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Institute
Knowledge and attitude towards voluntary blood donation among students from Mumbai University
(2018)
Background: Blood is scarce; its demand far outweighs the supply. In addition to limited supply, the issue of safety especially with regard to the risk of transfusion transmissible infection is also an issue of utmost concern especially in the developing countries. Blood transfusion services in India have gained special significance in recent years and forms a vital part of national health care system. Voluntary Non-Remunerated Blood Donation (VNRBD) is the safest of all types of blood donations. One of the potential sources that can be tapped for blood donation is the young and physically fit students from educational institutions across India. Methods: A cross-sectional study was carried out among students from Mumbai University, India during May–June 2017. Two hundred and fifty students were approached to participate in the study of which 201 agreed to participate (males: 104; females: 97). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23. Results: High number of participants agreed about encouraging general public about voluntary blood donation (96%; 193/201), lack of awareness about VBD in general public (82%; 164/201). But not a single participant was able to respond to the knowledge part of the questionnaire with 100% accuracy. Almost all the participants had correct knowledge about blood groups (98%; 196/201) and blood matching need (195/201; 97%). Conclusions: Participants showed good attitude but demonstrated poor knowledge about voluntary blood donation. Details about blood donation should be incorporated in the undergraduate curriculum and periodic awareness programs should be organized for students.
Background: Epilepsy is a chronic disorder of the brain that affects people worldwide. The overall prevalence (3.0-11.9 / 1,000) and incidence (0.2-0.6/1,000) of epilepsy in India are comparable to the rates of high-income countries. The high prevalence of negative attitudes towards epilepsy has been highlighted by several studies. Pharmacy students represent a better-educated section of society regarding drugs and have the potential to create awareness, and influence attitudes towards the disease. Thus, it is important that they have the appropriate and updated knowledge and appropriate attitude towards epilepsy and antiepileptic drugs. Objective of the present study was to determine the Mumbai University pharmacy student’s awareness about epilepsy, so as to know the kind of education and awareness strategies that would be applicable to them.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. Two hundred and fifty students were approached to participate in the study of which 213 agreed to participate (males: 107; females: 106). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Response rate for this study was 85.2% (213/250). Ninety six percent (204/213) of the participants had heard or read about epilepsy. Overall knowledge was poor (40.2%) and attitude was fair (75.3%). None of the participants were aware about recent research regarding hereditary nature of epilepsy. Only 2 (0.98%) students were aware how to perform the first aid in epilepsy. Only 6.8% participants felt that epileptics should participate in sports.
Conclusions: The findings of this study show that, even with extensive curriculum covering diseases, drugs and relevant laws of land, the knowledge and attitude scores were low. There is a need to have focused education and campaigns to increase the knowledge and attitude towards epilepsy.
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.
Background: Compromised immune function, associated with human immune deficiency virus (HIV) infection, is improved by antiretroviral therapy (ART) which also decreases bone mineral density (BMD), and possibly the quality of life (QoL). However, physical (aerobic/resistance) exercises, were reported to induce reverse effects in uninfected individuals and were appraised in the literature for evidence of similar benefits in people living with HIV/AIDS(PLWHA). The main study objective was to evaluate the impact of physical (aerobic and resistance) exercises on CD4+ count,
BMD and QoL in PLWHA.
Methods: A systematic review was conducted using the Cochrane Collaboration protocol. Searching databases, up to June 2017, only randomized control trials investigating the effects of either aerobic, resistance or a combination of both exercise types with a control/other intervention(s) for a period of at least 4 weeks among adults living with HIV, were included. Two independent reviewers determined the eligibility of the studies. Data were extracted and risk of bias (ROB) was assessed with the Cochrane Collaboration ROB tool. Meta-analyses were conducted using random effect models using the Review Manager (RevMan) computer software.
Results: Nineteen studies met inclusion criteria(n = 491 participants at study completion) comprising male and female with age range 22–66 years. Two meta-analyses across 13 sub-group comparisons were performed. However, there were no RCTs on the impact of physical exercises on BMD in PLWHA. The result showed no significant change in CD4+ count unlike a significant effect of 5.04 point (95%CI:-8.49,-3.74,p = 0.00001) for role activity limitation due to physical health (QoL sub-domain). Overall, the GRADE evidence for this review was of moderate quality.
Conclusions: There was evidence that engaging in moderate intensity aerobic exercises (55–85% Maximum heart rate-MHR), for 30–60 min, two to five times/week for 6–24 weeks significantly improves role activity limitation due to physical health problems, otherwise physical(aerobic or/and resistance) exercises have no significant effects on CD4+ count and other domains of QoL. Also, there is lack of evidence on the impact of exercises on BMD in PLWHA due to the paucity of RCTs. The moderate grade evidence for this review suggests that further research may likely have an important impact on our confidence in the estimate of effects and may change the estimate.
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: Hand hygiene practices (HHP), as a critical component of infection prevention/control, were investigated among physiotherapists in an Ebola endemic region.
Method: A standardized instrument was administered to 44 randomly selected physiotherapists (23 males and 21 females), from three tertiary hospitals in Enugu, Nigeria. Fifteen participants (aged 22–59 years) participated in focus group discussions (FGDs) and comprised 19 participants in a subsequent laboratory study. After treatment, the palms/fingers of physiotherapists were swabbed and cultured, then incubated aerobically overnight at 37°C, and examined for microbial growths. An antibiogram of the bacterial isolates was obtained.
Results: The majority (34/77.3%) of physiotherapists were aware of the HHP protocol, yet only 15/44.1% rated self-compliance at 71–100%. FGDs identified forgetfulness/inadequate HHP materials/infrastructure as the major barriers to HHP. Staphylococcus aureus were the most prevalent organisms, prior to (8/53.33%) and after (4/26.67%) HPP, while Pseudomonas spp. were acquired thereafter. E. coli were the most antibiotic resistant microbes but were completely removed after HHP. Ciprofloxacin and streptomycin were the most effective antibiotics.
Conclusion: Poor implementation of HPP was observed due to inadequate materials/infrastructure/poor behavioral orientation. Possibly, some HPP materials were contaminated; hence, new microbes were acquired. Since HPP removed the most antibiotic resistant microbes, it might be more effective in infection control than antibiotic medication.
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.
Introduction:
Human Immunodeficiency Virus (HIV) infection remains prevalent co-morbidity, and among fracture patients. Few studies have investigated the role of exercise interventions in preventing bone demineralization in people who have fractures and HIV. If exercise exposed, HIV-infected individuals may experience improved bone health outcomes (BMD), function, quality of life (QoL). The study will aim to assess the impact of home based exercises on bone mineral density, functional capacity, QoL, and some serological markers of health in HIV infection among Nigerians and South Africans.
Methods and design:
The study is an assessor-blinded randomized controlled trial. Patients managed with internal and external fixation for femoral shaft fracture at the study sites will be recruited to participate in the study. The participants will be recruited 2 weeks post-discharge at the follow-up clinic with the orthopaedic surgeon. The study population will consist of all persons with femoral fracture and HIV-positive and negative (HIV-positive medically confirmed) aged 18 to 60 years attending the above-named health facilities. For the HIV-positive participants, a documented positive HIV result, as well as a history of being followed-up at the HIV treatment and care center. A developed home based exercise programme will be implemented in the experimental group while the control group continues with the usual rehabilitation programme. The primary outcome measures will be function, gait, bone mineral density, physical activity, and QoL.
Discussion:
The proposed trial will compare the effect of a home-based physical exercise-training programme in the management of femoral fracture to the usual physiotherapy management programmes with specific outcomes of bone mineral density, function, and inflammatory markers.
Background: Mobile text reminder (SMS) system is considered a viable strategy for targeting/facilitating healthy behavioural change including adherence to prescribed physical exercises (PE) and medication (antiretroviral therapy-ART) which should improve the quality of life (Qol) in people living with HIV/AIDS(PLWHA). Thus, the literature was appraised for evidence of SMS effectiveness in improving ART and PE adherence behaviours and QoL in PLWHA.
Methods: Eight databases–AMED, CINAHL, Cochrane Library, EMBASE, EMCARE, Ovid MEDLINE, PsycINFO, and PubMed-were searched up to December 2020, using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocol.This review included only randomised control trials (RCTs) investigating the effectiveness of SMS in improving QoL or PE or ART adherence behaviour or a combination of these variables in PLWHA >18 years.
Two independent reviewers determined the eligibility of the studies. Data were extracted and the quality of the study was assessed with the Physiotherapy Evidence Database (PEDro) tool. The primary outcomes were ART and PE adherence behaviours while the secondary outcome was QoL.
Result: A pooled estimate of effect was not calculated due to the heterogeneity of methods and outcome measures.
Therefore, a narrative synthesis of ten studies that met the inclusion criteria (n = 1621 participants at study completion) comprising males/females, aged ≥ 18 years, was done. There was a significant improvement in ART adherence behaviour except in three underpowered studies. Only the SMS interventions that were developed using the Starks 3-steps Adherence model was associated with positive outcome. The only study that evaluated QoL was underpowered and reported no significant change while there were no RCTs on PE.
Conclusion: Effects of SMS intervention trends towards a significant improvement in ART adherence behaviour in PLWHA. It is plausible that SMS reminders developed using the broader framework of the interpersonal health behaviour theory(ies) may have positive outcome. Nevertheless, the observed heterogeneity in the methods/outcome measures warrants a cautious interpretation of the findings. There is a lack/paucity of RCTs and therefore no evidence in support of the effectiveness of SMS intervention in improving PE adherence and QoL.
Lack of knowledge regarding antibiotics use has been widely identified as a main reason for inappropriate antibiotics use which leads to antibiotic resistance phenomenon. This study aimed to evaluate the effects of pharmacist-initiated educational intervention on promoting appropriate use of antibiotics and reducing self-medication with antibiotics. A pre and post intervention study using two validated self-administered questionnaires was performed in Yogyakarta province. A-two hour session of course and case discussion was delivered as method of intervention. Pharmacy customers attended Gema Cermat program were invited conveniently to complete both of pre- and post-educational questionnaires. Descriptive presentation was conducted to show scores on questions. Knowledge scores were categorized as poor, adequate and high. Of 268 respondents, 34.22% respondents had poor level of knowledge before receiving educational intervention, but this number decreased into 12.21% after post-interventional phase. Another 28.23% respondents had adequate level of knowledge before and then elevated into 38.28% after receiving education about appropriate use of antibiotics. Pre-education, 37.43% participants had a high level of knowledge about antibiotics use and resistance, whereas after education the number became slightly higher (49.25%). A vast majority of respondents (75.24%) became more aware about appropriate antibiotics practice after receiving educational inter- vention. Overall, didactic educational intervention imposed higher knowledge and better practice regarding antibiotics use (p < 0.05). This study showed that using didactical education intervention towards antibiotics use and resistance can be an initial strategy that led to substantial improvement of appropriate antibiotics use. Further systemic interventions to educate people should be performed and evaluated in order to promote the appropriate use of antibiotics.
Objective: To determine the distribution of symptoms of post-stroke depression (PSD) in relation to some predisposing factors in an African population.
Relevance: Environment is a key determinant of behavior, and varied socio-cultural contexts must have implications for modifiable characteristics (age, duration of the stroke, marital status, type of employment, gender, the location of cerebral lesion and complications) of individuals vulnerable to PSD, which may be targeted to enhance recovery.
Method: This was a cross-sectional observational study of 50 (22 females and 28 males) stroke survivors (mean age=54.76±8.79 years), at the physiotherapy department, the University of Nigeria teaching hospital, Enugu, selected using convenience sampling technique. Data were collected using Becks Depression Inventory and analyzed using Z-score, Chi-square test and univariate logistic regression, at p<0.05.
Results: PSD was more prevalent in females (45.45%); young(100%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%); complications(45%); cold case >3 years(47.05%); self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (χ2 =4.92,df=1,p=0.03), and was related to the risk of PSD (3.7[1.1-12.0], p=0.03, φ = +0.31, φ2=0.1).
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.
Hypertension is a serious global public health problem. It accounts for 10% of all deaths in India and is the leading noncommunicable disease.1 Recent studies have shown that the prevalence of hypertension is 25% in urban and 10% in rural people in India.2 It exerts a substantial public health burden on cardiovascular health status and health care systems in India.3 Antihypertensive treatment effectively reduces hypertension-related morbidity and mortality.1 The cost of medications has always been a barrier to effective treatment.
Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease.1 India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India.2 Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized.
Background: Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease. India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India. Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized. The present study assesses the cost-effectiveness of antidiabetic drugs in patients with T2DM from Mumbai, India.
Methods: A prospective cross-sectional study was performed to assess the cost-effectiveness of antidiabetic drugs in patients with T2DM. Face-to-face interviews were conducted by using a validated questionnaire in a total of 152 (76 males, 76 females) patients with T2DM from F-North Ward, Mumbai, India. Cost-effectiveness was determined on the basis of cost of antidiabetic drug/s, efficacy, adverse drug reactions, safety of administration, frequency of administration, and bioavailability.
Results: For treatment of T2DM in non-obese participants, Glimepiride+Pioglitazone costed least (`3.7) per unit of effectiveness followed by Glimepiride (`6.6), Gliclazide (`8.1), Repaglinide (`24.5), and Vildagliptin (`45.2). For treatment of T2DM in obese participants, Metformin cost least (` 6.7) per unit of effectiveness followed by Glimepiride + Metformin (`5.9) and Repaglinide (`24.5).
Conclusions: In case of non-obese participants, cost effectiveness and prescribed treatments did not show a match, while for obese participants prescribed treatments were in line with cost effectiveness.
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparative, interventional clinical trial. But has this now 20-year-long ethical debate truly been put to rest? The choice of standard of care in clinical trials remains a complex issue, particularly for comparative trials conducted in emerging countries.
Objective: To determine the burden and factors associated with post-stroke depression in East central Nigeria.
Method: We carried out this cross-sectional study of 50 stroke survivors (mean age=54.8 ± 8.8 years), at the physiotherapy Department of the University of Nigeria Teaching Hospital, Enugu. Data were collected using Becks Depression Inventory , it was analyzed using Z-scores, Chi-square test and univariate logistic regression.
Results: PSD was more common in females (45.45%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%). Self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (p=0.03), and was related to the risk ofOR3.7 (95% CI 1.1-12.0 )
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.
A decline in the CD4 count is a common feature in HIV/AIDS, suggesting a compromise in immunity of patients. In response, highly active antiretroviral therapy (HAART) is prescribed to slow-down a diminution in the CD4 count and risk of AIDS-related malignancies. However, exercise may improve both the utility and population of innate immune cell components, and may be beneficial for patients with HIV infection. Comparing the effects of different exercises against HAART, on CD4 count, helps in understanding the role and evidence-based application of exercises to ameliorate immune deficiency.
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).