Significance Of Differences In Outcomes Research Articles

Evaluation of antihypoxic effects of therapeutic breathing mixtures with high argon content on the example of acute blood loss in laboratory animals: a preclinical randomized experimental study

Background. According to the hypothesis of the study, the therapeutic efficacy of measures to treat hypoxic (ischemic) emergencies can be significantly increased by using an artificial gas mixture with normal or increased oxygen content and a high content of argon, being bioactive despite its chemical inertness.Objective. To experimentally evaluate the antihypoxic effects of argon on the example of acute massive blood loss in experimental animals.Methods. The study was carried out on 72 albino male gray rats with a baseline body weight of 220–250 g. The experiments were performed at the premises of the Konstantinov St. Petersburg Nuclear Physics Institute of the Kurchatov Institute and the Smorodintsev Research Institute of Influenza (Russia). Prior to the experiment, the animals were quarantined for 2 weeks in the vivariums of the performing organizations. Acute massive blood loss in rats was formed by taking blood (12 ± 1% of body weight on average) using syringe method by transcutaneous cardiac puncture. Rats were randomized into 3 groups (24 individuals each) depending on the gaseous medium where the animal was placed after artificial blood loss. Composition of the applied gaseous medium in the comparison groups: medium No. 1 — oxygen 21% vol.; argon — 30% vol.; nitrogen — the rest; medium No. 2 — oxygen 21% vol.; argon — the rest; medium No. 3 (control) — air. The postoperative follow-up (post-conditioning) for 8 hours involved assessing and recording the following indicators: survival/lethality rates; recovery rates (anesthesia recovery, somatic mobilization); clinical symptoms of possible intoxication with the gas mixture during inhalation exposure. The surviving animals were then monitored for 4 days to evaluate their health and behavioral performance. Upon completing the observation period, the animals were euthanized.Results. After artificially-induced blood loss, all the non-survivors died within 1.5–8 hours after the operation. In group 1 (post-conditioning in medium No. 1), the lethality of laboratory animals amounted to 4 individuals out of 24 (16%); in group 2 (post-conditioning in medium No. 2) — 2 individuals out of 24 (8%). In the control group, the lethality rate was significantly higher — 10 animals out of 24 (42%). The surviving animals demonstrated no lethality or morbidity within 4 days after the exposure. Analysis of outcomes between experimental groups and controls revealed that the significance of differences in the lethality index between group 1 and control (by Fisher’s two-sided criterion) comprised p = 0.06; between group 2 and control — p = 0.017. When the statistical “power” of the experimental group was increased (by combining samples 1 and 2), the significance of differences in outcomes in this group compared to the control accounted for p < 0.001.Conclusion. The conducted studies confirmed the hypothesis about the pronounced antihypoxic effect of argon, which significantly increased the survival rate of experimental animals after massive artificially-induced blood loss.

Blackcurrant Anthocyanins Improve Blood Lipids and Biomarkers of Inflammation and Oxidative Stress in Healthy Women in Menopause Transition without Changing Body Composition.

Recent cell and animal studies suggest the potential of blackcurrants (BCs; Ribes nigrum) as a dietary agent that may reduce the risk of cardiovascular disease (CVD) by improving dyslipidemia, oxidative stress, and inflammation. This study aimed to examine the effects of BC anthocyanin (ACN) extract supplementation on biomarkers of CVD risk in healthy adult women in menopause transition. The effects of BC ACN supplementation on body composition, fasting blood lipids and biomarkers of inflammation and oxidative stress were evaluated using anthropometric measures and blood samples collected from a pilot randomized controlled clinical trial in peri- and early postmenopausal women. Thirty-eight eligible peri- and early postmenopausal women aged 45-60 completed the entire trial, in which they were randomly assigned into one of three treatment groups: placebo (control group), 392 mg/day (low BC group), or 784 mg/day (high BC group) for six months. The significance of differences in outcomes was tested using repeated-measures ANOVA. Overall, following six-month BC consumption, significantly decreased triglyceride (TG) levels were observed between treatment groups (p < 0.05) in a dose-dependent manner. Plasma interleukin-1β (IL-1β) was significantly reduced in a dose and time dependent manner (p < 0.05). Significant decreases in thiobarbituric acid reactive substances (TBARS) levels were also observed between treatment groups (p < 0.05) in a dose-dependent manner. Six-month change in oxidized LDL was inversely correlated with changes in catalase (CAT) and total antioxidant capacity (TAC) (p < 0.05), while C-reactive protein (hs-CRP) change was positively correlated with changes in TG and IL-1β (p < 0.01). Together, these findings suggest that daily BC consumption for six months effectively improved dyslipidemia, inflammation, and lipid peroxidation, thus potentially mitigating the risk of postmenopausal CVD development in study participants. Future studies with larger sample sizes and at-risk populations are warranted to confirm these findings.

Risk factors and prognosis of the development of pseudophakic myopia in children

Recent studies indicate the prevalence of myopic refraction in children with pseudophakia, which significantly reduces the functional results of treatment and may be an indication for replacing the intraocular lens (IOL). Therefore, studies conducted to achieve the target refraction in children with pseudophakia are relevant. Purpose To determine the risk factors for the prognosis of myopic refraction in children after extraction of congenital cataract and IOL implantation. Material and methods The study presents the results of refraction examination in 69 (110 eyes) children aged 1 to 12 years 36 months after extraction of congenital cataract with implantation of soft IOL. Results The obtained data of anamnesis, results of ophthalmological, echobiometric, clinical and laboratory studies were subjected to statistical processing assessing the significance of differences in outcomes depending on the impact of possible risk factors for the development of pseudophakic myopia; a regression logistic model and a ROC-curve were constructed. Conclusion According to the authors, reliable risk factors for the development of pseudophakic myopia in children can be such indicators as axial eye length at the time of IOL implantation exceeding the age norm by more than 0.2 mm; the child from the first pregnancy; the AL/CR ratio of ≥3.0; myopia on the paired eye; strabismus of more than 4 prism diopters; hereditary load; tension of eye's fibrous capsule: pressure of ≤180 mm Hg at the time of IOL implantation. The presented reliable factors, as well as a combination of less significant signs (the child being outside for less than 1 hour per day, intermarriage of the patient's parents, near-sight visual loads of more than 3 hours per day, the blood Ca level of less than 1.8 mmol/L) can be used for prognosis of the development of pseudophakic myopia and to help make adjustments in the management tactics for patients to achieve target refraction.

Pilot study: An inpatient drug rehabilitation program based on intensive short-term dynamic psychotherapy

Addiction programs are plagued with high dropout and relapse rates. A large proportion of patients suffering from addiction also suffer from personality disorders. A 30-day inpatient program based on intensive short-term dynamic psychotherapy was developed to address features of personality disorders such as anxiety regulation, emotion recognition, and handling of fear responses and projective processes. The hypothesis was that addressing comorbid symptoms of personality disorder might improve recovery from drug addiction. We used a pilot randomized controlled trial design with six-month follow-up of both cases and controls. Rates of remission, relapse and drop out were recorded at each time point. N-1 chi-squared (χ2) tests were conducted to examine the statistical significance of differences in outcomes in patients receiving the experimental treatment and controls. A control group of 20 patients and an experimental group of 42 patients were treated. Dropout: control group 40%; experimental group 23.8%. Sobriety at six months: control group 17.6%, experimental group 48.8%. Future study is warranted to examine intensive short-term dynamic psychotherapy’s long-term effects, study moderators of effects, and study its efficacy using a randomized controlled design.

Determining the minimum clinically important differences for outcomes in the DOMINO trial.

Although less likely to be reported in clinical trials than expressions of the statistical significance of differences in outcomes, whether or not a treatment has delivered a specified minimum clinically important difference (MCID) is also relevant to patients and their caregivers and doctors. Many dementia treatment randomised controlled trials (RCTs) have not reported MCIDs and, where they have been done, observed differences have not reached these. As part of the development of the Statistical Analysis Plan for the DOMINO trial, investigators met to consider expert opinion- and distribution-based values for the MCID and triangulated these to provide appropriate values for three outcome measures, the Standardised Mini-mental State Examination (sMMSE), Bristol Activities of Daily Living Scale (BADLS) and Neuropsychiatric Inventory (NPI). Only standard deviations (SD) were presented to investigators who remained blind to treatment allocation. Adoption of values for MCIDs based upon 0.4 of the SD of the change in score from baseline on the sMMSE, BADLS and NPI in the first 127 participants to complete DOMINO yielded MCIDs of 1.4 points for sMMSE, 3.5 for BADLS and 8.0 for NPI. Reference to MCIDs is important for the full interpretation of the results of dementia trials and those conducting such trials should be open about the way in which they have determined and chosen their values for the MCIDs.