Categories
Nevin Manimala Statistics

What tool do undergraduate pharmacy students prefer when grading systematic review evidence: AMSTAR-2 or ROBIS?

Cochrane Evid Synth Methods. 2023 Aug 9;1(6):e12023. doi: 10.1002/cesm.12023. eCollection 2023 Aug.

ABSTRACT

INTRODUCTION: While systematic reviews (SRs) are considered the highest form of evidence in the hierarchy, the quality and standard of reviews varies. Two quality assessment tools have been developed to assess the variation in such standards. This study compared the preference, validity, reliability, and applicability of using A Measurement Tool to Assess Systematic Reviews (AMSTAR-2) and the Risk of Bias in Systematic Reviews (ROBIS) for critically appraising evidence by pharmacy students.

MATERIALS AND METHODS: Students attended eight lectures on evidence-based medicine. Students independently assessed two SRs using AMSTAR-2 and ROBIS. The agreement between both tools were calculated using Spearman’s test while interrater reliability was calculated using Fleiss’ κ statistics.

RESULTS: Students reported a preference for the AMSTAR-2 tool due to its clear and distinct rating criteria as well as guidance provided by the tool’s developer. In comparison, students found the items on the ROBIS tool difficult to judge as it was subjective. A moderate agreement between both tools on the overall domain ratings was noted (Spearman r s = 0.60). There was slight agreement in the overall confidence using AMSTAR-2 (κ = 0.05; 95% confidence interval [CI]: 0.01-0.12) and the overall domain in ROBIS (κ = 0.09; 95% CI: 0.01-0.16).

CONCLUSION: The AMSTAR-2 tool had a low level of concordance in ratings of review among students. However, the AMSTAR-2 tool was preferred by students due to the clear guidance and ease of use.

PMID:40476276 | PMC:PMC11795889 | DOI:10.1002/cesm.12023

Categories
Nevin Manimala Statistics

Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010

Cochrane Evid Synth Methods. 2024 May 15;2(5):e12057. doi: 10.1002/cesm.12057. eCollection 2024 May.

ABSTRACT

INTRODUCTION: An important mechanism of research waste is inadequate incorporation of, and references to, previous relevant research. Identifying references for a research manuscript can be challenging, in part due to the exponential rise in potentially relevant literature to consider. For large research projects, such as developing or updating reporting guidelines, it may be helpful to construct a supportive topic-specific bibliographic database.

METHODS: In support of updating the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the CONsolidated Standards Of Reporting Trials (CONSORT) 2010, we developed the SPIRIT-CONSORT Evidence Bibliographic database (SCEBdb): a freely available topic-specific bibliographic database of publications providing an evidence foundation for the updates. We searched multiple sources of potential publications and tagged included ones with database-specific keywords. For context, we also formulated 10 core considerations for constructing topic-specific bibliographic databases and identified and described 5 illustrative other databases.

RESULTS: As of April 2024, the SCEBdb included 846 publications. The database proved useful as a supplementary information source for our scoping review of published comments on SPIRIT 2013 and CONSORT 2010, for a supplementary Delphi process, and in the writing phase of the guidance documents. We expect that the database will be useful for future projects within the fields of clinical research methodology, bias, evidence synthesis, and randomized trials.

CONCLUSION: The methods involved in constructing the SCEBdb, and our suggested core considerations for topic-specific bibliographic databases, could be helpful for researchers reflecting on whether, and how, to develop a topic-specific bibliographic database.

PMID:40476263 | PMC:PMC11795946 | DOI:10.1002/cesm.12057

Categories
Nevin Manimala Statistics

EValuation of Acute and Early Phase P2Y12 Inhibitor DE-escalation After PerCutaneous Intervention (EVADE PCI)

Kans J Med. 2025 Apr 14;18(2):31-34. doi: 10.17161/kjm.vol18.22921. eCollection 2025 Mar-Apr.

ABSTRACT

INTRODUCTION: Aspirin and an oral P2Y12 inhibitor are recommended for one year after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes. While ticagrelor or prasugrel, more potent P2Y12 inhibitors, are preferred over clopidogrel, de-escalation often is based on provider judgment. This study compared cardiovascular outcomes and bleeding risks between patients who remained on ticagrelor or prasugrel (unchanged group) and those de-escalated to clopidogrel within 30 days of PCI.

METHODS: The authors analyzed data from patients admitted between June 2014 and December 2022 for acute coronary syndromes requiring PCI who received an oral P2Y12 inhibitor within 72 hours of admission. The primary outcome was a composite of all-cause mortality, urgent revascularization, stent thrombosis, stroke, and major bleeding at one year. Secondary outcomes included the individual components of the composite outcome. Statistical analyses included chi-square tests, Student’s t-tests, or non-parametric equivalents, as appropriate.

RESULTS: A total of 210 patients met the inclusion criteria, with 149 remaining on unchanged P2Y12 therapy and 61 undergoing de-escalation. There was no statistically significant difference in the composite outcome between the unchanged and de-escalated groups (n [%]: 25 [17] vs. 6 [10]; χ2 [1, N = 210] = 1.658, p = 0.198). Additionally, secondary outcomes, including all-cause mortality, urgent revascularization, stent thrombosis, stroke, and major bleeding, did not differ significantly between groups.

CONCLUSIONS: A composite outcome of all-cause mortality, urgent revascularization, stent thrombosis, stroke, and major bleeding at one year was similar between patients who continued ticagrelor or prasugrel and those de-escalated to clopidogrel within 30 days of PCI. Larger studies are needed to confirm these findings and assess the optimal timing for therapy adjustments.

PMID:40476260 | PMC:PMC12135783 | DOI:10.17161/kjm.vol18.22921

Categories
Nevin Manimala Statistics

Potential Mediating Role of Polygenic Hazard Score in the Association Between Neurofilament Light Chain and Default Mode Network Connectivity Across the Alzheimer’s Disease Continuum

IBRO Neurosci Rep. 2025 May 1;18:732-738. doi: 10.1016/j.ibneur.2025.04.018. eCollection 2025 Jun.

ABSTRACT

BACKGROUND: Alzheimer’s disease (AD) is a complex neurodegenerative disorder marked by progressive cognitive decline and disrupted brain network connectivity, particularly within the default mode network (DMN). Neurofilament light chain (NfL) serves as a biomarker for axonal injury, but the role of genetic predisposition, assessed via the Polygenic Hazard Score (PHS), in mediating the association between plasma NfL and DMN connectivity remains unclear. This study investigates whether PHS mediates the association between plasma NfL levels and DMN connectivity in individuals across different cognitive stages, including cognitively normal (CN), mild cognitive impairment (MCI), and AD.

METHODS: Data were extracted from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Plasma NfL concentrations were measured using the Simoa assay, and resting-state fMRI (rs-fMRI), assessed DMN connectivity. The cohort included 102 participants (nCN=28, nMCI=52, and nAD=22). Partial correlation analyses and mediation models were performed, adjusting for age and gender. Statistical significance was set at p < 0.05, after corrections for multiple comparisons.

RESULTS: Plasma NfL levels were significantly higher in AD group compared to CN and MCI groups (p = 0.030). DMN connectivity showed substantial declines in the AD group, particularly in the posterior and ventral regions. Significant negative correlations were observed between plasma NfL and ventral DMN connectivity in AD. However, mediation analysis indicated no significant indirect effect of PHS, suggesting that genetic risk does not mediate the plasma NfL-DMN association.

CONCLUSION: These findings suggest that elevated plasma NfL levels are associated with disrupted ventral DMN connectivity in AD, reflecting neurodegeneration-related network dysfunction. However, the lack of a mediating effect by PHS indicates that this relationship is likely independent of genetic risk burden.

CLINICAL TRIAL NUMBER: not applicable.

PMID:40476223 | PMC:PMC12139489 | DOI:10.1016/j.ibneur.2025.04.018

Categories
Nevin Manimala Statistics

Oxidized Mannan: A Novel Adjuvant Candidate for Enhancing Immune Responses in Veterinary Rabies Vaccine

Chonnam Med J. 2025 May;61(2):84-89. doi: 10.4068/cmj.2025.61.2.84. Epub 2025 May 23.

ABSTRACT

Rabies continues to pose a serious public health threat worldwide, with vaccination being the most effective means of prevention. However, commercially available inactivated rabies vaccines often require multiple doses and lack potent adjuvants to enhance their efficacy. This study aimed to investigate the coupling of whole inactivated rabies virus to mannan under oxidizing conditions to improve immune responses against a standard rabies vaccine. We explored the conjugation of whole inactivated rabies virus with oxidized mannan (Rab-OxMan) to enhance immune responses. Mice were immunized intraperitoneally with 350 µg of the Rab-OxMan formulation on days 1 and 7. Two weeks after immunization, serum samples were collected to measure levels of IgG, IgM, and TNF-α using ELISA. The vaccine’s potency was also evaluated using the National Institutes of Health (NIH) assay. Our findings showed a significant increase in IgG levels and a decrease in IgM levels in the Rab-OxMan group compared to the Alum-adjuvanted vaccine group (p<0.05). Additionally, TNF-α levels were notably higher in the Rab-OxMan group (p<0.05). Statistical analysis revealed that IgG levels had the highest sensitivity and specificity, with a significant correlation between the measured variables. Importantly, the Rab-OxMan formulation provided 1.8 times greater protection in challenge tests compared to the alum-adjuvanted group. This study is the first to demonstrate that oxidized mannan can serve as a novel adjuvant for veterinary rabies vaccines. The results highlight significant improvements in the immunogenicity and efficacy of rabies vaccines, suggesting a promising strategy for enhancing rabies prevention and potentially reducing the incidence of this deadly disease.

PMID:40476209 | PMC:PMC12133443 | DOI:10.4068/cmj.2025.61.2.84

Categories
Nevin Manimala Statistics

QFR measurements post CTO percutaneous coronary intervention: Can the long term outcome be predicted?

Int J Cardiol Heart Vasc. 2025 May 6;59:101689. doi: 10.1016/j.ijcha.2025.101689. eCollection 2025 Aug.

ABSTRACT

BACKGROUND: QFR, a non-invasive tool using 3D coronary artery imaging and fluid dynamics, helps assess revascularization benefits in patients with coronary chronic total occlusion (CTO).

METHODS AND RESULTS: A retrospective study of 616 CTO patients who underwent PCI for CTO, with QFR assessed post-procedure. In a 5-year follow-up study involving 616 patients, the study used three tertiles (first tertile: QFR ≥ 0.88, second tertile: 0.85 ≤ QFR < 0.88, third tertile: QFR < 0.85) to determine the “cut-off” value. QFR showed strong predictive power with an area under the curve (AUC) of 0.80 (95 % confidence interval: 0.77-0.83, P < 0.001). The occurrence of MACCEs among all participants in the study was 28.4 %. This rate varied across different groups, with 63.9 % in the low QFR tertile, 14.8 % in the middle tertile, and 12.6 % in the high QFR group. During the follow-up period, a variation in the occurrence of MACCEs was observed among the three groups (P < 0.05). Analysis using Kaplan-Meier curves indicated a statistically major difference in the cumulative rates of MACCEs across the groups. Competing risk regression analysis indicated that QFR is negatively associated with all-cause mortality, cardiovascular mortality, and composite MACCEs.

CONCLUSION: The study found a high prognostic value of physiological assessment using QFR after successful CTO intervention.

PMID:40476177 | PMC:PMC12138560 | DOI:10.1016/j.ijcha.2025.101689

Categories
Nevin Manimala Statistics

Effects of General Anesthesia on the Success Rate of Pneumatic Reduction in the Treatment of Intussusception

Med J Islam Repub Iran. 2024 Dec 3;38:141. doi: 10.47176/mjiri.38.141. eCollection 2024.

ABSTRACT

BACKGROUND: Intussusception is one of the most frequent reasons for intestinal obstruction in young children, which needs to be treated immediately. When it comes to non-operative reduction, there is no gold standard. Our goal was to look into how general anesthesia affected the success rate of pneumatically reduced intussusception guided by fluoroscopy.

METHODS: This prospective study was done throughout the time between January 2023 and January 2024 by collaboration between the Pediatric Surgery Unit and Diagnostic Radiology Departments, Al-Azhar University Hospital, New Damietta, Egypt. Under general anesthesia, pneumatic reduction guided by fluoroscopy was performed on all intussusception patients. Children with pathologic lead points discovered by ultrasonography, those with symptoms of intestinal perforation or peritonitis, and those who were hemodynamically unstable were excluded. Statistical analysis of the obtained data was done using the SPSS program (version 20).

RESULTS: In all, 34 children between the ages of 3-28 months, pneumatic reduction under general anesthesia was successful in 32 individuals (94.1% overall). On the first trial, the intussusception was succeeded in 26 patients; on the second try, it was reduced in 5 patients, and in the third, in 1 patient. In two cases, the intussusception failed after three successive trials. One of them was diagnosed as an extended intussusception mass, which was later surgically confirmed, and the other was an appendico-cecal intussusception. During the reduction efforts, there was no bowel perforation or death reported.

CONCLUSION: As a first-line therapy for pediatric intussusception, fluoroscopy-guided PR under GA is straightforward, risk-free, and successful, with no complications or mortalities.

PMID:40476172 | PMC:PMC12138778 | DOI:10.47176/mjiri.38.141

Categories
Nevin Manimala Statistics

The Association between Oligohydramnios and the Risk of Malpresentation: A Meta-Analysis

Med J Islam Repub Iran. 2024 Dec 18;38:149. doi: 10.47176/mjiri.38.149. eCollection 2024.

ABSTRACT

BACKGROUND: There is no consensus on the role of oligohydramnios on the increased risk of fetal malpresentation. Therefore, we decided, for the first time, to collect all published studies on this topic to synthesize all available data through a systematic review and meta-analysis to evaluate the effect of oligohydramnios on the increased risk of fetal malpresentation.

METHODS: A search was done in the following international electronic bibliographic databases: PubMed, Web of Science, and Scopus to April 2021. Heterogeneity among studies was determined by the Q-test and I2 statistic. Publication bias was assessed by Begg and Egger tests. The results were reported using odds ratio (OR) estimates with 95% confidence intervals (CI) using a random-effects model. Data were analyzed using Stata software Version 14 (StataCorp).

RESULTS: The meta-analysis identified 431 articles, comprising 227,351 participants, exploring the link between oligohydramnios and malpresentation. A significant association was found (OR, 1.79 [95% CI, 1.42-2.15]), indicating that oligohydramnios increases the risk of malpresentation. The analysis also revealed substantial heterogeneity among the included studies (I² = 80.2%; P < 0.001).

CONCLUSION: This meta-analysis provides robust evidence that oligohydramnios is a significant risk factor for fetal malpresentation. These findings underscore the critical importance of monitoring amniotic fluid levels during pregnancy. The results suggest that healthcare providers should prioritize the assessment of amniotic fluid volume in pregnant patients, especially those presenting with risk factors for oligohydramnios.

PMID:40476169 | PMC:PMC12138669 | DOI:10.47176/mjiri.38.149

Categories
Nevin Manimala Statistics

Understanding Suboptimal Insulin Use in Type 1 and Type 2 Diabetes: A Cross-Sectional Survey of People with Diabetes

Patient Prefer Adherence. 2025 May 31;19:1625-1638. doi: 10.2147/PPA.S511332. eCollection 2025.

ABSTRACT

PURPOSE: This analysis aimed to document suboptimal insulin dosing (missed or skipped and mistimed basal and/or bolus) in people with diabetes (PwD), including type 1 diabetes (T1D) and type 2 diabetes (T2D). Additionally, barriers and solutions for optimal insulin dosing were explored.

PATIENTS AND METHODS: This multinational, cross-sectional, online survey was conducted in the United States, the United Kingdom, and Germany. Eligible PwD with T1D or T2D used an analog insulin pen. Data were analyzed using descriptive statistics.

RESULTS: A total of 1150 PwD (T1D: 300; T2D: 850) were included. Overall, a proportion of PwD reported missing 1 or more basal (48.2%) or bolus dose (59.6%) in the past 30 days. Among those who reported missing doses, the average number [standard deviation] was 3.6 [3.6] basal doses and 4.6 [7.4] bolus doses. PwD reported forgetting, being too busy/distracted, and finding it too complicated or burdensome as key reasons for missed doses. A proportion of PwD reported mistiming 1 or more basal (45.7%) dose or bolus (53.6%) dose in the past 30 days. Among those who reported mistiming doses, the average was 3.9 [4.0] basal and 5.1 [8.1] bolus doses. Key reasons reported for mistiming doses included being too busy or distracted, being out of routine, or having an unexpected or earlier/later-than-expected meal.

CONCLUSION: Suboptimal insulin use is prevalent among PwD, with nearly half of participants reporting missed or mistimed doses in the past 30 days. Results indicate the need for support to help PwD self-manage the complexity of insulin treatment and to improve outcomes due to suboptimal insulin dosing. Such support might include devices that record measurements and dosing and provide feedback.

PMID:40476160 | PMC:PMC12139093 | DOI:10.2147/PPA.S511332

Categories
Nevin Manimala Statistics

Understanding Psoriasis Patient Preferences for Biologic Dosing Frequencies: Insights From a Patient Survey

J Psoriasis Psoriatic Arthritis. 2025 Jun 2:24755303251345804. doi: 10.1177/24755303251345804. Online ahead of print.

ABSTRACT

Biologic dosing frequency is a key concern among psoriasis (PsO) patients and physicians, yet dosing optimization remains a challenge. This study evaluates patient dosing preferences for IL-17 and IL-23 inhibitors, risankizumab (RZB) every 12 weeks, guselkumab (GUS) every 8 weeks, and ixekizumab (IXE) every 4 weeks, in managing PsO. This phone survey study evaluated 87 adults on RZB (n = 29), GUS (n = 35), or IXE (n = 23) from 2019 onward at two clinical sites. Patients were assessed for baseline PsO bothersome severity, current dosing frequency satisfaction, frequency of PsO flares, and preferred dosing frequency. Most patients were males (57.5%) with an average age of 54.1 years and an average treatment duration of 19.0 months. At baseline before treatment, 87% were ‘very bothered’ by their PsO. After treatment, 86% were either ‘3-somewhat’ or ‘4-very satisfied’ with their current dosing schedule, with no significant differences between each drug (P = 0.7). Across all biologics the majority of participants (62% with RZB, 57% with GUS, and 48% with IXE) preferred maintaining their current dosing frequency. No statistically significant differences were observed in dosing frequency preference between treatment groups, suggesting dosing schedule is not a primary concern for most patients. This aligns with previous research demonstrating effective disease control is the most important factor for patient satisfaction; however, tailoring dosing regimens to individual patient needs can also strengthen long-term adherence, as demonstrated in recent studies.

PMID:40476147 | PMC:PMC12133784 | DOI:10.1177/24755303251345804