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Nevin Manimala Statistics

Impact of using routine healthcare data on the efficiency of implementation trials: a qualitative comparative case study

Trials. 2026 Apr 11. doi: 10.1186/s13063-026-09706-3. Online ahead of print.

ABSTRACT

BACKGROUND: Randomised implementation trials evaluate the effects of implementation strategies on implementation outcomes and may also monitor clinical effectiveness. Routine healthcare data are used in implementation trials for participant identification, intervention delivery, and/or outcome ascertainment. Trial efficiency (scientific, operational, statistical, and economic) is operationalised across trial design, processes, superstructure, infrastructure, and stakeholder engagement (the Trial Efficiency Pentagon). Despite frequent usage, the contribution of routine data to implementation trial efficiency remains underexplored. We aimed to investigate how the use of routine healthcare data affects trial efficiency in two implementation trials.

METHODS: We conducted a qualitative comparative case study of two implementation trials, one UK-based and one US-based. Participants were purposively sampled from trial teams involved in the use and management of routine healthcare data. Data were collected through semi-structured interviews, document analysis, and feedback workshops. Framework analysis guided by the Trial Efficiency Pentagon was used to analyse the data, and data flow diagrams were developed to visualise routine data pathways within each trial.

RESULTS: The two trials (DIGITS and IMP2ART) used routine data to characterise the practice population of eligible patients, support clinical and economic outcome evaluation, facilitate audit and feedback, and assist in intervention delivery. Common facilitators that supported the use of routine data included sufficient IT and hardware capacity, relatively low cost, centralised regulatory approval for multi-site studies, and strong collaboration and partnerships. Common barriers included administrative complexity, redundant bureaucratic processes, and challenges with data sharing requirements. Key differences included the DIGITS trial’s in-house data warehouses within an integrated healthcare system ensured high data quality and enabled preliminary analyses. In contrast, the IMP2ART trial, managing a larger national sample, employed an external research database to integrate data from various EHR systems but faced challenges such as legacy systems, diverse coding practices and site-specific approvals. Data quality can act as either a facilitator or a barrier.

CONCLUSIONS: Routine data has an impact on implementation trial efficiency across trial design, processes, superstructure, infrastructure, and stakeholder engagement. To improve trial efficiency in public healthcare systems, researchers must address technological and regulatory barriers to accessing data. In private healthcare systems, data use and access hinges on investing in robust IT infrastructure and ensuring comprehensive organisational commitment.

TRIAL REGISTRATION: IMP2ART trial registration: ISRCTN15448074; DIGITS trial Clinicaltrials.gov Identifier: NCT05160233.

PMID:41965800 | DOI:10.1186/s13063-026-09706-3

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Nevin Manimala Statistics

Translation, cross-cultural adaptation and validation of the Spanish version of the Spinal Cord Injury Pain Instrument (SCIPI)

Spinal Cord. 2026 Apr 11. doi: 10.1038/s41393-026-01196-z. Online ahead of print.

ABSTRACT

STUDY DESIGN: Single-center observational study.

OBJECTIVES: To perform the translation, cross-cultural adaptation, and analysis of the measurement properties of the Spanish version of the Spinal Cord Injury Pain Instrument (SCIPI) for the screening of neuropathic pain (NP) in spinal cord injury (SCI).

SETTING: Hospital, Spain.

METHODS: Participants with SCI and pain were included for the pre-final version (n = 10) and the final version (n = 136). Translation and cross-cultural adaptation of the SCIPI were performed by native speakers in both languages. The statistical analysis included internal consistency, validity, test-retest reliability, and diagnostic accuracy.

RESULTS: All the items of the pre-final version of the SCIPI were understood. Moderate test-retest reliability (intraclass correlation coefficient (ICC) = 0.78, 95% confidence interval (CI), 0.69 to 0.84, p < 0.001) and CR coefficient of internal consistency of 0.484 were found. Strong correlations between the SCIPI and the Douleur Neuropathique 4 (DN4) were revealed (rho = 0.619, p < 0.001). The best cutoff value was 2 points, with an outstanding discriminant ability according to the area under the curve (AUC) value (AUC = 0.937) associated with high sensitivity (91.13%) and specificity (91.67%).

CONCLUSIONS: The Spanish version of the SCIPI may be a reliable and valid tool, with an excellent discriminant ability, for the screening of NP in people with SCI.

PMID:41965781 | DOI:10.1038/s41393-026-01196-z

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Nevin Manimala Statistics

Rapid detection and quantification of glyphosate in water using a handheld portable biosensor

Sci Rep. 2026 Apr 11. doi: 10.1038/s41598-026-44827-4. Online ahead of print.

ABSTRACT

Glyphosate is the most extensively applied systemic herbicide worldwide, yet its safety remains under scrutiny, with ongoing investigations into potential carcinogenicity. Epidemiological studies associate chronic glyphosate exposure with elevated risks of non-Hodgkin lymphoma and possible endocrine disruption, emphasizing the need for sensitive detection methods. Here, we report a handheld enzymatic biosensor, GlyphoSense Chip, for direct, rapid detection of underivatized glyphosate in drinking water. The device integrates a photodiode-based CMOS chip with an engineered glyphosate N-acetyltransferase and a colorimetric reaction, achieving a sensitivity of 38 µV·mL µg-1·s-1 and quantification within one minute. Biosensor response was linear over 0.016-12.5 µg mL-1 (R2 = 0.993) with a detection limit of 0.028 µg mL-1. Recovery analysis in fortified tap water yielded relative standard errors of 1.2-5.8%, and results were statistically indistinguishable from quantitative mass spectrometry (p > 0.05). This work establishes a robust, field-deployable platform for glyphosate monitoring in water resource safety applications.

PMID:41965777 | DOI:10.1038/s41598-026-44827-4

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Nevin Manimala Statistics

The Efficacy of COVID-19 Vaccination in Mortality Among Multi-Ethnic Long-Term Care Residents in New Zealand

Australas J Ageing. 2026 Jun;45(2):e70155. doi: 10.1111/ajag.70155.

ABSTRACT

OBJECTIVE: Older adults faced heightened vulnerability during the COVID-19 pandemic, leading to increased mortality. This study investigated the impact of COVID-19 vaccination on COVID-19-related mortality among the main ethnic groups in long-term care during the Delta-Omicron wave in New Zealand.

METHODS: We used national health datasets (interRAI Long Term Care Facility, COVID-19 immunisation, COVID-19 test results, mortality) from August 2021 to August 2022. Multi-state modelling assessed transition hazards from infection to COVID death and other causes of death among Māori, Pacific, Asian and European residents. Transition hazard ratios compared the risk of transitioning from infection to COVID versus non-COVID death.

RESULTS: A total of 34,147 long-term care residents (female: 64.0%, mean age: 84.8 years SD = 8.5) were included. For Māori aged < 85, Asians < 63 and Europeans < 93 who had 3+ doses of vaccine, the risk of COVID death was statistically lower than non-COVID death. Unvaccinated residents showed higher hazards for transitioning to COVID death. For Pacific peoples, transition hazard ratios were not statistically significant, likely due to small sample size. However, successive vaccine doses suggested reduced COVID mortality.

CONCLUSIONS: COVID-19 vaccination reduced the risk of COVID deaths across ethnicities in New Zealand’s long-term care. However, the level of protection offered by the vaccine varied by ethnicity and age.

PMID:41964395 | DOI:10.1111/ajag.70155

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Nevin Manimala Statistics

Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized Study

J Pain Palliat Care Pharmacother. 2026 Apr 11:1-7. doi: 10.1080/15360288.2026.2655779. Online ahead of print.

ABSTRACT

BACKGROUND: Oral mucositis (OM) pain in patients undergoing cancer treatments remains inadequately managed with conventional treatments. This study aimed to examine pain outcomes associated with methylene blue (MB) mouthwash compared with a standard supportive care mouthrinse in hospitalized patients with OM.

METHODS: In this open label, non-randomized clinical trial, patients selected MB (0.05%) or standard-of-care mixed medication mouthwash. Both groups performed an oral rinse every 8 h for three days. The primary outcome was change in pain numeric rating scores (0-10) from pre-administration to post-administration. Secondary outcomes included changes in daily oral intake volume and opioid use.

RESULTS: Forty-three evaluable patients were included in the analysis. Using a linear mixed model with subject-specific intercepts, both treatment groups demonstrated statistically significant reductions in pain from pre- to post- administration (standard of care: estimate=-0.64, 95% CI [-1.23, -0.05], p = 0.034; MB estimate=-0.87, 95% CI [-1.31, -0.42], p < 0.001). The administration timing-by-treatment interaction effect was not statistically significant, indicating that pain reduction did not differ significantly between groups.

CONCLUSIONS: In this non-randomized study, MB mouthwash was associated with short-term pain reductions in OM-related pain similar to standard-of-care mouthwash. These findings support feasibility and tolerability and underscore the need for larger randomized trials.

PMID:41964386 | DOI:10.1080/15360288.2026.2655779

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Nevin Manimala Statistics

Characterization, antifungal potential, cytocompatibility, and regenerative potential of mucoadhesive gel containing antifungal-β-cyclodextrin inclusion complexes

J Prosthodont. 2026 Apr 11. doi: 10.1111/jopr.70135. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to characterize a mucoadhesive gel containing nystatin (NYS) or chlorhexidine (CHX), complexed or not with β-cyclodextrin (βCD), and evaluate its rheological and mucoadhesive properties, antifungal efficacy, cytocompatibility, and collagen synthesis potential.

MATERIALS AND METHODS: Mucoadhesive formulations were produced using chitosan and hydroxyethylcellulose, incorporating NYS or CHX at 32 mg/g, or complexed with βCD (NYS:βCD, equivalent to 16.1 mg/g of NYS, and CHX:βCD, equivalent to 4.8 mg/g of CHX), and compared to a pure gel (GEL) and a commercially available 2% miconazole gel (DK). The formulations were evaluated for their rheological and mucoadhesive properties; antifungal activity against Candida albicans by halo inhibition, XTT metabolic assay, minimum inhibitory concentration (MIC) and minimum fungicidal concentration (MFC); cytocompatibility in an organotypic oral mucosa model by LIVE/DEAD and Alamar Blue metabolic assay; and collagen synthesis potential by fluorometric quantification. All microbiological and cytocompatibility tests were performed using mucoadhesive leachates. Statistical analysis was performed (α = 0.05).

RESULTS: Elastic behavior was predominant in the formulations, and greater mucoadhesiveness was observed in the complexed groups (p < 0.05). Limited antifungal activity was found in the GEL and DK groups, while the NYS, NYS:βCD, CHX, and CHX:βCD formulations exhibited significantly superior antifungal efficacy (p < 0.05). While formulations containing CHX significantly reduced cellular metabolic activity, those containing NYS demonstrated better cytocompatibility and increased collagen production.

CONCLUSION: The mucoadhesive gel containing NYS:βCD optimized both antifungal activity without compromising its rheological, mucoadhesive properties, and cytocompatibility at lower therapeutic doses compared to noncomplexed NYS. These findings suggest significant advantages for the treatment of oral candidiasis.

PMID:41964385 | DOI:10.1111/jopr.70135

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Nevin Manimala Statistics

Effectiveness of a Parent-Child Interaction Therapy-Based Trauma-Focused Interaction Module for Trauma-Exposed Children: A Pilot Randomized Controlled Trial

Clin Psychol Psychother. 2026 Mar-Apr;33(2):e70263. doi: 10.1002/cpp.70263.

ABSTRACT

BACKGROUND: Despite the high prevalence of posttraumatic symptoms in early childhood, there remain significant gaps in clearly defined or widely accepted treatments specifically adapted for young children. This shortcoming highlights the urgent need for developmentally sensitive, evidence-based psychological interventions targeting children who have experienced trauma during early childhood.

OBJECTIVE: This study aimed to develop a Trauma-Focused Interaction module integrated into Parent-Child Interaction Therapy (TFI-PCIT) and to preliminarily evaluate its effectiveness in reducing trauma-related symptoms and behavioural difficulties in traumatized children aged 2-8 years, as well as its impact on parental stress and burnout.

METHOD: A fully integrated mixed-methods randomized controlled design was employed. A total of 19 parent-child dyads were assigned through stratified block randomization to an intervention group (n = 9) or control group (n = 10). The intervention group received the TFI-PCIT module, while the control group received no intervention during the study period. Between-group differences were analysed using linear mixed models, and within-group changes were examined with independent samples t-tests. Postintervention qualitative interviews were conducted to deepen interpretation of outcomes.

RESULTS: Compared to controls, children who received TFI-PCIT demonstrated statistically significant reductions in trauma symptoms and behavioural problems. Parents in the intervention group showed significant decreases in parenting stress and burnout. Qualitative findings reinforced quantitative results, indicating improved emotional regulation and strengthened parent-child interactions.

CONCLUSION: These findings provide preliminary evidence that TFI-PCIT may be a promising, developmentally sensitive intervention for young traumatized children and their caregivers.

PMID:41964379 | DOI:10.1002/cpp.70263

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Nevin Manimala Statistics

Comparative Efficacy of Photodynamic Therapy Versus Cryotherapy for Actinic Keratosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

J Cosmet Dermatol. 2026 Apr;25(4):e70749. doi: 10.1111/jocd.70749.

ABSTRACT

BACKGROUND: Photodynamic therapy and cryotherapy are treatment options for actinic keratosis; however, their efficacy and safety remain debated.

AIMS: To perform a high-quality systematic review and meta-analysis exploring the efficacy and safety of photodynamic therapy and cryotherapy in actinic keratosis.

METHODS: A systematic search was performed applying the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched PubMed, Web of Science, Cochrane, Science Direct, Ovid, EBSCO, Wiley, and Google Scholar for randomized controlled trials.

RESULTS: A total of seven studies with 1233 patients were identified. PDT and cryotherapy showed similar success in clearing lesions (RR, 1.02; 95% CI, 0.92-1.13; p = 0.74). While both treatments performed comparably on the head and face (RR, 1.10; 95% CI, 0.94-1.28; p = 0.24), data from one trial suggested cryotherapy might be more effective for lesions on the arms and legs (RR, 0.88; 95% CI, 0.82-0.94; p < 0.05). However, more research is needed to confirm this finding. Cosmetic outcomes were significantly better for PDT (74.62% vs. 49.11%: RR, 1.52; 95% CI, 1.4-1.65; p < 0.00001) than cryotherapy. Similarly, PDT was superior to cryotherapy in patient satisfaction though the overall difference was not statistically significant (RR, 1.43; 95% CI, 0.91-2.25; p = 0.12). PDT was associated with a significantly higher risk of burning sensations and pain (RR, 1.95; 95% CI, 1.27-3.02; p = 0.002), whereas cryotherapy more frequently led to vesicles and blisters.

CONCLUSION: Lesion clearance may depend on location. It is comparable for head and face lesions, while data from one trial suggests cryotherapy may be better for extremity lesions. PDT is associated with a higher occurrence of pain/burning, while cryotherapy leads to more vesicles/blisters. Future research should focus on standardized protocols, including blinded post-treatment assessments to improve reliability and minimize bias.

PMID:41964358 | DOI:10.1111/jocd.70749

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Nevin Manimala Statistics

Evolutionary and environmental drivers of dry-season deciduousness in a legume genus

New Phytol. 2026 Apr 11. doi: 10.1111/nph.71148. Online ahead of print.

ABSTRACT

Leaf deciduousness is a key drought-avoidance strategy in tropical flora, reducing water loss during seasonal dry periods. While winter-deciduousness in temperate regions is well-understood, the evolutionary and environmental drivers of dry-season deciduousness remain poorly explored. Using the genus Mimosa, a species-rich and morphologically diverse lineage, we applied an eco-evolutionary framework to investigate the role of dry-season deciduousness across time and space. We combined a time-sliced trait-dependent diversification model, analyses of joint evolution of environmental niches in relation to leaf habit (deciduous vs evergreen), and phylogenetic multilevel models to test whether deciduousness influenced diversification and to identify its environmental drivers. Lineages switch from evergreen to deciduous habit more frequently before c. 7 Ma, whereas deciduous to evergreen transitions and increased speciation rates of evergreen lineages became dominant after this time. Deciduous lineages exhibited faster evolutionary rates along gradients of vapor pressure deficit, which also emerged as the strongest environmental predictor of deciduousness. However, most variation in leaf habit was explained by species-level (nonphylogenetic) variation and phylogeny. Although deciduous lineages respond rapidly to atmospheric dryness, dry-season deciduousness appears to be primarily shaped by the interplay between species identity and shared ancestry rather than by environmental conditions alone.

PMID:41964351 | DOI:10.1111/nph.71148

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Nevin Manimala Statistics

Morphometric Analysis of the Radial Artery in a Select White South African Donor Cohort

Anat Histol Embryol. 2026 May;55(3):e70108. doi: 10.1111/ahe.70108.

ABSTRACT

The radial artery is a vital access point for various cardiovascular and neurological interventions yet detailed morphometric studies in African populations are limited. This study aimed to investigate the radial artery dimensions in thirty adult body donors housed in the Department of Clinical Anatomy, University of KwaZulu-Natal, Durban, South Africa. The external and internal diameters, along with wall thickness of the radial artery, were measured at three anatomical sites viz. the point of origin, at the wrist joint and in the anatomical snuffbox bilaterally using a digital vernier calliper in sixty upper limb specimens (BREC/00006978/2024). There was a progressive distal tapering pattern, with the external diameters of the radial artery decreasing from its point of origin to the anatomical snuffbox. The internal diameter of the radial artery was 2.98 ± 0.76 mm at the origin, 2.20 ± 0.75 mm at the wrist joint and 1.75 ± 0.69 mm in the anatomical snuffbox. The wall thickness of the radial artery also decreased distally, from its point of origin to the anatomical snuffbox. There were no statistically significant differences between biological sex or laterality. The internal radial artery diameters suggest that a 5 French (5Fr) sheath may be suitable in 32% of upper limbs at the wrist and in 38% of upper limbs in the anatomical snuffbox. The findings of this study can contribute to the existing knowledge in this field and may help clinicians during cardiovascular and neurological interventional procedures within this select sample.

PMID:41964349 | DOI:10.1111/ahe.70108