Brohancock5574
To examine responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial.
REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, evaluating single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized (VMS substudy) to daily E2/P4 (mg/mg) of 1/100, 0.5/100, 0.5/50, 0.25/50, or placebo. Proportions of women with ≥50% or ≥75% reductions in moderate to severe VMS (responders), and those with no severe VMS as well as the weekly number of days without moderate to severe VMS with TX-001HR versus placebo were determined. Mixed model repeated measures was used to analyze data and Fisher exact test was employed to compare E2/P4 versus placebo.
Seven hundred twenty-six women were eligible for the VMS efficacy analysis (E2/P4 1/100 [n = 141], 0.5/100 [n = 149], 0.5/50 [n = 147], 0.25/50 [n = 154], or placebo [n = 135]). Significantly more women treated with all E2/P4 doses versus placebo were ≥50% responders and ≥75% responders at weeks 4 and 12 (P < 0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; P < 0.05). The proportion of women without severe hot flushes at week 12 was 43% to 56% for all E2/P4 doses versus 26% for placebo (P ≤ 0.01).
Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4 1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.
Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4 1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.
There has been an increase in the use of electronic systems to collect patient-reported outcome measures. There is limited data on the added value of electronic reporting on increasing patient response proportions and little knowledge of which patients are more likely to respond.
(1) What proportion of patients completed patient-reported outcome questionnaires at baseline and at 1 year and 2 years of follow-up after shoulder arthroplasty, and what methods did they use to complete these questionnaires (either automated or manual data collection)? (2) What factors were associated with questionnaire completion?
Our shoulder arthroplasty registry from a high-volume, tertiary care center implemented an electronic platform to collect patient-reported outcomes. A total of 2128 patients underwent shoulder arthroplasty between 2016 and 2019. Patients without an email address on file were excluded; 90% (1907 of 2128) of patients were included in the study. The population was 50% women (954 of 1907) with a mean ag are associated with a higher likelihood of completing questionnaires has implications for targeted follow-up or representative sampling of the population in a registry. Populations that are less likely to respond may require more effort to reach to prevent exacerbating health outcome disparities. Random sampling with upweighting of hard-to-reach populations may also provide a solution to achieve a representative population of patients undergoing shoulder arthroplasty.
The knowledge of which patient characteristics are associated with a higher likelihood of completing questionnaires has implications for targeted follow-up or representative sampling of the population in a registry. Populations that are less likely to respond may require more effort to reach to prevent exacerbating health outcome disparities. Random sampling with upweighting of hard-to-reach populations may also provide a solution to achieve a representative population of patients undergoing shoulder arthroplasty.
Machine learning (ML) is a subdomain of artificial intelligence that enables computers to abstract patterns from data without explicit programming. A myriad of impactful ML applications already exists in orthopaedics ranging from predicting infections after surgery to diagnostic imaging. Protein Tyrosine Kinase inhibitor However, no systematic reviews that we know of have compared, in particular, the performance of ML models with that of clinicians in musculoskeletal imaging to provide an up-to-date summary regarding the extent of applying ML to imaging diagnoses. By doing so, this review delves into where current ML developments stand in aiding orthopaedists in assessing musculoskeletal images.
This systematic review aimed (1) to compare performance of ML models versus clinicians in detecting, differentiating, or classifying orthopaedic abnormalities on imaging by (A) accuracy, sensitivity, and specificity, (B) input features (for example, plain radiographs, MRI scans, ultrasound), (C) clinician specialties, and (2) to compare the perforate (95% confidence interval [CI] 37 to 54; p < 0.001) and a mean increase in specificity of 0.048 (95% CI 0.029 to 0.068; p < 0.001) in detecting abnormalities on musculoskeletal images.
At present, ML models have comparable performance to clinicians in assessing musculoskeletal images. ML models may enhance the performance of clinicians as a technical supplement rather than as a replacement for clinical intelligence. Future ML-related studies should emphasize how ML models can complement clinicians, instead of determining the overall superiority of one versus the other. This can be accomplished by improving transparent reporting, diminishing bias, determining the feasibility of implantation in the clinical setting, and appropriately tempering conclusions.
Level III, diagnostic study.
Level III, diagnostic study.
To evaluate the results obtained from the combination of intragastric botulinum toxin A (IGBTA), intragastric balloon (IGB), and IGBTA(+)IGB in the treatment of obesity.
Three separate treatment groups were set up. IGBTA, IGB, and IGBTA(+)IGB were administered to Group 1, 2, and 3, respectively. The body mass indexes (BMI) of patients were measured before and 6 months after the treatment. The intragroup and intergroup treatment results have been evaluated. P<0.05 was considered significant.
The mean BMI decreased by 1.6 kg/m in 40 patients who received IGBTA in group 1 (P<0.001), 3.95 kg/m in 42 patients who received IGB in group 2 (P<0.001), and 4.9 kg/m in 39 patients who received IGBTA and IGB in group 3 (P<0.001) after 6 months of treatment. The intolerance because of the application was the highest in group 3, followed by group 2.
The treatment was most successful in group 3 followed by group 2 and group 1, respectively. The authors recommend the group 3 treatment, provided that nausea, vomiting, and flatulence have a high index of probability in such a treatment.