bluuebunny/crossref_metadata_2025_split huggingface dataset:
Generalizability of Randomized Clinical Trial Outcomes for Diabetes Control Resulting From Bariatric Surgery
Authors: Livingston Edward H. , Zelicha Hila , Dutson Erik P. , Li Zhaoping , Maciejewski Matthew L. , Chen Yijun 
Published: April 2024

Objective:
To assess the external validity of randomized controlled trials (RCTs) of bariatric surgical treatment on diabetes control.

Background:
Multisite RCTs provide the strongest evidence supporting clinical treatments and have the greatest internal validity. However, characteristics of trial participants may not be representative of patients receiving treatment in the real world. There is a need to assess how the results of RCTs generalize to all contemporary patient populations undergoing treatments.

Methods:
All patients undergoing sleeve gastrectomy at University of California Los Angeles (UCLA) between January 8, 2018 and May 19, 2023 had their baseline characteristics, weight change, and diabetes control compared with those enrolled in the surgical treatment and medications potentially eradicate diabetes efficiently (STAMPEDE) and diabetes surgery study (DSS) RCTs of bariatric surgery’s effect on diabetes control. Weight loss and diabetes control were compared between UCLA patients who did and did not fit the entry criteria for these RCTs.

Results:
Only 65 (17%) of 387 patients with diabetes fulfilled the eligibility criteria for STAMPEDE, and 29 (7.5%) fulfilled the criteria for DSS due to being older, having higher body mass index, and lower HbA1c. UCLA patients experienced slightly less weight loss than patients in the RCTs but had similar diabetes control. The 313 (81%) patients not eligible for study entry into either RCT had similar long-term diabetes control as those who were eligible for the RCTs.

Conclusions:
Even though only a very small proportion of patients undergoing bariatric surgery met the eligibility criteria for the 2 major RCTs, most patients in this contemporary cohort had similar outcomes. Diabetes outcomes from STAMPEDE and DSS generalize to most patients undergoing bariatric surgery for diabetes control.
The Intermalleolar Method for Intraoperative Rotational Assessment of the Tibia – A Prospective Clinical Validation Study
Authors: Roberts Michael S. , Conroy Jordan P. , DeSarno Michael , Blankstein Michael , Hahn Jesse C. , Bartlett Craig S. , Schottel Patrick C. 
Published: April 2024

OBJECTIVES:
To determine the accuracy of the intermalleolar method, an intraoperative fluoroscopic method for assessing tibial rotation in patients undergoing intramedullary nail fixation for tibial shaft fractures, by comparing it to the gold standard, computed tomography (CT).

METHODS:

Design: Prospective cohort study

Setting:
Academic Level 1 trauma center

Patient Selection Criteria:
Consecutive patients, age 18 years and older, with unilateral tibial shaft fractures who underwent intramedullary fixation from September, 2021 to January, 2023.

Outcome Measures and Comparisons:
Intraoperatively, tibial rotation measurements were performed using the intermalleolar method on both the uninjured and injured limbs. Postoperatively, patients underwent bilateral low-dose lower extremity rotational CT scans. CT measurements were made by four blinded observers. Mean absolute rotational differences and standard errors were calculated to compare the injured and uninjured limbs. Subgroup analysis was performed assessing accuracy relating to injured versus uninjured limbs, BMI, AO/OTA fracture pattern, tibial and fibular fracture location, and distal articular fracture extension requiring fixation.

RESULTS:
Of the 20 tibia fractures, the mean patient age was 43.4 years. The intermalleolar method had a mean absolute rotational difference of 5.1 degrees (SE 0.6, range 0 – 13.7) compared to CT. Sixty percent (24/40) of the measurements were within 5 degrees, 90% (36/40) of the measurements were within 10 degrees, and 100% (40/40) were within 15 degrees of the CT. No patients were revised for malrotation postoperatively.

CONCLUSION:
The intermalleolar method is accurate and consistently provides intraoperative tibial rotation measurements within 10 degrees of the mean CT measurement for adult aged patients undergoing intramedullary nail fixation for unilateral tibial shaft fractures. This method may be employed in the operating room to accurately quantify tibial rotation and assist with intraoperative rotational corrections.

LEVEL OF EVIDENCE:
Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Surgery for Spinal Stenosis in Achondroplasia: Causes of Reoperation and Reduction of Risks
Authors: Hariharan Arun R. , Nugraha Hans K. , Huser Aaron J. , Feldman David S. 
Published: April 2024

Background:
Individuals with achondroplasia are prone to symptomatic spinal stenosis requiring surgery. Revision rates are thought to be high; however, the precise causes and rates of reoperation are unknown. The primary aim of this study is to investigate the causes of reoperation after initial surgical intervention in individuals with achondroplasia and spinal stenosis. In addition, we report on surgical techniques aimed at reducing the risks of these reoperations.

Methods:
A retrospective review was conducted over an 8-year period of all patients with achondroplasia at a single institution that serves as a large referral center for patients with skeletal dysplasias. Patients with achondroplasia who underwent spinal surgery for stenosis were identified and the need for revision surgery was studied. Data collected included demographic, surgical, and revision details. Fisher exact test was used to determine if an association existed between construct type and the need for revisions.

Results:
Thirty-three of the 130 (22%) patients with achondroplasia required spinal stenosis surgery. Twenty-four individuals who met the criteria were selected for analysis. The initial spine surgery was at an average age of 18.7 years (SD: 10.1 y). Nine patients (38%) required revision surgeries, and 3 required multiple revisions. Five of 9 (56%) of the revisions had primary surgery at an outside institution. Revision surgeries were due to caudal pseudarthrosis (the distal instrumented segment) (8), proximal junctional kyphosis (PJK) (7), and new neurological symptoms (7). There was a significant association found between construct type and the need for revision (P=0.0111). The pairwise comparison found that short fusions were significantly associated with the need for revision compared with the interbody group (P=0.0180). PJK was associated with short fusions when compared with the long fusion group (P=0.0294) and the interbody group (P=0.0300). Caudal pseudarthrosis was associated with short fusions when compared with the interbody group (P=0.0015). Multivariate logistic regression found long fusion with an interbody was predictive of and protective against the need for revision surgery (P=0.0246). To date, none of the initial cases that had long fusions with caudal interbody required a revision for distal pseudarthrosis.

Conclusions:
In patients with achondroplasia, the rate of surgery for spinal stenosis is 22% and the risk of revision is 38% and is primarily due to pseudarthrosis, PJK, and recurrent neurological symptoms. Surgeons should consider discussing spinal surgery as part of the patient’s life plan and should consider wide decompression of the stenotic levels and long fusion with the use of an interbody cage at the caudal level in all patients to reduce risks of revision.

Level of Evidence:
Level IV—Retrospective case series.
Postoperative Patient Portal Messaging Is Associated With Return to the Emergency Department After Lumbar Spine Surgery
Authors: Chua Theresa L. , Lucaciu Andreea R. , Jeffers Tierney R. , Fogel Harold A. , Hershman Stuart H. , Bernstein David N. , Tobert Daniel G. 
Published: April 2024

Study Design.
Retrospective study.

Objective.
To explore the association between patients undergoing lumbar spine surgery who message their care team via an electronic patient portal (EPP) postoperatively and emergency department (ED) visits within 90 days of surgery.

Summary of Background Data.
Secure patient messaging through electronic patient portals has grown over recent years. Despite its frequent utilization by patients to engage with their care team, its association with clinical outcomes remains unknown in spine surgery.

Materials and Methods.
This study was approved by our Institutional Review Board. Inclusion criteria were adults who underwent single-stage lumbar spine surgery between January 2016 and June 2023. Patients with incomplete information, multistage surgeries, and those who died within 90 days of surgery were excluded. Patient sociodemographic, surgical, hospital readmission, and patient-provider engagement data were collected.

Results.
A total of 13,135 patients were included. A total of 1711 patients (13%) had a postoperative ED visit, and 4791 patients (36%) used the patient portal to send a message after surgery. Sending a postoperative patient message after undergoing lumbar spine surgery was associated with an increased likelihood of having an ED visit that does not lead to readmission (1.29 [1.10–1.53], P = 0.002). Patients with high school degrees were more likely to have an ED visit without readmission (1.33 [1.08–1.65], P = 0.008).

Conclusion.
Patients at a higher risk of presenting to the ED postoperatively should be identified and may benefit from additional counseling and access to the care team virtually to limit unnecessary healthcare utilization. Focusing on patients who reach out via EPP messaging postoperatively may be a good target patient group to address first. Future research is needed to investigate the possible health literacy and other socioeconomic barriers affecting these patients so that appropriate, more cost-effective resources can be utilized to avoid clinically unnecessary and costly ED visits.
First-Line Respiratory Support for Children With Hematologic Malignancy and Acute Respiratory Failure
Authors: Asif Hassaan , McNeer Jennifer L. , Ghanayem Nancy S. , Cursio John F. , Kane Jason M. 
Published: April 2024

OBJECTIVES:
To characterize trends in noninvasive ventilation (NIV) and invasive mechanical ventilation (IMV) use over time in children with hematologic malignancy admitted to the PICU with acute respiratory failure (ARF), and to identify risk factors associated with NIV failure requiring transition to IMV.

DESIGN:
Retrospective cohort analysis using the Virtual Pediatric Systems (VPS, LLC) between January 1, 2010 and December 31, 2019.

SETTING:
One hundred thirteen North American PICUs participating in VPS.

PATIENTS:
Two thousand four hundred eighty children 0–21 years old with hematologic malignancy admitted to participating PICUs for ARF requiring respiratory support.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
There were 3013 total encounters, of which 868 (28.8%) received first-line NIV alone (NIV only), 1544 (51.2%) received first-line IMV (IMV only), and 601 (19.9%) required IMV after a failed NIV trial (NIV failure). From 2010 to 2019, the NIV only group increased from 9.6% to 43.1% and the IMV only group decreased from 80.1% to 34.2% (p < 0.001). The NIV failure group had the highest mortality compared with NIV only and IMV only (36.6% vs. 8.1%, vs. 30.5%, p < 0.001). However, risk-of-mortality (ROM) was highest in the IMV only group compared with NIV only and NIV failure (median Pediatric Risk of Mortality III ROM 8.1% vs. 2.8% vs. 5.5%, p < 0.001). NIV failure patients also had the longest median PICU length of stay compared with the other two study groups (15.2 d vs. 6.1 and 9.0 d, p < 0.001). Higher age was associated with significantly decreased odds of NIV failure, and diagnosis of non-Hodgkin lymphoma was associated with significantly increased odds of NIV failure compared with acute lymphoid leukemia.

CONCLUSIONS:
For children with hematologic malignancy admitted to the PICU with ARF, NIV has replaced IMV as the most common initial therapy. NIV failure rate remains high with high-observed mortality despite lower PICU admission ROM.
One-Year Recovery Among Survivors of Prolonged Severe COVID-19: A National Multicenter Cohort
Authors: Makam Anil N. , Burnfield Judith , Prettyman Ed , Nguyen Oanh Kieu , Wu Nancy , Espejo Edie , Blat Cinthia , Boscardin W. John , Ely E. Wesley , Jackson James C. , Covinsky Kenneth E , Votto John ,   for the Recovery After Transfer to an LTACH for COVID-19 (RAFT COVID) Study
Published: April 2024

OBJECTIVES:Understanding the long-term effects of severe COVID-19 illness on survivors is essential for effective pandemic recovery planning. Therefore, we investigated impairments among hospitalized adults discharged to long-term acute care hospitals (LTACHs) for prolonged severe COVID-19 illness who survived 1 year.DESIGN:The Recovery After Transfer to an LTACH for COVID-19 (RAFT COVID) study was a national, multicenter, prospective longitudinal cohort study.SETTING AND PATIENTS:We included hospitalized English-speaking adults transferred to one of nine LTACHs in the United States between March 2020 and February 2021 and completed a survey.INTERVENTIONS:None.MEASUREMENTS AND MAIN RESULTS:Validated instruments for impairments and free response questions about recovering. Among 282 potentially eligible participants who provided permission to be contacted, 156 (55.3%) participated (median age, 65; 38.5% female; 61.3% in good prior health; median length of stay of 57 d; 77% mechanically ventilated for a median of 26 d; 42% had a tracheostomy). Approximately two-thirds (64%) had a persistent impairment, including physical (57%), respiratory (49%; 19% on supplemental oxygen), psychiatric (24%), and cognitive impairments (15%). Nearly half (47%) had two or more impairment types. Participants also experienced persistent debility from hospital-acquired complications, including mononeuropathies and pressure ulcers. Participants described protracted recovery, attributing improvements to exercise/rehabilitation, support, and time. While considered life-altering with 78.7% not returning to their usual health, participants expressed gratitude for recovering; 99% returned home and 60% of previously employed individuals returned to work.CONCLUSIONS:Nearly two-thirds of survivors of among the most prolonged severe COVID-19 illness had persistent impairments at 1 year that resembled post-intensive care syndrome after critical illness plus debility from hospital-acquired complications.
Sleep and Circadian Health of Critical Survivors: A 12-Month Follow-Up Study*
Authors: Henríquez-Beltrán Mario , Vaca Rafaela , Benítez Iván D. , González Jessica , Santisteve Sally , Aguilà Maria , Minguez Olga , Moncusí-Moix Anna , Gort-Paniello Clara , Torres Gerard , Labarca Gonzalo , Caballero Jesús , Barberà Carme , Torres Antoni , de Gonzalo-Calvo David , Barbé Ferran , Targa Adriano D. S. 
Published: April 2024

OBJECTIVES:To investigate the sleep and circadian health of critical survivors 12 months after hospital discharge and to evaluate a possible effect of the severity of the disease within this context.DESIGN:Observational, prospective study.SETTING:Single-center study.PATIENTS:Two hundred sixty patients admitted to the ICU due to severe acute respiratory syndrome coronavirus 2 infection.INTERVENTIONS:None.MEASUREMENTS AND MAIN RESULTS:The cohort was composed of 260 patients (69.2% males), with a median (quartile 1–quartile 3) age of 61.5 years (52.0–67.0 yr). The median length of ICU stay was 11.0 days (6.00–21.8 d), where 56.2% of the patients required invasive mechanical ventilation (IMV). The Pittsburgh Sleep Quality Index (PSQI) revealed that 43.1% of the cohort presented poor sleep quality 12 months after hospital discharge. Actigraphy data indicated an influence of the disease severity on the fragmentation of the circadian rest-activity rhythm at the 3- and 6-month follow-ups, which was no longer significant in the long term. Still, the length of the ICU stay and the duration of IMV predicted a higher fragmentation of the rhythm at the 12-month follow-up with effect sizes (95% CI) of 0.248 (0.078–0.418) and 0.182 (0.005–0.359), respectively. Relevant associations between the PSQI and the Hospital Anxiety and Depression Scale (rho = 0.55, anxiety; rho = 0.5, depression) as well as between the fragmentation of the rhythm and the diffusing lung capacity for carbon monoxide (rho = –0.35) were observed at this time point.CONCLUSIONS:Our findings reveal a great prevalence of critical survivors presenting poor sleep quality 12 months after hospital discharge. Actigraphy data indicated the persistence of circadian alterations and a possible impact of the disease severity on the fragmentation of the circadian rest-activity rhythm, which was attenuated at the 12-month follow-up. This altogether highlights the relevance of considering the sleep and circadian health of critical survivors in the long term.
Early Experience With Biologically Effective Dose-Comparable Short-Course Whole Brain Radiation Therapy for Metastatic Intracranial Disease
Authors: McClelland Shearwood 
Published: April 2024

Background:
For inpatients with metastatic intracranial disease burden exceeding established guidelines for stereotactic radiosurgery (SRS), the standard of care involves whole brain radiation therapy (WBRT), typically administered as a 2-week course of treatment with biologically effective dose (BED) of 60 Gy. However, shorter course WBRT provides theoretical advantages in quality of life and decreasing systemic therapy delay. This retrospective study evaluates our early experience with BED-comparable short-course WBRT (23 Gy in 5 fractions; BED=58.3 Gy) for metastatic intracranial disease.

Methods:
Over a recent 2-month timeframe, 3 inpatients with intracranial disease burden exceeding SRS guidelines were administered BED-comparable short-course WBRT. Due to the high intracranial disease burden, 23 Gy was chosen over 20 Gy for 5-fraction WBRT due to the desire to optimally mimic the durability of the classic 30 Gy in 10 fraction treatment regimen.

Results:
The mean age at treatment was 65.7 years, the mean Karnofsky Performance Status (KPS) was 60, and the mean number of intracranial metastases was 20.3. The mean duration between inpatient Radiation Oncology consultation and the start of WBRT (following CT radiation therapy simulation) was 6.7 days. All patients completed WBRT no later than 2 weeks from the initial inpatient consultation.

Conclusions:
For inpatients with intracranial metastatic disease burden exceeding established SRS guidelines, BED-comparable short-course WBRT administered to 23 Gy in 5 fractions (4.6 Gy/fraction) is safe and efficacious. Given previous literature indicating that nearly half of the patients prescribed traditional 2-week WBRT die without completing treatment, BED-comparable WBRT represents an attractive and promising WBRT alternative in this patient population.
One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study
Authors: Park Su Jung , Yoo Kwang Ho 
Published: April 2024

BACKGROUND
With the continuous increasing availability of new filler products, each hyaluronic acid filler brand has distinctive pharmacokinetics, which may be associated with different complications. Therefore, the long-term safety of new generations of fillers should be evaluated.

OBJECTIVE
This prospective, multicenter, observational, postmarketing study (ClinicalTrials.gov identifier: NCT04738019) aimed to investigate the incidence of delayed-onset nodules and adverse reactions after the injection of new hyaluronic acid fillers (YYS series) into the facial skin.

METHODS
Subjects scheduled to receive an injection YYS series filler were followed up for 52 weeks. The authors aimed to determine the incidence of a self-reported delayed-onset nodule—a visible or palpable nodule or mass at the injection site that was detected beyond the 14th day following the injection—during the 1-year follow-up period.

RESULTS
Among the 1,022 subjects who received an injection of the YYS series, the incidences of delayed-onset nodules were 0% for YYS 360, YYS 540, and YYS 720. A 0.21% incidence (1 delayed hypersensitivity reaction) of a delayed-onset adverse reaction was noted for YYS 720, although none were reported for YYS 360 and YYS 540.

CONCLUSION
In this study, a notably low frequency of adverse reactions associated with the YYS series was observed.
A Systematic Review of the Epidemiology, Clinical Characteristics, Treatment, and Outcomes for Desmoplastic Trichoepithelioma: Underscoring Mohs Micrographic Surgery in Management
Authors: Nanda Rahul , Srivastava Divya , Nijhawan Rajiv I. 
Published: April 2024

BACKGROUND
Desmoplastic trichoepithelioma (DTE) is an uncommon benign adnexal tumor that histologically may mimic malignant tumors including basal cell carcinoma and microcystic adnexal carcinoma.

OBJECTIVE
To present a systematic review of the epidemiology, clinical characteristics, treatment, and outcome data on DTEs, with emphasis on comparing Mohs micrographic surgery (MMS) with other treatments.

METHODS
Using the OVID platform, MEDLINE and Embase were searched from inception for studies providing original data on DTEs.

RESULTS
A total of 338 cases of DTE from 61 articles were included. No recurrence/persistence (0%) was reported following MMS (n = 24, mean follow-up of 41.9 months), 13.1% with standard excision (n = 38, mean follow-up 16.9 months), and 2.1% for electrosurgery/cautery (n = 49, follow-up 3–72 months). 100% recurrence/persistence for imiquimod (n = 2) and liquid nitrogen (n = 4) were identified. In patients who underwent biopsy only, there was a 12.5% recurrence/persistence (n = 32, mean follow-up 16.5 months). Overall, duration of follow-up varied from 2 months to 6 years for the various management strategies.

CONCLUSION
Data are limited regarding DTE outcomes. In this review, surgical modalities, specifically MMS, had the lowest rates of recurrence/persistence compared with other options. Given that most lesions are found on cosmetically sensitive locations, MMS seems to be the optimal management strategy for actively managing DTEs.