Category: Statistics

Eur J Prev Cardiol. 2023 Jul 25:zwad245. doi: 10.1093/eurjpc/zwad245. Online ahead of print.

ABSTRACT

AIM: We aimed to perform a systematic review and meta-analysis of randomised controlled trials (RCTs) to determine the impact of a polypill-based strategy (PBS) on therapeutic adherence and cardiovascular outcomes compared with usual care for secondary prevention of cardiovascular diseases (CVD).

METHODS: We systematically searched PubMed, Cochrane, and Scopus databases from inception to January 2023, including RCTs comparing PBS to usual care in patients with prior CVD. We assessed efficacy outcomes of therapeutic adherence, systolic blood pressure (SBP) and low-density lipoprotein-cholesterol (LDL-C), and safety outcomes of all-cause and cardiovascular mortality. Statistical analysis was performed with Review Manager 5.4.1 and R Version 4.2.1.

RESULTS: A total of eight RCTs with a population of 6,541 individuals were included, of whom 3,318 (50.7%) were treated with PBS. Follow-up ranged from 6 to 60 months. PBS was associated with a significantly increased therapeutic adherence (risk ratio [RR] 1.22; 95% CI 1.10 to 1.34; p<0.001). Cardiovascular mortality (RR 0.61; 95% CI 0.44 to 0.85; p=0.004), SBP (mean difference [MD] -1.47 mmHg; 95% CI -2.86 to -0.09; p=0.04), and LDL-C (MD -3.83 mg/dL; 95% CI -6.99 to -0.67; p=0.02) were significantly lower in PBS group. The incidence of all-cause mortality was similar between groups (RR 0.83; 95% CI 0.54 to 1.29; p=0.41).

CONCLUSIONS: In patients with pre-existing CVD, a PBS is associated with lower cardiovascular mortality and improved therapeutic adherence, along with a modest decrease in SBP and LDL-C compared with usual care. Thus, PBS may be considered a preferred option for this patient population.

PMID:37490769 | DOI:10.1093/eurjpc/zwad245

Clin Infect Dis. 2023 Jul 25;77(Supplement_2):S156-S170. doi: 10.1093/cid/ciad341.

ABSTRACT

BACKGROUND: Increasing trends of antimicrobial resistance are observed around the world, driven in part by excessive use of antimicrobials. Limited access to diagnostics, particularly in low- and middle-income countries, contributes to diagnostic uncertainty, which may promote unnecessary antibiotic use. We investigated whether introducing a package of diagnostic tools, clinical algorithm, and training-and-communication messages could safely reduce antibiotic prescribing compared with current standard-of-care for febrile patients presenting to outpatient clinics in Uganda.

METHODS: This was an open-label, multicenter, 2-arm randomized controlled trial conducted at 3 public health facilities (Aduku, Nagongera, and Kihihi health center IVs) comparing the proportions of antibiotic prescriptions and clinical outcomes for febrile outpatients aged ≥1 year. The intervention arm included a package of point-of-care tests, a diagnostic and treatment algorithm, and training-and-communication messages. Standard-of-care was provided to patients in the control arm.

RESULTS: A total of 2400 patients were enrolled, with 49.5% in the intervention arm. Overall, there was no significant difference in antibiotic prescriptions between the study arms (relative risk [RR]: 1.03; 95% CI: .96-1.11). In the intervention arm, patients with positive malaria test results (313/500 [62.6%] vs 170/473 [35.9%]) had a higher RR of being prescribed antibiotics (1.74; 1.52-2.00), while those with negative malaria results (348/688 [50.6%] vs 376/508 [74.0%]) had a lower RR (.68; .63-.75). There was no significant difference in clinical outcomes.

CONCLUSIONS: This study found that a diagnostic intervention for management of febrile outpatients did not achieve the desired impact on antibiotic prescribing at 3 diverse and representative health facility sites in Uganda.

PMID:37490746 | DOI:10.1093/cid/ciad341

Clin Infect Dis. 2023 Jul 25;77(Supplement_2):S199-S205. doi: 10.1093/cid/ciad324.

NO ABSTRACT

PMID:37490743 | DOI:10.1093/cid/ciad324

AIDS Care. 2023 Jul 25:1-8. doi: 10.1080/13548506.2023.2229236. Online ahead of print.

ABSTRACT

In Mozambique, women are the most affected by HIV/AIDS and heterosexual encounters remain the main route for HIV/AIDS. Condom use is the most effective method of HIV/AIDS prevention, and the intention to use and buy/get condoms has a significant role in safe sex behavior. This study aimed to evaluate the efficacy of two psychosocial interventions – the Didactic and ACCENT Interventions – to prevent HIV/AIDS among Mozambican Women. Participants were Mozambican women (n = 150), users of the gynecology clinic of the Central Hospital of Beira. The study design was a randomized controlled trial (RCT) with assignment to three groups: Didactic intervention, ACCENT intervention, and Control group. Measures were from an adaption of the Women’s Health Questionnaire, which includes questions about sociodemographic, clinical, and behavioral variables related to HIV prevention/risk. There was a significant group effect on condom use and safer sex preparatory behaviors, F(2, 146) = 6.45, p = .002, with Bonferroni post-hoc tests showing differences between the ACCENT vs. Control groups and ACCENT vs. Didactic groups (all p = .022). There were no statistically significant time effects on both condom use and safer sex preparatory behaviors. Results are promising for HIV/AIDS prevention in Mozambican women at sexual risk, but replication is needed for generalizability of findings.

PMID:37490699 | DOI:10.1080/13548506.2023.2229236

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(7):74-79. doi: 10.17116/jnevro202312307174.

ABSTRACT

OBJECTIVE: To compare the efficacy and safety of non-immunogenic staphylokinase (Fortelysine) and alteplase in patients with ischemic stroke (IS) in real-world clinical practice.

MATERIAL AND METHODS: A retrospective, observational, non-interventional study of data the register of the Territorial Compulsory Health Insurance Fund was conducted. The proportion of patients with a favorable outcome, the degree of disability at discharge from the hospital, the duration of hospitalization, the proportion of lethal outcome in the groups of Fortelysine and alteplase were evaluated. The effect of the Rankin scale points at the hospitalization, the choice of a medical organization, the month of hospitalization, the choice of a thrombolytic on achieving a favorable outcome was determined.

RESULTS: The data of 1238 patients from 26 hospitals of the Sverdlovsk region were included. There were no statistically significant differences in the proportion of a favorable outcome between the groups of Fortelysine and alteplase (26% and 25% respectively, p=0.845). Mediana of duration of hospitalization in the Fortelysine group was one day less, which is statistically significant compared to the alteplase group (9 [7;12] and 10 [7;13] respectively, p<0.001). There were no differences in the frequency of mortality (11% and 13% respectively, p=0.331). The hospital, the year and month of hospitalization, the level of disability at the baseline have a statistically significant effect on the outcome of hospitalization. The choice of a thrombolytic drug did not have a statistically significant effect on the frequency of favorable outcome.

CONCLUSIONS: The comparable efficacy and safety of Fortelysine and alteplase in IS has been proven in clinical study and confirmed by real-world clinical practice.

PMID:37490668 | DOI:10.17116/jnevro202312307174

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(7):41-49. doi: 10.17116/jnevro202312307141.

ABSTRACT

OBJECTIVE: Evaluation of the efficacy and safety of Prospect in the treatment of cognitive, behavioral and mental disorders in patients with vascular dementia (VSD).

MATERIAL AND METHODS: In a double-blind, placebo-controlled, parallel-group randomised clinical trial, 406 patients aged 60-85 years old with a diagnosis of mild/moderate vascular dementia (10-24 on the Mini-Mental State Examination (MMSE)) and without signs of depression (Cornell Scale for Depression in Dementia (CSDD) scores ≤10) were included. At Visit 1, complaints and medical history were collected, vital signs were recorded, cognitive impairment was assessed using MMSE and MoCA, NPI-C and CSDD were completed, and an MRI brain scan was performed. Patients were randomised into two groups: patients in group 1 received Prospekta in a dosage of 2 tablets two times a day for 24 weeks, and patients in group 2 received Placebo according to the study drug regimen.

RESULTS: Patients in both groups had no differences in demographic and baseline clinical characteristics. Administration of Prospekta for 24 weeks reduced cognitive impairment in patients with vascular dementia compared to the placebo group. The mean MoCA score increased from 17.0±3.6 [17.1±3.6] to 20.5±4.7 [20.4±4.7] in patients treated with Prospekta, whereas it increased from 17.3±3.7 [17.3±3.8] to 19.2±4.9 [19.2±5.0] in the Placebo group. Treatment with the medication also reduced the severity of neuropsychiatric symptoms as measured by the NPI-C scale. The mean score on this scale decreased from 57.0±26.7 [56.7±25.4] to 39.8±23.6 [39.8±23.5] in the Prospekta group and from 55.5±25.5 [55.3±24.4] to 42.8±27.6 [42.3±25.3] in the Placebo group. The difference in mean MoCA and NPI-C scores between the Prospekta and Placebo groups was statistically significant.

CONCLUSION: Prospekta is an effective and safe drug for treating cognitive, behavioural and mental disturbances in patients with vascular dementia.

PMID:37490664 | DOI:10.17116/jnevro202312307141

Menopause. 2023 Jul 25. doi: 10.1097/GME.0000000000002227. Online ahead of print.

ABSTRACT

OBJECTIVE: Translation and cross-cultural validation of the Serbian version of the Lower Extremity Functional Scale (Srb-LEFS).

METHODS: This prospective cross-sectional study initially included 186 postmenopausal women aged 60 to 75 years who underwent an x-ray examination of both knees, along with body mass, body height, waist circumference, knee range of motion, and blood pressure measurements. The laboratory analyses included the evaluation of fasting glucose levels and lipid profile. All participants completed the LEFS, Lequesne index, and 36-Item Short-Form Survey-RAND.

RESULTS: The analyses revealed good internal consistency (α = 0.95), good test-retest reliability, and a two-factor structure of the Srb-LEFS. Concurrent validity analysis confirmed a significant positive correlation between Srb-LEFS scores and the 36-Item Short-Form Survey-RAND Physical Functioning subscale (r = 0.889, P < 0.0001), the Lequesne index (r = -0.976, P < 0.0001), and the Numeric Rating Scale for pain (r = -0.762, P < 0.0001). Convergent validity analyses revealed a statistically significant negative correlation between the Srb-LEFS scores and age (r = -0.25, P = 0.006), body mass index (r = -0.31, P < 0.01), and waist circumference (r = -0.37, P < 0.0001). The Srb-LEFS scores were statistically significantly higher among participants that reported moderate physical activity levels, as well as those that had fewer comorbidities, minor structural knee damage, greater knee range of motion, and greater quadriceps femoris muscle strength.

CONCLUSIONS: The Serbian version of the LEFS is feasible, valid, and reliable for use in both clinical practice and clinical studies to assess self-reported physical functioning in older individuals with knee osteoarthritis.

PMID:37490640 | DOI:10.1097/GME.0000000000002227

Diabetes Care. 2023 Jul 25:dc230206. doi: 10.2337/dc23-0206. Online ahead of print.

ABSTRACT

OBJECTIVE: To study the relationships between artificial sweeteners, accounting for all dietary sources(total and by type of artificial sweetener) and risk of type 2 diabetes (T2D), in a large-scale prospective cohort.

RESEARCH DESIGN AND METHODS: The analyses included 105,588 participants from the web-based NutriNet-Santé study (France, 2009-2022; mean age 42.5 ± 14.6 years, 79.2% women). Repeated 24-h dietary records, including brands and commercial names of industrial products, merged with qualitative and quantitative food additive composition data, enabled artificial sweetener intakes to be accurately assessed from all dietary sources. Associations between artificial sweeteners (total, aspartame, acesulfame potassium [K], and sucralose) and T2D were investigated using Cox proportional hazard models adjusted for potential confounders, including weight variation during follow-up.

RESULTS: During a median follow-up of 9.1 years (946,650 person-years, 972 incident T2D), compared with nonconsumers, higher consumers of artificial sweeteners (i.e., above the sex-specific medians of 16.4 mg/day in men and 18.5 mg/day in women) had higher risks of developing T2D (hazard ratio [HR] 1.69; 95% CI 1.45-1.97; P-trend <0.001). Positive associations were also observed for individual artificial sweeteners: aspartame (HR 1.63 [95% CI 1.38-1.93], P-trend <0.001), acesulfame-K (HR 1.70 [1.42-2.04], P-trend <0.001), and sucralose (HR 1.34 [1.07-1.69], P-trend = 0.013).

CONCLUSIONS: Potential for reverse causality cannot be eliminated; however, many sensitivity analyses were computed to limit this and other potential biases. These findings of positive associations between artificial sweetener intakes and increased T2D risk strengthen the evidence that these additives may not be safe sugar alternatives. This study provides important insights in the context of on-going reevaluation of artificial sweeteners by health authorities worldwide.

PMID:37490630 | DOI:10.2337/dc23-0206

J Pediatr Gastroenterol Nutr. 2023 Jul 25. doi: 10.1097/MPG.0000000000003895. Online ahead of print.

ABSTRACT

Genetic variations, in specific COMT, OPRM1 and MAO-A polymorphisms, have been associated with hypnotizability in adults. The aim of this exploratory study was to investigate whether these polymorphisms are also associated with response to hypnotherapy (HT) in children. Patients (8-18 years, n=260) diagnosed with a functional abdominal pain disorder (FAPDs) from a previous trial assessing HT efficacy were approached for participation and 144 agreed to collect a buccal sample. Primary aim was to explore the association between COMT, OPRM1 and MAO-A polymorphisms with treatment success after 3-month HT. Additionally, associations between these polymorphisms and adequate relief, anxiety, depression, quality of life, somatization, hypnotic susceptibility, expectations, pain beliefs, and coping strategies were evaluated. Participants with different variations of COMT, MAO-A and OPRM1 achieved similar treatment success levels (p > .05). No associations were found between these polymorphisms and secondary outcomes. This suggest that in pediatric patients with FAPDs, COMT, OPRM1 and MAO-A polymorphisms do not predict HT response.

PMID:37490618 | DOI:10.1097/MPG.0000000000003895

J Speech Lang Hear Res. 2023 Jul 25:1-17. doi: 10.1044/2023_JSLHR-22-00495. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to examine changes in English and Spanish morphosyntactic standardized scores over time in bilingual children.

METHOD: One hundred bilingual children participated in this longitudinal study. The average age of the children at the beginning of the study was 5;11 (years;months). A subset of the participants was identified as children with developmental language disorder (DLD, n = 43). Children completed behavioral testing in Spanish and English at three time points over a period of 2 years. Growth curve modeling was employed to analyze longitudinal data.

RESULTS: Distinct patterns of Spanish and English language growth were observed. While the average standard score in English increased, the average score in Spanish decreased over time for both groups. Children with DLD showed persistent language difficulties in both Spanish and English over time in comparison to their peers.

CONCLUSIONS: The results of this study provide evidence of a shift in language proficiency from Spanish to English for bilingual children with and without language disorders. This study also shows that bilingual children with DLD show a protracted but parallel growth in morphosyntactic skills in comparison to children without DLD.

SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.23671464.

PMID:37490611 | DOI:10.1044/2023_JSLHR-22-00495