Surrogate and patient discrepancy regarding consent for critical care research.
Crit Care Med
; 40(9): 2590-4, 2012 Sep.
Article
en En
| MEDLINE
| ID: mdl-22732283
ABSTRACT
OBJECTIVE:
Critically ill patients frequently display impaired decision-making capacity due to their underlying illness and the use of sedating medications. Healthcare providers often rely on surrogates to make decisions for medical care and participation in clinical research. However, the accuracy of surrogate decisions for a variety of critical care research studies is poorly understood.DESIGN:
Cross-sectional observational study.SETTING:
Academic medical center. PATIENTS Medical intensive care unit patients and their designated surrogates. INTERVENTION Patients were asked whether they would consent to participate in hypothetical research studies of increasing complexity, and surrogates independently indicated whether they would consent to enroll the patient in the same scenarios.RESULTS:
Overall, 69 medical intensive care unit patients were enrolled into the study. The majority of surrogates were either the spouse (58%) or parent (22%) of the patient. The percentage of patients that would agree to participate in a research study and the percentage of surrogates that would agree to have the patient enrolled into a research study both declined as the risk of the study increased (p < .001 for both analyses). In addition, the overall discrepancy, the false-negative rates, and the false-positive rates between patient and surrogates were greater as the risk of the study increased (p < .001, p < .001, and p = .049, respectively). κ values for all seven scenarios demonstrated less-than-moderate agreement (range 0.03-0.41).CONCLUSIONS:
There are significant discrepancies in the willingness to participate in various types of clinical research proposals between critically ill patients and their surrogate decision makers. The results of this study raise concerns about the use of surrogate consent for inclusion of critically ill patients into research protocols.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Consentimiento por Terceros
/
Toma de Decisiones
/
Investigación Biomédica
/
Prioridad del Paciente
/
Consentimiento Informado
/
Unidades de Cuidados Intensivos
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prevalence_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Crit Care Med
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos