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This paper is a thorough analysis of Evaluating Safety and Effectiveness of Low-Dose Methotrexate at Reducing Inflammation in HIV-Infected Adults Taking Antiretroviral Medications article funded by National Institute of Allergy and Infectious Disease (NIAID), and National Heart, Lung, and Blood Institute (NHLBI).
The aim of the study under analysis is revealed in examining the security and efficiency of low-dose methotrexate at decreasing inflammation in people with HIV and rheumatoid arthritis. The target population of the research is adults suffering from HIV and at risk for cardiovascular diseases. Speaking of the type of clinical research, it should be noted that it is the interventional research. In other words, it is the epidemiological study that reflects the evaluation of the direct influence of treatment based on the collected data.
The research focuses on several data elements including demographic, clinical, and administrative data. Demographic data comprises people of both sexes of 40 years and older from the United States and Puerto Rico. Clinical data is represented by means of participants with HIV infection, who possess one or several following criteria: on permanent ART for 24 weeks or more, having HIV-1 RNA level, CD4 T-cell count greater than or equal to 400 cells/mm^3, postmenopausal female candidates, and others, and duration of the research. Administrative data includes the availability of the Monitoring Committee, responsible parties (NIAID and NHLBI), the information about study sponsor, investigators, and verification date (March 2016). In addition, such specific parameters as laboratory values are included.
The research began December 2013. However, it is currently recruiting people till June 2016.
It goes without saying that this is quantitative research as it comprises conducting various surveys based on clinical analysis that corresponds to a large number of respondents. The principal objective of the research is to obtain a numerical estimate of the issue and the reaction of respondents towards it. Speaking of the studied intervention, one might note methotrexate (MTX) drug (5 mg, 10 mg, and 15 mg capsules were given to patients in accordance with their peculiarities), placebo given in the same quantity as methotrexate, and Folic acid dietary supplement (1 tablet per day).
This research is undoubtedly significant as the number of HIV infected people growing as well as their concomitant diseases. In particular, the study focuses on cardiovascular problems of adults with HIV. Results of the research would contribute to the enhancement of patients’ living conditions. In order to collect required data, researchers invited people with described diseases and intervened in their treatment analyzing the outcome.
Clinical analyses could be provided by any U.S. laboratory with CLIA certification or its adequation. Menopausal candidates are eligible for the research in the case if they do not require using of contraceptives. Therapy must be finished at least 60 days before the study admission. The above are eligibility requirements of the research. Ethical issues pertaining to data seems to be appropriate and accurate as the study does not violate ethical principles of privacy of participants. Data security and confidentiality are ensured by the Monitoring Committee and investigators.
It is also very important to point out the fact that researches would be able to access the information all over the United States by means of using ClinicalTrials.gov identifier, particularly, NCT01949116. After collecting the information to one research, it would be possible to access it from one database due to the interoperability of health information systems.
The interoperability of health information systems impacts the study allowing remote health monitoring and remote diagnostics such as the electronic monitoring of patients or access to their clinical information. This progress occurred due to the wide spread of ICT, wireless capabilities, and comparative affordability of devices. The main tendency of health information systems focuses on public health rather than individuals’ level. The availability of standardized digital patient data provides unprecedented opportunities for data aggregation. In its turn, aggregated medical data provide a number of benefits for health care such as assistance for research in medicine, assessment of the effectiveness of pharmaceutical products as in this case, the provision of general information for patients who are interested in a particular treatment, and assistance for government’s monitoring general health conditions.
To ensure interoperability of health information systems, it is necessary to achieve standards of information and communication technologies (ICT) that would ensure personal privacy and security and address current needs of the developing world. Moreover, it seems helpful to introduce some applications based on the mobile telephony that are becoming more and more popular. For example, public communication during natural disasters or pandemics, self-education of patients concerning health issues, remote communication of doctors with a patient via mobile devices, and the remote collection of health data.
In conclusion, it should be stressed that analysis of the data that was made by researchers could be proved. It could not be easily argued and denied as there is evidence of it based on plenty of clinical analysis corresponding to several criteria. Therefore, the information presented in the article appears to be accurate and trustworthy.
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