Category: Nevin Manimala

Hand (N Y). 2026 Jan 27:15589447251406715. doi: 10.1177/15589447251406715. Online ahead of print.

ABSTRACT

BACKGROUND: There are no studies about the biomechanical behavior of ligamentous reconstructions in the trapeziometacarpal (TM) joint. The aim of our study was to analyze the stabilizing effect of 2 different dorsoradial ligament reconstructions of the TM joint: (1) monofascicular ligament reconstruction; and (2) bifascicular ligament reconstruction.

METHODS: Ten fresh-frozen human cadaveric upper extremities were used. The dorsoradial dislocation of the thumb metacarpal (MC1) after applying a dislocating force was measured in 4 different situations using a 3-dimensional motion tracking system: (1) with the dorsoradial and ulnar ligaments intact; (2) after their section; (3) after dorsal ligament reconstruction with the bifascicular technique; and (4) after reconstruction with the monofascicular technique. The data were further analyzed and considered statistically significant at P < .05.

RESULTS: The MC1 moved dorsoradially 0.36 cm (standard deviation [SD] 0.19 cm) with the intact ligaments. After sectioning the ligaments, the displacement was 0.64 cm (SD 0.24 cm). With the bifascicular technique, the MC1 moved 0.31 cm (SD 0.16 cm), and with the monofascicular technique, it moved 0.57 cm (SD 0.19 cm).

CONCLUSIONS: The monofascicular reconstruction technique seems to be insufficient to stabilize the TM joint. Dorsal ligament reconstruction with the bifascicular technique restores the original stability of the TM joint. Moreover, it is not necessary to reconstruct the ulnar ligament to restore the dorsoradial stability of the TM joint after bifascicular reconstruction.

PMID:41593449 | DOI:10.1177/15589447251406715

Neurosurg Rev. 2026 Jan 28;49(1):164. doi: 10.1007/s10143-025-04074-z.

ABSTRACT

BACKGROUND: The choice of structural grafts for transforaminal lumbar interbody fusion (TLIF) may influence clinical and radiographic outcomes. It remains unclear whether using one versus two grafts per level affects postoperative results.

PURPOSE: To compare clinical and radiographic outcomes in patients undergoing one- or two-level TLIF with either one or two structural grafts per level.

METHODS: This is a single-center post hoc analysis of prospectively collected data (October 2011-April 2017). The study allocated subjects who underwent one- or two-level TLIF into two groups based on the number of structural allografts per spinal level. Primary clinical outcomes included Visual Analog Scale, VAS back and leg; Oswestry Disability Index, ODI; Short Form, SF-36 v2, Physical and Mental Component Summary. Secondary radiographic outcomes included fusion rates, lumbar/segmental sagittal alignment, anterior and posterior vertebral body height.

RESULTS: A total of 115 patients were included: 38 and 78 were implanted with one or two grafts per level, respectively. At the 24 months postoperatively, there were no significant differences between the groups in primary clinical and radiographic outcomes, nor complication rates. However, both groups showed statistically significant (p < 0.0001) improvements from baseline across all primary clinical measures at the 24 months follow-up.

CONCLUSIONS: One or two structural grafts per level yield comparable clinical and radiographic outcomes in one- or two-level TLIF. When feasible, using a single graft per level may be considered without compromising patient outcomes.

PMID:41593407 | DOI:10.1007/s10143-025-04074-z

Drug Saf. 2026 Jan 28. doi: 10.1007/s40264-025-01634-6. Online ahead of print.

ABSTRACT

BACKGROUND: The US Food and Drug Administration (FDA) requires pharmaceutical manufacturers to implement Risk Evaluation and Mitigation Strategy (REMS) programs for certain medications that carry serious safety risks. One possible REMS requirement is routine monitoring via laboratory tests. However, in March 2020, the FDA issued a temporary enforcement discretion policy enabling prescribers to apply medical judgment for completing REMS-required laboratory testing.

OBJECTIVE: We aimed to assess whether physicians were aware of the FDA’s temporary policy and if they changed their laboratory testing practices during the coronavirus disease 2019 pandemic.

METHODS: We designed a survey of US physicians prescribing one of seven medications: ambrisentan, bosentan, clozapine, isotretinoin, lenalidomide, pomalidomide, and thalidomide. The study was conducted over two waves, May 2022 to October 2022 and October 2022 to January 2023. Multivariable logistic regression modeling was used to examine predictors of each outcome.

RESULTS: The combined response rate between the two waves of survey administration was 21%. Among 949 physician respondents, 438 (47%; 927 question respondents) reported awareness and 192 (21%; 926 question respondents) reported changing practices. Among the 438 physicians who reported awareness, 176 (40%) reported changing practices. Characteristics associated with awareness included sex (female vs male, odds ratio [OR] = 1.92, 95% confidence interval [CI] 1.37-2.69); recency of medical school graduation (25-34 vs ≤ 15 years, OR = 0.50, 95% CI 0.31-0.81); practice setting (academic hospital vs outpatient group, OR = 0.58, 95% CI 0.37-0.88); prescribing experience (≥ 21 vs ≤10 patients, OR = 2.92, 95% CI 2.06-4.14); and timing of survey completion (wave 2 vs wave 1, OR = 0.47, 95% CI 0.34-0.66). Characteristics associated with practice changes included race (Asian vs White, OR = 0.62, 95% CI 0.38-0.99) and awareness of FDA’s policy (yes vs no, OR = 14.07, 95% CI 7.93-24.96), in addition to sex (female vs male, OR = 1.99, 95% CI 1.31-3.01), recency of medical school graduation (≥ 35 vs < 15 years: OR = 0.53, 95% CI 0.30-0.93), and timing of survey completion (wave 2 vs wave 1: OR = 0.58, 95% CI 0.34-0.99).

CONCLUSIONS: Although policy awareness was correlated with laboratory practice changes, fewer than half of physicians who were aware of the FDA’s policy reported changing their practices.

PMID:41593404 | DOI:10.1007/s40264-025-01634-6

Indian J Pediatr. 2026 Jan 28. doi: 10.1007/s12098-026-05992-6. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the accuracy of Face2Gene (F2G) app in the diagnosis of a genetic syndrome as a first correct response, after uploading the image of the patient in the app (top 1 accuracy), first 3 responses (top 3 accuracy), and first 10 responses (top 10 accuracy) out of 30 differential diagnoses given by the app. Also, to determine the accuracy of the app for rare and ultra-rare diagnoses given by the app.

METHODS: Frontal facial images of individuals with the diagnosis of a genetic syndrome (established clinically or molecularly) were analysed with and without additional clinical features.

RESULTS: In this study, a total of 118 children were recruited. Overall, the molecularly confirmed eventual diagnosis appeared in the “top 10” suggested syndromes by Face2Gene in 75/118 cases, providing a diagnostic yield of 63.6%. In this study, the top 1 accuracy for correct first diagnosis by the app and clinician’s first diagnosis was 45.8% (n = 54). The Mcnemar test was examined for the clinician’s accurate diagnosis as compared to top 1, top 3, and top 10 accuracy by the app and the p-value was statistically significant for top 10 accuracy (0.0005) and not for the top 1 and 3 diagnoses. The top 10 accuracy for the app in the rare cases was 21/30 cases (70%), and for ultra-rare cases was 28/64 (43.8%).

CONCLUSIONS: The Face2Gene app is useful as an assistant to clinicians in the diagnosis of rare and ultra-rare diseases. The top 10 accuracy is better than clinical diagnosis, and the yield is better for the ultra-rare cases and the single gene disease category, too.

PMID:41593402 | DOI:10.1007/s12098-026-05992-6

Pharmacoecon Open. 2026 Jan 27. doi: 10.1007/s41669-025-00632-9. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVE: Hospital-level care at home is gaining traction, but evidence on health economic implications remains limited. The aim of this study was to estimate expected costs of continuous remote monitoring of vital signs in the post-discharge setting, to assess the burden of readmissions among relevant patient groups, and to compare monitoring costs with the potential savings from reduced readmissions. The study was conducted from a restricted societal perspective within the Danish healthcare system.

METHODS: The costs of 3-day post-discharge home monitoring were estimated using a micro-costing approach based on the WARD-Home project. The analysis excluded healthcare costs incurred outside the hospital sector or beyond the 3-day period. Readmission rates, length of stay, and associated costs were analyzed using Danish registry data on patients potentially suitable for post-discharge monitoring but currently not receiving it.

RESULTS: Estimated per-patient costs of 3-day monitoring were EUR 159. Registry data showed an overall 3-day readmission rate of 1.7%, with average length of stay of 4.4 days, and costs of EUR 4674. Comparing average costs of readmissions within 3 days-corresponding to monitoring duration-with the monitoring costs indicated that if post-discharge monitoring reduces readmissions, cost-neutrality could be achieved if it prevents one readmission in every 29 patients monitored.

CONCLUSIONS: Continuous remote monitoring offers a solution to post-discharge patients at risk of short-term deterioration and readmission. If one readmission is prevented per every 29 patients monitored, the approach has the potential to achieve cost-neutrality. Future studies are needed to validate these estimates and determine whether reductions in readmissions and actual cost savings can be achieved in practice.

PMID:41593391 | DOI:10.1007/s41669-025-00632-9

Appl Psychophysiol Biofeedback. 2026 Jan 27. doi: 10.1007/s10484-026-09766-w. Online ahead of print.

ABSTRACT

This study examined heart rate variability (HRV) in children with attention deficit hyperactivity disorder (ADHD) using a case-control design. A total of 52 children aged 6-12 years participated. ADHD diagnosis was confirmed by a child psychiatrist according to DSM-5 criteria, and comorbidities (e.g., anxiety, ODD) were excluded. Participants were then stratified into ADHD (n = 33; 17 boys, 16 girls) and control groups (n = 19; 12 boys, 7 girls), with MOXO d-CPT used to characterize performance profiles. Resting-state HRV was recorded for 5 min using the validated Polar H10 device. Time-domain (SDNN, RMSSD), frequency-domain (VLF, LF, HF), and non-linear indices were analyzed. The Good performance group demonstrated significantly lower VLF power compared to the Weak group (η² = 0.176, p < 0.05), and the SNS Index was significantly higher in the Weak hyperactivity group (d = 0.49, p = 0.048), indicating increased sympathetic activation associated with poorer performance. Non-significant trends were observed for SDNN (η² = 0.08) and RMSSD (η² = 0.07), suggesting modest parasympathetic differences, though these did not reach statistical significance. These findings highlight VLF and the SNS Index as the most robust HRV metrics associated with impulsivity and hyperactivity performance on the MOXO d-CPT, while other HRV domains showed only preliminary or non-significant effects. Future longitudinal studies are needed to evaluate HRV’s potential for monitoring treatment response and its specificity to cognitive subdomains in ADHD.

PMID:41593388 | DOI:10.1007/s10484-026-09766-w

Eur Radiol. 2026 Jan 27. doi: 10.1007/s00330-026-12319-8. Online ahead of print.

ABSTRACT

Mismatch imaging has become a key concept in neuroradiology, offering valuable insights into the pathophysiology of cerebrovascular and oncological conditions. By highlighting discrepancies between neuroimaging parameters, mismatch-based algorithms have revolutionized diagnosis, treatment planning, and patient prognosis. In stroke-related clinical scenarios, the mismatch concept is now essential in identifying candidates for thrombolysis or estimating the stroke onset time. However, the increasing use of mismatched terminology can lead to confusion, particularly when the exact mismatch target or required imaging modalities are unclear. Concerning stroke evaluation, there is a wide range of computed tomography perfusion (CT) maps and MRI sequences that are currently used for describing and determining mismatch concepts. Apart from the well-known penumbra-core mismatch related to CTP, the combination of features of different MRI sequences has provided a wide range of mismatch scenarios, such as perfusion-weighted imaging (PWI)/diffusion-weighted imaging (DWI) mismatch, magnetic resonance angiography (MRA)/DWI mismatch, susceptibility-weighted imaging (SWI)/DWI mismatch, or the DWI/FLAIR mismatch. Each one of these mismatches has its own clinical and physiopathological meaning, ranging from time-to-onset stroke estimation to selection of endovascular procedures. This article explores the different mismatch concepts used for stroke evaluation, including other related, less-used ones, focusing on their underlying physiopathology, clinical relevance, and supporting scientific evidence, all from a practical and educational perspective. KEY POINTS: Question Mismatch imaging offers transformative diagnostic insights in stroke, yet consistent definitions and standardized methodologies are essential to fully realize its clinical potential. Findings Our study reviews mismatch paradigms, outlines their pathophysiological basis, and compares clinical implications, highlighting critical limitations and the need for standardized imaging methodologies. Clinical relevance Standardizing mismatch imaging enhances diagnostic accuracy, optimizes patient selection for therapies, and improves prognostic assessment, ultimately enabling more consistent and reliable clinical decision-making in stroke.

PMID:41593382 | DOI:10.1007/s00330-026-12319-8

Naunyn Schmiedebergs Arch Pharmacol. 2026 Jan 28. doi: 10.1007/s00210-025-04964-5. Online ahead of print.

ABSTRACT

PURPOSE: This Phase 1 study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of INTP23.1, a proposed denosumab biosimilar, compared with US- and EU-licensed reference denosumab (Xgeva®) in healthy male volunteers.

METHODS: This randomized, double-blind, three-arm, 36 week, parallel-group trial (CTRI/2020/09/027619), assessed a single 35 mg subcutaneous dose of INTP23.1, Xgeva (US), or Xgeva (EU), administered in the upper arm. PK endpoints were statistically compared using geometric least-squares means (LSM) and 90% confidence intervals (CIs). PD markers were evaluated, immunogenicity and safety were assessed through validated assays, and adverse events (AEs) were monitored.

RESULTS: A total of 234 healthy male volunteers were enrolled. Baseline demographics were similar across the three treatment sequence groups. PK equivalence was demonstrated, with all geometric LSM ratios and 90% CIs for maximum serum concentration, area under the concentration-time curve (AUC) from time zero to the last measurable concentration, and AUC from time zero to infinity falling within the predefined bioequivalence range of 80.00% to 125.00%. PD responses showed comparable suppression of C-terminal telopeptide (CTX) and procollagen type 1 N-terminal propeptide (P1NP) across treatment groups. Immunogenicity profiles were similar, with low anti-drug antibody incidence and no neutralizing antibodies detected. AEs were generally mild or moderate in intensity, and no unexpected safety signals were observed.

CONCLUSIONS: INTP23.1 demonstrated comparable PK, PD, immunogenicity, and safety to US- and EU-licensed denosumab reference products in healthy male volunteers. These findings support further clinical development of INTP23.1 as a denosumab biosimilar for approved indications.

TRIAL REGISTRATION NUMBER: CTRI/2020/09/027619; Registered 07/09/2020.

PMID:41593375 | DOI:10.1007/s00210-025-04964-5

Eur J Nucl Med Mol Imaging. 2026 Jan 28. doi: 10.1007/s00259-026-07763-z. Online ahead of print.

ABSTRACT

PURPOSE: To compare the performance of a multidisciplinary team (MDT) with the proposed standardized PROMISE classification system for indeterminate bone uptake on staging PSMA PET.

METHODS: 744 staging PSMA PET/CT scans (140 ¹⁸F-PSMA-1007 and 604 ⁶⁸Ga-PSMA-11 PET/CT) were retrospectively reviewed for the presence of indeterminate bone metastatic staging. 95 scans which were discussed at an MDT meeting were further analysed for the comparison with the PROMISE classification system. MDT interpretation of the bone staging was recorded as positive or negative, based on risk stratification, imaging review, and clinically suitable management options. Additional resources were occasionally used, such as bone biopsy, musculoskeletal MRI, or re-evaluation after initial androgen deprivation therapy. MDT and PROMISE classification were compared for agreement. Statistical assessment was made on any differences in age, PSA, T-stage, Gleason score, risk, SUVmax and tracer used between negative and positive patients in both methods. Discordant cases were correlated with follow up data.

RESULTS: The overall incidence of indeterminate bone uptake in staging PSMA PET scans was 16.9%, reaching 40% for ¹⁸F-PSMA-1007. There was substantial agreement between MDT and PROMISE interpretation (87.3%). The MDT was more likely to interpret an indeterminate bone uptake as negative in patients with lower Gleason score and in scans where ¹⁸F-PSMA-1007 was used. The data from long-term follow up favoured the MDT interpretation in all the cases of disagreement. Examples of pitfalls in rib or thoracic spine foci of uptake are presented and recommendations for PET reporters and MDTs have been generated based on the results.

CONCLUSION: PROMISE may interpret indeterminate bone PSMA uptake with high accuracy. Therefore, PET reporters are recommended to use the PROMISE algorithm, while being mindful of common pitfalls related to the Gleason score, tracer used and anatomical localisation of indeterminate bone findings. Additional discussion in an MDT meeting is recommended with a view to resolve all equivocal findings.

PMID:41593361 | DOI:10.1007/s00259-026-07763-z

Support Care Cancer. 2026 Jan 27;34(2):134. doi: 10.1007/s00520-026-10382-x.

ABSTRACT

Psychiatric symptoms are frequently found in patients with cancer and often require specific pharmacological treatment. Depression seems to be the most common psychiatric disorder followed by adjustment disorders, anxiety, and delirium. Psychiatric comorbidities are responsible for worse quality of life and low adherence to anticancer treatment. Many different psychiatric drugs are beneficial, but there are increasing risks of drug-drug interactions (DDIs) with anticancer drugs. We conducted a PRISMA-compliant systematic review (PROSPERO registered) on drug-drug interactions between psychiatric and anticancer medications, using predefined search terms in electronic databases and specialized interaction software. Only six studies met the predefined inclusion criteria, confirming a significant lack of evidence on this topic. The available studies were often limited by small sample sizes, inadequate controls, or insufficient assessment of drug interactions. Our expanded search in drug interaction software allowed us to cross-reference results and identify clinically relevant interactions. The aim of this paper is to collect and summarize in a user-friendly format the most significant DDIs and to show unfavorable and potentially dangerous combination of drugs.

PMID:41593353 | DOI:10.1007/s00520-026-10382-x