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Institute
Chronic kidney disease is one of the main causes of mortality worldwide. It affects more than 800 million patients globally, accounting for approximately 10% of the general population. The significant burden of the disease prompts healthcare systems to implement adequate preventive and therapeutic measures. This systematic review and meta-analysis aimed to provide a concise summary of the findings published in the existing body of research about the influence that mobile health technology has on the outcomes of patients with the disease. A comprehensive systematic literature review was conducted from inception until March 1st, 2023. This systematic review and meta-analysis included all clinical trials that compared the efficacy of mobile app-based educational programs to that of more conventional educational treatment for the patients. Eleven papers were included in the current analysis, representing 759 CKD patients. 381 patients were randomly assigned to use the mobile apps, while 378 individuals were assigned to the control group. The mean systolic blood pressure was considerably lower in the mobile app group (MD -4.86; 95%-9.60, -0.13; p=0.04). Meanwhile, the mean level of satisfaction among patients who used the mobile app was considerably greater (MD 0.75; 95% CI 0.03, 1.46; p=0.04). Additionally, the mean self-management scores in the mobile app groups were significantly higher (SMD 0.534; 95% CI 0.201, 0.867; p=0.002). Mobile health applications are potentially valuable interventions for patients. This technology improved the self-management of the disease, reducing the mean levels of systolic blood pressure with a high degree of patient satisfaction.
Economic and political/governmental infrastructural factors are major contributors to the economic development/growth of all sectors of a country, such as in the area of healthcare systems and clinical research, including the pharmaceutical industry. But what is the interaction between economic, and political/governmental infrastructural factors and the development of healthcare systems, especially, the performance of the pharmaceutical industry? Information from selected articles of a literature search of PubMed and by using Google Advanced Search led to the generation of five categories of infrastructural factors, and were filled with data from 41 African Countries using the World Health Organization data repository. Median changes over time were given and tested by Wilcoxon signed-rank test and Friedman test, respectively. Analysis of factors related to availability of healthcare facilities showed that physicians and pharmacies were significant increased, with insignificantly decreased number of hospital beds. Healthcare Financing by the Government showed notable differences. Private health spending decreased significantly unlike Gross National Income. Analysis of infrastructural factors showed that stable supply of electricity and the associated use of the Internet improved significantly. The low level of data on the expansion of paved road networks suggests less developed medical services in remote rural areas. Healthcare systems in African countries improved over the last two decades, but differences between the individual countries still prevail and some of the countries cannot yet offer an attractive sales market for the products of pharmaceutical companies.
Monitoring of clinical trials is a fundamental process required by regulatory agencies. It assures the compliance of a center to the required regulations and the trial protocol. Traditionally, monitoring teams relied on extensive on-site visits and source data verification. However, this is costly, and the outcome is limited. Thus, central statistical monitoring (CSM) is an additional approach recently embraced by the International Council for Harmonisation (ICH) to detect problematic or erroneous data by using visualizations and statistical control measures. Existing implementations have been primarily focused on detecting inlier and outlier data. Other approaches include principal component analysis and distribution of the data. Here we focus on the utilization of comparisons of centers to the Grand mean for different model types and assumptions for common data types, such as binomial, ordinal, and continuous response variables. We implement the usage of multiple comparisons of single centers to the Grand mean of all centers. This approach is also available for various non-normal data types that are abundant in clinical trials. Further, using confidence intervals, an assessment of equivalence to the Grand mean can be applied. In a Monte Carlo simulation study, the applied statistical approaches have been investigated for their ability to control type I error and the assessment of their respective power for balanced and unbalanced designs which are common in registry data and clinical trials. Data from the German Multiple Sclerosis Registry (GMSR) including proportions of missing data, adverse events and disease severity scores were used to verify the results on Real-World-Data (RWD).
Background
Symptoms of depression are prevalent in people living with human immune deficiency virus/acquired immune deficiency syndrome (PLWHA), and worsened by lack of physical activity/exercises, leading to restriction in social participation/functioning. This raises the question: what is the extent to which physical exercise training affected, symptoms of depression, physical activity level (PAL) and social participation in PLWHA compared to other forms of intervention, usual care, or no treatment controls?
Method
Eight databases were searched up to July 2020, according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocol. Only randomised controlled trials involving adults who were either on HAART/HAART-naïve and reported in the English language, were included. Two independent reviewers determined the eligibility of the studies, extracted data, assessed their quality, and risk of bias using the Physiotherapy Evidence Database (PEDro) tool. Standardised mean difference (SMD) was used as summary statistics for the mean primary outcome (symptoms of depression) and secondary outcomes (PAL and social participation) since different measuring tools/units were used across the included studies. Summary estimates of effects were determined using a random-effects model (I2).
Results
Thirteen studies met the inclusion criteria with 779 participants (n = 596 participants at study completion) randomised into the study groups, comprising 378 males, 310 females and 91 participants with undisclosed gender, and with an age range of 18–86 years. Across the studies, aerobic or aerobic plus resistance exercises were performed 2–3 times/week, at 40–60 min/session, and for between 6-24 weeks, and the risk of bias vary from high to low. Comparing the intervention to control groups showed significant difference in the symptoms of depression (SMD = − 0.74, 95% confidence interval (CI) − 1.01, − 0.48, p ≤ 0.0002; I2 = 47%; 5 studies; 205 participants) unlike PAL (SMD = 0.98, 95% CI − 0.25, 2.17, p = 0.11; I2 = 82%; 2 studies; 62 participants) and social participation (SMD = 0.04, 95% CI − 0.65, 0.73, p = 0.91; I2 = 90%; 6 studies; 373 participants).
Conclusion
Physical exercise training could have an antidepressant-like effect in PLWHA but did not affect PAL and social participation. However, the high heterogeneity in the included studies, implies that adequately powered randomised controlled trials with clinical/methodological similarity are required in future studies.
Background: Upsurge in cardiopulmonary dysfunctions in Enugu, Nigeria, involved mainly cement workers, automobile spray painters, woodworkers, and Cleaners and was worsened in the dry season, suggesting the need for an occupation-specific characterization of the disease features and seasonal evaluation of air quality for prevention and management.
Methods: We conducted a randomized cross-sectional study of eighty consenting participants (in Achara Layout, Enugu), comprising 20 cement workers (39.50 ± 14.95 years), 20 automobile spray painters (40.75 ± 9.85 years), 20 woodworkers (52.20 ± 9.77 years), and 20 cleaners (42.30 ± 9.06 years). The air quality, some haematological (fibrinogen-Fc, and C-reactive protein-CRP), and cardiopulmonary parameters were measured and analyzed using ANCOVA, at p < 0.05.
Results: The dry season particulate matter (PM) in ambient air exceeded the WHO standards in the New layout [PM10 = 541.17 ± 258.72 µg/m3; PM2.5 = 72.92 ± 25.81 µg/m3] and the University campus [PM10 = 244 ± 74.79 µg/m3; PM2.5 = 30.33 ± 16.10 µg/m3], but the former was twice higher. The PM differed significantly (p < 0.05) across the sites. Forced expiratory volume at the first second (FEV1) (F = 6.128; p = 0.001), and Peak expiratory flow rate (PEFR) (F = 5.523; p = 0.002), differed significantly across the groups. FEV1/FVC% was < 70% in cement workers (55.33%) and woodworkers (61.79%), unlike, automobile spray painters (72.22%) and cleaners (70.66%). FEV1 and work duration were significantly and negatively related in cement workers (r = -0.46; r2 = 0.2116; p = 0.041 one-tailed). CRP (normal range ≤ 3.0 mg/L) and Fc (normal range—1.5–3.0 g/L) varied in cement workers (3.32 ± 0.93 mg/L versus 3.01 ± 0.85 g/L), automobile spray painters (2.90 ± 1.19 mg/L versus 2.54 ± 0.99 mg/L), woodworkers (2.79 ± 1.10 mg/L versus 2.37 ± 0.92 g/L) and cleaners (3.06 ± 0.82 mg/L versus 2.54 ± 0.70 g/L).
Conclusion(s): Poor air quality was evident at the study sites, especially in the dry season. Cement workers and automobile spray painters showed significant risks of obstructive pulmonary diseases while woodworkers had restrictive lung diseases. Cement workers and cleaners recorded the highest risk of coronary heart disease (CRP ≥ 3.0 mg/L). The similarity in Fc and CRP trends suggests a role for the inflammation-sensitive proteins in the determination of cardiovascular risk in cement workers and cleaners. Therefore, there are occupation-specific disease endpoints of public health concern that likewise warrant specific preventive and management approaches among the workers.
Background
Systematic reviews demonstrated that gait variables are the most reliable predictors of future falls, yet are rarely included in fall screening tools. Thus, most tools have higher specificity than sensitivity, hence may be misleading/detrimental to care. Therefore, this study aimed to determine the validity, and reliability of the velocity field diagram (VFD -a gait analytical tool), and the Timed-up-and-go test (TUG)-commonly used in Nigeria as fall screening tools, compared to a gold standard (known fallers) among community-dwelling older adults.
Method
This is a cross-sectional observational study of 500 older adults (280 fallers and 220 non-fallers), recruited by convenience sampling technique at community health fora on fall prevention. Participants completed a 7-m distance with the number of steps and time it took determined and used to compute the stride length, stride frequency, and velocity, which regression lines formed the VFD. TUG test was simultaneously conducted to discriminate fallers from non-fallers. The cut-off points for falls were: TUG times ≥ 13.5 s; VFD’s intersection point of the stride frequency, and velocity regression lines (E1) ≥ 3.5velots. The receiver operating characteristic (ROC) area under the curves (AUC) was used to explore the ability of the E1 ≥ 3.5velots to discriminate between fallers and non-fallers. The VFD’s and TUG’s sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were determined. Alpha was set at p < 0.05.
Results
The VFD versus TUG sensitivity, specificity, PPV and NPV were 71%, 27%, 55%, and 42%, versus 39%, 59%, 55%, and 43%, respectively. The ROC’s AUC were 0.74(95%CI:0.597,0.882, p = 0.001) for the VFD. The optimal categorizations for discrimination between fallers/non-fallers were ≥ 3.78 versus ≤ 3.78 for VFD (fallers versus non-fallers prevalence is 60.71% versus 95.45%, respectively), with a classification accuracy or prediction rate of 0.76 unlike TUG with AUC = 0.53 (95% CI:0.353,0.700, p = 0.762), and a classification accuracy of 0.68, and optimal characterization of ≥ 12.81 s versus ≤ 12.81 (fallers and non-fallers prevalence = 92.86% versus 36.36%, respectively).
Conclusion
The VFD demonstrated a fair discriminatory power and greater reliability in identifying fallers than the TUG, and therefore, could replace the TUG as a primary tool in screening those at risk of falls.
Public knowledge and awareness towards antibiotics use in Yogyakarta: A cross sectional survey
(2020)
Irrational use of antibiotics is a public health problem. Our study aimed to evaluate knowledge and awareness of antibiotics, and to examine its’ associated factors. We conducted a cross sectional survey. The questionnaire was adapted from WHO Multi-country survey. Adults aged 18 years old and were receiving prescription from eight outpatient clinics and pharmacies in Yogyakarta province completed the survey. The questionnaire was consisted of three sections, i.e. socio-demographic factors, knowledge of antibiotics, and experiences in using antibiotics. Scores on questions and data were presented descriptively and analyzed using logistic regression to evaluate the influence of variables on knowledge of antibiotics. Out of 268 respondents, a cumulative 76% of them used antibiotics in last six months. Majority of respondents (58%) had low level knowledge on antibiotic use and awareness, and incorrectly identified that cold and cough are treatable with antibiotics (75%). Interestingly, 71% of participants agreed that internet is a major source of information on antibiotics (71%), while only 58% and 45% of respondents see pharmacists and medical professionals respectively. The antibiotics were received from prescription (79%) and 70% of respondents completed the full course of antibiotics prescribed, but only 32% of them became more cautious about antibiotic use. We found the highest association between gender, age, education level, with the knowledge of antibiotics. The overall level of knowledge and awareness on antibiotics use among residents in Yogyakarta is low. This mandates public health awareness intervention programs to be implemented on the use of antibiotics.
Background: The globalization of clinical research should also benefit the population in developing markets. In this context, the approval of tested medicines and the associated expansion of medical care beyond clinical studies would be desirable as a possible long-term benefit.
Objectives: This study was designed to compare the development of the number of clinical trials with the number of marketing authorizations of medicines on the African continent. To contrast these 2 parameters, the data were analyzed using the model of an ecological study.
Methods: To reflect the broad spectrum of African developing countries with diverse levels of development, the data collection was based on 2 geographically selected sample countries each from Central, North, East, West, and Southern Africa. Based on the ClinicalTrials.gov registry, the first step was to collect trends data on the development of the clinical trials in the 10 selected countries of the country list of the African Region published by the World Health Organization for the period 2015 to 2018. Subsequently, data on the current number of marketing authorizations of medicines in the selected sample countries were identified using the online registries of the national authorities. The data were utilized in comparative analyses.
Results: Eight out of 10 model countries showed an increase in the number of clinical trials, with the exceptions of Cameroon and Libya, which showed an overall decline in research activity over the entire time. In direct comparison with drug registrations, the numbers indicate a similar development. The only exception here is Nigeria, a country with a solid performance in clinical research and yet a decrease in medicine registrations since 2015.
Conclusions: The expected increase in the development of clinical research as result of the globalization trend can basically be observed in most of the model countries. However, this increase does not guarantee an improvement in the number of medicine registrations. Although this is evident in some of the selected model countries, it cannot be projected to the entire African region. This may be linked to the diverse development of the individual countries due to the different political situations and the varying degrees of clinical research infrastructure.
Introduction: Piper crocatum Ruiz & Pav (P. crocatum) has been reported to accelerate the diabetic wound healing process empirically. Some studies showed the benefits of P. crocatum in treating various diseases but its mechanisms in diabetic wound healing have never been reported. In the present study we investigated the diabetic wound healing activity of the active fraction of P. crocatum on wounded hyperglycemia fibroblasts (wHFs).
Methods: Bioassay-guided fractionation was performed to get the most active fraction. The selected active fraction was applied to wHFs within 72 h incubation. Mimicking a diabetic condition was done using basal glucose media containing an additional 17 mMol/L D-glucose. A wound was simulated via the scratch assay. The collagen deposition was measured using Picro-Sirius Red and wound closure was measured using scratch wound assay. Underlying mechanisms through p53, aSMA, SOD1 and Ecadherin were measured using western blotting.
Results: We reported that FIV is the most active fraction of P. crocatum. We confirmed that FIV\(7.81 mg/ml, 15.62 mg/ml, 31.25 mg/ml, 62.5 mg/ml, and 125 mg/ml) induced the collagen deposition and wound closure of wHFs. Furthermore, FIV treatment (7.81 mg/ml, 15.62 mg/ml, 31.25 mg/ml) down-regulated the protein expression level of p53 and up-regulated the protein expression levels of aSMA, E-cadherin, and SOD1.
Discussion/conclusions: Our findings suggest that ameliorating collagen deposition and wound closure through protein regulation of p53, aSMA, E-cadherin, and SOD1 are some of the mechanisms by which FIV of P. crocatum is involved in diabetic wound healing therapy.
Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach
(2021)
Regulatory authorities have encouraged the usage of a risk-based monitoring (RBM) system in clinical trials before trial initiation for detection of potential risks and inclusion of a mitigation plan in the monitoring strategy. Several RBM tools were developed after the International Council for Harmonization gave sponsors the flexibility to initiate an approach to enhance quality management in a clinical trial. However, various studies have demonstrated the need for improvement of the available RBM tools as each does not provide a comprehensive overview of the characteristics, focus, and application. This research lays out a rationale for a risk methodology assessment (RMA) within the RBM system. The core purpose of RMA is to deliver a scientifically based evaluation and decision of any potential risk in a clinical trial. Thereby, a monitoring plan can be developed to elude prior identified risk outcome. To demonstrate RMA’s theoretical approach in practice, a Shiny web application (R Foundation for Statistical Computing) was designed to describe the assessment process of risk analysis and visualization tools that eventually aid in focusing monitoring activities. RMA focuses on the identification of an individual risk and visualizes its weight on the trial. The scoring algorithm of the presented approach computes the assessment of the individual risk in a radar plot and computes the overall score of the trial. Moreover, RMA’s novelty lies in its ability to decrease biased decision making during risk assessment by categorizing risk influence and detectability; a characteristic pivotal to serve RBM in assessing risks, and in contributing to a better understanding in the monitoring technique necessary for developing a functional monitoring plan. Future research should focus on validating the power of RMAs to demonstrate its efficiency. This would facilitate the process of characterizing the strengths and weaknesses of RMA in practice.