Randomized controlled trials: what are they and who needs them?

Dentistry is rapidly entering a new era of evidence‐based practice, and society is demanding prevention and treatment that has been proven to be effective in terms of meaningful health outcomes. Practitioners, individual patients and the public need randomized controlled trials because they provide...

Celý popis

Uloženo v:
Podrobná bibliografie
Vydáno v:Periodontology 2000 Ročník 59; číslo 1; s. 14 - 31
Hlavní autoři: Pihlstrom, Bruce L., Curran, Alice E., Voelker, Helen T., Kingman, Albert
Médium: Journal Article
Jazyk:angličtina
Vydáno: Oxford, UK Blackwell Publishing Ltd 01.06.2012
Témata:
Dental Care - standards
Dental Research - classification
Dental Research - standards
Evidence-Based Dentistry
Humans
Informed Consent
Patient Safety
Patient Selection
Randomized Controlled Trials as Topic - classification
Randomized Controlled Trials as Topic - standards
Research Design - standards
Treatment Outcome
ISSN:0906-6713, 1600-0757, 1600-0757
On-line přístup:Získat plný text
Tagy: Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
Popis
Shrnutí:Dentistry is rapidly entering a new era of evidence‐based practice, and society is demanding prevention and treatment that has been proven to be effective in terms of meaningful health outcomes. Practitioners, individual patients and the public need randomized controlled trials because they provide the highest level of scientific evidence to change clinical practice and inform public health policy. Well‐designed randomized controlled trials are conceptually simple but deceptively complex to design, implement and translate into clinical practice. Randomized controlled trials are fundamentally different from observational clinical research because they randomly assign volunteers to receive test or control interventions, they are prospective and the success of the test intervention is based on a meaningful clinical outcome that is specified before the trial begins. To be successful, randomized controlled trials must be carefully designed and powered to answer a specific question that will be generalizable to the population under study. Randomized controlled trials can be designed to evaluate efficacy, effectiveness, superiority, equivalence or noninferiority. Prominent issues and challenges in designing and conducting randomized controlled trials include carefully defining enrollment criteria, establishing an organizational infrastructure, use of a data‐coordinating center, developing a manual of procedures, obtaining informed consent, recruiting and ensuring the safety of volunteer subjects, ensuring data quality, analysis and publication of trial outcomes, and translating results into clinical practice.
Bibliografie:ark:/67375/WNG-P6W5RJ3X-L
ArticleID:PRD439
istex:D3A1234DB57FC441669232FCBEED4793BDECC8C4
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
ObjectType-Review-3
content type line 23
ISSN:0906-6713
1600-0757
1600-0757
DOI:10.1111/j.1600-0757.2011.00439.x