Using "Real-World Data" to Study Cleft Lip/Palate Care: An Exploration of Speech Outcomes from a Multi-Center US Learning Health Network.

OBJECTIVE: To assess the ability of a cleft-specific multi-site learning health network registry to describe variations in cleft outcomes by cleft phenotypes, ages, and treatment centers. Observed variations were assessed for coherence with prior study findings. DESIGN: Cross-sectional analysis of prospectively collected data from 2019-2022. SETTING: Six cleft treatment centers collected data systematically during routine clinic appointments according to a standardized protocol. PARTICIPANTS: 714 English-speaking children and adolescents with non-syndromic cleft lip/palate. INTERVENTION: Routine multidisciplinary care and systematic outcomes measurement by cleft teams. OUTCOME MEASURES: Speech outcomes included articulatory accuracy measured by Percent Consonants Correct (PCC), velopharyngeal function measured by Velopharyngeal Competence (VPC) Rating Scale (VPC-R), intelligibility measured by caregiver-reported Intelligibility in Context Scale (ICS), and two CLEFT-Q™ surveys, in which patients rate their own speech function and level of speech distress. RESULTS: 12year-olds exhibited high median PCC scores (91-100%), high frequency of velopharyngeal competency (62.50-100%), and high median Speech Function (80-91) relative to younger peers parsed by phenotype. Patients with bilateral cleft lip, alveolus, and palate reported low PCC scores (51-91%) relative to peers at some ages and low frequency of velopharyngeal competency (26.67%) at 5 years. ICS scores ranged from 3.93-5.0 for all ages and phenotypes. Speech Function and Speech Distress were similar across phenotypes. CONCLUSIONS: This exploration of speech outcomes demonstrates the current ability of the cleft-specific registry to support cleft research efforts as a source of "real-world" data. Further work is focused on developing robust methodology for hypothesis-driven research and causal inference.

Deep-learning synthesized pseudo-CT for MR high-resolution pediatric cranial bone imaging (MR-HiPCB).

PURPOSE: CT is routinely used to detect cranial abnormalities in pediatric patients with head trauma or craniosynostosis. This study aimed to develop a deep learning method to synthesize pseudo-CT (pCT) images for MR high-resolution pediatric cranial bone imaging to eliminating ionizing radiation from CT. METHODS: 3D golden-angle stack-of-stars MRI were obtained from 44 pediatric participants. Two patch-based residual UNets were trained using paired MR and CT patches randomly selected from the whole head (NetWH) or in the vicinity of bone, fractures/sutures, or air (NetBA) to synthesize pCT. A third residual UNet was trained to generate a binary brain mask using only MRI. The pCT images from NetWH (pCTNetWH ) in the brain area and NetBA (pCTNetBA ) in the nonbrain area were combined to generate pCTCom . A manual processing method using inverted MR images was also employed for comparison. RESULTS: pCTCom (68.01 ± 14.83 HU) had significantly smaller mean absolute errors (MAEs) than pCTNetWH (82.58 ± 16.98 HU, P < 0.0001) and pCTNetBA (91.32 ± 17.2 HU, P < 0.0001) in the whole head. Within cranial bone, the MAE of pCTCom (227.92 ± 46.88 HU) was significantly lower than pCTNetWH (287.85 ± 59.46 HU, P < 0.0001) but similar to pCTNetBA (230.20 ± 46.17 HU). Dice similarity coefficient of the segmented bone was significantly higher in pCTCom (0.90 ± 0.02) than in pCTNetWH (0.86 ± 0.04, P < 0.0001), pCTNetBA (0.88 ± 0.03, P < 0.0001), and inverted MR (0.71 ± 0.09, P < 0.0001). Dice similarity coefficient from pCTCom demonstrated significantly reduced age dependence than inverted MRI. Furthermore, pCTCom provided excellent suture and fracture visibility comparable to CT. CONCLUSION: MR high-resolution pediatric cranial bone imaging may facilitate the clinical translation of a radiation-free MR cranial bone imaging method for pediatric patients.

A Randomized Controlled Trial Evaluating the BREASTChoice Tool for Personalized Decision Support About Breast Reconstruction After Mastectomy.

OBJECTIVE: To evaluate a web-based breast reconstruction decision aid, BREASTChoice. SUMMARY AND BACKGROUND DATA: Although postmastectomy breast reconstruction can restore quality of life and body image, its morbidity remains substantial. Many patients lack adequate knowledge to make informed choices. Decisions are often discordant with patients' preferences. METHODS: Adult women with stages 0-III breast cancer considering postmastectomy breast reconstruction with no previous reconstruction were randomized to BREASTChoice or enhanced usual care (EUC). RESULTS: Three hundred seventy-six patients were screened; 120 of 172 (69.8%) eligible patients enrolled. Mean age = 50.7 years (range 25-77). Most were Non-Hispanic White (86.3%) and had a college degree (64.3%). Controlling for health literacy and provider seen, BREASTChoice users had higher knowledge than those in EUC (84.6% vs. 58.2% questions correct; P < 0.001). Those using BREASTChoice were more likely to know that reconstruction typically requires more than 1 surgery, delayed reconstruction lowers one's risk, and implants may need replacement over time (all ps < 0.002). BREASTChoice compared to EUC participants also felt more confident understanding reconstruction information (P = 0.009). There were no differences between groups in decisional conflict, decision process quality, shared decision-making, quality of life, or preferences (all ps > 0.05). There were no differences in consultation length between BREASTChoice and EUC groups (mean = 29.7 vs. 30.0 minutes; P > 0.05). BREASTChoice had high usability (mean score = 6.3/7). Participants completed BREASTChoice in about 27 minutes. CONCLUSIONS: BREASTChoice can improve breast reconstruction decision quality by improving patients' knowledge and providing them with personalized risk estimates. More research is needed to facilitate point-of-care decision support and examine BREASTChoice's impact on patients' decisions over time.

MR Cranial Bone Imaging: Evaluation of Both Motion-Corrected and Automated Deep Learning Pseudo-CT Estimated MR Images.

BACKGROUND AND PURPOSE: CT imaging exposes patients to ionizing radiation. MR imaging is radiation free but previously has not been able to produce diagnostic-quality images of bone on a timeline suitable for clinical use. We developed automated motion correction and use deep learning to generate pseudo-CT images from MR images. We aim to evaluate whether motion-corrected pseudo-CT produces cranial images that have potential to be acceptable for clinical use. MATERIALS AND METHODS: Patients younger than age 18 who underwent CT imaging of the head for either trauma or evaluation of cranial suture patency were recruited. Subjects underwent a 5-minute golden-angle stack-of-stars radial volumetric interpolated breath-hold MR image. Motion correction was applied to the MR imaging followed by a deep learning-based method to generate pseudo-CT images. CT and pseudo-CT images were evaluated and, based on indication for imaging, either presence of skull fracture or cranial suture patency was first recorded while viewing the MR imaging-based pseudo-CT and then recorded while viewing the clinical CT. RESULTS: A total of 12 patients underwent CT and MR imaging to evaluate suture patency, and 60 patients underwent CT and MR imaging for evaluation of head trauma. For cranial suture patency, pseudo-CT had 100% specificity and 100% sensitivity for the identification of suture closure. For identification of skull fractures, pseudo-CT had 100% specificity and 90% sensitivity. CONCLUSIONS: Our early results show that automated motion-corrected and deep learning-generated pseudo-CT images of the pediatric skull have potential for clinical use and offer a high level of diagnostic accuracy when compared with standard CT scans.

School-age anthropometric and patient-reported outcomes after open or endoscopic repair of sagittal craniosynostosis.

OBJECTIVE: Several studies have compared perioperative parameters and early postoperative morphology between endoscope-assisted strip craniectomy with orthotic therapy (endoscopic repair) and cranial vault remodeling (open repair). To extend these results, the authors evaluated school-age anthropometric outcomes after these techniques across three institutions. METHODS: School-aged children (age range 4-18 years) with previously corrected isolated sagittal craniosynostosis were enrolled. Upon inclusion, 3D photographs and patient-reported outcomes were obtained, and the cephalic index and head circumference z-scores were calculated. Analyses of covariance models controlling for baseline differences and a priori covariates were performed. RESULTS: Eighty-one participants (median [range] age 7 [4-15] years) were included. The mean (95% CI) school-age cephalic index was significantly higher in the endoscopic cohort, though within the normal range for both groups (endoscopic 78% [77%-79%] vs open 76% [74%-77%], p = 0.027). The mean change in the cephalic index from preoperation to school age was significantly greater in the endoscopic group (9% [7%-11%] vs open 3% [1%-5%], p < 0.001). Compared to preoperative measurements, mean school-age head circumference z-scores decreased significantly more in the open cohort (-1.6 [-2.2 to -1.0] vs endoscopic -0.3 [-0.8 to -0.2], p = 0.002). Patient-reported levels of stigma were within the normal limits for both groups. CONCLUSIONS: Endoscopic and open repair techniques effectively normalize school-age anthropometric outcomes. However, endoscopic repair produces a clinically meaningful and significantly greater improvement in the school-age cephalic index, with maintenance of head growth. These findings demonstrate the importance of early referral by pediatricians and inform treatment decisions.

Predictors of Digital Amputation in Diabetic Patients With Surgically Treated Finger Infections.

BACKGROUND: Diabetes is a well-established risk factor for severe digital infection, and patients are more likely to require digital amputation for adequate source control. This study aims to identify factors predictive of digital amputation compared with preservation in patients with diabetes who present with surgically treated finger infections. METHODS: Current Procedural Terminology (CPT) and International Classification of Diseases Versions 9 and 10 (ICD-9/10) databases from a single academic medical center were queried to identify patients with type 1 or type 2 diabetes mellitus who underwent surgical treatment in the operating room for treatment of a digital infection from 2010 to 2020. Electronic medical records were reviewed to obtain historical and acute clinical variables at the time of hospital presentation. Bivariate and multivariable regression were used to identify factors associated with amputation. RESULTS: In total, 145 patients (61 digital amputation, 84 digital preservation) met inclusion criteria for this retrospective cohort study. Mean hospital stay was 6 days, and the average patient underwent 2 operations. Multivariable analysis revealed that the presence of osteomyelitis, ipsilateral upper extremity dialysis fistula, end-stage renal disease, and vascular disease each had significant independent predictive value for amputation rather than digital preservation. CONCLUSIONS: Digital amputation is common in the setting of diabetic finger infection. The 4 variables found to independently predict the outcome of amputation can be understood as factors which decrease the likelihood of successful digital salvage and increase the potential consequence of ongoing uncontrolled infection. Further study should focus on clinical factors affecting surgical decision making and how the treatment rendered affects patient outcomes.

The stigma of digital amputation: a survey of amputees with analysis of risk factors.

The purpose of this study was to quantify the stigma associated with digital amputation and examine factors associated with it. One hundred and sixty-four digital amputees completed the Neurological Quality of Life-Stigma questionnaire and a battery of Patient-Reported Outcome Measurement Information System instruments. Multivariable analysis examined factors associated with stigma experience. The mean observed stigma score of 47 (SD 8, range 36-64) was similar to the mean value of the normal population. Younger age, a worker's compensation claim and depression were each independently associated with a more severe experience of stigma after digital amputation. Socioeconomic variables, anatomical details and mechanism of injury were not independently associated with stigma. Digital amputation is not highly stigmatizing overall. Surgeons should consider referring at-risk patients to a mental health provider for support during the coping and adjustment process after amputation.Level of evidence: III.

Cranial vault imaging for pediatric head trauma using a radial VIBE MRI sequence.

OBJECTIVE: Head trauma is the most common indication for a CT scan. In this pilot study, the authors assess the feasibility of a 5-minute high-resolution 3D golden-angle (GA) stack-of-stars radial volumetric interpolated breath-hold examination (VIBE) MRI sequence (GA-VIBE) to obtain clinically acceptable cranial bone images and identify cranial vault fractures compared to CT. METHODS: Patients younger than 18 years of age presenting after head trauma were eligible for the study. Three clinicians reviewed and assessed 1) slice-by-slice volumetric CT and inverted MR images, and 2) 3D reconstructions obtained from inverted MR images and the gold standard (CT). For each image set, reviewers noted on 5-point Likert scales whether they recommended that a repeat scan be performed and the presence or absence of cranial vault fractures. RESULTS: Thirty-one patients completed MRI after a clinical head CT scan was performed. Based on CT imaging, 8 of 31 patients had cranial fractures. Two of 31 patients were sedated as part of their clinical MRI scan. In 30 (97%) of 31 MRI reviews, clinicians agreed (or strongly agreed) that the image quality was acceptable for clinical diagnosis. Overall, comparing MRI to acceptable gold-standard CT, sensitivity and specificity of fracture detection were 100%. Furthermore, there were no discrepancies between CT and MRI in classification of fracture type or location. CONCLUSIONS: When compared with the gold standard (CT), the volumetric and 3D reconstructed images using the GA-VIBE sequence were able to produce clinically acceptable cranial images with excellent ability to detect cranial vault fractures.

Results of a near continuous glucose monitoring technology in surgical intensive care and trauma.

INTRODUCTION: Near-continuous glucose monitoring is expected to increase time in range (TIR) of 80-120mg/dL and to avoid hypoglycemia without increasing workload. We investigated a near-continuous glucose monitor in surgical critically ill and trauma patients. METHODS: Patients were enrolled at a surgical intensive care unit associated with a level 1 trauma center. Glucose measurements were compared to the gold standard Yellow Springs Instrument (YSI). The technology withdraws 0.13mL of blood every 15min from a central venous line, centrifuges the sample, and uses mid-infrared spectroscopy to measure glucose. We plotted a Clarke Error Grid, calculated Mean Absolute Relative Deviation (MARD) to analyze trend accuracy, and we present a Bland Altman plot of device versus standard glucose measurements. RESULTS: 24 patients were enrolled. One patient was withdrawn due to poor blood return from central venous line. A total of 347 glucose measurements from 23 patients were compared to the gold standard. 94.8% of the data points were in zone A of the Clarke Error Grid and 5.2% in zone B. The MARD was 8.02%. The majority of data points achieved the benchmark for accuracy. The remaining 5.2% are clinically benign. The MARD was below 10%. The Bland Altman plot shows good agreement between the device and reference glucose measurements. There were no device related adverse events. CONCLUSION: Our data suggests that near continuous monitoring via infrared spectroscopy is safe and accurate for use in critically ill surgical and trauma patients. A large scale multi-center study is underway to confirm these findings.