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Origin ID
QR325
Preferred Label
intervention study
étude d'interventionCategory label
Intervention studyEtude d'interventionQ-Code supplementary keywords
clinical trialnon-randomized clinical trialrandomized clinical trialessai cliniqueQ-Code acronym
RCTQ-Code scope note
an investigation involving intentional change in some aspect of the status of the subjects, e.g., introduction of a preventive or therapeutic regimen or an intervention designed to test a hypothesized relationship; usually an experiment such as a randomized controlled trial. (Dicepid)une enquête impliquant le changement intentionnel dans certains aspects de l'état des sujets, par exemple, l'introduction d'un régime préventif ou thérapeutique ou une intervention visant à tester une relation hypothétique; habituellement une expérience comme un essai contrôlé randomisé. (Dicepid)Q-Code conceptual content
Adaptive Clinical Trial (Pub Type) "Clinical study in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study. (MeSH 2018)Adaptive Clinical Trials as Topic ; Works about clinical studies in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study. (MeSH 2018)clinical trial (Syn: therapeutic trial) ; A research activity that involves the administration of a test regimen to humans to evaluate its efficacy or its effectiveness and safety. The term is broadly polysemic: meanings include from the first test of a drug in humans without any control treatment to a rigorously designed randomized controlled trial. Four phases of clinical trials or types of trials are distinguished: Phase I trial It is the first test of a drug (or a candidate vaccine) in a small group of humans to determine its safety and mode of action. It usually involves a relatively small number of healthy volunteers. The focus is on safety and pharmacological profiles; it may also assess dose and route of administration. Phase II trial Pilot efficacy studies. Initial trial to examine efficacy, usually in volunteers; with vaccines, the focus is on immunogenicity, and with drugs, on demonstration of safety and efficacy in comparison to existing regimens. Usually but not always, subjects are randomly allocated to the study and control groups. Phase III trial Extensive clinical trial. This phase is intended for complete assessment of safety and efficacy. It commonly involves large numbers of patients with the disease or condition of interest, sometimes thousands; it uses random allocation to study and control groups. Phase IV trial Postmarketing clinical trial. Conducted after the regulatory authority has approved registration and marketing begins. The common aim is to estimate the incidence of rare adverse reactions and other potential effects of long-term use in real life; it may also uncover potentially new uses and indications.(Dicepid)CLINICAL TRIAL ; a research which involves a test regime followed by patients intended to evaluate its efficacy and safety. The term is subject to a wide variation in usage. (Woncadic)Clinical Trial [Publication Type]A work that reports on the results of a clinical study in which participants are assigned to receive one or more interventions so that researchers can evaluate the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. While most clinical trials concern humans, this publication type may be used for clinical veterinary articles meeting the requisites for humans. (MeSH)Clinical trial, phases ; sequential stages of clinical testing, required by regulatory agencies, used in the development of medical treatments. Pre-clinical testing involves experiments on animals or cells to estimate safety and potential efficacy. Phase I trials are small studies (50-100 subjects) conducted in human beings for the first time to assess safety, pharmacology, or dosing. Phase I studies are usually conducted on healthy volunteers though some are conducted on patients with terminal diseases, such as cancer patients. Phase II trials are larger studies (500 or more subjects) conducted on patients with a disease to assess safety and efficacy and establish a therapeutic dose. Phase III trials are large studies (up to several thousand subjects) conducted on patients to obtain more information on safety and efficacy. Phase IV (or post-marketing) studies are conducted after a treatment has been approved for marketing to gather more information on safety and efficacy and to expand the range of the population being treated.(NIEHS)Clinical Trials as Topic ; Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries(MeSH)Controlled Clinical Trial [Publication Type] ; A work that reports on a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL. (MeSH)DOUBLE-BLIND TRIAL ; a trial involving two study groups, one receiving active drug the other placebo, where neither the patients nor the clinicians know which is which. This eliminates bias from the assessment of the results of the trial. (Woncadic)intervention study ; An investigation involving intentional change in some aspect of the status of the subjects, e.g., introduction of a preventive or therapeutic regimen or an intervention designed to test a hypothesized relationship; usually an experiment such as a randomized controlled trial. (Dicepid)Non-Randomized Controlled Trials as Topic A study where participants are assigned to a treatment, procedure, or intervention my methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.(MeSH)Pragmatic Clinical Trial [Publication Type] Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts. (MeSH)RANDOMIZED CONTROLLED TRIAL (RCT) (Syn. Controlled Clinical Trial (CCT)) ;an epidemiologic experiment in which subjects in a population are randomly allocated into groups, usually called "study" and "control" groups, to receive or not receive an experimental, preventive, or therapeutic procedure, manoeuvre, or intervention. Randomized, controlled trials are generally regarded as the most scientifically rigorous method available in medical research. (Woncadic)Randomized Controlled Trial [Publication Type] A work that reports on a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. (MeSH)Bibliographic link
Citation
Heather N. The efficacy-effectiveness distinction in trials of alcohol brief intervention. Addiction science & clinical practice. 2014; 9: 13. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25127717
Hummers-Pradier E, Bleidorn J, Schmiemann G, Joos S, Becker A, Altiner A, Chenot JF, Scherer M, null. General practice-based clinical trials in Germany - a problem analysis. Trials. 2012; 13: 205. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23136890
Nordmann AJ, Kasenda B, Briel M. Meta-analyses: what they can and cannot do. Swiss medical weekly. 2012; 142: w13518. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22407741
Unverzagt S, Peinemann F, Oemler M, Braun K, Klement A. Meta-regression analyses to explain statistical heterogeneity in a systematic review of strategies for guideline implementation in primary health care. PloS one. 2014; 9(10): e110619. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25343450
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