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      Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

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          Abstract

          Recently, we have been noticing an increase in the emergence and re-emergence of microbial infectious diseases. In the previous 100 years, there were several incidences of pandemics caused by different microbial species like the influenza virus, human immunodeficiency virus (HIV), dengue virus, severe acute respiratory syndrome Coronavirus (SARS-CoV), middle east respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2 that were responsible for severe morbidity and mortality among humans. Moreover, non-communicable diseases, including malignancies, diabetes, heart, liver, kidney, and lung diseases, have been on the rise. The medical fraternity, people, and governments all need to improve their preparedness to effectively tackle health emergencies. Clinical research, therefore, assumes increased significance in the current world and may potentially be applied to manage human health-related problems. In the current review, we describe the critical aspects of clinical research that include research designs, types of study hypotheses, errors, types of sampling, ethical concerns, and informed consent.

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          A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19

          Abstract Background Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown. Methods We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days. Results We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage points (95% confidence interval, −7.0 to 2.2; P=0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. Conclusions After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.)
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            Introduction to systematic review and meta-analysis

            Systematic reviews and meta-analyses present results by combining and analyzing data from different studies conducted on similar research topics. In recent years, systematic reviews and meta-analyses have been actively performed in various fields including anesthesiology. These research methods are powerful tools that can overcome the difficulties in performing large-scale randomized controlled trials. However, the inclusion of studies with any biases or improperly assessed quality of evidence in systematic reviews and meta-analyses could yield misleading results. Therefore, various guidelines have been suggested for conducting systematic reviews and meta-analyses to help standardize them and improve their quality. Nonetheless, accepting the conclusions of many studies without understanding the meta-analysis can be dangerous. Therefore, this article provides an easy introduction to clinicians on performing and understanding meta-analyses.
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              Hypothesis testing, type I and type II errors

              Hypothesis testing is an important activity of empirical research and evidence-based medicine. A well worked up hypothesis is half the answer to the research question. For this, both knowledge of the subject derived from extensive review of the literature and working knowledge of basic statistical concepts are desirable. The present paper discusses the methods of working up a good hypothesis and statistical concepts of hypothesis testing.
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                Author and article information

                Journal
                Cureus
                Cureus
                2168-8184
                Cureus
                Cureus (Palo Alto (CA) )
                2168-8184
                4 January 2023
                January 2023
                : 15
                : 1
                : e33374
                Affiliations
                [1 ] Physiology, Department of Biomedical Sciences, Saint James School of Medicine, The Quarter, AIA
                [2 ] Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND
                [3 ] Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND
                Author notes
                Venkataramana Kandi ramana20021@ 123456gmail.com
                Article
                10.7759/cureus.33374
                9898800
                36751199
                c09bdbc9-8f97-41ea-9e33-68f105f3a0eb
                Copyright © 2023, Purna singh et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 4 January 2023
                Categories
                Medical Education
                Infectious Disease
                Public Health

                ethical concerns,informed consent,sampling types,study hypothesis,research designs,clinical research,pandemics,microbial infectious diseases,emergence and re-emergence

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