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Measuring contraceptive efficacy and side effects.

To assess effectiveness of contraceptives, one reports all pregnancies during use. Multiple and single decrement life-table pregnancy rates computed from these reports constitute the fundamental measures of effectiveness in clinical trials. Minimally biased evaluation of a new method requires a randomized, double-blind (or its nearest semblance), multicentered study of sexually active women. New contraceptives are studied in special, volunteer populations. Evaluation of marketed contraceptives implies broader-gauged representation, larger numbers and longer time frames. Prospective studies, like clinical trials, should include several methods, and may use subsamples for case-control analysis of risk. Well-designed and executed multicentered, prospective studies, nevertheless, may represent specially selected populations. Risk-benefit analyses based on findings from selected populations require careful scrutiny. Although the most persuasive estimates of effectiveness derive from national, representative samples, moderately large samples in the USA have not been able to distinguish among products within a class. Formidable problems of recall are present in household surveys. In the United Kingdom, Europe and North America, analysis of risks and benefits may be enriched by better utilization of the data collection and record linkage resources of national health statistics systems.

Actuarial Analysis↗

PubMed2026

Transitioning to adult care for patients with IBD: the impact of a structured IBD transition program on service engagement.

BACKGROUND AND AIMS: The British Society of Gastroenterology recommend use of structured transition programs to improve control of chronic gastrointestinal disease in adolescents. We sought to determine the impact of attending a structured transition program on engagement of patients with inflammatory bowel disease (IBD) services and disease outcomes. METHODS: We performed a retrospective multicenter study of patients with IBD prior to and post-transfer to adult services. Patients were grouped into those who attended a structured transition program and those who received standard care, transferred with a referral letter. RESULTS: A total of 282 patients were included: 155 patients in our structured transition program cohort and 127 patients in the standard care cohort. Patients who took part in a structured transition program had significantly better engagement with adult IBD services with significantly lower rates of nonattendance at outpatient clinics 1-year post-transfer (12.3% vs 27.2%, P = .002) and significantly lower rates of disengagement with services (4.2% vs 13.1%, P = .015). There were no significant differences seen in rates of biologic failure, need for steroid/surgery or median fecal calprotectin levels between either group. Attending a structured transition program was the only factor that positively impacted engagement with IBD services in a multivariate analysis (OR 4.08, confidence interval 1.41-11.91, P = .01). CONCLUSION: Structured transition programs in IBD can improve engagement of patients with IBD services with significantly lower rates of disengagement with IBD services seen in our study. Large prospective studies are needed in this field to further investigate this and the impact of these programs on disease outcomes.

Humans↗

PubMed2025

ctDNA can detect minimal residual disease in curative treated non-small cell lung cancer patients using a tumor agnostic approach.

BACKGROUND: Circulating tumor DNA (ctDNA) has the potential to become a reliable biomarker for identifying minimal residual disease (MRD) and predicting recurrence in patients with non-small cell lung cancer (NSCLC) following curative treatment. However, there is a lack of studies that investigate the clinical validity of ctDNA using a tumor-agnostic approach, which can provide significant clinical benefits. METHODS: We analyzed samples from 45 NSCLC patients recruited in a prospective national multicenter study, all of whom had undergone curative treatment. A total of 38 pre-treatment plasma samples and 76 post-treatment plasma samples were examined using a commercially available cancer personalized profiling by deep sequencing (CAPP-seq) strategy, and a tumor-agnostic approach. Post-treatment samples were collected at two distinct landmark time points: Follow-up 1 (0.5-4.5 months post-treatment) and Follow-up 2 (4.5-7.5 months post-treatment). RESULTS: Detectable ctDNA post-treatment was significantly associated with increased risk of tumor recurrence and shorter recurrence-free survival (RFS). Using only a single blood sample taken from Follow-up 2, we correctly identified MRD in 50% of the patients who later experienced recurrence. However, subgroup analysis further revealed that in patients treated with radiotherapy or chemoradiotherapy (CRT), ctDNA detection was significantly linked to shorter RFS in the MRD analysis from Follow-up 2, but not in the MRD analysis from Follow-up 1. CONCLUSION: These findings suggest that post-treatment ctDNA, detected using a tumor-agnostic approach, is a reliable biomarker for predicting recurrence in NSCLC patients following curative treatment. However, the optimal timing for blood sampling to detect MRD appears to depend on the type of curative treatment received.

Humans↗

PubMed2026

Genetic Profile, Treatment Response, and Outcomes of BCR::ABL1-Positive Mixed-Phenotype Acute Leukemia: A Study From the BCR::ABL1 Pathology Group.

Mixed-phenotype acute leukemia (MPAL) with BCR::ABL1 fusion is rare, and its clinicopathological features, genetic landscape, therapeutic response, and patient outcomes remain incompletely defined, as does its relationship to blast-phase chronic myeloid leukemia. In this multicenter study of 44 patients, 86.4% had B/myeloid MPAL, 72.7% showed lymphoid predominance, 40.9% had complex karyotypes, and 68.3% harbored somatic mutations, most commonly RUNX1 mutations (46.3%). RUNX1 mutations frequently co-occurred with acute myeloid leukemia (AML)-associated alterations, whereas DNMT3A, TET2, and BCORL1 mutations were restricted to RUNX1-mutated cases. In contrast, acute lymphoblastic leukemia (ALL)-associated alterations (IKZF1 mutation/deletion and ETV6 mutations) were confined to RUNX1-wild-type patients. TP53 and signaling pathway mutations (NRAS, KRAS, PTPN11, and FLT3) were not detected. Forty-two patients received induction chemotherapy and/or immunotherapy combined with tyrosine kinase inhibitors: 74.2% of lymphoid-predominant patients and 63.6% of myeloid-predominant patients received ALL- and AML-type therapies, respectively. Ten patients relapsed, and 2 had primary refractory disease; some exhibited a dynamic shift in predominant lineage immunophenotype, chromosomal alterations, and somatic mutations at the relapse or refractory stage. The overall remission rate was 86.8%, with no significant differences across ALL-, AML-, or hybrid-type regimens. After a median follow-up of 24.2 months, the median overall survival was 52.5 months. Complex karyotype was associated with inferior overall survival compared with cases lacking additional chromosomal alterations (P = .02), whereas RUNX1 mutations were not. No significant differences in genetic profiles, treatment response, or outcomes were observed between patients with and without chronic myeloid leukemia-like features. This study provides a comprehensive genomic and clinical characterization of BCR::ABL1-positive MPAL, supporting improved risk stratification and future therapeutic strategies.

Adolescent↗

PubMed2025

Cell-free DNA aneuploidy score as a dynamic early response marker in prostate cancer.

Cell-free circulating tumor DNA (ctDNA) has emerged as a promising biomarker for response evaluation in metastatic castration-resistant prostate cancer (mCRPC). The current study evaluated the modified fast aneuploidy screening test-sequencing system (mFast-SeqS), a quick, tumor-agnostic and affordable ctDNA assay that requires a small input of DNA, to generate a genome-wide aneuploidy (GWA) score in mCRPC patients, and correlated this to matched metastatic tumor biopsies. In this prospective multicenter study, GWA scores were evaluated from blood samples of 196 mCRPC patients prior to treatment (baseline) with taxanes (docetaxel and cabazitaxel) and androgen receptor signaling inhibitors (ARSI; abiraterone and enzalutamide), and from 74 mCRPC patients at an early timepoint during treatment (early timepoint; median 21 days). Z-scores per chromosome arm were tested for their association with tumor tissue genomic alterations. We found that a high tumor load in blood (GWAhigh) at baseline was associated with poor response to ARSI [HR: 2.63 (95% CI: 1.86-3.72) P < 0.001] but not to taxanes. Interestingly, GWAhigh score at the early timepoint was associated with poor response to both ARSIs [HR: 6.73 (95% CI: 2.60-17.42) P < 0.001] and taxanes [2.79 (95% CI: 1.34-5.78) P = 0.006]. A significant interaction in Cox proportional hazards analyses was seen when combining GWA status and type of treatment (at baseline P = 0.008; early timepoint P = 0.018). In summary, detection of ctDNA in blood by mFast-SeqS is cheap, fast and feasible, and could be used at different timepoints as a potential predictor for outcome to ARSI and taxane treatment in mCRPC.

Humans↗

PubMed2026

Clinical Variability and Genotype-Driven Outcomes in CHRND-Related Congenital Myasthenic Syndrome.

BACKGROUND: Congenital myasthenic syndromes (CMS) caused by pathogenic variants in CHRND, encoding the δ-subunit of the nicotinic acetylcholine receptor (AChR), are rare, and data on genotype-phenotype correlations and long-term outcomes are limited. METHODS: We performed a retrospective, multicenter study of nine patients with genetically confirmed CHRND-related CMS from specialized neuromuscular centers. Clinical, electrophysiological, genetic, and therapeutic data were systematically collected. All diagnoses were established by exome sequencing during routine clinical work-up. RESULTS: Eight patients were compound heterozygous and one was homozygous for pathogenic CHRND variants, including nonsense, missense, splice-site variants, and one microdeletion. Disease onset ranged from the neonatal period (n = 7) to adolescence (n = 2). Three patients were followed longitudinally for 22-43 years. Ocular involvement, particularly ptosis and ophthalmoparesis, was present in all patients. Generalized fatigable weakness was common, whereas bulbar and respiratory involvement occurred in a subset and reflected overall disease severity. Genotypes including a null allele or a homozygous missense variant tended to be associated with more severe phenotypes, while compound heterozygous missense variants were linked to a broader and generally milder spectrum, sometimes limited to ocular symptoms. Long-term outcomes ranged from minimal symptoms under therapy to severe motor impairment with respiratory insufficiency, highlighting substantial interindividual variability. CONCLUSIONS: This study expands the phenotypic and genotypic spectrum of CHRND-related CMS and underscores the critical role of genotype in determining disease severity. Comprehensive genetic testing, longitudinal phenotyping, and genotype-informed management are essential for optimal diagnosis and care in this rare disorder.

Humans↗

PubMed2026

Fourteen-Day Amoxicillin- or Tetracycline-Containing Bismuth Quadruple Therapy versus 14-Day Metronidazole-Based Triple Therapy as the Treatment for Clarithromycin-Resistant Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial.

BACKGROUND/AIMS: Combination therapy comprising a proton pump inhibitor (PPI), amoxicillin, and metronidazole (PAM) is used to treat clarithromycin-resistant Helicobacter pylori in the Republic of Korea, but eradication rates are decreasing due to an increasing incidence of clarithromycin resistance. We compared PAM, bismuth compounds plus PAM (PAM-B), and the combination of PPI, bismuth compounds, metronidazole, and tetracycline (PBMT) to determine whether PAM-B can achieve an eradication rate higher than that of PAM and comparable to that of PBMT. METHODS: This prospective multicenter study enrolled patients with clarithromycin-resistant H. pylori infections in the Busan and Gyeongsangnam-do of the Republic of Korea between December 2022 and February 2024. RESULTS: In the intention-to-treat (ITT) analysis, the eradication rate was significantly lower in the PAM group (68.2%) than in the PAM-B group (84.8%, p=0.024), whereas the difference from the PBMT group (81.8%) was not significant (p=0.070). The rate remained lowest in the PAM group (75.4%) in the per-protocol (PP) analysis (PAM-B, 96.5%, p=0.001; PBMT, 94.6%, p=0.004). Eradication rates were comparable between the PAM-B and PBMT groups in both the ITT (p=0.640) and PP analyses (p=0.633). Nausea and vomiting were significantly less frequent in the PAM-B group than in the PBMT group (6.8% vs 25.0%; p=0.007). Severe adverse events were rare, and all symptoms resolved after treatment discontinuation. CONCLUSIONS: PAM-B yielded eradication rates higher than those of PAM and comparable to those of PBMT, with no significant increase in the incidence of adverse events, suggesting the potential of PAM-B as a first-line treatment for clarithromycin-resistant H. pylori infection. Further large-scale studies are needed to validate these results. Registered retrospectively with the Clinical Research Information Service (CRIS; KCT0012265).

Humans↗

PubMed2026

Non-Cancer Causes of Death in Patients With Metastatic Hormone-Sensitive Prostate Cancer: A Real-World Analysis.

BACKGROUND: As overall survival improves in metastatic hormone-sensitive prostate cancer (mHSPC), non-cancer causes of death are increasingly relevant. METHODS: We conducted a real-world multicenter study of patients diagnosed with mHSPC treated with ADT alone or in combination. Causes of death before progression to castration-resistant prostate cancer (CRPC) were classified as cancer- or non-cancer-related. Deaths were classified as non-cancer-related if they occurred in the absence of cancer progression. RESULTS: Among 565 patients, 35 (6.2%) died from non-cancer-related causes without disease progression, mainly infections (34%) and cardiovascular events (20%). CONCLUSIONS: Non-cancer mortality represents a meaningful proportion of deaths in mHSPC, supporting systematic cardiovascular risk evaluation and infection-prevention strategies.

Humans↗

PubMed2026

Ex Vivo Tumor-Derived Organoid Pharmacotyping Identifies Personalized Therapeutic Options for Patients with Biliary Tract Cancer.

UNLABELLED: Biliary tract cancers (BTC) pose clinical challenges due to poor chemotherapy response and aggressive disease course. We evaluated patient-derived tumor organoid-based drug sensitivity testing as a tool to guide therapy. In this multicenter study, 26 tumor organoids were successfully derived from 43 patients with BTC and tested with an average of 50 cancer-directed therapies using the Clinical Laboratory Improvement Amendments-certified PARIS assay. Despite most organoids being from late-stage disease, 24/26 (92.3%) exhibited strong sensitivity to one or more targeted agents. Active drugs included inhibitors of EGFR/HER2, MEK, ERK, BCR-ABL and SRC family, mTOR, PI3K, MDM2, BCL2, and BET. Drug sensitivities aligned with known genetic biomarkers but were also observed in cultures lacking them, indicating ex vivo testing can expand actionability beyond genomics. In five cases, results guided therapy; one patient with an FGFR-BICC1 fusion refractory to FGFR inhibitors responded to dasatinib, achieving symptomatic improvement, stable disease, and >8-month survival. SIGNIFICANCE: Ex vivo drug testing of tumor-derived organoids is clinically feasible and can be used to identify personalized treatment options for patients with BTC, to evaluate the functional relevance of genomic biomarkers, and to guide treatment in real time.

Humans↗

PubMed1979

Clinical experience of naproxen in the treatment of primary dysmenorrhea.

The effect of naproxen, Naprosyn, Syntex, in treatment of primary dysmenorrhea was studied in a double-blind, randomized, placebo controlled multicenter study. Nintyseven women, aged between 18--40 years, with severe dysmenorrhea, were treated with either naproxen, 48 women, or placebo, 49 women, for two consecutive menstrual cycles. No oral contraceptive was used. The patients were allowed to take supplementary analgesics 4--6 hours after the study drug was taken if adequate relief was not achieved. The recommended dose of naproxen was 1--2 tablets, 250 mg, as needed, with a maximum of 5 tablets daily. Medication was started at first sign of menstrual distress. Improvement was achieved in 70 per cent of the women in the naproxen group (good to excellent relief) but only in 30 per cent in the placebo group. This difference is statistically significant (p less than 0.001). There was much more supplementary medication used in the placebo group compared to the naproxen treated patients (p less than 0.001). Fewer patients had to stay in bed, or stay at home from work or school, in the naproxen group compared to the placebo group. Few side-effects were reported and most of them belonged to the dysmenorrhea symptomatology. No side-effects could be rement according to the patients' own judgement.

Adult↗

PubMed1976

[Field study on the therapeutic value of trasylol in traumatic shock].

A report of the results of a multicenter study including 4686 patients concerning the therapeutic value of Trasylol (Aprotinin) in traumatic shock. The group treated additionally with Trasylol showed, beside a reduced overall mortality, a statistically significant reduction of mortality in those treated within the first 30 min after the injury. Surgery performed in the posttraumatic stage showed a lower mortality in the Trasylol group. The importance of a time factor in shock treatment and the effects of Trasylol in traumatic shock are emphasized.

Aprotinin↗

PubMed1976

[Austrian complex-study on dipropylacetate. Pediatric experiences].

The clinical trial of Dipropylacetat (Convulex) demonstrates the advantages of a well organized multicenter-study. In rather short time reliable information concerning indication, compatibility and dosage can be received. The results of this project are similar to other observations dealing with DPA: Good therapeutical effect in primary generalized epilepsies independent of the seizure-type. Astonishing results influencing Lennox-Syndrome. In cases not treated before, Convulex shows at least the same effect than the "standard anticonvulsants" but less side effects, especially sedation. In those untreated "new-comers" therapeutical effect comes earlier than in cases of premedication. 20 to 50 mg/kg/day can be recommended in childhood. In rare cases the dosage was increased up to 120 mg/kg/day without problems.

Austria↗

PubMed1979

[Beta-blockader, pindolol, in the therapy of angina pectoris; a report on a multicentric controlled study].

68 patients with angina pectoris were treated 14 days with placebo and four weeks with 15 mg/die pindolol (Visken) in a double blind multicenter study. The patients were divided into two groups at random: group I received pindolol/placebo, group II pacebo/pindolol. Pindolol reduced in both groups significantly the number and intensity of angina pectoris attacks and the consumption of nitroglycerin capsules. There was no evidence for a rebound phenomenon after abrupt cessation of pindolol treatment. In the wash out period still a relevant antianginous effect of the beta-blocker could be observed. The oxygen demand of the myocardium was reduced by reduction of systolic blood pressure and heart rate whereas diastolic blood pressure remained unchanged. The tolerance of the preparation was good.

Angina Pectoris↗

PubMed1979

Efficacy of antiparkinson agents in preventing antipsychotic-induced extrapyramidal symptoms.

The types of extrapyramidal syndrome (EPS) reactions produced by antipsychotic agents and the prophylactic use of antiparkinson agents in preventing EPS are reviewed. EPS are classified as akathisias, dystonias, parkinson-like symptoms and tardive dyskinesia, and have a varied incidence reported to range from 10.6 to 100%. Incidence may vary with age, gender, drug and dosage. The prophylactic use of antiparkinson agents to prevent EPS is controversial. Many psychiatrists believe the effect of EPS on patients is more harmful than the side effects of anticholinergics, whereas others believe that because of side effects, increased cost, greater risk to tardive dyskinesia and improper use, the use of antiparkinson agents cannot be justified. Most studies of prophylactic use of antiparkinson agents have lacked adequate control groups, adequate blinding procedures for investigators rating EPS, uniform definitions of EPS, random sampling and careful reporting of group characteristics such as dosage and drugs received. There is a lack of definitive studies of the value of antiparkinson agents in preventing the occurrence of EPS in patients receiving antipsychotics. A large, multicenter study should be undertaken to resolve the issue.

Antiparkinson Agents↗

PubMed2026

Plasma proteomics: considerations for preanalytical variability; a systematic review with narrative synthesis.

BACKGROUND: The plasma proteome (PP) is a dynamic system subject to pathology-associated changes and a focus for novel disease biomarker discovery. Disease-related PP research assumes protein concentrations in test specimens accurately reflect the in vivo milieu. However, measures to maintain the physicochemical integrity of the proteome before assay are often rudimentary, poorly described, or lacking standardisation in published studies. Contrastingly, in laboratory medicine, there is an expectation that errors in the so-called "preanalytical phase" (PAP) that impact patient results are understood, monitored, and mitigated against, while also being well described in research publications. There is therefore scope for good practice from laboratory medicine to inform PP research workflows. This review considers factors in the PAP which may impact the validity of PP results. CONTENT: A systematic review was conducted per PRISMA guidelines, limited to English-language peer-reviewed studies (2014-2024). Candidate studies were imported, screened, and managed using Covidence systematic review software. SUMMARY: 15 eligible studies were reviewed, covering many relevant processes. 11 studies reported statistically significant differences in PP due to factors in the PAP. Temperature and time-to-processing were the most commonly reported factors affecting the PP, with significant effects reported in 8 studies. OUTLOOK: PAP variability can significantly affect results in PP studies. Careful consideration of the effect of each stage of the PAP is needed when working with the PP. In multicenter studies, pre-defined and research question-specific sample processing workflows are essential for reducing PAP variability, which helps ensure the validity of PP studies.

Humans↗

PubMed2026

The role of artificial intelligence in the diagnosis and prognosis of traumatic brain injury based on brain CT scans: a systematic review.

Traumatic brain injury (TBI) is a leading cause of emergency department visits and a major contributor to injury-related mortality and long-term neurological disability. Non-contrast computed tomography (CT) is the gold-standard imaging modality for the rapid diagnosis of TBI. Clinical outcomes depend strongly on early detection and prompt acute management. Artificial intelligence (AI)-based models may support faster automated identification of traumatic findings and early prediction of patient prognosis. A systematic literature search was conducted in PubMed/MEDLINE, Scopus, IEEE Xplore, ACM Digital Library, and the Cochrane Library in accordance with PRISMA 2020 guidelines to evaluate AI-based models for automated detection of TBI-related findings on CT and for prediction of clinical outcomes. Risk of bias and applicability were assessed using QUADAS-2 for diagnostic accuracy studies and PROBAST + AI for prediction model studies. Twenty-two studies were included. Sixteen studies evaluated diagnostic tasks and 10 evaluated prognostic outcomes, with four studies contributing to both categories. Diagnostic performance was generally high, with many studies reporting AUC values approaching or exceeding 0.90, particularly for larger lesion volumes.Prognostic performance was more variable, with moderate to high discrimination and substantial heterogeneity. Only 9 studies incorporated independent external validation, and performance was frequently lower in external cohorts. All prognostic model studies were judged to be at high overall risk of bias using PROBAST + AI, and most diagnostic accuracy studies also demonstrated high or unclear risk of bias in at least one QUADAS-2 domain, most frequently in patient selection. AI-based models applied to brain CT demonstrate strong technical performance for both diagnostic and prognostic tasks in TBI. However, most studies relied on retrospective designs and lacked independent external validation which limits models generalizability and raises concern for potential overfitting. Prospective, multicenter studies with standardized methodologies and rigorous external validation are required before widespread clinical implementation.

Humans↗

PubMed1979

Comparative evaluation of research diagnostic criteria for schizophrenia.

Criteria for establishing a diagnosis of schizophrenia have been proposed by several different authors. This study compared six different research diagnostic criteria (RDC) in a series of 166 patients who received a clinical diagnosis of schizophrenia in a multicenter study. The alternative criteria differed in the proportion of clinical diagnoses that were confirmed, with the Washington University (Feighner) criteria accepting only 26%. The criteria also disagreed concerning which particular patients qualified for the diagnosis. The Washington University and New York RDC disagreed 50% of the time, and some other disagreement rates were even higher. More evaluative research is needed before arbitrary criteria are permitted to redefine the concept of schizophrenia.

Computers↗

PubMed2026

Beyond da Vinci: a systematic review of next-generation multiport robotic platforms in pediatric surgery.

As robotic surgery expands beyond the da Vinci platform, the relevance of new-generation systems to pediatric patients remains uncertain. This review examined the technical characteristics, applications, and perioperative outcomes of alternative multiport robotic platforms in children. PubMed/MEDLINE, Web of Science, Scopus, and the Cochrane Library were searched through 28 February 2026 in accordance with PRISMA 2020. Owing to clinical heterogeneity, findings were synthesized narratively, with Wilson 95% confidence intervals for key binary outcomes. Six studies reported 166 patients across 27 procedure types. Senhance accounted for 164 patients, while Hugo RAS and Hinotori were each represented by one patient. Ages ranged from 15 days to 17 years and weights from 3.8 to more than 100 kg. Senhance was the only platform used with 3-mm robotic instruments. Conversion or planned escalation occurred in 19 patients (11.4%; 95% CI, 7.5-17.2%). Four intraoperative complications were reported (2.4%; 95% CI, 0.9-6.0%). Across all reports, 20 patients experienced postoperative complications (12.0%; 95% CI, 7.9-17.9%). In the largest cohort, seven patients required reintervention (4.6%; 95% CI, 2.2-9.2%) and seven were readmitted (4.6%; 95% CI, 2.2-9.2%). No deaths or comparative pediatric studies were reported. Published experience remains sparse and is almost entirely limited to Senhance. Current evidence describes early clinical use without establishing comparative safety, effectiveness, or platform superiority. Prospective multicenter studies with standardized reporting are needed.

Humans↗