Tag: statistics

Mult Scler Relat Disord. 2024 Jun 20;89:105740. doi: 10.1016/j.msard.2024.105740. Online ahead of print.

ABSTRACT

BACKGROUND: Spasticity is a common and potentially debilitating symptom of multiple sclerosis (MS) with a highly variable presentation. Understanding, quantifying, and managing MS-associated spasticity (MSS) is a challenge for research and in clinical practice. The tetrahydrocannabinol:cannabidiol oromucosal spray nabiximols has demonstrated beneficial effects in the treatment of MSS in clinical studies as well as real-world observational studies, and is approved for the treatment of MSS in 29 countries globally. Most randomized studies evaluated the efficacy of nabiximols using the change in average daily spasticity scores reported by patients using the spasticity Numeric Rating Scale as a primary endpoint. This study, RELEASE MSS1 (NCT04657666), was conducted using a prespecified primary endpoint of change in spastic muscle tone (Modified Ashworth Scale Lower Limb Muscle Tone-6 [MAS LLMT-6]) to corroborate the efficacy of nabiximols as adjunctive therapy observed with the patient-measured spasticity Numeric Rating Scale primary endpoint in the previous pivotal studies.

METHODS: This was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial. Because of the prevalence and functional impact of lower limb spasticity on the individual patient’s overall experience of MS spasticity, the MAS LLMT-6 was derived from the clinician-rated MAS. The MAS LLMT-6 is the average transformed MAS score of 6 muscle groups (knee flexors, knee extensors, and ankle plantar flexors; all assessed bilaterally). Secondary measures included MAS LLMT-4 scores, defined as the average of the 4 individual MAS-transformed scores of knee flexors and knee extensors bilaterally. Patients had a diagnosis of MS and an untransformed MAS score of at least 2 in ≥2 of 6 LLMT-6 muscle groups despite current treatment with ≥1 of the following oral antispasticity agents: baclofen, tizanidine, or dantrolene. Eligible participants were randomly assigned to 1 of 2 treatment sequences. Each treatment sequence consisted of two treatment periods, each consisting of a 14-day dose titration phase followed by a 7-day dose maintenance phase.

RESULTS: Of 68 patients enrolled, 33 were assigned to nabiximols followed by placebo and 35 were assigned to placebo followed by nabiximols. Least squares mean changes in MAS LLMT-6 scores from baseline to day 21 were -0.23 for nabiximols and -0.26 for placebo; the least squares mean treatment difference in MAS LLMT-6 scores for nabiximols versus placebo was 0.04, which was not statistically significant (P = 0.7152). Mean changes in MAS LLMT-4 scores from baseline to day 21 also were not significantly different between the nabiximols and placebo groups. Safety results in this study were consistent with the known safety profile of nabiximols in patients with MSS.

CONCLUSION: Despite the established efficacy of nabiximols in MSS observed using patient-reported measures, the primary endpoint was not met in this study. The findings from this study reflect and emphasize some of the challenges in the evaluation and treatment of MS spasticity. CLINICAL TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): : NCT04657666.

PMID:39106541 | DOI:10.1016/j.msard.2024.105740

Stud Hist Philos Sci. 2024 Aug 5;107:1-10. doi: 10.1016/j.shpsa.2024.07.005. Online ahead of print.

ABSTRACT

We propose that the epistemic functions of replication in science are best understood by relating them to kinds of experimental error/uncertainty. One kind of replication, which we call “direct replications,” principally serves to assess the reliability of an experiment through its precision: the presence and degree of random error/statistical uncertainty. The other kind of replication, which we call “conceptual replications,” principally serves to assess the validity of an experiment through its accuracy: the presence and degree of systematic errors/uncertainties. To illustrate the aptness of this general view, we examine the Hubble constant controversy in astronomy, showing how astronomers have responded to the concordances and discordances in their results by carrying out the different kinds of replication that we identify, with the aim of establishing a precise, accurate value for the Hubble constant. We contrast our view with Machery’s “re-sampling” account of replication, which maintains that replications only assess reliability.

PMID:39106538 | DOI:10.1016/j.shpsa.2024.07.005

Injury. 2024 Aug 2;55(10):111766. doi: 10.1016/j.injury.2024.111766. Online ahead of print.

ABSTRACT

BACKGROUND: The sustentaculum tali is a biomechanically important stabilizer of the hindfoot and contributes to articular congruency of the subtalar joint. Sustentaculum injury associated with a talus fracture has been described infrequently and treatment of this combined injury varies. The purpose of this study was to describe and evaluate the outcomes of the combined talus and sustentaculum fracture.

METHODS: Retrospective chart and radiographic review was performed on all talus fractures (n = 436) requiring operative fixation over a 21-year period at a single Level-1 trauma center. All talus fractures with sustentaculum fractures were included. Statistical analysis was performed using Chi-squared and Fishers exact tests where appropriate.

RESULTS: Sustentaculum fractures occurred in 6.2 % (n = 27) of patients with talus fractures. Average follow-up was 14 months; 18.5 % were open fractures, 88.8 % were from high-energy mechanisms, and 44.4 % were polytraumas. Diagnosis of the sustentaculum fracture was missed on presenting radiographs in 69.2 % (n = 18). The most common associated talus fracture was a talar neck fracture (40.7 %) and the majority (73.7 %) were Hawkins II. Overall, 40.7 % (n = 11) of the sustentaculum fractures were treated with independent fixation and 7.4 % (n = 2) were treated with acute subtalar arthrodesis. Subtalar post-traumatic osteoarthritis (PTOA) at final follow-up was seen in 23.1 % of combined injuries. Independent sustentaculum fixation did not influence the rate of PTOA or re-operation (p = 0.92, p = 0.91, respectively).

CONCLUSION: Talar fractures have an associated sustentaculum fracture in approximately 6 % of cases, especially with Hawkins II fracture-dislocations. Over two-thirds of the associated sustentaculum fractures were missed on presenting radiographs, reiterating the need for heightened awareness and consideration of advanced imaging for all talus fractures. The rate of PTOA following these combined injuries at mean follow-up of 24 months does not exceed established rates after isolated talus fractures. Further research is required to determine the optimal management of the sustentaculum in these combined injuries.

LEVEL OF EVIDENCE: IV.

PMID:39106534 | DOI:10.1016/j.injury.2024.111766

Psychiatry Res Neuroimaging. 2024 Jul 6;343:111858. doi: 10.1016/j.pscychresns.2024.111858. Online ahead of print.

ABSTRACT

Autism is a neurodevelopmental disorder that manifests in individuals during childhood and has enduring consequences for their social interactions and communication. The prediction of Autism Spectrum Disorder (ASD) in individuals based on the differences in brain networks and activities have been studied extensively in the recent past, however, with lower accuracies. Therefore in this research, identification at the early stage through computer-aided algorithms to differentiate between ASD and TD patients is proposed. In order to identify features, a Multi-Layer Perceptron (MLP) model is developed which utilizes logistic regression on characteristics extracted from connectivity matrices of subjects derived from fMRI images. The features that significantly contribute to the classification of individuals as having Autism Spectrum Disorder (ASD) or typically developing (TD) are identified by the logistic regression model. To enhance emphasis on essential attributes, an AND operation is integrated. This involves selecting features demonstrating statistical significance across diverse logistic regression analyses conducted on various random distributions. The iterative approach contributes to a comprehensive understanding of relevant features for accurate classification. By implementing this methodology, the estimation of feature importance became more dependable, and the potential for overfitting is moderated through the evaluation of model performance on various subsets of data. It is observed from the experimentation that the highly correlated Left Lateral Occipital Cortex and Right Lateral Occipital Cortex ROIs are only found in ASD. Also, it is noticed that the highly correlated Left Cerebellum Tonsil and Right Cerebellum Tonsil are only found in TD participants. Among the MLP classifier, a recall of 82.61 % is achieved followed by Logistic Regression with an accuracy of 72.46 %. MLP also stands out with a commendable accuracy of 83.57 % and AUC of 0.978.

PMID:39106532 | DOI:10.1016/j.pscychresns.2024.111858

Rev Med Inst Mex Seguro Soc. 2024 Jan 8;62(1):1-8. doi: 10.5281/zenodo.10278115.

ABSTRACT

BACKGROUND: Acute coronary syndrome (ACS) is the most serious manifestation of coronary heart disease. The Infarction Code (according to its initialism in Spanish, CI: Código Infarto) program aims to improve the care of these patients.

OBJECTIVE: To describe the clinical presentation and outcomes of CI program in a coronary care unit (CCU).

MATERIAL AND METHODS: A database of a CCU with 5 years of consecutive records was analyzed. Patients diagnosed with ACS were included. The groups with acute myocardial infarction with and without ST-segment elevation were compared using Student’s t, Mann-Whitney U and chi-squared tests. We calculated the relative risk (RR) and 95% confidence intervals (95% CI) of cardiovascular risk factors for mortality.

RESULTS: A total of 4678 subjects were analyzed, 78.7% men, mean age 63 years (± 10.7). 80.76% presented acute myocardial infarction with positive ST-segment elevation and fibrinolytic was granted in 60.8% of cases. Percutaneous coronary intervention was performed in 81.4% of patients, which was successful in 82.5% of events. Patients classified as CI presented mortality of 6.8% vs. 11.7%, p = 0.001. Invasive mechanical ventilation had an RR of 26.58 (95% CI: 20.61-34.3) and circulatory shock an RR of 20.86 (95% CI: 16.16-26.93).

CONCLUSIONS: The CI program decreased mortality by 4.9%. Early fibrinolysis and successful coronary angiography are protective factors for mortality within CCU.

PMID:39106526 | DOI:10.5281/zenodo.10278115

Rev Med Inst Mex Seguro Soc. 2024 Jan 8;62(1):1-6. doi: 10.5281/zenodo.10278107.

ABSTRACT

BACKGROUND: Knowledge of one’s own chronic kidney disease (CKD) can improve long-term quality of life (QoL). Peritoneal dialysis presents with residual symptoms that reduce the QoL.

OBJECTIVE: To correlate knowledge of the disease and QoL in patients with CKD and on continuous ambulatory peritoneal dialysis (CAPD).

MATERIAL AND METHODS: A descriptive, cross-sectional, and prospective study was carried out in patients with CKD treated at a second-level hospital of the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) in Puebla. SF-36 and KiKS questionnaires were applied. Age, sex, education, marital status, perception of QoL, and level of knowledge were recorded. Descriptive statistics and Spearman’s coefficient were used.

RESULTS: 199 patients with CKD in CAPD were included, 62.8% women, minimum age range was 18 to 20 years with 4% and maximum of 61 years or more with 49.2%, 35.6% of patients completed primary school, and 65.3% were married. The most frequent comorbidity was diabetes (57.2%). The least affected QoL domain was pain. KiKS recorded a mean of 0.54 (regular knowledge about the disease). It was recorded a weak and significant correlation in the QoL domains: physical health, physical role, pain, general health, mental health (p ≤ 0.05).

CONCLUSIONS: There is a significant but weak correlation between the perception of QoL and the level of knowledge of the disease in CKD patients with CAPD.

PMID:39106524 | DOI:10.5281/zenodo.10278107

Rev Med Inst Mex Seguro Soc. 2024 Jan 8;62(1):1-6. doi: 10.5281/zenodo.10278103.

ABSTRACT

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organs and body systems.

OBJECTIVE: To describe the sociodemographic, clinical, and biochemical characteristics of the Lupus-IMMS-Mexico (LUPUS-IMMex) patient cohort from a tertiary-level center.

MATERIAL AND METHODS: Observational descriptive study of 160 patients with diagnosis of SLE belonging to the aforementioned cohort. Various variables were analyzed at the time of diagnosis. For quantitative variables, normality tests were applied, followed by measures of central tendency and dispersion according to their distribution. For categorical variables, frequencies and percentages were calculated.

RESULTS: 81.87% of the patients were female, with a median age at diagnosis of 28 years. 18.12% had a family history of SLE, and concurrently with SLE, 32.50% had hypertension, and 11.25% had antiphospholipid syndrome. The most common clinical manifestation was joint involvement (68.12%), renal (49.37%) and hematological (43.75%) manifestations.

CONCLUSIONS: SLE affects millions globally. Lack of awareness leads to delayed diagnoses, suboptimal management, and diminished quality of life. After analyzing 160 patients with SLE, their clinical, socioeconomic, and therapeutic characteristics are largely like other cohorts, with differences attributable to ethnic and geographical influences. Informing patients about SLE and providing reliable resources are essential for self-care. Awareness promotes research, therapies, and enhances medical care and the lives of patients globally.

PMID:39106519 | DOI:10.5281/zenodo.10278103

Ter Arkh. 2024 Jul 30;96(7):690-694. doi: 10.26442/00403660.2024.07.202907.

ABSTRACT

AIM: Evaluation in real clinical practice of the effectiveness and safety of levilimab therapy in patients with highly and moderately active rheumatoid arthritis (RA).

MATERIALS AND METHODS: A prospective observational study (6 months) involving 35 patients with RA (29 women and 6 men, mean age 53.17±13.2 years) who were treated at the Ochapovsky Regional Clinic Hospital of Krasnodar Region. All patients included in the study were prescribed the drug levilimab (Ilsira).

RESULTS: After 1 month of observation, there was a decrease in the clinical and laboratory activity of the process in the form of a decrease in the number of painful joints – 17.0 (14.0; 20.0) vs 8.0 (6.0; 10.0); p=0.000001, number of swollen joints – 3.0 (2.0; 4.0) vs 0.0 (0.0; 0.0); p=0.000002, reduction in pain intensity according to visual analog scale – 60.0 (60.0; 70.0) mm vs 30.0 (20.0; 40.0) mm (p=0.000001). Also, by the end of the first month of therapy, there was a decrease in clinical activity indices DAS28-ESR by 43%, SDAI by 60%, CDAI by 55%. Positive dynamics of laboratory parameters were noted – a decrease in erythrocyte sedimentation rate by 76%, a decrease in C-reactive protein level by 98%. By the 6th month of therapy, a decrease in RF by 36% and ACCP by 11% was recorded, but the dynamics of these indicators did not reach statistical significance. By the end of 4 weeks of treatment, 24 (68.6%) patients showed an increase in the level of total blood cholesterol – 5.1 (3.91; 6.0) mmol/L vs 6.1 (4.99; 7.07) mmol/L (p=0.000006), while 11 (45.8%) patients from this group had initially elevated cholesterol levels (6.4±0.6 mmol/L). In 5 (14.3%) patients, an increase in alanine aminotransferase (ALT) was recorded in the 4th week – 17.0 (11.0; 25.0) U/L vs 32.0 (22.0; 43.0) U/L (p=0.000062) and aspartate aminotransferase (AST) – 19.0 (14.0; 24.0) U/L vs 25.0 (18.0; 36.0) U/L (p=0.000171), in 1 (2.85%) of the patient, an increase in ALT and AST above normal was noted (ALT 144 U/L, AST 52 U/L), which required discontinuation of levilimab. In 2 (5.7%) patients, by the end of the 4th week a decrease in the absolute number of neutrophils was registered – 3.2 (2.6; 4.0)×10E⁹/L vs 2.3 (2.0; 2.5)×10E⁹/L (p=0.002), which did not require discontinuation of treatment, since the number of cells remained more than 1×10E⁹/L. During treatment with levilimab 162 mg subcutaneously once a week, the proportion of patients taking prednisolone decreased from 46% at the start of therapy to 11% at the end of 6 months of therapy.

CONCLUSION: Levilimab is a highly effective drug for the treatment of patients with highly and moderately active RA and has a favorable tolerability and safety profile.

PMID:39106512 | DOI:10.26442/00403660.2024.07.202907

Ter Arkh. 2024 Jul 30;96(7):666-674. doi: 10.26442/00403660.2024.07.202781.

ABSTRACT

AIM: To evaluate the impact of a decrease in glomerular filtration rate (GFR) on the prognosis of patients with chronic heart failure (CHF), to analyze real clinical practice regarding the frequency of prescribing pathogenetic therapy for CHF, achieving target dosages depending on the gradation of GFR in patients included in the CHF Register of the Tyumen region.

MATERIALS AND METHODS: The analysis included medical data of 4077 patients (1662 men and 2415 women) with NYHA class I-IV CHF who underwent examination and treatment in medical organizations of the Tyumen region for the period from January 2020 to May 2023. Criteria for inclusion in the register: proven heart failure. Chronic kidney disease (CKD) was assessed by GFR calculated using the CKD-EPI formula (ml/min/1.73 m²). The primary end point was defined as death from all causes.

RESULTS: GFR<60 ml/min/1.73 m² was recorded in 34.6% of patients, more common in women (40.2 and 26.6%, respectively; p<0.001). When dividing patients into phenotypes according to LVEF, no statistically significant differences were found in the distribution of patients according to GFR. In patients with HFrEF and HFpEF GFR<45 ml/min/1.73 m² was associated with an increased risk of meeting the endpoint. Analysis of prescribed pathogenetic therapy showed that in patients with HFrEF, the frequency of prescription of ACE inhibitors, â-blockers and MRA decreased (p=0.023, 006 and 0.01, respectively), and ARNI, on the contrary, increased with a decrease in GFR (p=0.026). In patients with HFpEF, a similar trend towards a decrease in the frequency of prescription of ACEIs and MCBs with a decrease in GFR (p<0.001) remained, but it was compensated by an inversely proportional increase in the frequency of prescription of ARBs (p<0.001). 100% of the target dosage is achieved in more than 90% of patients taking MRA across the entire LVEF range. While for â-blockers and ARNI/ACE/ARB the percentage of patients receiving the full therapeutic dosage of drugs is significantly lower. When analyzing target dosages of pathogenetic drugs, gradations of achieved doses were distributed evenly throughout the entire range of GFR.

CONCLUSION: GFR<60 ml/min/1.73 m² occurs in every 3 patients with CHF across the entire range of LVEF. A decrease in GFR worsens the prognosis of patients with both HFrEF and HFpEF, increasing in direct proportion with the severity of the stage of CKD. Inclusion of patients in the monitoring program within the framework of the CHF service allows the treatment to be significantly brought closer to optimal drug therapy, at the same time, certain efforts are required to overcome difficulties with titration to target dosages.

PMID:39106509 | DOI:10.26442/00403660.2024.07.202781

Ter Arkh. 2024 Jul 7;96(6):614-621. doi: 10.26442/00403660.2024.06.202804.

ABSTRACT

AIM: To study the efficacy and safety of Eladis® in comparison with placebo in patients with non-productive cough.

MATERIALS AND METHODS: A phase III clinical trial enrolled 250 patients aged 18-65 years with acute respiratory viral infection with upper respiratory tract involvement or acute bronchitis. Patients were randomized into 2 groups of 125 subjects: group 1 received Eladis® (40 mg tablets), group 2 received a matching placebo. The patients received the study drugs 1 tablet BID for 7-14 days. After the treatment, patients were followed up (day 7±2) to assess the effect of therapy on the frequency of coughing attacks, the frequency and severity of daytime and nocturnal cough, the severity of cough, the duration of clinical cough cure, and the effect on the severity of the main acute respiratory viral infection symptoms.

RESULTS AND CONCLUSION: The results of the study demonstrate the overall efficacy and statistically significant superiority of Eladis® over placebo: there were significant differences between the study groups in the proportion of patients who decreased the coughing attack frequency by ≥50% by day 5 (p<0.0001). In addition, the clinical cure of cough in the Eladis® group occurred 2 days earlier: the median time was 6 days, vs 8 days in placebo group. There was a decrease in the frequency of cough attacks and a decrease in its severity by more than 3.5 points by day 5 of treatment. All the effects were associated with high safety of the drug.

PMID:39106503 | DOI:10.26442/00403660.2024.06.202804