Group recruitment sessions enhance patient understanding in a small multi-centre phase III clinical trial.
Contemp Clin Trials
; 33(2): 286-90, 2012 Mar.
Article
en En
| MEDLINE
| ID: mdl-22101222
INTRODUCTION: There is continuing concern that patient information leaflets, tailored to current regulatory requirements, fail to meet patients' needs. Provision of comprehensible information is vital if patients are to provide valid informed consent. The design of the ARIX (acupuncture for radiation induced xerostomia) trial provided an opportunity to deliver researcher led, enhanced patient information to groups of potential participants. METHODS: Between November 2009 and September 2010, 149 patients attended a trial introduction meeting at their local site. All meetings followed the same format. The study coordinator delivered a PowerPoint presentation containing standard trial information together with customised local details. This was followed by group questions and answers. Patients could sign a consent form immediately afterwards or with local staff at a later date. Participants who completed the study were invited to feedback their views on these meetings. RESULTS: One hundred and forty nine patients attended a meeting of whom 116 ultimately participated in ARIX and provided feedback. Eighty four (72%) reported that the meeting helped their understanding of the trial 'very much'. Fourteen attendees reported feeling uncomfortable at having the information presented in a group setting but of these, only one felt under pressure to join the trial. Eighty three patients (71%) felt 'not at all' uncomfortable and 111 (95%) 'not at all' under pressure to participate. CONCLUSION: Trial introduction meetings involving researcher led presentation of information, followed by group discussion, can help enhance the information provided in the patient information leaflet in a useful and non coercive manner.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Traumatismos por Radiación
/
Revelación de la Verdad
/
Xerostomía
/
Terapia por Acupuntura
/
Selección de Paciente
/
Sujetos de Investigación
/
Consentimiento Informado
Tipo de estudio:
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Límite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Contemp Clin Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2012
Tipo del documento:
Article
País de afiliación:
Reino Unido
Pais de publicación:
Estados Unidos