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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: Patient satisfaction is considered as an indicator of the healthcare quality. Information on patient satisfaction based on medical expertise of the physician, interpersonal skills, physician-patient interaction time, perception and needs of the patient allow policymakers to identify areas for improvement. Primary care services and healthcare structure differ between the countries. The present study was done to determine and analyze the determinants associated with patient satisfaction in India, Pakistan, Spain and USA.
Methods: This descriptive study was performed in January to August 2019 among students from Mumbai University, India, Dow University of Health Sciences, Karachi, Pakistan, University CEU Cardenal Herrera, Valencia, Spain, Texas State University, Texas, USA. On the basis of the eligibility criterion (those who gave a written informed consent and were registered students of respective university) 890 (India: 369, Pakistan: 128, Spain: 195, USA: 99) students were selected for the present study.
Results: India had almost similar male (49%) to female (51%) ratio of participants. For other 3 countries (PK, ES, US), female participant percentage was nearly 20% or even more as compared to male participants. Overall participant’s satisfaction score about medial expertise of the doctor were highest in India (71%) and were lowest in Spain (43%). Overall satisfaction score about time spent with doctor were highest for India (64%) and were lowest for Spain (41%). Overall satisfaction score about communication with doctor were highest for US (60%) and were lowest for PK (53%). Overall satisfaction score for medical care given by the doctor was lowest in PK (43%) and was highest in US (64%). Overall satisfaction about doctor, highest number of US (83%) and lowest number of PK (32%) participants were satisfied about medical interaction with doctors.
Conclusions: These multi-country findings can provide information for health policy making in India, Pakistan, Spain and USA. Although the average satisfaction per country, except Pakistan is more than 60%, the results suggest that there is ample room for improvement.
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.
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: 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: India has the third largest HIV epidemic in the world. The Indian epidemic is characterized by low levels in the general population and elevated concentrations among high-risk groups. The present study was planned to determine the awareness of HIV among students from Mumbai University.
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 199 agreed to participate (males: 132; females: 67). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Study participants had high knowledge (86%) and attitude score (87%). There was no significant difference between males and female participants for attitude and knowledge, except for one question regarding knowledge about HIV transmission via breastfeeding to child.
Conclusions: Present study showed that there are no misconceptions or negative attitudes regarding HIV among students. A longitudinal study with a larger sample size across India is recommended for further investigation.
Background: Antimicrobial resistance has become a serious global problem. A potential post-antibiotic era is threatening present and future medical advances. In Pakistan, the usage of antibiotic is unnecessarily high and due to over exposure to these drugs, bacteria are developing resistance against these drugs. It is necessary to improve public awareness about the rational use of antibiotics in order to bring a change in consumer’s behaviour. Therefore, present study was undertaken to assess the existing knowledge, attitude and practices related to antibiotic usage among university students.
Methods: A cross-sectional study was carried out among university students from Karachi, Pakistan during May-June 2018. 200 students were approached to participate in the study of which 159 agreed to participate (males: 70, females: 89). Pretested questionnaire was distributed to the study subjects and the collected data was analyzed using IBM SPSS version 23.
Results: Substantial number of (33% and 50%) participants were unaware about the differences in antibiotic: anti-inflammatory drugs and antibiotic: antipyretics respectively. 29% of the participants thought it is right to stop antibiotics only based on symptomatic improvement. Thirty nine percent and eighty three percent participants believed that antibiotics should always be prescribed to treat flu like symptoms and pneumonia respectively.
Conclusions: Participants demonstrated average knowledge about antibiotics. Similarly, their attitude and practice toward antibiotic use was associated with misconceptions. An educational intervention is necessary to make them aware about rational use of antibiotics.
Background: Oral cancers (OC) are malignant lesions occurring in the oral cavity that include squamous cell carcinomas (SCC), salivary gland and odontogenic neoplasms. Even though it is the eighth most common malignancy globally but in Pakistan it is the second commonest type of cancer. Lack of awareness about ill-effects of preventable risk factors of oral cancer increases the burden of disease due to the associated high cost of treatment, permanent impairment and high mortality. Hence, awareness can be very helpful in prevention, control and early diagnosis of oral cancer.
Methods: A cross-sectional study was carried out among university students from Karachi, Pakistan during April to May 2018. Three hundred students were approached to participate in the study of which 277 agreed to participate. Pretested questionnaire was distributed and collected data was analysed using IBM SPSS version 23.
Results: There were 125 (45%) males and 152 (55%) females in the study and response rate was 94%. Sixty one percent (154/250) respondents correctly identified smoking, and tobacco chewing as possible causes of oral cancer. Almost one third (74%; 184/250) respondents correctly responded that oral cancer does not spread from person to person through touch or speaking. Sixty six percent (164/250) respondents believed that oral cancer is curable. Mean score of knowledge was higher in females (61%) than males (53%). Significantly higher number of females compared to male participants answered correctly to questions regarding cause of oral cancer, spread of disease and occurrence of oral cancer in AIDS patients.
Conclusions: Participants showed poor knowledge about oral cancer. Female participants showed better knowledge compared to male counterparts. Details about oral cancer should be incorporated in the university curriculum and periodic awareness programs should be organized for students.
Background: Discovery of antibiotics have helped to manage the devastating diseases. Presently, the antibiotic era is threatened by the emergence of high level of antibiotic resistance of important pathogens. Misuse of antibiotics poses a serious risk to infectious disease control. It is necessary to improve public awareness to bring a change in the behavior of consumers. Therefore, present study was undertaken to assess the existing knowledge, attitude and practices related to antibiotic usage among university students.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. 300 students were approached to participate in the study of which 250 agreed to participate (males: 117; females: 133). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Substantial number (33% and 40%) participants were unaware about the differences in antibiotic-anti-inflammatory drugs and antibiotic-antipyretics respectively. 28% of the participants thought it is right to stop antibiotics only based on symptoms improvement. Sixty eight percent and seventy nine percent participants believed that antibiotics should always be prescribed to treat flu like symptoms and pneumonia respectively.
Conclusions: Participants demonstrated poor knowledge about antibiotics. Similarly, their attitude and practice toward antibiotic use was associated with misconceptions. An educational intervention can be introduced to make them aware about rational antibiotic practices.
Background: Pharmacovigilance (PV); also known as drug safety surveillance, is the science of enhancing patient care and patient safety regarding the use of medicines by collecting, monitoring, assessing, and evaluating information from healthcare providers and patients. Pharmacists are pivotal players in adverse drug event (ADE) monitoring and reporting. However, most pharmacists are unaware or not knowledgeable about the guidelines used by their respective countries’ drug regulatory bodies. It is the need of the hour to train pharmacy students on the concept of pharmacovigilance.
Methods: A cross-sectional study was carried out among pharmacy students from Mumbai University, India during May-June 2017. On the basis of the eligibility criterion 352 students were selected for the present study. Four hundred students were approached to participate in the study of which 201 agreed to participate (males: 179; females: 173). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Overall pharmacovigilance knowledge (44%) and perception (58%) was low among the participants of the present study. Seventy four percent of the participants felt that adverse drug reaction (ADR) reporting should be made compulsory for healthcare professionals. And only 21% agreed that the topic of Pharmacovigilance is well covered in pharmacy curriculum.
Conclusions: Pharmacy council of India, pharmacy teacher’s association and respective pharmacy college should take necessary steps to increase the knowledge and create awareness regarding pharmacovigilance and adverse drug reaction reporting among pharmacy students.