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Comparison of outcomes of the 50-year follow-up of a randomized trial assessed by study questionnaire and by data linkage: The CONCUR study.
Shahbaz, Mohammad; Harding, Jane E; Milne, Barry; Walters, Anthony; Underwood, Lisa; von Randow, Martin; Xu, Lois; Gamble, Greg D.
Afiliación
  • Shahbaz M; Liggins Institute, The University of Auckland, Auckland, New Zealand.
  • Harding JE; Liggins Institute, The University of Auckland, Auckland, New Zealand.
  • Milne B; Centre of Methods and Policy Application in Social Sciences, The University of Auckland, Auckland, New Zealand.
  • Walters A; Liggins Institute, The University of Auckland, Auckland, New Zealand.
  • Underwood L; Centre of Methods and Policy Application in Social Sciences, The University of Auckland, Auckland, New Zealand.
  • von Randow M; Centre of Methods and Policy Application in Social Sciences, The University of Auckland, Auckland, New Zealand.
  • Xu L; Centre of Methods and Policy Application in Social Sciences, The University of Auckland, Auckland, New Zealand.
  • Gamble GD; Liggins Institute, The University of Auckland, Auckland, New Zealand.
Clin Trials ; : 17407745241259088, 2024 Jun 22.
Article en En | MEDLINE | ID: mdl-38907609
ABSTRACT
BACKGROUND/

AIMS:

Self-reported questionnaires on health status after randomized trials can be time-consuming, costly, and potentially unreliable. Administrative data sets may provide cost-effective, less biased information, but it is uncertain how administrative and self-reported data compare to identify chronic conditions in a New Zealand cohort. This study aimed to determine whether record linkage could replace self-reported questionnaires to identify chronic conditions that were the outcomes of interest for trial follow-up.

METHODS:

Participants in 50-year follow-up of a randomized trial were asked to complete a questionnaire and to consent to accessing administrative data. The proportion of participants with diabetes, pre-diabetes, hyperlipidaemia, hypertension, mental health disorders, and asthma was calculated using each data source and agreement between data sources assessed.

RESULTS:

Participants were aged 49 years (SD = 1, n = 424, 50% male). Agreement between questionnaire and administrative data was slight for pre-diabetes (kappa = 0.10), fair for hyperlipidaemia (kappa = 0.27), substantial for diabetes (kappa = 0.65), and moderate for other conditions (all kappa >0.42). Administrative data alone identified two to three times more cases than the questionnaire for all outcomes except hypertension and mental health disorders, where the questionnaire alone identified one to two times more cases than administrative data. Combining all sources increased case detection for all outcomes.

CONCLUSIONS:

A combination of questionnaire, pharmaceutical, and laboratory data with expert panel review were required to identify participants with chronic conditions of interest in this follow-up of a clinical trial.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Nueva Zelanda Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Nueva Zelanda Pais de publicación: Reino Unido