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Nevin Manimala Statistics

Predictors of postoperative sacroiliac joint dysfunction and distal failure after iliac and S2-alar-iliac spinopelvic fixation

J Neurosurg Spine. 2025 Oct 10:1-12. doi: 10.3171/2025.6.SPINE25395. Online ahead of print.

ABSTRACT

OBJECTIVE: Sacroiliac joint dysfunction is an underrecognized cause of lower back pain, particularly in patients with prior spinal fusion. The relationship between spinopelvic fixation and sacroiliac joint dysfunction requires further investigation. The authors compared outcomes among patients who underwent iliac and S2-alar-iliac (S2AI) pelvic fixation techniques.

METHODS: The authors performed a retrospective analysis of patients who underwent index spinopelvic fixation with iliac or S2AI techniques between 2016 and 2022. Patients with < 2-year follow-up data, prior spinopelvic fixation, prior or concomitant sacroiliac joint dysfunction or sacroiliac joint fusion, > 1 pelvic screw per side, and inadequate postoperative standing radiographs were excluded. Summary statistics and univariate and multivariable analyses were performed.

RESULTS: Eighty-nine patients were included in the final analysis. The mean ± SD age was 63.49 ± 8.64 years and 58.4% of patients were female. Forty-two (47.3%) patients were former or current smokers, and 20 (22.5%) had preexisting diabetes. Patients underwent pelvic fixation for long construct fusion (> 3 levels), L5-S1 high-grade spondylolisthesis, and L5-S1 pseudarthrosis in 67 (75.3%), 2 (2.2%), and 20 (22.5%) cases, respectively. The mean number of fusion levels was 6.79 ± 3.86. Sixty-nine (77.5%) and 9 (10.1%) patients underwent posterior column osteotomy and 3-column osteotomy, respectively. Eighty-one (91.0%) patients underwent bilateral pelvic fixation, and 54 (60.7%) and 35 (39.3%) patients underwent iliac and S2AI techniques, respectively. Seventeen (19.1%) patients developed distal failure, defined as implant complication between L5-pelvis and/or L5-S1 pseudarthrosis, with 15 (16.9%) having reoperation. Fourteen (15.7%) patients had postoperative sacroiliac joint dysfunction diagnosed by sacroiliac joint injections, including 10 (11.2%) patients who underwent subsequent sacroiliac joint fusion. Head-to-head univariate comparison showed no difference in postoperative sacroiliac joint dysfunction between iliac and S2AI techniques. Multivariable analysis showed diabetes (p = 0.030) and higher postoperative pelvic tilt (p = 0.024) were significant predictors of sacroiliac joint dysfunction. Performing posterior column osteotomy predicted lower frequency of sacroiliac joint dysfunction (p = 0.006). After exclusion of patients with preexisting bony fusion at L5-S1, multivariable analysis showed that a greater number of fusion levels (p = 0.002) was an independent and significant predictor of distal failure. Pelvic fixation technique (iliac vs S2AI) did not predict distal failure.

CONCLUSIONS: There were no significant differences in sacroiliac joint dysfunction or the rates of distal failure following index pelvic fixation with either the iliac or S2AI technique. Higher postoperative pelvic tilt predicted sacroiliac joint dysfunction, and a higher number of fusion levels predicted distal failure.

PMID:41072054 | DOI:10.3171/2025.6.SPINE25395

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Nevin Manimala Statistics

Characteristics and in-hospital outcomes of patients presenting to a level 1 trauma center classified under the modified Brain Injury Guidelines

J Neurosurg. 2025 Oct 10:1-8. doi: 10.3171/2025.6.JNS25342. Online ahead of print.

ABSTRACT

OBJECTIVE: The Brain Injury Guidelines (BIG) were modified in 2020 to improve efficiency and safety in triage decision-making. The aim of this study was to present characteristics and in-hospital outcomes of patients classified under category 1 of the modified BIG (mBIG 1).

METHODS: A retrospective review of patients presenting with acute traumatic brain injury (TBI) to a level 1 trauma center between 2019 and 2023 was performed. Patients meeting clinical and radiographic criteria for mBIG 1 were identified. An additional cohort of patients was identified who were taking 81 mg of aspirin once daily (ASA81) before the hospital, but who otherwise met mBIG 1 criteria. Summary statistics and univariate analyses were performed.

RESULTS: Three hundred three patients were identified and classified as mBIG 1. The mean patient age was 54.45 (SD 1.17) years and 41.3% were female. There were 144 patients (47.5%) who transferred from an outside hospital. The median admission Glasgow Coma Scale score was 15 (interquartile range [IQR] 15-15). Patients underwent an average of 2.28 (SD 0.03) CT scans. There were 123 (40.6%), 18 (5.9%), and 126 (41.6%) patients with subdural hematoma, intraparenchymal hemorrhage, and subarachnoid hemorrhage, respectively, with 36 patients (11.9%) presenting with multiple hemorrhages. Eleven patients (3.6%) experienced hemorrhage progression. No patient underwent neurosurgical intervention. The mean Injury Severity Score was 13.12 (SD 7.04). The median hospital length of stay (LOS) was 1.01 (IQR 0.37-4.56) days, 75.2% of patients were discharged home, 24.1% were discharged to rehabilitation, and 0.7% died in the hospital. An additional 25 patients were identified who were taking ASA81 prehospital, but otherwise met mBIG 1 criteria. None of these patients underwent neurosurgical intervention and there were no in-hospital deaths. One patient (4.0%) taking ASA81 experienced progression of their hemorrhage but still met mBIG 1 criteria. When compared to the mBIG 1 cohort, the aspirin cohort was significantly older (p < 0.001), but otherwise showed no differences in demographic, clinical, or radiographic variables. The combined mBIG 1 + aspirin cohort was stratified by hemorrhage progression (n = 12). Hospital LOS was significantly greater in the progression cohort (p = 0.017) and fewer patients were discharged home (p = 0.001). There was no difference in age, hypertension, admission mean arterial pressure, platelet count, international normalized ratio, partial thromboplastin time, hemorrhage pattern, and aspirin use between the groups.

CONCLUSIONS: Hemorrhage progression was rare, including cases in which patients were receiving prehospital low-dose aspirin therapy. More data are needed that evaluate the role of low-dose aspirin in the triage of patients with mild TBI.

PMID:41072050 | DOI:10.3171/2025.6.JNS25342

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Nevin Manimala Statistics

Postoperative administration of naloxegol after spinal deformity surgery: analysis of 234 patients

J Neurosurg Spine. 2025 Oct 10:1-7. doi: 10.3171/2025.6.SPINE241465. Online ahead of print.

ABSTRACT

OBJECTIVE: Naloxegol, a peripherally acting mu-opioid receptor antagonist, is used to treat opioid-induced constipation. However, its effectiveness following adult spinal deformity surgery remains poorly understood. The objective of this study was to examine naloxegol’s impact on postoperative bowel function in patients undergoing adult spinal deformity surgery.

METHODS: A retrospective analysis was conducted of consecutive spinal deformity surgeries from a single surgeon’s practice, comparing outcomes before and after the introduction of universal postoperative naloxegol administration (12.5 mg daily for 7 days). Multivariable logistic regression and propensity score-matched analyses were used to evaluate the relationship between naloxegol use and markers of postoperative ileus (POI).

RESULTS: Two hundred thirty-four patients (72.2% female, mean age 60.7 [SD 15.8] years, mean BMI 28.8 [SD 5.1]) were analyzed. One hundred fifty-four (65.8%) of these patients were opioid-naïve and 80 (34.1%) received naloxegol. The naloxegol group had significantly lower odds of lateral lumbar interbody fusion (OR 0.13, p = 0.0001) and shorter operative times (5.65 vs 6.75 hours, p = 0.0008). There was no statistical association between naloxegol and postoperative abdominal imaging, nasogastric tube placement, or gastroenterology consultation in either the matched or multivariate analyses (p > 0.05). A gastroenterology consultation (n = 15 patients, 6.5%) was positively associated with anterior lumbar interbody fusion (OR 5.54, p = 0.010) and diabetes (OR 12.37, p = 0.001) and negatively associated with preoperative opioid use (OR 0.18, p = 0.036). Postoperative abdominal imaging correlated positively with the number of vertebrae fused (OR 1.09, p = 0.031) and negatively with preoperative opioid use (OR 0.44, p = 0.026). Weighted time-to-event analysis found a difference in time to first flatus (p = 0.0282), but not in time to bowel movement (p = 0.5600) with naloxegol.

CONCLUSIONS: Postoperative naloxegol had no significant impact on bowel function recovery or markers of POI after spinal deformity surgery. Patients with a history of opioid exposure required fewer consultations and imaging. Further research is required to understand whether pre-induction administration impacts POI and return to bowel function.

PMID:41072046 | DOI:10.3171/2025.6.SPINE241465

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Nevin Manimala Statistics

Assessment of auditory pathway microstructure in vestibular schwannoma patients: a quantitative diffusion tensor tractography study

J Neurosurg. 2025 Oct 10:1-7. doi: 10.3171/2025.6.JNS241972. Online ahead of print.

ABSTRACT

OBJECTIVE: Vestibular schwannomas (VSs) are cerebellopontine angle tumors that can result in cranial nerve dysfunction, most commonly sensorineural hearing loss. Conventional structural MRI is unable to provide correlative information on cranial nerve function. In this study, the authors used multitensor tractography to study the white matter microstructural properties of the auditory neural pathway as a correlate of cranial nerve function in a cohort of VS patients. They evaluated the relationship between the auditory neural pathway microstructural properties using pure-tone audiometry (PTA) and the speech discrimination score (SDS).

METHODS: Retrospective chart review of 258 patients with VS treated at the Toronto Western Hospital Gamma Knife Radiosurgery Unit was conducted. Of these, 3T MR images were analyzed for 57 surgically naive patients with unilateral VS who had preoperative diffusion tensor imaging (DTI) and PTA and SDS results. Patients were excluded if they had bilateral tumors, previous surgical treatment (Gamma Knife radiosurgery or resection), or did not undergo DTI. DTI-derived metrics (fractional anisotropy [FA], radial diffusivity [RD], axial diffusivity [AD], and mean diffusivity [MD]) of five regions of interest positioned along the auditory neural pathway (ipsilateral superior olivary nucleus [SON] and trapezoid body [TB] and contralateral inferior colliculus, lateral lemniscus [LL], and medial geniculate body [MGB]) were measured bilaterally in all subjects. The diffusion metrics were correlated with quantitative average high-frequency (4000 and 8000 Hz) PTA and SDS results.

RESULTS: Salient areas of neuroanatomical correlation included the LL and SON (affected side), where a statistically significant diffusion metric change was seen. This was characterized by higher FA and lower RD values (LL and SON) and a higher AD value (SON). SDS positively correlated with the TB AD. PTA showed a significant negative relationship with MD at the LL and a positive relationship with AD at the inferior colliculus (affected side). PTA also showed a significant negative relationship with RD and MD at the SON and TB, and a positive relationship with FA and AD at the MGB on the contralateral side (all p < 0.05).

CONCLUSIONS: This work outlines that quantitative DTI is a useful tool to evaluate the white matter microstructural alterations in the auditory neural pathway. Importantly, as a noninvasive tool, diffusion metrics can help in understanding the pathophysiology of hearing impairment in this group of patients.

PMID:41072040 | DOI:10.3171/2025.6.JNS241972

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Nevin Manimala Statistics

Prevalence of Germline Mutations among Young Women with Breast Cancer in Louisiana by Cancer Subtype and Race

South Med J. 2025 Oct;118(10):679-681. doi: 10.14423/SMJ.0000000000001881.

ABSTRACT

OBJECTIVE: Black women in Louisiana have an increased breast cancer incidence. In addition, mortality and incidence of breast cancer in younger patients are on the rise, regardless of race or germline mutations. Most available germline mutation data in breast cancer are based primarily on White patient populations. We sought to evaluate the relationship between race, pathogenic germline mutations, and breast cancer subtypes among young women (younger than 40 years old) diagnosed as having breast cancer in Louisiana.

METHODS: We collected and reviewed a 10-year retrospective database from 2012 to 2022 of 773 women younger than age 40 years diagnosed as having breast cancer in a Louisiana-based regional health system. Associations between subtypes and germline mutations were assessed using the χ2 test.

RESULTS: In total, 632 patients had available genetics data: 38% of patients with pathogenic germline mutations were Black or African American and 62% were White, 53% of Black or African American patients had a variant of uncertain significance (VUS) vs 47% of White patients. The association between pathogenic germline mutations and triple-negative breast cancer (estrogen receptor [ER]/human epidermal growth factor receptor 2 [HER2]) was noted with P = 0.0122. The presence of VUS was not statistically significant when compared with no mutation in the triple-negative cohort (odds ratio [OR] 1.13; 95% confidence interval [CI] 0.70-1.83; P = 0.6224). No statistically significant difference was noted in the prevalence of germline mutations among ER+/HER2 and ER/HER2+ cancers. Evaluation of the germline mutations demonstrated an association between germline mutation and race (P = 0.0045). VUS was twofold in Black or African American patients compared with no mutation (OR 2.12; 95% CI 1.35-3.34; P = 0.0012). The presence of a pathogenic germline mutation was 1.19 times as common in Black or African American patients compared with no mutation (OR 1.19; 95% CI 0.79-1.79; P = 0.4018].

CONCLUSIONS: These data demonstrate that triple-negative breast cancer continues to have a significant association with germline mutations in a young patient population. Pathogenic germline mutations and VUS may be more common in younger Black or African American patients as demonstrated by our research, however.

PMID:41072033 | DOI:10.14423/SMJ.0000000000001881

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Nevin Manimala Statistics

A Silver Lining for Massive Weight Loss Patients with Breast Cancer: A Propensity-Matched Analysis Comparing Abdominal Outcomes after DIEP and Abdominoplasty

South Med J. 2025 Oct;118(10):657-662. doi: 10.14423/SMJ.0000000000001889.

ABSTRACT

OBJECTIVES: Patients with a history of massive weight loss (MWL) frequently undergo body-contouring surgery such as abdominoplasty, and the safety profile of this procedure is well accepted. The deep inferior epigastric artery perforator (DIEP) flap is a procedure where excess abdominal tissue is used to reconstruct the breast. The abdominal muscles are preserved by isolating the flap on vascular perforators to the abdominal skin and adipose tissue, whereas in abdominoplasty, the same tissue is removed and discarded. In this study, the abdominal-contouring outcomes of patients who underwent DIEP breast reconstruction following MWL were compared with the abdominal contouring outcomes of those who received abdominoplasty following MWL.

METHODS: A propensity-matched retrospective cohort study was performed comparing MWL patients who underwent either DIEP flap breast reconstruction after breast cancer treatments with mastectomy or abdominoplasty. Patients were matched for multiple preoperative variables. Statistical analysis included an independent-samples t test and the Fisher exact test for univariate analysis and multivariate analysis for predictive variables of postoperative complications.

RESULTS: Eighteen patients with a history of MWL who underwent DIEP flaps were matched to 18 patients who underwent abdominoplasty. Patient data for the DIEP cohort were obtained from a database of 314 patients and a total of 484 flaps performed at our institution. Patient data for the abdominoplasty cohort were obtained from a database of 155 patients who underwent abdominoplasty at our institution. Groups differed on body mass index and total body weight loss (P = 0.008 and P = 0.002, respectively), but they did not differ in excess body weight loss (P = 0.094). All abdominoplasty patients and 50% of the DIEP patients had undergone bariatric surgery. Complication rates at the abdominal site were similar between the two groups (DIEP 33% vs body-contouring surgery 39%, P = 0.73).

CONCLUSIONS: Patients with DIEP procedures were found to have abdominal complication rates similar to those who received standard abdominoplasty. This information can be used by plastic surgeons to counsel MWL patients considering DIEP that their chance of a postoperative abdominal complication is similar to abdominal body-contouring procedures.

PMID:41072029 | DOI:10.14423/SMJ.0000000000001889

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Nevin Manimala Statistics

High-Throughput Computing to Detect Harmful Drug-Drug Interactions in Older Adults: Protocol for a Population-Based Cohort Study

JMIR Res Protoc. 2025 Oct 10;14:e77224. doi: 10.2196/77224.

ABSTRACT

BACKGROUND: Drug-drug interactions (DDIs) are a major concern, especially for older adults taking multiple medications. Although Health Canada and the US Food and Drug Administration (FDA) use population-based studies to identify adverse drug events, detecting harmful DDIs is challenging due to the millions of potential drug combinations. Traditional pharmacoepidemiologic studies are slow and inefficient, often missing important harmful DDIs.

OBJECTIVE: This protocol outlines a novel approach to efficiently identify harmful DDIs using administrative health care data.

METHODS: Using high-throughput computing, we will conduct multiple population-based, new-user cohort studies using Ontario’s linked administrative health care data. The cohorts will be selected from the population of Ontario residents aged 66 years and older who filled at least one oral outpatient drug prescription from 2002 to 2023. In each cohort, the exposed group will comprise individuals who are regular users of one drug (drug A) who start a new prescription for a second drug (drug B); the referent group will comprise regular users of drug A not taking drug B. We will evaluate 74 acute outcomes within 30 days of cohort entry, including hospitalizations, emergency department visits, and mortality. Propensity score methods will balance exposed and referent groups on more than 400 baseline health characteristics. Modified Poisson and binomial regression models will estimate risk ratios (RRs) and risk differences (RDs). To ensure findings are both statistically and clinically meaningful, we will apply prespecified thresholds for effect sizes (eg, lower bounds of 95% CIs≥1.33 for RRs and ≥0.1% for RDs) and control the false discovery rate at 5% using the Benjamini-Hochberg procedure to address multiplicity. Subgroup and sensitivity analyses, including negative control outcomes and E-values, will assess robustness.

RESULTS: In a preliminary analysis, we identified approximately 3.8 million older adults who filled prescriptions for over 500 unique medications during the study period (2002-2023), and therefore, approximately 200,000 potential drug combinations will be available for study. The initial drug pair cohorts had a median of 583 new users per cohort (IQR 237-2130); the median overlap in drug pair prescriptions was 57 days (IQR 30-90). The protocol was finalized on August 30, 2025, and outlines the analysis of data from 2002 to 2023. The analysis is scheduled to be completed by fall 2026, with results interpreted in 2027. The final manuscript submission is planned for December 2028.

CONCLUSIONS: This study aims to identify credible signals of harmful DDIs in older adults in routine care. This study will use an innovative approach that leverages data from provincial administrative health care databases and integrates high-throughput computing and rigorous pharmacoepidemiologic methods to generate robust real-world evidence that can inform safer prescribing practices and regulatory decision-making.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77224.

PMID:41072015 | DOI:10.2196/77224

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Nevin Manimala Statistics

User Engagement With and Perceived Impact of a Digital Cognitive Training App on Cognition, Daily Functioning, and Mental Fitness: Secondary Analysis of Cross-Sectional Survey Data

JMIR Form Res. 2025 Oct 10;9:e80027. doi: 10.2196/80027.

ABSTRACT

BACKGROUND: Cognitive difficulties are common and can interfere with daily functioning. While digital cognitive training apps are widely used, few studies have examined whether personalized tools support perceived improvements in cognitive functioning, daily functioning, and overall mental fitness among general adult users.

OBJECTIVE: The purpose of this secondary analysis was to explore the self-reported cognitive benefits of Elevate, a commercial, personalized cognitive training app developed to support cognitive functioning, as well as engagement with the app. We aimed to (1) describe demographics, engagement metrics, and self-reported improvements; (2) examine associations between app engagement and self-reported improvements in cognitive functioning skills directly targeted by the app; and (3) examine associations between app engagement and self-reported improvements in daily functioning and overall mental fitness as potential transfer effects of cognitive training.

METHODS: Adult Elevate users (aged ≥18 years) who used the app at least twice in the previous 30 days completed a brief web-based survey on perceived cognitive, functional, and mental fitness improvements. Responses were linked to objective app use data, including total active weeks, mean active days per week, and mean time per day. Ordinal logistic regressions tested associations between engagement metrics and self-reported outcomes controlling for demographic variables. A Bonferroni correction was applied to adjust for multiple comparisons.

RESULTS: A total of 3367 adult Elevate users were included. Participants were primarily middle-aged (mean 55, SD 16 y), White (2557/3336, 76.65%), and female (2184/3362, 64.96%), with 67.72% (2274/3358) holding at least a college degree. Using the app across more weeks was associated with a greater likelihood of reporting improvements in all cognitive skills (odds ratios [ORs] 1.0014-1.0027, 95% CI 1.0006-1.0036), several areas of daily functioning (eg, motivation and task efficiency; ORs 1.0014-1.0017, 95% CI 1.0006-1.0026), and overall mental fitness (OR 1.0021, 95% CI 1.0012-1.0031). More days of use per week were linked to improvement in math only (OR 1.15, 95% CI 1.09-1.22), whereas spending more time per day was associated with improvements in speaking, reading, math, motivation, personal progress, and mental fitness (ORs 1.02-1.04, 95% CI 1.01-1.06).

CONCLUSIONS: Greater use of the Elevate app was linked to self-reported improvements in cognitive skills, daily functioning, and overall mental fitness. These findings suggest that personalized, adaptive cognitive training apps such as Elevate may serve as scalable tools for enhancing everyday cognitive and functional well-being. Future research should use rigorous, longitudinal methods to confirm these effects and clarify which app features drive meaningful outcomes.

PMID:41072012 | DOI:10.2196/80027

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Nevin Manimala Statistics

Evaluation of Machine Learning Model Performance in Diabetic Foot Ulcer: Retrospective Cohort Study

JMIR Med Inform. 2025 Oct 10;13:e71994. doi: 10.2196/71994.

ABSTRACT

BACKGROUND: Machine learning (ML) has shown great potential in recognizing complex disease patterns and supporting clinical decision-making. Diabetic foot ulcers (DFUs) represent a significant multifactorial medical problem with high incidence and severe outcomes, providing an ideal example for a comprehensive framework that encompasses all essential steps for implementing ML in a clinically relevant fashion.

OBJECTIVE: This paper aims to provide a framework for the proper use of ML algorithms to predict clinical outcomes of multifactorial diseases and their treatments.

METHODS: The comparison of ML models was performed on a DFU dataset. The selection of patient characteristics associated with wound healing was based on outcomes of statistical tests, that is, ANOVA and chi-square test, and validated on expert recommendations. Imputation and balancing of patient records were performed with MIDAS (Multiple Imputation with Denoising Autoencoders) Touch and adaptive synthetic sampling, respectively. Logistic regression, support vector machine (SVM), k-nearest neighbors, random forest (RF), extreme gradient boosting (XGBoost), Bayesian additive regression trees, and artificial neural network were trained, cross-validated, and optimized using random sampling on the patient dataset. To evaluate model calibration and clinical utility, calibration curves, Brier scores, and decision curve analysis (DCA) were performed.

RESULTS: The exploratory dataset consisted of 700 patient records with 199 variables. After dataset cleaning, the variables used for model training included age, smoking status, toe systolic pressure, blood pressure, oxygen saturation, hemoglobin, hemoglobin A1c, estimated glomerular filtration rate, wound location, diabetes type, Texas wound classification, neuropathy, and wound area measurement. The SVM obtained a stable accuracy of 0.853 (95% CI 0.810-0.896) with an area under the receiver operating characteristic curve of 0.922 (95% CI 0.889-0.955). The RF and XGBoost acquired an accuracy of 0.838 (95% CI 0.793-0.883) and 0.815 (95% CI 0.768-0.862), respectively, with areas under the receiver operating characteristic curve of 0.917 (95% CI 0.883-0.951) for RF and 0.889 (95% CI 0.849-0.929) for XGBoost. SVM, RF, and XGBoost were well-calibrated, with average Brier scores around 0.127 (SD 0.013). DCA showed that the SVM provided the highest net clinical benefit across relevant risk thresholds.

CONCLUSIONS: Handling missing values, feature selection, and addressing class imbalance are critical components of the key steps in developing ML applications for clinical research. Seven models were selected for comparing their predictive power regarding complete wound healing, and each model representing a different branch in ML. In this initial DFU dataset used as an example, the SVM achieved the best performance in predicting clinical outcomes, followed by RF and XGBoost. The model’s calibration and clinical utility were determined through calibration curves, Brier scores, and DCA, demonstrating its potential relevance in clinical decision-making.

PMID:41072008 | DOI:10.2196/71994

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Understanding Patient Perceptions of Bacterial Vaginosis Treatments: Mixed Methods Sentiment Analysis Study of Online Drug Review Forums

Online J Public Health Inform. 2025 Oct 10;17:e71720. doi: 10.2196/71720.

ABSTRACT

BACKGROUND: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in people of childbearing age in the United States. More information about what patients do and do not like about the most common BV products and the extent to which they reduce BV symptoms is important for understanding patients’ health and the current treatment landscape for BV.

OBJECTIVE: Using data from online drug review forums, this study’s objectives were to (1) quantitatively characterize the patient voice via sentiments (positive to negative) and emotions about the three most common Food and Drug Administration (FDA)-approved treatments for BV-oral metronidazole (OM), vaginal metronidazole (VM), vaginal clindamycin (VC)-and (2) qualitatively summarize themes characterizing the patient-perceived impact of BV and BV products.

METHODS: Data for this mixed methods descriptive study came from 1645 users’ reviews of BV products posted on WebMD.com and Drugs.com. Reviewer attributes, reviewer-submitted star ratings, and sentiment analysis (SA) using word-emotion association were analyzed with descriptive statistics and bivariate associations. A traditional qualitative analysis using qualitative description was also performed.

RESULTS: Most reviewers were female (n=629, 99.4%), between the ages of 18 and 44 years, and reported using BV products for less than 1 month, though qualitative results suggested most reported recurrent BV infections. Quantitative results revealed reviewers’ preference for vaginal products. The mean star ratings for VC were significantly higher when compared to OM and VM. VC reviews had the highest proportion of positive emotion words compared to OM and VM. Qualitative results for VC supported the quantitative findings: favorable themes related to perceptions of value, effectiveness in alleviating symptoms, and minimal side effects. Additionally, despite some concerns related to the cost of VC, reviewers said they would use the medication again. Other qualitative findings supported BV medical education campaigns for patients and providers on BV treatment.

CONCLUSIONS: Overall, people want a BV treatment that is easy to use, quickly alleviates symptoms, and has minimal side effects. Patients use product reviews to inform their decision-making about BV treatment, ask and seek answers to health-related questions, and share their experiences, presenting a unique opportunity for comprehensive patient education through clinical encounters or public health outreach efforts.

PMID:41072007 | DOI:10.2196/71720