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Nevin Manimala Statistics

Integrated Online-to-Offline Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial

JMIR Res Protoc. 2024 Oct 23;13:e60962. doi: 10.2196/60962.

ABSTRACT

BACKGROUND: HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment.

OBJECTIVE: This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia.

METHODS: The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called “CINTAI” for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of “CINTAI” compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts.

RESULTS: We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive).

CONCLUSIONS: Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60962.

PMID:39441624 | DOI:10.2196/60962

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Nevin Manimala Statistics

Short-Term Efficacy of Transumbilical Single-Incision Versus Conventional Laparoscopic Cholecystectomy: A Retrospective Cohort Study

J Laparoendosc Adv Surg Tech A. 2024 Oct 23. doi: 10.1089/lap.2024.0325. Online ahead of print.

ABSTRACT

Background: With the rising demand for minimally invasive and cosmetically appealing surgeries, transumbilical single-incision laparoscopic cholecystectomy (SILC) has been increasingly adopted, albeit in a limited number of medical centers. Our team has successfully executed transumbilical SILC for benign gallbladder diseases. This study retrospectively analyzed and compared the efficacy of transumbilical SILC with that of conventional laparoscopic cholecystectomy (CLC). Methods: We analyzed data from 358 cases of laparoscopic cholecystectomy performed at Shanghai East Hospital of Tongji University between January 2021 and October 2023. Of these, 186 cases underwent SILC (observation group), while 172 cases underwent CLC (control group). We compared patient demographics, perioperative outcomes, and satisfaction with incision scars. Primary outcomes included surgical efficacy and safety, whereas secondary outcomes encompassed postoperative hospitalization duration, pain levels, hospital costs, and scar satisfaction. Results: No significant differences were observed in patient demographics between the two groups. Both the SILC and CLC groups exhibited similar operative times (39.56 ± 14.55 minutes versus 41.82 ± 16.13 minutes, P = .164) and intraoperative blood loss (11.34 ± 3.90 mL versus 11.28 ± 3.87 mL, P = .885). The single-incision approach led to earlier postoperative bowel function recovery (22.03 ± 3.60 hours versus 24.17 ± 3.22 hours, P < .01), lower 24-hour postoperative pain scores (2.06 ± 0.84 versus 2.35 ± 0.72, P < .01), shorter postoperative hospital stays (2.88 ± 0.86 days versus 3.33 ± 0.96 days, P < .01), comparable hospitalization costs (3411.67 ± 790.86$ versus 3494.50 ± 558.76$, P = .257), and better Scar Cosmesis Assessment and Rating scores (1.78 ± 0.70 versus 2.17 ± 0.89, P < .01). Patient satisfaction was higher with the single-incision technique (8.52 ± 0.79 versus 7.80 ± 0.75, P < .01). Both groups experienced one case of incision infection (SILC 0.54%, CLC 0.58%), and there was one case of postoperative bile leakage in the CLC group (0.58%). However, the difference in complications was not statistically significant (P > .05). Conclusion: Transumbilical SILC demonstrates safe and effective near-term efficacy, offering benefits such as reduced postoperative pain and improved cosmetic outcomes, which support its clinical adoption.

PMID:39441619 | DOI:10.1089/lap.2024.0325

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Nevin Manimala Statistics

Clinical Utility of Deep Learning Assistance for Detecting Various Abnormal Findings in Color Retinal Fundus Images: A Reader Study

Transl Vis Sci Technol. 2024 Oct 1;13(10):34. doi: 10.1167/tvst.13.10.34.

ABSTRACT

PURPOSE: To evaluate the clinical usefulness of a deep learning-based detection device for multiple abnormal findings on retinal fundus photographs for readers with varying expertise.

METHODS: Fourteen ophthalmologists (six residents, eight specialists) assessed 399 fundus images with respect to 12 major ophthalmologic findings, with or without the assistance of a deep learning algorithm, in two separate reading sessions. Sensitivity, specificity, and reading time per image were compared.

RESULTS: With algorithmic assistance, readers significantly improved in sensitivity for all 12 findings (P < 0.05) but tended to be less specific (P < 0.05) for hemorrhage, drusen, membrane, and vascular abnormality, more profoundly so in residents. Sensitivity without algorithmic assistance was significantly lower in residents (23.1%∼75.8%) compared to specialists (55.1%∼97.1%) in nine findings, but it improved to similar levels with algorithmic assistance (67.8%∼99.4% in residents, 83.2%∼99.5% in specialists) with only hemorrhage remaining statistically significantly lower. Variances in sensitivity were significantly reduced for all findings. Reading time per image decreased in images with fewer than three findings per image, more profoundly in residents. When simulated based on images acquired from a health screening center, average reading time was estimated to be reduced by 25.9% (from 16.4 seconds to 12.1 seconds per image) for residents, and by 2.0% (from 9.6 seconds to 9.4 seconds) for specialists.

CONCLUSIONS: Deep learning-based computer-assisted detection devices increase sensitivity, reduce inter-reader variance in sensitivity, and reduce reading time in less complicated images.

TRANSLATIONAL RELEVANCE: This study evaluated the influence that algorithmic assistance in detecting abnormal findings on retinal fundus photographs has on clinicians, possibly predicting its influence on clinical application.

PMID:39441571 | DOI:10.1167/tvst.13.10.34

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The Mechanical Properties of Orthodontic Aligners of Clear Aligner After Intraoral Use in Different Time Periods

Orthod Craniofac Res. 2024 Oct 23. doi: 10.1111/ocr.12867. Online ahead of print.

ABSTRACT

OBJECTIVE: Although the technique of orthodontic aligners has risen in popularity, their mechanical properties have not been thoroughly investigated. The aim of this study was to evaluate the mechanical properties of the orthodontic aligners Clear Aligner after intraoral use for 7, 10 and 14 days, and to compare them with as-received aligners (0 days). It was also sought to examine the properties of the unprocessed raw material (polyethylene glycol terephthalate) used to manufacture these aligners.

MATERIALS/METHODS: Thirty-two aligners by four patients were evaluated and studied at 0, 7, 10, 14 days of use. Each aligner was divided into three segments (two posterior and one anterior), which resulted in 96 samples. Also, 16 samples of unprocessed material were studied. For all samples, elastic modulus, ultimate tensile stress (UTS) and yield stress were calculated by conducting tensile testing. Additionally, material hardness was tested. The two-tailed Mann-Whitney test was performed, having set the level of significance at p = 0.05.

RESULTS: Analysis of the measurements indicated a statistically significant decrease in elastic modulus between days 0 and 14 of use, of UTS between days 0 and 7, 7 and 10, and of yield stress between days 0 and 7. For hardness, in every period, posterior segments demonstrated significantly higher values than anterior segments. All properties of the unprocessed material were statistically significantly higher than the processed samples.

CONCLUSIONS: The unprocessed material presented significant differences in every property tested in comparison to the processed aligners. The processed material showed further deterioration over time during use. The present study provides evidence that thermoforming and ageing affect the mechanical properties of the aligners.

PMID:39441556 | DOI:10.1111/ocr.12867

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Correlation of White Matter Microstructure MRI and Inflammatory Cytokine Alterations With Symptom Severity in Premenstrual Syndrome

J Magn Reson Imaging. 2024 Oct 23. doi: 10.1002/jmri.29632. Online ahead of print.

ABSTRACT

BACKGROUND: Women with premenstrual syndrome (PMS) are at increased risk for depression throughout their lives. White matter (WM) microstructure and inflammatory cytokine alterations have been proposed in its etiology.

PURPOSE: To investigate whether WM, assessed using diffusion tensor imaging (DTI), and inflammatory cytokine levels are altered in PMS, and to examine the relationships between WM microstructure, inflammatory cytokines, and symptom severity.

STUDY TYPE: Prospective.

SUBJECTS: Forty-two PMS patients and 58 healthy controls (HCs), categorized according to the daily record of severity of problems (DRSP).

FIELD STRENGTH/SEQUENCE: 3-T, echo planar imaging DTI.

ASSESSMENT: Fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD) were measured by using tract-based spatial statistics (TBSS). Venous blood was collected to measure cytokines, including interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α). Symptoms were assessed by using the DRSP.

STATISTICAL TESTS: Two-sample t test or Mann-Whitney U test were used to compare the DRSP and cytokines. Abnormal DTI metrics in WM were extracted and the differences between groups were analyzed by using two sample t-tests. Spearman’s correlation (r) was used to assess the relationship between DTI metrics, cytokines, and DRSP. A P-value <0.05 with FDR correction was considered statistically significant.

RESULTS: Compared with HCs, PMS patients showed significantly lower FA in the corpus callosum and corona radiata, and significantly higher MD, AD, and RD in the corticospinal tract (CST), and significantly higher MD and RD in the anterior thalamic radiation (ATR). These differential metrics were significantly correlated with DRSP. Patients showed significantly higher IL-1β and TNF-α than HCs. Moreover, TNF-α correlated positively with MD, AD, and RD in both groups (r range, 0.256-0.315).

DATA CONCLUSION: Alterations of WM microstructure and IL-1β and TNF-α may be associated with PMS symptom severity, and TNF-α may correlate with DTI metrics of CST and ATR pathways.

EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 2.

PMID:39441549 | DOI:10.1002/jmri.29632

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Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study

Int J Rheum Dis. 2024 Oct;27(10):e15320. doi: 10.1111/1756-185X.15320.

ABSTRACT

AIM: Evaluate the efficacy and safety ® (olokizumab) in patients with rheumatoid arthritis (RA) in real-world clinical practice, with a targeted assessment of patient report outcomes (PRO) and central sensitization.

METHODS: An open-label observational non-interventional study was conducted, enrolling 183 patients with moderate and severe RA activity. All patients received OKZ 64 mg SC as injections every 4 weeks (Q4W) with methotrexate. The patients’ follow-up period was 24 weeks or less. RA activity (DAS28-CRP), pain severity (NRS), patient global assessment (PGA, NRS), functional impairment (NRS), fatigue (FACIT-F), central sensitization (central sensitization inventory, CSI), and symptoms of neuropathic pain (PainDETECT) were evaluated.

RESULTS: The study cohort was comprised of 144 patients. And 39 patients were lost to follow-up, refused OKZ treatment, or were not dosed with OKZ for administrative reasons. In 6 months, DAS28-CRP decreased to 3.3 ± 0.9 (p < .001) and statistically significant reductions in pain intensity, PGA, functional impairment, and fatigue were achieved. Pain intensity decreased as early as 2 days after the first OKZ administration (p < .05). The number of patients with CSI >40 in 24 weeks decreased from 71.0% to 21.0% (p < .001), with PainDETECT >18 – from 21.5% to 13.2%. NSAIDs use decreased from 70.8% to 33.8% (р < .001), steroids – from 54.2% to 32.6%. AEs were reported in 14.2% patients, serious events were observed in three patients.

CONCLUSION: OKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system.

PMID:39441547 | DOI:10.1111/1756-185X.15320

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Personal Recovery With Bipolar Disorder: A Network Analysis

Clin Psychol Psychother. 2024 Sep-Oct;31(5):e70001. doi: 10.1002/cpp.70001.

ABSTRACT

BACKGROUND: Personal recovery is valued by people with bipolar disorder (BD), yet its conceptualisation is unclear. Prior work conceptualising personal recovery has focussed on qualitative evidence or clinical factors without considering broader psychosocial factors. This study used a network analysis of Bipolar Recovery Questionnaire (BRQ) responses, aiming to identify (1) independent relationships between items to identify those most “central” to personal recovery and (2) how the relationships between items reflect themes of personal recovery.

METHODS: The model was developed from BRQ responses (36 items) from 394 people diagnosed with bipolar disorder. The undirected network was based on a partial correlation matrix and was weighted. Strength scores were calculated for each node. Community detection analysis identified potential themes. The accuracy of the network was assessed using bootstrapping.

RESULTS: Two consistent communities were identified: “Access to meaningful activity” and “Learning from experiences.” “I feel confident enough to get involved in things in life that interest me” was the strongest item, although the strength stability coefficient (0.36) suggested strength should be interpreted with caution. The average edge weight was 0.02; however, stronger edges were identified.

LIMITATIONS: The network showed low stability, possibly due to sample heterogeneity. Future work could incorporate demographic variables, such as time since BD diagnosis or stage of personal recovery, into network estimation.

CONCLUSIONS: Network analysis can be applied to personal recovery, not only clinical symptoms of BD. Clinical applications could include tailoring recovery-focussed therapies towards encouraging important aspects of recovery, such as feeling confident to get involved with life.

PMID:39441546 | DOI:10.1002/cpp.70001

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Preliminary Characterisation of Immune Cell Populations in the Oral Mucosa of a Small Cohort of Healthy Dogs (Canis lupus familiaris)

Anat Histol Embryol. 2024 Nov;53(6):e13113. doi: 10.1111/ahe.13113.

ABSTRACT

Pre-determined anatomical locations in the oral cavity were biopsied, and their histomorphology was characterised using haematoxylin and eosin staining (H&E). The most abundant cell type was of dendritic morphology. Lymphocyte foci were not evident in the palatoglossal folds or the gingiva. Immunohistochemical staining (IHC) for validated leukocyte markers followed, including CD3, CD20, CD79α, CD204, and Iba1. Consistent with H&E findings, CD204 immunoreactivity predominated amongst all niches. With the exception of the alveolar mucosa and palatoglossal folds, we also demonstrate a significant difference in the population of macrophages by region for only the Iba1 antigen (p < 0.0001). B lymphocytes were found, and a significant difference was noted in the sub-epithelium where CD20-positive cells outnumbered those labelled as CD79a positive (p = 0.001), suggesting the possibility that these cells are in an active state in health. A similar significant difference was found in the subepithelial tissue for myeloid cells, as there were more cells labelled as CD204 positive over Iba1, which, along with their distribution pattern, indicates a possible functional and morphological overlap between these cells. No significant difference was found in epithelial tissues for cells of either myeloid or lymphoid origins. The results from this study suggest different regions of the oral cavity exhibit variations in the distribution of immune cells, particularly macrophages and B lymphocytes. Though more studies would be needed to confirm these findings, these differences may have implications for the immune response and overall health of the oral mucosa.

PMID:39441534 | DOI:10.1111/ahe.13113

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Retraction Note: Long-run equilibrium relationship between energy consumption and CO2 emissions: a dynamic heterogeneous analysis on North Africa

Environ Sci Pollut Res Int. 2024 Oct 23. doi: 10.1007/s11356-024-35373-5. Online ahead of print.

NO ABSTRACT

PMID:39441514 | DOI:10.1007/s11356-024-35373-5

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From the highway to receiving water bodies: identification and simultaneous quantification of small microplastics (< 100 µm) in highway stormwater runoff

Environ Sci Pollut Res Int. 2024 Oct 23. doi: 10.1007/s11356-024-35302-6. Online ahead of print.

ABSTRACT

Highway stormwater (HSW) runoff is among the environment’s most important sources of microplastics. This study aimed to characterize via vibrational spectroscopy and quantify SMPs (small microplastics < 100 µm) in HSW runoff from a trafficked highway entering a facility equipped with a filtration system and in those flowing out to the receiving water body near agricultural activities. Samples of the inlet runoff (from the highway) and outlet runoff (the discharge into the environment) were collected in different periods to investigate potential seasonal and spatial differences. The sampling, methodology, and analysis were thoroughly carried out to quantify and simultaneously identify SMPs via Micro-FTIR to obtain a specific novel dataset to assess the environmental quality of highway pollution. A significant difference between inlet and outlet samples was reported; the highest abundance in inlet samples was 39813 ± 277 SMPs L.1 (SW10 IN; average length of 77 µm), while the highest one in outlet samples was 15173 ± 171 SMPs L-1 (SW10 OUT; SMPs’ average length of 63 µm). Polyamide 6 (PA 6) and High-Density Polyethylene (HDPE) were predominant. Our results show that these HSW treatment plants, designed for managing regulated pollutants, can intercept SMPs, improving the quality of HSW runoff discharged into the environment.

PMID:39441510 | DOI:10.1007/s11356-024-35302-6