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Nevin Manimala Statistics

Assessment of retrospective collection of EQ-5D-5L in a US COVID-19 population

Health Qual Life Outcomes. 2023 Sep 8;21(1):103. doi: 10.1186/s12955-023-02187-x.

ABSTRACT

BACKGROUND: It is imperative to evaluate health related quality of life (HRQoL) pre-COVID-19, but there is currently no evidence of the retrospective application of the EuroQol 5-Dimension, 5 level version (EQ-5D-5L) for COVID-19 studies.

METHODS: Symptomatic patients with SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022-04/30/2022. Consented participants completed the EQ-5D-5L questionnaire twice: a modified version where all the questions were past tense to retrospectively assess pre-COVID-19 baseline QoL, and the standard version in present tense to assess current HRQoL. Duncan’s new multiple range test was adopted for post analysis of variance pairwise comparisons of EQ visual analog scale (EQ VAS) means between problem levels for each of 5 domains. A linear mixed model was applied to check whether the relationship between EQ VAS and utility index (UI) was consistent pre-COVID-19 and during COVID-19. Matching-adjusted indirect comparison was used to compare pre-COVID-19 UI and EQ VAS scores with those of the US population. Lastly, Cohen’s d was used to quantify the magnitude of difference in means between two groups.

RESULTS: Of 676 participants, 10.2% were age 65 or more years old, 73.2% female and 71.9% white. Diabetes was reported by 4.7% participants and hypertension by 11.2%. The estimated coefficient for the interaction of UI-by-retrospective collection indicator (0 = standard prospective collection, 1 = retrospective for pre-COVID-19), -4.2 (SE: 3.2), P = 0.197, indicates that retrospective collection does not significantly alter the relationship between EQ VAS and UI. After adjusting for age, gender, diabetes, hypertension, and percent of mobility problems, the predicted means of pre-COVID-19 baseline EQ VAS and UI were 84.6 and 0.866, respectively. Both means were close to published US population norms (80.4 and 0.851) compared to those observed (87.4 and 0.924). After adjusting for age, gender, diabetes, and hypertension, the calculated ES between pre-COVID-19 and COVID-19 for UI and EQ VAS were 0.15 and 0.39, respectively. Without retrospectively collected EQ-5D-5L, using US population norms tended to underestimate the impact of COVID-19 on HRQoL.

CONCLUSION: At a group level the retrospectively collected pre-COVID-19 EQ-5D-5L is adequate and makes it possible to directly evaluate the impact of COVID-19 on HRQoL. ( ClinicalTrials.gov NCT05160636).

PMID:37679771 | DOI:10.1186/s12955-023-02187-x

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Acute phase proteins and total antioxidant capacity in free-roaming cats infected by pathogenic leptospires

BMC Vet Res. 2023 Sep 7;19(1):148. doi: 10.1186/s12917-023-03697-y.

ABSTRACT

BACKGROUND: Leptospirosis is a neglected but widespread zoonotic disease throughout the world. Most mammals are hosts of Leptospira spp., including domestic cats, species in which no consensus has been reached on the clinical presentation or diagnosis of the disease. The study of acute-phase proteins (APPs) and biomarkers of oxidative status would contribute to knowledge about the disease in cats. This report evaluated four APPs: Serum amyloid A-SAA, Haptoglobin-Hp, albumin and Paraoxonase 1-PON1 and the antioxidant response through Total Antioxidant Capacity-TAC, in 32 free-roaming cats. Cats were classified as seroreactive for anti-leptospiral antibodies (group 1, n = 8), infected with Leptospira spp (group 2, n = 5) and leptospires-free cats (group 3, n = 19).

RESULTS: SAA differences were observed between groups 1 and 2 (p-value = 0.01) and between groups 2 and 3 (p-value = 0.0001). Hp concentration differences were only detected between groups 2 and 3 (p-value = 0.001). Albumin concentrations only differed between groups 1 and 3 (p-value = 0.017) and 2 and 3 (p-value < 0.005). Cats in groups 1 (p-value < 0.005) and 2 (p-value < 0.005) had lower PON1 concentrations than group 3. No statistically significant differences between pairs of groups were detected for TAC concentrations. The principal component analysis (PCA) retained two principal components, (PC1 and PC2), explaining 60.1% of the observed variability of the inflammatory proteins and the antioxidant TAC.

CONCLUSIONS: Increases in Serum SAA, Hp, and decreases in PON1 activity may indicate an active inflammatory state in infected cats (currently or recently infected).

PMID:37679743 | DOI:10.1186/s12917-023-03697-y

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Nevin Manimala Statistics

Using big data and Population Health Management to assess care and costs for patients with severe mental disorders and move toward a value-based payment system

BMC Health Serv Res. 2023 Sep 7;23(1):960. doi: 10.1186/s12913-023-09655-6.

ABSTRACT

BACKGROUND: Mental health (MH) care often exhibits uneven quality and poor coordination of physical and MH needs, especially for patients with severe mental disorders. This study tests a Population Health Management (PHM) approach to identify patients with severe mental disorders using administrative health databases in Italy and evaluate, manage and monitor care pathways and costs. A second objective explores the feasibility of changing the payment system from fee-for-service to a value-based system (e.g., increased care integration, bundled payments) to introduce performance measures and guide improvement in outcomes.

METHODS: Since diagnosis alone may poorly predict condition severity and needs, we conducted a retrospective observational study on a 9,019-patient cohort assessed in 2018 (30.5% of 29,570 patients with SMDs from three Italian regions) using the Mental Health Clustering Tool (MHCT), developed in the United Kingdom, to stratify patients according to severity and needs, providing a basis for payment for episode of care. Patients were linked (blinded) with retrospective (2014-2017) physical and MH databases to map resource use, care pathways, and assess costs globally and by cluster. Two regions (3,525 patients) provided data for generalized linear model regression to explore determinants of cost variation among clusters and regions.

RESULTS: Substantial heterogeneity was observed in care organization, resource use and costs across and within 3 Italian regions and 20 clusters. Annual mean costs per patient across regions was €3,925, ranging from €3,101 to €6,501 in the three regions. Some 70% of total costs were for MH services and medications, 37% incurred in dedicated mental health facilities, 33% for MH services and medications noted in physical healthcare databases, and 30% for other conditions. Regression analysis showed comorbidities, resident psychiatric services, and consumption noted in physical health databases have considerable impact on total costs.

CONCLUSIONS: The current MH care system in Italy lacks evidence of coordination of physical and mental health and matching services to patient needs, with high variation between regions. Using available assessment tools and administrative data, implementation of an episodic approach to funding MH could account for differences in disease phase and physical health for patients with SMDs and introduce performance measurement to improve outcomes and provide oversight.

PMID:37679722 | DOI:10.1186/s12913-023-09655-6

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Is Mutans Streptococci count a risk predictor of Early Childhood Caries? A systematic review and meta-analysis

BMC Oral Health. 2023 Sep 7;23(1):648. doi: 10.1186/s12903-023-03346-8.

ABSTRACT

BACKGROUND: The review aims to determine the risk predictability of mutans streptococci in the development of carious lesions in children with primary dentition.

METHODS: Longitudinal observational studies with at least 6 months follow-up and evaluating mutans streptococci presence in caries-free children under 6 years of age for the development of any cavitated or non-cavitated carious lesion. Six databases and grey literature were searched without any restrictions. Risk of bias was evaluated using the New Castle Ottawa scale for longitudinal studies, and the certainty of the evidence was evaluated by Grading of Recommendations Assessment, Development and Evaluation using GRADEpro software. Meta-analysis was performed using a random effect (DerSimonian and Laird, DL) model, and heterogeneity was evaluated using tau-squared, I2 statistics and prediction interval. Sensitivity analysis was performed to assess the relationship between the mutans streptococci presence at baseline and the caries development, according to the sample and methods used for the microbiological assessment and the length of follow-up of the studies. Publication bias was checked by funnel plot using a random effect (DerSimonian and Laird, DL) model.

RESULTS: Twelve studies met the inclusion criteria and were included in the review. Four studies received a maximum of 9 stars, and among the remaining eight studies, six received 8 stars and the rest two studies were assigned 7 stars in the risk of bias scale. After pooling the results quantitatively, odds ratio (OR) was found to be 4.13 (95% CI: 3.33, 5.12), suggesting that children with mutans streptococci had 4 times higher odds of developing caries later (p < 0.001). Four studies were pooled to compare future caries experience among children with and without mutans streptococci at baseline, obtaining standardized mean difference (SMD) of 0.85 (95% CI: 0.33, 1.37), indicating a large effect (p < 0.001). Certainty of evidence was found to be moderate, and no publication bias was reported by the funnel plot criteria of symmetry.

CONCLUSIONS: Presence of mutans streptococci in a preschool child is a risk predictor for future caries experience. Early identification of children with increased caries-risk may facilitate in implementation of appropriate preventive strategies.

PMID:37679718 | DOI:10.1186/s12903-023-03346-8

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Effect of acceptance and commitment therapy for depressive disorders: a meta-analysis

Ann Gen Psychiatry. 2023 Sep 7;22(1):34. doi: 10.1186/s12991-023-00462-1.

ABSTRACT

OBJECTIVE: To systematically evaluate the effect of Acceptance and Commitment Therapy (ACT) on depressive disorders.

METHODS: The electronic databases of Web of Science Core Collection, Pubmed, EMBASE, Cochrane Library, PsycInfo, CNKI, Wanfang and Weipu were used to select relevant publications. Screening, data extraction, and quality assessment were undertaken following PRISMA guidelines for preferred reporting of systematic reviews and meta-analysis. RevMan5.4 was used for meta-analysis.

RESULTS: 11 studies with a total of 962 patients were included. Random-effects model analysis showed that ACT could effectively reduce the level of depressive symptoms in patients with depressive disorders (SMD = – 1.05, 95% CI: – 1.43– 0.66, P < 0.00001), improve psychological flexibility (MD = 4.84, 95% CI: 2.70-6.97, P < 0.00001), and have good maintenance effect (SMD = – 0.70, 95% CI: – 1.15– 0.25, P = 0.002). All differences were statistically significant.

CONCLUSIONS: ACT not only improves depressive symptoms and psychological flexibility, but also has a good maintenance effect, and it is particularly effective in Chinese patients. Large randomized controlled trials are needed to validate the findings from this meta-analysis.

PMID:37679716 | DOI:10.1186/s12991-023-00462-1

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A systematic review of randomised controlled trials with adaptive and traditional group sequential designs – applications in cardiovascular clinical trials

BMC Med Res Methodol. 2023 Sep 7;23(1):200. doi: 10.1186/s12874-023-02024-1.

ABSTRACT

BACKGROUND: Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can potentially be stopped early, therefore, it can reduce pre-planned sample size and trial resources. In contrast, trials with adoptive designs provide greater flexibility and are more efficient due to the ability to modify trial design according to the interim analysis results. In this systematic review, we aim to explore characteristics of adaptive and traditional group sequential trials in practice and to gain an understanding how these trial designs are currently being reported in cardiology.

METHODS: PubMed, Embase and Cochrane Central Register of Controlled Trials database were searched from January 1980 to June 2022. Randomised controlled phase 2/3 trials with either adaptive or traditional group sequential design in patients with cardiovascular disease were included. Descriptive statistics were used to present the collected data.

RESULTS: Of 456 articles found in the initial search, 56 were identified including 43 (76.8%) trials with traditional group sequential design and 13 (23.2%) with adaptive. Most trials were large, multicentre, led by the USA (50%) and Europe (28.6%), and were funded by companies (78.6%). For trials with group sequential design, frequency of interim analyses was determined mainly by the number of events (47%). 67% of the trials stopped early, in which 14 (32.6%) were due to efficacy, and 5 (11.6%) for futility. The commonly used stopping rule to terminate trials was O’Brien- Fleming-type alpha spending function (10 (23.3%)). For trials with adaptive designs, 54% of the trials stopped early, in which 4 (30.8%) were due to futility, and 2 (15.4%) for efficacy. Sample size re-estimation was commonly used (8 (61.5%)). In 69% of the trials, simulation including Bayesian approach was used to define the statistical stopping rules. The adaptive designs have been increasingly used (from 0 to 1999 to 38.6% after 2015 amongst adaptive trials). 25% of the trials reported “adaptive” in abstract or title of the studies.

CONCLUSIONS: The application of adaptive trials is increasingly popular in cardiovascular clinical trials. The reporting of adaptive design needs improving.

PMID:37679710 | DOI:10.1186/s12874-023-02024-1

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Urban-rural disparities in immunization coverage among children aged 12-23 months in Ethiopia: multivariate decomposition analysis

BMC Health Serv Res. 2023 Sep 7;23(1):969. doi: 10.1186/s12913-023-09940-4.

ABSTRACT

BACKGROUND: Immunization is one of the most cost-effective public health interventions for improving children’s health and survival. In Ethiopia, low immunization coverage and disparity across residences are major public health problems. However, the factors that contributed to the urban-rural disparity have not been thoroughly investigated. Therefore, the objective of this study was to examine the change and contributing factors in full immunization coverage across geographic locations (urban-rural) in Ethiopia.

METHODS: We analyzed data on children aged 12 to 23 months obtained from the 2019 mini-Ethiopian demographic and health survey. A total of 996 weighted samples (299 in urban and 697 in rural areas) were included in the analysis. A multivariate decomposition analysis technique was used to determine the disparity and identify factors that contribute to the disparity across geographical locations. Statistical significance was defined at a 95% confidence interval with a p-value of less than 0.05.

RESULTS: The percentage of children aged 12-23 months who received full immunization increased from 36.84% (95% CI:31.59, 42.41) in rural areas to 64.59% (95% CI:47.10, 78.89) in urban areas. The decomposition analysis showed that the observed urban-rural disparity was attributed to a change in the effect of population characteristics (coefficient) across residences. Specifically, receiving 1-3 (β = 0.0895, 95% CI: 0.0241, 0.1550) and 4 or more (β = 0.1212, 95% CI: 0.0224, 0.2199) antenatal care visits, delivering at a health facility (β = 0.1350, 95% CI: 0.0227, 0.2472), and the source of information about immunization status from vaccination cards (β = 0.2666, 95% CI:0.1763, 0.3569) significantly contributed to the widening urban-rural disparity. On the other hand, being of high wealth status (β=-0.141, 95% CI: -0.1945, -0.0876), receiving postnatal care (β=-0.0697, 95% CI: -0.1344, -0.0051), and having four or more living children (β=-0.1774, 95% CI: -0.2971, -0.0577) significantly contributed to narrowing the urban-rural disparity.

CONCLUSIONS: There was a significant urban-rural disparity in immunization coverage in Ethiopia, with urban children more likely to complete immunization. The change in the composition of population characteristics was not significant for the observed disparity. The observed disparity in full immunization coverage was mainly driven by the coefficients related to maternal healthcare utilization, household wealth status, the number of living children, and the source of immunization information. Therefore, strengthening maternal health services utilization, encouraging mothers to maintain their children’s immunization records, and addressing economic inequality, particularly in rural areas, may narrow the urban-rural disparity and enhance immunization coverage nationwide.

PMID:37679707 | DOI:10.1186/s12913-023-09940-4

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Perception towards the implementation of telemedicine during COVID-19 pandemic: a cross-sectional study

BMC Health Serv Res. 2023 Sep 7;23(1):967. doi: 10.1186/s12913-023-09927-1.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has led to a surge in the use of telemedicine as a means of delivering healthcare services remotely. Healthcare providers play a key role in the adoption and implementation of telemedicine for its effectiveness. Despite its benefits, there have been unclear concerns about its effectiveness and acceptance in the process of implementing telemedicine. The objective of the study was to assess health professionals’ perceptions towards the implementation of telemedicine during the COVID-19 pandemic.

METHODS: A cross-sectional study design was conducted among eight hundred forty-five study participants from December 2020 to February 2021. A pre-test was performed on 5% of the total sample size, and the quality of the data was ensured by checking its completeness and consistency. Descriptive statistics and bivariable and multivariable logistic regression were used. The Variables with a P-value equal to or less than 0.25 in bivariable logistic regression were entered into a multivariable logistic regression, and model fitness was assessed.

RESULT: The study revealed that 60.9% of professionals had a good perception toward telemedicine implementation, with an 87.2% response rate. Health professionals with IT support staff, ICT training, who use social media platforms regularly, and availability of computer or smartphone within/outside their health facility were 4.7, 3.3, 3.7, and 13.2 times more likely to have a positive association towards telemedicine implementation respectively.

CONCLUSION: More than half of the health professionals had a good perception of telemedicine. Social media use, ICT training, computer accessibility, and the presence of IT support staff were all found to have positive associations with the telemedicine perception. In the era of the COVID-19 pandemic, the government should take the initiative to strengthen opportunities for health professionals to learn and apply telemedicine in their medical practice by providing ICT training, IT infrastructure and support staff, improving computer access, and recommending health professionals’ positive use of social media in the health facility.

PMID:37679700 | DOI:10.1186/s12913-023-09927-1

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Efficacy and safety of HIMABERB® Berberine on glycemic control in patients with prediabetes: double-blind, placebo-controlled, and randomized pilot trial

BMC Endocr Disord. 2023 Sep 7;23(1):190. doi: 10.1186/s12902-023-01442-y.

ABSTRACT

BACKGROUND: Prediabetes and diabetes involve alterations in glucose homeostasis, including increased fasting blood glucose and impaired glucose tolerance. Berberine has been identified as a potential regulator of glucose homeostasis with implications on the management of type 2 diabetes mellitus (DM). Given a paucity of data on berberine in prediabetes, evaluation of its effect in individuals with prediabetes may prove clinically valuable.

OBJECTIVE: The present pilot study aimed to investigate the effect of daily oral berberine on markers of glycemic control and insulin resistance among individuals with prediabetes.

METHODS: A randomized, double-blinded, placebo-controlled trial was conducted for 12 weeks among 34 individuals with prediabetes as defined by the American Diabetes Association (fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/L, glycosylated hemoglobin (HbA1c) between 5.7% and 6.4%, or 2-hour 75-gram oral glucose tolerance test (2 h-OGTT) between 7.8 and 11.1 mmol/L). HIMABERB® 500 mg was given three times daily to the treatment group, and placebo was administered three times daily to the control group. Glycemic control markers and physical parameters were evaluated for both groups on days 0, 28, 56, and 84. The glycemic control markers assessed included FPG, fasting insulin (FI), 2 h-OGTT, HbA1c, and homeostatic model assessment-insulin resistance (HOMA-IR). The observed outcomes were analyzed using independent t-test statistics to determine the significance of differences over time after treatment initiation and between treatment and control groups.

RESULTS: Significant decreases in all markers of glycemic control were observed in the treatment group at intermediate time points and the endpoint of the study compared to baseline levels and to the control group. For the treatment group, FPG decreased from 6.75 ± 0.23 mmol/L to 5.33 ± 0.28 mmol/L, FI from 9.81 ± 0.36 to 7.88 ± 0.52 mmol/L, 2 h-OGTT from 10.44 ± 0.52 to 8.12 ± 0.40 mmol/L, HbA1c from 6.40% ± 0.20-5.43% ± 0.21%, and HOMA-IR from 3.61 ± 0.31 to 2.41 ± 0.14. The decreases in glycemic control markers compared to the control group were clinically and statistically significant (p<10– 5). No severe adverse effects, kidney or liver toxicity were detected.

CONCLUSION: After 12 weeks, berberine (HIMABERB®) intervention in individuals with prediabetes significantly reduced glycemic control markers, with mean FPG and 2 h-OTGG being reduced to below prediabetic thresholds, supporting the investigation of the use of HIMABERB® for delaying progression to diabetes mellitus.

TRIAL REGISTRATION: http://ctri.nic.in (CTRI/2021/12/038751) (20/12/2021).

PMID:37679692 | DOI:10.1186/s12902-023-01442-y

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Association between independent practice time and patient outcomes in the emergency department: a retrospective study of residents in three urban hospitals in Taiwan

BMC Emerg Med. 2023 Sep 7;23(1):103. doi: 10.1186/s12873-023-00877-9.

ABSTRACT

BACKGROUND: The purpose of the study was to investigate the relationship between the independent practice time of residents and the quality of care provided in the Emergency Department (ED) across three urban hospitals in Taiwan. The study focused on non-pediatric and non-obstetric complaints, aiming to provide insights into the optimal balance between resident autonomy and patient safety.

METHODS: A comprehensive retrospective study was conducted using de-identified electronic health records (EHRs) from the hospital’s integrated medical database (iMD) from August 2015 to July 2019. The independent practice time was defined as the duration from the first medical order by a resident to the first modifications by the attending physician. The primary outcome was revisits to the ED within 72 h following discharge. Statistical analysis was conducted using RStudio and pyGAM.

RESULTS: The study identified several factors associated with shorter independent practice times (< 30 minutes), including older patient age, male sex, higher body temperature, higher heart rate, lower blood pressure, and the presence of certain comorbidities. Residents practicing independently for 30-120 minutes were associated with similar adjusted odds of patient revisits to the ED (OR 1.034, 95% CI 0.978-1.093) and no higher risk of 7-day mortality (OR 0.674, 95% CI 0.592-0.767) compared to the group with less autonomy. However, independent practice times exceeding 120 minutes were associated with higher odds of revisiting the ED within 72 h. For the group with 120-210 minutes of independent practice time, the OR was 1.113 (95% CI: 1.025-1.208, p = 0.011). For the group with > 210 minutes, the OR was 1.259 (95% CI: 1.094-1.449, p = 0.001), indicating an increased risk of adverse outcomes as the independent practice time increasing.

CONCLUSIONS: The study concludes that while providing residents an independent practice time between 30 to 120 minutes may be beneficial, caution should be exercised when this time exceeds 120 minutes. The findings underscore the importance of optimal supervision in enhancing patient care quality and safety. Further research is recommended to explore the long-term effects of different levels of resident autonomy on patient outcomes and the professional development of the residents themselves.

PMID:37679682 | DOI:10.1186/s12873-023-00877-9