فهرست مطالب

Health Technology Assessment in Action
Volume:4 Issue: 1, Aug 2020

  • تاریخ انتشار: 1399/08/10
  • تعداد عناوین: 6
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  • Afshin Ostovar, Elham Ehsani-Chimeh*, Zeynab Fakoorfard Page 1
    Introduction

     Coronavirus disease (COVID 19) has spread around the world since the beginning of 2020.  The definitive diagnosis of COVID19 is RT-PCR laboratory test. However because of low sensitivity, the use of the chest CT scan has become important for the rapid diagnosis and clinical decision-making. This study aims to define the diagnostic value of CT scans in the process of diagnosing COVID 19 in medical Centers.

    Methods

     This study is a rapid health technology assessment (HTA) and had two major phases. In Phase 1, Rapid review was done for defining sensitivity and specificity rate of CT. During this phase, studies related to the diagnostic and technical data on the use of CT in the diagnosis of COVID19 was reviewed and sensitivity and specificity of CT in these studies were extracted. In phase 2, sequential testing was run to evaluate the diagnostic value of chest CT to diagnose COVID 19 according to 2 scenarios before and after adding RT-PCR test result.

    Results

    CT scan has a high sensitivity to diagnosing cases of COVID 19. Due to its low specificity, relying on CT scan to diagnose COVID 19 alone in medical centers, can lead to a significant proportion of false positive cases. This Study showed if the probability of COVID 19 before the CT scan were about 50%, with a positive CT scan, this probability will be between 60 and 70% depending on the CT specificity.

    Conclusion

    With the available evidence, the use of CT scan lonely is not sufficient for diagnosis. The RT-PCR test is also necessary to improve the diagnosis and continue the process of treatment and isolation of patients.

    Keywords: COVID 19, CT scan, health technology assessment (HTA), RT-PCR test, Sensitivity, Specificity
  • Zahra Gharibnaseri, Alireza Olyaeemanesh * Page 2
    Introduction

    Remdesivir is an antiviral drug manufactured by Gilead Sciences, Inc., which in-vitro studies have shown positive results in controlling coronavirus infection. Therefore, this drug has been proposed as a possible effective option in the treatment of Covid-19, and although it has not yet received any approval from the countries’ pharmaceutical authorities and has not passed the first and second phases of clinical trials, it is prescribed on a trial basis for patients with Covid-19. Researchers in more than 20 countries are monitoring the results of using the drug in a clinical setting to prescribe Remdesivir to larger populations if patients respond positively.

    Materials and methods

    This article is a rapid review of health technology assessment studies that collects related articles by searching medical databases and tries to create a policy guide for Remdesivir through their analysis. The search was conducted on the MEDLINE and Cochrane Library database using keywords including drug name and disease name. The titles and abstracts of the articles were reviewed, and the studies were selected based on the inclusion and exclusion criteria. In addition, the list of related study references were reviewed and added to the study list in cases where a new related article was found. Inclusion criteria included: studies that examined the safety and efficacy of Remdesivir in the population of patients with Covid-19, studies in Persian or English, and all types of studies. The search of the mentioned databases was carried out on April 21, 2020. In order to identify ongoing clinical trials in Iran and some countries, clinical trial registration systems were also searched.

    Results

    After matching the inclusion and exclusion criteria on the search results, a cohort study was found that declared positive response of Remdesivir efficacy in compassionate use. The study has emphasized that due to design limitations, the results obtained on the efficacy of Remdesivir were not reliable, and only through randomized clinical trials sufficient confidence can be achieved. Among other search results, there were two studies on patients receiving this drug. There is also a letter to the editor that introduces Remdesivir as a good possible treatment for Covid-19. Most of the studies were review studies (25 studies), most of which reported on the course of treatment for Covid-19 disease and devoted part to Remdesivir position in the treatment of this disease. None of these studies were systematic reviews. Also, in search of clinical trial registration systems, 15 phases two and three clinical trials were found, as well as a retrospective observation study that assessed Remdesivir safety and efficacy. Of the 15 trials, 13 were in the patient recruitment phase, one was terminated early, and the other was suspended. The results of the terminated trial have been published in the Lancet journal . This study, which was the first clinical trial to be randomized and controlled with placebo, 237 patients were divided into two groups: placebo and Remdesivir groups. The results obtained on the 28th day of the trial show that; although the rate of recovery in the Remdesivir group was numerically better than the placebo group, this difference was not statistically significant and studies on a higher number of patients were needed to prove the significance of this difference. On the other hand, this drug has not been shown to reduce viral load in samples taken from the upper respiratory tract. This study also showed that the incidence of side effects in the group receiving the drug was higher than the control group. Twelve percent of patients in the Remdesivir group had to discontinue the drug due to serious side effects, while in the control group, it occurred in only 5 percent of patients. Despite the publication of the results of the trial and the ambiguity in the results of other clinical trials, the US Food and Drug Administration (FDA) issued a letter on May 1, 2020, in which it authorized Gilead to distribute its drug under an emergency use authorization (EUA). Under this license, Remdesivir is prescribed only for hospitalized patients with severe Covid-19, including those with SpO2≤94% and requiring supplemental oxygen or mechanical respiratory support, under the supervision of health care professionals and under strict EUA conditions.

    Conclusion

    Based on the results of this study, it was found that the evidence for certain decision about the safety and efficacy of Remdesivir in the treatment of Covid-19 is very limited, and only if clinical trials that have begun extensively in multiple countries are completed, a decision can be made to approve or reject the prescription. Due to the ambiguity in the efficacy of Remdesivir, its prescription in patients with Covid-19 has so far been limited to clinical trials, compassionate use, or emergency use.

  • Mahsa Dalili Shoaei, Meisam Dastani * Page 3

    In late 2019, the epidemic of COVID-19 (Coronavirus 2019) appeared in Wuhan, China, and rapidly spread around the world. Due to this situation, the use of social networks has increased among people. The present study is a narrative review to review studies conducted on the subject of social media and COVID-19 in the Web of Science database. The investigations show that social media has been used to share viewpoints, health care, and distance learning during the COVID-19 crisis. Therefore, governments and experts can use the useful experiences of the application of social media in the spread of the COVID-19 crisis and employ social media to prevent the spread of this epidemic and even in similar future crises.

    Keywords: Social Networks, Social Media, Outbreak, Crisis, COVID-19, Narrative Review
  • Elham Khatooni, Farzan Berenjian, Zhaleh Abdi * Page 4
    Introduction

     The corona virus disease (COVID-19) 2019 pandemic has resulted in significant morbidity and mortality around the world and led to serious challenges for health systems. To date, there are no medical treatments for COVID-19 with proven effectiveness. To treat COVID-19 patients a wide range of existing antibiotics, such as Hydroxychloroquine(HCQ) and chloroquine(CQ), have been recommended as potential treatment. This study is a rapid systematic review aimed to identify and summarize evidence on efficacy and safety of HCQ and CQ for COVID-19 infection.

    Methodology

     This study is a rapid systematic review that that systematically searches electronic databases including PubMed, EMBASE, ClinicalTrials.gov, Cochrane Library till 22 May 2020. Peer-reviewed Randomized clinical trials, reviews and observational studies that investigated efficacy and safety of HCQ and CQ for prevention and treatment of COVID-19 infection were included. Other types of studies, including case reports, physician's opinion, commentaries and letter to the editors were excluded.

    Findings

     There were 7 review articles, five clinical trial studies, and 8 observational studies focusing on CQ or HCQ to treat COVID-19 patients. Of five clinical trial included, three showed favorable outcomes among patients received CQ or HCQ. One of them reported no change compared to control group. Another one suggested that high doses of CQ especially in combination with other drugs such as Azithromycin and Oselatamivir should not be recommended for older patients due to risks associated with its safety. Eight observational studies were included in our review, of which 4 studies concluded that there is no difference between the use of HCQ or combination of HCQ and Azithromycin with other medications. Three studies showed that administration of a combination of HCQ and Azithromycin or HCQ alone is associated with improved clinical outcomes. One study investigated the side effects associated with administration of HCQ and azithromycin together. It concluded that the combination of HCQ and Azithromycin significantly prolongs the QT interval in patients with COVID-19.

    Conclusion

    The included studies reported conflicting results on the efficacy and safety HCQ and CQ in treating COVID-19. Therefore, it seems there are not sufficient evidence about the effectiveness and safety of HCQ and CQ to treat patients with COVID-19 and more studies, which also report long-term follow up results, are needed.

  • Mohammad Reza Mobinizadeh *, Morteza Arab-Zozani Page 5
    Introduction

     Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) appeared for the first time in December 2019 in Wuhan, China. Due to the lack of unified and integrated evidence for favipiravir, this study was conducted with the aim of rapid reviewing the existing evidence to help evidence-based decision-making on the therapeutic potential of this drug in the treatment of COVID-19 patients.

    Methods

     This study is a rapid health technology assessment (HTA). By searching pertinent databases, the research team collected relevant articles and tried to create a policy guide through a thematic approach. This rapid review was done in four steps: 1) searching for evidence through databases, 2) screening the evidence considering eligibility criteria, 3) data extraction, and 4) analyzing the data through thematic analysis.

    Results

     After applying the entry criteria, four studies were finally found (a clinical trial that "the publisher temporarily removed the article from the journal's site" and three review studies). After searching the sources mentioned in the mentioned articles, two ongoing clinical trials were found in China. Also, by searching the clinical trial site, www.clinicaltrials.gov, five clinical trial studies were found during the search. The result of the search in the clinical trial registration system in Iran was a study that is in the process of patient’s recruiting. A limited number of other articles have been found, mostly in the form of reflections from physicians or researchers and letters to the editors who have predicted the drug's performance on the SARS-CoV-2 virus, which needs further clinical study for being approved

    Conclusion

    With the available evidence, it is not possible to make a definite conclusion about the safety and efficacy of this drug in the treatment of patients with COVID-19.