Tag: pubmed

Stat Methods Med Res. 2025 Nov 27:9622802251399914. doi: 10.1177/09622802251399914. Online ahead of print.

ABSTRACT

A parallel randomized trial is frequently used to investigate the treatment effectiveness as compared to the gold standard. In early phase trials, a group sequential design has the potential to reduce the expected sample size as compared to the traditional one-stage design, and protect participants when a new treatment is not as effective as expected. When the outcome is binary, a group sequential design based on exact binomial distribution is preferable as compared to the asymptotic limiting distribution. To improve the design efficiency, we propose to develop new parallel two-stage adaptive design and promising zone design allowing sample size adjustment in the second stage based on the outcome from the first stage. The conditional probability is guaranteed in the proposed designs when a trial proceeds to the second stage. All these designs control the type I error rate, but only the proposed two designs guarantee the conditional probability constraint. We used a real example from a completed cancer trial to illustrate the application of the proposed designs. The adaptive design substantially increases unconditional power but requires a large sample size as compared to the group sequential design. The promising zone design achieves a good balance between statistical power and the expected sample size.

PMID:41308079 | DOI:10.1177/09622802251399914

Cancer Control. 2025 Jan-Dec;32:10732748251401264. doi: 10.1177/10732748251401264. Epub 2025 Nov 27.

ABSTRACT

IntroductionThe national epidemiology of lung cancer (LC) in Finland, subdivided by histology and regional data, has not yet been studied in detail. This study examines the incidence, mortality, and mortality-to-incidence ratios (MIR) of LC and its subtypes in men and women during 2000-2019 in different regions of Finland.MethodsAn observational register-based study was conducted using nationwide data from the Finnish Cancer Registry (FCR). The cases were classified into adenocarcinoma (ADC), squamous cell carcinoma (SQC), small cell lung carcinoma (SCLC), and other and unknown histological types. The incidence and mortality were explored nationwide and separately in the 5 collaborative areas for healthcare and social welfare. MIR were used to estimate survival.ResultsThe incidence and mortality of LC declined in men (78.6 to 25.9/100 000) but increased in women (5.0 to 15.1). The incidence of ADC increased from 4.4 to 7.2, while SQC and SCLC decreased from 5.0 to 3.6 and 3.5 to 3.0. The incidence of ADC increased in men and women, surpassing SQC as the most common histology with varying regional pace. The incidence of SQC and SCLC decreased in men but increased in women. MIR showed similar regional improvements to LC survival for ADC and SQC, but not for SCLC.ConclusionThe Finnish LC rates changed slowly from a predominantly SQC and SCLC histology to ADC being the most common LC type. Sex-specific LC rates are converging nationwide. This study reports detailed Finnish LC data to inform future research and public health efforts.

PMID:41308077 | DOI:10.1177/10732748251401264

J Back Musculoskelet Rehabil. 2025 Nov 27:10538127251400428. doi: 10.1177/10538127251400428. Online ahead of print.

ABSTRACT

BackgroundCore endurance and lower limb strength are frequently targeted in sports performance and injury prevention programs, However, their independent and combined influence on dynamic balance remains inadequately understood among collegiate football players.ObjectiveTo examine the relationships among core endurance, lower limb isometric strength, and dynamic balance performance in collegiate male football playersMethodsSixty healthy athletes (aged 18-25 years) completed core endurance tests, isometric strength assessments using handheld dynamometry for the hip, knee, and ankle, and the Modified Star Excursion Balance Test (mSEBT). Pearson’s correlation and multiple linear regression analyses were conducted to examine associations and identify predictors of dynamic balance. Multiple linear regression focused on posteromedial reach score of the right leg as the primary outcome.ResultsLeft ankle invertor strength had significant positive correlations with posteromedial (r = 0.47, p < 0.001) and posterolateral (r = 0.37, p = 0.004) SEBT reach distances, while trunk flexor endurance was a statistically significant inverse predictor of balance performance (β = -0.456, p = 0.001). The final regression model explained 20.4% of the variance in posteromedial reach performance (adjusted R² = 0.150, p = 0.008).ConclusionThese findings underscore that dynamic balance in collegiate football players may depend more on specific distal joint strength and neuromuscular coordination than on overall core endurance, highlighting the importance of targeted ankle invertor and dynamic core stability training for injury prevention.

PMID:41308067 | DOI:10.1177/10538127251400428

Can J Psychiatry. 2025 Nov 27:7067437251394369. doi: 10.1177/07067437251394369. Online ahead of print.

ABSTRACT

ObjectiveThe effectiveness of current treatment options for depressive symptoms has been widely investigated with acknowledgment that some patients were either not adequately responding to treatment, finding the existing treatment intolerable, or otherwise prefer alternative options. There is increasing interest in microbiota modulation as an alternate form of depression treatment, with a growing number of trials and reviews on the subject published in the last five years. This systematic review aimed to analyze all completed randomized control trials (RCTs) that assessed depression symptoms in adults not using antidepressants, before and after oral methods of microbiota manipulation.MethodAll completed parallel-arm RCTs that assessed depression symptoms in adult participants before and after oral methods of microbiota manipulation were retrieved from four databases, MEDLINE, Embase, PsycINFO, and Cochrane Central Register of Controlled Trials. Data on study and intervention characteristics as well as RCT conclusions were collected independently and in duplicate, and each study’s findings were summarized individually. Risk of bias was completed.ResultsWe included 66 RCTs in our review, 34 of which concluded significant differences between the intervention and control group in depressive symptom using different interventions and measures. Of the 66 trials, 54 used probiotic interventions, seven used prebiotic, eight used synbiotic and two used oral fecal microbiota transplantation. Wide variation was observed in studies’ design, intervention composition and consumption methods across all 66 RCTs. No statistical synthesis or meta-analyses were possible due to the wide variety of interventions, measures and outcomes.ConclusionsThe heterogeneity of the existing RCTs did not allow for concrete conclusions on whether oral microbiota manipulation interventions are viable alternative treatment options for adults experiencing depression symptoms. We encourage the development of standardized guidelines for the design and reporting of microbiota studies in depression for the possibility of future intervention efficacy testing.

PMID:41308055 | DOI:10.1177/07067437251394369

Psychother Res. 2025 Nov 27:1-13. doi: 10.1080/10503307.2025.2592967. Online ahead of print.

ABSTRACT

ABSTRACTObjective: Potential negative effects of psychological treatments are recognized in research, yet the attitudes toward their disclosure during the informed consent procedure remain unexplored. This study examined individuals’ perception of receiving such information, investigating the awareness regarding deterioration, non-response, and new symptoms, and how this knowledge affects willingness to initiate treatment. Method: A mixed-method approach was used in relation to an online survey of adults in Sweden (N = 500, 75.6% women, age M = 38.2), including both individuals with (76.6%) and without prior experience of psychological treatments. Descriptive statistics, t-tests, one-way ANOVA, and Pearson’s correlation tests were conducted to explore factors that might affect the willingness to initiate treatment, while thematic analysis was employed for open-ended responses. Results: The majority (72%) of respondents favored being informed, emphasizing the importance of transparency, realistic expectations, and preparedness. Common concerns included increased anxiety and hesitation toward treatment. No variable was related to the willingness to initiate treatment. Conclusion: Most respondents preferred disclosure of potential negative effects. Clinicians should incorporate information about potential negative effects into the informed consent procedure, balancing risks and benefits and explain the nocebo effect, thereby enhancing patient engagement, trust, and willingness to engage in treatment.

PMID:41308053 | DOI:10.1080/10503307.2025.2592967

Arch Pathol Lab Med. 2025 Nov 27. doi: 10.5858/arpa.2025-0472-CP. Online ahead of print.

ABSTRACT

CONTEXT.—: Optical genome mapping (OGM) represents a promising cytogenomic technology that detects structural variants, including fusions, rearrangements, copy number variants, and loss of heterozygosity, in a single assay. Unlike karyotyping, fluorescence in situ hybridization, or chromosomal microarray, OGM leverages long-molecule imaging to map the whole genome with high resolution. This positions OGM as a novel tool for constitutional and somatic/cancer genomics. However, its current and planned utilization in clinical and research settings remains unknown, necessitating further investigation.

OBJECTIVE.—: To investigate the current utilization of OGM in clinical and research laboratories, assess its applications, and evaluate future utilization strategies.

DESIGN.—: In 2024, a supplemental questionnaire was incorporated into 6 College of American Pathologists proficiency testing programs to evaluate OGM’s utilization.

RESULTS.—: Of 921 returned questionnaires, 712 were analyzed after duplicates were removed. Sixty-seven (9.4%) currently offered OGM testing: 5.2% (37) for research only, 1.8% (13) for only clinical use, and 2.4% (17) for both. Future adoption plans showed 7.6% (53 of 700 laboratories) and 7.9% (55 of 700 laboratories) aiming to implement OGM clinically within 12 and 24 months, respectively. The most common applications included hematologic malignancies and constitutional/germline postnatal disorders, followed by prenatal testing. International laboratories demonstrated statistically higher utilization rates than domestic laboratories (P = .001).

CONCLUSIONS.—: This first survey on OGM clinical utilization reveals its status as a niche technology, with 67 laboratories currently using it. Its primary clinical applications are in constitutional/germline analysis and hematologic malignancies. Although international laboratories led in 2024, 108 laboratories (domestic and international) plan clinical adoption within 24 months, signaling OGM’s potential for broader integration.

PMID:41308031 | DOI:10.5858/arpa.2025-0472-CP

Cancer Med. 2025 Dec;14(23):e71316. doi: 10.1002/cam4.71316.

ABSTRACT

INTRODUCTION: Thyroid cancer is one of the most common cancers in adolescents and young adults (AYA, 15 to 39 years), with an excellent 5-year survival of 98%. However, treatments for thyroid cancer such as radioactive iodine and thyroid hormone suppression may increase the risk for multiple late effects (LEs). We investigated the incidence of severe LE that clustered in AYA thyroid cancer survivors in a large population-based cohort.

METHODS: California and Utah Cancer Registry records identified AYAs diagnosed with first thyroid cancer during 2006-2018 linked to statewide hospitalization, ambulatory surgery, and emergency department data. Cohort entry began 2 years from diagnosis. Severe LE included cardiovascular, respiratory, renal, and liver diseases, diabetes, and second cancers. Cumulative incidence of each LE, accounting for the competing risk of death, was calculated. Latent class analysis (LCA) identified clustering of LE over the study period. The number of LE classes was identified by selecting models with the lowest likelihood-ratio G² statistic, Akaike’s Information Criterion, and Bayesian Information Criterion. Probabilities of each LE are presented in each class.

RESULTS: Of 14,268 survivors, median follow-up time was 7 years. The LCA model identified 3 classes: 88% with low LEs, 9% experiencing moderate LEs with elevated probability of diabetes, liver, and respiratory conditions, and the remaining 3% experiencing the highest probability of all LEs, including cardiovascular disease. Non-Hispanic (nH)-Black and Hispanic survivors, those on public insurance, residing in lower socioeconomic status neighborhoods, or diagnosed with distant stage disease experience greater odds of being in the moderate and cardiovascular classes.

CONCLUSION: While most survivors of AYA thyroid cancer have a low incidence of LEs, a small proportion have a high probability of multiple morbidities. Multidisciplinary survivorship care should include identifying and supporting thyroid cancer survivors at higher risk for developing multiple LEs through early screening.

PMID:41308028 | DOI:10.1002/cam4.71316

J Med Internet Res. 2025 Nov 27;27:e74149. doi: 10.2196/74149.

ABSTRACT

BACKGROUND: Nurse-led telecare consultations have emerged as a promising approach for the long-term management of stroke survivors, particularly in the context of COVID-19 pandemic-related disruptions. While several studies have explored its use, the effectiveness of nurse-led telecare consultations in post-acute stroke care remains unclear.

OBJECTIVE: This study aimed to evaluate the effectiveness of nurse-led telecare consultation for poststroke management among stroke survivors who were discharged from the hospital and lived in the community.

METHODS: A systematic search was conducted across 6 databases-CINAHL, MEDLINE, PsycINFO, PubMed, Embase, and CENTRAL-for randomized controlled trials published from inception to February 2025. Included studies examined nurse-led telecare consultations compared to usual care among stroke survivors living in the community. Studies involving individuals who were hospitalized or institutionalized were excluded, along with reviews, abstracts without full texts, non-English or non-Chinese articles, and studies not meeting the criteria for randomized controlled trials. Primary and secondary outcomes included blood pressure (BP), psychological burden, quality of life, medication adherence, health care service use, stroke recurrence, survivor functioning, and coping. Continuous outcomes were analyzed using mean differences (MDs) or standardized MDs with 95% CIs under a random-effects model and dichotomous outcomes using odds ratios with 95% CIs via the Mantel-Haenszel method. Heterogeneity was assessed using the chi-square test and I² statistics.

RESULTS: In total, 9 studies involving 2524 participants were included. Ischemic stroke was the most common type (n=1568, 62.13%) of stroke. Meta-analysis showed that nurse-led telecare significantly increased the likelihood of achieving target BP (odds ratio 2.33, 95% CI: 1.83-2.98; P<.001). For continuous outcomes, pooled analyses showed nonsignificant but directionally favorable reductions in systolic BP (MD -4.83, 95% CI -12.51 to 2.85; I² =92%), diastolic BP (MD -6.41, 95% CI -13.76 to 0.93; I²=97%), and low-density lipoprotein cholesterol (MD 0.01, 95% CI -0.08 to 0.09; I²=97%). Heterogeneity was substantial for several key outcomes (I²>90% for systolic BP and diastolic BP). Some outcomes, such as medication adherence and stroke recurrence, were reported by only 1 (11.11%) study. Additional benefits were observed in coping ability and reduced hospital readmissions, but findings for psychological well-being and quality of life were mixed.

CONCLUSIONS: Nurse-led telecare consultations may support better BP management and coping and reduce hospital readmissions among community-dwelling stroke survivors. However, the pooled effects for continuous outcomes were inconclusive, and heterogeneity remained high. Therefore, these findings should be interpreted with caution, and further high-quality trials with standardized outcome measures and longer-term follow-up are warranted to confirm effectiveness.

TRIAL REGISTRATION: PROSPERO CRD42023492692; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023492692.

PMID:41307946 | DOI:10.2196/74149

Augment Altern Commun. 2025 Nov 27:1-12. doi: 10.1080/07434618.2025.2588563. Online ahead of print.

ABSTRACT

This study aimed to elicit and analyze the views and preferences of a variety of AAC stakeholders regarding terminology related to augmentative and alternative communication (AAC) and the people who use or could benefit from it. We used an anonymous online survey to ask nonspeaking AAC users, speaking AAC users, relatives of AAC users, and AAC professionals their preferences on 119 English terms related to AAC, AAC users, and communication disability. The survey also collected demographic information, including age, country, connection to AAC, and disability identity. A total of 556 participants completed the survey. We aimed to determine broad terminology preferences across stakeholder groups and identify areas of disagreement between stakeholders. By making comparisons between related terms and between stakeholder groups, we were able to achieve this aim. There were statistically significant preferences between terms within all groups of related terms. Stakeholder groups also frequently disagreed with each other about AAC terminology: between-group differences in the frequency with which respondents supported, disliked, and/or were unfamiliar with terms were present for 81 of the 119 terms. The preferences uncovered in this study can support respectful language guidance around AAC. Further work should ideally address terminology preferences among stakeholder samples that are less focused on the United States, more focused on marginalized cultural groups, include stakeholders with more limited language skills, and/or address terminology in languages other than English.

PMID:41307945 | DOI:10.1080/07434618.2025.2588563

Clin Infect Dis. 2025 Nov 27:ciaf655. doi: 10.1093/cid/ciaf655. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical heterogeneity in Staphylococcus aureus bacteremia (SAB) complicates clinical management and research. We have previously identified five clinically distinct subphenotypes of SAB associated with differences in outcomes and response to adjunctive rifampicin. Here, we aimed to identify these subphenotypes in geographically diverse observational cohorts, including a higher prevalence of methicillin-resistant S. aureus (MRSA) bacteremia and the USA300 clone.

METHODS: We studied three cohorts of adults with SAB from observational studies: a UK retrospective study (Edinburgh cohort 2, n=463); a Dutch prospective study (IDISA, n=490); and a USA prospective study (SABG-PCS, n=755). Subphenotypes were identified from routinely available clinical data using latent class analysis.

RESULTS: Patients from the SABG-PCS cohort had greater multimorbidity and more MRSA bacteremia (40.2%, 303/755), including infection with the USA300 clone (14.7%, 111/755). Five distinct subphenotypes were identified in each cohort: (A) older age and cardio-metabolic multimorbidity; (B) nosocomial acquisition and intravenous catheter portal of entry; (C) community acquisition and metastatic infection; (D) chronic kidney disease; and (E) younger age, injection drug use, and metastatic infection. Bacterial genotypes varied substantially between the Edinburgh 2 and SABG-PCS cohorts but did not differ between subphenotypes within each cohort. 90-day mortality was highest in subphenotype A, and persistent bacteremia in subphenotypes C and E.

CONCLUSIONS: We have reproducibly identified five clinical subphenotypes of SAB in observational cohorts including diverse bacterial genetic lineages and a cohort with a high prevalence of MRSA and USA300 bacteremia. These robustly reproducible clinical subphenotypes provide a framework to rationalize the heterogeneity intrinsic to SAB.

PMID:41307923 | DOI:10.1093/cid/ciaf655