What does it take to deliver an international neurosurgical trial? Experiences from STICH II.
Br J Neurosurg
; 28(4): 461-6, 2014 Aug.
Article
em En
| MEDLINE
| ID: mdl-24205922
ABSTRACT
BACKGROUND AND PURPOSE:
When undertaking multicentre randomised controlled trials some obstacles cause a slower than required recruitment rate. This article discusses factors that affected the completion of the international neurosurgical trial STICH II, which took almost 6 years.METHODS:
We reviewed the following factors recruitment of participating sites, patient recruitment, patient screening, trial fatigue and maintenance of profile and maintenance of quality and standards. We discuss the practical strategies employed by the STICH II team to address these factors and optimise patient recruitment.CONCLUSION:
Although STICH II attained its final recruitment target, it took longer to complete than anticipated. Publishing and sharing the experiences of the STICH II trial team is an important step towards ensuring that other potential neurosurgical triallists are aware of the issues that can slow patient recruitment and strategies that can help to overcome them.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Seleção de Pacientes
/
Doenças do Sistema Nervoso
/
Neurocirurgia
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Humans
Idioma:
En
Revista:
Br J Neurosurg
Assunto da revista:
NEUROCIRURGIA
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Reino Unido