Categories
Nevin Manimala Statistics

Diagnostic Errors in Clinical Laboratory Testing Process: Incidence and Impacts on Patient Safety-A 3-Year Voluntary Incident Report Analysis

Int J Qual Health Care. 2026 Mar 14:mzag038. doi: 10.1093/intqhc/mzag038. Online ahead of print.

ABSTRACT

INTRODUCTION: Diagnostic errors in laboratory processes can compromise the accuracy of final diagnoses. Such errors represent a significant patient safety concern and are linked to adverse clinical outcomes. This study aimed to determine the frequency, types, and impacts of laboratory-related diagnostic errors on the final clinical diagnosis, patient harm, and organizational reputation in a large private hospital network in Thailand.

METHODS: A retrospective study analyzed diagnostic errors in clinical laboratory testing processes at Bangkok Hospital Headquarters (BHQ), Thailand, over a three-year period (January 1, 2021-December 31, 2023). Data were retrieved from a voluntary incident reporting system covering domains such as clinical hematology, clinical chemistry, metabolic diagnostics, genetics, microbiology, hormonology, serology, and coagulation. Descriptive statistics were employed to classify errors by laboratory process, sub-process, and subtype, identify causal factors, and evaluated the clinical impacts.

RESULTS: Out of 5,951,783 samples processed, 34,395 incidents were reported, of which 1,031 (2.9%) related to diagnostic errors. Errors predominantly occurred in the pre-analytical process (89.2%), followed by post-analytical (10.7%) and analytical process (0.1%). The most common error subtypes were incorrect test ordering (48.2%) and specimen collection (34.6%). Human factors accounted for 91.1% of errors, with technical and organizational factors contributing minimally. 90.6% of errors had no impact on final clinical diagnosis; 7.8% resulted in delayed diagnosis, 0.9% in missed diagnosis, and 0.7% in wrong diagnoses. Most errors (98%) caused no patient harm, 1.9% led to temporary harm, and one error affected organizational reputation. No sentinel events were reported.

DISCUSSION AND CONCLUSION: To strengthen diagnostic safety across healthcare systems, organizations should adopt comprehensive, system-level strategies that effectively address human-factor vulnerabilities and streamline laboratory workflows. Implementing evidence-based strategies could contribute to achieving higher diagnostic accuracy and advancing patient safety within clinical laboratory processes.

PMID:41832967 | DOI:10.1093/intqhc/mzag038

Categories
Nevin Manimala Statistics

Long-Term follow-up of S0221, comparing alternative Dose-Schedules of anthracycline/taxane therapy in early breast cancer

JNCI Cancer Spectr. 2026 Mar 14:pkag024. doi: 10.1093/jncics/pkag024. Online ahead of print.

ABSTRACT

BACKGROUND: S0221 investigated weekly vs (vs) every 2 weeks (Q2W) dosing of doxorubicin(A)/cyclophosphamide (C) followed by paclitaxel (P) in patients with high-risk early breast cancer. After an interim analysis, randomization to the two AC arms was stopped for futility and the trial was modified to study only the P schedules.

PATIENTS AND METHODS: Between December 2003 and November 2010, 2716 patients were randomized in a 2 x 2 factorial design to: 15 weeks of weekly A and daily C vs 6 cycles of Q2W AC; and weekly P for 12 weeks vs 6 cycles of Q2W P. Between January 2011 and January 2012, an additional 578 patients were assigned to 4 cycles of Q2W AC x 4 and randomized to weekly vs Q2W P. Updated survival was assessed using log-rank tests and Cox regression models. We compared outcomes by breast cancer subtype as well.

RESULTS: At a median follow-up of 12.1 years, there were no significant differences among the four treatment arms in disease free survival [DFS] (p = 0.91) or overall survival [OS] (p = 0.34) in the original protocol. Among the 578 patients assigned AC for 4 cycles and randomized to P weekly vs Q2W P, there were no overall differences in DFS (p = 0.32) or OS (p = 0.42).

CONCLUSION: As there were no significant outcome differences in DFS or OS between the studied schedules of AC and P with extended follow-up in the original or revised protocol, either paclitaxel schedule may be recommended, with selection based on toxicity, cost, or patient preference.

PMID:41832961 | DOI:10.1093/jncics/pkag024

Categories
Nevin Manimala Statistics

New insights into susceptibility to major depression in a Colombian population

Trends Psychiatry Psychother. 2026 Mar 15. doi: 10.47626/2237-6089-2025-1095. Online ahead of print.

ABSTRACT

OBJECTIVE: Major Depressive Disorder (MDD) is a multifactorial psychiatric disease influenced by a combination of genetic and environmental factors. Among the genes linked to MDD, the Melanocortin 1 Receptor (MC1R), Catechol-O-Methyltransferase (COMT), Brain-Derived Neurotrophic Factor (BDNF), and the serotonin transporter (5-HTT) are of particular interest due to their critical roles in stress regulation and neural function. Despite their biological significance, the contribution of specific polymorphisms within these genes to MDD risk remains understudied.

METHODS: This retrospective observational case-control study included 87 Colombian patients diagnosed with MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). The control group comprised Latino/admixed individuals without, sourced from the gnomAD v2.1.1 database. The complete coding region of the MC1R gene and three polymorphisms: 5-HTTLPR Insertion/Deletion 44 bp, BDNF-c.196G>A, and COMT-c.472G>A were genotyped using PCR and Sanger sequencing.

RESULTS: The polymorphisms rs885479 and rs4680 were identified as protective factors against MDD, while the polymorphisms rs796296176, rs779504604, rs1805005 were associated with an increased risk of developing MDD (OR:22.87, OR:51.26, OR: 1.97, respectively).

CONCLUSION: Several of the analyzed polymorphisms (rs796296176, rs779504604, rs1805005) increase the risk for MDD. Notably, we provide novel evidence of these polymorphisms in MC1R as a risk to MDD.

PMID:41832959 | DOI:10.47626/2237-6089-2025-1095

Categories
Nevin Manimala Statistics

Outcomes of Multidisciplinary Dialectical Behavior Therapy and Acceptance and Commitment Therapy Informed Training of Caregivers of Children and Teens in a Behavioral Health Day Program

Occup Ther Health Care. 2026 Mar 15:1-17. doi: 10.1080/07380577.2026.2640978. Online ahead of print.

ABSTRACT

This study examined the effectiveness of multidisciplinary dialectical behavior therapy and acceptance and commitment therapy informed training for caregivers of youth in a day program setting. A one-group pretest-posttest design was used to assess the impact of multidisciplinary caregiver psychoeducation on caregiver stress and family function. Data was collected from 22 caregivers, revealing statistically significant improvements in caregiver stress and family functioning, suggesting that the caregiver education delivered within a day program setting is an effective intervention among families with children experiencing mental health challenges.

PMID:41832939 | DOI:10.1080/07380577.2026.2640978

Categories
Nevin Manimala Statistics

Prospective evaluation of the semi-quantitative hepatic subcapsular flow score and hepatic capsular retraction sign in the diagnosis of biliary atresia

Eur Radiol. 2026 Mar 15. doi: 10.1007/s00330-026-12392-z. Online ahead of print.

ABSTRACT

OBJECTIVES: To establish a semi-quantitative hepatic subcapsular flow (HSF) score using color Doppler ultrasonography (CDUS) and evaluate the performance of both the HSF score and hepatic capsular retraction (HCR) sign for identifying biliary atresia (BA), while simultaneously correlating with liver fibrosis.

MATERIALS AND METHODS: This study prospectively recruited 170 infants (35 BA and 135 non-BA; 124 males and 46 females) with a median age of 50 days (interquartile range 35-71). Multimodal ultrasound (grayscale ultrasound, CDUS, elastography) was utilized to evaluate the HSF score, HCR sign, and established markers (triangular cord [TC] sign, gallbladder, porta hepatis lymph nodes [PHLNs]). Diagnostic performance of individual and combined indicators was evaluated using the receiver operating characteristic curve (ROC). Additionally, correlations were analyzed between HSF score, HCR sign, and serum and histopathological liver fibrosis indicators.

RESULTS: The HSF score (cutoff ≥2) demonstrated an area under the ROC curve (AUC) of 0.950, superior to the cutoff ≥1 (p = 0.036) and higher (though not significantly) than established markers (all p > 0.05). The HCR sign had a lower AUC than other markers (all p < 0.05) but had high specificity within the studied cohort. It was also associated with higher liver stiffness measurement and fibrosis stage (p < 0.001, p = 0.001).

CONCLUSION: The liver capsule in BA infants undergoes significant morphological changes, which can be assessed using the HSF score and HCR sign. The HSF score provides reliable diagnostic performance for BA. The HCR sign, as a supplementary diagnostic marker, shows high specificity and correlates with the severity of liver fibrosis. These two indicators may support the diagnosis of BA and fibrosis assessment.

KEY POINTS: Question Can novel ultrasonographic signs-HSF score and HCR sign-improve the non-invasive diagnosis of BA and fibrosis assessment in cholestatic infants? Findings The HSF score demonstrated excellent diagnostic performance, while the HCR sign offered high specificity and was associated with liver fibrosis. Clinical relevance The HSF score is reliable for diagnosing BA, and the HCR sign serves as a high-specificity marker correlated with the severity of liver fibrosis, thus aiding in early diagnosis and fibrosis assessment.

PMID:41832932 | DOI:10.1007/s00330-026-12392-z

Categories
Nevin Manimala Statistics

Can ADC differentiate cellular from acellular mucin in mucinous adenocarcinoma tumor beds after treatment of rectal cancer? A multicenter study

Eur Radiol. 2026 Mar 15. doi: 10.1007/s00330-026-12466-y. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine if the apparent diffusion coefficient (ADC) can distinguish acellular mucin from cellular mucin in the treated tumor bed of patients with mucinous rectal adenocarcinoma after neoadjuvant therapy.

MATERIALS AND METHODS: This retrospective study included patients with mucinous rectal adenocarcinoma treated with neoadjuvant therapy, followed by restaging MRI and surgical resection or biopsy. Three radiologists blinded to histopathology results independently segmented volumes of interest on diffusion-weighted imaging and ADC maps. A medical physicist performed histogram analysis of ADC map segmentations, calculating various ADC metrics: mean, standard deviation, median, 1st quartile, 2nd quartile, 3rd quartile, and 4th quartile. The Wilcoxon rank sum test with false discovery rate correction for multiple testing was used to examine associations between ADC metrics and tumor mucin cellularity at histopathology for each reader. Multivariable logistic regression was used to adjust for acquisition parameters and institutions.

RESULTS: Of 150 patients (mean age, 58 ± 14 years; 48/150 (32% female), 25 patients (17%) had acellular mucin and 125 (83%) had cellular mucin at histopathology. At univariable analysis, there was no significant association between any ADC metric and tumor mucin cellularity (q-value = 0.14-0.58). At multivariable analysis, most ADC metrics were significantly associated with tumor mucin cellularity for all readers (q-values = 0.016-0.025) with odds ratios between 0.09 (95% CI: 0.02, 0.42) and 0.49 (95% CI: 0.22, 0.96).

CONCLUSIONS: ADC may be a potential tool for assessing pathologic complete response in mucinous rectal adenocarcinoma after neoadjuvant treatment, after adjusting for acquisition parameters and institutions.

KEY POINTS: QuestionCan the apparent diffusion coefficient (ADC) distinguish between cellular and acellular mucin (i.e., pathologic complete response) in mucinous rectal adenocarcinoma after neoadjuvant therapy? FindingsAfter controlling for acquisition parameters, ADC metrics were significantly associated with tumor mucin cellularity. Clinical relevanceAcellular mucin is equivalent to clinical complete response and can undergo watch-and-wait management, whereas cellular mucin is incomplete response, and its safety for watch-and-wait management is not validated. ADC may be a potential tool to make the distinction to assist treatment decision-making.

PMID:41832931 | DOI:10.1007/s00330-026-12466-y

Categories
Nevin Manimala Statistics

Intraindividual development of MR lung perfusion parameters in children after congenital diaphragmatic hernia at 2 and 10 years

Eur Radiol. 2026 Mar 15. doi: 10.1007/s00330-026-12443-5. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to analyze the intraindividual development of lung perfusion in children with congenital diaphragmatic hernia (CDH) at the ages of 2 and 10 years, as well as to investigate prenatal and postnatal influencing factors.

MATERIALS AND METHODS: Fifty-nine children after CDH were examined as part of a monocentric follow-up program using dynamic contrast-enhanced MRI (DCE-MRI) at 2 years (hereafter referred to as Examination 1, E1) and again at 10 years of age (Examination 2, E2). Pulmonary blood flow (PBF) and pulmonary blood volume (PBV) were quantified separately for each lung. Additionally, prenatal parameters (observed-to-expected fetal lung volume, o/e FLV) and postnatal factors (extracorporeal membrane oxygenation (ECMO); fetoscopic tracheal occlusion (FETO); patch repair; recurrence; and reoperation for recurrence) were recorded.

RESULTS: Ipsilateral perfusion remained consistently reduced between E1 and E2 (63.4 ± 27.8 vs 62.0 ± 23.6 mL/100 mL/min; p = 0.8001), while PBV significantly decreased (p = 0.0213). Low prenatal o/e FLV values correlated with reduced ipsilateral PBF (E1: r = 0.51; p = 0.0082; E2: r = 0.03; p = 0.0342). Patients who underwent ECMO showed a decrease in contralateral PBF over time (p = 0.0435), and those with FETO tended to exhibit poorer perfusion courses.

CONCLUSION: Patients with prenatally more severe lung hypoplasia, particularly those with low o/e FLV, exhibit persistently reduced lung perfusion even in the long term. These ongoing impairments remain stable over time, indicating permanently compromised lung development. Early identification and detailed risk assessment are therefore essential to initiate targeted therapeutic interventions.

KEY POINTS: Question Lung perfusion development in children with CDH between ages 2 and 10, including prenatal and postnatal influencing factors. Findings Ipsilateral lung perfusion remained reduced, PBV decreased, and low prenatal o/e FLV correlated with persistently impaired perfusion. Clinical relevance Children with severe prenatal lung hypoplasia show lasting perfusion deficits into adolescence. Early risk assessment enables timely, targeted interventions to mitigate long-term pulmonary impairment.

PMID:41832930 | DOI:10.1007/s00330-026-12443-5

Categories
Nevin Manimala Statistics

Should AI results be disclosed in mammography reports? A randomised survey study of patient responses to concordant and discordant interpretations

Eur Radiol. 2026 Mar 15. doi: 10.1007/s00330-026-12405-x. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess how disclosing artificial intelligence (AI) results, particularly discordant findings, affects patient trust, anxiety, follow-up intentions, and attitudes toward AI in mammography. The study also assessed whether adding an explanatory note mitigates adverse reactions.

MATERIALS AND METHODS: A cross-sectional randomised experimental survey was conducted among 600 women (mean age 55.4 ± 6.8 years) undergoing mammography in two academic centres in Milan, Italy, between January 2023 and January 2024. Participants were randomised into four hypothetical BI-RADS 1 scenarios: Radiologist Only (control), AI No-Flag (AI concordant with radiologist), AI Flagged (AI discordant false-positive), and AI Flagged + Explanation (discordant AI with contextual information). Primary outcomes included trust (0-100 scale), worry, second-opinion intent, legal action intent, and AI approval. Analyses involved ANOVA, chi-square tests, and logistic regression with Bonferroni correction.

RESULTS: Disclosure of a discordant AI result significantly reduced trust in the radiologist (73.0 vs 90.1; p < 0.001), and increased anxiety (58.0% vs 16.0%; OR = 15.4), second-opinion intent (50.0% vs 8.7%; OR = 10.2), and legal action consideration (60.7% vs 38.7%; OR = 2.49). Adding explanatory context significantly mitigated these effects (e.g., anxiety: 25.3%; OR = 0.26). Compared to the Radiologist Only scenario, the AI Flagged + explanation scenario showed only a modest increase in anxiety (p = 0.04) and no significant trust reduction (p = 0.42). AI approval remained high (> 85%) across all groups.

CONCLUSION: Disclosing discordant AI results reduces trust and increases anxiety, second-opinion intent, and legal concerns. Contextualised disclosure of AI results mitigates adverse emotional and behavioural responses, supporting its use as a communication strategy in AI-integrated mammography.

KEY POINTS: Question Current guidelines lack clear recommendations on disclosing AI-generated mammography findings, creating uncertainty about patient trust, anxiety, and medicolegal implications of discordant results. Findings Disclosing discordant AI mammography findings reduced patient trust, increased anxiety, second-opinion seeking, and litigation intent; adding contextual explanations significantly mitigated these adverse effects. Clinical relevance Providing clear context about AI limitations in mammography reports mitigates patient anxiety, enhances trust in radiologists, and reduces unnecessary follow-up and potential medicolegal actions, supporting optimal patient communication during clinical implementation of AI.

PMID:41832929 | DOI:10.1007/s00330-026-12405-x

Categories
Nevin Manimala Statistics

Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China

Eur Radiol. 2026 Mar 15. doi: 10.1007/s00330-026-12460-4. Online ahead of print.

ABSTRACT

In the last decade, advanced AI methods were applied to radiology, providing tools for clinical practice. Regulations across countries are a relevant topic, considering that AI tools must be regarded as medical devices. We describe the regulatory scenarios in the EU, USA, and China. For the EU, we considered the 2017 Medical Device Regulation, including AI tools as “active” medical devices, the 2018 General Data Protection Regulation, protecting data privacy, and the risk-based approach by the 2024 AI Act. For the USA, we considered the three FDA premarket pathways: the 510(k)-clearance demonstrating substantial equivalence, the De Novo classification for novel devices without predicates, and the Premarket Approval process for high-risk applications demanding rigorous clinical evidence; recent regulations regarded lifecycle management, post-marketing surveillance and adaptive algorithms, underscoring the importance of real-world evidence of AI tool performance. For China, the role of the 2022 Guidance for classification and definition of AI medical software by the National Medical Products Administration is illustrated, describing how to determine whether a tool is an AI-enabled medical device, categorizing the associated risk level. The NMPA published six premarket technical review guides related to AI-enabled medical devices in radiology and medical imaging; protection of patient privacy is enforced by the law and de-identification is mandatory for manufacturers. Regulations in these three scenarios show meaningful convergences about patient’s data protection, risk assessment and classification, ensuring equity and generalizability, transparency and explainability, and the need of human oversight. The radiology community will act in a world scenario more homogeneous than expected. KEY POINTS: Question Regulatory fragmentation across the EU, USA, and China creates uncertainty for radiology AI development, validation, and clinical adoption, requiring clearer international harmonization. Findings Despite differences, regulations in the EU, USA, and China converge on core requirements: patient data protection, risk classification, transparency, bias mitigation, and human oversight. Clinical relevance By highlighting convergences across major jurisdictions, this review informs radiologists and developers on safe integration of AI tools, ensuring patient safety, equity, and trustworthy adoption in clinical practice.

PMID:41832928 | DOI:10.1007/s00330-026-12460-4

Categories
Nevin Manimala Statistics

Potentially toxic elements (PTEs) pollution in road dust and their relations with socio-economic development: a case study from a fast-growing industrial city in South China

Environ Monit Assess. 2026 Mar 15;198(4):317. doi: 10.1007/s10661-026-15077-8.

ABSTRACT

This study investigated the accumulation levels, ecological and health risks, and the impact of socio-economic development on potentially toxic elements (PTEs) present in road dust collected from the major roads of low latitude industrialized City, Dongguan, China. The concentrations of PTEs decreased in the order of zinc (Zn) > lead (Pb) > chromium (Cr) > arsenic (As) > cadmium (Cd) > mercury (Hg). Similarly high levels of Cd and Zn accumulation were observed, and other PTEs were generally moderately accumulated or enriched. The ecological risk was relatively high for Cd and Hg and low for other PTEs. Most of sampling sites were moderately to heavily polluted, and the ecological risk was generally moderate to very high. The non-carcinogenic risks to both adults and children were safe at internationally accepted levels. However, higher levels of carcinogenic risk were observed in males and females, mainly due to the contribution of Cr and As. Spatial distribution patterns revealed higher accumulation level, ecological and health risks in districts of Binhai, Central City with higher GDP. In the present study, a positive relationship was observed between PTEs concentrations and GDP of Dongguan’s six districts (R = 0.66, p = 0.15) and a similar significant pattern was revealed for the first time at the global level (R = 0.66, p = 0.0021). It is evident that socio-economic development had a significant impact on PTEs contamination and the resulting ecological and health risks. Therefore, industrial cities such as Dongguan need to adopt broader strategies that decouple the relationship between socio-economic development and the emission of PTEs concentration (e.g. Cd, Cr and As), to mitigate this emission during economic growth and transition towards a more sustainable development model.

PMID:41832927 | DOI:10.1007/s10661-026-15077-8