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Nevin Manimala Statistics

Mindfulness in the Orthopedic Clinic Waiting Room Decreases Pain: Results From A Randomized Controlled Trial

Int J Behav Med. 2025 Nov 10. doi: 10.1007/s12529-025-10398-3. Online ahead of print.

ABSTRACT

BACKGROUND: Pain is the leading reason patients seek orthopedic care, but many experience significant delays before seeing a provider. This single-site, parallel-group randomized controlled trial evaluated whether an audio-recorded, brief mindfulness-based intervention (BMBI) delivered in an orthopedic clinic waiting room could reduce pain among patients awaiting an x-ray.

METHODS: Participants (n = 159) had a mean age of 52 years (SD = 16.3), were predominantly female (64%) and white (78%). Average pain intensity at baseline was 5.65 (SD = 2.18). Participants were randomized in a 1:1 ratio to receive either a 4-min audio-recorded BMBI or a 4-min injury management control recording. Pain unpleasantness and pain intensity were measured pre- and post-intervention using numeric rating scales.

RESULTS: BMBI Participants reported significantly lower post-intervention pain unpleasantness (4.26 vs. 4.95, p = .021, d = .39) and pain intensity (4.23 vs. 5.21, p < .001, d = .59) compared to the control group. Although pain decreased in both groups, reductions were significantly greater in the BMBI group (p < .05). Notably, 52% of BMBI participants experienced a clinically meaningful pain reduction (i.e., ≥ 10%), compared to 33% in the control group (p = .041). Additionally, more BMBI participants expressed interest in further pain management resources (54% vs. 38%, p = .032).

CONCLUSIONS: An audio-recorded BMBI can produce statistically significant and clinically meaningful reductions in acute pain among orthopedic patients in the waiting room and may enhance their desire to seek additional pain management resources. As such, audio-delivered BMBIs represent a complementary pain management approach that can be delivered without clinician involvement. Findings highlight the need to further enhance patient engagement with MBIs in the waiting room and assess their effectiveness across a variety of healthcare environments.

TRIAL REGISTRATION: This trial was prospectively registered. Registry: ClinicalTrials.gov, TRN: NCT06171009, Registration date: September 19th 2024.

PMID:41214294 | DOI:10.1007/s12529-025-10398-3

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Nevin Manimala Statistics

Comparative Outcomes of Uterus-Preserving and Hysterectomy Approaches in Laparoscopic Lateral Suspension

Int Urogynecol J. 2025 Nov 10. doi: 10.1007/s00192-025-06398-2. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The objective was to compare the anatomical and functional outcomes of laparoscopic lateral suspension (LLS) with and without concomitant hysterectomy in the treatment of pelvic organ prolapse, in order to guide patient-centered surgical planning.

METHODS: This retrospective cohort study included 87 patients who underwent LLS between 2021 and 2024. Patients were divided into two groups: LLS with concomitant total laparoscopic hysterectomy (n = 43), and uterus-preserving LLS (n = 44). Surgical parameters, Pelvic Organ Prolapse Quantification (POP-Q) scores, complication rates, recurrence, pelvic pain, and urinary incontinence outcomes were compared over a minimum of 12 months’ follow-up.

RESULTS: Both groups achieved significant improvements in all POP-Q points (p < 0.0001), with no statistically significant difference in anatomical success, recurrence, pelvic pain, or urinary incontinence. Operative time, blood loss, and hospital stay were significantly higher in the hysterectomy group (p < 0.0001). Vaginal length was better preserved in uterus-preserving procedures. No major intra- or postoperative complications were reported.

CONCLUSIONS: Concomitant hysterectomy during LLS increases surgical burden without offering clear anatomical or functional advantages. Uterus-preserving LLS is a safe and effective option and may be preferred in appropriately selected patients through shared decision making.

PMID:41214285 | DOI:10.1007/s00192-025-06398-2

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Nevin Manimala Statistics

Creation and Validation of a Comprehensive Instrument to Assess UI in Female Athletes and Active Women

Int Urogynecol J. 2025 Nov 10. doi: 10.1007/s00192-025-06325-5. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESES: A variety of instruments have been used to measure UI in studies about athletic UI (AUI). However, few studies used instruments with questions about bowel, bladder, and sexual habits. A more comprehensive screening tool has been developed: the Active Women Incontinence Screening Tool (AWIST). The purposes of this study were to identify gaps left by prior UI instruments, describe attributes of the AWIST previously excluded by UI screening tools, and evaluate validity and reliability of the AWIST.

METHODS: Key concepts were identified using a comparative analysis of 17 instruments used across 92 AUI studies. We used the Delphi method to validate the content of the AWIST, which involved two phases of review by eight experts. The Content Validity Index (CVI) was assessed at the item (I-CVI) and the scale (S-CVI) levels, where consensus among all selected items was determined using a modified Kappa statistic (K*) set at 0.60.

RESULTS: In the first phase, the AWIST demonstrated a mean relevance score of 3.67 (σ = 0.61, range 2-4; mean I-CVI 0.98, σ = 0.07). In the second phase, the AWIST had a main relevance score of 3.67 (σ = 0.57, range 2-4; mean I-CVI 0.99, σ = 0.05). The S-CVI/UA was 0.95 and the S-CVI-Ave was 0.99.

CONCLUSION: The AWIST is a comprehensive, validated screening tool created to evaluate key factors of AUI in women. Branching logic makes it equally useful for assessing nonathletic women. The AWIST is equally appropriate for research and clinical use.

PMID:41214284 | DOI:10.1007/s00192-025-06325-5

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Nevin Manimala Statistics

Comparability of Canadian SARS-CoV-2 seroprevalence estimates with statistical adjustment for socio-demographic representation

Can J Public Health. 2025 Nov 10. doi: 10.17269/s41997-025-01128-z. Online ahead of print.

ABSTRACT

OBJECTIVE: SARS-CoV-2 serological surveillance used blood donors, research cohorts, and residual patient samples. Differences in socio-demographic characteristics across these sources may bias seroprevalence estimates, necessitating statistical adjustment.

METHODS: We re-analyzed data from six serosurveillance sources, comparing the estimated percent of the population positive for SARS-CoV-2 anti-nucleocapsid antibodies for six regions during periods when the sources’ sample collection overlapped. We assessed the concordance between sources with and without using multilevel regression and poststratification (MRP) to adjust for differences in representation by age, sex, and race.

RESULTS: Across regions and timepoints, unadjusted seroprevalence differed between sources by up to 20%. MRP did not consistently improve comparability of seroprevalence across sources. In 2022, seroprevalence was consistently highest among blood donors, and MRP increased regional seroprevalence across all sources (except in Manitoba during January-April 2022 in ABC Study). In a secondary regression analysis, immunoassay kit and sample type (dried blood spot or venous blood draw) strongly influenced the odds that a sample was classified as seropositive.

CONCLUSION: Adjusting for representativeness using common socio-demographic variables did not systematically improve concordance in seropositivity estimates between serosurveillance sources. While discrepancies between sources might be influenced by studies’ representativeness of characteristics we did not assess, methods for measuring seropositivity appear to explain much of the differences between sources. Serosurveillance findings are influenced by many aspects of study design beyond representativeness, such as sample type (venous blood draw or dried blood spots), choice of immunoassay, and laboratory procedures such as dilution or immunoassay calibration.

PMID:41214282 | DOI:10.17269/s41997-025-01128-z

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Nevin Manimala Statistics

Orienting field effects on the flow of an active nematic liquid crystal in a channel

Eur Phys J E Soft Matter. 2025 Nov 10;48(10-12):67. doi: 10.1140/epje/s10189-025-00527-x.

ABSTRACT

We examine the influence of an external orienting field on the director orientation and fluid flow of an active nematic liquid crystal confined in a channel, subject to infinite anchoring of the director and no-slip conditions at the channel walls. A mathematical model based on the Ericksen-Leslie dynamic equations for nematic liquid crystals is employed, with an additional active stress tensor accounting for the activity of the fluid. By solving the fully coupled nonlinear equations numerically, we investigate the dynamic response and the steady state of the active nematic when an orienting field is switched on. The dynamic behaviour when an orienting field is switched off is also examined, with our model demonstrating how the activity of the liquid crystal can enhance or hinder the classically observed kickback immediately after switch-off and generate nontrivial steady-state solutions. Specifically, we find that kickback, which can delay relaxation of the system to a steady state, can be made less pronounced, and eventually completely avoided, for contractile agents with a high activity parameter, even with a high magnitude orienting field value.

PMID:41214270 | DOI:10.1140/epje/s10189-025-00527-x

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Nevin Manimala Statistics

A first examination of skin-transferred microbiota demonstrates the feasibility of utilizing microbes to determine the age of latent fingerprints: A proof-of-concept study

Forensic Sci Int. 2025 Nov 7;378:112710. doi: 10.1016/j.forsciint.2025.112710. Online ahead of print.

ABSTRACT

Friction ridge skin patterns, including latent fingerprints (LFs), have long been essential for human identification. However, traditional ridge examinations do not convey temporal information. The ability to estimate the Time-since-Deposition (TsDp) of LFs could provide valuable chronological context in criminal investigations, helping to reconstruct timelines and corroborate alibis. A recent study explored LF microbiota as potential biological “clocks” for TsDp estimations at the Phylum taxonomical rank. In that instance, it was revealed that the composition, relative abundance, and succession patterns of microorganisms varied over time. This dynamic nature made the transferred skin microbiome a promising candidate for investigating predictable temporal changes of LFs in semi-controlled environments, such as indoor locations. The present article further expands the taxonomic resolution of the original study by identifying time-dependent microbial taxa at the Family rank and suggesting specific temporal signatures through statistical analyses. The same experimental conditions were considered: three donors, hand washing conditions, and aging for 1, 7, 14, and 21 days. For this analysis, the relative abundance, presence, and temporal shifts were examined with a focus on time-variant taxa. The 16S rRNA gene (V4 region) sequencing revealed distinct temporal signatures across the observed time points and handwashing conditions. For example, in unwashed hands, the combined presence of Mycosphaerellaceae and Coxiellaceae indicated a freshly deposited LF. In contrast, under washed conditions, the presence of Ruminococcaceae and Beijerinckiaceae was associated with a recent deposition. These preliminary findings further demonstrate the potential of microbiome analysis as a forensic tool for estimating TsDp in LFs and are a feasibility study for further work.

PMID:41213205 | DOI:10.1016/j.forsciint.2025.112710

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Nevin Manimala Statistics

Effect of influenza vaccination on post-admission outcomes for influenza patients in England: a population-based cohort study

Vaccine. 2025 Nov 9;68:127933. doi: 10.1016/j.vaccine.2025.127933. Online ahead of print.

ABSTRACT

INTRODUCTION: In the UK, adults 65 years and over and those in clinical risk groups are among those eligible for seasonal influenza vaccination. While vaccine effectiveness for reducing cases of influenza is well documented, less is known about impact on wider hospital and post-discharge outcomes in the UK. We investigated whether vaccinated adults hospitalised with confirmed influenza infection had different outcomes to non-vaccinated adults during contact with health services.

METHODS: A retrospective cohort study using the Combined Intelligence for Population Health Action platform, linking primary care, secondary care and laboratory data for Cheshire and Merseyside (2.7 M population), UK. We accessed 2081 laboratory-confirmed influenza hospital admissions for adults ≥16 years (October 2018-April 2024). We studied the association of influenza vaccination with several hospital and post-discharge outcomes, considering competing risks and potential confounding factors. We included age-based subgroup analyses.

RESULTS: Vaccination uptake was recorded as 38.8 %, 52.7 % and 20.9 % among ≥16, ≥65 and 16-64 years respectively. Among the full cohort and ≥ 65 years cohort, vaccination was associated with a reduction in length of hospital stay in competing risk models (17 %, 95 %CI 7-26 %; 19 %, 95 % CI 7-31 %), risk of death up to six months after discharge (aHR 0.66, 95 %CI 0.48-0.90; aHR 0.67, 95 %CI 0.48-0.92) and change in vaccination status in the next season (aOR 0.19, 95 %CI 0.13-0.27; aOR 0.07 95 %CI 0.04-0.13). No statistically significant difference was detected for admission to critical care or other post-discharge outcomes (readmission, attendance to general practice or emergency department).

CONCLUSIONS: Influenza vaccination was associated with benefits beyond acute illness, reducing length of hospital stay and mortality among adults hospitalised with laboratory-confirmed influenza. Findings support policy decisions, including greater outreach to high-risk, low-uptake groups and advocate for the national integration of laboratory data with comprehensive healthcare data to enable more robust vaccine evaluations.

PMID:41213184 | DOI:10.1016/j.vaccine.2025.127933

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Nevin Manimala Statistics

VeRUS: verification of reference intervals based on the uncertainty of sampling

Clin Chem Lab Med. 2025 Nov 11. doi: 10.1515/cclm-2025-0728. Online ahead of print.

ABSTRACT

OBJECTIVES: Laboratories are required to routinely verify reported reference intervals (RIs), but common verification methods like the CLSI-EP28-A3c binomial test are often impractical due to sample collection requirements. Indirect verification methods like equivalence limits (ELs) use routine data from patient care but lack systematic evaluation. This study aimed to develop and evaluate a novel indirect verification method: verification of reference intervals based on the uncertainty of sampling (VeRUS).

METHODS: VeRUS compares the to-be-verified candidate RI to an RI estimated from local routine data. Acceptable differences are based on the sampling uncertainty intrinsic to the nonparametric method for establishing RIs with n=120 samples. The three verification methods were systematically compared with simulated test sets resembling 10 differently distributed biomarkers and a wide range of plausible candidate RIs.

RESULTS: The binomial test is inherently unable to reject too wide RIs; e.g. the 99.8 %-interval, for which ELs and VeRUS showed high rejection rates (mean 89.2 %, SD 31.5 % and mean 95.8 %, SD 2.3 %, respectively). Moreover, the binomial test incorrectly accepts 29.3 % of “too narrow” 80%-intervals, whereas the false acceptance rates of ELs and VeRUS were lower (mean 21.7 %, SD 40.9 % and mean 7.2 %, SD 4.7 %, respectively). Overall, both indirect verification methods demonstrated increased statistical power, while ELs were least consistent among different biomarker distributions.

CONCLUSIONS: Its robust performance without the need for sample collection makes VeRUS an attractive tool for RI verification. By enabling routine verification of previously practically unverifiable RIs (e.g., in pediatrics), VeRUS may enhance clinical decision-making and improve patient care.

PMID:41213183 | DOI:10.1515/cclm-2025-0728

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Nevin Manimala Statistics

Modeling Alzheimer’s Disease Biomarkers’ Trajectory in the Absence of a Gold Standard Using a Bayesian Approach

Stat Med. 2025 Nov;44(25-27):e70283. doi: 10.1002/sim.70283.

ABSTRACT

To advance our understanding of Alzheimer’s Disease (AD), especially during the preclinical stage when patients’ brain functions are mostly intact, recent research has shifted towards studying AD biomarkers across the disease continuum. A widely adopted framework in AD research, proposed by Jack and colleagues, maps the progression of these biomarkers from the preclinical stage to symptomatic stages, linking their changes to the underlying pathophysiological processes of the disease. However, most existing studies rely on clinical diagnoses as a proxy for underlying AD status, potentially overlooking early stages of disease progression where biomarker changes occur before clinical symptoms appear. In this work, we develop a novel Bayesian approach to directly model the underlying AD status as a latent disease process and biomarker trajectories as nonlinear functions of disease progression. This allows for more data-driven exploration of AD progression, reducing potential biases due to inaccurate clinical diagnoses. We address the considerable heterogeneity among individuals’ biomarker measurements by introducing a subject-specific latent disease trajectory as well as incorporating random intercepts to further capture additional inter-subject differences in biomarker measurements. We evaluate our model’s performance through simulation studies. Applications to the Alzheimer’s Disease Neuroimaging Initiative (ADNI) study yield interpretable clinical insights, illustrating the potential of our approach in facilitating the understanding of AD biomarker evolution.

PMID:41213170 | DOI:10.1002/sim.70283

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Nevin Manimala Statistics

On “Confirmatory” Methodological Research in Statistics and Related Fields

Stat Med. 2025 Nov;44(25-27):e70303. doi: 10.1002/sim.70303.

ABSTRACT

Empirical substantive research, such as in the life or social sciences, is commonly categorized into the two modes exploratory and confirmatory, both of which are essential to scientific progress. The former is also referred to as hypothesis-generating or data-contingent research, while the latter is also called hypothesis-testing research. In the context of empirical methodological research in statistics, however, the exploratory-confirmatory distinction has received very little attention so far. Our paper aims to fill this gap. First, we revisit the concept of empirical methodological research through the lens of the exploratory-confirmatory distinction. Second, we examine current practice with respect to this distinction through a literature survey including 115 articles from the field of biostatistics. Third, we provide practical recommendations toward a more appropriate design, interpretation, and reporting of empirical methodological research in light of this distinction. In particular, we argue that both modes of research are crucial to methodological progress, but that most published studies-even if sometimes disguised as confirmatory-are essentially exploratory in nature. We emphasize that it may be adequate to consider empirical methodological research as a continuum between “pure” exploration and “strict” confirmation, recommend transparently reporting the mode of conducted research within the spectrum between exploratory and confirmatory, and stress the importance of study protocols written before conducting the study, especially in confirmatory methodological research.

PMID:41213159 | DOI:10.1002/sim.70303