Nevin Manimala

Acta Radiol. 2024 May 24:2841851241253775. doi: 10.1177/02841851241253775. Online ahead of print.

ABSTRACT

BACKGROUND: Brain magnetic resonance imaging voxel-based morphometry (VBM) and perfusion single-photon emission computed tomography (SPECT) are useful for differentiating dementia with Lewy bodies (DLB) from Alzheimer’s disease (AD).

PURPOSE: To determine whether combining multiple parameters of VBM and SPECT using a multiparametric scoring system (MSS) improves diagnostic accuracy in differentiating DLB from AD.

MATERIAL AND METHODS: In total, 23 patients with DLB and 57 patients with AD underwent imaging using a voxel-based specific regional analysis system for AD (VSRAD), an easy Z-score imaging system, and a Z-Graph using three-dimensional stereotactic surface projection. The cutoff values were determined using the receiver operating characteristic curve to differentiate DLB from AD for all parameters. Patients were scored 1 (DLB) or 0 (AD) for each statistically significant parameter, according to a threshold. The total score was determined for each case to obtain a cutoff value for the MSS.

RESULTS: The mean Z-scores in the medial temporal lobes using the VSRAD were significantly lower in patients with DLB than in those with AD. Each Z-score of the summed Z-scores in all four segmented regions of the occipital lobes using the Z-Graph was significantly higher in patients with DLB than in those with AD. Among the five parameters, the highest accuracy was 80% for the Z-score of the summed Z-scores in the left medial occipital lobe. For the MSS, a cutoff value of four improved the diagnostic accuracy to 82%.

CONCLUSION: MSS was more accurate than any single parameter of VBM or SPECT in differentiating DLB from AD.

PMID:38785068 | DOI:10.1177/02841851241253775

Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241258230. doi: 10.1177/10760296241258230.

ABSTRACT

Valuable data on deep vein thrombosis (DVT) patients with coexisting pulmonary embolism (PE) is scarce. This study aimed to identify risk factors associated with these patients and develop logistic regression models to select high-risk DVT patients with coexisting PE. We retrospectively collected data on 150 DVT patients between July 15, 2022, and June 15, 2023, dividing them into groups based on the presence of coexisting PE. Univariate and multivariate logistic regression analyses were performed to identify significant risk factors and construct predictive models. Discrimination and calibration statistics evaluated the validation and accuracy of the developed models. Of the 130 patients analyzed, 40 (30.77%) had coexisting PE. Univariate analysis revealed four significant predictors of DVT patients with coexisting PE: sex (OR 3.83, 95% CI: [1.76; 8.59], P = 0.001), body mass index (BMI) (OR 1.50, 95% CI: [1.28; 1.75], P < 0.001), chronic disease (OR 5.15, 95% CI: [2.32; 11.8], P < 0.001), and high-density lipoprotein (HDL) (OR 0.03, 95% CI: [0.01; 0.20], P < 0.001). Additionally, BMI > 24 kg/m² (OR 9.70, 95% CI: [2.70; 67.5], P < 0.001) and BMI > 28 kg/m² (OR 4.80, 95% CI: [2.15; 11.0], P < 0.001) were associated with concurrent PE. Three multiple regression models were constructed, with areas under the receiver-operating characteristic curves of 0.925 (95% CI: [0.882; 0.968]), 0.908 (95% CI: [0.859; 0.957]), and 0.890 (95% CI: [0.836; 0.944]), respectively. Sex, BMI, chronic disease, and HDL levels are significant predictors of DVT patients with coexisting PE.

PMID:38785063 | DOI:10.1177/10760296241258230

Ter Arkh. 2023 Dec 28;95(12):1165-1171. doi: 10.26442/00403660.2023.12.202554.

ABSTRACT

AIM: Evaluation of the efficacy and safety of the drug Aterixen^® (XC221GI, 1-[2-(1-methylimidazole-4-yl)-ethyl]perhydroazine-2,6-dione), in the treatment of uncomplicated forms of influenza and other ARVI in adults.

MATERIALS AND METHODS: The phase III clinical trial enrolled 260 people aged 18-65 years with mild and moderate forms of influenza or other ARVI. Patients were randomly assigned to two groups: in group 1 (n=130), patients were prescribed the drug Aterixen® in tablets of 100 mg 2 times a day for 5 days; in group 2 (n=130) – a placebo corresponding to the drug, in the same regimen. The primary endpoint of the efficacy assessment was the time in hours from the first administration of the drug to clinical improvement. The main efficacy analysis was performed in a population of patients with PCR-confirmed influenza or ARVI who completed the study according to the protocol (per protocol infected). Additionally, efficacy was evaluated in ITT and PP populations, including patients with both identified and undetected pathogen. The population for safety analysis included all patients, without exception, who were exposed to at least one exposure to the study drug or placebo.

RESULTS: A statistically significant superiority of the drug Aterixen^® over placebo in primary endpoint was revealed in both the main and additional analysis in all studied populations: clinical improvement in the group of the studied drug occurred 24 hours faster compared with the placebo group. The evaluation of the effectiveness of secondary endpoints confirmed the superiority of the drug Aterixen^® over placebo in terms of relief of catarrhal symptoms and symptoms of intoxication. A favorable safety profile of the drug has been demonstrated.

CONCLUSION: The drug has demonstrated a favorable safety profile for use in outpatient practice. Aterixen^® is an effective and safe treatment for influenza and other ARVI in adults.

PMID:38785056 | DOI:10.26442/00403660.2023.12.202554

Ter Arkh. 2023 Dec 28;95(12):1141-1150. doi: 10.26442/00403660.2023.12.202540.

ABSTRACT

AIM: To evaluate the efficacy of Artneo (AN) in comparison with a combination of glucosamine hydrochloride and chondroitin sulfate (GC) in patients with osteoarthritis (OA) of the knee joint (KJ).

MATERIALS AND METHODS: 70 patients with stages I-III of primary knee OA were randomized into 2 groups. Participants in the 1st (n=35) took AN 1 caps/day, in the 2nd (n=35) GC according to the standard regimen. After 7, 30, 90, 180 days, the Lequesne index (severity of OA), pain when moving according to VAS, WOMAC score were assessed, after 1, 3, 6 months – quality of life SF-36 and morning stiffness, after 6 months – MRI with T2 mapping, laboratory safety indicators.

RESULTS: Over the course of 6 months of use, an improvement in the WOMAC index and a decrease in pain were observed without intergroup differences, and a greater decrease in stiffness in the AN group. After 3 months, the severity of OA decreased from moderate to mild in the AN group and was significantly lower compared to the GC group; quality of life (physical component of SF-36) was higher in the AN group. After 6 months, there was an improvement in cartilage ultrastructure (T2 relaxation time) in both groups and a more pronounced reduction of the synovitis area (MRI) in the AN group (2.95 and 1.37 times in the AN and GC group, respectively). There were no clinically significant adverse reactions observed in both groups.

CONCLUSION: The use of AN in patients with stage I-III primary knee OA was not inferior in efficacy to the combination of GC. Further studies with greater statistical power (sample size) and follow-up period are warranted including in real clinical practice.

PMID:38785054 | DOI:10.26442/00403660.2023.12.202540

Ter Arkh. 2023 Dec 28;95(12):1103-1111. doi: 10.26442/00403660.2023.12.202490.

ABSTRACT

AIM: To study overall drug resistance genes (resistome) in the human gut microbiome and the changes in these genes during COVID-19 in-hospital therapy.

MATERIALS AND METHODS: A single-center retrospective cohort study was conducted. Only cases with laboratory-confirmed SARS-CoV-2 RNA using polymerase chain reaction in oro-/nasopharyngeal swab samples were subject to analysis. The patients with a documented history of or current comorbidities of the hepatobiliary system, malignant neoplasms of any localization, systemic and autoimmune diseases, as well as pregnant women were excluded. Feces were collected from all study subjects for subsequent metagenomic sequencing. The final cohort was divided into two groups depending on the disease severity: mild (group 1) and severe (group 2). Within group 2, five subgroups were formed, depending on the use of antibacterial drugs (ABD): group 2A (receiving ABD), group 2AC (receiving ABD before hospitalization), group 2AD (receiving ABD during hospitalization), group 2AE (receiving ABD during and before hospitalization), group 2B (not receiving ABD).

RESULTS: The median number of antibiotic resistance (ABR) genes (cumulative at all time points) was significantly higher in the group of patients treated with ABD: 81.0 (95% CI 73.8-84.5) vs. 51.0 (95% CI 31.1-68.4). In the group of patients treated with ABD (2A), the average number of multidrug resistance genes (efflux systems) was significantly higher than in controls (group 2B): 47.0 (95% CI 46.0-51.2) vs. 21.5 (95% CI 7.0-43.9). Patients with severe coronavirus infection tended to have a higher median number of ABR genes but without statistical significance. Patients in the severe COVID-19 group who did not receive ABD before and during hospitalization also had more resistance genes than the patients in the comparison group.

CONCLUSION: This study demonstrated that fewer ABR genes were identified in the group with a milder disease than in the group with a more severe disease associated with more ABR genes, with the following five being the most common: SULI, MSRC, ACRE, EFMA, SAT.

PMID:38785049 | DOI:10.26442/00403660.2023.12.202490

Public Health Nutr. 2024 May 24:1-26. doi: 10.1017/S1368980024001150. Online ahead of print.

ABSTRACT

OBJECTIVE: Research is available on improved coverage and practices from several large-scale maternal nutrition programs, but not much is known on change in inequalities. This study analyses wealth- and education-inequality using Erreygers and Concentration indices for four indicators: adequate IFA consumption, women’s dietary diversity, and counseling on IFA and dietary diversity.

DESIGN: A pretest-post-test, control group design.

SETTING: Maternal nutrition intervention programs conducted in Bangladesh, Burkina Faso, and Ethiopia during 2015-2022.

PARTICIPANTS: Recently delivered women (RDW) and pregnant women (PW).

RESULTS: Statistically significant reductions in education inequality were observed for adequate IFA consumption, counselling on IFA and dietary diversity in intervention areas of Bangladesh, and for adequate IFA consumption in intervention areas of Burkina Faso.A significant decrease in wealth inequality was observed for adequate IFA consumption in the intervention areas of Bangladesh whereas a significant increase was observed in the non-intervention areas for counselling on IFA in Ethiopia and for dietary diversity in Burkina Faso.

CONCLUSION: The results can be attributed to the extensive delivery system at community level in Bangladesh and being predominantly facility-based in the Burkina Faso and Ethiopia. COVID-19 disruptions (in Burkina Faso and Ethiopia) and indicator choice also had a role in the results.The main take-aways for nutrition programs are a) assess equality issues through formative studies during designing, b) monitor inequality indicators during implementation, c) diligently address inequality through targeted interventions, setting aside resources and motivating frontline workers to reduce disparities, and d) make equality analysis a routine part of impact evaluations.

PMID:38785047 | DOI:10.1017/S1368980024001150

Int J Retina Vitreous. 2024 May 23;10(1):39. doi: 10.1186/s40942-024-00558-0.

ABSTRACT

BACKGROUND: The aim of this study is to evaluate near and distance visual acuity (VA) and their correlation with the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) outcomes in patients with diabetic macular edema (DME) and macular edema due to retinal vein occlusion (RVO) treated with aflibercept.

METHODS: In this prospective study, we included 87 eyes of patients diagnosed with DME (n = 61) and RVO (n = 26), who received aflibercept treatment and were followed until the 8th injection. Near VA was examined on the 1st, 2nd, 3rd, 4th, 6th, and 8th injection, and patients completed the NEI VFQ-25 on the 1st, 4th, and 8th aflibercept injection.

RESULTS: The mean near VA at baseline in all eyes was 0.89 ± 0.12 logMAR. With every administration, there was a statistically significant improvement; on the 4th (0.70 ± 0.19; p = 0.000) and the 8th application (0.60 ± 0.19; p = 0.000). At baseline, the mean NEI VFQ-25 total score was 71 ± 14%, and improved to 81 ± 13% (p = 0.000) on the 8th injection. The most significant score gain was recorded in the near VA subscale (+ 20 ± 14%, p = 0.000). There was no statistically significant difference between DME and RVO group in the questionnaire or near VA outcomes.

CONCLUSION: Aflibercept treatment resulted in a remarkable improvement of near vision by 4 lines of logMAR optotype after the 8th application. The near vision questionnaire subscale, initially scoring the lowest, exhibited the greatest gain during the treatment period. This underscores the importance of near vision and reading ability for patients with DME and RVO.

PMID:38783380 | DOI:10.1186/s40942-024-00558-0

Adv Rheumatol. 2024 May 23;64(1):42. doi: 10.1186/s42358-024-00383-x.

ABSTRACT

BACKGROUND: The diagnostic and prognostic relevance of Human Leukocyte Antigen B-27 (HLA-B27) in Axial Spondyloarthritis (AxSpA) is undeniable, with 70% of Ankylosing Spondylitis (AS) patients carrying the B27 gene, contrasted with a mere 4.35% in the general population. Flow cytometry (FC) and Polymerase Chain Reaction (PCR) have emerged as the predominant techniques for routine HLA-B27 typing. While various studies have compared these methods, none have catered to the unique characteristics of the Brazilian demographic. Therefore, this research aims to compare FC and PCR in a Brazilian cohort diagnosed with AxSpA.

METHODS: An analytical cross-sectional study was undertaken involving 62 AxSpA outpatients from a Brazilian University Hospital. Both FC and PCR-SSP assays were utilized to ascertain HLA-B27 typing. The outcomes (either confirming or refuting the allele’s presence) underwent rigorous scrutiny. Agreement between the methodologies was assessed using the kappa statistic. A p-value of < 0.05 was deemed statistically significant.

RESULTS: Of the participants, 90.3% (n = 56) were HLA-B27 positive according to FC, while 79% (n = 49) were identified as positive using the PCR method. FC exhibited a sensitivity rate of 98% paired with a specificity of 38.5%. The Positive Predictive Value for FC stood at 85.7%, and the Negative Predictive Value was 83.5%. Consequently, the overall accuracy of the FC method was gauged at 85.5%. A kappa coefficient of κ = 0.454 was derived.

CONCLUSIONS: FC demonstrated noteworthy sensitivity and satisfactory accuracy in HLA-B27 detection, albeit with a reduced specificity when contrasted with PCR-SSP. Nevertheless, given its cost-effectiveness and streamlined operation relative to PCR, FC remains a pragmatic option for preliminary screening in clinical practice, especially in low-income regions. To optimize resource allocation, we advocate for a refined algorithm that initiates by assessing the relevance of HLA-B27 typing based on Choosing Wisely recommendations. It then leans on FC, and, if results are negative yet clinical suspicion persists, advances to PCR. This approach aims to balance diagnostic accuracy and financial prudence, particularly in regions contending with escalating medical costs.

PMID:38783377 | DOI:10.1186/s42358-024-00383-x

Tob Control. 2024 May 23:tc-2023-058511. doi: 10.1136/tc-2023-058511. Online ahead of print.

ABSTRACT

BACKGROUND: Philip Morris International (PMI) claims to be transforming and has committed to a ‘smoke-free’ future. In 2020, it announced an ‘aspirational’ target for reduced cigarette shipments by 2025.

METHODS: PMI cigarette shipment data are taken from PMI quarterly financial reports 2008-2023. Trends in these data before and after the 2020 announcement are analysed using linear regression, and auto regressive integrated moving average and error, trend, seasonal time-series models to assess if PMI’s 2025 target would be met on pre-existing trends, and if the trend changed after the announcement. These trends are also compared with the global retail market for cigarettes, using sales data from Euromonitor.

RESULTS: Findings were consistent across all three models. PMI’s shipment target of 550 billion cigarette sticks by 2025 would readily have been met given pre-existing shipment trends. Following the 2020 announcement, the decline in PMI cigarette shipments stalled markedly with a statistically significant change in trend (p<0.001). The current and projected trend to 2025 is consistent with no further decline in cigarette volumes, meaning PMI is unlikely to hit its target. This mirrors a global pattern in which declines in cigarette sales have stalled since 2020.

CONCLUSIONS: PMI’s 2025 target was not ‘aspirational’ but highly conservative-it would have been met based on pre-existing trends in declining cigarette shipments. Yet PMI will nonetheless fail to meet that target providing evidence it is not transforming. Stalling of the decline of PMI and global cigarette sales raises significant concerns about progress in global tobacco control.

PMID:38782585 | DOI:10.1136/tc-2023-058511

BMJ Evid Based Med. 2024 May 23:bmjebm-2023-112681. doi: 10.1136/bmjebm-2023-112681. Online ahead of print.

ABSTRACT

OBJECTIVE: The objectives of this scoping review were to provide an overview of existing guidelines for the development and validation of patient-reported outcome measures (PROMs), review them for comprehensiveness and clarity and provide recommendations for their use based on the goals of the instrument developers.

DESIGN: Scoping review.

METHODS: A literature search was performed in PubMed, Scopus, PsycInfo and Google Scholar up to 2 June 2023 to identify guidelines for the development and validation of PROMs. Screening of records and reports as well as data extraction were performed by two reviewers. To assess the comprehensiveness of the included guidelines, a mapping synthesis was performed and steps to develop and validate a measurement instrument outlined in the included guidelines were mapped to an a priori framework including 20 steps, which was based on the guideline by de Vet et al.

RESULTS: A total of 40 guidelines were included. Statistical advice (at least partially) was provided in 98% of the guidelines (39/40) and 88% (35/40) of the guidelines included examples for steps required to develop and validate PROMs. However, 78% (31/40) of the guidelines were not comprehensive and two essential steps in PROM development (‘consideration and elaboration of the measurement model’ and ‘responsiveness’) were not included in 80% and 72% of the guidelines, respectively. Three guidelines included all 20 steps and six included almost all steps (≥90% of steps) for developing and validating a PROM.

DISCUSSION: Most guidelines on PROM development and validation do not appear to be comprehensive, and some crucial steps are missing in most guidelines. Nevertheless, for some purposes of PROMs, many guidelines provide helpful advice and support.

CONCLUSION: At least 15 guidelines may be recommended, including three comprehensive guidelines that can be recommended for the development and validation of PROMs for most purposes (eg, to discriminate between subjects with a particular condition and subjects without that condition, to evaluate the effects of treatments (between a pre and post time-points) or to evaluate a status quo).

PMID:38782559 | DOI:10.1136/bmjebm-2023-112681