Patient-reported Physical Function Research Articles

Association of prolonged symptom duration with poor outcomes in lumbar spine surgery: a Michigan Spine Surgery Improvement Collaborative study.

There is a scarcity of large multicenter data on how preoperative lumbar symptom duration relates to postoperative patient-reported outcomes (PROs). The objective of this study was to determine the effect of preoperative and baseline symptom duration on PROs at 90 days, 1 year, and 2 years after lumbar spine surgery. The Michigan Spine Surgery Improvement Collaborative registry was queried for all lumbar spine operations between January 1, 2017, to December 31, 2021, with a follow-up of 2 years. Patients were stratified into three subgroups based on symptom duration: < 3 months, 3 months to < 1 year, and ≥ 1 year. The primary outcomes were reaching the minimal clinically important difference (MCID) for the PROs (i.e., leg pain, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), EQ-5D, North American Spine Society satisfaction, and return to work). The EQ-5D score was also analyzed as a continuous variable to calculate quality-adjusted life years. Multivariable Poisson generalized estimating equation models were used to report adjusted risk ratios, with the < 3-month cohort used as the reference. There were 37,223 patients (4670 with < 3-month duration, 9356 with 3-month to < 1-year duration, and 23,197 with ≥ 1-year duration) available for analysis. Compared with patients with a symptom duration of < 1 year, patients with a symptom duration of ≥ 1 year were significantly less likely to achieve an MCID in PROMIS PF, EQ-5D, back pain relief, and leg pain relief at 90 days, 1 year, and 2 years postoperatively. Similar trends were observed for patient satisfaction and return to work. With the EQ-5D score as a continuous variable, a symptom duration of ≥ 1 year was associated with 0.04, 0.05, and 0.03 (p < 0.001) decreases in EQ-5D score at 90 days, 1 year, and 2 years after surgery, respectively. A symptom duration of ≥ 1 year was associated with poorer outcomes on several outcome metrics. This suggests that timely referral and surgery for degenerative lumbar pathology may optimize patient outcome.

Using bookmarking methods with orthopedic clinicians and patients with fractures produces score interpretation labels for patient-reported outcome measures

ObjectiveThe objective of this study was to determine the patient-reported outcome measure (PROM) score ranges associated with descriptive labels (i.e., within normal limits, mild, moderate, severe) by using bookmarking methods with orthopedic clinicians and patients who have experienced a bone fracture.Study design and settingWe created vignettes comprised of six items and responses from the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function, Physical Function, and Pain Interference item banks reflecting different levels of severity. Two groups of patients with fractures (n = 11) and two groups of orthopedic clinicians (n = 16) reviewed the vignettes and assigned descriptive labels independently and then discussed as a group until reaching consensus via a videoconference platform.ResultsPROMIS Physical Function and Pain Interference thresholds (T = 50, 40, 25/30 and T = 50/55, 60, 65/70, respectively) for patients with bone fractures were consistent with the results from other patient populations. Upper Extremity thresholds were about 10 points (1 SD) more severe (T = 40, 30, 25/20) compared to the other measures. Patient and clinician perspectives were similar.ConclusionBookmarking methods generated meaningful score thresholds for PROMIS measures. These thresholds between severity categories varied by domain. Threshold values for severity represent important supplemental information to interpret PROMIS scores clinically.

Differences in Time to Achieve Minimum Clinically Important Difference Between Patients Undergoing Anterior Cervical Discectomy and Fusion and Cervical Disc Replacement

To compare patients undergoing anterior cervical discectomy and fusion (ACDF) versus cervical disc replacement (CDR) for time to minimum clinically important difference (MCID) achievement and predictors of delayed MCID achievement for the patient-reported outcomes (PROs), Patient-Reported Outcomes Measurement Information System Physical Function, Neck Disability Index, Visual Analog Scale (VAS) neck, and VAS arm. PROs of patients undergoing ACDF or CDR were collected preoperatively and postoperatively at 6-week/12-week/6-month/1-year/2-year periods. MCID achievement was calculated through comparison of changes in Patient-Reported Outcomes Measurement to previously established values in literature. Time to MCID achievement and predictors for delayed MCID achievement were determined through Kaplan-Meier survival analysis and multivariable Cox regression, respectively. One hundred ninety-seven patients were identified, with 118 and 79 undergoing ACDF and CDR, respectively. Kaplan-Meier survival analysis demonstrated faster time to achieve MCID for CDR patients in Patient-Reported Outcomes Measurement Information System Physical Function (P= 0.006). Early predictors of MCID achievement through Cox regression were CDR procedure, Asian ethnicity, elevated preoperative PROs of VAS neck and VAS arm (hazard ratio, 1.16-7.28). Workers' compensation was a late predictor of MCID achievement (hazard ratio, 0.15). Most patients achieved MCID in physical function, disability, and back pain outcomes within 2 years of surgery. Patients undergoing CDR achieved MCID faster in physical function. Early predictors of MCID achievement were CDR procedure, Asian ethnicity, and elevated preoperative PROs of pain outcomes. Workers' compensation was a late predictor. These findings may be helpful in managing patient expectations.

Does Baseline Severity of Arm Pain Influence Outcomes Following Single-Level Anterior Cervical Discectomy and Fusion?

Retrospective cohort. To assess preoperative arm pain severity influence on postoperative patient-reported outcomes measures (PROMs) and minimal clinically important difference (MCID) achievement following single-level anterior cervical discectomy and fusion (ACDF). There is evidence that preoperative symptom severity can affect postoperative outcomes. Few have evaluated this association between preoperative arm pain severity and postoperative PROMs and MCID achievement following ACDF. Individuals undergoing single-level ACDF were identified. Patients were grouped by preoperative Visual Analog Scale (VAS) arm ≤8 vs. >8. PROMs collected preoperatively and postoperatively included VAS-arm/VAS-neck/Neck Disability Index (NDI)/12-item Short Form (SF-12) Physical Composite Score (PCS)/SF-12 mental composite score (MCS)/Patient-Reported Outcomes Measurement Information System physical function (PROMIS-PF). Demographics, PROMs, and MCID rates were compared between cohorts. A total of 128 patients were included. The VAS arm ≤8 cohort significantly improved for all PROMs excepting VAS arm at 1-year/2-years, SF-12 MCS at 12-weeks/1-year/2-years, and SF-12 PCS/PROMIS-PF at 6-weeks, only (p ≤0.021, all). The VAS arm >8 cohort significantly improved for VAS neck at all timepoints, VAS arm from 6-weeks to 1-year, NDI from 6-weeks to 6-months, and SF-12 MCS/PROMIS-PF at 6-months (p ≤0.038, all). Postoperatively, the VAS arm >8 cohort had higher VAS-neck (6 weeks/6 months), VAS-arm (12 weeks/6 months), NDI (6 weeks/6 months), lower SF-12 MCS (6 weeks/6 months), SF-12 PCS (6 months), and PROMISPF (12 weeks/6 months) (p ≤0.038, all). MCID achievement rates were higher among the VAS arm >8 cohort for the VAS-arm at 6-weeks/12-weeks/1-year/overall and NDI at 2 years (p ≤0.038, all). Significance in PROM score differences between VAS arm ≤8 vs. >8 generally dissipated at the 1-year and 2-year timepoint, although higher preoperative arm pain patients suffered from worse pain, disability, and mental/physical function scores. Furthermore, clinically meaningful rates of improvement were similar throughout the vast majority of timepoints for all PROMs studied.

Patients with and without COVID-19 in the Intensive Care Unit: Physical Status Outcome Comparisons 3Months after Discharge.

Many patients with COVID-19 infections were admitted to an intensive care unit (ICU). Physical impairments are common after ICU stays and are associated with clinical and patient characteristics. To date, it is unknown if physical functioning and health status are comparable between patients in the ICU with COVID-19 and patients in the ICU without COVID-19 3months after ICU discharge. The primary objective of this study was to compare handgrip strength, physical functioning, and health status between patients in the ICU with COVID-19 and patients in the ICU without COVID-19 3months after ICU discharge. The second objective was to identify factors associated with physical functioning and health status in patients in the ICU with COVID-19. In this observational, retrospective chart review study, handgrip strength (handheld dynamometer), physical functioning (Patient-Reported Outcomes Measurement Information System Physical Function), and health status (EuroQol 5 Dimension 5 Level) were compared between patients in the ICU with COVID-19 and patients in the ICU without COVID-19 using linear regression. Multilinear regression analyses were used to investigate whether age, sex, body mass index, comorbidities in medical history (Charlson Comorbidity Index), and premorbid function illness (Identification of Seniors At Risk-Hospitalized Patients) were associated with these parameters in patients in the ICU with COVID-19. In total, 183 patients (N = 92 with COVID-19) were included. No significant between-group differences were found in handgrip strength, physical functioning, and health status 3months after ICU discharge. The multilinear regression analyses showed a significant association between sex and physical functioning in the COVID-19 group, with better physical functioning in men compared with women. Current findings suggest that handgrip strength, physical functioning, and health status are comparable for patients who were in the ICU with COVID-19 and patients who were in the ICU without COVID-19 3months after ICU discharge. Aftercare in primary or secondary care in the physical domain of postintensive care syndrome after ICU discharge in patients with COVID-19 and in patients without COVID-19 who had an ICU length of stay >48hours is recommended. Patients who were in the ICU with and without COVID-19 had a lower physical status and health status than healthy people, thus requiring personalized physical rehabilitation. Outpatient aftercare is recommended for patients with an ICU length of stay >48hours, and functional assessment is recommended 3months after hospital discharge.

Perioperative Predictors in Patients Undergoing Lateral Lumbar Interbody Fusion for Minimum Clinically Important Difference Achievement

To identify perioperative predictors of minimum clinically important difference (MCID) for patients undergoing lateral lumbar interbody fusion (LLIF) for the patient-reported outcome measures (PROMs) of Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), Visual Analog Scale (VAS) Back, VAS Leg, Oswestry Disability Index (ODI), and Patient Health Questionnaire-9 (PHQ-9). Patients undergoing LLIF were identified through retrospective review of a single-surgeon database. Overall MCID achievement was determined as the number of unique patients achieving ΔPROM thresholds of PROMIS-PF=4.5, VAS Back=2.1, VAS Leg=2.8, ODI=14.9, and PHQ-9=3.0 over a 2-year postoperative time period. Univariate and multivariable logistic regression were utilized to determine perioperative predictors for MCID achievement. Two-hundred and ninety patients were identified. For PROMIS-PF MCID achievement, increased preoperative PROMIS-PF and POD 1 VAS pain were significant negative predictors. For VAS Back, primary fusion with revision decompression was a negative predictor, while increased preoperative VAS Back was a positive predictor of MCID achievement. For VAS Leg, increased preoperative VAS Leg was a positive predictor. For ODI, increased POD 0 VAS pain was a negative predictor, while increased preoperative ODI was a positive predictor. For PHQ-9, increased preoperative PHQ-9 was a positive predictor. In patients undergoing LLIF, perioperative predictors for MCID achievement were highly dependent on PROM. Preoperative PROM was the most consistent perioperative predictor for achieving MCID. Elevated acute postoperative pain and primary fusion after failed index decompression were significant predictors of failing to achieve MCID. Surgeons may use these findings in prognostication and management of postoperative expectations.

Poor mental health scores correlate with inferior outcomes following minimally invasive transforaminal lumbar interbody fusion.

Limited spine literature has studied the strength of association of mental health with other outcomes at time of survey collection. We aim to evaluate the degree to which mental health correlates with outcomes in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) at several postoperative periods. Patients having undergone elective MIS-TLIF were searched within a retrospective single-surgeon database. Five hundred eighty-five patients were included. Patient-reported outcomes (PROs) including Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF), 12-item Short Form Physical Component Score (SF-12 PCS) and Mental Component Score (SF-12 MCS), Patient Health Questionnaire-9 (PHQ-9), Visual Analog Scale (VAS) back and leg pain, and Oswestry Disability Index (ODI) scores were collected preoperatively and at 6-week, 12-week, 6-month, 1-year, and 2-year periods. Pearson's correlation tests were used to evaluate the association between both SF-12 MCS and PHQ-9 scores to other PROs at each period. SF-12 MCS correlated with PROMIS PF (|r|= 0.308-0.531), SF-12 PCS (|r|= 0.207-0.328), VAS back (|r|= 0.279-0.474), VAS leg (|r|= 0.178-0.395), and ODI (|r|= 0.450-0.538) at all time points (P ≤ 0.021, all) except for preoperative SF-12 PCS and 1-year VAS leg. PHQ-9 correlated with PROMIS PF (|r|= 0.366-0.701), SF-12 PCS (|r|= 0.305-0.568), VAS back (|r|= 0.362-0.714), VAS leg (|r|= 0.319-0.694), and ODI (|r|= 0.613-0.784) at all periods (P < 0.001, all). Poor mental health scores were correlated with lower physical function, elevated pain scores, and higher disability. PHQ-9 scores demonstrated stronger correlation in all relationships compared to SF-12 MCS. Optimization of patient mental health may lead to improved patient perception regarding function, pain, and disability following MIS-TLIF.

Neck Disability Index as a Prognostic Factor for Outcomes Following Cervical Disc Replacement.

Retrospective review. We aim to elucidate the potential relationship between neck disability index (NDI) and outcomes following cervical disk replacement (CDR). The use of preoperative disability scores as predictors of outcomes following spine surgery has previously been studied, yet no literature has been published regarding its use in CDR. A retrospective database of a single orthopedic spine surgeon was searched for single-level CDR patients with preoperative NDI scores, excluding those with trauma, infection, or malignancy. Patients were separated into 2 cohorts by NDI score: Mild-Moderately Disabled (MD) (NDI<50) and Severely Disabled (NDI≥50). Patient-reported outcome measures were collected and compared within and between groups up to 1 year postoperatively and included Patient-reported Outcome Measurement Information System Physical Function, 12-Item Short Form (SF-12) Physical Component Score and Mental Component Score, visual analog scale (VAS) neck and arm pain, and NDI. MCID achievement rates were compared between the groups. All PROM scores significantly improved for both cohorts at one or more postoperative time points compared with preoperative baseline ( P ≤0.049, all), with the exception of SF-12 Mental Component Score, which only significantly improved in the MD cohort at 2 postoperative points ( P ≤0.007, both). Between groups, the MD cohort reported significantly superior scores at one or more time points for all studied patient-reported outcome measures ( P ≤0.047, all). MCID achievement rate did not significantly vary for any outcome at any time between cohorts. Regardless of preoperative disability, both groups reported improvement in physical function, pain, and disability scores following CDR. While not finding significance, patients with severe disability preoperatively consistently demonstrated higher minimal clinically important difference achievement in NDI. These data do not promote the use of NDI as a prognostic factor for outcomes following CDR. Further study with larger patient populations may be useful to clarify this potential relationship.

The Influence of Workers' Compensation Status on Patient-Reported Outcomes after Cervical Disc Arthroplasty at an Ambulatory Surgical Center.

Workers' compensation (WC) status tends to negatively affect patient outcomes in spine surgery. This study aims to evaluate the potential effect of WC status on patient-reported outcomes (PROs) after cervical disc arthroplasty (CDR) at an ambulatory surgical center (ASC). A single-surgeon registry was retrospectively reviewed for patients who had undergone elective CDR at an ASC. Patients with missing insurance data were excluded. Propensity score-matched cohorts were generated by the presence or lack of WC status. PROs were collected preoperatively and at 6-week, 12-week, 6-month, and 1-year time points. PROs included the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), visual analog scale (VAS) neck and arm pain, and Neck Disability Index. PROs were compared within and between groups. Minimum clinically important difference (MCID) achievement rates were compared between groups. Sixty-three patients were included, with 36 without WC (non-WC) and 27 with WC. The non-WC cohort demonstrated postoperative improvement in all PROs at all time points, with the exception of VAS arm past the 12-week point ( P ≤ 0.030, all). The WC cohort demonstrated postoperative improvement in VAS neck at 12-week, 6-month, and 1-year time points ( P ≤ 0.025, all). The WC cohort improved in VAS arm and Neck Disability Index at the 12-week and 1-year points as well ( P ≤ 0.029, all). The non-WC cohort reported superior PRO scores in every PRO at one or more postoperative time points ( P ≤ 0.046, all). The non-WC cohort demonstrated higher rates of minimum clinically important difference achievement in PROMIS-PF at 12 weeks ( P ≤ 0.024). Patients with WC status undergoing CDR at an ASC may report inferior pain, function, and disability outcomes compared with those with private or government-provided insurance. Perceived inferior disability in WC patients persisted into the long-term follow-up period (1 year). These findings may aid surgeons in setting realistic preoperative expectations with patients at risk of inferior outcomes.

Physical and mental health of breast cancer patients and survivors before and during successive SARS-CoV-2-infection waves

PurposeDuring the first SARS-CoV-2-infection wave, a deterioration in emotional well-being and increased need for mental health care were observed among patients treated or being treated for breast cancer. In this follow-up study, we assessed patient-reported quality of life (QoL), physical functioning, and psychosocial well-being during the second SARS-CoV-2-infection wave in a large, representative cohort.MethodsThis longitudinal cohort study was conducted within the prospective, multicenter UMBRELLA breast cancer cohort. To assess patient-reported QoL, physical functioning and psychosocial well-being, COVID-19-specific surveys were completed by patients during the first and second SARS-CoV-2-infection waves (April and November 2020, respectively). An identical survey was completed by a comparable reference population during the second SARS-CoV-2-infection waves. All surveys included the validated EORTC-QLQ-C30/BR23, HADS and “De Jong-Gierveld Loneliness” questionnaires. Pre-COVID-19 EORTC-QLQ-C30/BR23 and HADS outcomes were available from UMBRELLA. Response rates were 69.3% (n = 1106/1595) during the first SARS-CoV-2-infection wave and 50.9% (n = 822/1614) during the second wave. A total of 696 patients responded during both SARS-CoV-2-infection waves and were included in the analysis comparing patient-reported outcomes (PROs) during the second SARS-CoV-2-infection wave to PROs during the first wave. Moreover, PROs reported by all patients during the second SARS-CoV-2-infection wave (n = 822) were compared to PROs of a similar non-cancer reference population (n = 241) and to their pre-COVID-19 PROs.ResultsPatient-reported QoL, physical functioning, and psychosocial well-being of patients treated or being treated for breast cancer remained stable or improved from the first to the second SARS-CoV-2-infection wave. The proportion of emotional loneliness reduced from 37.6 to 29.9% of patients. Compared to a similar non-cancer reference population, physical, emotional, and cognitive functioning, future perspectives and symptoms of dyspnea and insomnia were worse in patients treated or being treated for breast cancer during the second SARS-CoV-2-infection wave. PROs in the second wave were similar to pre-COVID-19 PROs.ConclusionAlthough patients scored overall worse than individuals without breast cancer, QoL, physical functioning, and psychosocial well-being did not deteriorate between the first and second wave. During the second wave, PROs were similar to pre-COVID-19 values. Overall, current findings are cautiously reassuring for future mental health of patients treated or being treated for breast cancer.

487 Clinical Outcomes of Decompressive Spine Surgery for Painless Cervical Myelopathy: An Analysis of the Michigan Spine Surgery Improvement Collaborative (MSSIC) Registry

INTRODUCTION: Cervical myelopathy (CM) is the occurrence of neurologic dysfunction secondary to any etiology that results in direct cervical spinal cord compression. Although axial neck pain and radicular arm pain are common presenting features in CM, some patients present atypically with myelopathic symptoms in the absence of neck or arm pain. To date, little is known regarding the outcomes of surgical decompression in these patients. METHODS: This is a retrospective study of prospectively collected data from the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry. A total of 340 patients undergoing spine surgery for painless CM were analyzed. Surgical and patient reported outcomes, including minimal clinically important difference (MCID) in modified Japanese Orthopedic Association (mJOA) scores and Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores, were assessed at 90 days, 1 year, and 2 years postoperatively. RESULTS: At 90 days following surgery, a MCID in PROMIS PF and mJOA scores was seen in 42% and 36% of patients, respectively. The proportion of patients with MCID in mJOA scores remained stable at 1- and 2-year follow-up, while the percentage of patients with MCID in PROMIS PF scores decreased to 22% at two years post-operatively. When stratifying by pre-operative CM severity, patient reported outcomes and surgical complications did not significantly vary. Importantly, patient satisfaction remained above 80% at 90 days, 1 year, and 2 years after surgery. CONCLUSIONS: Following surgical intervention, clinically significant improvement was seen in a modest number of patients. The high degree of sustained patient satisfaction suggests that our measured outcomes may not accurately capture the degree of improvement that is important to patients, or it may represent happiness from not experiencing further functional decline.

Establishing Minimum Clinically Important Difference Thresholds for Physical Function and Pain in Patients Undergoing Anterior Lumbar Interbody Fusion

To establish minimum clinically important difference (MCID) in anterior lumbar interbody fusion (ALIF) for the physical function patient-reported outcome measures, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), 12-Item Short Form (SF-12) physical component score (PCS), Veterans RAND 12 (VR-12) PCS, and pain patient-reported outcome measures visual analog scale (VAS) back and VAS leg through anchor- and distribution-based calculations. Patients undergoing ALIF with preoperative and 6-month Oswestry Disability Index were included. Using Oswestry Disability Index as the anchor, anchor-based calculation methods were the average change, minimum detectable change, and receiver operating characteristic curve methods. Distribution-based methods were the standard error of measurement, reliable change index, effect size, and half of the standard deviation (0.5ΔSD). Fifty-one patients were identified. Anchor-based methods ranged from 2.9 to 11.5 for PROMIS-PF, 8.2-13.6 for SF-12 PCS, 7.8-16.8 for VR-12 PCS, 0.5-3.9 for VAS back, and 1.0-3.4 for VAS leg. The area under curve ranged from 0.59 (VAS back) to 0.78 (VR-12 PCS). Distribution-based methods ranged from 1.0 to 4.2 for PROMIS-PF, 1.8-12.2 for SF-12 PCS, 1.9-6.2 for VR-12 PCS, 0.4-1.6 for VAS back, and 0.5-1.7 for VAS leg. The MCID values greatly relied on the calculation method. The minimum detectable change method was selected as the most appropriate MCID calculation method. The MCID values that may be utilized for ALIF patients are 7.3 for PROMIS-PF, 8.2 for SF-12 PCS, 7.8 for VR-12 PCS, 3.2 for VAS back, and 2.2 for VAS leg.

Patient-Reported Allergies Do Not Affect Long-Term Patient-Reported Outcome Measures After Spine Surgery.

A gap in the literature exists regarding the association between number of allergies and patient-reported outcomes measures (PROMs) for patients undergoing spine surgery. Consecutive cervical or lumbar spine surgery patients were identified from a prospective registry from April 2017 to July 2020. Patients were grouped into those with 0, 1, 2, or ≥3 allergies. Demographics were compared between the groups. PROMs included Neck Disability Index, Oswestry Disability Index, visual analog scale (VAS) neck pain, VAS arm pain, VAS back pain, VAS leg pain, short form 12 (SF-12) physical component score, SF-12 mental component score, and patient-reported outcomes measurement information system physical function (PROMIS-PF), and outcomes were compared between the groups through multivariable analysis at up to 1-year follow-up. Associations between number of allergies and achieving a minimal clinically important difference (MCID) in the 9 aforementioned PROMs at 1-year follow-up were assessed. This study included 148 cervical and 517 lumbar patients. After controlling for demographic differences, a higher number of allergies was associated with less improvement in VAS neck pain, SF-12 physical component score, and PROMIS-PF at 12 weeks following cervical surgery and less improvement in PROMIS-PF at 2 weeks following lumbar surgery (P < 0.05). However, these associations failed to persist after 6 months and 12 weeks following surgery in cervical and lumbar patients, respectively (P > 0.05). No association was identified between number of allergies and achievement of MCID in any of the 9 studied PROMs at 1-year follow-up. The higher number of allergies was associated with less improvement in PROMs in the early postoperative period but not at longer-term follow-up. These findings provide data that can be utilized while counseling patients and setting postoperative expectations.

Construct validity of the PROMIS PF-10 in patients with inflammatory rheumatic diseases and severe limitations in physical functioning

Objective Assessing the construct validity of the Patient-Reported Outcomes Measurement Information System Physical Function 10-Item Short Form (PROMIS PF-10) in a subpopulation of rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) patients with severe limitations in physical functioning (PF). Method RA/axSpA patients with severe functional limitations completed the PROMIS PF-10, Health Assessment Questionnaire – Disability Index (HAQ-DI for RA) or Bath Ankylosing Spondylitis Functional Index (BASFI for axSpA), 36-item Short Form Health Survey (SF-36), EuroQol 5-dimensions 5-level (index score, EQ-VAS), and performed the Six-Minute Walk Test (6MWT). Construct validity was assessed by computing Spearman rank or Pearson correlation coefficients and testing hypotheses about correlations between the PROMIS PF-10 and measures of PF and quality of life. Results Data from 316 patients (180 RA/136 axSpA, 91.7%/47.8% female, mean ± sd age 58.6 ± 13.2/54.0 ± 11.3 years) were analysed. The median (IQR) PROMIS PF-10 score was 34.5 (31.4–37.6) in RA and 36.0 (32.8–38.3) in axSpA patients. The PROMIS PF-10 correlated strongly with the HAQ-DI, BASFI, and EQ-5D-5L index score (r > 0.6), moderately with the SF-36 Physical Component Summary score, EQ-VAS, and 6MWT (0.30 ≤ r ≤ 0.60), and weakly with the SF-36 Mental Component Summary score (r < 0.30). Five of six hypotheses (83%) were confirmed in both groups. Conclusion The overall strong correlation of the PROMIS PF-10 with measures of PF and moderate to weak correlations with outcomes measuring different constructs were confirmed in subpopulations of RA and axSpA patients with severe functional limitations, supporting its construct validity.

Outcomes of percutaneous femoral derotational osteotomy in pediatric patients.

Percutaneous femoral derotational osteotomies are performed in both adult and pediatric patients. There is little published on the outcomes after femoral derotational osteotomy in pediatric patients. A retrospective cohort study of pediatric patients treated with percutaneous femoral derotational osteotomy by one of two surgeons between 2016 and 2022 was performed. Data collected included patient demographics; surgical indications; femoral version; tibial torsion; magnitude of rotational correction; complications; time to hardware removal; pre-operative and post-operative patient-reported outcome scores, including Limb Deformity-Scoliosis Research Society and Patient-Reported Outcomes Measurement Information System; and time to consolidation. Descriptive statistics were used to summarize the data and t tests used to compare means. Thirty-one femoral derotational osteotomies in 19 patients were included with an average age of 14.7 (9-17) years. The average rotational correction was 21.5° ± 6.4° (10°-40°). The average length of follow-up was 17.9 ± 6.7 months. There were no instances of nonunion, joint stiffness, or nerve injury. No patients returned to the operating room for additional surgeries other than routine hardware removal. There were no cases of avascular necrosis of the femoral head. Of the 19 patients, 8 completed both a pre-operative and post-operative survey set. There were significant improvements in the Limb Deformity-Scoliosis Research Society Self-Image/Appearance sub-category and the Patient-Reported Outcomes Measurement Information System Physical Function sub-category. Femoral derotational osteotomy using a percutaneous drill hole technique with antegrade trochanteric entry femoral nail is safe in the pediatric population and improves self-image in patients with symptomatic femoral version abnormalities.

Nirogacestat, a γ-Secretase Inhibitor for Desmoid Tumors

BackgroundDesmoid tumors are rare, locally aggressive, highly recurrent soft-tissue tumors without approved treatments.MethodsWe conducted a phase 3, international, double-blind, randomized, placebo-controlled trial of nirogacestat in adults with progressing desmoid tumors according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Patients were assigned in a 1:1 ratio to receive the oral γ-secretase inhibitor nirogacestat (150 mg) or placebo twice daily. The primary end point was progression-free survival.ResultsFrom May 2019 through August 2020, a total of 70 patients were assigned to receive nirogacestat and 72 to receive placebo. Nirogacestat had a significant progression-free survival benefit over placebo (hazard ratio for disease progression or death, 0.29; 95% confidence interval, 0.15 to 0.55; P<0.001); the likelihood of being event-free at 2 years was 76% with nirogacestat and 44% with placebo. Between-group differences in progression-free survival were consistent across prespecified subgroups. The percentage of patients who had an objective response was significantly higher with nirogacestat than with placebo (41% vs. 8%; P<0.001), with a median time to response of 5.6 months and 11.1 months, respectively; the percentage of patients with a complete response was 7% and 0%, respectively. Significant between-group differences in secondary patient-reported outcomes, including pain, symptom burden, physical or role functioning, and health-related quality of life, were observed (P≤0.01). Frequent adverse events with nirogacestat included diarrhea (in 84% of the patients), nausea (in 54%), fatigue (in 51%), hypophosphatemia (in 42%), and maculopapular rash (in 32%); 95% of adverse events were of grade 1 or 2. Among women of childbearing potential receiving nirogacestat, 27 of 36 (75%) had adverse events consistent with ovarian dysfunction, which resolved in 20 women (74%).ConclusionsNirogacestat was associated with significant benefits with respect to progression-free survival, objective response, pain, symptom burden, physical functioning, role functioning, and health-related quality of life in adults with progressing desmoid tumors. Adverse events with nirogacestat were frequent but mostly low grade. (Funded by SpringWorks Therapeutics; DeFi ClinicalTrials.gov number, NCT03785964.)

(Cost-)effectiveness of a personalized multidisciplinary eHealth intervention for knee arthroplasty patients to enhance return to activities of daily life, work and sports – rationale and protocol of the multicentre ACTIVE randomized controlled trial

BackgroundWith the worldwide rising obesity epidemic and the aging population, it is essential to deliver (cost-)effective care that results in enhanced societal participation among knee arthroplasty patients. The purpose of this study is to describe the development, content, and protocol of our (cost-)effectiveness study that assesses a perioperative integrated care program, including a personalized eHealth app, for knee arthroplasty patients aimed to enhance societal participation post-surgery compared to care as usual.MethodsThe intervention will be tested in a multicentre randomized controlled trial with eleven participating Dutch medical centers (i.e., hospitals and clinics). Working patients on the waiting-list for a total- or unicompartmental knee arthroplasty with the intention to return to work after surgery will be included. After pre-stratification on medical centre with or without eHealth as usual care, operation procedure (total- or unicompartmental knee arthroplasty) and recovery expectations regarding return to work, randomization will take place at the patient-level. A minimum of 138 patients will be included in both the intervention and control group, 276 in total. The control group will receive usual care. On top of care as usual, patients in the intervention group will receive an intervention consisting of three components: 1) a personalized eHealth intervention called ikHerstel (‘I Recover’) including an activity tracker, 2) goal setting using goal attainment scaling to improve rehabilitation and 3) a referral to a case-manager. Our main outcome is quality of life, based on patient-reported physical functioning (using PROMIS-PF). (Cost-)effectiveness will be assessed from a healthcare and societal perspective. Data collection has been started in 2020 and is expected to finish in 2024.DiscussionImproving societal participation for knee arthroplasty is relevant for patients, health care providers, employers and society. This multicentre randomized controlled trial will evaluate the (cost-)effectiveness of a personalized integrated care program for knee arthroplasty patients, consisting of effective intervention components based on previous studies, compared to care as usual.Trial registrationTrialsearch.who.int; reference no. NL8525, reference date version 1: 14–04-2020.

Accelerometer-Based Navigation in Primary Total Knee Arthroplasty Leads to Improved Alignment but No Change in Patient-Reported Outcomes

BackgroundComputer and accelerometer-based navigation (ABN) tools have demonstrated improved mechanical alignment in primary total knee arthroplasty (TKA). ABN, in particular, is attractive due to avoidance of pins and trackers. Prior literature has yet to demonstrate an associated improvement in functional outcomes using ABN compared to conventional instrumentation (CONV). The purpose of this study was to compare alignment and functional outcomes between CONV and ABN in primary TKA in a large patient series. MethodsA retrospective study of 1,925 TKAs performed by a single surgeon sequentially was performed. There were 1,223 TKAs performed with CONV and measured resection technique. There were 702 TKAs performed with distal femoral ABN and restricted kinematic alignment goals. We compared radiographic alignment, Patient-Reported Outcomes Measurement Information System scores, rates of manipulation under anesthesia, and needs for aseptic revisions between cohorts. Chi-squared, Fisher’s exact, and t-tests were used to compare demographics and outcomes. ResultsThe ABN cohort had higher rates of neutral alignment postoperatively than the CONV cohort (ABN 74% versus CONV 56%, P < .001). Rates of manipulation under anesthesia (ABN 2.8% versus CONV 3.4%, P = .382) and aseptic revision (ABN 0.9% versus CONV 1.6%, P = .189) were similar. The Patient-Reported Outcomes Measurement Information System physical function (ABN 42.6 versus CONV 42.9, P = .4554), physical health (ABN 63.4 versus CONV 63.3, P = .944), mental health (ABN 51.4 versus CONV 52.7, P = .4349), and pain (ABN 32.7 versus CONV 30.9, P = .256) scores were similar. ConclusionABN is valuable in its ability to improve postoperative alignment but does not improve complication rates or patient-reported functional outcomes.

Patient-reported Outcomes of Revision Ankle Open Reduction Internal Fixation

Ankle fractures may require revision surgery for malunion or suboptimal joint congruence results after initial surgical or nonsurgical treatment. There is limited literature on the outcomes of patients undergoing such revision surgery for ankle fracture malunion. In this retrospective case series, we determined clinical and functional outcomes of revision ankle open reduction internal fixation (ORIF) for 7 patients with ankle fracture malunion through patient-reported and radiographic outcomes. Patient-reported Outcomes Measurement Information System physical function and pain interference scores prerevision and postrevision procedure were obtained from 7 patients treated from January 2017 to October 2020. Postoperative complications including persistent pain, infection, hardware removal, hardware failure, and conversion to ankle arthrodesis were analyzed. Seven patients who underwent revision ORIF surgery for ankle fracture malunion between January 2017 and October 2020 were included. The average age was 46.3 12.2 years old; 85.7% of the patients were female; 14.3% were male. The average amount of time between revision ORIF procedure and collection of postoperative Patient-Reported Outcomes Measurement Information System scores was 19.3±5.9 months. Each of the 7 patients showed an increase in physical function after revision surgery (average preoperative physical function score: 30.7; average postoperative physical function score: 48.9). All patients showed a decrease in pain after revision surgery (average preoperative pain interference score: 64.8; average postoperative pain interference score: 55.7). Of the 7 participants who underwent revision ORIF, a majority did not experience any complications at least 1 year postprocedure, including infection, reoperation, or hardware removal. One participant underwent hardware removal for persistent pain and developed overlying cellulitis. For patients with ankle fracture malunion without significant post-traumatic degenerative changes of the ankle joint, revision ankle ORIF can be an effective method for improving physical function, decreasing pain, and preserving ankle joint motion. Level of Evidence: Level IV—case series.

Effects of Aerobic Exercise in the Intensive Care Unit on Patient-Reported Physical Function and Mental Health Outcomes in Severely Burned Children-A Multicenter Prospective Randomized Trial.

Forty-eight children between the ages of seven and seventeen with ≥30% total body surface area (TBSA) burn were randomized in a 1:2 fashion to receive treatment with standard-of-care (SOC) or standard-of-care plus exercise (SOC+Ex). Surveys administered at admission and discharge collected patient-reported information regarding physical and mental health outcomes. The results are given as means +/- standard deviation. Significance was set at p < 0.05. The average age of the SOC and SOC+Ex groups were 12 ± 3 and 13 ± 4 years, respectively. The average %TBSA burned in the SOC and SOC+Ex groups were 54 ± 17 and 48 ± 14, respectively. The SOC+Ex group averaged 10 ± 9 exercise sessions (range of 1 to 38 sessions) with an attendance rate of 25% (10 sessions out of 40 BICU days). Both groups demonstrated significant improvement in patient-reported physical and mental outcomes during hospital admission (p < 0.05) However, additional exercise did not exhibit any additional benefits for measured levels. Our recommendation is for all pediatric patients in the BICU to continue with the SOC and consult with their physician over the benefits of additional aerobic exercise. This study suggests that perhaps there is potential for increasing the amount of exercise that can be administered to pediatric burn survivors beyond SOC as we did not find aerobic exercise to be of any harm to any patients if it is performed properly and under supervision.