Tag: statistics

Expert Opin Drug Metab Toxicol. 2025 May 5. doi: 10.1080/17425255.2025.2501128. Online ahead of print.

ABSTRACT

INTRODUCTION: Model Informed Precision Dosing (MIPD) allows determining the optimal dosage regimen and its correction based on the target plasma/serum concentrations of the drug. MIPD software must go through a validation and clinical study of its effectiveness and safety before being used in clinical practice.

AREAS COVERED: This narrative literature review provides insight into what is known to date about efficacy and safety trials of MIPD concept. Relevant publications were searched for in the PubMed database, without time or language constraints.

EXPERT OPINION: The application of MIPD in clinical practice logically and theoretically has great potential to improve the treatment of patients by leading to optimal exposure of target tissues to drugs, while achieving full effect and minimizing toxicity. Greater implementation of MIPD in clinical practice is hindered by the fact that the beneficial effects of MIPD on treatment outcomes and reduction of drug toxicity have been proven through clinical studies only for a small number of drugs. It is necessary to conduct well-designed clinical studies of the effects of MIPD, with sufficient statistical power, to prove the benefits of MIPD administration and to justify the costs of implementation in clinical practice.

PMID:40323636 | DOI:10.1080/17425255.2025.2501128

JAMA Neurol. 2025 May 5. doi: 10.1001/jamaneurol.2025.0716. Online ahead of print.

ABSTRACT

IMPORTANCE: MR CLEAN-LATE (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands for Late Arrivals) showed efficacy of endovascular treatment (EVT) in the late window (6-24 hours after stroke symptom onset or time last seen well) among patients with ischemic stroke selected based on collateral flow. Therefore, the future role of computed tomography perfusion (CTP) imaging in patient selection for late-window EVT may change.

OBJECTIVE: To investigate the interaction among CTP parameters (core volumes, penumbra volumes, and mismatch ratio) and the association of EVT with functional outcomes among patients in the late window after ischemic stroke selected based on collateral flow.

DESIGN, SETTING, AND PARTICIPANTS: This is a post hoc secondary analysis of MR CLEAN-LATE, a multicenter randomized clinical trial, with open-label treatment and blinded end point, conducted from February 2, 2018, to January 27, 2022, in 18 Dutch stroke intervention centers. Participants included 502 patients with anterior circulation large vessel occlusion and present collateral flow on results of computed tomographic angiography in the late window after stroke, who gave deferred consent and were included in MR CLEAN-LATE. All patients had completed follow-up at 90 days. This secondary analysis included 313 patients (62%) with available CTP results. Statistical analysis was performed in September 2023.

INTERVENTION: Patients were randomized to receive EVT (EVT group) and best medical management vs best medical management alone (no EVT group).

MAIN OUTCOMES AND MEASURES: The primary outcome was functional outcome at 90 days measured by the modified Rankin Scale score. The treatment effect was analyzed in subgroups of core volumes, penumbra volume, and mismatch ratios using ordinal regression analysis. An interaction analysis was performed to assess whether CTP parameters modified the EVT effect on the modified Rankin Scale score at 90 days. All analyses were adjusted for relevant prognostic factors.

RESULTS: Among the 313 patients (158 women [50%]) in the study, the median age was 73 years (IQR, 63-80 years), and the EVT group had fewer male participants than the no EVT group (73 of 168 [43%] vs 82 of 145 [57%]). Penumbra volumes significantly modified the association of EVT with outcomes (P < .001 for interaction), with the largest effect size among patients with penumbras of 120 mL or more (adjusted common odds ratio [ACOR], 6.89 [95% CI, 2.96-16.04]) and the smallest effect size among patients with penumbras of 72 mL or less (ACOR, 0.49 [95% CI, 0.22-1.08]). Core volume and mismatch ratio did not modify the EVT effect.

CONCLUSIONS AND RELEVANCE: Based on results from this secondary analysis of the MR CLEAN-LATE randomized clinical trial, there was a direct interaction between penumbra volume and treatment effect, and a trend toward potential harm of EVT was seen among patients with the smallest penumbras, which warrants further research. However, core volume and mismatch ratio did not seem to have additional value in patient selection.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN19922220.

PMID:40323620 | DOI:10.1001/jamaneurol.2025.0716

JAMA Neurol. 2025 May 5. doi: 10.1001/jamaneurol.2025.0806. Online ahead of print.

ABSTRACT

IMPORTANCE: Migraine and major depressive disorder are frequently comorbid; however, evidence evaluating the efficacy of preventive migraine therapy in patients with both diseases is limited.

OBJECTIVE: To evaluate the efficacy and safety of fremanezumab in adults with migraine and comorbid major depressive disorder.

DESIGN, SETTING, AND PARTICIPANTS: The UNITE study was a double-blind, placebo-controlled, parallel-group, randomized clinical trial consisting of a 4-week screening period, 12-week double-blind period, and 12-week open-label extension (OLE), conducted between July 9, 2020, and August 31, 2022. The trial was conducted at 55 centers across 12 countries. Eligible patients were adults with episodic migraine (EM) or chronic migraine (CM), history of major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for 12 or more months before screening, and active symptoms of depression (9-item Patient Health Questionnaire score of 10 or more) at screening.

INTERVENTIONS: Patients were randomized 1:1 to receive monthly fremanezumab (225 mg) or matched placebo. All patients in the OLE received quarterly fremanezumab (675 mg).

MAIN OUTCOMES AND MEASURES: The primary end point was the mean change from baseline in monthly migraine days during the 12-week double-blind period.

RESULTS: Of the 540 patients screened for the study, 353 patients (mean [SD] age, 42.9 [12.3] years; 310 female [88%]; EM, 48%; CM, 52%) were eligible and randomized to receive fremanezumab (n = 175) or placebo (n = 178). Mean (SE) change from baseline in monthly migraine days during the 12-week double-blind period was -5.1 (0.50; 95% CI, -6.09 to -4.13) for fremanezumab and -2.9 (0.49; 95% CI, -3.89 to -1.96) for placebo (P <.001). Mean (SE) change from baseline in the Hamilton Depression Rating Scale-17 Items score at week 8 was -6.0 (0.55; 95% CI, -7.10 to -4.95) for fremanezumab and -4.6 (0.54; 95% CI, -5.66 to -3.55) for placebo (least squares mean [SE] difference: -1.4 [0.61]; 95% CI, -2.61 to -0.22; P = .02). Adverse events were consistent with other fremanezumab trials. Results were maintained throughout the OLE.

CONCLUSIONS AND RELEVANCE: Treatment with fremanezumab compared with placebo resulted in significant reductions in monthly migraine days and depressive symptoms. No new safety concerns were observed. To the authors’ knowledge, this was the first placebo-controlled, randomized clinical trial, specifically designed to assess patients with migraine and comorbid depressive disorder, to demonstrate significant improvements in migraine and depressive symptoms with a single pharmacological intervention.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04041284.

PMID:40323613 | DOI:10.1001/jamaneurol.2025.0806

JAMA Netw Open. 2025 May 1;8(5):e258283. doi: 10.1001/jamanetworkopen.2025.8283.

ABSTRACT

IMPORTANCE: The oral microbiome likely plays key roles in human health. Yet, population-representative characterizations are lacking.

OBJECTIVE: To characterize the composition, diversity, and correlates of the oral microbiome in US adults.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed data from the population-representative National Health and Nutrition Examination Survey (NHANES) from 2009 to 2012. Microbiome data were made publicly available in 2024. NHANES participants were aged 18 to 69 years and provided oral rinse samples in 1 of 2 consecutive NHANES cycles (2009-2010 and 2011-2012).

EXPOSURES: Demographic, socioeconomic, behavioral, anthropometric, metabolic, and clinical characteristics.

MAIN OUTCOMES AND MEASURES: Oral microbiome measures, characterized through 16S ribosomal RNA gene sequencing, included α diversity (observed amplicon sequence variants [ASVs], Faith phylogenetic diversity, Shannon-Weiner Index, and Simpson Index); β diversity (unweighted UniFrac, weighted UniFrac, and Bray-Curtis dissimilarity); and prevalence and relative abundance at phylum level through genus level. Analyses accounted for the NHANES complex sample design.

RESULTS: This study included 8237 US adults aged 18 to 69 years, representing 202 314 000 individuals (102 813 000 men [50.8%]; mean [SD] age, 42.3 [14.4] years; 9.3% self-reported as Mexican American, 12.1% as non-Hispanic Black, 64.7% as non-Hispanic White, 5.9% as other Hispanic, and 8.1% as other non-Hispanic individuals). The oral microbiome encompassed 37 bacterial phyla, 99 classes, 212 orders, 446 families, and 1219 genera. Five phyla (Firmicutes, Actinobacteria, Bacteroidetes, Proteobacteria, and Fusobacteria) and 6 genera (Veillonella, Streptococcus, Prevotella 7, Rothia, Actinomyces, and Gemella) were present in nearly all US adults (weighted prevalence, >99%). These genera were the most abundant, accounting for 65.7% of total abundance. Observed ASVs showed a quadratic pattern with age (peak at 30 years), were similar by sex, significantly lower among non-Hispanic White individuals, and increased with greater body mass index (BMI), alcohol use, and periodontal disease severity. All covariates together accounted for a modest proportion of oral microbiome variability as measured by β diversity: R2 = 8.7% (95% CI, 8.4%-9.1%) for unweighted UniFrac, R2 = 7.2% (95% CI, 6.6%-7.7%) for weighted UniFrac, and R2 = 6.3% (95% CI, 3.1%-6.7%) for Bray-Curtis matrices. By contrast, relative abundance of a few genera explained a high percentage of variability in β diversity for weighted UniFrac: Aggregatibacter (R2 = 22.4%; 95% CI, 22.1%-22.8%), Lactococcus (R2 = 21.6%; 95% CI, 20.9%-22.3%), and Haemophilus (R2 = 18.4%; 95% CI, 18.1%-18.8%). Prevalence and relative abundance of numerous genera were associated with age, race and ethnicity, smoking, BMI categories, alcohol use, and periodontal disease severity.

CONCLUSIONS AND RELEVANCE: This cross-sectional study of the oral microbiome in US adults showed that a few genera were universally present and a different set of genera explained a high percentage of oral microbiome diversity across the population. This comprehensive characterization provides a contemporary reference standard for future studies.

PMID:40323603 | DOI:10.1001/jamanetworkopen.2025.8283

JAMA Netw Open. 2025 May 1;8(5):e258330. doi: 10.1001/jamanetworkopen.2025.8330.

ABSTRACT

IMPORTANCE: Treatments are urgently needed for the more than 9500 rare diseases with no US Food and Drug Administration-approved therapies. Although repurposing can be less time- and cost-intensive compared with novel drug development, hurdles have impeded systematic repurposing. Rare disease nonprofit organizations (RDNPs) are well-positioned to overcome barriers and have spearheaded rare disease repurposing efforts for decades. However, no comprehensive data are available on the state of rare disease repurposing or features of successful efforts.

OBJECTIVE: To characterize the state of rare disease drug repurposing, identify factors associated with successful outcomes, and share thematic insights using the interactive Repurposing of All Drugs, Mapping All Paths (ROADMAP) Project web tool.

DESIGN, SETTING, AND PARTICIPANTS: The ROADMAP study was a qualitative study using a mixed-methods analysis of US-based RDNP leaders and their stakeholders, including a national survey and semistructured interviews of RDNP leaders, conducted from September 29, 2021, to January 6, 2022. Surveys and interviews revealed themes associated with RDNP strategies, timelines, and support mechanisms. Data were analyzed from January 22, 2024, to April 23, 2024.

MAIN OUTCOMES AND MEASURES: The primary survey outcome was the repurposing project stage (abandoned, early, clinical, late, or successful). Qualitative outcomes included themes characterizing repurposing experiences. Two random forest models of drug- and disease- specific as well as organization-specific variables were used to evaluate factor importance toward inferring the project stage. Orthogonal significance testing was conducted using Spearman rank correlation, and P values in each model were corrected for multiple hypothesis testing using a Benjamini-Hochberg procedure.

RESULTS: Representative organizations submitted survey responses, including 147 of 698 potential US-based RDNPs. The median RDNP age was 10 years (IQR, 5-20 years), and the median annual revenue was $355 390 (IQR, $90 028-$946 108). Among 34 leaders who were interviewed, representing 25 RDNPs, 23 were female (67.6%), and the RDNPs had a median age of 15 years (IQR, 6-19 years) and a median revenue of $670 719 (IQR, $193 587-$1 830 890). Among the surveyed RDNPs, 58 of 138 (42.0%) specifically identifying their involvement in repurposing supported repurposing projects, and 94 drugs were in various stages of repurposing, of which 23 met success criteria (5 with US Food and Drug Administration approval and 18 with off-label use with subjective benefit). Survey factors associated with successful outcomes included nonprofit-supported patient recruitment into trials (Gini importance, 3.90; ρ = 0.50; adjusted P < .001) and provision of nonfinancial research support (Gini importance, 0.69; ρ = 0.33; adjusted P = .02). Interview themes were synthesized into a 5-stage repurposing framework with roadblocks and recommendations that included (1) enabling drug repurposing, (2) identifying a drug therapy, (3) validating a drug therapy, (4) clinical use and testing, and (5) reaching an optimal end point for clinical practice.

CONCLUSIONS AND RELEVANCE: The findings of this qualitative study of RDNP repurposing suggest that several opportunities were associated with successful outcomes and can be considered to optimize systematic repurposing among RDNPs, external collaborators, and policymakers with the use of an interactive tool showcasing insights to facilitate data-driven drug repurposing.

PMID:40323602 | DOI:10.1001/jamanetworkopen.2025.8330

JAMA Netw Open. 2025 May 1;8(5):e258353. doi: 10.1001/jamanetworkopen.2025.8353.

ABSTRACT

IMPORTANCE: Patients with cancer and cancer survivors frequently experience symptoms that increase the need for health care services and impair quality of life. Effective symptom management is critical for comprehensive patient-centered cancer care.

OBJECTIVE: To evaluate the effectiveness of adding a bilingual (English and Spanish), web-based self-management program to an electronic health record (EHR)-integrated patient-reported outcome for cancer (cPRO) assessment in reducing symptom burden and health care resource use (HCRU).

DESIGN, SETTING, AND PARTICIPANTS: This patient-level randomized clinical trial was performed at the Northwestern Memorial HealthCare system in Chicago, Illinois. Participants included 1614 adult patients with cancer or cancer survivors in 30 clinics who were enrolled between April 1, 2020, and April 8, 2023, and followed up for 12 months until May 8, 2024.

INTERVENTIONS: Usual care (UC) consisting of an EHR-integrated cPRO assessment or enhanced care (EC), which offered an additional tailored web-based self-management program.

MAIN OUTCOMES AND MEASURES: Patient-Reported Outcomes Measurement Information System measures of anxiety, depression, fatigue, pain interference, and physical function collected at baseline and monthly for 12 months. Secondary outcomes included HCRU measures (inpatient and/or observation visits and days, emergency department and/or urgent care visits, and days of hospital stay).

RESULTS: A total of 1614 patients were included in the analysis, with 804 randomized to EC and 810 to UC. The mean (SD) age was 61 (13) years; 1095 patients (67.8%) were female. Only 419 EC participants (52.1%) accessed the website, with only 197 (47%) returning; the median time per visit was 45 seconds (IQR, 45-105 seconds). There were no statistically significant differences between EC and UC across the cPRO outcomes over 12 months. The mean change from baseline at each assessment time point for treatment effects (EC vs UC) ranged from -0.19 (95% CI, -0.86 to 0.33; P = .64) for physical function to 0.11 (95% CI, -0.75 to 0.79; P = .87) for fatigue. Zero-inflated negative binomial and logistic regression models showed no significant differences in HCRU outcomes: inpatient and/or observation visits (incidence rate ratio [IRR], 0.90; 95% CI, 0.72-1.12), emergency department and/or urgent care visits (IRR, 0.99; 95% CI, 0.84-1.16), and days of hospital stay (IRR, 1.05; 95% CI, 0.83-1.33).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, adding a bilingual web-based self-management program to EHR-integrated cPRO did not reduce symptom burden or HCRU compared with cPRO alone. Low engagement with the web-based program highlights the need for strategies to enhance engagement and tailor interventions to those who would benefit most.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03988543.

PMID:40323601 | DOI:10.1001/jamanetworkopen.2025.8353

JAMA Netw Open. 2025 May 1;8(5):e258549. doi: 10.1001/jamanetworkopen.2025.8549.

ABSTRACT

IMPORTANCE: Infants have among the highest rates of emergency department (ED) visits of all age groups. Women with disabilities experience significant social disparities, may experience barriers accessing child primary care, and may seek care in the ED.

OBJECTIVE: To compare ED use among newborns and infants (hereafter infants) of women with or without disabilities, overall and by timing and acuity of the ED visit.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study analyzed data for all live-born infants in Ontario, Canada, born to women with or without a disability from April 1, 2008, to March 31, 2021. Data were analyzed March 2023 to October 2024.

EXPOSURE: Maternal physical, sensory, or intellectual or developmental disability or multiple disabilities status was ascertained using diagnostic algorithms applied to health care encounters before delivery.

MAIN OUTCOMES AND MEASURES: The main outcome was any ED visit between an infant’s hospitalization discharge date and their first birthday, and by timing and acuity. Cox proportional hazards regression was used to generate hazard ratios (HRs) for the association between maternal disability and the main outcome, adjusted for sociodemographic characteristics and infant sex and year of birth.

RESULTS: Of 1 596 932 total infants, there were 139 698 (8.7%) born to women with a physical disability, 48 112 (3.0%) to women with a sensory disability, 2547 (0.2%) to women with an intellectual or developmental disability, and 10 312 (0.6%) to women with multiple disabilities. The remaining 1 396 263 infants (87.4%) were born to a woman without a recognized disability. Among women without a disability, 558 965 infants (40.0%) had an ED visit in the first year of life (incidence rate, 1.11 per 1000 person-days). Compared with this referent group, infants born to a woman with a disability of a physical (46.9%; 1.30 visits per 1000 person-days; adjusted HR [AHR], 1.14 [95% CI, 1.13-1.15]), sensory (45.2%; 1.25 visits per 1000 person-days; AHR, 1.09 [95% CI, 1.07-1.10]), or intellectual or developmental (55.4%; 1.55 visits per 1000 person-days; AHR, 1.24 [95% CI, 1.17-1.30]) nature or with multiple disabilities (51.0%; 1.42 visits per 1000 person-days; AHR, 1.18 [95% CI, 1.15-1.22]) were more likely to have an ED visit. Similar patterns were observed for ED visits at fewer than 28 days from delivery, from 28 to 365 days, and for ED visits for high-acuity, moderate-acuity, and low-acuity reasons.

CONCLUSIONS AND RELEVANCE: In this population-based cohort study, infants of women with disabilities were more likely to use the ED, indicating a need for accessible family supports and improved early child primary care access.

PMID:40323599 | DOI:10.1001/jamanetworkopen.2025.8549

JAMA Netw Open. 2025 May 1;8(5):e258558. doi: 10.1001/jamanetworkopen.2025.8558.

ABSTRACT

IMPORTANCE: Evidence of cost savings attributable to indicated and timely care remain rare in psychiatry. Interventions to provide evidence-based psychiatric care to Medicaid patients that lower total costs of care are particularly challenging.

OBJECTIVE: To investigate Medicaid costs and care outcomes associated with use of an outpatient telepsychiatry clinic.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed Medicaid patients using and not using the services of an outpatient telepsychiatry clinic (Frontier Psychiatry, Billings, Montana) in 2022. Data analysis was performed from June to September 2024.

EXPOSURE: Receipt of care through an outpatient telepsychiatry clinic.

MAIN OUTCOMES AND MEASURES: Differences in Medicaid costs and cost subtypes between telepsychiatry patients and controls were assessed. Quality metrics, including inpatient hospitalizations, hospital readmissions, and admissions from the emergency department, were also compared.

RESULTS: In total, there were 2686 patients using the outpatient telepsychiatry clinic’s services (1665 female [62.0%]; mean [SD] age, 30.55 [14.67] years) and 2686 propensity-matched controls (1665 female [62.0%]; mean [SD] age, 31.37 [15.92] years). Across categories examined, the telepsychiatry patients had care costs per member per month (PMPM) similar to those for propensity-matched control patients ($685.5 [95% CI, $632.9-$738.2] vs $734.0 [95% CI, $645.7-$822.3]; P = .10) over the study period. PMPM costs to Medicaid from the telepsychiatry clinic’s patients were higher for professional services vs control patients ($464.0 [95% CI, $443.4-$484.5] vs $388.4 [95% CI, $368.1-$408.7]; P < .001) but were lower for inpatient hospitalization fees ($201.6 [95% CI, $146.2-$228.7] vs $260.6 [95% CI, $220.2-$341.5]; P = .04). Telepsychiatry clinic patients had a 38.0% lower mean annualized hospitalization rate per 1000 patients than controls (274.3 [95% CI, 237.1-311.6] hospitalizations per 1000 patients vs 442.6 [95% CI, 396.5-488.7] hospitalizations per 1000 patients; P < .001) and a 17.9% lower rate of admissions from the emergency department (patients vs controls, 299.7 admissions [47.7%] vs 519.0 admissions [58.1%]).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of 5372 patients, use of an outpatient telepsychiatry clinic’s services was associated with decreases in inpatient hospitalization rates and lower rates of admissions from the emergency department, with similar costs to Medicaid. These findings suggest that outpatient telepsychiatry care could play an important role in reducing hospital admissions among patients enrolled in Medicaid.

PMID:40323598 | DOI:10.1001/jamanetworkopen.2025.8558

JAMA Pediatr. 2025 May 5. doi: 10.1001/jamapediatrics.2025.0682. Online ahead of print.

ABSTRACT

IMPORTANCE: Parental technology use in a child’s presence (hereafter, PTU), often referred to as technoference, is a growing concern in family dynamics, and no studies have quantitatively synthesized associations with children’s health and development.

OBJECTIVE: To systematically review and synthesize literature on associations between PTU in their child’s presence and motor development, cognitive development, psychosocial health, physical activity, screen time, and sleep in early childhood.

DATA SOURCES: Peer-reviewed studies from MEDLINE, CINAHL, SPORTDiscus, PsycINFO, PsycArticles, Web of Science, Scopus, and ProQuest published from inception to July 2024.

STUDY SELECTION: A total of 6212 studies were initially identified. Studies were included if they examined associations between PTU in the presence of their apparently healthy children (birth to age 4.9 years) and motor development, cognitive development, psychosocial health, physical activity, screen time, or sleep.

DATA EXTRACTION AND SYNTHESIS: PRISMA guidelines were followed. Random-effect models were conducted to determine the pooled estimates of the associations and moderating effects of the type of exposure (distraction/interruption). The risk of bias was assessed using the JBI critical appraisal tools.

MAIN OUTCOMES AND MEASURES: Association between PTU in the child’s presence and motor development, cognitive development, psychosocial health, physical activity, screen time, and sleep.

RESULTS: Twenty-one studies involving 14 900 participants from 10 countries were included in the meta-analysis. Significant associations were found between parental technology use in the child’s presence and cognition (r = -0.14; 95% CI, -0.23 to -0.04), internalizing behavior and emotions (r = 0.13; 95% CI, 0.08 to 0.19), externalizing behavior (r = 0.15; 95% CI, 0.09 to 0.21), prosocial behavior (r = -0.08; 95% CI, -0.13 to -0.02), attachment (r = -0.10; 95% CI, -0.19 to -0.01), and screen time (r = 0.23; 95% CI, 0.13 to 0.32). No moderating effects of the type of PTU exposure on any associations were found. No study examined motor development, physical activity, or sleep.

CONCLUSIONS AND RELEVANCE: Parents’ use of technology in their child’s presence was negatively associated with cognitive and psychosocial outcomes and screen time among young children, although the effect sizes were small. Further research focusing on potential impacts on physical activity, sleep, and motor skills is needed. Understanding these associations is crucial for informing research and guidelines aimed at minimizing the potential negative effects of this phenomenon on early childhood development.

PMID:40323594 | DOI:10.1001/jamapediatrics.2025.0682

J Craniofac Surg. 2025 May 5. doi: 10.1097/SCS.0000000000011422. Online ahead of print.

ABSTRACT

PURPOSE: Temporal mandibular joint (TMJ) space volume is pivotal in upholding optimal joint function and occlusal stability. Mandibular setback surgery can impact TMJ space volume due to condylar positioning adjustments. This study aims to investigate the changes in TMJ space volume following mandibular setback surgery with intended manual condylar positioning.

METHODS: This is a retrospective study of 20 patients of class III (skeletal), who underwent Le Fort I osteotomy and BSSO surgery at the OMFS Department of PNUDH between 2015 and 2022 by one surgeon. CBCT scans were obtained preoperatively (T0) and at specified postoperative time points (T1) and (T2). The groups were categorized into group A (Total space volume), group B (non-asymmetric), and group C (asymmetric). TMJ space volume measurements were taken using CBCT imaging software. Each slice of the TMJ space was drawn manually using specialized software. The measured areas in each slice were added to determine the TMJ volumes, and the statistical analysis was done.

RESULTS: Preliminary findings from this study indicate that there was a highly significant difference in TMJ space volume between group A, group B, and group C at T0, T1, and T2 following surgery. However, there were no significant differences within the groups, which means that the intended manual condylar positioning gives stability to the TMJ joint space.

CONCLUSIONS: This study suggests that mandibular setback surgery with intended manual condylar positioning can lead to transient changes in TMJ space volume, with subsequent recovery and adaptation.

PMID:40323583 | DOI:10.1097/SCS.0000000000011422