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Nevin Manimala Statistics

The Role of Social Media for Identifying Adverse Drug Events Data in Pharmacovigilance: Protocol for a Scoping Review

JMIR Res Protoc. 2023 Aug 2;12:e47068. doi: 10.2196/47068.

ABSTRACT

BACKGROUND: Adverse drug events (ADEs) are a considerable public health burden resulting in disability, hospitalization, and death. Even those ADEs deemed nonserious can severely impact a patient’s quality of life and adherence to intervention. Monitoring medication safety, however, is challenging. Social media may be a useful adjunct for obtaining real-world data on ADEs. While many studies have been undertaken to detect adverse events on social media, a consensus has not yet been reached as to the value of social media in pharmacovigilance or its role in pharmacovigilance in relation to more traditional data sources.

OBJECTIVE: The aim of the study is to evaluate and characterize the use of social media in ADE detection and pharmacovigilance as compared to other data sources.

METHODS: A scoping review will be undertaken. We will search 11 bibliographical databases as well as Google Scholar, hand-searching, and forward and backward citation searching. Records will be screened in Covidence by 2 independent reviewers at both title and abstract stage as well as full text. Studies will be included if they used any type of social media (such as Twitter or patient forums) to detect any type of adverse event associated with any type of medication and then compared the results from social media to any other data source (such as spontaneous reporting systems or clinical literature). Data will be extracted using a data extraction sheet piloted by the authors. Important data on the types of methods used (such as machine learning), any limitations of the methods used, types of adverse events and drugs searched for and included, availability of data and code, details of the comparison data source, and the results and conclusions will be extracted.

RESULTS: We will present descriptive summary statistics as well as identify any patterns in the types and timing of ADEs detected, including but not limited to the similarities and differences in what is reported, gaps in the evidence, and the methods used to extract ADEs from social media data. We will also summarize how the data from social media compares to conventional data sources. The literature will be organized by the data source for comparison. Where possible, we will analyze the impact of the types of adverse events, the social media platform used, and the methods used.

CONCLUSIONS: This scoping review will provide a valuable summary of a large body of research and important information for pharmacovigilance as well as suggest future directions of further research in this area. Through the comparisons with other data sources, we will be able to conclude the added value of social media in monitoring adverse events of medications, in terms of type of adverse events and timing.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47068.

PMID:37531158 | DOI:10.2196/47068

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Nevin Manimala Statistics

The Effect of Hyperbaric Oxygen Therapy on Corneal Endothelial Structure and Anterior Segment Parameters

Cutan Ocul Toxicol. 2023 Aug 2:1-9. doi: 10.1080/15569527.2023.2243499. Online ahead of print.

ABSTRACT

PURPOSE: To assess the effect of hyperbaric oxygen therapy (HBOT) on corneal endothelial structure and anterior segment parameters in healthy eyes.

METHODS: 17 eyes of 17 patients who were scheduled to receive HBOT for other than ophthalmologic indications were investigated in this prospective study. Central corneal thickness (CCT) and corneal endothelial properties were evaluated using a specular microscope. Endothelial cell density (ECD), average cell area (AVG), coefficient of variation in cell size (CV), percentage of hexagonal cells (HEX), CCT, intraocular pressure (IOP), spherical equivalent (SE), axial length (AL) and anterior chamber depth (ACD) values were measured before the HBOT, after the 1st session, and after the 20th session of therapy.

RESULTS: 47% of the patients (n = 8) received HBOT because of avascular necrosis, 35% (n = 6) due to sudden hearing loss, 12% (n = 2) for diabetic foot, and 6% (n = 1) for wound infection. The mean IOP was 14,80 mmHg before HBOT, 14,20 mmHg after the 1st session, and 13,73 mmHg after the 20th session. The mean ACD was 3,38 mm before HBOT, 3,34 mm after the 1st session, and 3,16 mm after the 20th session. Although the mean IOP and ACD decreased after HBOT sessions, it was not statistically significant (p > 0.05). A significant reduction was observed in SE values after 20 sessions of HBOT compared to the values measured before HBOT (p = 0,009). The mean ECD was 2572,53 ± 261,51 cells/mm2 before HBOT, 2554,47 ± 236,13 after the 1st session, and 2563,13 ± 226,92 after the 20th session. When the corneal properties measured before and after HBOT sessions were compared, no significant difference was found in terms of CCT, ECD, AVG, CV, and HEX (p > 0.05).

CONCLUSION: We observed no significant change in CCT, corneal endothelial layer properties, and anterior segment morphology after the 1st session, and after the 20th session of HBOT. Although HBOT reduced IOP and ACD, it was not statistically significant. HBOT may lead to a significant decrease in SE values after the 20th session.

PMID:37531136 | DOI:10.1080/15569527.2023.2243499

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Nevin Manimala Statistics

Intraoperative Identification of Thyroid and Parathyroid Tissues During Human Endocrine Surgery Using the MasSpec Pen

JAMA Surg. 2023 Aug 2. doi: 10.1001/jamasurg.2023.3229. Online ahead of print.

ABSTRACT

IMPORTANCE: Intraoperative identification of tissues through gross inspection during thyroid and parathyroid surgery is challenging yet essential for preserving healthy tissue and improving outcomes for patients.

OBJECTIVE: To evaluate the performance and clinical applicability of the MasSpec Pen (MSPen) technology for discriminating thyroid, parathyroid, and lymph node tissues intraoperatively.

DESIGN, SETTING, AND PARTICIPANTS: In this diagnostic/prognostic study, the MSPen was used to analyze 184 fresh-frozen thyroid, parathyroid, and lymph node tissues in the laboratory and translated to the operating room to enable in vivo and ex vivo tissue analysis by endocrine surgeons in 102 patients undergoing thyroidectomy and parathyroidectomy procedures. This diagnostic study was conducted between August 2017 and March 2020. Fresh-frozen tissues were analyzed in a laboratory. Clinical analyses occurred in an operating room at an academic medical center. Of the analyses performed on 184 fresh-frozen tissues, 131 were included based on sufficient signal and postanalysis pathologic diagnosis. From clinical tests, 102 patients undergoing surgery were included. A total of 1015 intraoperative analyses were performed, with 269 analyses subject to statistical classification. Statistical classifiers for discriminating thyroid, parathyroid, and lymph node tissues were generated using training sets comprising both laboratory and intraoperative data and evaluated on an independent test set of intraoperative data. Data were analyzed from July to December 2022.

MAIN OUTCOMES AND MEASURES: Accuracy for each tissue type was measured for classification models discriminating thyroid, parathyroid, and lymph node tissues using MSPen data compared to gross analysis and final pathology results.

RESULTS: Of the 102 patients in the intraoperative study, 80 were female (78%) and the median (IQR) age was 52 (42-6) years. For discriminating thyroid and parathyroid tissues, an overall accuracy, defined as agreement with pathology, of 92.4% (95% CI, 87.7-95.4) was achieved using MSPen data, with 82.6% (95% CI, 76.5-87.4) accuracy achieved for the independent test set. For distinguishing thyroid from lymph node and parathyroid from lymph node, overall training set accuracies of 97.5% (95% CI, 92.8-99.1) and 96.1% (95% CI, 91.2-98.3), respectively, were achieved.

CONCLUSIONS AND RELEVANCE: In this study, the MSPen showed high performance for discriminating thyroid, parathyroid, and lymph node tissues intraoperatively, suggesting this technology may be useful for providing near real-time feedback on tissue type to aid in surgical decision-making.

PMID:37531134 | DOI:10.1001/jamasurg.2023.3229

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Nevin Manimala Statistics

Differences in Use of Clinical Decision Support Tools and Implementation of Aspirin, Blood Pressure Control, Cholesterol Management, and Smoking Cessation Quality Metrics in Small Practices by Race and Sex

JAMA Netw Open. 2023 Aug 1;6(8):e2326905. doi: 10.1001/jamanetworkopen.2023.26905.

ABSTRACT

IMPORTANCE: Practice-level evidence is needed to clarify the value of population-based clinical decision support (CDS) tools in reducing racial and sex disparities in cardiovascular care.

OBJECTIVE: To evaluate the association between CDS tools and racial and sex disparities in the aspirin use, blood pressure control, cholesterol management, and smoking cessation (ABCS) care quality metrics among smaller primary care practices.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used practice-level data from the Agency for Healthcare Research and Quality-funded EvidenceNOW initiative. The national initiative from May 1, 2015, to April 30, 2021, spanned 12 US states and focused on improving cardiovascular preventive care by providing quality improvement support to smaller primary care practices. A total of 576 primary care practices in EvidenceNOW submitted both survey data and electronic health record (EHR)-derived ABCS data stratified by race and sex.

MAIN OUTCOMES AND MEASURES: Practice-level estimates of disparities between Black and White patients and between male and female patients were calculated as the difference in proportions of eligible patients within each practice meeting ABCS care quality metrics. The association between CDS tools (EHR prompts, standing orders, and clinical registries) and disparities was evaluated by multiply imputed multivariable models for each CDS tool, adjusted for practice rurality, ownership, and size.

RESULTS: Across the 576 practices included in the analysis, 219 (38.0%) had patient panels that were more than half White and 327 (56.8%) had panels that were more than half women. The proportion of White compared with Black patients meeting metrics for blood pressure (difference, 5.16% [95% CI, 4.29%-6.02%]; P < .001) and cholesterol management (difference, 1.49% [95% CI, 0.04%-2.93%] P = .04) was higher; the proportion of men meeting metrics for aspirin use (difference, 4.36% [95% CI, 3.34%-5.38%]; P < .001) and cholesterol management (difference, 3.88% [95% CI, 3.14%-4.63%]; P < .001) was higher compared with women. Conversely, the proportion of women meeting practice blood pressure control (difference, -1.80% [95% CI, -2.32% to -1.28%]; P < .001) and smoking cessation counseling (difference, -1.67% [95% CI, -2.38% to -0.95%]; P < .001) metrics was higher compared with men. Use of CDS tools was not associated with differences in race or sex disparities except for the smoking metric. Practices using CDS tools showed a higher proportion of men meeting the smoking counseling metric than women (coefficient, 3.82 [95% CI, 0.95-6.68]; P = .009).

CONCLUSIONS AND RELEVANCE: The findings of this cross-sectional study suggest that practices using CDS tools had small disparities that were not statistically significant, but CDS tools were not associated with reductions in disparities. More research is needed on effective practice-level interventions to mitigate disparities.

PMID:37531106 | DOI:10.1001/jamanetworkopen.2023.26905

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Nevin Manimala Statistics

Prevalence of Use of Potentially Inappropriate Medications Among Older Adults Worldwide: A Systematic Review and Meta-Analysis

JAMA Netw Open. 2023 Aug 1;6(8):e2326910. doi: 10.1001/jamanetworkopen.2023.26910.

ABSTRACT

IMPORTANCE: The use of potentially inappropriate medications (PIMs) is widespread yet continues to receive little attention in outpatient services.

OBJECTIVE: To estimate the overall prevalence of PIM use in outpatient services.

DATA SOURCES: PubMed, Embase, and Web of Science were searched to identify relevant studies published from January 1, 1990, to November 21, 2022.

STUDY SELECTION: Observational studies that reported the prevalence of PIM use among older patients in outpatient services were screened.

DATA EXTRACTION AND SYNTHESIS: Two reviewers independently selected eligible articles, extracted data, and assessed the risk of bias. A random-effects meta-analysis was conducted to pool the prevalence estimates.

MAIN OUTCOMES AND MEASURES: The global patterns in the prevalence of PIM use among older patients in outpatient services were estimated, and the temporal trends and regional differences in PIM use were investigated.

RESULTS: A total of 94 articles with 132 prevalence estimates were analyzed, including nearly 371.2 million older participants from 17 countries. Overall, the pooled prevalence of PIM use was 36.7% (95% CI, 33.4%-40.0%). Africa had the highest prevalence of PIM use (47.0%; 95% CI, 34.7%-59.4%), followed by South America (46.9%; 95% CI, 35.1%-58.9%), Asia (37.2%; 95% CI, 32.4%-42.2%), Europe (35.0%; 95% CI, 28.5%-41.8%), North America (29.0%; 95% CI, 22.1%-36.3%), and Oceania (23.6%; 95% CI, 18.8%-28.8%). In addition, the prevalence of PIM use is highest in low-income areas. Use of PIMs among older patients has become increasingly prevalent in the past 2 decades.

CONCLUSIONS AND RELEVANCE: This study of patterns of PIM use by different groups, such as geographic regions and World Bank countries, suggests noticeable geographic environment and economic income differences in the burden of PIMs in outpatient services. Furthermore, the high prevalence trend in the past 2 decades indicates that the global burden of PIM use continues to be worthy of attention.

PMID:37531105 | DOI:10.1001/jamanetworkopen.2023.26910

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Nevin Manimala Statistics

Longitudinal assessment of bone health index as a measure of bone health in short-statured children before and during treatment with recombinant growth hormone

J Pediatr Endocrinol Metab. 2023 Aug 3. doi: 10.1515/jpem-2023-0084. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of our study was the longitudinal assessment of bone health index (BHI) in short-statured children during growth hormone (GH) treatment to estimate changes in their bone health.

METHODS: 256 short-statured children (isolated GH deficiency (IGHD) n=121, multiple pituitary hormone deficiency (MPHD) n=49, intrauterine growth retardation (small for gestational age (SGA)) n=52, SHOX (short stature homeobox gene) deficiency n=9, Ullrich Turner syndrome (UTS) n=25) who started with GH between 2010 and 2018 were included. Annual bone ages (Greulich and Pyle, GP) and BHI were, retrospectively, analysed in consecutive radiographs of the left hand (BoneXpert software) from GH therapy start (T0) up to 10 years (T10) thereafter, with T max indicating the individual time point of the last available radiograph. The results are presented as the median (25 %/75 % interquartile ranges, IQR) and statistical analyses were performed using non-parametric tests as appropriate.

RESULTS: The BHI standard deviation scores (SDS) were reduced (-0.97, -1.8/-0.3) as bone ages were retarded (-1.6 years, -2.31/-0.97) in all patients before start of GH and were significantly lower in patients with growth hormone deficiency (GHD) (-1.04, -1.85/-0.56; n=170) compared to non-GHD patients (-0.79, -1.56/-0.01; n=86; p=0.022). BHI SDS increased to -0.17 (-1/0.58) after 1 year of GH (T1, 0.5-1.49, p<0.001) and to -0.20 (-1/-0.50, p<0.001) after 5.3 years (T max, 3.45/7.25).

CONCLUSIONS: BHI SDS are reduced in treatment-naive short-statured children regardless of their GH status, increase initially with GH treatment while plateauing thereafter, suggesting sustained improved bone health.

PMID:37531076 | DOI:10.1515/jpem-2023-0084

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Nevin Manimala Statistics

Assessing the impact of green human resource management practices on environmental performance in China: role of higher education

Environ Sci Pollut Res Int. 2023 Aug 2. doi: 10.1007/s11356-023-28523-8. Online ahead of print.

ABSTRACT

The goal is for governments and executives to make environmental protection and the preservation of natural resources a priority. The current research examines how green human resource management practices have altered environmental performance in China’s manufacturing sector. The survey used a trustworthy and valid questionnaire adapted from the literature to obtain the data. Random sampling method has been applied to collect data from manufacturers in China’s Guangdong Province. Workers in China’s industrial sector are the focus of this study, and each individual is treated as a separate unit of analysis. Three hundred of the 500 questionnaires were returned with sufficient data for statistical analysis. The predicted serial mediation model was analyzed using structural equation modeling (SEM) and the PROCESS model 4. The findings revealed that green HRM practices have a major impact on environmental performance and pro-environmental actions partially mediate the relationship between GHRM and environmental performance. In addition, higher education helped moderate the effect of green HRM on environmental outcomes. In terms of environmental performance, green recruitment, green selection, and green performance, green rewards via higher education has the greatest impact (p 0.01 significance level). Through an extension of the ability-motivation-opportunity theory, this study offers useful tips for policymakers, new and current organizations, and, in particular, manufacturing enterprises, on how to implement an incentive plan to promote environmentally friendly activities and product development, which in turn will increase customer loyalty.

PMID:37531058 | DOI:10.1007/s11356-023-28523-8

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Nevin Manimala Statistics

Development of response surface method prediction model for traffic-related roadside noise levels based on traffic characteristics

Environ Sci Pollut Res Int. 2023 Aug 2. doi: 10.1007/s11356-023-28934-7. Online ahead of print.

ABSTRACT

Recently, several urban areas are trying to mitigate the environmental impacts of traffic, where noise pollution is one of the main consequences. Thus, studying the determinants of traffic-related noise generation and developing a model that predicts the level of noise by controlling the influencing factors are crucial for transportation planning purposes. This research aims at utilizing the response surface method (RSM) to develop a robust statistical prediction model of traffic-related noise levels and optimize different traffic characteristics’ ranges to reduce the expected noise levels. The results indicate that the rate of Leq increase is higher at traffic flow values less than the 1204 veh/h. The interaction effect of flow-speed and flow-heavy vehicle percentage pairs shows that Leq has peak values around 45.8 km/h and 28.71%, respectively, with almost symmetric value distribution about those center points. The main effects study indicates a direct effect of traffic flow, speed, density, and traffic composition on roadside noise levels. The prediction model has good representativeness of observed noise levels by predicted noise levels as the model has a high coefficient of determination (R2 = 95.87% and R2 adj = 92.26%) with a significance level of 0.0036. Then, the research presents a methodology to perform an optimization of the roadside noise level by defining traffic characteristics that can keep the noise level below 65 dB(A) or minimize noise level. Decision-makers could use the proposed method to control the roadside noise level.

PMID:37531052 | DOI:10.1007/s11356-023-28934-7

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Nevin Manimala Statistics

Modelling biochemical oxygen demand using improved neuro-fuzzy approach by marine predators algorithm

Environ Sci Pollut Res Int. 2023 Aug 2. doi: 10.1007/s11356-023-28935-6. Online ahead of print.

ABSTRACT

Biochemical oxygen demand (BOD) is one of the most important parameters used for water quality assessment. Alternative methods are essential for accurately prediction of this parameter because the traditional method in predicting the BOD is time-consuming and it is inaccurate due to inconstancies in microbial multiplicity. In this study, the applicability of four hybrid neuro-fuzzy (ANFIS) methods, ANFIS with genetic algorithm (GA), ANFIS with particle swarm optimization (PSO), ANFIS with sine cosine algorithm (SCA), and ANFIS with marine predators algorithm (MPA), was investigated in predicting BOD using distinct input combinations such as potential of hydrogen (pH), dissolved oxygen (DO), electrical conductivity (EC), water temperature (WT), suspended solids (SS), chemical oxygen demand (COD), total nitrogen (TN), and total phosphorus (T-P) acquired from two river stations, Gongreung and Gyeongan, South Korea. The applicability of multi-variate adaptive regression spline (MARS) in determination of the best input combination was examined. The ANFIS-MPA was found to be the best model with the lowest root mean square error and mean absolute error and the highest determination coefficient. It improved the root mean square error of ANFIS-PSO, ANFIS-GA, and ANFIS-SCA models by 13.8%, 12.1%, and 6.3% for Gongreung Station and by 33%, 25%, and 6.3% for Gyeongan Station in the test stage, respectively.

PMID:37531049 | DOI:10.1007/s11356-023-28935-6

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Nevin Manimala Statistics

The learning curve on robot-assisted transaxillary thyroidectomy performed by a single endocrine surgeon in a third-level institution in Europe: a cumulative sum (CUSUM) analysis

Updates Surg. 2023 Aug 2. doi: 10.1007/s13304-023-01619-z. Online ahead of print.

ABSTRACT

Robot-assisted transaxillary thyroidectomy is widely performed in Asian countries, although it is still under discussion in the Western World. However, there have been few studies reporting on the learning curve of robot-assisted transaxillary thyroidectomy. We used the cumulative sum (CUSUM) analysis to assess the learning curve of gasless robot-assisted transaxillary thyroidectomy at a third-level institution in Europe. We included all consecutive patients operated by a single surgeon without previous experience of robotic surgery from February 2012 to January 2023. The primary endpoint of the study was the learning curve extracted from the median operative time using the CUSUM method for the quantitative assessment. Overall, 583 patients were enrolled. The median operative time for thyroid lobectomy and total thyroidectomy was 70 and 90 min, respectively. The CUSUM analysis showed that the learning curve for thyroid lobectomy and total thyroidectomy is 66 and 56 cases, respectively. Moreover, the presence of thyroiditis resulted associated with shorter operative time for total thyroidectomy (p = 0.044), whereas no factors resulted associated with surgical complications. The learning curve for performing robotic transaxillary thyroid lobectomy for a surgeon without previous robotic experience is 66 cases. After that, 56 cases must be performed to acquire proficiency in robotic transaxillary total thyroidectomy. Training programs may reduce the slope of the learning curve.

PMID:37531041 | DOI:10.1007/s13304-023-01619-z