Tag: statistics

Cornea. 2025 Dec 5. doi: 10.1097/ICO.0000000000004065. Online ahead of print.

ABSTRACT

PURPOSE: To assess the effect of surgical decision making on the type of corneal crosslinking (CXL) protocol in eyes with keratoconus (KC) based on stromal thickness maps and thinnest corneal pachymetry (TCP).

METHODS: A prospective, nonrandomized cohort study was performed between January 2022 and January 2023. Patients were allocated to Epi-off or transepithelial CXL (TE-CXL) procedures depending on the TCP value using Scheimpflug. TCP ≥450 μm was used to designate patient’s eye to the Epi-off CXL procedure and TCP <450 μm to TE-CXL. On the same day, a combined Placido and Anterior Segment OCT evaluation was performed to assess epithelial thickness (ET) and minimum stromal thickness (MinST). The type of surgery was then finally selected: Epi-off CXL was indicated when MinST ≥400 μm, whereas TE-CXL procedure was indicated when MinST <400 μm. We assessed the percentage of cases in which MinST data changed the surgical decision (Utility).

RESULTS: The study included 245 eyes, MinST was 407.26 ± 50.92 (range 223-497). Stromal thickness maps assessed before surgery altered the surgeon’s decision making in 5.30% (13 out of 245) of cases. The procedure was changed from Epi-off to TE-CXL and from TE-CXL to Epi-Off in 3.67% and 1.63% of the cases, respectively.

CONCLUSIONS: Anterior segment optical coherence tomography stromal thickness maps have minimal impact on the surgical decision making for conventional Epi-off and TE-CXL protocols. Considering that MinST data provide objective information on stromal thickness, unlike TCP, and avoid the need for deepithelialization, their implications in sub-400 protocols may be greater.

PMID:41379517 | DOI:10.1097/ICO.0000000000004065

J Surg Orthop Adv. 2025 Winter;34(4):203-206.

ABSTRACT

The purpose of the study was to determine the relationship between increased body mass index (BMI) and tibial prosthesis characteristics. A retrospective analysis of total knee arthroplasties (TKAs) was completed, and a Cox multivariate regression was performed. In total, 8,548 TKAs were completed, and cumulative survivability was 98.0% at 5 years and 97.1% at 10 years. Age < 70 years (p < 0.01), male sex (p < 0.01), and BMI ≥ 40 kg/m2 (p = 0.04) were significantly related to revision in all implants. Implant type, contact surface area, base plate surface area, and tibial stem length did not have a statistically significant effect on implant survivability (p = 0.62 – 0.91). When stratified based on BMI, there was a significant decrease in survivability for those BMI ≥ 40 kg/m2 (p < 0.01). Patients with high BMI do not necessarily require larger implants, and surface area and stem length do not affect survivability. Patient factors appear to drive survivability outcomes after primary TKA more than the implant factors. (Journal of Surgical Orthopaedic Advances 34(4):203-206, 2025).

PMID:41379512

J Surg Orthop Adv. 2025 Winter;34(4):193-195.

ABSTRACT

The purpose of this study was to quantify femoral rotation in the axial plane for posterior-stabilized total knee replacements performed with a modified gap-balancing technique. In total, 2442 knees were selected from a computer-assisted orthopaedic surgery navigation system database. The knees were stratified into three groups based on preoperative coronal plane alignment. The computer navigation recorded distal femoral and tibial resection angles, and the rotational position of the femoral component. Means were calculated for each of the three groups. There was substantial variation of femoral axial rotation in all three groups. In aggregate, the mean rotational position for all knees was 2.4° external (-10.2° – 20.9°). The mean rotation for the varus group was 2.5° (-9.8° – 15.7°), 2.5° (-9.8° – 20.9°) for the neutral group, and 1.1° (-10.2° – 9.9°) for the valgus group (p < 0.0001). The data indicates that choosing a predetermined rotational position for the femoral component may lead to flexion gap asymmetry more frequently than by adjusting the rotational position intraoperatively to achieve a rectangular flexion space. This is the first study to quantify differences between varus and valgus knees related to flexion gap stability. Correlation of these findings to clinical outcomes is needed. There is no single rotational position for the femoral component that will produce a balanced flexion gap for every knee. There is a statistically significant difference between mean rotational position for femoral components for varus and valgus knees. (Journal of Surgical Orthopaedic Advances 34(4):193-195, 2025).

PMID:41379510

J Surg Orthop Adv. 2025 Winter;34(4):174-177.

ABSTRACT

There is a dearth of studies analyzing outcomes in patients with chronic obstructive pulmonary disorder (COPD) receiving total ankle arthroplasty (TAA). The present study aimed to compare preoperative characteristics and 30-day postoperative outcomes for patients with COPD undergoing TAA. The National Surgical Quality Improvement Program (NSQIP) database was queried for primary TAA (CPT: 27702) from 2012 – 2020. Baseline comorbidities were compared using univariable statistics and subsequently multivariable regression was performed to measure the effect of COPD on operative time, LOS, and 30-day readmissions after TAA. In a sample of 1,619 total patients, on multivariate regression, COPD was found to be an independent risk factor predictor for shorter operative time ( b = -0.33; p = 0.037), and hospital LOS (b = 0.37; p = 0.039). In conclusion, it was determined that COPD is an independent risk factor for shorter operative time and increased duration of hospital length of stay in patients undergoing TAA. Clinical level of evidence: Level III. (Journal of Surgical Orthopaedic Advances 34(4):174-177, 2025).

PMID:41379505

J Surg Orthop Adv. 2025 Winter;34(4):168-173.

ABSTRACT

Patients undergoing thumb ligament reconstruction tendon interposition (LRTI) for carpometacarpal (CMC) arthritis are often treated with metacarpophalangeal (MCP) arthrodesis for concomitant MCP hyperextension. The effects of MCP arthrodesis on LRTI were evaluated in this study. Thirty-one LRTI surgeries were compared to 22 LRTIs with MCP arthrodesis surgeries. All patients answered Michigan Hand Outcomes (MHQ), QuickDASH, and Visual Analog Score (VAS) questionnaires. Grip, tip pinch, lateral pinch and opposition were measured. The LRTI alone and LRTI with MCP arthrodesis cohorts were then compared to each other and all of the non-operative thumbs of the same patients. The LRTI and MCP arthrodesis group showed no statistical difference in MHQ, QuickDASH, VAS, or measured strength compared to LRTI alone. This study shows no difference in patient reported outcomes between patients with LRTI alone and LRTI with MCP arthrodesis performed by the same surgeon on average 4 years after surgery. (Journal of Surgical Orthopaedic Advances 34(4):168-173, 2025).

PMID:41379504

Acta Orthop. 2025 Dec 11;96:897-903. doi: 10.2340/17453674.2025.44923.

ABSTRACT

BACKGROUND AND PURPOSE: Both cemented and uncemented stem fixation is used in 2-stage hip revision arthroplasty addressing periprosthetic joint infection (PJI). We aimed to compare the risk of infection relapse and the risk of reoperation for any reason between uncemented and cemented stem fixation.

METHODS: Patients who underwent 2-stage hip revision arthroplasty for PJI between 2005 and 2020 were included. Data on baseline demographics, implant type, and microbiological and antibiotic treatment data was obtained from a local registry and medical records. Kaplan-Meier analysis compared relapse-free survival and reoperation-free survival between uncemented (n = 60) and cemented (n = 34) stems. Cox regression models were fitted to assess adjusted hazard ratios (aHR) for the risk of relapse or reoperation with 95% confidence intervals (CIs).

RESULTS: 94 patients underwent 2-stage revision hip arthroplasty for PJI. Unadjusted 2-year relapse-free survival rates were 95% (CI 89-100) for patients with uncemented stem fixation and 97% (CI 90-100) for those with cemented fixation. Reoperation-free survival at 10 years was 82% (CI 70-95) for patients with uncemented fixation and 61% (CI 43-85) for those with cemented fixation. Using cemented fixation as the reference, the aHR for infection relapse was 2.0 (CI 0.2-20.1, P = 0.6) for uncemented fixation, whereas the aHR for reoperation was 0.3 (CI 0.1-0.9, P = 0.03).

CONCLUSION: We showed no statistical difference in the risk of infection relapse, but uncemented stem fixation in 2-stage revision arthroplasty for PJI was associated with a reduced risk of reoperation for any reason. Uncemented stems may thus be a suitable choice in 2-stage revisions for PJI when this concept is believed to provide better fixation.

PMID:41379462 | DOI:10.2340/17453674.2025.44923

JAMA Oncol. 2025 Dec 11. doi: 10.1001/jamaoncol.2025.5220. Online ahead of print.

ABSTRACT

IMPORTANCE: Breast cancer treatment is associated with cancer-related cognitive impairment (CRCI). However, the association of endocrine therapy (ET) vs chemotherapy plus endocrine therapy (CET) with CRCI is poorly understood.

OBJECTIVE: To compare patient-reported CRCI between women with breast cancer treated with ET vs CET and to consider whether menopausal status may be associated.

DESIGN, SETTINGS, AND PARTICIPANTS: This was a prespecified secondary analysis of RxPONDER (SWOG S1007), a multinational phase 3 randomized clinical trial of more than 5000 women with hormone receptor-positive ERBB2-negative (formerly HER2-negative) breast cancer with 1 to 3 involved lymph nodes and Oncotype DX (21-gene recurrence score) of 25 or less. Participants were enrolled from February 2011 to September 2017, with results first reported in December 2020. Participants were randomly assigned to CET or ET, with ongoing follow-up. This secondary analysis assessed cognitive function using the Patient-Reported Outcomes Measurement Information System Perceived Cognitive Function Concerns (PCF) questionnaire at baseline, 6, 12, and 36 months. Data were analyzed from July 2022 to August 2025.

INTERVENTION: Random assignment to CET or ET.

MAIN OUTCOMES AND MEASURES: Mean PCF standardized (T) scores by menopausal status over time using generalized estimating equations analysis for continuous outcomes.

RESULTS: Of the 568 patients who completed the baseline questionnaire and were included in the analysis, 139 (24%) were premenopausal (median [range] age, 47.8 [28.0-56.3] years) and 429 (76%) were postmenopausal (median [range] age, 62.3 [37.3-87.6] years). Among the 274 (48%) who received CET and the 294 (52%) who received ET alone, CET was determined to have a greater negative association with patient-reported CRCI in both the pre- and postmenopausal participants during the 36-month follow-up. In the ET alone group, PCF scores for premenopausal participants decreased from baseline to 6 and 12 months (53.53, 51.51, and 51.72, respectively) but recovered to baseline (54.36) at 36 months. For postmenopausal participants, mean PCF scores were essentially stable (51.72, 51.13, 51.11, and 51.70, respectively); however, in the CET group, PCF scores for both pre- and postmenopausal participants decreased from baseline to 6 and 12 months (premenopausal, 52.84, 49.27, 48.04; postmenopausal, 50.65, 48.39, 47.13, respectively) and did not return to baseline at 36 months (premenopausal, 49.25; postmenopausal, 48.44). The difference in longitudinal mean PCF scores over time between CET and ET groups was -3.02 (95% CI, -5.33 to -0.72; P = .01) for premenopausal and -2.37 (95% CI, -3.92 to -0.82; P = .003) for postmenopausal participants.

CONCLUSIONS AND RELEVANCE: This secondary analysis of the RxPONDER found that CET had a greater negative association with patient-reported CRCI compared to ET alone in both pre- and postmenopausal participants over a 36-month follow-up period. Interventions to prevent or treat CRCI are needed to improve the long-term quality of life of these patients treated with chemotherapy.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01272037.

PMID:41379459 | DOI:10.1001/jamaoncol.2025.5220

JAMA Otolaryngol Head Neck Surg. 2025 Dec 11. doi: 10.1001/jamaoto.2025.4542. Online ahead of print.

ABSTRACT

IMPORTANCE: Inducible laryngeal obstruction (ILO) presents as episodic shortness of breath that can range in severity and may greatly impact daily life. Respiratory retraining therapy (RRT) provided by speech-language pathologists is the standard of care. Limited data exist on treatment effectiveness, with no published randomized clinical trials comparing treatments.

OBJECTIVE: To evaluate the effectiveness of video biofeedback (directly showing participants their laryngeal anatomy as they perform breathing exercises) compared with RRT in the treatment of episodic, inhalational dyspnea attributed to ILO.

DESIGN, SETTING, AND PARTICIPANTS: This pilot randomized clinical trial was conducted at a single-institution laryngology clinic. Patients with inhalational dyspnea attributed to ILO were included. Data were collected from March 2023 to July 2024, and data were analyzed from July 2024 to March 2025.

INTERVENTIONS: Video biofeedback and RRT.

MAIN OUTCOMES AND MEASURES: The primary end point was the difference in the Dyspnea Index (DI) score at 1 month posttreatment compared with pretreatment. The Clinical Global Impressions-Improvement scale was also used to assess patients’ perceived response to treatment.

RESULTS: A total of 54 patients newly diagnosed with episodic shortness of breath attributed to ILO were evenly randomized to biofeedback or RRT. Of these, 25 participants in the biofeedback group, and 20 in the RRT group completed the full assigned intervention. The mean (SD) age was 46.4 (16.2) years in the biofeedback group and 49.4 (20.0) years in the RRT group. A total of 42 patients (78%) were female. DI score was reduced by a mean (SD) of 3.54 (4.75) points in the biofeedback group and 4.15 (4.44) points in the RRT group, representing a mean difference of 0.61 (95% CI, -2.21 to 3.43) between the 2 groups. Most patients in both groups (14 of 22 [64%] in the biofeedback group and 12 of 19 [63%] in the RRT group) self-reported at least some improvement.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, video biofeedback and RRT were not different in the treatment of ILO. Biofeedback presents potential advantages, as it is easily accessible and imposes no additional cost to patients. Physicians should be thoughtful in selection of which treatment they recommend to patients, taking individual patient factors, such as comorbidities and access to care, into account.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05770518.

PMID:41379457 | DOI:10.1001/jamaoto.2025.4542

JAMA Netw Open. 2025 Dec 1;8(12):e2547584. doi: 10.1001/jamanetworkopen.2025.47584.

ABSTRACT

IMPORTANCE: Intraventricular hemorrhage (IVH) is a significant complication of preterm birth, affecting approximately 20% of preterm infants. Despite its prevalence, the effect of IVH beyond the impact of prematurity alone has been scarcely studied beyond early childhood, posing an important knowledge gap.

OBJECTIVE: To investigate the association of IVH with national school performance throughout childhood to adolescence.

DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study included all very preterm infants (<32 weeks’ gestation) and full-term infants (≥37 weeks’ gestation) born in New South Wales, Australia, between January 1, 2007, and December 31, 2013. Cohorts were very preterm children with low-grade (grades 1-2) or high-grade (grades 3-4) IVH, very preterm controls without IVH, and full-term controls. Analyses were conducted from January 30 to September 18, 2024.

EXPOSURE: IVH grade 1 to 4.

MAIN OUTCOMES AND MEASURES: The primary outcome was overall performance on standardized national school assessments at age 8 to 9, 10 to 11, and 12 to 13 years, including adjusted mean differences (AMDs) in z scores between children with IVH and very preterm controls. Secondary outcomes were domain-specific performance in reading, writing, spelling, grammar, and numeracy and whether children met the national minimum standards overall and for each domain. Academic trajectories were also compared by group.

RESULTS: This study included 408 189 children: 557 with low-grade IVH, 85 with high-grade IVH, 2557 very preterm controls without IVH, and 404 990 full-term controls. Children with low-grade IVH performed similarly to preterm controls at age 8 to 9 years (AMD in overall academic z score, -0.06; 95% CI, -0.14 to 0.03), 10 to 11 years (AMD, -0.09; 95% CI, -0.21 to 0.03), and 12 to 13 years (AMD, -0.04; 95% CI, -0.24 to 0.16). Children with grade 2 IVH (n = 145), however, performed significantly worse than very preterm controls at age 8 to 9 years (AMD, -0.20; 95% CI, -0.36 to -0.04). Children with high-grade IVH performed significantly worse than very preterm controls at age 8 to 9 years (AMD, -0.50; 95% CI, -0.71 to -0.30), 10 to 11 years (AMD, -0.59; 95% CI, -0.85 to -0.34), and 12 to 13 years (AMD, -0.61; 95% CI, -1.05 to -0.17). Numeracy was a consistently weak domain for children with high-grade IVH throughout school age (eg, at age 8 to 9 years, AMD in the numeracy z score compared with very preterm controls was -0.49 [95% CI, -0.70 to -0.28]). Differences in academic trajectories between groups remained fixed with increasing age; however, all groups showed improvement over time (eg, adjusted β for very preterm children, 32.3 [95% CI, 31.2-33.5]; children with low-grade IVH, 31.5 [95% CI, 29.0-34.0]; high-grade IVH, 30.2 [95% CI, 24.1-36.4]).

CONCLUSIONS AND RELEVANCE: In this cohort study, the association of low-grade IVH with worse school performance appeared limited to children with grade 2 IVH. Children with high-grade IVH consistently showed poorer academic performance into adolescence than their peers born very preterm without IVH. Nevertheless, very preterm children, regardless of IVH grade, demonstrated academic progress over time, underscoring the need for ongoing educational support to help them to realize their full potential.

PMID:41379448 | DOI:10.1001/jamanetworkopen.2025.47584

JAMA Netw Open. 2025 Dec 1;8(12):e2548617. doi: 10.1001/jamanetworkopen.2025.48617.

ABSTRACT

IMPORTANCE: Corticosteroids are frequently used to manage symptoms in patients with diffuse large B-cell lymphoma (DLBCL), but longstanding clinical caution suggests that prebiopsy administration may reduce diagnostic accuracy. The association between steroids and biopsy outcomes in patients with systemic DLBCL remains unexamined.

OBJECTIVE: To determine whether corticosteroid use before biopsy is associated with diagnostic yield in patients with newly diagnosed DLBCL.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective case series of adult patients newly diagnosed with DLBCL at a single institution tertiary academic medical system affiliated with Brown University between 2015 and 2024. Patients were identified through institutional hematology and pathology databases. Patients with relapsed or refractory DLBCL or primary central nervous system lymphoma were excluded. Logistic regression was used to assess the association between steroid exposure (dose, duration, and withdrawal) and diagnostic yield.

EXPOSURE: Corticosteroid administration within 30 days before tissue biopsy.

MAIN OUTCOMES AND MEASURES: Diagnostic yield of initial biopsy for DLBCL, repeat biopsy rates, and time from first negative biopsy to chemotherapy initiation.

RESULTS: Of 320 patients (mean [SD] age, 68 [14] years and 164 [51%] female), 48 (15%) received corticosteroids prebiopsy. Diagnostic yield was 83% (40 of 48 patients) in the steroid group and 81% (221 of 272 patients) in the nonsteroid group, with no statistically significant difference between the groups (prevalence ratio [PR], 1.03; 95% CI, 0.89-1.18). Among patients with negative first biopsies, time to treatment initiation did not differ significantly between groups. No significant associations were observed between diagnostic yield and total steroid dose, duration, or days off steroids before biopsy. Biopsy type was significantly associated with diagnostic yield. Compared with excisional and incisional biopsies, core needle and fine needle aspiration were 12% (PR, 0.88; 95% CI, 0.81-0.96; P = .01) and 69% (OR, 0.31; 95% CI, 0.18-0.63; P < .001) less likely to be diagnostic, respectively.

CONCLUSIONS AND RELEVANCE: In this case series of 320 patients with DLBCL, prebiopsy corticosteroid administration was not associated with reduced diagnostic yield or delay in treatment in patients with newly diagnosed DLBCL. Biopsy technique was most associated with diagnostic success. These findings support a clinically pragmatic approach to steroid use during lymphoma evaluation.

PMID:41379445 | DOI:10.1001/jamanetworkopen.2025.48617