Tag: nevin manimala

Clin Trials. 2025 Jan 10:17407745241302488. doi: 10.1177/17407745241302488. Online ahead of print.

ABSTRACT

BACKGROUND/AIMS: When conducting a randomised controlled trial in surgery, it is important to consider surgical learning, where surgeons’ familiarity with one, or both, of the interventions increases during the trial. If present, learning may compromise trial validity. We demonstrate a statistical investigation into surgical learning within a trial of cleft palate repair.

METHODS: The Timing of Primary Surgery compared primary surgery, using the Sommerlad technique, for cleft palate repair delivered at 6 or 12 months of age. Participating surgeons had varying levels of experience with the intervention and in repair across the age groups. Trial design aimed to reduce the surgical learning via pre-trial surgical technique training and balancing the randomisation process by surgeon. We explore residual learning effects by applying visual methods and statistical models to a surgical outcome (fistula formation) and a process indicator (operation time).

RESULTS: Notably, 26 surgeons operated on 521 infants. As the trial progressed, operation time reduced for surgeons with no pre-trial Sommerlad experience (n = 2), before plateauing at 30 operations, whereas it remained stable for those with prior experience. Fistula rates remained stable regardless of technique experience. Pre-trial age for primary surgery experience had no impact on either measures.

CONCLUSION: Managing learning effects through design was not fully achieved but balanced between trial arms, and residual effects were minimal. This investigation explores the presence of learning, within a randomised controlled trial that may be valuable for future trials. We recommend such investigations are undertaken to aid trial interpretation and generalisability, and determine success of trial design measures.

PMID:39791255 | DOI:10.1177/17407745241302488

Worldviews Evid Based Nurs. 2025 Feb;22(1):e12765. doi: 10.1111/wvn.12765.

ABSTRACT

BACKGROUND: Coronary artery disease (CAD) is a major health problem of atherosclerotic cardiovascular (CV) disease and early intervention is regarded important. Given the proven effect of a lifestyle intervention with nursing telephone counselling and mHealth use in health care, yet the comparisons of both support are lacking, this study is proposed.

OBJECTIVES: This study aimed to compare the effects of a coronary artery disease (CAD) support program using a mobile application versus nurse phone advice on exercise amount and physical and psychological outcomes for clients at risk of CAD.

METHODS: A prospective randomized controlled trial was conducted. Ethical approval was obtained. Two-hundred and twenty-six clients were screened, and a total of 168 clients who were at risk of CAD and routinely used smartphones were randomized into the app support group (App group) or the nurse phone advice (NPA) group. Although all participants received the same health talk delivered by a cardiac nurse at the community center, the App group received additional CAD app support, whereas the NPA group received nurse phone advice for 20 min monthly. The app content comprised (1) CAD knowledge in 10 modules, (2) individual exercise records with their own goals and health measures, and (3) a chest pain action list. The intervention lasted for 3 months. Health outcome data were collected at baseline (T0) and after 1 (T1) and 3 (T2) months. The outcomes were the total amount of exercise (primary outcome), self-efficacy in illness management, perceived stress, and CAD risk profile (body weight, body mass index, and lipid concentration). Generalized estimating equation models were used to assess differential changes in all outcomes within 3 months.

RESULTS: The attrition rates at 3 months were 3.49% and 9.30% for the App and NPA groups, respectively. The App support group was superior to the NPA group in significantly increasing total exercise amount and reducing body weight, waist circumference, triglycerides, and increased self-efficacy in illness management.

LINKING EVIDENCE TO ACTION: The result provides further insights of app development to support health promotion programs for community-dwelling adults at risk of CAD.

PMID:39791254 | DOI:10.1111/wvn.12765

JMIR Public Health Surveill. 2025 Jan 9;11:e60022. doi: 10.2196/60022.

ABSTRACT

BACKGROUND: High response rates are needed in population-based studies, as nonresponse reduces effective sample size and bias affects accuracy and decreases the generalizability of the study findings.

OBJECTIVE: We tested different strategies to improve response rate and reduce nonresponse bias in a national population-based COVID-19 surveillance program in England, United Kingdom.

METHODS: Over 19 rounds, a random sample of individuals aged 5 years and older from the general population in England were invited by mail to complete a web-based questionnaire and return a swab for SARS-CoV-2 testing. We carried out several nested randomized controlled experiments to measure the impact on response rates of different interventions, including (1) variations in invitation and reminder letters and SMS text messages and (2) the offer of a conditional monetary incentive to return a swab, reporting absolute changes in response and relative response rate (95% CIs).

RESULTS: Monetary incentives increased the response rate (completed swabs returned as a proportion of the number of individuals invited) across all age groups, sex at birth, and area deprivation with the biggest increase among the lowest responders, namely teenagers and young adults and those living in more deprived areas. With no monetary incentive, the response rate was 3.4% in participants aged 18-22 years, increasing to 8.1% with a £10 (US $12.5) incentive, 11.9% with £20 (US $25.0), and 18.2% with £30 (US $37.5) (relative response rate 2.4 [95% CI 2.0-2.9], 3.5 [95% CI 3.0-4.2], and 5.4 [95% CI 4.4-6.7], respectively). Nonmonetary strategies had a modest, if any, impact on response rate. The largest effect was observed for sending an additional swab reminder (SMS text message or email). For example, those receiving an additional SMS text message were more likely to return a completed swab compared to those receiving the standard email-SMS approach, 73.3% versus 70.2%: percentage difference 3.1% (95% CI 2.2%-4.0%).

CONCLUSIONS: Conditional monetary incentives improved response rates to a web-based survey, which required the return of a swab test, particularly for younger age groups. Used in a selective way, incentives may be an effective strategy for improving sample response and representativeness in population-based studies.

PMID:39791251 | DOI:10.2196/60022

Anat Histol Embryol. 2025 Jan;54(1):e70012. doi: 10.1111/ahe.70012.

ABSTRACT

This study investigates the gross morphological and morphometric characteristics of thoracic and lumbar intervertebral discs (IVDs) in guinea pigs, utilising micro-CT imaging and anatomical dissection. The findings reveal 13 thoracic and six lumbar IVDs were identified, with thoracic discs transitioning from rounded forms at T1-T3 to triangular and heart-shaped structures at T4-T13, while lumbar IVDs exhibited a consistently flattened heart shape. Morphometric analysis revealed statistically significant differences, with lumbar IVDs being larger in lateral and dorsoventral width, disc area, annulus fibrosus (AF) area and nucleus pulposus (NP) area, and ventral height compared to thoracic discs. Specifically, significant increases in lateral width and disc area were observed in lumbar segments L5 and L6, while thoracic IVDs demonstrated fluctuating alterations in some parameters, such as dorsal and ventral height. Histologically, both thoracic and lumbar IVDs feature a well-organised NP, AF and endplates (EP). The EP was composed of cartilaginous materials, including hyaline cartilage, fibrocartilage and calcified cartilage, and bony materials, including extensive secondary ossification centres with many large vascular channels and bone trabeculae. In conclusion, this study indicates that although thoracic and lumbar IVDs conserve key histological properties, their distinct morphological and morphometric characteristics in guinea pigs reflect their adaptations to biomechanical demands. However, due to some fundamental differences between human and guinea pig, use of this species as a model for human IVD research and interpreting the extracted data should be cautious.

PMID:39791227 | DOI:10.1111/ahe.70012

Helicobacter. 2025 Jan-Feb;30(1):e70005. doi: 10.1111/hel.70005.

ABSTRACT

BACKGROUND: As seen globally, there are up to sixfold differences in gastric cancer mortality by ethnicity in Aotearoa New Zealand, and H. pylori is the major modifiable risk factor. This study investigates whether current H. pylori testing and treatment approaches are equitable.

MATERIALS AND METHODS: The study design was a retrospective cohort analysis of linked administrative health data. Laboratory testing data and pharmacy dispensing were linked to the Northern region health user population dataset (1.9 million) from 2015 to 2018. We investigated an individual’s first test for H. pylori. Regression analyses compared ethnic differences in rates of H. pylori testing, infection, treatment, and retesting, adjusted for age, sex, and calendar year.

RESULTS: Ethnic inequities were present across the clinical pathway. Compared to sole-European, testing rates were lowest in Māori (OR 0.69) and Pacific (OR 0.81) and highest in Middle-Eastern/Latin-American/African (MELAA) (OR 2.21) and Asian (OR 2.02). Positivity rates were highest in MELAA (RR 2.96, 39%) and Pacific (RR 2.84, 38%) followed by Asian (RR 1.93, 26%) and Māori (RR 1.71, 23%). Treatment rates were similar for Asian (HR 1.05), MELAA (HR 1.03), and Māori (HR 0.98) compared to sole-European but lower in Pacific (HR 0.90). Māori and Pacific were half as likely to be retested as sole-European.

CONCLUSIONS: Despite the higher prevalence of H. pylori and gastric cancer, Māori and Pacific are relatively underserved with lower rates of testing and treatment than sole-European. Improved guidelines and the consistent application of these along with an equity-focused test and treat program are likely to be particularly beneficial for Māori and Pacific in addressing inequities.

PMID:39791223 | DOI:10.1111/hel.70005

Mol Med Rep. 2025 Mar;31(3):67. doi: 10.3892/mmr.2025.13432. Epub 2025 Jan 10.

ABSTRACT

Subarachnoid hemorrhage (SAH), a prevalent cerebrovascular condition associated with a high mortality rate, frequently results in neuronal apoptosis and an unfavorable prognosis. The adjunctive use of traditional Chinese medicine (TCM) with surgical interventions exerts a therapeutic impact on SAH, potentially by facilitating apoptosis. However, the mechanism by which TCM mediates apoptosis following SAH remains unclear. In the present study, C57BL/6J mice were subjected to the modified single‑clamp puncture method to produce an in vivo model of SAH. Treatment of these mice with notoginsenoside R1 (NGR1) prevented short‑term neurological deficits, reduced the expression levels of apoptosis‑associated proteins and mitigated brain edema. In addition, an in vitro model of SAH was established by treating HT22 mouse neuronal cells with oxyhemoglobin (OxyHb). Treatment of these cells with NGR1 resulted in attenuation of the OxyHb‑induced apoptosis. Furthermore, RNA sequencing analysis was used to examine NGR1 + OxyHb and OxyHb groups. Statistically significant changes in the expression levels of apoptosis‑associated genes in OxyHb‑stimulated HT22 cells upon administration of NGR1 were observed. The present study investigated the potential mechanism by which NGR1 mitigates neuronal apoptosis, presenting a novel therapeutic approach for treating SAH through the use of a single TCM component.

PMID:39791208 | DOI:10.3892/mmr.2025.13432

Mol Ecol. 2025 Jan 10:e17639. doi: 10.1111/mec.17639. Online ahead of print.

ABSTRACT

Invading species along with increased anthropogenization may lead to hybridization events between wild species and closely related domesticates. As a consequence, wild species may carry introgressed alleles from domestic species, which is generally assumed to yield adverse effects in wild populations. The opposite evolutionary consequence, adaptive introgression, where introgressed genes are positively selected in the wild species, is possible but has rarely been documented. Grey wolves (Canis lupus) are widely distributed across the Holarctic and frequently coexist with their close relative, the domestic dog (C. familiaris). Despite ample opportunity, hybridization rarely occurs in most populations. Here we studied the geographically isolated grey wolves of the Iberian Peninsula, who have coexisted with a large population of loosely controlled dogs for thousands of years in a human-modified landscape. We assessed the extent and impact of dog introgression on the current Iberian grey wolf population by analysing 150 whole genomes of Iberian and other Eurasian grey wolves as well as dogs originating from across Europe and western Siberia. We identified almost no recent introgression and a small (< 5%) overall ancient dog ancestry. Using a combination of single scan statistics and ancestry enrichment estimates, we identified positive selection on six genes (DAPP1, NSMCE4A, MPPED2, PCDH9, MBTPS1, and CDH13) for which wild Iberian wolves carry alleles introgressed from dogs. The genes with introgressed and positively selected alleles include functions in immune response and brain functions, which may explain some of the unique behavioural phenotypes in Iberian wolves such as their reduced dispersal compared to other wolf populations.

PMID:39791197 | DOI:10.1111/mec.17639

Eur J Pain. 2025 Feb;29(2):e4782. doi: 10.1002/ejp.4782.

ABSTRACT

BACKGROUND: The internet is increasingly used as a primary source of information for patients with musculoskeletal pain. Private physiotherapy practices provide informative content on low back pain (LBP) and neck pain (NP) on their websites, but the extent to which this information is biopsychosocial, guidelines-consistent, and fear-inducing is unknown. The aim of this study was to analyse the information on websites of private physiotherapy practices in the Netherlands about LBP and NP regarding consistency with the guidelines and the biopsychosocial model and to explore the use of fear-inducing language.

METHODS: The content of all existing Dutch private physiotherapy practice websites was examined in a cross sectional study design. Content analysis was based on predetermined criteria of the biopsychosocial model and evidence-based guidelines. Descriptive statistics were applied.

RESULTS: After removing duplicates and sites without information, 834 (10%) of 8707 websites remained. Information about LBP was found on 449 (54%) websites and 295 (35%) websites informed about NP. A majority of websites (LBP: n = 287, 64%; NP: n = 174, 59%) were biomedically oriented. Treatment advice was given 1855 times on n = 560 (67%) websites. Most of the recommended interventions were inconsistent with or not mentioned in the guidelines. Fear-inducing language was provided n = 1624 (69%) times.

CONCLUSIONS: The majority of the information on the Dutch private physiotherapy websites was biomedical and not in line with the current guidelines and fear-inducing.

SIGNIFICANCE: This study revealed that the majority of private physiotherapy practice websites that provide information on LBP and NP are inconsistent with the biopsychosocial model and current guidelines. This information has a negative impact on patients’ knowledge, attitudes, beliefs, and expectations, potentially affecting treatment outcomes. Consequently, most physiotherapy practice websites are unreliable sources of information on LBP and NP for patients. There is an urgent need to implement strategies to make websites reliable and helpful sources of information.

PMID:39791187 | DOI:10.1002/ejp.4782

J Law Med. 2024 Nov;31(3):515-522.

ABSTRACT

Risk assessment is an important component of judicial decision-making in many areas of the law. In Australia, those convicted of terrorist offences may be the subject of continued detention in prison or extended supervision in the community if there is an “unacceptable risk” of them committing future terrorism offences. Forensic psychologists and psychiatrists may provide evidence of risk through identifying and measuring risk factors with the aid of tools that use scales based on statistical or actuarial risk prediction. This column focuses on criticisms of the use of the second revision of the Violent Extremism Risk Assessment tool (VERA-2R) in determining the risk of future terrorist acts.

PMID:39789681

J Am Med Inform Assoc. 2025 Jan 10:ocae317. doi: 10.1093/jamia/ocae317. Online ahead of print.

ABSTRACT

OBJECTIVE: Propose a framework to empirically evaluate and report validity of findings from observational studies using pre-specified objective diagnostics, increasing trust in real-world evidence (RWE).

MATERIALS AND METHODS: The framework employs objective diagnostic measures to assess the appropriateness of study designs, analytic assumptions, and threats to validity in generating reliable evidence addressing causal questions. Diagnostic evaluations should be interpreted before the unblinding of study results or, alternatively, only unblind results from analyses that pass pre-specified thresholds. We provide a conceptual overview of objective diagnostic measures and demonstrate their impact on the validity of RWE from a large-scale comparative new-user study of various antihypertensive medications. We evaluated expected absolute systematic error (EASE) before and after applying diagnostic thresholds, using a large set of negative control outcomes.

RESULTS: Applying objective diagnostics reduces bias and improves evidence reliability in observational studies. Among 11 716 analyses (EASE = 0.38), 13.9% met pre-specified diagnostic thresholds which reduced EASE to zero. Objective diagnostics provide a comprehensive and empirical set of tests that increase confidence when passed and raise doubts when failed.

DISCUSSION: The increasing use of real-world data presents a scientific opportunity; however, the complexity of the evidence generation process poses challenges for understanding study validity and trusting RWE. Deploying objective diagnostics is crucial to reducing bias and improving reliability in RWE generation. Under ideal conditions, multiple study designs pass diagnostics and generate consistent results, deepening understanding of causal relationships. Open-source, standardized programs can facilitate implementation of diagnostic analyses.

CONCLUSION: Objective diagnostics are a valuable addition to the RWE generation process.

PMID:39789670 | DOI:10.1093/jamia/ocae317