The Coronavirus Disease 2019 Rebound Study: A Prospective Cohort Study to Evaluate Viral and Symptom Rebound Differences in Participants Treated With Nirmatrelvir Plus Ritonavir Versus Untreated Controls.

BACKGROUND: The uptake of nirmatrelvir plus ritonavir (NPR) in patients with coronavirus disease 2019 (COVID-19) has been limited by concerns around the rebound phenomenon despite the scarcity of evidence around its epidemiology. The purpose of this study was to prospectively compare the epidemiology of rebound in NPR-treated and untreated participants with acute COVID-19 infection. METHODS: We designed a prospective, observational study in which participants who tested positive for COVID-19 and were clinically eligible for NPR were recruited to be evaluated for either viral or symptom clearance and rebound. Participants were assigned to the treatment or control group based on their decision to take NPR. Following initial diagnosis, both groups were provided 12 rapid antigen tests and asked to test on a regular schedule for 16 days and answer symptom surveys. Viral rebound based on test results and COVID-19 symptom rebound based on patient-reported symptoms were evaluated. RESULTS: Viral rebound incidence was 14.2% in the NPR treatment group (n = 127) and 9.3% in the control group (n = 43). Symptom rebound incidence was higher in the treatment group (18.9%) compared to controls (7.0%). There were no notable differences in viral rebound by age, gender, preexisting conditions, or major symptom groups during the acute phase or at the 1-month interval. CONCLUSIONS: This preliminary report suggests that rebound after clearance of test positivity or symptom resolution is higher than previously reported. However, notably we observed a similar rate of rebound in both the NPR treatment and control groups. Large studies with diverse participants and extended follow-up are needed to better understand the rebound phenomena.

Treatment of Early-onset Scoliosis: Similar Outcomes Despite Different Etiologic Subtypes in Traditional Growing Rod Graduates.

BACKGROUND: It is unclear whether traditional growing rod (TGR) treatment outcomes vary by early-onset scoliosis (EOS) subtype. The goal of this study was to compare radiographic outcomes and complications of TGR treatment by EOS subtype. METHODS: We queried an international database of EOS patients from 20 centers to identify "graduates" who had (1) undergone primary TGR treatment from 1993 to 2014; (2) completed TGR treatment; and (3) had an uneventful clinical examination within 6 months after completion of TGR treatment with no anticipated further intervention. We included 202 patients in 4 etiologic subgroups: neuromuscular (n=65), syndromic (n=57), idiopathic (n=52), and congenital (n=28). Mean age at surgery was 7.1 years (range, 1.6 to 14.9 y); mean duration of follow-up was 8 years (range, 2 to 18.6 y). The groups did not differ by mean age, body mass index, sex, number of lengthenings, or duration of follow-up. The following preoperative differences were significant: (1) greater mean major curve in the neuromuscular versus idiopathic subgroup; (2) shorter spinal height (T1-S1) in the congenital versus idiopathic subgroup; and (3) smaller proportion of ambulatory patients in the neuromuscular subgroup versus all other subgroups. RESULTS: We found no significant differences among subgroups in mean major curve correction or changes in thoracic height (T1-T12), spinal height, or global kyphosis at any point. Rates of deep surgical site infection, implant-related complications, and neurological complications were not different among subgroups. The medical complication rate was significantly lower in the idiopathic group compared with the other groups. CONCLUSIONS: Major curve correction and spinal and thoracic height increases did not differ significantly at any point by EOS subtype. Rates of deep surgical site infection, implant-related complications, and neurological complications did not differ by subtype. Except for the lower rate of medical complications in the idiopathic group, our findings suggest that, after TGR treatment, patients can expect similar outcomes regardless of their EOS subtype. LEVEL OF EVIDENCE: Level III, therapeutic.

Prevalence of junctional kyphosis in early-onset scoliosis: can it be corrected at final fusion?

PURPOSE: To investigate the risk and predictive factors of junctional issues after conversion from Traditional growing rod (TGR) to definitive spinal fusion in Early-onset scoliosis (EOS). METHODS: Retrospective review of a multicenter EOS database. TGR patients who received final fusion with at least two-year follow-up were included. Proximal (PJA) and Distal junctional angles (DJA) on pre-final fusion, post-final fusion (within one year of surgery), and at latest follow-up were measured on lateral upright spinal radiographs. Differences in values among designated time points and predictive factors of junctional issues were evaluated statistically. RESULTS: Forty-six of 251 patients (28 females, 18 males and mean age at final fusion: 12 ± 2 [9-17] years) met the inclusion criteria. Mean follow-up between first postoperative measurement and latest follow-up was 49 ± 22 (24-112) months. No statistical differences in PJA and DJA values were available at pre-fusion, first post-fusion, or latest follow-up (p = 0.827, p = 0.076). Fifty percent of patients had extension of TGR instrumentation at fusion, either proximal or distal. No factor including sex and etiology, lumbar lordosis, thoracic kyphosis, major curve magnitude, PJA, and DJA at pre-fusion was found to be a predictive issue for extension of index TGR instrumentation, except the history of at least one implant-related complication during the period from index surgery to the definitive fusion. CONCLUSION: PJA and DJA remained stable when transitioning from TGR to final posterior spinal fusion. But 50% of patients had extension of construction at fusion, either proximal or distal.

Improvement of Pulmonary Function Measured by Patient-reported Outcomes in Patients With Spinal Muscular Atrophy After Growth-friendly Instrumentation.

BACKGROUND: Children with spinal muscular atrophy (SMA) sustain a progressive reduction in pulmonary function (PF) related to both muscular weakness and the concomitant effects of spinal deformity on the thorax. Growth-friendly instrumentation is commonly utilized for younger patients with scoliosis and SMA to halt the progression of spinal curvature, but its effect on PF in these patients has not previously been investigated. Using the change in Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24) PF subdomain scores, the authors will investigate whether PF improves in patients with SMA after a growth-friendly intervention. METHODS: This was a multicenter retrospective cohort study from 2 international registries of patients with SMA undergoing spinal deformity surgery from 2005 to 2015. Data collected were age, sex, degree of major coronal curve, type of growth-friendly construct, forced vital capacity (FVC), and EOSQ-24 scores at the patient's preoperative, 1-year postoperative, and 2-year postoperative visits. Differences in EOSQ-24 PF scores and FVC between baseline and postoperative assessment were examined by paired tests. RESULTS: A total of 74 patients were identified (mean age, 7.6±2.3 y, major curve 68.1±22.4 degrees, 51.4% female individuals). The mean EOSQ-24 PF scores improved significantly from 70.6 preoperatively to 83.6 at 1 year (P=0.092) and 86.5 at 2 years postoperatively (P=0.020). The scores in patients with rib-based constructs showed steeper increases at 1-year assessments than those in patients with spine-based constructs. The mean paired FVC value decreased from 63.9% predicted preoperatively, to 57.6% predicted at 1 year postoperatively (P=0.035), and 61.9% predicted preoperatively, to 56.3% predicted at 2 years postoperatively (P=0.178). CONCLUSIONS: Patients with SMA who received growth-friendly instrumentation did experience improvements in PF as measured by EOSQ-24 assessing the caregivers' perception. Given the uncertain reliability of PFTs in this young population, EOSQ-24 is an important tool for measuring improvements in health-related quality of life. LEVEL OF EVIDENCE: Level III-retrospective study.

Idiopathic Early-onset Scoliosis: Growing Rods Versus Vertically Expandable Prosthetic Titanium Ribs at 5-year Follow-up.

BACKGROUND: Distraction-based techniques allow spinal growth until skeletal maturity while preventing curve progression. METHODS: Two multicenter early-onset scoliosis databases were used to identify patients with idiopathic spine abnormalities treated with traditional growing rods (TGR) or vertically expandable titanium ribs (VEPTR). Patients underwent at least 4 lengthenings and had at least 5-year follow-up. Significance was set at P<0.05. RESULTS: In total, 50 patients treated with TGR and 22 treated with VEPTR were included. Mean (±SD) age at surgery was 5.5 (±2.0) years for the TGR group versus 4.3 (±1.9) years for the VEPTR group (P=0.044); other demographic parameters were similar. VEPTR patients had more procedures (mean 15±4.2) than TGR patients (mean 10±4.0) (P=0.001). Unilateral constructs were present in 18% (4 of 22) of VEPTR and 16% (8 of 50) of TGR patients. Bilateral constructs spanned a mean 2.1 additional surgical levels and exposed patients to 1.6 fewer procedures than unilateral constructs. Curve correction was similar between bilateral and unilateral constructs. TGR patients experienced greater curve correction (50%) than VEPTR patients (27%) (P<0.001) and achieved a greater percentage of thoracic height gain (24%) than VEPTR patients (12%) (P=0.024). At latest follow-up, TGR patients had better maintenance of curve correction, less kyphosis, and 15% greater absolute gain in thoracic height versus VEPTR patients. TGR patients had a lower rate of wound complications (14%) than VEPTR patients (41%) (P=0.011). CONCLUSIONS: In patients with idiopathic early-onset scoliosis, TGRs produced greater initial curve correction, greater thoracic height gains, less kyphosis, and lower incidence of wound complications compared with VEPTR. LEVEL OF EVIDENCE: Level III.

Characterizing Use of Growth-friendly Implants for Early-onset Scoliosis: A 10-Year Update.

BACKGROUND: Growth-friendly treatment of early-onset scoliosis (EOS) has changed with the development and evolution of multiple devices. This study was designed to characterize changes in the use of growth-friendly implants for EOS from 2007 to 2017. METHODS: We queried the Pediatric Spine Study Group database for patients who underwent index surgery with growth-friendly implants from July 2007 to June 2017. In 1298 patients, we assessed causes of EOS; preoperative curve magnitude; age at first surgery; patient sex; construct type; lengthening interval; incidence of "final" fusion for definitive treatment; and age at definitive treatment. α=0.05. RESULTS: From 2007 to 2017, the annual proportion of patients with idiopathic EOS increased from 12% to 33% (R=0.58, P=0.006). Neuromuscular EOS was the most common type at all time points (range, 33% to 44%). By year, mean preoperative curve magnitude ranged from 67 to 77 degrees, with no significant temporal changes. Mean (±SD) age at first surgery increased from 6.1±2.9 years in 2007 to 7.8±2.5 years in 2017 (R=0.78, P<0.001). As a proportion of new implants, magnetically controlled growing rods increased from <5% during the first 2 years to 83% in the last 2 years of the study. Vertically expandable prosthetic titanium ribs decreased from a peak of 48% to 6%; growth-guidance devices decreased from 10% to 3%. No change was seen in mean surgical lengthening intervals (range, 6 to 9 mo) for the 614 patients with recorded lengthenings. Final fusion was performed in 88% of patients who had undergone definitive treatment, occurring at a mean age of 13.4±2.4 years. CONCLUSIONS: From 2007 to 2017, neuromuscular EOS was the most common diagnosis for patients treated with growth-friendly implants. Patient age at first surgery and the use of magnetically controlled growing rods increased during this time. Preoperative curve magnitude, traditional growing rod lengthening intervals, and rates of final fusion did not change. LEVEL OF EVIDENCE: Level II.

Best Practice Guidelines for Surgical Site Infection Prevention With Surgical Treatment of Early Onset Scoliosis.

BACKGROUND: Postoperative surgical site infection (SSI) is unfortunately a commonly encountered complication in the surgical treatment of children with Early Onset Scoliosis (EOS). There is documented variation in the treatment of this patient population. Previous work building consensus for the approach to high risk patients (eg, neuromuscular etiology) has been promising. The goal of the current study is to apply similar principles to develop consensus-based guidelines for the treatment of patients with EOS. METHODS: A focus group from 2 multicenter pediatric spine deformity study groups developed a list of statements to be distributed to a larger group of EOS experts. Using the Delphi process, participants were presented with a systematic review of the literature as well as a review of current practices in growth friendly surgery. The first round was conducted using an electronic survey. Results of this survey were then discussed face-to-face and the statements were further refined. A final round was conducted using the Audience Response System, allowing participants to vote for each statement (strongly agree or agree). Agreement >80% or disagreement <20% was considered consensus. RESULTS: A total of 29 of 57 statements reached consensus. Negative statements (statements of disagreement) were excluded, so the final consensus guidelines included 22 statements. The number of statements from the previously published Best Practice Guidelines (BPG) approved for insertion and lengthening growth friendly procedures were 12 of 14 and 11 of 14, respectively. The high risk BPG therefore does not cover all of the issues specific to the EOS population, and explains why 22 statements reached consensus in the current guideline. Upon completion of the surveys, 100% of the participants agreed to support its publication. CONCLUSIONS: Using the Delphi process several "best practices" were developed for growth friendly surgical treatment of EOS. LEVEL OF EVIDENCE: Level V.

Early Onset Scoliosis: Is there an Improvement in Quality of Life With Conversion From Traditional Growing Rods to Magnetically Controlled Growing Rods?

BACKGROUND: Modern treatment of early onset scoliosis (EOS) includes implantation of traditional growing rods (TGR) or magnetically controlled growing rods (MCGR) for posterior-based distraction if nonoperative treatment plans failed. The recent MCGR innovation has largely been expected to improve patient and family burden by avoiding frequent return to the operating room. At least one study has shown no HRQoL difference between TGR and MCGR, but none have specifically investigated a cohort of conversion patients whose families have experienced both. METHODS: An EOS database was queried for all patients treated with TGR, MCGR, and those converted from TGR to MCGR who had at least 1 pretreatment and 1 posttreatment HRQoL assessment (EOSQ-24). Data on demographics, diagnoses, and major curve size, as well as EOSQ-24 domain scores were studied. RESULTS: There were 156 TGR, 114 MCGR, and 32 conversion patients, with an average of 2.0 years between first and final EOSQ-24 surveys. There was no significant difference in outcome in any EOSQ-24 domain between the converts and the other 2 treatment groups. There was a significant post-op improvement in MCGR versus TGR in transfers and energy level (P=0.01; P=0.01). CONCLUSIONS: Although patient families and their surgeons may subjectively report improved HRQoL after conversion from TGR lengthenings to in-office MCGR lengthenings, these improvements were seen in transfer and fatigue domains, not burden or satisfaction. Although the EOSQ-24 is a well-validated EOS metric, it may not be sensitive enough to overcome the QoL floor-effect associated with the diagnosis itself, or perhaps the improvement in QoL must be assessed over a longer interval to assess meaningful change. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Growth-Friendly Spine Surgery in Escobar Syndrome.

BACKGROUND: The aims of this study were to characterize the spinal deformity of patients with Escobar syndrome, describe results of growth-friendly treatments, and compare these results with those of an idiopathic early-onset scoliosis (EOS) cohort to determine whether the axial stiffness in Escobar syndrome limited correction. METHODS: We used 2 multicenter databases to review the records of 8 patients with EOS associated with Escobar syndrome who had at least 2-year follow-up after initiation of growth-friendly treatment from 1990 to 2016. An idiopathic EOS cohort of 16 patients matched for age at surgery (±1 y), postoperative follow-up (±1 y), and initial curve magnitude (±10 degrees) was identified. A randomized 1:2 matching algorithm was applied (α=0.05). RESULTS: In the Escobar group, spinal deformity involved 7 to 13 vertebrae and ranged from no vertebral anomalies in 3 patients to multiple segmentation defects in 6 patients. Mean age at first surgery was 5 years (range, 1.4 to 7.8 y) with a mean follow-up of 7.5 years (range, 4.0 to 10 y). Mean major curve improved from 76 degrees at initial presentation, to 43 degrees at first instrumentation, to 37 degrees at final follow-up (both P<0.001). Mean pelvic obliquity improved from 16 degrees (range, 5 to 31 degrees) preoperatively to 4 degrees (range, 0 to 8 degrees) at final follow-up (P=0.005). There were no differences in the mean percentage of major curve correction between the idiopathic EOS and Escobar groups at the immediate postoperative visit (P=0.743) or final follow-up (P=0.511). There were no differences between the cohorts in T1-S1 height at initial presentation (P=0.129) or in growth per month (P=0.211). CONCLUSIONS: Multiple congenital fusions and spinal curve deformity are common in Escobar syndrome. Despite large areas of congenital fusion, growth-friendly constructs facilitate spinal growth and improve curve correction. These results are comparable to those in idiopathic EOS. LEVEL OF EVIDENCE: Level III-case-control study.

Rod fracture and lengthening intervals in traditional growing rods: is there a relationship?

PURPOSE: Is there any relationship between lengthening intervals and rod fracture in traditional growing rod (TGR) surgery? METHODS: A multicenter EOS database was queried for patients who had: (1) dual growing rods for EOS; (2) minimum 2-year follow-up; (3) a minimum of 2 lengthenings; and (4) revision surgery due to rod fracture. Of 138 patients who met the criteria: 56 patients experienced at least one-rod fracture (RF group) and 82 patients had no rod fractures (NRF group). In addition to each patient's lengthening intervals, demographics, construct details, and radiographic parameters were compared. RESULTS: RF and NRF patients had a mean pre-op age of 5.7 years (range 1.3-10.7) and 7.3 years (range 1.6-12.8), respectively (p < 0.001). There was no significant association between etiologies and rod fracture or between BMI and rod fracture (p = 0.979). There was no significant difference between lengthening intervals between the RF and NRF groups (p > 0.05). RF and NRF patients had statistically similar mean pre-op major curve size and max kyphosis (p = 0.279; p = 0.619, respectively). Stainless steel rods fractured more frequently compared with Titanium rods (SS 49.2 % vs. Ti 38 %; p = 0.004). Rod fracture occurred more in rods smaller than 4 mm (p = 0.011). CONCLUSIONS: Lengthening intervals were not statistically different in RF and NRF groups and there was no association between lengthening interval and rod fracture in TGR cases. It was shown that patients who had rod fracture were younger and were more likely to have SS rods with smaller than 4 mm diameter.

Quantifying Anesthesia Exposure in Growing Rod Treatment for Early Onset Scoliosis.

BACKGROUND: Growing rod (GR) treatment for early-onset scoliosis requires repeated anesthesia exposure (AE). At a minimum, GR treatment requires AE for diagnostic imaging, index GR surgery, periodic lengthenings, and final fusion. Adjunct procedures and complication-related procedures also increase AE. To our knowledge, this is the first study to quantify AE in GR treatment and to establish preoperative expectations. METHODS: A single-center retrospective review of 16 patients who completed GR treatment and underwent final fusion. Duration of all AE related to GR treatment for "standard" care procedures (ie, advanced imaging, index surgery, lengthenings, final fusion) and "associated" care procedures (ie, revisions, adjunctive surgical procedures, wound-related complications) were reviewed. Etiologies were classified per the classification of early-onset scoliosis. Mean total anesthesia time (TAT) was tallied and analyzed for standard care and associated care procedures. RESULTS: There were 5 syndromic, 8 neuromuscular, and 3 idiopathic patients. The mean age at the first AE event related to GR treatment was 7.4 years (range, 3.8 to 11 y). Mean age at the index GR surgery and final fusion was 8.1 years (range, 3.9 to 14.4 y) and 12.8 years (range, 9.7 to 19 y), respectively. The percentage of TAT for each procedural category was 7% for advanced imaging, 14% for index GR, 14% for lengthenings, 21% for final fusion, 27% for revisions, 9% for adjunct surgery, and 9% for wound complications. Standard care procedures accounted for 55% of TAT, whereas associated care procedures accounted for 45%. CONCLUSIONS: This study quantified expected duration of AE in GR treatment. Revisions and final fusion contributed most to TAT. Given the recent controversy of repeated AE in young children, efficiency measures should be implemented to reduce AE and avoid duplication without compromising the goals of surgical treatment. Associated care procedures accounted for 45% of the total AE. LEVEL OF EVIDENCE: Level IV.

Implant Complications After Magnetically Controlled Growing Rods for Early Onset Scoliosis: A Multicenter Retrospective Review.

BACKGROUND: Traditional growing rods have a reported wound and implant complication rate as high as 58%. It is unclear whether the use of magnetically controlled growing rods (MCGR) will affect this rate. This study was performed to characterize surgical complications following MCGR in early onset scoliosis. METHODS: A multicenter retrospective review of MCGR cases was performed. Inclusion criteria were: (1) diagnosis of early onset scoliosis of any etiology; (2) 10 years and younger at time of index surgery; (3) preoperative major curve size >30 degrees; (4) preoperative thoracic spine height <22 cm. Complications were categorized as wound related and instrumentation related. Complications were also classified as early (<6 mo from index surgery) versus late (>6 mo). Distraction technique and interval of distraction was surgeon preference without standardization across sites. RESULTS: Fifty-four MCGR patients met inclusion criteria. There were 30 primary and 24 conversion procedures. Mean age at initial surgery was 7.3 years (range, 2.4 to 11 y), and mean duration of follow-up 19.4 months. Twenty-one (38.8%) of 54 patients had at least 1 complication. Fifteen (27.8%) had at least 1 revision surgery. Six (11.1%) had broken rods (2 to 4.5 and 4 to 5.5 mm rods); two 5.5 mm rods failed early (4 mo) and 4 late (mean=14.5 mo). Six (11.1%) patients experienced 1 episode of lack or loss of lengthening, of which 4 patients subsequently lengthened. Seven patients (13.0%) had either proximal or distal fixation-related complication at average of 8.4 months. Two patients (3.7%) had infections requiring incision and drainage; 1 early (2 wk) with wound drainage and 1 late (8 mo). The late case required removal of one of the dual rods. CONCLUSIONS: This study shows that compared with traditional growing rods, MCGR has a lower infection rate (3.7% vs. 11.1%). MCGR does not appear to prevent common implant-related complications such as rod or foundation failure. The long-term implication remains to be determined. LEVEL OF EVIDENCE: Level IV.

Preliminary comparison of primary and conversion surgery with magnetically controlled growing rods in children with early onset scoliosis.

PURPOSE: Non-invasive distraction of magnetically controlled growing rods (MCGR) avoids repeated surgical lengthening in patients with early onset scoliosis, but it is not known how effective this technique is in previously operated children. METHODS: In a retrospective, multicentre study, the data were obtained for 27 primary (P) patients [mean age 7.0 (2.4-10.7) years at surgery] and 23 conversion (C) patients [mean age 7.7 (3.6-11.0) years at conversion from standard growing rods] with 1-year follow-up. RESULTS: The mean major curve was 63.9° in the P group and 46.5° in the C group at baseline (preoperatively, p = 0.0009) and 39.5° and 39.6°, respectively, at 1-year follow-up (p = 0.99). The mean percentage change of spinal growth from baseline to 1-year follow-up was 18.3 % in the P group and 6.5 % in the C group (p = 0.007). Comparing the spinal growth from postoperative to 1-year follow-up no statistical difference was observed between the study groups (1.8 % P vs -2.2 % C, p = 0.09). CONCLUSIONS: Scoliosis can be equally controlled after conversion from traditional growing rods into MCGR, but spinal growth from baseline is less in the conversion patients as compared with the primary group. LEVEL OF EVIDENCE: III.

Do Longer Surgical Procedures Result in Greater Contamination of Surgeons' Hands?

BACKGROUND: A surgical site infection is a substantial cause of complications in patients. Different methods are being used to decrease surgical site infections; however, these infections still can cause complications, especially in patients undergoing longer operations (> 3 hours). There is evidence that the efficacy of the scrubbing material fades after 3 hours. However, we do not know the longevity of hand cleanliness after application of scrubbing materials in a long operation. It can be postulated that if the surgeon's scrubbed hands are recolonized after a certain time, they may serve as a progressive source of contamination during surgery. QUESTIONS/PURPOSES: We asked: (1) Is there a correlation between surgical duration and hand contamination at the end of surgery? (2) At what point during surgery does hand contamination reach or exceed prescrub levels? METHODS: Three spine surgeons using the same scrubbing technique and materials consisting of chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w were enrolled in our study. Between December 2014 and April 2015, spine procedures of 3 hours or more, which were the first case of the day, were selected for this study (20 cases). Cases in which glove changing occurred (perforations, reprepping, and redraping) or cultures obtained after scrubbing were positive (indicative of insufficient hand sanitization) were excluded (0% of cases). Twenty cases (100% enrollment) were analyzed. Surgeons' hands were swabbed with sterile cotton tip applicators and 5 mL sterile phosphate-buffered saline before hand scrubbing (prescrub), immediately after hand scrubbing (postscrub), and immediately after surgery (postoperative). Results were reported in colony-forming units per milliliter. The correlation between duration of surgery and hand recontamination was tested by regression analysis of time versus colony-forming units per milliliter. Receiver-operating characteristic curve tested the cutoff point, where recontamination occurred. RESULTS: With a longer duration of surgery, more colony-forming units are recovered from gloved hands at the end of surgery (R = 0.94, R(2) = 0.89, p = 0.005). The receiver-operating characteristic curve suggested that 5 hours is the cutoff point for hand recolonization. At 5 hours, contamination reached or exceeded prescrub levels (area under the curve, 0.66; 95% CI, 0.23-1.0), whereas before 5 hours, there was no contamination detected at the end of surgery. CONCLUSIONS: Our results show that duration of surgery correlates with hand recontamination and at 5 hours, recolonization of a surgeon's hands become detectable. Recolonization may have started even earlier than 5 hours. However, these levels are not detectable in the laboratory at earlier times. CLINICAL RELEVANCE: Based on this pilot study, rescrubbing is highly recommended before the fifth hour of an operation, ideally at some point between the fourth and fifth hours. FUTURE: We also recommend the surgical site infection rates in operations using rescrubbing should be compared with those from surgeries with just the conventional single-scrubbing technique, in a randomized controlled trial, to determine the effectiveness of this novel rescrubbing method.

Anterior column realignment (ACR) for focal kyphotic spinal deformity using a lateral transpsoas approach and ALL release.

STUDY DESIGN: Retrospective case series. OBJECTIVES: Introduce and evaluate the safety of a new technique of anterior column realignment (ACR) using a lateral transpsoas approach with release of anterior longitudinal ligament and annulus for correction of focal kyphotic deformity. SUMMARY OF BACKGROUND DATA: Spinal sagittal imbalance can adversely affect the long-term outcomes of patients with spinal deformity. METHODS: Clinical and radiographic review of patients who underwent ACR. RESULTS: Seventeen consecutive patients (12 females; 5 males) with a mean age of 63 years (range, 35-76 y) and a mean follow-up of 24 months (range, 12-82 mo) were identified. Fourteen of 17 (82%) had previous spine surgery and 12/17 (71%) had previous fusion. Twelve of the 17 (71%) underwent ACR for adjacent segment disease. Fifteen patients (88%) had Smith-Petersen osteotomies at the ACR level.The mean motion segment angle was 9 degrees preoperatively, which corrected to -19 degrees after ACR and to -26 degrees after posterior instrumentation. Motion segment angle was maintained at -23 degrees at the latest follow-up. The mean lumbar lordosis was -16 degrees preoperatively, which improved to -38 degrees after ACR and to -45 degrees after posterior instrumentation. Lumbar lordosis was maintained at -51 degrees at the latest follow-up. Pelvic tilt averaged 34 degrees before ACR and improved to 24 degrees after ACR and posterior instrumentation and maintained at 25 degrees at the latest follow-up. Patients with preoperative negative T1 spinopelvic inclination (T1SPI) corrected from -6 to -2 degrees and those with 0 or positive T1SPI corrected from 5 to -3 degrees after ACR at the latest follow-up.Eight patients (47%) had 10 complications. Four complications occurred after ACR. Two of 4 were neurological (1 persistent weakness) and 1 was vascular injury during anterior plate removal. CONCLUSION: Compared with posterior-based techniques, our preliminary results of ACR showed similar correction capacity and similar rate of morbidities for the treatment of focal kyphotic spinal deformity. Careful case selection, attention to the details of the technique, and enough experience are prudent elements for a desirable outcome.

The hospital at home in the USA: current status and future prospects.

The annual cost of hospital care services in the US has risen to over $1 trillion despite relatively worse health outcomes compared to similar nations. These trends accentuate a growing need for innovative care delivery models that reduce costs and improve outcomes. HaH-a program that provides patients acute-level hospital care at home-has made significant progress over the past two decades. Technological advancements in remote patient monitoring, wearable sensors, health information technology infrastructure, and multimodal health data processing have contributed to its rise across hospitals. More recently, the COVID-19 pandemic brought HaH into the mainstream, especially in the US, with reimbursement waivers that made the model financially acceptable for hospitals and payors. However, HaH continues to face serious challenges to gain widespread adoption. In this review, we evaluate the peer-reviewed evidence and discuss the promises, challenges, and what it would take to tap into the future potential of HaH.

Self-Reported Medication Use Across Racial and Rural or Urban Subgroups of People Who Are Pregnant in the United States: Decentralized App-Based Cohort Study.

BACKGROUND: Maternal health outcomes have been underresearched due to people who are pregnant being underrepresented or excluded from studies based on their status as a vulnerable study population. Based on the available evidence, Black people who are pregnant have dramatically higher maternal morbidity and mortality rates compared to other racial and ethnic groups. However, insights into prenatal care-including the use of medications, immunizations, and prenatal vitamins-are not well understood for pregnant populations, particularly those that are underrepresented in biomedical research. Medication use has been particularly understudied in people who are pregnant; even though it has been shown that up to 95% of people who are pregnant take at least 1 or more medications. Understanding gaps in use could help identify ways to reduce maternal disparities and optimize maternal health outcomes. OBJECTIVE: We aimed to characterize and compare the use of prenatal vitamins, immunizations, and commonly used over-the-counter and prescription medications among people who are pregnant, those self-identifying as Black versus non-Black, and those living in rural versus urban regions in the United States. METHODS: We conducted a prospective, decentralized study of 4130 pregnant study participants who answered survey questionnaires using a mobile research app that was only available on iOS (Apple Inc) devices. All people who were pregnant, living in the United States, and comfortable with reading and writing in English were eligible. The study was conducted in a decentralized fashion with the use of a research app to facilitate enrollment using an eConsent and self-reported data collection. RESULTS: Within the study population, the use of prenatal vitamins, antiemetics, antidepressants, and pain medication varied significantly among different subpopulations underrepresented in biomedical research. Black participants reported significantly lower frequencies of prenatal vitamin use compared to non-Black participants (P<.001). The frequency of participants who were currently receiving treatment for anxiety and depression was also lower among Black and rural groups compared to their non-Black and urban counterparts, respectively. There was significantly lower use of antidepressants (P=.002) and antiemetics (P=.02) among Black compared to non-Black participants. While prenatal vitamin use was lower among participants in rural areas, the difference between rural and urban groups did not reach statistical significance (P=.08). There were no significant differences in vaccine uptake for influenza or tetanus-diphtheria-pertussis (TDaP) across race, ethnicity, rural, or urban status. CONCLUSIONS: A prospective, decentralized app-based study demonstrated significantly lower use of prenatal vitamins, antiemetics, and antidepressants among Black pregnant participants. Additionally, significantly fewer Black and rural participants reported receiving treatment for anxiety and depression during pregnancy. Future research dedicated to identifying the root mechanisms of these differences can help improve maternal health outcomes, specifically for diverse communities.

Is spinal height gain associated with rod orientation and the use of cross-links in magnetically controlled growing rods in early-onset scoliosis?

Optimal orientation for magnetically controlled growing rods (MCGRs) is unclear. The objective of this study was to investigate associations of rod orientation with implant-related complications (IRCs) and spinal height gains. Using an international early-onset scoliosis (EOS) database, we retrospectively reviewed 57 patients treated with dual MCGRs from May 2013 to July 2015 with minimum 2-year follow-up. Outcomes of interest were IRCs and left/right rod length gains and thoracic (T1-T12) and spinal (T1-S1) heights. We compared patients with two rods lengthened in the cephalad ( standard; n  = 18) versus opposite ( offset; n  = 39) directions. Groups did not differ in age, sex, BMI, duration of follow-up, EOS cause, ambulatory status, primary curve magnitude, baseline thoracic height, or number of distractions/year. We compared patients whose constructs used ≥1 cross-link (CL group; n  = 22) versus no CLs (NCL group; n  = 35), analyzing thoracic height gains per distraction ( α  = 0.05). Offset and standard groups did not differ in left or right rod length gains overall or per year or in thoracic or spinal height gain. Per distraction, the CL and NCL groups did not differ significantly in left or right rod length or thoracic or spinal height gain. Complications did not differ significantly between rod orientation groups or between CL groups. MCGR orientation and presence of cross-links were not associated with differences in rod length gain, thoracic height, spinal height, or IRCs at 2-year follow-up. Surgeons should feel comfortable using either MCGR orientation. Level of evidence: 3, retrospective.

The Power of Patient Engagement With Electronic Health Records as Research Participants.

Electronic health record (EHR) technology has become a central digital health tool throughout health care. EHR systems are responsible for a growing number of vital functions for hospitals and providers. More recently, patient-facing EHR tools are allowing patients to interact with their EHR and connect external sources of health data, such as wearable fitness trackers, personal genomics, and outside health services, to it. As patients become more engaged with their EHR, the volume and variety of digital health information will serve an increasingly useful role in health care and health research. Particularly due to the COVID-19 pandemic, the ability for the biomedical research community to pivot to fully remote research, driven largely by EHR data capture and other digital health tools, is an exciting development that can significantly reduce burden on study participants, improve diversity in clinical research, and equip researchers with more robust clinical data. In this viewpoint, we describe how patient engagement with EHR technology is poised to advance the digital clinical trial space, an innovative research model that is uniquely accessible and inclusive for study participants.

The role of traditional growing rods in the era of magnetically controlled growing rods for the treatment of early-onset scoliosis.

PURPOSE: To describe the clinical and radiographic profile of early-onset scoliosis (EOS) patients treated with traditional growing rods (TGR) during the magnetically-controlled growing rod (MCGR) era. METHODS: A US multicenter EOS database was reviewed to identify (1) patients who underwent TGR after MCGR surgery was introduced at their institution, (2) patients who underwent MCGR during the same time period. Of 19 centers, 8 met criteria with all EOS etiologies represented. Clinical notes were reviewed to determine the indication for TGR. Patient demographics and pre-operative radiographs were compared between groups. RESULTS: A total of 25 TGR and 127 MCGR patients were identified. The TGR patients were grouped by indication into the sagittal plane profile (n = 11), trunk height (n = 6), co-morbidities/need for MRI (n = 4), and other (ex: behavioral issues, remaining growth). Four patients had a combination of sagittal profile and short stature with sagittal profile listed as primary factor. The TGR short trunk group had a mean T1-S1 length of 192 mm vs 273 mm for the MCGR group (p = 0.0002). The TGR sagittal profile group, had a mean maximal kyphosis of 61° vs 55° for the MCGR group (p = 0.09). CONCLUSION: TGR continues to have a role in the MCGR era. In this study, the most commonly reported indications for TGR were sagittal plane profile and trunk height. These results suggest that TGR is indicated in patients of short stature with stiff hyperkyphotic curves. As further experience is gained with MCGR, the indications for TGR will likely be refined.