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Nevin Manimala Statistics

Urine Albumin-Creatinine Ratio Variability in People With Type 2 Diabetes: Clinical and Research Implications

Am J Kidney Dis. 2024 Mar 15:S0272-6386(24)00620-6. doi: 10.1053/j.ajkd.2023.12.018. Online ahead of print.

ABSTRACT

RATIONALE & OBJECTIVE: Evidence has demonstrated that albuminuria is a key diagnostic and prognostic marker of diabetic chronic kidney disease, but the impact of its day-to-day variability has not been adequately considered. This study quantified within-individual variability of albuminuria in people with type 2 diabetes to inform clinical albuminuria monitoring.

STUDY DESIGN: Descriptive cross-sectional analysis.

SETTING & PARTICIPANTS: People with type 2 diabetes (n=826, 67.1 [IQR, 60.3-72.4] years, 64.9% male) participating in the Progression of Diabetic Complications (PREDICT) cohort study.

EXPOSURE: Four spot urine collections for measurement of urinary albumin-creatinine ratio (UACR) within 4 weeks.

OUTCOME: Variability of UACR.

ANALYTICAL APPROACH: We characterized within-individual variability (coefficient of variation [CV], 95% limits of random variation, intraclass correlation coefficient), developed a calculator displaying probabilities that any observed difference between a pair of UACR values truly exceeded a 30% difference, and estimated the ranges of diagnostic uncertainty to inform a need for additional UACR collections to exclude or confirm albuminuria. Multiple linear regression examined factors influencing UACR variability.

RESULTS: We observed high within-individual variability (CV 48.8%; 95% limits of random variation showed a repeated UACR to be as high/low as 3.78/0.26 times the first). If a single-collection UACR increased from 2 to 5mg/mmol, the probability that UACR actually increased by at least 30% was only 50%, rising to 97% when 2 collections were obtained at each time point. The ranges of diagnostic uncertainty were 2.0-4.0mg/mmol after an initial UACR test, narrowing to 2.4-3.2 and 2.7-2.9mg/mmol for the mean of 2 and 3 collections, respectively. Some factors correlated with higher (female sex; moderately increased albuminuria) or lower (reduced estimated glomerular filtration rate and sodium-glucose cotransporter 2 inhibitor/angiotensin-converting enzyme inhibitor/angiotensin receptor blocker treatment) within-individual UACR variability.

LIMITATIONS: Reliance on the mean of 4 UACR collections as the reference standard for albuminuria.

CONCLUSIONS: UACR demonstrates a high degree of within-individual variability among individuals with type 2 diabetes. Multiple urine collections for UACR may improve capacity to monitor changes over time in clinical and research settings but may not be necessary for the diagnosis of albuminuria.

PLAIN-LANGUAGE SUMMARY: Albuminuria (albumin in urine) is a diagnostic and prognostic marker of diabetic chronic kidney disease. However, albuminuria can vary within an individual from day to day. We compared 4 random spot urinary albumin-creatinine ratio (UACR) samples from 826 participants. We found that a second UACR collection may be as small as a fourth or as large as almost 4 times the first sample’s UACR level. This high degree of variability presents a challenge to our ability to interpret changes in albuminuria. Multiple collections have been suggested as a solution. We have constructed tools that may aid clinicians in deciding how many urine collections are required to monitor and diagnose albuminuria. Multiple urine collections may be required for individual monitoring but not necessarily for diagnosis.

PMID:38551531 | DOI:10.1053/j.ajkd.2023.12.018

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Nevin Manimala Statistics

Quadriceps femoris muscle ultrasound in sarcoidosis: an observational case-control study

Eur J Phys Rehabil Med. 2024 Mar 29. doi: 10.23736/S1973-9087.24.08232-7. Online ahead of print.

ABSTRACT

BACKGROUND: Although loss of muscle mass may be associated with general weakness, intolerance to physical activity and fatigue, it is underestimated and poorly understood in patients with sarcoidosis.

AIM: To compare the quadriceps femoris muscle (QFM) thickness measured by ultrasonography (US) between the female patients with sarcoidosis and controls, secondly to assess the correlation between the muscle strength, fatigue and QFM thickness.

DESIGN: Observational, case-control study.

SETTING: Physical Medicine and Rehabilitation Department of a University Hospital.

POPULATION: Thirty-one women with sarcoidosis and 27 healthy volunteers were included in the study.

METHODS: The participants were evaluated for the following outcomes: 1) handgrip strength; 2) QFM thickness measured using US; and 3) sonographic thigh adjustment ratio (STAR). The sarcoidosis group was also evaluated with the 30-second chair stand test (30s-CST) and Fatigue Severity Scale (FSS).

RESULTS: The QFM thickness and STAR values of the patients with sarcoidosis were significantly lower than those of the controls (P=0.0001). However, no statistically significant difference was observed between the handgrip strengths of the groups (P=0.581). There was no statistically significant correlation between the STAR values and handgrip strength in the sarcoidosis group; however, there was a significant positive correlation between the STAR values and 30s-CST (r=0.467, P=0.008).

CONCLUSIONS: Loss of muscle mass is one of the musculoskeletal conditions in patients with sarcoidosis that may be associated with nonspecific symptoms, such as general debility, intolerance to physical activity, and fatigue. In the present study, no difference was observed in hand grip strength between the groups, while we found that QFM thickness was affected in patients with sarcoidosis when compared to the controls. The ultrasonographic QFM evaluation seems to be an innovative tool which may be used at all stages of sarcoidosis patient follow-up.

CLINICAL REHABILITATION IMPACT: The grip strength is a commonly used test to detect muscle weakness, but onset of a decrease in muscle mass in the lower extremities may occur earlier. Considering the increased burden of musculoskeletal problems in this population, performing 30s-CST and sonographic QFM thickness is practical methods to identify risky patients.

PMID:38551519 | DOI:10.23736/S1973-9087.24.08232-7

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Nevin Manimala Statistics

Development and preliminary validation of the Clinician Affective REsponse (CARE) scale

Res Psychother. 2024 Mar 21. doi: 10.4081/ripppo.2024.736. Online ahead of print.

ABSTRACT

The present study reports on the development and validation of the clinician affective response (CARE) scale. The CARE scale was designed as a self-report measure of therapists’ patterns of thoughts, feelings, and behaviors toward the patient during an individual psychotherapy session. An initial pool of 116 items was generated, and its quality was evaluated by subject matter experts. Validation data were gathered from licensed psychotherapists (n=554). We used exploratory factor analysis and item response theory-graded response modeling to select items, confirmatory factor analysis to test how well the factor structure fit the data, and k-fold cross-validation to ascertain the robustness of the model. Criterion validity was evaluated by correlating the scores of the scale with the characteristics of therapists, patients, and treatment. The selected model consists of 15 items and a 3-factor structure, which showed excellent model fit, good internal consistency, and evidence of criterion validity. The CARE scale, short and quick to complete, enables therapists to reflect on and recognize their inner experiences and quantify these experiences in ways conducive to statistical analysis and research. Furthermore, the monitoring of these affective reactions toward their patients can guide therapeutic interventions and inform clinical supervisors.

PMID:38551502 | DOI:10.4081/ripppo.2024.736

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Nevin Manimala Statistics

Reproducibility of #Enzian classification by transvaginal ultrasound and its correlation with symptoms

Facts Views Vis Obgyn. 2024 Mar;16(1):47-58. doi: 10.52054/FVVO.16.1.008.

ABSTRACT

BACKGROUND: The #Enzian classification represents a system to describe endometriotic lesions during surgery. Its use is well established in correlating ultrasound and surgical findings.

OBJECTIVES: To describe interobserver reproducibility of ultrasound use and symptom correlation with compartments involved using #Enzian classification.

MATERIALS AND METHODS: Two experienced operators performed transvaginal sonography (TVS) in 52 patients affected by pelvic endometriosis. A rate agreement was determined. A further 200 women with endometriotic TVS signs, with no previous surgery and not taking any hormonal therapy, were staged by one of three different operators according to the #Enzian (compartments A, B, C, O, T, FA, FB, FI, FU, FO). Statistical analysis compared all the compartments, as single or associated, with single or combined symptoms (dysmenorrhea, dyspareunia, heavy menstrual bleeding – HMB, bowel symptoms).

MAIN OUTCOME MEASURES: Evaluation of the reproducibility of #Enzian classification in assessing pelvic endometriosis among different operators using TVS, and of possible associations between symptoms and specific #Enzian compartments.

RESULTS: Excellent agreement between the two operators in evaluating almost all the compartments (k >0.8) was observed. Dysmenorrhea did not correlate with any specific compartment. We observed a significant association between dyspareunia and B compartment (p=0.02). HMB is associated with FA (p=0.02). Bowel symptoms were associated with B (p=0.02). Combining more symptoms, we observed more significant associations with different compartments.

CONCLUSIONS: #ENZIAN classification is reproducible in the evaluation of pelvic endometriosis. Some symptoms are correlated to specific ultrasound signs of the disease.

WHAT IS NEW?: An accurate evaluation of symptoms could guide TVS examination to detect specific endometriotic lesions and establish the best management for the patients.

PMID:38551474 | DOI:10.52054/FVVO.16.1.008

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Nevin Manimala Statistics

Estimation of a decreasing mean residual life based on ranked set sampling with an application to survival analysis

Int J Biostat. 2024 Mar 29. doi: 10.1515/ijb-2023-0051. Online ahead of print.

ABSTRACT

The mean residual lifetime (MRL) of a unit in a population at a given time t, is the average remaining lifetime among those population units still alive at the time t. In some applications, it is reasonable to assume that MRL function is a decreasing function over time. Thus, one natural way to improve the estimation of MRL function is to use this assumption in estimation process. In this paper, we develop an MRL estimator in ranked set sampling (RSS) which, enjoys the monotonicity property. We prove that it is a strongly uniformly consistent estimator of true MRL function. We also show that the asymptotic distribution of the introduced estimator is the same as the empirical one, and therefore the novel estimator is obtained “free of charge”, at least in an asymptotic sense. We then compare the proposed estimator with its competitors in RSS and simple random sampling (SRS) using Monte Carlo simulation. Our simulation results confirm the superiority of the proposed procedure for finite sample sizes. Finally, a real dataset from the Surveillance, Epidemiology and End Results (SEER) program of the US National Cancer Institute (NCI) is used to show that the introduced technique can provide more accurate estimates for the average remaining lifetime of patients with breast cancer.

PMID:38551082 | DOI:10.1515/ijb-2023-0051

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Nevin Manimala Statistics

Safer and more efficient vital signs monitoring protocols to identify the deteriorating patients in the general hospital ward: an observational study

Health Soc Care Deliv Res. 2024 Mar;12(6):1-143. doi: 10.3310/HYTR4612.

ABSTRACT

BACKGROUND: The frequency at which patients should have their vital signs (e.g. blood pressure, pulse, oxygen saturation) measured on hospital wards is currently unknown. Current National Health Service monitoring protocols are based on expert opinion but supported by little empirical evidence. The challenge is finding the balance between insufficient monitoring (risking missing early signs of deterioration and delays in treatment) and over-observation of stable patients (wasting resources needed in other aspects of care).

OBJECTIVE: Provide an evidence-based approach to creating monitoring protocols based on a patient’s risk of deterioration and link these to nursing workload and economic impact.

DESIGN: Our study consisted of two parts: (1) an observational study of nursing staff to ascertain the time to perform vital sign observations; and (2) a retrospective study of historic data on patient admissions exploring the relationships between National Early Warning Score and risk of outcome over time. These were underpinned by opinions and experiences from stakeholders.

SETTING AND PARTICIPANTS: Observational study: observed nursing staff on 16 randomly selected adult general wards at four acute National Health Service hospitals. Retrospective study: extracted, linked and analysed routinely collected data from two large National Health Service acute trusts; data from over 400,000 patient admissions and 9,000,000 vital sign observations.

RESULTS: Observational study found a variety of practices, with two hospitals having registered nurses take the majority of vital sign observations and two favouring healthcare assistants or student nurses. However, whoever took the observations spent roughly the same length of time. The average was 5:01 minutes per observation over a ’round’, including time to locate and prepare the equipment and travel to the patient area. Retrospective study created survival models predicting the risk of outcomes over time since the patient was last observed. For low-risk patients, there was little difference in risk between 4 hours and 24 hours post observation.

CONCLUSIONS: We explored several different scenarios with our stakeholders (clinicians and patients), based on how ‘risk’ could be managed in different ways. Vital sign observations are often done more frequently than necessary from a bald assessment of the patient’s risk, and we show that a maximum threshold of risk could theoretically be achieved with less resource. Existing resources could therefore be redeployed within a changed protocol to achieve better outcomes for some patients without compromising the safety of the rest. Our work supports the approach of the current monitoring protocol, whereby patients’ National Early Warning Score 2 guides observation frequency. Existing practice is to observe higher-risk patients more frequently and our findings have shown that this is objectively justified. It is worth noting that important nurse-patient interactions take place during vital sign monitoring and should not be eliminated under new monitoring processes. Our study contributes to the existing evidence on how vital sign observations should be scheduled. However, ultimately, it is for the relevant professionals to decide how our work should be used.

STUDY REGISTRATION: This study is registered as ISRCTN10863045.

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/05/03) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

PMID:38551079 | DOI:10.3310/HYTR4612

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Nevin Manimala Statistics

Prevalence of sex-chromosome aneuploidy estimated using SNP genotype intensity information in a large population of juvenile dairy and beef cattle

J Anim Breed Genet. 2024 Mar 29. doi: 10.1111/jbg.12866. Online ahead of print.

ABSTRACT

Aneuploidy is a genetic condition characterized by the loss or gain of one or more chromosomes. Aneuploidy affecting the sex chromosomes can lead to infertility in otherwise externally phenotypically normal cattle. Early identification of cattle with sex chromosomal aneuploidy is important to minimize the costs associated with rearing infertile cattle and futile breeding attempts. As most livestock breeding programs routinely genotype their breeding populations using single nucleotide polymorphism (SNP) arrays, this study aimed to assess the feasibility of integrating an aneuploidy screening tool into the existing pipelines that handle dense SNP genotype data. A further objective was to estimate the prevalence of sex chromosome aneuploidy in a population of 146,431 juvenile cattle using available genotype intensity data. Three genotype intensity statistics were used: the LogR Ratio (LRR), R-value (the sum of X and Y SNP probe intensities), and B-allele frequency (BAF) measurements. Within the female-verified population of 124,958 individuals, the estimated prevalence rate was 0.0048% for XO, 0.0350% for XXX, and 0.0004% for XXY. The prevalence of XXY in the male-verified population was 0.0870% (i.e., 18 out of 20,670 males). Cytogenetic testing was used to verify 2 of the XXX females who were still alive. The proposed approach can be readily integrated into existing genomic pipelines, serving as an efficient, large-scale screening tool for aneuploidy. Its implementation could enable the early identification of infertile animals with sex-chromosome aneuploidy.

PMID:38551070 | DOI:10.1111/jbg.12866

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Nevin Manimala Statistics

Could tranexamic acid be a suitable alternative to cryotherapy for symptomatic cervical ectopy? Results from a randomized clinical trial

Int J Gynaecol Obstet. 2024 Mar 29. doi: 10.1002/ijgo.15458. Online ahead of print.

ABSTRACT

OBJECTIVE: Cervical ectropion occurs due to the eversion of the endocervix that exposes glandular cells to the vaginal milieu. The aim of the present study was to evaluate and compare the clinical efficacy of effervescent vaginal tablets of tranexamic acid and cryotherapy in women with symptomatic cervical ectopy.

METHODS: The current randomized clinical trial was conducted on 92 samples of women with cervical erosive ectropion from March 20, 2022 to August 27, 2022. Participants were divided into two groups; the intervention group (n = 46) was treated with a 400 mg effervescent vaginal tablet of tranexamic acid and the control group (n = 46) underwent cryotherapy. All the patients were requested to visit weekly in the first month and then monthly for the next 3 months, and the outcomes encompass improvement of symptoms (leukorrhea, dyspareunia, pelvic pain, post-coital bleeding, and suprapubic pain) and cervical erosive ectropion view were monitored based on repeated examinations.

RESULTS: In this study, no statistically significant difference was observed in cure rate of symptoms between study groups (P value > 0.05). Women in both the tranexamic acid and cryotherapy groups reported significant improvements in dyspareunia (34 [75%] vs 31 [67%]), pelvic pain (34 [75%] vs 34 [74%]), post-coital bleeding (37 [81%] vs 31 [67%]), leukorrhea (36 [78%] vs 36 [78%]), suprapubic pain (32 [71%] vs 33 [73%]) disappearance of cervical ectropion tranexamic acid (40 [86%], vs 39 [84%]).

CONCLUSION: Our findings highlighted the equal effect of tranexamic acid and cryotherapy for treating cervical ectropion. Due to the ease of use, availability, and fewer side effects of tranexamic acid, it can be a suitable alternative to cryotherapy.

TRIAL REGISTRATION: IRCT20220115053719N1. The name of the registry: Iranian Registry of Clinical Trials. URL of registration: https://en.irct.ir/trial/61483.

PMID:38551066 | DOI:10.1002/ijgo.15458

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Nevin Manimala Statistics

Assessment of COVID-19 Messaging Strategies to Increase Testing for Students With Intellectual and Developmental Disabilities

J Sch Health. 2024 Mar 29. doi: 10.1111/josh.13448. Online ahead of print.

ABSTRACT

BACKGROUND: Students with intellectual and developmental disabilities (IDD) were disproportionately impacted by the COVID-19 pandemic. This study’s goal was to assess the effectiveness of 2 messaging strategies on participation in SARS-CoV-2 weekly testing.

METHODS: Cluster randomized trials were conducted at 2 school systems, the special school district (SSD) and Kennedy Krieger Institute (Kennedy) to assess messaging strategies, general versus enhanced, to increase weekly screening for SARS-CoV-2. Testing was offered to staff and students from November 23, 2020 to May 26, 2022. The primary outcomes were percentage of students and staff consented weekly and percentage of study participants who had a test performed weekly. Generalized estimating equation models were utilized to evaluate the primary outcomes.

RESULTS: Increases in enrollment and testing occurred during study start up, the beginning of school years, and following surges in both systems. No statistical difference was observed in the primary outcomes between schools receiving standard versus enhanced messaging.

IMPLICATIONS FOR SCHOOL HEALTH POLICY, PRACTICE, AND EQUITY: Frequent and consistent communication is vital for families and staff. Weekly screening testing within schools is possible and highlighted the importance of utilizing equitable protocols to provide important testing to students with IDD.

CONCLUSION: Enhanced messaging strategies did not increase the number of participants enrolled or the percentage of enrolled participants being tested on a weekly basis.

PMID:38551064 | DOI:10.1111/josh.13448

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The DIAD Approach to Correlative Synchrotron X-ray Imaging and Diffraction Analysis of Human Enamel

Chem Biomed Imaging. 2024 Mar 8;2(3):222-232. doi: 10.1021/cbmi.3c00122. eCollection 2024 Mar 25.

ABSTRACT

The Dual Imaging and Diffraction (DIAD) beamline at Diamond Light Source (Didcot, U.K.) implements a correlative approach to the dynamic study of materials based on concurrent analysis of identical sample locations using complementary X-ray modalities to reveal structural detail at various length scales. Namely, the underlying beamline principle and its practical implementation allow the collocation of chosen regions within the sample and their interrogation using real-space imaging (radiography and tomography) and reciprocal space scattering (diffraction). The switching between the two principal modes is made smooth and rapid by design, so that the data collected is interlaced to obtain near-simultaneous multimodal characterization. Different specific photon energies are used for each mode, and the interlacing of acquisition steps allows conducting static and dynamic experiments. Building on the demonstrated realization of this state-of-the-art approach requires further refining of the experimental practice, namely, the methods for gauge volume collocation under different modes of beam-sample interaction. To address this challenge, experiments were conducted at DIAD devoted to the study of human dental enamel, a hierarchical structure composed of hydroxyapatite mineral nanocrystals, as a static sample previously affected by dental caries (tooth decay) as well as under dynamic conditions simulating the process of acid demineralization. Collocation and correlation were achieved between WAXS (wide-angle X-ray scattering), 2D (radiographic), and 3D (tomographic) imaging. While X-ray imaging in 2D or 3D modes reveals real-space details of the sample microstructure, X-ray scattering data for each gauge volume provided statistical nanoscale and ultrastructural polycrystal reciprocal-space information such as phase and preferred orientation (texture). Careful registration of the gauge volume positions recorded during the scans allowed direct covisualization of the data from two modalities. Diffraction gauge volumes were identified and visualized within the tomographic data sets, revealing the underlying local information to support the interpretation of the diffraction patterns. The present implementation of the 4D microscopy paradigm allowed following the progression of demineralization and its correlation with time-dependent WAXS pattern evolution in an approach that is transferable to other material systems.

PMID:38551011 | PMC:PMC10966737 | DOI:10.1021/cbmi.3c00122