Brief Communication
Pharmacoepidemiology
Kourosh Zali
Abstract
The presence of a placebo arm is certainly a substantial element in randomized control trials (RCTs) because the effectiveness or efficacy of a new therapy can be evaluated through a direct comparison between the test treatment and the placebo arm. Conducting a placebo-controlled RCT is often very difficult ...
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The presence of a placebo arm is certainly a substantial element in randomized control trials (RCTs) because the effectiveness or efficacy of a new therapy can be evaluated through a direct comparison between the test treatment and the placebo arm. Conducting a placebo-controlled RCT is often very difficult or even impossible. To solve this problem, the availability of standard treatments and ethical concerns have led scientists to consider an active or positive control treatment as a comparator to assess the treatment effect without a placebo arm. Such an assessment is often made under a so-called “non-inferiority trial” (NIT) design. Non-inferiority margin (NIM) is the most important part of an NIT. Because there is no well-established method to determine the NIM, it is very important that this margin be pre-specified and the criteria for how it was established well defined prior to conducting the study. All methods of determination of NIM rely upon subjective judgment with unverifiable assumptions. This article demonstrates six simple methods to calculate NIM.
Original Article
COVID-19
Fazlollah Keshavarzi; Berry Wei Qi Ting; Betty Zhi Xin Tang; Kai Xin Chang; Fei San Chee; Kar Mey Chen
Abstract
Background. The worldwide economic impact of the COVID-19 pandemic is comparable with the largest disastrous events of modern human history, such as the first and second world wars. This study investigated the nationwide impact of the pandemic on the local Malaysian firms.Methods. A cross-sectional, ...
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Background. The worldwide economic impact of the COVID-19 pandemic is comparable with the largest disastrous events of modern human history, such as the first and second world wars. This study investigated the nationwide impact of the pandemic on the local Malaysian firms.Methods. A cross-sectional, online survey was carried out in East and West Malaysia by inviting the Malaysian firms’ executives to fill in a questionnaire that was adopted from previous similar studies in other countries. The final questionnaire included 16 questions distributed in three categories. The executives of firms were contacted through email and social media. SSPS was used to analyse the collected data.Results. A total of 379 responses were received. Nearly 42% of firms reported a small impact with some difficulties in business operations but overall stability. Approximately 32% of businesses were severely impacted, and operations were barely maintained. Six percent of the firms had no significant difficulties and 5.3% reported that the pandemic provided new opportunities for development.Conclusion. Almost one-third of the Malaysian firms are affected significantly by the COVID-19 pandemic. The business operation of half of the Malaysian firms is also affected to some extent. Supportive policies are needed to reduce the companies’ manufacturing costs and assist them in surviving and eventually returning to normal business operations.
Case-Report
COVID-19
Samira Zouhri; Mohcine El Baroudi
Abstract
A woman in her sixties with a normal medical history was admitted to a general medical floor with Neuropathic pain symptoms such as a burning sensation throughout her body (head, back, spine, throat, and tongue with dry mouth, chest, abdomen, kidneys, thighs, toes), inability to eat, urinary incontinence, ...
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A woman in her sixties with a normal medical history was admitted to a general medical floor with Neuropathic pain symptoms such as a burning sensation throughout her body (head, back, spine, throat, and tongue with dry mouth, chest, abdomen, kidneys, thighs, toes), inability to eat, urinary incontinence, difficulty wearing clothing, and difficulty leaning on the back. There was a difficulty and delay in diagnosing the patient's condition, which was confirmed to have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with no respiratory symptoms. The patient's pain did not respond to the covid-19's first-line medications, but it did respond to neuropathic medication with Pregabalin and Alprazolam. Our study shows that Pregabalin could be helpful in relieving the patient’s pain and very effective for treating neuropathic pain with a safe profile, unlike Alprazolam, which interferes with the same stages of sleep, which made her sleep condition worse.
