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 [1] and an explanation and elaboration article [2] 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. [3]
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, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published articles. [4]
There are many extensions to the STROBE Statement which cover a variety of different topic domains such as nutritional epidemiology, [5] [6] [7] genetic association studies, [8] rheumatology, [9] [10] molecular epidemiology, [11] infectious disease molecular epidemiology, [12] respondent-driven sampling, [13] routinely collected health data [14] [15] (e.g., health administrative data, electronic health records, and registry data), antimicrobial stewardship programs, [16] seroepidemiologic studies for influenza, [17] medical abortion, simulation-based research, newborn infection, [18] veterinary, [19] and sports injury and illness.
A draft checklist for reporting observational studies in conference abstracts is also available. [20]
In 2010, three years after STROBE's publication, the original creators reconvened and deemed an update unnecessary at the time. [21] However, since, calls have supported for the reporting guideline to be updated, similarly to other reporting guidelines (like CONSORT and PRISMA) which have been updated as needed. An assessment of extension content [22] as well as a survey of authors of observational studies [23] [24] provided several areas to improve upon.
The STROBE Statement checklist is also available to use within a Writing Aid Tool [25] [26] add-in for Microsoft Word that includes the STROBE checklist within the software.
The STROBE Statement has also been adapted as a public, open-source repository for epidemiological research methods and reporting skills for observational studies. Epidemiologists, statisticians, and public health researchers are able to comment and edit the tool to inform future updates of the reporting guideline. [27]
A randomized controlled trial 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.
Cochrane is a British international charitable organisation formed to synthesize medical research findings to facilitate evidence-based choices about health interventions involving health professionals, patients and policy makers. It includes 53 review groups that are based at research institutions worldwide. Cochrane has approximately 30,000 volunteer experts from around the world.
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints.
The Mediterranean diet is a diet inspired by the eating habits and traditional food typical of southern Spain, southern Italy, and Crete, and formulated in the early 1960s. It is distinct from Mediterranean cuisine, which covers the actual cuisines of the Mediterranean countries. While inspired by a specific time and place, the "Mediterranean diet" was later refined based on the results of multiple scientific studies.
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, critically appraises and summarizes interpretations into a refined evidence-based conclusion. For example, a systematic review of randomized controlled trials is a way of summarizing and implementing evidence-based medicine.
A hierarchy of evidence, comprising levels of evidence (LOEs), that is, evidence levels (ELs), is a heuristic used to rank the relative strength of results obtained from experimental research, especially medical research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study and the endpoints measured affect the strength of the evidence. In clinical research, the best evidence for treatment efficacy is mainly from meta-analyses of randomized controlled trials (RCTs). Systematic reviews of completed, high-quality randomized controlled trials – such as those published by the Cochrane Collaboration – rank the same as systematic review of completed high-quality observational studies in regard to the study of side effects. Evidence hierarchies are often applied in evidence-based practices and are integral to evidence-based medicine (EBM).
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes.
In epidemiology, reporting bias is defined as "selective revealing or suppression of information" by subjects. In artificial intelligence research, the term reporting bias is used to refer to people's tendency to under-report all the information available.
In epidemiology, Mendelian randomization is a method using measured variation in genes to examine the causal effect of an exposure on an outcome. Under key assumptions, the design reduces both reverse causation and confounding, which often substantially impede or mislead the interpretation of results from epidemiological studies.
Consolidated Standards of Reporting Trials (CONSORT) 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.
Molecular epidemiology is a branch of epidemiology and medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations. This field has emerged from the integration of molecular biology into traditional epidemiological research. Molecular epidemiology improves our understanding of the pathogenesis of disease by identifying specific pathways, molecules and genes that influence the risk of developing disease. More broadly, it seeks to establish understanding of how the interactions between genetic traits and environmental exposures result in disease.
A prospective cohort study is a longitudinal cohort study that follows over time a group of similar individuals (cohorts) who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome. For example, one might follow a cohort of middle-aged truck drivers who vary in terms of smoking habits, to test the hypothesis that the 20-year incidence rate of lung cancer will be highest among heavy smokers, followed by moderate smokers, and then nonsmokers.
Peter Christian Gøtzsche is a Danish physician, medical researcher, and former leader of the Nordic Cochrane Center at Rigshospitalet in Copenhagen, Denmark. He is a co-founder of the Cochrane Collaboration and has written numerous reviews for the organization. His membership in Cochrane was terminated by its Governing Board of Trustees on 25 September 2018.
John P. A. Ioannidis is a Greek-American physician-scientist, writer and Stanford University professor who has made contributions to evidence-based medicine, epidemiology, and clinical research. Ioannidis studies scientific research itself, meta-research primarily in clinical medicine and the social sciences.
Critical appraisal in evidence based medicine, is the use of explicit, transparent methods to assess the data in published research, applying the rules of evidence to factors such as internal validity, adherence to reporting standards, conclusions, generalizability and risk-of-bias. Critical appraisal methods form a central part of the systematic review process. They are used in evidence synthesis to assist clinical decision-making, and are increasingly used in evidence-based social care and education provision.
The Enhancing the Quality and Transparency of health research Network is an international initiative aimed at promoting transparent and accurate reporting of health research studies to enhance the value and reliability of medical research literature. The EQUATOR Network was established with the goals of raising awareness of the importance of good reporting of research, assisting in the development, dissemination and implementation of reporting guidelines for different types of study designs, monitoring the status of the quality of reporting of research studies in the health sciences literature, and conducting research relating to issues that impact the quality of reporting of health research studies. The Network acts as an "umbrella" organisation, bringing together developers of reporting guidelines, medical journal editors and peer reviewers, research funding bodies, and other key stakeholders with a mutual interest in improving the quality of research publications and research itself. The EQUATOR Network comprises four centres at the University of Oxford, Bond University, Paris Descartes University, and Ottawa Hospital Research Institute.
PRISMA 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.
Cynthia Mulrow is an American physician and scholar from Edinburg, Texas. She has regularly contributed academic research on many topics to the medical community. Her academic work mainly focuses on systematic reviews and evidence reports, research methodology, and chronic medical conditions.
The GRADE approach is a method of assessing the certainty in evidence and the strength of recommendations in health care. It provides a structured and transparent evaluation of the importance of outcomes of alternative management strategies, acknowledgment of patients and the public values and preferences, and comprehensive criteria for downgrading and upgrading certainty in evidence. It has important implications for those summarizing evidence for systematic reviews, health technology assessments, and clinical practice guidelines as well as other decision makers.
Allegiance bias in behavioral sciences is a bias resulted from the investigator's or researcher's allegiance to a specific school of thought. Researchers/investigators have been exposed to many types of branches of psychology or schools of thought. Naturally they adopt a school or branch that fits with their paradigm of thinking. More specifically, allegiance bias is when this leads therapists, researchers, etc. believing that their school of thought or treatment is superior to others. Their superior belief to these certain schools of thought can bias their research in effective treatments trials or investigative situations leading to allegiance bias. Reason being is that they may have devoted their thinking to certain treatments they have seen work in their past experiences. This can lead to errors in interpreting the results of their research. Their “pledge” to stay within their own paradigm of thinking may affect their ability to find more effective treatments to help the patient or situation they are investigating.