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Medicine utilization studies in Australian individual-level dispensing data: A blinded, multi-center replicated analysis.
Gillies, Malcolm B; Bharat, Chrianna; Camacho, Ximena; Daniels, Benjamin; Hall, Kelly; Kelly, Thu-Lan; Kelty, Erin; Lin, Jialing; Litchfield, Melisa; Lopez, Derrick; Noghrehchi, Firouzeh; Raubenheimer, Jacques; Varney, Bianca; Pratt, Nicole.
Afiliación
  • Gillies MB; Medicines Intelligence Research Program, School of Population Health, UNSW Sydney, Kensington, Australia.
  • Bharat C; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Camacho X; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Daniels B; National Drug and Alcohol Research Centre, UNSW Sydney, Kensington, Australia.
  • Hall K; Medicines Intelligence Research Program, School of Population Health, UNSW Sydney, Kensington, Australia.
  • Kelly TL; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Kelty E; Medicines Intelligence Research Program, School of Population Health, UNSW Sydney, Kensington, Australia.
  • Lin J; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Litchfield M; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Lopez D; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, Australia.
  • Noghrehchi F; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Raubenheimer J; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, Australia.
  • Varney B; Methods and Data Working Group, NHMRC Centre of Research Excellence in Medicines Intelligence, University of South Australia, University of New South Wales, University of Sydney, University of Western Australia, Australia.
  • Pratt N; School of Population and Global Health, University of Western Australia, Perth, Australia.
Pharmacoepidemiol Drug Saf ; 33(3): e5776, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38479400
ABSTRACT

PURPOSE:

Medicine dispensing data require extensive preparation when used for research and decisions during this process may lead to results that do not replicate between independent studies. We conducted an experiment to examine the impact of these decisions on results of a study measuring discontinuation, intensification, and switching in a cohort of patients initiating metformin.

METHODS:

Four Australian sites independently developed a HARmonized Protocol template to Enhance Reproducibility (HARPER) protocol and executed their analyses using the Australian Pharmaceutical Benefits Scheme 10% sample dataset. Each site calculated cohort size and demographics and measured treatment events including discontinuation, switch to another diabetes medicine, and intensification (addition of another diabetes medicine). Time to event and hazard ratios for associations between cohort characteristics and each event were also calculated. Concordance was assessed by measuring deviations from the calculated median of each value across the sites.

RESULTS:

Good agreement was found across sites for the number of initiators (median 53 127, range 51 848-55 273), gender (56.9% female, range 56.8%-57.1%) and age group. Each site employed different methods for estimating days supply and used different operational definitions for the treatment events. Consequently, poor agreement was found for incidence of discontinuation (median 55%, range 34%-67%), switching (median 3.5%, range 1%-7%), intensification (median 8%, range 5%-12%), time to event estimates and hazard ratios.

CONCLUSIONS:

Differences in analytical decisions when deriving exposure from dispensing data affect replicability. Detailed analytical protocols, such as HARPER, are critical for transparency of operational definitions and interpretations of key study parameters.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Diabetes Mellitus / Metformina Límite: Female / Humans / Male País/Región como asunto: Oceania Idioma: En Revista: Pharmacoepidemiol Drug Saf Asunto de la revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Australia
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Diabetes Mellitus / Metformina Límite: Female / Humans / Male País/Región como asunto: Oceania Idioma: En Revista: Pharmacoepidemiol Drug Saf Asunto de la revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Australia