Protocol for a systematic scoping review of reasons given to justify the performance of randomised controlled trials.
BMJ Open
; 9(7): e027575, 2019 Jul 26.
Article
em En
| MEDLINE
| ID: mdl-31350242
ABSTRACT
INTRODUCTION:
Randomised controlled trials (RCTs) are widely viewed to generate the most reliable medical knowledge. However, RCTs are not always scientifically necessary and therefore not always ethical. Unfortunately, it is not clear when an RCT is not necessary or how this should be established. This study seeks to systematically catalogue justifications offered throughout the medical and ethics literature for performing randomisation within clinical trials. METHODS ANDANALYSIS:
We will systematically search electronic databases of the medical literature including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov; databases of philosophical literature including Philosopher's Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE, National Reference Centre for Bioethics; the library catalogue at the University of Ottawa; bibliographies of retrieved papers; and the grey literature. We will also pursue suggestions from experts in the fields of medical ethics, philosophy and clinical trial methodology. Article screening, selection and data extraction will be performed by two independent reviewers based on prespecified inclusion/exclusion criteria. A third reviewer will be consulted to resolve any discrepancies. We will then extract the reasons given to justify randomisation using methodology established to extract data in a defensible, systematic manner. We will track the reasons given, their frequency of use and changes over time. Finally, using grounded theory, we will combine the reasons into broader themes. These themes will form the foundation of our subsequent analysis from qualitative and quantitative perspectives. This review will map existing arguments that clinicians, ethicists and philosophers use to ethically justify randomisation in clinical trials. ETHICS AND DISSEMINATION No research ethics board approval is necessary because we are not examining patient-level data. This protocol complies with the reported guidance for conducting systematic scoping reviews. The findings of this paper will be disseminated via presentations and academic publication. In a subsequent phase of this research, we hope to engage with stakeholders and translate any recommendations derived from our findings into operational guidelines.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Editoração
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Conhecimentos, Atitudes e Prática em Saúde
/
Disseminação de Informação
Tipo de estudo:
Clinical_trials
/
Guideline
/
Qualitative_research
/
Systematic_reviews
Limite:
Humans
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Canadá