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External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?
External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?
Aims: to describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results.

Methods: a literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180 590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined.

Results: seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone.

Conclusions: we found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population
0742-3071
300-308
Saunders, C.
38a38da8-1eb3-47a8-80bc-b9cbb43f26e3
Byrne, Christopher D.
1370b997-cead-4229-83a7-53301ed2a43c
Guthrie, B.
e1c75ec8-3dcb-4608-82b4-76e5920fd40a
Lindsay, R.S.
95fb5901-ca5b-4fba-8c79-aa7ebd15a7c6
McKnight, J.A.
f92af395-d2ed-49c5-aeeb-0bdb73cb4dd0
Philip, S.
b1281366-f1b5-45a1-9703-c9ee2861911a
Sattar, N.
8f219920-7936-44a5-920c-0186d27d993e
Walker, J.J.
95629bda-4efa-4fad-b15a-0d0f23eff8c2
Wild, S.H.
eb23a87e-b8da-4f3f-8dab-e02e7b5104aa
Saunders, C.
38a38da8-1eb3-47a8-80bc-b9cbb43f26e3
Byrne, Christopher D.
1370b997-cead-4229-83a7-53301ed2a43c
Guthrie, B.
e1c75ec8-3dcb-4608-82b4-76e5920fd40a
Lindsay, R.S.
95fb5901-ca5b-4fba-8c79-aa7ebd15a7c6
McKnight, J.A.
f92af395-d2ed-49c5-aeeb-0bdb73cb4dd0
Philip, S.
b1281366-f1b5-45a1-9703-c9ee2861911a
Sattar, N.
8f219920-7936-44a5-920c-0186d27d993e
Walker, J.J.
95629bda-4efa-4fad-b15a-0d0f23eff8c2
Wild, S.H.
eb23a87e-b8da-4f3f-8dab-e02e7b5104aa

Saunders, C., Byrne, Christopher D., Guthrie, B., Lindsay, R.S., McKnight, J.A., Philip, S., Sattar, N., Walker, J.J. and Wild, S.H. (2013) External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? Diabetic Medicine, 30 (3), 300-308. (doi:10.1111/dme.12047). (PMID:23075287)

Record type: Article

Abstract

Aims: to describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results.

Methods: a literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180 590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined.

Results: seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone.

Conclusions: we found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population

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Published date: March 2013
Organisations: Human Development & Health

Identifiers

Local EPrints ID: 345267
URI: http://eprints.soton.ac.uk/id/eprint/345267
ISSN: 0742-3071
PURE UUID: 48d05c3f-1209-4619-84a1-2779e8a3523f
ORCID for Christopher D. Byrne: ORCID iD orcid.org/0000-0001-6322-7753

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Date deposited: 14 Nov 2012 15:26
Last modified: 27 Jan 2024 02:37

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Contributors

Author: C. Saunders
Author: B. Guthrie
Author: R.S. Lindsay
Author: J.A. McKnight
Author: S. Philip
Author: N. Sattar
Author: J.J. Walker
Author: S.H. Wild

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