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Institute
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.
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).
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.
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.
Background
Infant mortality in rural areas of Nigeria can be minimized if childhood febrile conditions are treated by trained health personnel, deployed to primary healthcare centres (PHCs) rather than the observed preference of mothers for patent medicine dealers (PMDs). However, health service utilization/patronage is driven by consumer satisfaction and perception of services/product value. The objective of this study was to determine ‘mothers’ perception of recovery’ and ‘mothers’ satisfaction’ after PMD treatment of childhood febrile conditions, as likely drivers of mothers’ health-seeking behaviour, which must be targeted to reverse the trend.
Methods
Ugwuogo-Nike, in Enugu, Nigeria, has many PMDs/PHCs, and was selected based on high prevalence of childhood febrile conditions. In total, 385 consenting mothers (aged 15–45 years) were consecutively recruited at PMD shops, after purchasing drugs for childhood febrile conditions, in a cross-sectional observational study using a pre-tested instrument; 33 of them (aged 21–47 years) participated in focus group discussions (FGDs). Qualitative data were thematically analysed while a quantitative study was analysed with Z score and Chi square statistics, at p < 0.05.
Results
Most participants in FGDs perceived that their child had delayed recovery, but were satisfied with PMDs’ treatment of childhood febrile conditions, for reasons that included politeness, caring attitude, drug availability, easy accessibility, flexibility in pricing, shorter waiting time, their God-fearing nature, and disposition as good listeners. Mothers’ satisfaction with PMDs’ treatment is significantly (p < 0.05) associated with mothers’ perception of recovery of their child (χ2 = 192.94, df = 4; p < 0.0001; Cramer’s V = 0.7079). However, predicting mothers’ satisfaction with PMDs’ treatment from a knowledge of mothers’ perception of recovery shows a high accord (lambda[A from B] = 0.8727), unlike when predicting mothers’ perception of recovery based on knowledge of mothers’ satisfaction with PMDs’ treatment (lambda[A from B] = 0.4727).
Conclusions
Mothers’ satisfaction could be the key ‘driver’ of mothers’ health-seeking behaviour and is less likely to be influenced by mothers’ perception of recovery of their child. Therefore, mothers’ negative perception of their child’s recovery may not induce proportionate decline in mothers’ health-seeking behaviour (patronage of PMDs), which might be influenced mainly by mothers’ satisfaction with the positive attributes of PMDs’ personality/practice and sets an important agenda for PHC reforms.
Purpose. To identify stroke survivors with symptoms of poststroke depression and the extent of psychiatry needs and care they have received while on physiotherapy rehabilitation. Participants. Fifty stroke survivors (22 females and 28 males) at the outpatient unit of Physiotherapy Department, University of Nigeria Teaching Hospital, Enugu, who gave their informed consent, were randomly selected. Their age range and mean age were 26–66 years and 54.76 ± 8.79 years, respectively. Method. A multiple case study of 50 stroke survivors for symptoms of poststroke depression was done with Beck’s Depression Inventory, mini mental status examination tool, and Modified Motor Assessment Scale. The tests were performed independently by the participants except otherwise stated and scored on a scale of 0–6. Data were analyzed using -test for proportional significance and chi-square test for determining relationship between variables, at p < 0.05. Results. Twenty-one (42.0%) stroke survivors had symptoms of PSD, which was significantly dependent on duration of stroke ( = 21.680, df = 6, and p = 0.001), yet none of the participants had a psychiatry review. Conclusions. Symptoms of PSD may be common in cold compared to new cases of stroke and may need psychiatry care while on physiotherapy rehabilitation.
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.
Roads to Health in Developing Countries: Understanding the Intersection of Culture and Healing
(2017)
Background:
The most important attribute to which all human beings aspire is good health because it enables us to undertake different forms of activities of daily living. The emergence of scientific knowledge in Western societies has enabled scientists to explore and define several parameters of health by drawing boundaries around factors that are known to influence the attainment of good health. For example, the World Health Organization defined health by taking physical and psychological factors into consideration. Their definition of health also included a caveat that says, “not merely the absence of sickness.”
This definition has guided scientists and health care providers in the Western world in the development of health care programs in non-Western societies.
Objective:
However, ethnomedical beliefs about the cause(s) of illness have given rise to alternative theories of health, sickness, and treatment approaches in the developing world. Thus, there is another side to the story.
Method:
Much of the population in developing countries lives in rural settings where the knowledge of health, sickness, and care has evolved over centuries of practice and experience. The definition of health in these settings tends to orient toward cultural beliefs, traditional practices, and social relationships. Invariably, whereas biomedicine is the dominant medical system in Western societies, traditional medicine — or ethno-medicine — is often the first port of call for patients in developing countries.
Results:
The 2 medical systems represent, and are influenced by, the cultural environment in which they exist. On one hand, biomedicine is very effective in the treatment of objective, measurable disease conditions. On the other hand, ethnomedicine is effective in the management of illness conditions or the experience of disease states. Nevertheless, an attempt to supplant 1 system of care with another from a different cultural environment could pose enormous challenges in non-Western societies.
Conclusion:
In general, we, as human beings, are guided in our health care decisions by past experiences, family and friends, social networks, cultural beliefs, customs, tradition, professional knowledge, and intuition. No medical system has been shown to address all of these elements; hence, the need for collaboration, acceptance, and partnership between all systems of care in cultural communities. In developing countries, the roads to health are incomplete without an examination of the intersection of culture and healing. Perhaps mutual exclusiveness rather inclusiveness of these 2 dominant health systems is the greatest obstacle to health in developing countries.
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.