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Attitudes on participation in clinical drug trials: A nationally representative survey of older adults with multimorbidity

J Am Geriatr Soc. 2024 Mar 14. doi: 10.1111/jgs.18857. Online ahead of print.

ABSTRACT

BACKGROUND: Older adults with multimorbidity are under-represented in clinical drug trials. Their inclusion will not increase unless they are willing and able to participate. Data on motivators and barriers to participation in trials of new medications of older adults with multimorbidity are needed.

METHODS: Cross-sectional internet and telephone survey of a nationally representative sample of adults ≥65 years with ≥3 chronic conditions (NORC University of Chicago Amerispeak Panel) conducted from March-April, 2023 to determine motivators and barriers to drug trial participation, described graphically and using statistics.

RESULTS: Surveyed 1318 (1142 Internet, 176 phone) with mean age 72.3 ± 6.3 (SD), 52% women; race: 83% White, 10% Black or African American, 5% Hispanic or Latino, 1.1% Asian; 4.4 ± 1.9 chronic conditions (of 16 queried), taking 7.5 ± 3.3 medications. Barriers included fear of side effects (48%), taking too many medications (44%), placebo (44%), mobility (33%), bathroom needs (25%), hearing (19%), eyesight (15%), video visits (33%; higher in women, Black or African-American respondents, and those ≥80 years). Sixty-five percent would join all in-person trials, 49% would join all-video trials. Travel >1 h was difficult for 66%, most difficult for women. Trust was a concern in 25% of Black respondents. Caregiving responsibilities or lack of time were not obstacles. Participants were most likely to consider a drug trial for a problem they have (63%) versus prevention (44%) and if invited by a physician (80%) or University healthcare system (58%). Getting better care was ranked very important (79%) followed by helping others (57%).

CONCLUSIONS: Major concerns of older patients with multimorbidity about participation in drug trials are potential side effects, taking too many medicines, and video visits. Physicians have the greatest influence on decisions and in-person visits are preferred. Proposed changes in trial design to increase enrollment of under-represented older adults may not align with patient-reported preferences.

PMID:38485469 | DOI:10.1111/jgs.18857

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A Modified Arthroscopic Triple-row Repair Technique for L-shaped Delaminated Rotator Cuff Tears

Orthop Surg. 2024 Mar 14. doi: 10.1111/os.14039. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the clinical outcomes of a modified arthroscopic triple-row (TR) repair technique with the suture bridge (SB) repair technique in treating L-shaped delaminated rotator cuff tears. Various surgical techniques for L-shaped delaminated rotator cuff tears have been reported, many of which aid in increasing the contact area and pressure of the rotator cuff. However, there is still debate over which technique yields superior results.

METHODS: From January 2017 to March 2020, 61 cases of L-shaped delaminated rotator cuff tears were included in this study. Of these, 34 cases underwent the modified arthroscopic triple-row repair technique, while 27 cases were addressed with the suture bridge repair technique. Functional assessment was conducted using the American Shoulder and Elbow Surgeons (ASES) score, the University of California Los Angeles (UCLA) shoulder score, the Constant score (CS), and the visual analogue scale (VAS) score. Magnetic Resonance Imaging (MRI) assessments for rotator cuff healing were performed at the 24-month postoperative mark. Statistical evaluations were conducted using SPSS for Windows (Version 25.0, IBM, Armonk, NY, USA), employing the Wilcoxon signed-rank test to compare preoperative and postoperative data and ROM differences, and the Mann-Whitney U test for statistical differences in clinical outcome scores between the two groups. A p-value of less than 0.05 was considered statistically significant.

RESULTS: Comparative analysis of the preoperative and final follow-up scores revealed a substantial enhancement in shoulder function, as indicated by the ASES, UCLA, CS, and VAS scores, with statistical significance (p < 0.001). At both the preoperative stage and final follow-up, no notable differences were observed in ASES, UCLA, CS, and VAS scores between the two groups. However, the TR repair group exhibited lower VAS scores than the SB group at 1 and 3 months postoperatively. Active range of motion (ROM) showed significant improvement in both groups. No significant differences in ROM were noted between the two groups either before the surgery or at the final follow-up.

CONCLUSION: The study demonstrates that both the modified arthroscopic TR and SB techniques for L-shaped delaminated cuff tears yield satisfactory outcomes, with no significant differences in overall clinical performance. Notably, early postoperative pain management appears more effective with the modified TR technique, suggesting its potential for enhanced early recovery experiences. This technique’s design, promoting securer fixation and optimal contact conditions, is implied to facilitate superior long-term healing, warranting further investigation into its long-term benefits.

PMID:38485458 | DOI:10.1111/os.14039

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Association of Handgrip Strength with Hip Fracture and Falls in Community-dwelling Middle-aged and Older Adults: A 4-Year Longitudinal Study

Orthop Surg. 2024 Mar 14. doi: 10.1111/os.14029. Online ahead of print.

ABSTRACT

OBJECTIVE: Hip fracture and falls are significant health concerns. Handgrip strength (HGS) is closely associated with overall muscle strength and physical health. However, the longitudinal relationship between HGS and the risk of hip fractures and falls remains unclear, particularly regarding gender differences. This longitudinal study aimed to investigate the association between HGS and the risk of hip fracture and falls in individuals aged 45 years and above, considering gender-specific differences over a 4-year period.

METHODS: This study included 10,092 participants (4471 men and 5621 women) aged 45 years and above from the China Health and Retirement Longitudinal Study (CHARLS). Incidents of hip fractures and falls were recorded during a 4-year follow-up, along with various demographic and clinical factors. Participants were categorized into five groups based on their HGS quintiles. Logistic regression models were employed to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) to assess the relationship between HGS and hip fracture/fall risk.

RESULTS: During the 4-year follow-up period, 223 cases of hip fracture (2.2%) and 1831 cases of falls (18.1%) were documented. Notably, higher HGS demonstrated a strong inverse association with the risk of hip fracture in both males and females (p < 0.05). In comparison to the lowest HGS quintile, the adjusted odds ratios (ORs) for hip fracture were 0.46 (0.27-0.78) for the total population, 0.4 (0.19-0.81) for males and 0.48 (0.23-0.98) for females in the highest HGS quintile. Furthermore, a profound and statistically significant negative correlation between HGS and falls was detected (p < 0.05). The adjusted ORs for falls in the highest HGS quintile, compared to the lowest quintile, were 0.62 (0.51-0.76) in the overall population, 0.59 (0.44-0.78) in males, and 0.78 (0.62-0.99) in females.

CONCLUSION: Our findings highlight the significant inverse association between HGS and the risk of hip fracture and falls in both males and females aged 45 years and above. Assessing handgrip strength may serve as a valuable tool for predicting fracture and fall risk.

PMID:38485456 | DOI:10.1111/os.14029

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31 P MR Spectroscopy in the Pancreas: Repeatability, Comparison With Liver, and Pilot Pancreatic Cancer Data

J Magn Reson Imaging. 2024 Mar 14. doi: 10.1002/jmri.29326. Online ahead of print.

ABSTRACT

BACKGROUND: Non-invasive evaluation of phosphomonoesters (PMEs) and phosphodiesters (PDEs) by 31-phosphorus MR spectroscopy (31 P MRS) may have potential for early therapy (non-)response assessment in cancer. However, 31 P MRS has not yet been applied to investigate the human pancreas in vivo.

PURPOSE: To assess the technical feasibility and repeatability of 31 P MR spectroscopic imaging (MRSI) of the pancreas, compare 31 P metabolite levels between pancreas and liver, and determine the feasibility of 31 P MRSI in pancreatic cancer.

STUDY TYPE: Prospective cohort study.

POPULATION: 10 healthy subjects (age 34 ± 12 years, four females) and one patient (73-year-old female) with pancreatic ductal adenocarcinoma.

FIELD STRENGTH/SEQUENCE: 7-T, 31 P FID-MRSI, 1 H gradient-echo MRI.

ASSESSMENT: 31 P FID-MRSI of the abdomen (including the pancreas and liver) was performed with a nominal voxel size of 20 mm (isotropic). For repeatability measurements, healthy subjects were scanned twice on the same day. The patient was only scanned once. Test-retest 31 P MRSI data of pancreas and liver voxels (segmented on 1 H MRI) of healthy subjects were quantified by fitting in the time domain and signal amplitudes were normalized to γ-adenosine triphosphate. In addition, the PME/PDE ratio was calculated. Metabolite levels were averaged over all voxels within the pancreas, right liver lobe and left liver lobe, respectively.

STATISTICAL TESTS: Repeatability of test-retest data from healthy pancreas was assessed by paired t-tests, Bland-Altman analyses, and calculation of the intrasubject coefficients of variation (CoVs). Significant differences between healthy pancreas and right and left liver lobes were assessed with a two-way analysis of variance (ANOVA) for repeated measures. A P-value <0.05 was considered statistically significant.

RESULTS: The intrasubject CoVs for PME, PDE, and PME/PDE in healthy pancreas were below 20%. Furthermore, PME and PME/PDE were significantly higher in pancreas compared to liver. In the patient with pancreatic cancer, qualitatively, elevated relative PME signals were observed in comparison with healthy pancreas.

DATA CONCLUSION: In vivo 31 P MRSI of the human healthy pancreas and in pancreatic cancer may be feasible at 7 T.

EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 2.

PMID:38485455 | DOI:10.1002/jmri.29326

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Neurosurgical treatment of tumors of the pineal region – literature review and overview of cases at OMIII

Magy Onkol. 2024 Mar 14;68(1):27-35. Epub 2023 Nov 23.

ABSTRACT

Pineal region tumors account for less than 1% of adult supratentorial tumors. Their treatment requires a multimodality approach. Previously, the treatment of choice was direct surgery, which is associated with high surgical risk. Advances in minimally invasive techniques and onco-radiotherapy offer a safe and multimodal personalized therapy. The aim of our study was to describe the practice of our Institute based on combined endoscopic and radiotherapy techniques. We performed a retrospective clinical study. We processed data from 23 adult patients who underwent endoscopic third ventricle fenestration and pineal tumor biopsy between 2014 and 2023. Descriptive statistics, t-test, Fisher’s exact test and Kaplan-Meier analysis were performed. Clinical improvement with endoscopic intervention was achieved in 78.3% of cases. Significant increase in preoperative performance status was observed in the postoperative period (p=2.755e-5), and radiotherapy resulted in regression or stable disease. Our results suggest a safe treatment with good clinical outcome and an excellent alternative to direct surgery.

PMID:38484373

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Mycoplasma hominis increases the risk for Ureaplasma parvum infection in Human immunodeficiency virus infected pregnant women

J Infect Dev Ctries. 2024 Feb 29;18(2):258-265. doi: 10.3855/jidc.17316.

ABSTRACT

INTRODUCTION: Mycoplasma hominis and Ureaplasma parvum have been recently linked to sexually transmitted diseases and other conditions. There are a limited number of studies conducted on South African pregnant women that have assessed the prevalence and risk factors for genital mycoplasmas.

METHODOLOGY: This study included 264 HIV infected pregnant women attending the King Edward VIII antenatal clinic in eThekwini, South Africa. DNA was extracted using the PureLink Microbiome kit and pathogens were detected using the TaqMan Real-time PCR assays. The statistical data analysis was conducted in a freely available Statistical Computing Environment, R software, version 3.6.3 using the RStudio platform.

RESULTS: The prevalence of M. hominis and U. parvum, was 215/264 (81.4%), and 203/264 (76.9%), respectively. In the M. hominis positive group, a significantly (p = 0.004) higher proportion, 80.5% tested positive for U. parvum infection when compared to 61.2% among the M. hominis negative. Of the U. parvum positive women, a significantly (p = 0.004) higher proportion of women (85.2%) tested positive for M. hominis when compared to 68.9% among the U. parvum negative. In the unadjusted and adjusted analysis, being M. hominis positive increased the risk for U. parvum by approximately 3 times more (p = 0.014) and 4-fold (p = 0.008), respectively.

CONCLUSIONS: This study showed a significant link between M. hominis and U. parvum infection. To date, there are a limited number of studies that have investigated M. hominisbeing a risk factor for U. parvum infection. Therefore, the data presented in the current study now fills in this gap in the literature.

PMID:38484352 | DOI:10.3855/jidc.17316

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Importance of evaluation of heart-type fatty acid binding protein (H-FABP) in COVID-19 Patients

J Infect Dev Ctries. 2024 Feb 29;18(2):172-176. doi: 10.3855/jidc.17419.

ABSTRACT

INTRODUCTION: Recent studies have documented the cardiovascular consequences of acute coronavirus disease 2019 (COVID-19), although one of the early cardiac markers that can be used for diagnosis, the heart-type fatty acid-binding protein (H-FABP), has not been covered. Through the evaluation of H-FABP levels, we aim to contribute to the early diagnosis and treatment of cardiac problems in COVID-19 infection patients.

METHODOLOGY: Seventy-five patients who were admitted to the emergency department of Mehmet Akif Ersoy Hospital with a complaint of chest pain in the last 6 hours and whose corona PCR tests were positive, were included in our study as the case group and 60 healthy volunteers as the control group. The routine cardiac markers such as creatine kinase MB (CK-MB) cardiac troponin T (cTnT), and H-FABP levels were analyzed by routine laboratory methods.

RESULTS: The mean age and gender distributions of the groups did not differ statistically (p > 0.05). CK-MB, cTnT, and H-FABP measurements were statistically different between the groups (p = 0.001; p < 0.01).

CONCLUSIONS: The relationship between AMI and COVID-19 with routine cardiac markers is already supported by recent studies. We also evaluated H-FABP levels in our study, as it affects the prognosis of the disease independent of the chronic disease history. At the same time, we showed that H-FABP levels increase earlier than routine cardiac markers, so it will be useful for COVID-19 patients with cardiac complaints.

PMID:38484342 | DOI:10.3855/jidc.17419

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Hormonal Contraception and Risk of Cardiometabolic Disease in Women with HIV

J Womens Health (Larchmt). 2024 Mar 14. doi: 10.1089/jwh.2023.0230. Online ahead of print.

ABSTRACT

Objective: We sought to determine the association of hormonal contraception (HC) and cardiometabolic outcomes among women with human immunodeficiency virus (HIV). Methods: We included women with HIV aged 18-45 years in clinical care in the Southeastern United States between 1998 and 2018. Oral and injectable HC use was captured from medication records. Our outcomes included incident cardiovascular/thrombotic disease (CVD) (atherosclerosis, hypertension, cerebrovascular disease, thrombosis, and heart failure) and incident metabolic disorders (diabetes, dyslipidemia, obesity, and non-alcoholic steatohepatitis). We excluded women with prevalent conditions. We used multivariable marginal structural models to examine time-varying current and cumulative HC use and cardiometabolic outcomes in separate analyses, adjusting for age, race, smoking, time-varying comorbidities, CD4 cell count, HIV RNA, and antiretroviral use. Women with HC exposure were compared with women without HC exposure. Results: Among the 710 women included, 201 women (28%) used HC. CVD analyses included 603 women without prevalent CVD and 93 incident events; metabolic analyses included 365 women without prevalent metabolic disease and 150 incident events. Current and cumulative oral HC use was associated with increased odds of CVD, though this was not statistically significant (adjusted odds ratio [aOR] = 2.08, [95% confidence interval (CI): 0.80-5.43] and aOR = 1.24 [95% CI: 0.96-1.60] per year of use, respectively). Oral HC was not associated with risk of incident metabolic disorders. Depot medroxyprogesterone acetate (DMPA) was not associated with risk of incident CVD. Current and cumulative DMPA use was significantly associated with decreased odds of incident metabolic disorders (aOR = 0.48 [95% CI: 0.23, 1.00] and aOR = 0.65 [95% CI: 0.42-1.00] per year of use, respectively). Conclusion: Our results suggest that cardiovascular risk should be considered when selecting contraception for women with HIV.

PMID:38484324 | DOI:10.1089/jwh.2023.0230

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Effect of Yoga in Industrial Workers with Chronic Venous Insufficiency: A Randomized Controlled Trial

J Integr Complement Med. 2024 Mar 14. doi: 10.1089/jicm.2023.0691. Online ahead of print.

ABSTRACT

Background and objective: Prolonged standing is one of the significant contributors to chronic venous insufficiency (CVI) in industry workers. Yoga is proven to be an effective therapy in treating occupational hazards. The current study aimed to investigate the effect of yoga on CVI among industry workers. Methodology: Male workers (n = 100) from machinery manufacturing industries in Bangalore meeting the inclusion and exclusion criteria were recruited for the study. The yoga group received a specifically designed yoga module for 6 days a week for 12 weeks, and the control group was offered lifestyle suggestions. Plasma homocysteine was used as the primary outcome variable, whereas Venous Clinical Severity Score, ankle brachial pressure index (ABPI), ankle and calf circumference, CVI questionnaire, and Chalder fatigue scale were assessed as secondary variables at baseline and the end of 12 weeks of intervention. Results: Eighty-eight participants (yoga = 43, control = 45) completed the study. A one-way analysis of covariates (ANCOVA) was used to determine the significant differences between groups in the post-values. A significant difference was found between groups in plasma homocysteine (partial eta squared = 0.34, p < 0.001). All variables, except for ABPI, calf circumference, and ankle circumference, had shown statistically significant differences between the yoga and control groups after 12 weeks of intervention, with moderate to high effect sizes. There were no significant adverse events associated with the intervention. Conclusions: Yoga practices can reduce the symptoms of CVI along with vascular inflammation as indicated by reduced plasma homocysteine. Overall, yoga practices are found to be safe and efficacious for managing CVI. IEC Reference Number: RES/IEC-SVYASA/184/2021 Trial Registration Number (If Clinical Trial): CTRI/2021/02/030944.

PMID:38484315 | DOI:10.1089/jicm.2023.0691

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The Role of [18F]FDG PET/CT in the Characterization of Thymic Epithelial Tumors at Initial Stage

Cancer Biother Radiopharm. 2024 Mar 14. doi: 10.1089/cbr.2023.0192. Online ahead of print.

ABSTRACT

Purpose: The aim of this study was to evaluate the potential role of [18F]FDG positron emission tomography/computed tomography (PET/CT) in the characterization of thymic epithelial tumors (TETs). Materials and Methods: A total of 73 patients who underwent preoperative [18F]FDG PET/CT were included in this study. Visual total score (VTS), maximum standard uptake values (SUVmax), metabolic tumor volume (MTV), total lesion glycolysis (TLG), and heterogeneity index (HI) parameters were analyzed to investigate the prediction of histopathologic grade and advanced stage. Results: The cohort included 26 patients with low-grade thymoma (LGT), 36 patients with high-grade thymoma (HGT), and 11 patients with thymic carcinoma (TC). Ninety-one percent of TC had VTS >2, whereas 31% of LGT and 75% of HGT had VTS >2. SUVmax, MTV, and TLG were statistically significantly higher in the TC group than in both thymoma and HGT. Using the cutoff value of 7.25 for SUVmax, TC was differentiated from thymomas with 91% sensitivity and 74% specificity. TC had significantly lower HI values than thymomas. HI parameters showed good diagnostic ability to differentiate TC from thymoma and TC from HGT. SUVmax, MTV, and TLG were significantly higher in advanced-stage disease than in early-stage disease. Conclusions: Visual and quantitative parameters can reliably predict both advanced disease and the grade of primary tumor in TETs. Therefore, as a promising metabolic imaging method, [18F]FDG PET/CT makes important contributions to preoperative evaluation in routine clinical practice.

PMID:38484307 | DOI:10.1089/cbr.2023.0192