Static Versus Articulating Spacer: Does Infectious Pathogen Type Affect Treatment Success?

BACKGROUND: Treatment with a static or an articulating antibiotic-containing spacer is a common strategy for treating periprosthetic joint infection (PJI), yet many patients have persistent infections after spacer treatment. Although previous studies have compared the efficacy of a static and articulating spacer for treating PJI, few studies have assessed infection control from the time of spacer implantation, or they defined treatment failure as including reinfection, reoperation, or chronic suppressive therapy. Additionally, few studies have examined whether there is an interaction between spacer and pathogen type with respect to treatment success. QUESTIONS/PURPOSES: (1) Is there a difference in failure-free survival (defined as no reoperation, reinfection, or suppressive antibiotic therapy) between static and articulating spacers after spacer implantation for PJI? (2) Did the relationship between spacer type and failure-free survival differ by pathogen type (staphylococcal versus nonstaphylococcal and difficult-to-treat [including methicillin-resistant Staphylococcus aureus, methicillin-susceptible S. aureus, Corynebacterium, Mycobacterium, Enterococcus spp, and other gram-negative bacterium] versus not-difficult-to-treat organisms)? METHODS: Between January 2014 and January 2022, a convenience sample of 277 patients was identified as having knee PJIs treated with an articulating (75% [208 of 277]) or static (25% [69 of 277]) antibiotic spacer and potentially eligible for this study. During that time, providers at our institution generally used spacers for later-presenting or chronic infections. Spacer choice was determined by surgeon preference, with static spacers used more often in instances of higher bone loss and poor soft tissue coverage. Thirty-one patients (8 static and 23 articulating spacers) were considered lost to follow-up or had incomplete datasets and were excluded from the analysis, resulting in a final analysis cohort of 246 patients: 25% (61 of 246) received a static spacer and 75% (185 of 246) received an articulating spacer. The mean ± standard deviation age of patients was 66 ± 9.9 years, BMI was 33.3 ± 6.9 kg/m2, and Elixhauser score was 18.1 ± 16.9. Demographic and clinical characteristics were similar between the two groups. Pathogen type was collected and categorized as staphylococcal versus nonstaphylococcal, and difficult-to-treat (including methicillin-resistant Staphylococcus aureus, methicillin-susceptible S. aureus, Corynebacterium, Mycobacterium, Enterococcus spp, and other gram-negative bacterium) versus not-difficult-to-treat, as defined by an infectious disease physician. Other variables we collected included sex, age, American Society of Anesthesiologists classification, BMI, and Elixhauser score. The primary outcome of interest was failure-free survival, which was a composite time-to-event outcome, with failure defined as reoperation, reinfection, death owing to infection, or chronic antibiotic use at a minimum of 1 year after the completion of the patient's Stage 1 postoperative antibiotic course, whichever came first. Reinfection was determined by the treating physicians in accordance with the Musculoskeletal Infection Society guidelines and included an evaluation of infectious laboratory values, cultures, and clinical signs of infection. We compared static and articulating spacers using a Cox proportional hazards model, with spacer type as the primary predictor variable. We compared staphylococcal versus nonstaphylococcal and difficult-to-treat versus not-difficult-to-treat infections by running additional models with interaction terms between spacer type and pathogen type. RESULTS: No difference was observed in the cause-specific hazard ratio for static versus articulating (reference) spacers (HR 1.45 [95% confidence interval 0.94 to 2.22]; p = 0.09), after adjusting for covariates. Additionally, no difference in the association between spacer type and failure-free survival was found between pathogen types or treatment difficulty after evaluating interactions (staphylococcal HR 0.37 [95% CI 0.15 to 0.91], nonstaphylococcal HR 0.79 [95% CI 0.49 to 1.28]; p value for interaction = 0.14; difficult-to-treat HR 0.37 [95% CI 0.14 to 0.99], not-difficult-to-treat HR 0.75 [95% CI 0.47 to 1.20]; p value for interaction = 0.20). CONCLUSION: The lack of a difference in failure-free survival and insufficient evidence of a difference in the association between spacer type and treatment failure by pathogen type suggests that infectious organism may not be an important consideration in the decision about spacer treatment type. Further studies should aim to elucidate which patient factors are the most influential in surgeon decision-making when choosing a spacer type in patients with PJI of the knee.Level of Evidence Level III, therapeutic study.

Single Shot Interscalene Block with Liposomal Bupivacaine versus Non-Liposomal Bupivacaine in Shoulder Arthroplasty.

BACKGROUND: Regional anesthesia is a valuable component of multimodal pain control in total shoulder arthroplasty (TSA), and multiple interscalene block anesthetic options exist, including non-liposomal interscalene bupivacaine (NLIB) and liposomal interscalene bupivacaine (LIB). The purpose of the current of study was to compare pain control and opioid consumption within 48 hours postoperative in those undergoing TSA with either LIB or NLIB. METHODS: This was a retrospective cohort study at a single academic medical center including consecutive patients undergoing inpatient (>23-hour hospitalization) primary anatomic or reverse TSA from 2016 to 2020 who received either LIB or a NLIB for perioperative pain control. Perioperative patient outcomes were collected including pain levels and opioid usage, as well as 30- and 90-day ED visits or readmissions. The primary outcome was postoperative pain and opioid use. RESULTS: Overall, 489 patients were included in this study (316 LIB and 173 NLIB). Pain scores at 3, 6, 12, and 48 hours postoperatively were not statistically significantly different (p>0.05 for all). However, the LIB group had improved pain scores at 24- and 36-hours postoperative (p<0.05 all). There was no difference in the incidence of severe postoperative pain, defined as a 9 or 10 NRS-11 score, between the two anesthesia groups after adjusting for preoperative pain and baseline opioid use (OR: 1.25; 95% CI: 0.57-2.74; p=0.57). Overall, 99/316 (31.3%) of patients receiving LIB did not require any postoperative opioids compared with 38/173 (22.0%) receiving NLIB; however, this difference was not statistically significant after adjusting for prior opioid use and preoperative pain (p=0.33). No statistically significant differences in postoperative total morphine equivalents or mean daily morphine equivalents consumed between the groups were found during their hospital stays (p>0.05 for both). Finally, no significant differences in 30- and 90-day ED visits or readmission rates were found (all p>0.05). CONCLUSION: LIB and NLIB demonstrated differences in patient reported pain scores at 24- and 36-hours post operation, although these did not reach clinical significance. There were no statistically significant differences in opioid consumption during the hospital stay, including opioid use, total morphine equivalents and daily mean morphine equivalents consumed during the hospital stay. Additionally, no differences were observed in 30- and 90-day ED visits or readmission rates.

Outcomes after total ankle arthroplasty with an average follow-up of 10 years: A systematic review and meta-analysis.

BACKGROUND: The literature demonstrating positive outcomes after total ankle arthroplasty (TAA) is mounting. However, the long-term outcomes of TAA (≥ 10 years) remain minimally reported. The purpose of this systematic review and meta-analysis was to evaluate outcome metrics over multiple TAA studies with greater than 10 years of average follow-up. METHODS: TAA studies were searched in Medline, Embase, and Scopus from the date of inception to September 12, 2022. Inclusion criteria included 1) studies of patients that underwent uncemented TAA, and 2) studies with an average follow-up time of at least ten years. Manuscripts in non-English languages and isolated abstracts were excluded. We collected American Orthopaedic Foot and Ankle Score (AOFAS) and Visual Analog Scale (VAS) scores from the included studies for pooled meta-analysis. Due to the varying definition of survivability between studies, this metric was not assessed in our final evaluation. RESULTS: Our data included approximately 3651 patients (3782 ankles). Of the 25 studies with an average follow-up of 10 years included in the systematic review, 5 provided pre- and post-operative AOFAS means and 5 provided pre- and post-operative VAS means with associated measures of variability and were included in our meta-analysis. The weighted mean difference between pre-and post-operative AOFAS and VAS scores was -40.36 (95% CI -47.24 to -33.47) and 4.52 (95% CI: 2.26-6.43), respectively. The risk of bias was low to moderate for the included studies. CONCLUSION: Outcomes following TAA are favorable and indicate patient-reported outcome improvement over long-term follow-up. However, a significant amount of heterogeneity exists between studies. Future, prospective, randomized research should focus on standardizing outcome measures, survivorship, and complication reporting methodologies to allow for pooled meta-analyses of these important outcome metrics.

Evaluation of alpelisib-induced hyperglycemia prophylaxis and associated risk factors in PIK3CA-mutated hormone-receptor positive, human epidermal growth factor-2 negative advanced breast cancer.

PURPOSE: SOLAR-1 investigated alpelisib-fulvestrant (ALP + FLV) in patients with HR + /HER2-, PIK3CA-mutated advanced breast cancer and demonstrated a clinically significant increase in all-grade and grade (G) 3-4 hyperglycemia (HG) compared to placebo-fulvestrant. Given high rates of HG, a preventative protocol and identification of associated risk factors was implemented. METHODS: This single-center, retrospective study included patients receiving ALP + FLV. One week before ALP initiation, patients started an insulin-sensitizer. Patients had fasting plasma glucose (FPG) levels drawn day 8, 15, 28, then monthly. Primary outcome was incidence of G2-4 HG by day 28. Risk factors assessed included age, BMI, FPG, and HbA1c. Number of risk factors were compared between patients with and without HG. RESULTS: Sixteen women were included with median age of 59 years. The cohort was 69% White, 25% Black, 75% with BMI ≥ 25 kg/m2, and 50% with history of diabetes. By day 28, 9 patients (56%) had G2-4 HG, with only 3 (19%) G3 and zero G4. Patients with G2-4 HG had a median of 2 risk factors compared to only 1 if no HG (p = 0.03). 5 patients (31%) required a temporary hold of ALP and 3 (19%) required dose reduction due to HG. 13 patients permanently discontinued ALP-9 due to disease progression and 4 from an adverse event (only 1 HG). CONCLUSION: Implementation of a HG prophylaxis protocol with ALP in a single-center study demonstrated fewer G3-4 HG events compared to that seen in SOLAR-1 (19% vs 36.6%). An increase in HG-associated risk factors correlated with a higher incidence of G2-4 HG.

Determinants and Trends of COVID-19 Vaccine Hesitancy and Vaccine Uptake in a National Cohort of US Adults: A Longitudinal Study.

We estimated the trends and correlates of vaccine hesitancy and its association with subsequent vaccine uptake among 5,458 adults in the United States. Participants belonged to the Communities, Households, and SARS-CoV-2 Epidemiology COVID (CHASING COVID) Cohort, a national longitudinal study. Trends and correlates of vaccine hesitancy were examined longitudinally in 8 interview rounds from October 2020 to July 2021. We also estimated the association between willingness to vaccinate and subsequent vaccine uptake through July 2021. Vaccine delay and refusal decreased from 51% and 8% in October 2020 to 8% and 6% in July 2021, respectively. Compared with non-Hispanic (NH) White participants, NH Black and Hispanic participants had higher adjusted odds ratios (aOR) for both vaccine delay (for NH Black, aOR = 2.0 (95% confidence interval (CI): 1.5, 2.7), and for Hispanic, 1.3 (95% CI: 1.0, 1.7)) and vaccine refusal (for NH Black, aOR = 2.5 (95% CI: 1.8, 3.6), and for Hispanic, 1.4 (95% CI: 1.0, 2.0)) in June 2021. COVID-19 vaccine hesitancy, compared with vaccine-willingness, was associated with lower odds of subsequent vaccine uptake (for vaccine delayers, aOR = 0.15, 95% CI: 0.13, 0.18; for vaccine refusers, aOR = 0.02; 95% CI: 0.01, 0.03 ), adjusted for sociodemographic factors and COVID-19 history. Vaccination awareness and distribution efforts should focus on vaccine delayers.

A Framework for Studying Healthcare Equity in Adolescent Idiopathic Scoliosis: Scoping Review and Meta-Analysis of Existing Literature.

INTRODUCTION: Health inequities remain a notable barrier for pediatric patients, especially in conditions such as adolescent idiopathic scoliosis (AIS), where the efficacy of nonsurgical treatment is dependent on early diagnosis and referral to a specialist. Social determinants of health (SDOH) are nonmedical factors that affect health outcomes, such as economic stability, neighborhood environment, and discrimination. Although these factors have been studied throughout the AIS literature, considerable inconsistencies remain across studies regarding the investigation of SDOH for this population. Through a scoping review, we analyze the existing literature to propose a comprehensive framework to consider when designing future prospective and retrospective studies of healthcare equity in AIS. METHODS: A systematic review was executed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. A meta-analysis was performed for each reported SDOH (race, ethnicity, insurance provider, and socioeconomic status) including only studies with complete and consistent variables and outcomes. Cobb angle measurements were aggregated and summarized as the weighted mean difference with 95% confidence interval using a fixed or random-effects model (substantial heterogeneity identified). RESULTS: Of 7,539 studies reviewed, nine studies met all the inclusion criteria. As expected, considerable inconsistencies were found across the nine studies making it difficult to aggregate data. Within the meta-analyses, the mean difference between White non-Hispanic and Hispanic patients was statistically significant (1.71; 95% confidence interval 0.78 to 2.65; P < 0.001). No other statistically significant differences were identified among the SDOH and presenting main Cobb angle magnitude. CONCLUSION: These studies provide insight into healthcare inequities in AIS, although notable inconsistencies make it difficult to aggregate data and draw the conclusions needed to drive necessary public health changes. However, our proposed framework can provide a guideline for future prospective and retrospective studies to standardize data reporting and allow for improved collaboration, study design, and future systematic reviews and meta-analyses.

Nonoperative Management, Repair, or Reconstruction of the Medial Collateral Ligament in Combined Anterior Cruciate and Medial Collateral Ligament Injuries-Which Is Best? A Systematic Review and Meta-analysis.

BACKGROUND: Combined injury of the anterior cruciate ligament (ACL) and the medial collateral ligament (MCL) is a common injury pattern and accounts for 20% of all ligamentous knee injuries. Despite advancements in surgical technique, there is no up-to-date consensus regarding the superiority of nonoperative versus operative management in higher-grade MCL tears of combined ACL-MCL injuries. PURPOSE: To interpret recent literature on treatment options and to provide an updated evidence-based approach for management of combined ACL-MCL knee injuries. STUDY DESIGN: Systematic review and meta-analysis; Level of evidence, 4. METHODS: We performed a systematic review on outcomes following treatment of concomitant ACL and MCL injuries. A computerized search was conducted in PubMed, Embase.com, and Scopus.com. Authors independently assessed eligible studies and screened titles and abstracts. Articles reporting on patients with concomitant ACL and MCL injuries with or without concomitant procedures were included. Data regarding study design, sample size, patient age and sex, length of follow-up, timing of surgery, indications, surgical methods, concomitant procedures, outcomes, and complications were recorded. Patient-reported outcomes (PROs) and functional outcomes, including Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee scores, Lysholm and Tegner scores, and range of motion, were estimated via meta-analysis and compared statistically by surgical approach. RESULTS: In total, 18 studies were included in the systematic review with level 1 to level 4 evidence, with a total of 1,534 cases, were included in the systematic review. Of these, 16 studies with sufficient statistical reporting including 997 cases with sufficient follow-up were included in meta-analysis. Three different approaches to combined ACL-MCL injuries were identified: ACL reconstruction with (1) nonoperative MCL, (2) MCL repair, and (3) MCL reconstruction. There was no statistical difference between nonoperative versus surgically managed MCL injuries for PROs, range of motion at final follow up, or quadriceps strength. CONCLUSION: Reconstruction of combined injury in a delayed fashion facilitates return of range of motion and may allow time for low-grade MCL tears to heal. If residual valgus or anteromedial rotatory laxity remains after a period of rehabilitation, then concomitant surgical management of ACL and MCL injuries is warranted. Avulsion MCL injuries and Stener-type lesions may benefit from early repair techniques.

Association of RBC Transfusion Thresholds and Outcomes in Medical Patients With Acute Respiratory Failure Supported With Extracorporeal Membrane Oxygenation: A Single-Center Retrospective Cohort Study.

BACKGROUND: The hemoglobin value to trigger RBC transfusion for patients receiving venovenous extracorporeal membrane oxygenation (ECMO) is controversial. Previous guidelines recommended transfusing to a normal hemoglobin level, but recent studies suggest that more RBC transfusions are associated with increased adverse outcomes. RESEARCH QUESTION: Is implementation of different institutional RBC transfusion thresholds for patients receiving venovenous ECMO associated with changes in RBC use and patient outcomes? STUDY DESIGN AND METHODS: This single-center retrospective study of patients receiving venovenous ECMO used segmented regression to test associations between implementation of institutional transfusion thresholds and trends in RBC use. Associations with secondary outcomes, including in-hospital survival, also were assessed. RESULTS: The study included 229 patients: 91 in the no threshold cohort, 48 in the hemoglobin < 8 g/dL cohort, and 90 in the hemoglobin < 7 g/dL cohort. Despite a decrease in number of RBC units transfused per day of ECMO support after implementation of different thresholds (mean ± SD: 0.6 ± 1.0 in the no threshold cohort, 0.3 ± 0.8 in the hemoglobin < 8 g/dL cohort, and 0.3 ± 1.1 in the hemoglobin < 7 g/dL cohort; P < .001), segmented regression showed no association between implementation of transfusion thresholds and changes in trends in number of RBC units per day of ECMO. We observed an increased hazard of death in the no threshold cohort compared with the hemoglobin < 8 g/dL cohort (adjusted hazard ratio [aHR], 2.08; 95% CI, 1.12-3.88) and in the hemoglobin < 7 g/dL cohort compared with the hemoglobin < 8 g/dL cohort (aHR, 1.93; 95% CI, 1.02-3.62). No difference was found in the hazard of death between the no threshold and hemoglobin < 7 g/dL cohorts (aHR, 1.08; 95% CI, 0.69-1.69). INTERPRETATION: We observed a decrease in number of RBC units per day of ECMO over time, but changes were not associated temporally with implementation of transfusion thresholds. A transfusion threshold of hemoglobin < 8 g/dL was associated with a lower hazard of death, but these findings are limited by study methodology. Further research is needed to investigate optimal RBC transfusion practices for patients supported with venovenous ECMO.

Association between sleep dysfunction and Patient-Reported Outcomes Measurement Information System scores in patients with rotator cuff tears.

OBJECTIVES: The purpose of this study was to utilize Patient-Reported Outcomes Measurement Information System (PROMIS) sleep scores to determine the prevalence of sleep dysfunction and its association with other PROMIS scores in patients with rotator cuff tears (RCT). METHODS: Patients were retrospectively identified using the International Classification of Diseases-10 codes for RCT pathology, and PROMIS outcomes were assessed at multiple visits between November 2017 and February 2020. Generalized linear mixed effects models were fitted with PROMIS sleep score as the predictor variable and other PROMIS scores as the response variable. Additionally, models were fit using a clinically significant dichotomization of PROMIS sleep scores to assess differences in average PROMIS scores. RESULTS: The study cohort included 481 patients, 201 (41.8 â€‹%) of whom had disrupted sleep at first visit. A higher percentage of those with disrupted sleep at first visit were female, nonwhite, and not married compared to those with normal sleep. PROMIS scores at first visit differed by sleep category. Higher PROMIS sleep scores were associated with higher anxiety, depression, fatigue, pain intensity, and pain interference scores and lower physical function, social participation, and upper extremity scores. Relationships were similar when dichotomous PROMIS sleep scores were considered. CONCLUSION: There was a high prevalence of sleep dysfunction in patients with RCT. Sleep disturbance is associated with increased anxiety, depression, fatigue, pain intensity, pain interference and decreased physical function, social participation, and upper extremity function in patients with RCTs. LEVEL OF EVIDENCE III: Retrospective Cohort Study.

Racial Disparities Exist in 90-Day Unplanned Return to the Emergency Department Following Orthopaedic Trauma Surgery.

OBJECTIVES: Racial disparities in healthcare outcomes exist, including in orthopaedic trauma care. The aim of this study was to determine the impact of race, social deprivation, and payor status on 90-day emergency department (ED) revisits among orthopaedic trauma surgery patients at a Level 1 trauma academic medical center. DESIGN: Retrospective chart review analysis. SETTING: Level 1 trauma academic center in Durham, NC. PATIENT SELECTION CRITERIA: Adult patients undergoing orthopaedic trauma surgery between 2017 and 2021. OUTCOME MEASURES AND COMPARISONS: The primary outcome of this retrospective cohort study was 90-day return to the ED. Logistic regression analysis was performed for variables of interest [race, social deprivation (measured by the Area Deprivation Index), and payor status] separately and combined, with each model adjusting for distance to the hospital. Results were interpreted as odds ratios (ORs) of 90-day ED revisits comparing levels of the respective variables. Statistical significance was assessed at α = 0.05. RESULTS: A total of 3120 adult patients who underwent orthopaedic trauma surgery between 2017 and 2021 were included in the analysis. Black race (OR = 1.47; 95% confidence interval [CI]: 1.17-1.84, P < 0.001) and Medicaid coverage (OR = 1.63, 95% CI: 1.20-2.21, P = 0.002) were significantly associated with higher odds of return to ED compared with non-Black or non-Medicaid-covered patients. While ethnic minority (Hispanic/Latino or non-White) was statistically significant while adjusting only for distance to the hospital (OR = 1.23, 95% CI: 1.00-1.50, P = 0.047), it was no longer significant after adjusting for the other sociodemographic variables (OR = 1.13, 95% CI: 0.91-1.39, P = 0.27). The weighted Area Deprivation Index was not associated with a difference in odds of return to ED in any adjusted models. CONCLUSIONS: The results highlight the presence of racial and socioeconomic disparities in ED utilization, with Black race and Medicaid coverage significantly associated with higher odds of return to the ED. Future research should delve deeper into comprehending the root causes contributing to these racial and socioeconomic utilization disparities and evaluate the effectiveness of targeted interventions to reduce them. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

A Randomized, Placebo-Controlled, Phase II Trial of Intravenous Allogeneic Non-HLA Matched, Unrelated Donor, Cord Blood Infusion for Ischemic Stroke.

Stroke remains a leading cause of death and disability in the US, and time-limited reperfusion strategies remain the only approved treatment options. To address this unmet clinical need, we conducted a phase II randomized clinical trial to determine whether intravenous infusion of banked, non-HLA matched unrelated donor umbilical cord blood (UCB) improved functional outcome after stroke. Participants were randomized 2:1 to UCB or placebo within strata of National Institutes of Health Stroke Scale Score (NIHSS) and study center. Study product was infused 3-10 days following index stroke. The primary endpoint was change in modified Rankin Scale (mRS) from baseline to day 90. Key secondary outcomes included functional independence, NIHSS, the Barthel Index, and assessment of adverse events. The trial was terminated early due to slow accrual and logistical concerns associated with the COVID-19 pandemic, and a total of 73 of a planned 100 participants were included in primary analyses. The median (range) of the change in mRS was 1 point (-2, 3) in UCB and 1 point (-1,4) in Placebo (P = 0.72). A shift analysis comparing the mRS at day 90 utilizing proportional odds modeling showed a common odds ratio of 0.9 (95% CI: 0.4, 2.3) after adjustment for baseline NIHSS and randomization strata. The distribution of adverse events was similar between arms. Although this study did not suggest any safety concerns related to UCB in ischemic stroke, we did not show a clinical benefit in the reduced sample size evaluated.

Multisite Study of the Management of Musculoskeletal Infection After Trauma: The MMUSKIT Study.

Background: The optimal duration and choice of antibiotic for fracture-related infection (FRI) is not well defined. This study aimed to determine whether antibiotic duration (≤6 vs >6 weeks) is associated with infection- and surgery-free survival. The secondary aim was to ascertain risk factors associated with surgery- and infection-free survival. Methods: We performed a multicenter retrospective study of patients diagnosed with FRI between 2013 and 2022. The association between antibiotic duration and surgery- and infection-free survival was assessed by Cox proportional hazard models. Models were weighted by the inverse of the propensity score, calculated with a priori variables of hardware removal; infection due to Staphylococcus aureus, Staphylococcus lugdunensis, Pseudomonas or Candida species; and flap coverage. Multivariable Cox proportional hazard models were run with additional covariates including initial pathogen, need for flap, and hardware removal. Results: Of 96 patients, 54 (56.3%) received ≤6 weeks of antibiotics and 42 (43.7%) received >6 weeks. There was no association between longer antibiotic duration and surgery-free survival (hazard ratio [HR], 0.95; 95% CI, .65-1.38; P = .78) or infection-free survival (HR, 0.77; 95% CI, .30-1.96; P = .58). Negative culture was associated with increased hazard of reoperation or death (HR, 3.52; 95% CI, 1.99-6.20; P < .001) and reinfection or death (HR, 3.71; 95% CI, 1.24-11.09; P < .001). Need for flap coverage had an increased hazard of reoperation or death (HR, 3.24; 95% CI, 1.61-6.54; P = .001). Conclusions: The ideal duration of antibiotics to treat FRI is unclear. In this multicenter study, there was no association between antibiotic treatment duration and surgery- or infection-free survival.

Statistical Evaluation of Responder Analysis in Stem Cell Clinical Trials.

BACKGROUND: In evaluating treatment efficacy, there is an ongoing discussion about which endpoint is more efficient to represent the treatment effect. Absolute change (AC) is the difference between before and after treatment, while relative change (RC) is the AC relative to the baseline value. Principal investigators sometimes support the credibility of relative change, but the FDA is more likely to support absolute change. Therefore, whether these two endpoints can be translated or combined is worth investigating in order to satisfy both parties. METHODS: In this article, a motivating example is presented to show that the choice of endpoint will result in different conclusions. The compared relationship of AC and RC is discussed in terms of required sample size, power, and precision. A new type of responder endpoint that combines the concepts of AC and RC is proposed. The comparative relationship regarding sample size, power, and precision of the proposed responder endpoint and the original two endpoints are also investigated. RESULTS: As a result, the performance of AC and RC is highly dependent on the choice of threshold that is often informed based on minimum clinically important difference or other clinical experience. Therefore, an absolute translation between them is hard to achieve. Inspired by the concept of responder analysis, three types of responder endpoints are proposed and discussed. The pattern of the third type of responder endpoint is having higher power, higher precision, and less required sample size in estimating the treatment effect compared to AC and RC within a range of thresholds. This advantage becomes more obvious when applying higher AC and RC thresholds and lower [Formula: see text] threshold. CONCLUSION: The proposed endpoint incorporates the information from the AC and RC endpoints and could be another wise choice when designing clinical trials especially when there is no absolute preference between AC and RC.

Effect of Risk-Stratified Care on Disability Among Adults With Low Back Pain Treated in the Military Health System: A Randomized Clinical Trial.

Importance: Tailored treatments for low back pain (LBP) based on stratifying risk for poor prognosis have emerged as a promising approach to improve quality of care, but they have not been validated in trials at the level of individual randomization in US health systems. Objective: To assess the clinical effectiveness of risk-stratified vs usual care on disability at 1 year among patients with LBP. Design, Setting, and Participants: This parallel-group randomized clinical trial enrolled adults (ages 18-50 years) seeking care for LBP with any duration in primary care clinics within the Military Health System from April 2017 to February 2020. Data analysis was conducted from January to December 2022. Interventions: Risk-stratified care, in which participants received physiotherapy treatment tailored for their risk category (low, medium, or high), or usual care, in which care was determined by participants' general practitioners and may have included a referral to physiotherapy. Main Outcomes and Measures: The primary outcome was the Roland Morris Disability Questionnaire (RMDQ) score at 1 year, with planned secondary outcomes of Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) and Physical Function (PF) scores. Raw downstream health care utilization was also reported within each group. Results: Analysis included 270 participants (99 [34.1%] female participants; mean [SD] age, 34.1 [8.5] years). Only 21 patients (7.2%) were classified as high risk. Neither group was superior on the RMDQ (least squares [LS] mean ratio of risk-stratified vs usual care: 1.00; 95% CI, 0.80 to 1.26), the PROMIS PI (LS mean difference, -0.75 points; 95% CI -2.61 to 1.11 points), or the PROMIS PF (LS mean difference, 0.05 points; 95% CI, -1.66 to 1.76 points). Conclusions and Relevance: In this randomized clinical trial, using risk stratification to categorize and provide tailored treatment for patients with LBP did not result in better outcomes at 1 year compared with usual care. Trial Registration: ClinicalTrials.gov Identifier: NCT03127826.

Association Between Preoperative Multidimensional Psychological Distress and Physical Function After Surgery for Sports-Related Injury.

Background: Psychological distress after orthopaedic surgery can lead to worse outcomes, including higher levels of disability and pain and lower quality of life. The 10-item Optimal Screening for Prediction for Referral and Outcome-Yellow Flag (OSPRO-YF) survey screens for multiple psychological constructs relevant to recovery from orthopaedic injury and may be useful to preoperatively identify patients who may require further psychological assessment and possible intervention after surgery. Purpose/Hypothesis: To determine the association between the OSPRO-YF and physiological patient-reported outcomes (PROs). It was hypothesized that higher OSPRO-YF scores (indicating worse psychological distress) would be associated with worse PRO scores at time of return to sport. Study Design: Case series; Level of evidence, 4. Methods: This study evaluated 107 patients at a single, academic health center who were assessed at a sports orthopaedics clinic and ultimately treated surgically for injuries to the knee, shoulder, foot, or ankle. Preoperatively, patients completed the OSPRO-YF survey as well as the following PRO measures: Patient-Reported Outcomes Measurement Information System (PROMIS), Single Assessment Numeric Evaluation, numeric rating scale for pain; American Shoulder and Elbow Surgeons standardized shoulder assessment form for patients with shoulder injuries, the International Knee Documentation Committee score (for patients with knee injuries), and the Foot and Ankle Ability Measure (FAAM; for patients with foot or ankle injuries). At the time of anticipated full recovery and/or return to sport, patients again completed the same PRO surveys. Multivariable regression was used to evaluate the association between total OSPRO-YF score at baseline and PRO scores at the time of functional recovery. Results: The baseline OSPRO-YF score predicted postoperative PROMIS Physical Function and FAAM Sports scores only. A 1-unit increase in the OSPRO-YF was associated with a 0.55-point reduction in PROMIS Physical Function (95% CI, -1.05 to -0.04; P = .033) indicating worse outcomes. Among patients who underwent ankle surgery, a 1-unit increase in OSPRO-YF was associated with a 6.45-point reduction in FAAM Sports (95% CI, -12.0 to -0.87; P = .023). Conclusion: The study findings demonstrated that the OSPRO-YF survey predicts certain long-term PRO scores at the time of expected return to sport, independent of baseline scores.

Sociodemographic Trends in Telemedicine Visit Completion in Spine Patients During the COVID-19 Pandemic.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: This study identifies potential disparities in telemedicine utilization in the wake of the COVID-19 pandemic and its aftermath in patients receiving spine surgery. SUMMARY OF BACKGROUND DATA: COVID-19 led to the rapid uptake of telemedicine in the spine surgery patient population. While previous studies in other medical subspecialties have identified sociodemographic disparities in telemedicine uptake, this is the first study to identify disparities in patients undergoing spine surgery. MATERIALS AND METHODS: This study included patients who underwent spine surgery between June 12, 2018 and July 19, 2021. Patients were required to have at least one scheduled patient visit, either virtual (video or telephone visit) or in-person. Binary socioeconomic variables used for modeling included: urbanicity, age at the time of the procedure, sex, race, ethnicity, language, primary insurer, and patient portal utilization. Analyses were conducted for the entire cohort and separately for cohorts of patients who had visits scheduled within specific timeframes: Pre-COVID-19 surge, initial COVID-19 surge, and post-COVID-19 surge. RESULTS: After adjusting for all variables in our multivariable analysis, patients who utilized the patient portal had higher odds of completing a video visit compared with those who did not (OR: 5.21; 95% CI: 1.28, 21.23). Hispanic patients (OR: 0.44; 95% CI: 0.2, 0.98) or those living in rural areas (OR: 0.58; 95% CI: 0.36, 0.93) had lower odds of completing a telephone visit. Patients with no insurance or on public insurance had higher odds of completing a virtual visit of either type (OR: 1.88; 95% CI: 1.10, 3.23). CONCLUSION: This study demonstrates the disparity in telemedicine utilization across different populations within the surgical spine patient population. Surgeons may use this information to guide interventions aimed at reducing existing disparities and work with certain patient populations to find a solution.

The Association Between Sociodemographic Factors, Social Determinants of Health, and Spine Surgical Patient Portal Utilization.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To examine patient portal use among the surgical spine patient population across different sociodemographic groups and assess the impact of patient portal use on clinical outcomes. SUMMARY OF BACKGROUND DATA: Patient portals (PP) have been shown to improve outcomes and quality of care. Engaging them requires internet access, technological literacy, and dexterity, which may serve as access barriers. METHODS: After exclusion criteria were applied, the study included data for 9211 encounters from 7955 patients. PP utilization was defined as having activated and used the Duke University Medical Center patient portal system, MyChart, at least once. Sociodemographic characteristics included urbanicity, age, race, ethnicity, language, employment, and primary insurer. Clinical outcomes included the length of hospital stay during the procedure, 30-day return to the emergency department, 30-day readmission, and being discharged somewhere other than home. RESULTS: Being older than 65, non-White, unemployed, non-English-speaking, male, not-partnered, uninsured or publicly insured (Medicaid, Medicare and under 65 years of age, or other government insurance), and living in a rural environment were all risk factors for decreased PP utilization among surgical spine patients. A one-risk factor decrease in the number of social risk factors was associated with a 78% increase in the odds of PP utilization [odds ratio (OR): 1.78; 95% Confidence interval (CI): 1.69-1.87; P <0.001]. Patients not utilizing the portal at the time of their procedure had higher odds of 30-day readmission (OR: 1.59; 95% CI: 1.26-2.00), discharge somewhere other than home (OR: 2.41, 95% CI: 1.95-2.99), and an increased length of hospital stay (geometric mean ratio: 1.21; 95% CI: 1.12-1.30) compared with those who utilized it. CONCLUSIONS: In patients undergoing spine procedures, PPs are not equally utilized among different sociodemographic groups. PP utilization is also associated with better outcomes. Interventions aimed at increasing PP uptake may improve care for certain patients.

Feasibility Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19-Related Acute Respiratory Distress Syndrome.

BACKGROUND: Treatment options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) are desperately needed. Allogeneic human umbilical cord derived mesenchymal stromal cells (hCT-MSCs) have potential therapeutic benefits in these critically ill patients, but feasibility and safety data are lacking. MATERIALS AND METHODS: In this phase I multisite study, 10 patients with COVID-19-related ARDS were treated with 3 daily intravenous infusions of hCT-MSCs (1 million cells/kg, maximum dose 100 million cells). The primary endpoint assessed safety. RESULTS: Ten patients (7 females, 3 males; median age 62 years (range 39-79)) were enrolled at 2 sites and received a total of 30 doses of study product. The average cell dose was 0.93 cells/kg (range 0.56-1.45 cells/kg and total dose range 55-117 million cells) with 5/30 (17%) of doses lower than intended dose. Average cell viability was 85% (range 63%-99%) with all but one meeting the >70% release criteria. There were no infusion-related reactions or study-related adverse events, 28 non-serious adverse events in 3 unique patients, and 2 serious adverse events in 2 unique patients, which were expected and unrelated to the study product. Five patients died: 3 by day 28 and 5 by day 90 of the study (median 27 days, range 7-76 days). All deaths were determined to be unrelated to the hCT-MSCs. CONCLUSION: We were able to collect relevant safety outcomes for the use of hCT-MSCs in patients with COVID-19-related ARDS. Future studies to explore their safety and efficacy are warranted.

Impact of maternal cytomegalovirus seroconversion on newborn and childhood hearing loss.

Objectives/hypothesis: The objective of this study is to describe long-term hearing outcomes in infants born to mothers with a known cytomegalovirus (CMV) positivity who were not tested for congenital CMV. Study type: Clinical research study. Design: Retrospective cohort study. Methods: Retrospective chart review was performed for mothers seropositive to CMV. Mother-infant dyads (130) were identified between January 1, 2013 and January 1, 2017. Outcomes data was collected through June 1, 2020. Demographics, risk factors for hearing loss, evidence of CMV infection, other causes of hearing loss, need for speech therapy services, and results of all hearing tests were collected. Results: All 130 infants were asymptomatic and 5 were tested for congenital CMV. Five were negative for CMV and excluded from analyses. Of the remaining 125, only 1 had low-viral avidity IgG antibodies. None had IgM antibodies. Four children (3.2%) had hearing loss at last audiogram and one child had delayed onset SNHL due to an enlarged vestibular aqueduct. Speech therapy for communication was required for 33 children (26.4%). Conclusions: Knowledge of maternal perinatal CMV status can allow for education about possible sequelae of cCMV, as well as trigger an alert for testing babies born to mothers with low-viral avidity IgG during the first trimester, when the risk of vertical transmission is highest. Also, babies born to CMV positive mothers may be more at risk for communication delays necessitating intervention. Studies focusing on the impact of maternal CMV related to childhood communication deficits could elucidate any direct relationships.

High Prevalence of Sleep Disturbance Is Associated with Femoroacetabular Impingement Syndrome.

Purpose: The purpose of this study was to identify an association between Patient-Reported Outcomes Measurement Information System (PROMIS) sleep scores and other PROMIS domains in patients with femoroacetabular impingement syndrome (FAIS). Methods: Patients were retrospectively identified for FAIS pathology, and PROMIS outcomes were assessed at multiple visits. Individual generalized linear mixed-effects models were fit with PROMIS sleep score as the predictor variable, and each subsequent PROMIS metric as the response variable. Additionally, models were fit using a clinically significant dichotomization of PROMIS sleep score to assess differences in average PROMIS scores between those with disrupted sleep (>55) and those with normal sleep (≤55). Results: PROMIS scores at baseline differed between those with and without sleep disturbance. Specifically, higher PROMIS sleep scores were associated with higher anxiety, depression, fatigue, pain intensity, and pain interference scores and lower physical function, and social participation. Conclusions: An association between PROMIS sleep score and other PROMIS outcomes does exist. Sleep disturbance is associated with increased anxiety, depression, fatigue, pain intensity, pain interference and decreased physical function, and social participation when analyzing PROMIS score, as both a continuous and dichotomized variable. Because of the observational design of this study, no causal inference can be made on these results. Level of Evidence: Level III, retrospective comparative trial.