Demographic and health factors associated with enrollment in posttrial studies: the Women's Health Initiative Hormone Therapy Trials.
Clin Trials
; 10(3): 463-72, 2013.
Article
en En
| MEDLINE
| ID: mdl-23480899
ABSTRACT
BACKGROUND:
After clinical trials end, continued follow-up of the assembled cohort often is desirable for additional research. Factors influencing participants' decisions to consent to additional follow-up and how these shape posttrial cohorts have not been broadly studied.PURPOSE:
We examined how two re-enrollment campaigns and the passage of time altered features of the posttrial cohorts compared with the original Women's Health Initiative (WHI) Hormone Therapy clinical trials.METHODS:
We examined associations that markers of sociodemography, health, lifestyle, and on-trial experiences had with re-enrollment and contrasted the characteristics of successive posttrial cohorts with those of the original enrollees.RESULTS:
The posttrial enrollment campaigns re-enrolled 81.1% and 82.5% of available women, respectively. Women who re-enrolled tended to have better health characteristics than those not re-enrolled. Compared to women of comparable age in the original cohort, women retained for the second posttrial follow-up less often had a history of cardiovascular disease (odds ratio (OR) = 0.36), hypertension (OR = 0.57), diabetes (OR = 0.59), or measured cognitive deficit (OR = 0.40). These women more often had graduated from high school (OR = 1.72) and had participated in other WHI trials (OR = 1.76).LIMITATIONS:
We have examined experience with creating follow-up cohorts from participants in a single study. Thus, our findings may not apply to other cohorts and protocols.CONCLUSIONS:
Posttrial enrollment in follow-up studies can be successful; however, the characteristics of the resulting cohort may differ substantially from the originally assembled group of trial participants. Collection during the original trial of potential predictors of differential re-enrollment may strengthen interpretation of findings.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Estudios de Cohortes
/
Ensayos Clínicos como Asunto
/
Selección de Paciente
/
Terapia de Reemplazo de Hormonas
/
Negativa a Participar
Tipo de estudio:
Etiology_studies
/
Guideline
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Aged
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
Clin Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2013
Tipo del documento:
Article
País de afiliación:
Estados Unidos