Categories
Nevin Manimala Statistics

Efficacy and safety of cotadutide, a dual GLP-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease

Diabetes Obes Metab. 2022 Apr 11. doi: 10.1111/dom.14712. Online ahead of print.

ABSTRACT

AIMS: To assess efficacy, safety and tolerability of cotadutide in patients with type 2 diabetes mellitus and chronic kidney disease (CKD).

MATERIALS AND METHODS: In this phase 2a study (NCT03550378), patients with BMI 25-45 kg/m2 , estimated glomerular filtration (eGFR) rate 30-59 mL/min/1.73 m2 and type 2 diabetes (HbA1c 6.5-10.5% [48-91 mmol/mol]) controlled with insulin and/or oral therapy combination, were randomized 1:1 to once-daily subcutaneous cotadutide (50-300 μg) or placebo for 32 days. Primary endpoint was plasma glucose concentration assessed using a mixed-meal tolerance test (MMTT).

RESULTS: Participants receiving cotadutide (n = 21) had significant reductions in MMTT area under the glucose concentration-time curve (AUC) (-26.71% vs +3.68%, p < 0.001), more time in target glucose range on continuous glucose monitoring (+14.79% vs -21.23%, p = 0.001) and significant reductions in absolute bodyweight (-3.41 kg vs -0.13 kg, p < 0.001) versus placebo (n = 20). In patients with baseline micro- or macroalbuminuria (n = 18), urinary albumin-to-creatinine ratios (UACR) decreased by 51% at day 32 with cotadutide versus placebo (p = 0.0504). No statistically significant difference was observed in mean change in eGFR between treatments. Mild/ moderate adverse events occurred in 71.4% of participants receiving cotadutide and 35.0% receiving placebo.

CONCLUSIONS: We established the efficacy of cotadutide in this patient population, with significantly improved postprandial glucose control and reduced bodyweight versus placebo. Reductions in UACR suggest potential benefits of cotadutide on kidney function, supporting further evaluation in larger, longer-term clinical trials. This article is protected by copyright. All rights reserved.

PMID:35403793 | DOI:10.1111/dom.14712

Categories
Nevin Manimala Statistics

Investigation of the relationship between inflammatory blood parameters and seborrheic dermatitis

J Cosmet Dermatol. 2022 Apr 11. doi: 10.1111/jocd.14984. Online ahead of print.

ABSTRACT

OBJECTIVE: Seborrheic dermatitis (SD) is a chronic inflammatory disease. The etiology of the disease is still unknown. The systemic immune-inflammation index (SII), red cell distribution width (RDW), mean platelet volume (MPV), C-reactive protein (CRP), monocyte to HDL cholesterol ratio (MHR), platelet to lymphocyte ratio (PLR), and neutrophil to lymphocyte ratio (NLR) have all been reported as inflammatory markers in recent studies. However, these inflammatory markers have not been explored in SD patients. This study aimed to explore inflammatory and hematological parameters in SD patients with healthy controls (HCs) and evaluate their possible relationship with disease severity.

MATERIALS AND METHODS: One hundred patients who presented to our hospital and were diagnosed with SD and 74 HCs were retrospectively included in our study. The seborrheic dermatitis area severity index (SDASI) score was used to assess the severity of the SD.

RESULTS: The patient group’s mean PLR, MPV ve CRP levels were statistically significantly higher than the HCs (p < 0.05). There was no statistically significant difference in the patients compared to the control group regarding RDW, NLR, MHR, and SII levels (p > 0.05). There was no statistically significant correlation between NLR, PLR, MPV, Monocyte/HDL cholesterol, SII levels with age, and SDASI in the patient group. There was a significant correlation between CRP with age and RDW with SDASI score.

CONCLUSION: Hematological parameters and CRP are low-cost tests. These tests can be used to define inflammation levels in inflammatory diseases. This study shows that PLR, CRP, and MPV may be used as novel inflammatory markers in SD.

PMID:35403790 | DOI:10.1111/jocd.14984

Categories
Nevin Manimala Statistics

Recommendations for reporting statistical results when comparing proportions

Cytopathology. 2022 May;33(3):301-304. doi: 10.1111/cyt.13083.

ABSTRACT

This article serves as the first in a series that will offer recommendations for optimal data reporting, specifically focusing on statistical methods most frequently reported by the Cytopathology audience. Recommendations for reporting statistical results when comparing proportions is the first topic in the series since comparing proportions, particularly utilising the chi-square test, was the most commonly reported inferential statistical test category over 2.5 years of Cytopathology articles.1 While this article will provide a summary of common tests used to compare proportions, an extensive review of each method, including test assumptions and calculations, is beyond the scope of this summary. The author recommends consulting a trained statistician prior to data collection to discuss an analytical plan, including determining the appropriate statistical test(s) to use.

PMID:35403761 | DOI:10.1111/cyt.13083

Categories
Nevin Manimala Statistics

Introducing an educational series about statistical reporting

Cytopathology. 2022 May;33(3):292. doi: 10.1111/cyt.13118.

NO ABSTRACT

PMID:35403762 | DOI:10.1111/cyt.13118

Categories
Nevin Manimala Statistics

Effects of specific collagen peptide supplementation combined with resistance training on Achilles tendon properties

Scand J Med Sci Sports. 2022 Apr 11. doi: 10.1111/sms.14164. Online ahead of print.

ABSTRACT

The purpose of this study was to investigate the effect of specific collagen peptides (SCP) combined with resistance training (RT) on changes in tendinous and muscular properties. In a randomized, placebo-controlled study, 40 healthy male volunteers (age: 26.3 ± 4.0 years) completed a 14-week high-load resistance training program. One group received a daily dosage of 5g SCP while the other group received 5g of a placebo (PLA) supplement. Changes in Achilles tendon cross-sectional area (CSA), tendon stiffness, muscular strength and thickness of the plantar flexors were measured. The SCP supplementation led to a significantly (p = 0.002) greater increase in tendon CSA (+11.0%) compared with the PLA group (+4.7%). Moreover, the statistical analysis revealed a significantly (p = 0.014) greater increase in muscle thickness in the SCP group (+7.3%) compared with the PLA group (+2.7%). Finally, tendon stiffness and muscle strength increased in both groups, with no statistical difference between the groups. In conclusion, the current study shows that the supplementation of specific collagen peptides combined with RT is associated with a greater hypertrophy in tendinous and muscular structures than RT alone in young physically active men. These effects might play a role in reducing tendon stress (i.e. deposition of collagen in load bearing structures) during daily activities.

PMID:35403756 | DOI:10.1111/sms.14164

Categories
Nevin Manimala Statistics

Talking with children and young people with 22q11DS about their mental health, behaviour, learning and communication

Child Care Health Dev. 2022 Apr 11. doi: 10.1111/cch.13013. Online ahead of print.

ABSTRACT

BACKGROUND: 22q11DS11.2 deletion syndrome (22q11DS) is a complex multi-system syndrome characterised by physical abnormalities, psychiatric comorbidities and cognitive deficits. The views of children and young people (CYP) about the challenges associated with their mental health, behaviour, learning and communication difficulties have not been reported. The aim of this study was to address this gap and to understand whether they had help and support with these and their views of this.

METHODS: A three-phase mixed-methods study was undertaken, involving interviews with CYP with 22q11DS, a follow-up survey for those aged 11-25 years and a stakeholder workshop at which CYP presented their views of living with 22q11DS to health professionals and parents. Interview transcripts were thematically analysed and non-parametric statistics were used to analyse survey data.

RESULTS: The interviews (n=13) and survey (n=32) indicated a mixed picture, with some CYP not reporting ongoing problems; others who had problems received help but a sizeable proportion had unmet needs and wanted to receive help. Two-thirds reported often experiencing negative feelings and almost half had difficulties with social interactions. Family members were the main sources of support, with teaching assistants identified as an important support at school.

CONCLUSIONS: The emotional impact of 22q11DS on CYP can be significant: they often do not understand the consequences of having 22q11DS and are frequently not given strategies to understand and manage their feelings, behaviour or problems. This leads to a range of emotions which manifest in different ways at home and at school. CYP are able to talk about the impact of different aspects of 22q11DS on them, facilitated by the use of creative methods, but they differ in how the condition affects them and their perceptions about that. It is imperative that CYP themselves are asked about their experiences, feelings and needs to ensure tailoring of interventions to their individual requirements.

PMID:35403745 | DOI:10.1111/cch.13013

Categories
Nevin Manimala Statistics

Robust inference on effects attributable to mediators: A controlled-direct-effect-based approach for causal effect decomposition with multiple mediators

Stat Med. 2022 May 10;41(10):1797-1814. doi: 10.1002/sim.9329. Epub 2022 Feb 2.

ABSTRACT

Effect decomposition is a critical technique for mechanism investigation in settings with multiple causally ordered mediators. Causal mediation analysis is a standard method for effect decomposition, but the assumptions required for the identification process are extremely strong. Moreover, mediation analysis focuses on addressing mediating mechanisms rather than interacting mechanisms. Mediation and interaction for mediators both contribute to the occurrence of disease, and therefore unifying mediation and interaction in effect decomposition is important to causal mechanism investigation. By extending the framework of controlled direct effects, this study proposes the effect attributable to mediators (EAM) as a novel measure for effect decomposition. For policymaking, EAM represents how much an effect can be eliminated by setting mediators to certain values. From the perspective of mechanism investigation, EAM contains information about how much a particular mediator or set of mediators is involved in the causal mechanism through mediation, interaction, or both. EAM is more appropriate than the conventional path-specific effect for application in clinical or medical studies. The assumptions of EAM for identification are considerably weaker than those of causal mediation analysis. We develop a semiparametric estimator of EAM with robustness to model misspecification. The asymptotic property is fully realized. We applied EAM to assess the magnitude of the effect of hepatitis C virus infection on mortality, which was eliminated by controlling alanine aminotransferase and treating hepatocellular carcinoma.

PMID:35403735 | DOI:10.1002/sim.9329

Categories
Nevin Manimala Statistics

Periapical and Endodontic Status of Patients with Inflammatory Bowel Disease: Age- and Sex- matched Case-control Study

Int Endod J. 2022 Apr 11. doi: 10.1111/iej.13747. Online ahead of print.

ABSTRACT

AIM: Crohn’s disease (CD) and ulcerative colitis (UC) are two chronic recurrent inflammatory processes of the gastrointestinal tract, grouped under the name Inflammatory Bowel Disease (IBD), causing clinical episodes of intestinal inflammation. The aim of this study was to investigate the possible association between IBD and the prevalence of apical periodontitis and root canal treatment.

METHODOLOGY: A case-control study design matched to age and sex was used. The study group (SG) included 28 patients with IBD (13 with CD, 15 with UC). Another 28 healthy subjects, without IBD and age- and sex- matched, were included in the control group (CG). Radiographic records were analyzed and apical periodontitis (AP) was diagnosed as radiolucent periapical lesions (RPLs), using the periapical index score (PAI). Student’s t test, χ2 test and multivariate logistic regression were used in the statistical analysis.

RESULTS: In the CG, only 17 subjects (61%) had at least one tooth with AP, while in the SG group they were 23 patients (82%) (OR = 2.98; CI 95% = 0.87 – 10.87; p = 0.08). The number of subjects with one or more root filled teeth (RFT) in the CG was 14 (50%), while in the SG they were 22 (79%) (OR = 3.67; 95% CI = 1.14 – 11.79; p = 0.026). At least one RFT with AP was evident in 3 subjects (10.7%) in the control group, while in the study group 15 patients (53.6%) showed RFT with AP (OR = 9.60; 95% CI = 2.35 – 39.35; p = 0.001). In the multivariate logistic regression analysis, only endodontic status was found to be associated with IBD (OR = 1.86; 95% CI = 1.24 – 2.80; p = 0.003).

CONCLUSION: IBD, ulcerative colitis and Crohn´s disease, is associated with higher prevalence of RFT and higher percentage of RFT with periapical lesions. Dentists should consider these findings when caring for IBD patients by monitoring the evolution of periapical lesions of endodontically treated teeth.

PMID:35403728 | DOI:10.1111/iej.13747

Categories
Nevin Manimala Statistics

Characterizing COPD Symptom Variability in the Stable State Utilizing the Evaluating Respiratory Symptoms in COPD Questionnaire

Chronic Obstr Pulm Dis. 2022 Apr 9. doi: 10.15326/jcopdf.2021.0263. Online ahead of print.

ABSTRACT

RATIONALE: It has been suggested that patients with COPD experience considerable daily respiratory symptom fluctuation. A standardized measure is needed to quantify and understand the implications of day-to-day symptom variability.

OBJECTIVES: To compare standard deviation with other statistical measures of symptom variability and identify characteristics of subjects with higher symptom variability.

METHODS: Individuals in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS) Exacerbations sub-study completed an Evaluating Respiratory Symptoms in COPD (E-RS) daily questionnaire. We calculated within-subject standard deviation (WS-SD) for each patient at week 0 and correlated this with measurements obtained four weeks later using Pearson’s r and Bland Altman plots. Median WS-SD value dichotomized participants into higher versus lower variability groups. Association between WS-SD and exacerbation risk during four follow up weeks was explored.

MEASUREMENTS AND MAIN RESULTS: Diary completion rates were sufficient in 140 (68%) of 205 sub-study participants. Reproducibility (r) of the WS-SD metric from baseline to week four was 0.32. Higher variability participants had higher St. George’s Respiratory Questionnaire (SGRQ) scores (47.3 ± 20.3 vs 39.6 ± 21.5, p=.04) than lower variability participants. Exploratory analyses found no relationship between symptom variability and HCRU exacerbations.

CONCLUSIONS: WS-SD of the E-RS can be used as a measure of symptom variability in studies of patients with COPD. Patients with higher variability have worse health-related quality of life. WS-SD should be further validated as a measure to understand the implications of symptom variability.

PMID:35403414 | DOI:10.15326/jcopdf.2021.0263

Categories
Nevin Manimala Statistics

Post-stroke shoulder-hand syndrome of phlegm-stasis obstruction treated with the combined therapy of eye acupuncture, Tengliao and rehabilitation training: a multi-central randomized controlled trial

Zhongguo Zhen Jiu. 2022 Apr 12;42(4):385-9. doi: 10.13703/j.0255-2930.20210426-0003.

ABSTRACT

OBJECTIVE: To assess the efficacy on relieving pain and improving the range of motion of shoulder joint in post-stroke shoulder-hand syndrome of phlegm-stasis obstruction in treatment of the combined therapy of eye acupuncture, Tengliao (Chinese herbal warm dressing technique) and rehabilitation training (eye acupuncture + Tengliao + rehabilitation) as compared with the combined treatment of Tengliao and rehabilitation training (Tengliao + rehabilitation) and the simple rehabilitation training (rehabilitation).

METHODS: A total of 356 patients with post-stroke shoulder-hand syndrome of phlegm-stasis obstruction were randomized into an eye acupuncture + Tengliao + rehabilitation group (group A, 122 cases, 2 cases dropped off), a Tengliao + rehabilitation group (group B, 120 cases, 3 cases dropped off) and a rehabilitation group (group C, 114 cases, 1 case dropped off). In the group C, the basic treatment was combined with routine rehabilitation training. In the group B, on the base of the treatment as the group C, Tengliao was exerted. A medical bag composed of over 20 Chinese herbal materials was heated and dressed at the affected area, 30 min each time, 5 times weekly. In the group A, besides the treatment as the group B, eye acupuncture was applied to heart region, kidney region, upper jiao region and lower jiao region, 30 min each time, 5 times weekly. The treatment lasted 28 days in all of three groups. Separately, before treatment, in 7, 14, 21 and 28 days of treatment, as well as in 14 days after treatment of follow-up, the score of visual analogue scale (VAS) for pain, the score of guides to evaluation of permanent impairment (GEPI) and the score of National Institutes of Health stroke scale (NIHSS) were observed in each group.

RESULTS: The scores of VAS, GEPI and NIHSS were all improved with the treatment lasting in the three groups (P<0.000 1). In 7, 14, 21 and 28 days of treatment and in follow-up as well, VAS scores in the group A were all lower than the group C (P<0.05). After 14 days of treatment, GEPI score showed increasing trend, while NIHSS score showed decreasing trend in the group A compared with the group B. Before treatment, GEPI score was lower and NIHSS score was higher in the group A compared with the group C (P<0.05). It was suggested that the illness was slightly serious in the group A. After propensity score matching, in 14, 21 and 28 days as well as in follow-up, GEPI scores in the group A were higher than the group C respectively (P<0.05). Regarding NIHSS score at each time point, the difference had no statistical significance between the group A and the group C (P>0.05).

CONCLUSION: The combined therapy of eye acupuncture, Tengliao and rehabilitation training obtains a better efficacy on post-stroke shoulder-hand syndrome of phlegm-stasis obstruction as compared with rehabilitation training.

PMID:35403396 | DOI:10.13703/j.0255-2930.20210426-0003