperatively. Pain self-efficacy was measured by the Pain Self-Efficacy Questionnaire (PSEQ). Threshold linear regression with Bayesian information criteria was utilized to identify the optimal threshold associated with daily opioid use. Multivariable analysis controlled for age, sex, education, income, and Oswestry Disability Index (ODI) and PROMIS-29, version 2 scores. RESULTS: Of 578 patients, 100 (17.3%) reported daily opioid use. Threshold regression identified a PSEQ cutoff score of <22 as predictive of daily opioid use. On multivariable logistic regression, patients with a PSEQ score <22 had two times greater odds of being daily opioid users than those with a score ≥22. Further, PSEQ <22 was associated with lower patient activation; increased leg and back pain; higher ODI; higher PROMIS pain, fatigue, depression, and sleep scores; and lower PROMIS physical function and social satisfaction scores (p<.05 for all). CONCLUSIONS: In patients presenting for elective spine surgery, a PSEQ score of <22 is associated with twice the odds of reporting daily opioid use. Further, this threshold is associated with greater pain, disability, fatigue, and depression. A PSEQ score <22 can identify patients at high risk for daily opioid use and can guide targeted rehabilitation to optimize postoperative quality of life.

Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial-using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME).

BACKGROUND: The OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered. METHODS: The FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants' motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments. RESULTS: Modifications were developed with input from the trial's patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions' core functions. Modifications were approved by the study funder and the trial steering committee. CONCLUSIONS: Full and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial's eventual results and considering future implementation efforts. TRIAL REGISTRATION: ClinicalTrials.gov NCT03859713. Registered on March 1, 2019.

Preoperative characteristics are associated with increased likelihood of low early postoperative mobility after adult spinal deformity surgery.

BACKGROUND CONTEXT: Low early postoperative mobility (LEPOM) has been shown to be associated with increased length of hospital stay, complication rates, and likelihood of nonhome discharge. However, few studies have examined preoperative characteristics associated with LEPOM in adult spinal deformity (ASD) patients. PURPOSE: To investigate which preoperative patient characteristics may be associated with LEPOM after ASD surgery. DESIGN: Retrospective review. PATIENT SAMPLE: Included were 86 ASD patients with fusion of ≥5 levels for whom immediate-postoperative AM-PAC Basic Mobility Inpatient Short Form (6-Clicks) scores had been obtained. OUTCOME MEASURES: The primary outcome of this study was the likelihood of LEPOM, defined as an AM-PAC score ≤15, which is associated with inability to stand for more than 1 minute. METHODS: Significant cutoffs for preoperative characteristics associated with LEPOM were determined via threshold linear regression. Multivariable logistic regression was used to assess the impact of preoperative characteristics on the likelihood of LEPOM. RESULTS: LEPOM was recorded in 38 patients (44.2%). Threshold regression identified the following cutoffs to be associated with LEPOM: preoperative Patient Reported Outcomes Measurement Information System (PROMIS) scores of ≥68 for Pain, <28.3 for Physical Function, and ≥63.4 for Anxiety; preoperative Oswestry disability index (ODI) score of ≥60; and body mass index (BMI) of ≥35.2. On multivariate analysis, preoperative PROMIS scores of ≥68 for Pain (odds ratio [OR] 5.3, confidence interval [CI] 1.2-22.8, p=.03), <28.3 for Physical Function (OR 10.1, CI 1.8-58.2, p=.01), and ≥63.4 for Anxiety (OR 4.7, CI 1.1-20.8, p=.04); preoperative ODI score ≥60 (OR 38.8, CI 4.0-373.6, p=.002); BMI ≥35.2 (OR 14.2, CI 1.3-160.0, p=.03), and male sex (OR 5.4, CI 1.2-23.7, p=.03) were associated with increased odds of LEPOM. CONCLUSIONS: Preoperative PROMIS Pain, Physical Function, and Anxiety scores; ODI score; BMI; and male sex were associated with LEPOM. Several of these characteristics are modifiable risk factors and thus may be candidates for optimization before surgery. LEVEL OF EVIDENCE: III.

Concurrent Validity of PROMIS With DASH and DVPRS in Transhumeral Amputees.

BACKGROUND: We sought to assess whether select domains of the Patient-Reported Outcomes Measurement Information System (PROMIS) significantly correlate with the Disabilities of the Arm, Shoulder, and Hand (DASH) score and the Defense and Veterans Pain Rating Scale (DVPRS) among transhumeral amputees. METHODS: We prospectively administered DASH, DVPRS, and PROMIS (including Upper Extremity, Pain Interference, and Pain Behavior domains) testing to patients presenting for consideration of osseointegration after transhumeral amputation. Concurrent validity was assessed via Pearson correlation testing. RESULTS: The mean DASH score of the cohort was 32.8. The mean DVPRS score was 1.8. The mean PROMIS scores were 33.8, 50.5, and 50.6 for Upper Extremity, Pain Interference, and Pain Behavior domains, respectively. Pearson testing demonstrated a significant, inverse correlation between DASH and PROMIS Upper Extremity scores (r = -0.85, P = .002). There was also significant correlation between DVPRS and PROMIS Pain Interference scores (r = 0.69, P = .03). The PROMIS Pain Behavior domain did not significantly correlate with either DASH or DVPRS. CONCLUSIONS: Patient-Reported Outcomes Measurement Information System Upper Extremity and Pain Interference scores demonstrated significant concurrent validity with traditional measures (DASH and DVPRS) of patient-reported outcome in our population of transhumeral amputees.

Preoperative patient activation predicts minimum clinically important difference for PROMIS pain and physical function in patients undergoing elective spine surgery.

BACKGROUND CONTEXT: Patient activation is a patient's willingness to take independent actions to manage their own health care. PURPOSE: The goal of this study is to determine whether preoperative patient activation measure (PAM) predicts minimum clinically important difference (MCID) for Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function, depression, and anxiety for patients undergoing elective spine surgery. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: A single-institution, academic database of patients undergoing elective spine surgery. OUTCOME MEASURE: MCID at 1-year follow-up for PROMIS pain, physical function, depression and anxiety. METHODS: We retrospectively reviewed a single-institution, academic database of patients undergoing elective spine surgery. Preoperative patient activation was evaluated using the PAM-13 survey, which was used to stratify patients into four activation stages. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on PROMIS pain and the physical function. RESULTS: Of the 430 patients, 220 (51%) were female with a mean age of 58.2±16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year follow up, 248 (58%) achieved MCID for PROMIS physical function, 256 (60%) achieved MCID for PROMIS pain, 151 (35.28%) achieved MCID for PROMIS depression, and 197 (46%) achieved MCID for PROMIS anxiety. For PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.49, 95% CI:1.27, 9.59), stage 3 (aOR:3.54, 95% CI:1.40, 8.98) and stage 4 (aOR:7.88, 95% CI:3.29, 18.9) were more likely to achieve MCID. For PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.82, 95% CI:1.18, 6.76) and stage 4 (aOR:5.44, 95% CI:2.41, 12.3) were more likely to achieve MCID. For PROMIS depression, when compared against patients at stage 1, patients at stage 4 were more likely to achieve MCID (Adjusted Odds Ratio (aOR):2.59, 95% CI:1.08-6.19). For PROMIS anxiety, when compared against patients at stage 1, stage 3 (Adjusted Odds Ratio (aOR):3.21, 95% CI:1.20-8.57), and stage 4 (aOR:5.56, 95% CI:2.20-14.01) were more likely to achieve MCID. CONCLUSION: Patients at higher stages of activation were more likely to achieve MCID for PROMIS pain, physical function, depression, and anxiety at 1-year follow-up. Routine preoperative assessment of patient activation may help identify patients at risk of poor outcomes.

Listening to the elephant in the room: response-shift effects in clinical trials research.

BACKGROUND: While a substantial body of work postulates that adaptation (response-shift effects) may serve to hide intervention benefits, much of the research was conducted in observational studies, not randomized-controlled trials. This scoping review identified all clinical trials that addressed response shift phenomena, and characterized how response-shift effects impacted trial findings. METHODS: A scoping review was done of the medical literature from 1968 to 2021 using as keywords "response shift" and "clinical trial." Articles were included if they were a clinical trial that explicitly examined response-shift effects; and excluded if they were not a clinical trial, a full report, or if response shift was mentioned only in the discussion. Clinical-trials papers were then reviewed and retained in the scoping review if they focused on randomized participants, showed clear examples of response shift, and used reliable and valid response-shift detection methods. A synthesis of review results further characterized the articles' design characteristics, samples, interventions, statistical power, and impact of response-shift adjustment on treatment effect. RESULTS: The search yielded 2148 unique references, 25 of which were randomized-controlled clinical trials that addressed response-shift effects; 17 of which were retained after applying exclusion criteria; 10 of which were adequately powered; and 7 of which revealed clinically-important response-shift effects that made the intervention look significantly better. CONCLUSIONS: These findings supported the presumption that response shift phenomena obfuscate treatment benefits, and revealed a greater intervention effect after integrating response-shift related changes. The formal consideration of response-shift effects in clinical trials research will thus not only improve estimation of treatment effects, but will also integrate the inherent healing process of treatments. KEY POINTS: This scoping review supported the presumption that response shift phenomena obfuscate treatment benefits and revealed a greater intervention effect after integrating response-shift related changes. The formal consideration of response-shift effects in clinical trials research will not only improve estimation of treatment effects but will also integrate the inherent healing process of treatments.

The impact of low back pain and vigorous activity on mental and physical health outcomes in older adults with arthritis.

Background: Nearly 50% of Americans aged 65 and above have been diagnosed with arthritis and an estimated 80% of adults experience low back pain (LBP). Little is known about the experience of LBP in older adults with arthritis and its relationships with mental and physical health. Objective: In this study, we examined the relationships between LBP and four physical and mental health conditions (psychological distress, insomnia, mobility limitations, and self-rated health) in older adults with arthritis in the National Health and Aging Trends Study (NHATS). We also examined whether vigorous exercise mediated the relationships between LBP and these four conditions. Materials and Methods: The data from this study comes from waves five through nine of the NHATS. The sample size ranged from 3,490 to 2,026 across these waves. All variables in this study are based on self-report. We used descriptive analyses including means and standard deviations for continuous variables or frequencies and proportions for demographic data. We used structural equation modeling (SEM) to examine if vigorous activity mediated the relationship between LBP with the four conditions. Results: The age range of the sample was 65 years of age and older. Among those with back pain 78.53% had no mobility limitations. There was a significant relationship between LBP with insomnia (B = 0.48, p < 0.001), perceived health status (B = -0.38, p < 0.0010), and psychological distress (0.67, p < 0.001). Activity mediated the relationship between LBP and insomnia, psychological distress and physical health in adjusted models. Discussion: The presence of low back pain in older adults with arthritis increases the risk of insomnia, psychological distress, mobility limitations, and poorer self-rated health. Consequently, targeting comorbid LBP may be an important component of the treatment plans of older adults with arthritis. In addition, providers of patients with arthritis and LBP should conduct routine assessments of mental and physical health to ensure the LBP is being adequately addressed.

Initial presentation for acute low back pain: is early physical therapy associated with healthcare utilization and spending? A retrospective review of a National Database.

BACKGROUND: Early initiation of physical therapy (PT) has been associated with lower healthcare costs and utilization; however, these studies have been limited to single institutions or healthcare systems. Our goal was to assess healthcare utilization and spending among patients who present for the first time with low back pain (LBP), according to whether they received early physical therapy (PT), using a large, nationwide sample; and geographic variation in rates of early PT and 30-day LBP-related spending. METHODS: Using the Truven MarketScan database, we identified nearly 980,000 US adults ages 18-64 years who initially presented with acute LBP from 2010 through 2014 and did not have nonmusculoskeletal causes of LBP. Approximately 110,000 patients (11%) received early PT (≤2 weeks after presentation). We compared healthcare utilization and spending at 30 days and 1 year after presentation between patients who received early PT and those who did not. Alpha = 0.05. RESULTS: At 30 days, early PT was associated with lower odds of chiropractor visits (odds ratio [OR] = 0.41, 95% confidence interval [CI] = 0.40-0.42), pain specialist visits (OR = 0.49, 95% CI = 0.47-0.51), emergency department visits (OR = 0.51, 95% CI = 0.49-0.54), advanced imaging (OR = 0.57, 95% CI = 0.56-0.58), orthopaedist visits (OR = 0.67, 95% CI = 0.66-0.69), and epidural steroid injections (OR = 0.68, 95% CI = 0.65-0.70). At 1 year, early PT was associated with less healthcare utilization. At 30 days, patients with early PT had lower mean LBP-related spending ($1180 ± $1500) compared with those without early PT ($1250 ± $2560) (P < 0.001). At 1 year, LBP-related spending was significantly less among patients who did not receive early PT ($2510 ± $3826) versus those who did ($2588 ± $3704). Early PT rates (range, 4-25%; P < 0.001) and 30-day LBP-related spending differed by state (range, $421 to -$410; P < 0.001). CONCLUSION: Early PT for acute LBP was associated with less 30-day and 1-year healthcare utilization and less 30-day LBP-related spending. Early PT rates and 30-day spending differed by US state. LEVEL OF EVIDENCE: IV.