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Consolidated Standards Of Reporting Trials
CONSORT (Consolidated Standards Of Reporting Trials) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials. It is part of the larger EQUATOR Network initiative to enhance the transparency and accuracy of reporting in research. The CONSORT Statement The main product of the CONSORT Group is the CONSORT Statement,Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar23;340:c332 which is an evidence-based, minimum set of recommendations for reporting randomized trials. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation. The most recent version of the Statement—the CONSORT 2010 Statement—consists of a 25-it ...
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Randomized Controlled Trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'experime ...
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California
California is a state in the Western United States, located along the Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the most populous U.S. state and the 3rd largest by area. It is also the most populated subnational entity in North America and the 34th most populous in the world. The Greater Los Angeles area and the San Francisco Bay Area are the nation's second and fifth most populous urban regions respectively, with the former having more than 18.7million residents and the latter having over 9.6million. Sacramento is the state's capital, while Los Angeles is the most populous city in the state and the second most populous city in the country. San Francisco is the second most densely populated major city in the country. Los Angeles County is the country's most populous, while San Bernardino County is the largest county by area in the country. California borders Oregon to the north, Nevada and Arizona to the ea ...
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Quality Assurance
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to ensure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a ''shift left'' since it focuses on quality eff ...
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Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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Strengthening The Reporting Of Observational Studies In Epidemiology
The STROBE ''(STrengthening the Reporting of OBservational studies in Epidemiology)'' Statement is a reporting guideline including a checklist of 22 items that are considered essential for good reporting of observational studies. It was published simultaneously in several leading biomedical journals in October and November 2007 and comprises both the checklist and an explanation and elaboration article which gives examples of good reporting and provides authors with more guidance on good reporting. It is also referred to in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals established by the International Committee of Medical Journal Editors and is endorsed by hundreds of biomedical journals. Purpose ''The STROBE Statement was developed by the STROBE Initiative, an international collaboration of epidemiologists, methodologists, statisticians, researchers and journal editors with the aim to assist authors when writing up analytical observational studies, ...
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Metascience
Metascience (also known as meta-research) is the use of scientific methodology to study science itself. Metascience seeks to increase the quality of scientific research while reducing inefficiency. It is also known as "''research on research''" and "''the science of science''", as it uses research methods to study how research is done and find where improvements can be made. Metascience concerns itself with all fields of research and has been described as "a bird's eye view of science". In the words of John Ioannidis, "Science is the best thing that has happened to human beings ... but we can do it better." In 1966, an early meta-research paper examined the statistical methods of 295 papers published in ten high-profile medical journals. It found that "in almost 73% of the reports read ... conclusions were drawn when the justification for these conclusions was invalid." Meta-research in the following decades found many methodological flaws, inefficiencies, and poor practices ...
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Preferred Reporting Items For Systematic Reviews And Meta-Analyses
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care intervention. PRISMA focuses on ways in which authors can ensure a transparent and complete reporting of this type of research. The PRISMA standard superseded the earlier QUOROM standard. It offers the replicability of a systematic literature review. Researchers have to figure out research objectives that answer the research question, states the keywords, a set of exclusion and inclusion criteria. In the review stage, relevant articles were searched, irrelevant ones are removed. Articles are analyzed according to some pre-defined categories. The PRISMA statement The aim of the PRISMA statement is to help authors improve the reporting of systematic reviews and meta-analyses. PRISMA has mainly focused o ...
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Systematic Review
A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on the topic, then analyzes, describes, and summarizes interpretations into a refined conclusion. For example, a systematic review of randomized controlled trials is a way of summarizing and implementing evidence-based medicine. While a systematic review may be applied in the biomedical or health care context, it may also be used where an assessment of a precisely defined subject can advance understanding in a field of research. A systematic review may examine clinical tests, public health interventions, environmental interventions, social interventions, adverse effects, qualitative evidence syntheses, methodological reviews, policy reviews, and economic evaluations. An understanding of systematic reviews and how to implement them in prac ...
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Uniform Requirements For Manuscripts Submitted To Biomedical Journals
The ICMJE recommendations (full title, "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals") are a set of guidelines produced by the International Committee of Medical Journal Editors for standardising the ethics, preparation and formatting of manuscripts submitted to biomedical journals for publication. Compliance with the ICMJE recommendations is required by most leading biomedical journals. Levels of real compliance are subject to debate. As of 9 January 2020, 5570 journals worldwide claim to follow the ICMJE recommendations.International Committee of Medical Journal Editors. Journals that have Requested Inclusion on the List of Publications that follow the ICMJE's Uniform Requirements For Manuscripts Submitted to Biomedical Journals omepage on the Internet Philadelphia: ICMJE; c2005 pdated 27 May 2006; cited 30 May 2006 Available fromhttp://www.icmje.org/journals.html/ref> The recommendations were first issued in 1979 un ...
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New England Journal Of Medicine
''The New England Journal of Medicine'' (''NEJM'') is a weekly medical journal published by the Massachusetts Medical Society. It is among the most prestigious peer-reviewed medical journals as well as the oldest continuously published one. History In September 1811, John Collins Warren, a Boston physician, along with James Jackson, submitted a formal prospectus to establish the ''New England Journal of Medicine and Surgery and Collateral Branches of Science'' as a medical and philosophical journal. Subsequently, the first issue of the ''New England Journal of Medicine and Surgery and the Collateral Branches of Medical Science'' was published in January 1812. The journal was published quarterly. In 1823, another publication, the ''Boston Medical Intelligencer'', appeared under the editorship of Jerome V. C. Smith. The editors of the ''New England Journal of Medicine and Surgery and the Collateral Branches of Medical Science'' purchased the weekly ''Intelligencer'' for $600 in ...
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British Medical Journal
''The BMJ'' is a weekly peer-reviewed medical trade journal, published by the trade union the British Medical Association (BMA). ''The BMJ'' has editorial freedom from the BMA. It is one of the world's oldest general medical journals. Originally called the ''British Medical Journal'', the title was officially shortened to ''BMJ'' in 1988, and then changed to ''The BMJ'' in 2014. The journal is published by BMJ Publishing Group Ltd, a subsidiary of the British Medical Association (BMA). The editor-in-chief of ''The BMJ'' is Kamran Abbasi, who was appointed in January 2022. History The journal began publishing on 3 October 1840 as the ''Provincial Medical and Surgical Journal'' and quickly attracted the attention of physicians around the world through its publication of high-impact original research articles and unique case reports. The ''BMJ''s first editors were P. Hennis Green, lecturer on the diseases of children at the Hunterian School of Medicine, who also was its f ...
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The Lancet
''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles, review articles ("seminars" and "reviews"), editorials, book reviews, correspondence, as well as news features and case reports. ''The Lancet'' has been owned by Elsevier since 1991, and its editor-in-chief since 1995 has been Richard Horton. The journal has editorial offices in London, New York City, and Beijing. History ''The Lancet'' was founded in 1823 by Thomas Wakley, an English surgeon who named it after the surgical instrument called a lancet (scalpel). Members of the Wakley family retained editorship of the journal until 1908. In 1921, ''The Lancet'' was acquired by Hodder & Stoughton. Elsevier acquired ''The Lancet'' from Hodder & Stoughton in 1991. Impact According to the ''Journal Citation Reports'', the journal has a 2 ...
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