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Nevin Manimala Statistics

Recruitment across two decades of NIH-funded Alzheimer’s disease clinical trials

Alzheimers Res Ther. 2023 Feb 2;15(1):28. doi: 10.1186/s13195-023-01177-x.

ABSTRACT

BACKGROUND: Timely accrual of a representative sample is a key factor in whether Alzheimer’s disease (AD) clinical trials successfully answer the scientific questions under study. Studies in other fields have observed that, over time, recruitment to trials has become increasingly reliant on larger numbers of sites, with declines in the average per-site recruitment rate. Here, we examined the trends in recruitment over a 20-year period of NIH-funded AD clinical trials conducted by the Alzheimer’s Disease Cooperative Study (ADCS), a temporally consistent network of sites devoted to interventional research.

METHODS: We performed retrospective analyses of eleven ADCS randomized clinical trials. To examine the recruitment planning, we calculated the expected number of participants to be enrolled per site for each trial. To examine the actual trial recruitment rates, we quantified the number of participants enrolled per site per month.

RESULTS: No effects of time were observed on recruitment planning or overall recruitment rates across trials. No trial achieved an overall recruitment rate greater than one subject per site per month. We observed the fastest recruitment rates in trials with no competition and the slowest in trials that overlapped in time. The highest recruitment rates were consistently seen early within trials and declined over the course of studies.

CONCLUSIONS: Trial recruitment projections should plan for fewer than one participant randomized per site per month and consider the number of other AD trials being conducted concurrently.

PMID:36732846 | DOI:10.1186/s13195-023-01177-x

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Nevin Manimala Statistics

Socio-demographic trends in malaria knowledge and implications for behaviour change interventions in Zanzibar

Malar J. 2023 Feb 2;22(1):39. doi: 10.1186/s12936-023-04472-y.

ABSTRACT

BACKGROUND: Zanzibar is among the few places within East Africa that have documented a significant reduction of malaria morbidity and mortality. Despite tremendous gains over the past decade, malaria transmission still persists in Zanzibar. This study aimed at understanding levels of malaria knowledge to provide recommendations that can be used to reinforce and scale up targeted malaria social and behaviour change interventions.

METHODS: A descriptive cross-sectional survey was conducted through an administered questionnaire to 431 households selected randomly. The interviewees were the heads of household or representative adults above 18 years. This study investigated the levels of knowledge about the causes, symptoms, and prevention of malaria in areas with high (> 1.9 per 1000) and low (< 1 per 1000) incidence of local malaria cases. The Principal Component Analysis (PCA) was used to compute the composite variable of each category. Descriptive statistics were calculated to understand variables of interest between low and high transmission areas. Multinomial logistic regression model was used to compare knowledge on malaria based on key variables.

RESULTS: A total of 431 heads of households were interviewed. Respondent age, education level, and wealth status were significantly associated with variations in level of malaria knowledge. Old age was found to be significantly associated with low knowledge of malaria (P < 0.001). The majority of study participants who had secondary and higher education levels had good knowledge of malaria (P < 0.006). Participants characterized as middle-income had good knowledge compared to those characterized as low-income (P < 0.001).

CONCLUSION: The study identified existing gaps in malaria knowledge in low and high transmission areas. Low levels of malaria knowledge were documented among elderly and populations with lower education and income levels. There is a need to extend mobilization, advocacy, and expand channels of communication to reach all community members. The reported gaps in knowledge are important to consider when designing strategies to engage communities in malaria elimination in Zanzibar. Tailored social and behavioural change interventions aiming to increase malaria knowledge could enhance the uptake of malaria prevention services in the community.

PMID:36732822 | DOI:10.1186/s12936-023-04472-y

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Nevin Manimala Statistics

From fox to fork? Toxocara contamination of spinach grown in the south of England, UK

Parasit Vectors. 2023 Feb 2;16(1):49. doi: 10.1186/s13071-023-05674-8.

ABSTRACT

BACKGROUND: Toxocara canis and Toxocara cati are intestinal parasites of dogs, cats and foxes, with infected animals shedding eggs of the parasite in their faeces. If humans accidentally ingest embryonated Toxocara spp. eggs from the environment, severe clinical consequences, including blindness and brain damage, can occur. Previous work has demonstrated the presence of Toxocara spp. eggs on vegetable produce grown in the UK, but only in small-scale community gardens. The aim of this study was to determine whether Toxocara spp. eggs are also present on vegetables grown on commercial farms in the UK, which supply produce to a greater number of people.

METHODS: A total of 120 samples (300 g each) of spinach (Spinacia oleracea) were collected across four farms in the south of England, UK. The samples were processed using a sieving approach followed by multiplex quantitative polymerase chain reaction analysis.

RESULTS: Overall, 23.0% of samples were positive for T. canis (28/120; 95% confidence interval 16.7-31.7%) and 1.7% for T. cati (2/120; 95% confidence interval 0.5-5.9%). There was a statistically significant difference in the number of positive samples between farms (P = 0.0064). To our knowledge, this is the first report of the isolation of Toxocara spp. from vegetables grown on commercial farms in the UK.

CONCLUSIONS: The results of this study highlight the requirement for the thorough washing of vegetables prior to their consumption, especially those such as spinach which may be eaten without first peeling or cooking, and effective farm biosecurity measures to minimise access to farmland by definitive host species of Toxocara spp.

PMID:36732821 | DOI:10.1186/s13071-023-05674-8

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Nevin Manimala Statistics

Association between career adaptability and turnover intention among nursing assistants: the mediating role of psychological capital

BMC Nurs. 2023 Feb 2;22(1):29. doi: 10.1186/s12912-023-01187-y.

ABSTRACT

BACKGROUND: High turnover intention of nursing assistants was detrimental to the sustainability of long-term care. Career adaptability is an important determinant in reducing turnover intention, but little research has explored the mechanism from the perspective of psychological capital. The aim of this study was to analyze the association between career adaptability and turnover intention and to examine the mediating role of psychological capital between career adaptability and turnover intention among nursing assistants in mainland China.

METHODS: A cross-sectional online study was conducted among 276 nursing assistants from eight nursing homes in Nanjing, China. The participants’ career adaptability, psychological capital, and turnover intention were obtained. SPSS 26.0 and Amos 24.0 software were employed for statistical analysis.

RESULTS: Career adaptability was positively related to psychological capital and negatively linked to turnover intention (P < 0.01). Psychological capital played a fully mediating role (β = -0.085, P < 0.05) in the relationship between career adaptability and turnover intention, and the largest indirect effect was generated through the curiosity dimension.

CONCLUSIONS: The management of long-term care facilities should focus on assessing the level of career adaptability of nursing assistants. The overall improvement of career adaptability and psychological capital is conducive in reducing turnover intention. Targeted interventions are recommended to improve career adaptability and reduce turnover intentions by increasing career curiosity. Online career adaptability programs can be developed for nursing assistant students to improve their psychological capital and facilitate career transitions.

PMID:36732804 | DOI:10.1186/s12912-023-01187-y

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Nevin Manimala Statistics

Breastfeeding difficulties in the first 6 weeks postpartum among mothers with chronic conditions: a latent class analysis

BMC Pregnancy Childbirth. 2023 Feb 2;23(1):90. doi: 10.1186/s12884-023-05407-w.

ABSTRACT

BACKGROUND: Breastfeeding difficulties frequently exacerbate one another and are common reasons for curtailed breastfeeding. Women with chronic conditions are at high risk of early breastfeeding cessation, yet limited evidence exists on the breastfeeding difficulties that co-occur in these mothers. The objective of this study was to explore clusters of breastfeeding difficulties experienced up to 6 weeks postpartum among mothers with chronic conditions and to examine associations between chronic condition types and breastfeeding difficulty clusters.

METHODS: We analyzed 348 mothers with chronic conditions enrolled in a prospective, community-based pregnancy cohort study from Alberta, Canada. Data were collected through self-report questionnaires. We used latent class analysis to identify clusters of early breastfeeding difficulties and multinomial logistic regression to examine whether types of chronic conditions were associated with these clusters, adjusting for maternal and obstetric factors.

RESULTS: We identified three clusters of breastfeeding difficulties. The “physiologically expected” cluster (51.1% of women) was characterized by leaking breasts and engorgement (reference outcome group); the “low milk production” cluster (15.4%) was discerned by low milk supply and infant weight concerns; and the “ineffective latch” cluster (33.5%) involved latch problems, sore nipples, and difficulty with positioning. Endocrine (adjusted relative risk ratio [RRR] 2.34, 95% CI 1.10-5.00), cardiovascular (adjusted RRR 2.75, 95% CI 1.01-7.81), and gastrointestinal (adjusted RRR 2.51, 95% CI 1.11-5.69) conditions were associated with the low milk production cluster, and gastrointestinal (adjusted RRR 2.44, 95% CI 1.25-4.77) conditions were additionally associated with the ineffective latch cluster.

CONCLUSION: Half of women with chronic conditions experienced clusters of breastfeeding difficulties corresponding either to low milk production or to ineffective latch in the first 6 weeks postpartum. Associations with chronic condition types suggest that connections between lactation physiology and disease pathophysiology should be considered when providing breastfeeding support.

PMID:36732799 | DOI:10.1186/s12884-023-05407-w

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Cost effectiveness of home care versus hospital care: a retrospective analysis

Cost Eff Resour Alloc. 2023 Feb 2;21(1):13. doi: 10.1186/s12962-023-00424-0.

ABSTRACT

BACKGROUND: Increased utilization of health services due to population growth affects the allocation of national resources and budgets. Hence, it is important for national policy. Home hospitalization is one of the solutions for dealing with the growing demand for hospital beds and reducing the duration of hospitalization and its costs. It is gradually becoming part of the regular care in many health systems, yet, studies on the economic aspects of Community-Based Home Hospitalization (CBHH) implementation in Israel are few. The aim of this study is to examine costs of CBHH in comparison to costs of inpatient hospital care in the Israeli public health system.

METHODS: Retrospective data was collected using document research in databases. A review of the costs of patients in CBHH at Maccabi Healthcare Services (MHS) was conducted. A total of 3374 patients were included in this study: 1687 patients who were in CBHH, and 1687 age- and sex-matched patients who were hospitalized in an internal department (the control group). The study population included the patients admitted to CBHH from January 2018 to July 2020, and patients admitted to internal medicine departments during the same period.

RESULTS: The number of hospitalizations during the follow up period were statistically significantly lower in the CBHH group compared with the control group (M = 1.18, SD = 0.56 vs. M = 1.61, SD = 1.29, p < 0.001). In addition, the mean number of hospitalization days was also statistically significantly lower for 4.3 (SD = 4.5) for CBHH patients compared to the control group (M = 4.3 days, SD = 4.5 vs. M = 7.5 days, SD = 10.3, p < 0.001). Furthermore, the mean cost per day was statistically significantly higher for inpatient hospitalization compared to CBHH (M = 1829.1, SD = 87.5 vs. M = 783.2, SD = 178.3, p < 0.001). Older patients, patients with diabetes and patients hospitalized in hospitals had a higher number of hospitalization days.

CONCLUSIONS: The costs of CBHH seem to be lower than those of inpatient care. Managing CBHH is characterized by constantly measuring financial feasibility that would be an impetus for further development of this service.

PMID:36732792 | DOI:10.1186/s12962-023-00424-0

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Nevin Manimala Statistics

Mapping of disease-specific Oxford Knee Score onto EQ-5D-5L utility index in knee osteoarthritis

J Orthop Surg Res. 2023 Feb 2;18(1):84. doi: 10.1186/s13018-023-03522-0.

ABSTRACT

BACKGROUND: EQ5D is a generic measure of health. It provides a single index value for health status that can be used in the clinical and economic evaluation of healthcare. Oxford Knee Score (OKS) is a joint-specific outcome measure tool designed to assess symptoms and function in osteoarthritis patients after joint replacement surgery. Though widely used, it has the disadvantage of lacking health index value. To fill the gap between functional and generic questionnaires with economic value, we linked generic EQ-5D-5L to the specific OKS to give a single index value for health status in KOA patients.

QUESTIONS/PURPOSES: Developing and evaluating an algorithm to estimate EuroQoL generic health utility scores (EQ-5D-5L) from the disease-specific OKS using data from patients with knee osteoarthritis (KO).

PATIENTS AND METHODS: This is a cross-sectional study of 571 patients with KO. We used four distinct mapping algorithms: Cumulative Probability for Ordinal Data, Penalized Ordinal Regression, CART (Classification and Regression Trees), and Ordinal random forest. We compared the resultant models’ degrees of accuracy.

RESULTS: Mobility was best predicted by penalized regression with pre-processed predictors, usual activities by random forest, pain/discomfort by cumulative probability with pre-processed predictors, self-care by random forest with RFE (recursive feature elimination) predictors, and anxiety/depression by CART with RFE predictors. Model accuracy was lowest with anxiety/depression and highest with mobility and usual activities. Using available country value sets, the average MAE was 0.098 ± 0.022, ranging from 0.063 to 0.142; and the average MSE was 0.020 ± 0.008 ranging from 0.008 to 0.042.

CONCLUSIONS: The current study derived accurate mapping techniques from OKS to the domains of EQ-5D-5L, allowing for the computation of QALYs in economic evaluations. A machine learning-based strategy offers a viable mapping alternative that merits further exploration.

PMID:36732785 | DOI:10.1186/s13018-023-03522-0

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Common mouse models of tauopathy reflect early but not late human disease

Mol Neurodegener. 2023 Feb 2;18(1):10. doi: 10.1186/s13024-023-00601-y.

ABSTRACT

BACKGROUND: Mouse models that overexpress human mutant Tau (P301S and P301L) are commonly used in preclinical studies of Alzheimer’s Disease (AD) and while several drugs showed therapeutic effects in these mice, they were ineffective in humans. This leads to the question to which extent the murine models reflect human Tau pathology on the molecular level.

METHODS: We isolated insoluble, aggregated Tau species from two common AD mouse models during different stages of disease and characterized the modification landscape of the aggregated Tau using targeted and untargeted mass spectrometry-based proteomics. The results were compared to human AD and to human patients that suffered from early onset dementia and that carry the P301L Tau mutation.

RESULTS: Both mouse models accumulate insoluble Tau species during disease. The Tau aggregation is driven by progressive phosphorylation within the proline rich domain and the C-terminus of the protein. This is reflective of early disease stages of human AD and of the pathology of dementia patients carrying the P301L Tau mutation. However, Tau ubiquitination and acetylation, which are important to late-stage human AD are not represented in the mouse models.

CONCLUSION: AD mouse models that overexpress human Tau using risk mutations are a suitable tool for testing drug candidates that aim to intervene in the early formation of insoluble Tau species promoted by increased phosphorylation of Tau.

PMID:36732784 | DOI:10.1186/s13024-023-00601-y

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Nevin Manimala Statistics

LoFTK: a framework for fully automated calculation of predicted Loss-of-Function variants and genes

BioData Min. 2023 Feb 2;16(1):3. doi: 10.1186/s13040-023-00321-5.

ABSTRACT

BACKGROUND: Loss-of-Function (LoF) variants in human genes are important due to their impact on clinical phenotypes and frequent occurrence in the genomes of healthy individuals. The association of LoF variants with complex diseases and traits may lead to the discovery and validation of novel therapeutic targets. Current approaches predict high-confidence LoF variants without identifying the specific genes or the number of copies they affect. Moreover, there is a lack of methods for detecting knockout genes caused by compound heterozygous (CH) LoF variants.

RESULTS: We have developed the Loss-of-Function ToolKit (LoFTK), which allows efficient and automated prediction of LoF variants from genotyped, imputed and sequenced genomes. LoFTK enables the identification of genes that are inactive in one or two copies and provides summary statistics for downstream analyses. LoFTK can identify CH LoF variants, which result in LoF genes with two copies lost. Using data from parents and offspring we show that 96% of CH LoF genes predicted by LoFTK in the offspring have the respective alleles donated by each parent.

CONCLUSIONS: LoFTK is a command-line based tool that provides a reliable computational workflow for predicting LoF variants from genotyped and sequenced genomes, identifying genes that are inactive in 1 or 2 copies. LoFTK is an open software and is freely available to non-commercial users at https://github.com/CirculatoryHealth/LoFTK .

PMID:36732776 | DOI:10.1186/s13040-023-00321-5

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Nevin Manimala Statistics

Impact of an intrapartum care quality improvement intervention in Brazilian private hospitals on care safety measures and adverse outcomes

Reprod Health. 2023 Feb 2;20(Suppl 2):27. doi: 10.1186/s12978-022-01541-4.

ABSTRACT

BACKGROUND: In 2015, a quality improvement (QI) intervention to reduce cesarean sections (CS)-the Adequate Childbirth Project (PPA)-was implemented in the private sector in Brazil. This analysis aims to compare safety care measures and adverse outcomes between women exposed to the PPA intervention to those receiving standard care.

METHODS: The analysis included a convenience sample of 12 private hospitals that participated in the PPA (2017-2018). Data collection was performed through chart review and interviews. Differences in 15 outcomes were examined using Pearson’s chi-square test and multiple logistic regressions.

RESULTS: The final weighted sample was comprised of 4789 births, 2570 in the PPA group (53.5%) and 2227 in the standard care group (46.5%). CS rate was significantly lower in the PPA group (67.3% vs 88.8%). After adjusting for potential confounders, PPA model was associated with decreased overall CS rate (OR = 0.30, 95% CI 0.24 to 0.36), as well as prelabor (OR = 0.41, 0.34 to 0.48) and repeated CS (OR = 0.45, 0.29 to 0.70). In terms of other safety care measures, women in the PPA model had an increased chance of absence of antibiotic prophylaxis in Group B Streptococcus (GBS) + women (OR = 4.63, 1.33 to 16.14) and for CSs (OR = 1.75, 1.38 to 2.22), while those with severe hypertension were less likely to not receiving magnesium sulphate (OR = 0.27, 0.09 to 0.77). Regarding obstetric and neonatal outcomes, PPA model was associated with a decreased chance of having an obstetric anal sphincter injury (OASI) following an episiotomy (OR = 0.34, 0.13 to 0.89), requiring antibiotics other than routine prophylaxis (OR = 0.84, 0.70 to 0.99), having a late preterm (OR = 0.36, 0.27 to 0.48) or early term baby (OR = 0.81, 0.70 to 0.94). There were no statistically significant differences for other outcomes.

CONCLUSIONS: The PPA intervention was able to reduce CS rates, late preterm and early term deliveries without increasing the chance of adverse outcomes. The bidirectional effect on safety care measures reinforces that QI initiatives includes closer observation of routine care when implementing interventions to reduce C-section rates.

PMID:36732761 | DOI:10.1186/s12978-022-01541-4