Categories
Nevin Manimala Statistics

Quality Criteria for Real-world Data in Pharmaceutical Research and Health Care Decision-making: Austrian Expert Consensus

JMIR Med Inform. 2022 Jun 17;10(6):e34204. doi: 10.2196/34204.

ABSTRACT

Real-world data (RWD) collected in routine health care processes and transformed to real-world evidence have become increasingly interesting within the research and medical communities to enhance medical research and support regulatory decision-making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which qualities RWD must meet in order to be acceptable for decision-making within regulatory or routine clinical decision support. In the absence of guidelines defining the quality standards for RWD, an overview and first recommendations for quality criteria for RWD in pharmaceutical research and health care decision-making is needed in Austria. An Austrian multistakeholder expert group led by Gesellschaft für Pharmazeutische Medizin (Austrian Society for Pharmaceutical Medicine) met regularly; reviewed and discussed guidelines, frameworks, use cases, or viewpoints; and agreed unanimously on a set of quality criteria for RWD. This consensus statement was derived from the quality criteria for RWD to be used more effectively for medical research purposes beyond the registry-based studies discussed in the European Medicines Agency guideline for registry-based studies. This paper summarizes the recommendations for the quality criteria of RWD, which represents a minimum set of requirements. In order to future-proof registry-based studies, RWD should follow high-quality standards and be subjected to the quality assurance measures needed to underpin data quality. Furthermore, specific RWD quality aspects for individual use cases (eg, medical or pharmacoeconomic research), market authorization processes, or postmarket authorization phases have yet to be elaborated.

PMID:35713954 | DOI:10.2196/34204

Categories
Nevin Manimala Statistics

Assessing Trauma Management in Urban and Rural Populations in Norway: A National Register-Based Research Protocol

JMIR Res Protoc. 2022 Jun 17;11(6):e30656. doi: 10.2196/30656.

ABSTRACT

BACKGROUND: Time is considered an essential determinant in the initial care of trauma patients. In Norway, response time (ie, time from dispatch center call to ambulance arrival at scene) is a controversial national quality indicator. However, no national requirements for response times have been established. There is an ongoing debate regarding the optimal configuration of the Norwegian trauma system. The recent centralization of trauma services and closure of emergency hospitals have increased prehospital transport distances, predominantly for rural trauma patients. However, the impact of trauma system configuration on early trauma management in urban and rural areas is inadequately described.

OBJECTIVE: The project will assess injured patients’ initial pathways through the trauma system and explore differences between central and rural areas in a Norwegian trauma cohort. This field is unexplored at the national level, and existing evidence for an optimal organization of trauma care is still inconclusive regarding the impact of prehospital time.

METHODS: Three quantitative registry-based retrospective cohort studies are planned. The studies are based on data from the Norwegian Trauma Registry (NTR; studies 1, 2, and 3) and the local Emergency Medical Communications Center (study 2). All injured patients admitted to a Norwegian hospital and registered in the NTR in the period between January 1, 2015, and December 31, 2020, will be included in the analysis. Trauma registry data will be analyzed using descriptive and relevant statistical methods to compare prehospital time in rural and central areas, including regression analyses and adjusting for confounders.

RESULTS: The project received funding in fall 2020 and was approved by the Oslo University Hospital data protection officer, case number 18/02592. Registry data including approximately 40,000 trauma patients will be extracted during the first quarter of 2022, and analysis will begin immediately thereafter. Results are expected to be ready for publication from the third quarter of 2022.

CONCLUSIONS: Findings from the study will contribute to new knowledge regarding existing quality indicators and with an increasing centralization of hospitals and residents, the study will contribute to further development of the Norwegian trauma system. A high generalizability to other trauma systems is expected, given the similarities between demographical changes and trauma systems in many high-income countries.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/30656.

PMID:35713952 | DOI:10.2196/30656

Categories
Nevin Manimala Statistics

Use of DNA image cytometry in conducting oral cancer screening in rural India

Cytopathology. 2022 Jun 17. doi: 10.1111/cyt.13159. Online ahead of print.

ABSTRACT

OBJECTIVES: Oral cancer screening can assist in the early detection of oral potentially malignant lesions (OPMLs) and prevention of oral cancers. It can be challenging for clinicians to differentiate OPMLs from benign conditions. Adjunct screening tools such as fluorescence visualization (FV) and DNA image cytometry (DNA-ICM) have shown success in identifying OPMLs in high-risk clinics. For the first time we aimed to assess these technologies into Indian rural settings and evaluate if these tools helped clinicians identify high-risk lesions during screening.

METHODS: Dental students and residents screened participants in five screening camps held in villages outside of Hyderabad, India, using extraoral, intraoral, and FV examinations. Lesion and normal tissue brushings were collected for DNA-ICM analysis and cytology.

RESULTS: Of the 1116 participants screened, 184 lesions were observed in 152 participants. Based on white light examination (WLE), 45 lesions were recommended for biopsy. Thirty-five were completed on site; 25(71%) were diagnosed with low-grade dysplasias (17 mild dysplasia, 8 moderate dysplasia) and the remaining 10 showed no signs of dysplasia. FV loss was noted in all but one dysplastic lesion and showed a sensitivity of 96% and specificity of 17%. Cytology combined with DNA-ICM had a 64% sensitivity and 86% specificity in detecting dysplasia.

CONCLUSION: DNA-ICM combined with cytology identified majority of dysplastic lesions and identified additional lesions, which were not considered high-risk during WLE to biopsy on site. Efforts to follow-up with these participants are ongoing. FV identified most high-risk lesions but added limited value over WLE.

PMID:35713951 | DOI:10.1111/cyt.13159

Categories
Nevin Manimala Statistics

Interactions between rearward-facing child restraint systems and the front row seatback in frontal impact sled tests

Traffic Inj Prev. 2022 Jun 17:1-6. doi: 10.1080/15389588.2022.2078812. Online ahead of print.

ABSTRACT

OBJECTIVE: Some child restraint system (CRS) manufacturers specify a minimum distance between the CRS and the seatback, whereas others require that the CRS may contact the seatback but cannot be “braced”; however, few studies have investigated these interactions. Therefore, the aim was to investigate the interactions between the front row seat and rearward-facing CRS models with and without a support leg during frontal crashes.

METHODS: Sled tests using the FMVSS 213 frontal crash pulse were performed with the Q1.5 and Q3 anthropomorphic test devices (ATDs) seated in rearward-facing infant and convertible CRS models, respectively. A front row vehicle seat was in front of the test bench in three track positions: brace, touch and gap. For the touch condition, the front row seat was translated aftward until the seatback contacted the CRS. For the brace condition, the front row seat was translated 20 mm aftward. For the gap condition, the front row seat was translated 50 mm forward. Each condition was tested with and without the support leg of the CRS.

RESULTS: The tests with a support leg were associated with significantly (p = 0.007) lower resultant linear head acceleration 3 ms clip compared to the tests without a support leg, but the reduction of head injury criterion 15 ms (HIC15) was not significant (p = 0.057). The Q1.5 ATD in the rearward-facing infant CRS with a support leg had the lowest injury metrics for the touch and gap conditions, whereas the Q3 in the rearward-facing convertible CRS had the lowest head injury metrics for the brace condition.

CONCLUSIONS: The use of a support leg provided a clear benefit in terms of reducing head injury metrics for the Q1.5 in the rearward-facing infant CRS, especially for the touch and gap conditions. The rearward-facing convertible CRS in the current study appears to benefit from being braced against the front row seat. However, further tests are required to allow further statistical comparisons and determine if these preliminary findings extend to other rearward-facing CRS models.

PMID:35713941 | DOI:10.1080/15389588.2022.2078812

Categories
Nevin Manimala Statistics

Nurse Spiritual Care Therapeutics Scale: Validation Among Nurses Who Care for Patients With Life-Threatening Illnesses in South Korea

J Hosp Palliat Nurs. 2022 Jun 18. doi: 10.1097/NJH.0000000000000895. Online ahead of print.

ABSTRACT

Although clinical and empirical literature documents the variety of spiritual care interventions available to palliative care clinicians, the frequency with which they are provided is rarely and inadequately measured. Given the growing interest in implementing spiritual care across Asia, including South Korea, this study sought to cross-culturally validate the Korean version of the Nurse Spiritual Care Therapeutics Scale (NSCTS-K), a scale initially developed in the United States. The World Health Organization process for cross-cultural adaptation of scales and Polit and Yang’s process for evaluating validation were implemented. With data from a sample of 252 Korean nurses providing care to patients with life-threatening illnesses, various statistical procedures for evaluating validity and reliability were applied during this cross-sectional, observational study. Exploratory factor analysis for the structural validity of the Korean scale generated 3 factors that accounted for 69.40% of the variance. The Cronbach α was 0.95. The NSCTS-K is one of the few scales available to determine the impact of nurse-provided spiritual care frequency on patient outcomes. Thus, this tool can quantify the frequency of spiritual care better and be used in quality improvement initiatives or palliative care research.

PMID:35713883 | DOI:10.1097/NJH.0000000000000895

Categories
Nevin Manimala Statistics

Maternal autonomy and childhood undernutrition: Analysis of 2018 Nigeria demographic and health survey

J Child Health Care. 2022 Jun 17:13674935221108011. doi: 10.1177/13674935221108011. Online ahead of print.

ABSTRACT

Existing knowledge of how maternal autonomy relates to child undernutrition in Nigeria is few and limited to children under 24 months old. Nothing is known about how it affects older children. Therefore, this study investigated whether mothers’ household autonomy affects children 24-59 months, as do children under 24 months old. We used data from 2018 Nigerian Demographic and Health Survey, which is a nationally representative survey. Samples include 3502 and 5463 children under 24 months and between 24 and 59 months old, respectively. Three anthropometry indexes were used to determine child undernutrition: weight-for-height, height-for-age, and weight-for-age, which indicate wasting, stunting, and underweight, respectively. Three domains of maternal autonomy: decision-making, financial-control, and mobility, were operationalized using responses from mothers. Results from logistic regression analysis show that in unadjusted models, maternal decision-making autonomy and mobility were associated with undernutrition in both samples. After adding covariates, only associations between maternal decision-making autonomy and underweight in children 24-59 months old retained statistical significance. Findings show that gendered social inequalities are linked to differences in child nutritional outcomes. Future studies could investigate how feeding practices mediate associations between maternal autonomy and childhood undernutrition.

PMID:35713878 | DOI:10.1177/13674935221108011

Categories
Nevin Manimala Statistics

Combining Literature Mining and Machine Learning for Predicting Biomedical Discoveries

Methods Mol Biol. 2022;2496:123-140. doi: 10.1007/978-1-0716-2305-3_7.

ABSTRACT

The major outcomes and insights of scientific research and clinical study end up in the form of publication or clinical record in an unstructured text format. Due to advancements in biomedical research, the growth of published literature is getting tremendous large in recent years. The scientists and clinical researchers are facing a big challenge to stay current with the knowledge and to extract hidden information from this sheer quantity of millions of published biomedical literature. The potential one-stop automated solution to this problem is biomedical literature mining. One of the long-standing goals in biology is to discover the disease-causing genes and their specific roles in personalized precision medicine and drug repurposing. However, the empirical approaches and clinical affirmation are expensive and time-consuming. In silico approach using text mining to identify the disease causing genes can contribute towards biomarker discovery. This chapter presents a protocol on combining literature mining and machine learning for predicting biomedical discoveries with a special emphasis on gene-disease relation based discovery. The protocol is presented as a literature based discovery (LBD) pipeline for gene-disease based discovery. The protocol includes our web based tools: (1) DNER (Disease Named Entity Recognizer) for disease entity recognition, (2) BCCNER (Bidirectional, Contextual clues Named Entity Tagger) for gene/protein entity recognition, (3) DisGeReExT (Disease-Gene Relation Extractor) for statistically validated results and visualization, and (4) a newly introduced deep learning based method for association discovery. Our proposed deep learning based method can be generalized and applied to other important biomedical discoveries focusing on entities such as drug/chemical, or miRNA.

PMID:35713862 | DOI:10.1007/978-1-0716-2305-3_7

Categories
Nevin Manimala Statistics

Biomedical Literature Mining for Repurposing Laboratory Tests

Methods Mol Biol. 2022;2496:91-109. doi: 10.1007/978-1-0716-2305-3_5.

ABSTRACT

Epidemiological studies identifying biological markers of disease state are valuable, but can be time-consuming, expensive, and require extensive intuition and expertise. Furthermore, not all hypothesized markers will be borne out in a study, suggesting that high-quality initial hypotheses are crucial. In this chapter, we describe a high-throughput pipeline to produce a ranked list of high-quality hypothesized biomarkers for diseases. We review an example use of this approach to generate a large number of candidate disease biomarker hypotheses derived from machine learning models, filter and rank them according to their potential novelty using text mining, and corroborate the most promising hypotheses with further statistical modeling. The example use of the pipeline uses a large electronic health record dataset and the PubMed corpus, to find several promising hypothesized laboratory tests with previously undocumented correlations to particular diseases.

PMID:35713860 | DOI:10.1007/978-1-0716-2305-3_5

Categories
Nevin Manimala Statistics

Spatial variability and source analysis of typical soil trace elements at permafrost section along national highway 214 in the eastern Qinghai-Tibet Plateau

Environ Geochem Health. 2022 Jun 17. doi: 10.1007/s10653-022-01299-5. Online ahead of print.

ABSTRACT

This paper attempts to reveal the enrichment status, spatial characteristics and material sources of typical soil trace elements at permafrost section along National Highway 214 on the Qinghai-Tibet Plateau. Therefore, the samples of typical trace elements in surface soil, being located at the northern slope of Bayan Kara Mountains, were collected and tested. The concentrations of typical trace elements in soil were analysed by mathematical statistics, spatial analysis and ecological assessment. The results show that: (1) the concentrations of As, Cd and Hg in the soil are higher than the local background values, and their degrees of variation were high. There was a certain degree of accumulation. Soil As and Hg elements constitute “slight pollution”, indicating there is a none-to-slight ecological hazard. (2) The distributions of soil As, Cd, Pb and Zn concentrations are lower near the highway and increase with distance from it and then become relatively low further away. The distributions of Cr, Cu, Hg and Ni concentrations show no obvious trends in any direction. (3) The spatial heterogeneity of typical trace elements in soil is affected by soil organic matter (SOM), cation exchange capacity (CEC), pH, slope curvature and aspect. At the local scale, soil texture and topography were the main affecting factors. Concentrations of Cd, Cr, Cu, Ni, Pb and Zn were mainly affected by natural factors, while those of As and Hg were affected by both natural and human factors.

PMID:35713839 | DOI:10.1007/s10653-022-01299-5

Categories
Nevin Manimala Statistics

Associations of organophosphate metabolites with thyroid hormone and antibody levels: findings from U.S. National Health and Nutrition Examination Survey (NHANES)

Environ Sci Pollut Res Int. 2022 Jun 17. doi: 10.1007/s11356-022-21385-6. Online ahead of print.

ABSTRACT

Studies have shown that organophosphate pesticides (OPs) exposure may disrupt thyroid endocrine functions in animal models, agricultural population, occupational workers, and work-related population. However, the relationships between OPs exposure and thyroid hormone levels in the general population are unclear. This study aimed to explore the relationships of OPs exposure with thyroid hormone and antibody levels in the general population. We analyzed a sample of 1089 US adults from the National Health and Nutrition Examination Survey (NHANES) 2001-2002. OPs exposure was estimated using measures of six non-specific dialkyl phosphate metabolites (DAPs), e.g., dimethylphosphate (DMP). Multiple linear regression models were used to examine the associations of OPs exposure with thyroid hormone and antibody levels. The medians of urinary ∑DAPs detected in males and females were 32.98 nmol/g creatinine and 40.77 nmol/g creatinine, with statistical significance (p = 0.001). After controlling for sociodemographic factors, we found that concentrations of urinary OPs metabolites were positively associated with the serum thyroid stimulating hormone (TSH) in the general US population, particularly in males; OPs metabolites were associated with the serum TgAb, tT3, fT3, and TSH. These findings showed that thyroid hormone and antibody disruption are probably associated with OPs exposure in the general population; more studies are needed to confirm our findings.

PMID:35713824 | DOI:10.1007/s11356-022-21385-6