Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom

for the RESTART Trial Steering Committee; Colin Baigent; Daniel Lasserson; Johanna Carrie; Martin S Dennis; Gordon D Murray; David E Newby; Peter AG Sandercock; Cathie L. M. Sudlow; William N. Whiteley; Nikola Sprigg; David J Werring; Phil M White

doi:10.1186/s13063-024-08631-7

Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom

for the RESTART Trial Steering Committee, Colin Baigent, Daniel Lasserson, Johanna Carrie, Martin S Dennis, Gordon D Murray, David E Newby, Peter AG Sandercock, Cathie L. M. Sudlow, William N. Whiteley, Nikola Sprigg, David J Werring, Phil M White

Research output: Contribution to journal › Article › peer-review

Abstract

Background
Healthcare systems data (HCSD) could improve the efficiency of clinical trials, but their accuracy and validity are uncertain. Our objective was to assess the accuracy of HCSD as the sole method of outcome detection in the REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) compared with adjudicated questionnaire follow-up and compare estimates of treatment effect.

Methods

RESTART was a prospective, open, assessor-blind, parallel-group randomised controlled trial (RCT) of antiplatelet therapy after intracerebral haemorrhage (ICH) in the UK.

We included 496 (92%) of 537 RESTART participants, who were resident in England or Scotland at randomisation. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy.

RESTART used annual questionnaires to detect its primary outcome (recurrent ICH) and secondary outcome (a composite of haemorrhagic or ischemic major adverse cardiovascular events [MACE]) over a median of 2.0 years; an independent adjudication committee verified outcomes using medical records and brain imaging. We obtained ICD10-coded HCSD on hospital admissions and deaths in England and Scotland to identify primary and secondary outcomes. We compared HCSD with a reference standard of adjudicated outcomes. We estimated the effects of antiplatelet therapy using HCSD alone in a Cox proportional hazards model adjusted for minimisation variables.

Results

In the original RESTART trial, 31 people experienced a primary outcome event. HCSD had sensitivity of 84% (95% CI 66 to 95%) and positive predictive value of 68% (51 to 82%) for recurrent ICH. HCSD estimated an effect of antiplatelet therapy (adjusted hazard ratio [aHR] 0.51, 95% CI 0.27 to 0.98; p = 0.044) that was almost identical to adjudicated outcomes (aHR 0.51, 95% CI 0.25 to 1.03; p = 0.060). HCSD had sensitivity of 84% (76 to 91%) and positive predictive value of 78% (69 to 85%) for MACE, on which HCSD estimated an effect of antiplatelet therapy (aHR 0.81, 95% CI 0.56 to 1.16; p = 0.247) that was similar to adjudicated outcomes (aHR 0.65, 95% CI 0.44 to 0.95; p = 0.025).

Conclusions

In a RCT of antiplatelet therapy for people with ICH, HCSD was reasonably accurate and provided similar estimates of treatment effect compared with adjudicated outcomes.

Original language	English
Article number	774
Number of pages	9
Journal	Trials
Volume	25
Issue number	1
Early online date	16 Nov 2024
DOIs	https://doi.org/10.1186/s13063-024-08631-7
Publication status	Published - 1 Dec 2024

Keywords

Healthcare systems data
Intracerebral haemorrhage
Trial outcome adjudication

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for the RESTART Trial Steering Committee, Baigent, C., Lasserson, D., Carrie, J., Dennis, M. S., Murray, G. D., Newby, D. E., Sandercock, P. AG., Sudlow, C. L. M., Whiteley, W. N., Sprigg, N., Werring, D. J., & White, P. M. (2024). Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom. Trials, 25(1), Article 774. https://doi.org/10.1186/s13063-024-08631-7

@article{84105c804a28420dae53e15717a4a525,

title = "Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom",

abstract = "BackgroundHealthcare systems data (HCSD) could improve the efficiency of clinical trials, but their accuracy and validity are uncertain. Our objective was to assess the accuracy of HCSD as the sole method of outcome detection in the REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) compared with adjudicated questionnaire follow-up and compare estimates of treatment effect.MethodsRESTART was a prospective, open, assessor-blind, parallel-group randomised controlled trial (RCT) of antiplatelet therapy after intracerebral haemorrhage (ICH) in the UK.We included 496 (92%) of 537 RESTART participants, who were resident in England or Scotland at randomisation. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy.RESTART used annual questionnaires to detect its primary outcome (recurrent ICH) and secondary outcome (a composite of haemorrhagic or ischemic major adverse cardiovascular events [MACE]) over a median of 2.0 years; an independent adjudication committee verified outcomes using medical records and brain imaging. We obtained ICD10-coded HCSD on hospital admissions and deaths in England and Scotland to identify primary and secondary outcomes. We compared HCSD with a reference standard of adjudicated outcomes. We estimated the effects of antiplatelet therapy using HCSD alone in a Cox proportional hazards model adjusted for minimisation variables.ResultsIn the original RESTART trial, 31 people experienced a primary outcome event. HCSD had sensitivity of 84% (95% CI 66 to 95%) and positive predictive value of 68% (51 to 82%) for recurrent ICH. HCSD estimated an effect of antiplatelet therapy (adjusted hazard ratio [aHR] 0.51, 95% CI 0.27 to 0.98; p = 0.044) that was almost identical to adjudicated outcomes (aHR 0.51, 95% CI 0.25 to 1.03; p = 0.060). HCSD had sensitivity of 84% (76 to 91%) and positive predictive value of 78% (69 to 85%) for MACE, on which HCSD estimated an effect of antiplatelet therapy (aHR 0.81, 95% CI 0.56 to 1.16; p = 0.247) that was similar to adjudicated outcomes (aHR 0.65, 95% CI 0.44 to 0.95; p = 0.025).ConclusionsIn a RCT of antiplatelet therapy for people with ICH, HCSD was reasonably accurate and provided similar estimates of treatment effect compared with adjudicated outcomes.",

keywords = "Healthcare systems data, Intracerebral haemorrhage, Trial outcome adjudication",

author = "Alice Hosking and Jacqueline Stephen and Jonathan Drever and Whiteley, {William N.} and Sudlow, {Cathie L. M.} and {Al-Shahi Salman}, Rustam and {for the RESTART Trial Steering Committee} and Colin Baigent and Daniel Lasserson and Frank Sullivan and Johanna Carrie and Dennis, {Martin S} and Murray, {Gordon D} and Newby, {David E} and Sandercock, {Peter AG} and Sudlow, {Cathie L. M.} and Whiteley, {William N.} and Nikola Sprigg and Werring, {David J} and White, {Phil M}",

note = "Funding: This work was funded by a British Heart Foundation Special Project grant (SP/12/2/20422).",

year = "2024",

month = dec,

day = "1",

doi = "10.1186/s13063-024-08631-7",

language = "English",

volume = "25",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

for the RESTART Trial Steering Committee, Baigent, C, Lasserson, D, Carrie, J, Dennis, MS, Murray, GD, Newby, DE, Sandercock, PAG, Sudlow, CLM, Whiteley, WN, Sprigg, N, Werring, DJ & White, PM 2024, 'Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom', Trials, vol. 25, no. 1, 774. https://doi.org/10.1186/s13063-024-08631-7

TY - JOUR

T1 - Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom

AU - Hosking, Alice

AU - Stephen, Jacqueline

AU - Drever, Jonathan

AU - Whiteley, William N.

AU - Sudlow, Cathie L. M.

AU - Al-Shahi Salman, Rustam

AU - for the RESTART Trial Steering Committee

AU - Baigent, Colin

AU - Lasserson, Daniel

AU - Sullivan, Frank

AU - Carrie, Johanna

AU - Dennis, Martin S

AU - Murray, Gordon D

AU - Newby, David E

AU - Sandercock, Peter AG

AU - Sudlow, Cathie L. M.

AU - Whiteley, William N.

AU - Sprigg, Nikola

AU - Werring, David J

AU - White, Phil M

N1 - Funding: This work was funded by a British Heart Foundation Special Project grant (SP/12/2/20422).

PY - 2024/12/1

Y1 - 2024/12/1

N2 - BackgroundHealthcare systems data (HCSD) could improve the efficiency of clinical trials, but their accuracy and validity are uncertain. Our objective was to assess the accuracy of HCSD as the sole method of outcome detection in the REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) compared with adjudicated questionnaire follow-up and compare estimates of treatment effect.MethodsRESTART was a prospective, open, assessor-blind, parallel-group randomised controlled trial (RCT) of antiplatelet therapy after intracerebral haemorrhage (ICH) in the UK.We included 496 (92%) of 537 RESTART participants, who were resident in England or Scotland at randomisation. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy.RESTART used annual questionnaires to detect its primary outcome (recurrent ICH) and secondary outcome (a composite of haemorrhagic or ischemic major adverse cardiovascular events [MACE]) over a median of 2.0 years; an independent adjudication committee verified outcomes using medical records and brain imaging. We obtained ICD10-coded HCSD on hospital admissions and deaths in England and Scotland to identify primary and secondary outcomes. We compared HCSD with a reference standard of adjudicated outcomes. We estimated the effects of antiplatelet therapy using HCSD alone in a Cox proportional hazards model adjusted for minimisation variables.ResultsIn the original RESTART trial, 31 people experienced a primary outcome event. HCSD had sensitivity of 84% (95% CI 66 to 95%) and positive predictive value of 68% (51 to 82%) for recurrent ICH. HCSD estimated an effect of antiplatelet therapy (adjusted hazard ratio [aHR] 0.51, 95% CI 0.27 to 0.98; p = 0.044) that was almost identical to adjudicated outcomes (aHR 0.51, 95% CI 0.25 to 1.03; p = 0.060). HCSD had sensitivity of 84% (76 to 91%) and positive predictive value of 78% (69 to 85%) for MACE, on which HCSD estimated an effect of antiplatelet therapy (aHR 0.81, 95% CI 0.56 to 1.16; p = 0.247) that was similar to adjudicated outcomes (aHR 0.65, 95% CI 0.44 to 0.95; p = 0.025).ConclusionsIn a RCT of antiplatelet therapy for people with ICH, HCSD was reasonably accurate and provided similar estimates of treatment effect compared with adjudicated outcomes.

AB - BackgroundHealthcare systems data (HCSD) could improve the efficiency of clinical trials, but their accuracy and validity are uncertain. Our objective was to assess the accuracy of HCSD as the sole method of outcome detection in the REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) compared with adjudicated questionnaire follow-up and compare estimates of treatment effect.MethodsRESTART was a prospective, open, assessor-blind, parallel-group randomised controlled trial (RCT) of antiplatelet therapy after intracerebral haemorrhage (ICH) in the UK.We included 496 (92%) of 537 RESTART participants, who were resident in England or Scotland at randomisation. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy.RESTART used annual questionnaires to detect its primary outcome (recurrent ICH) and secondary outcome (a composite of haemorrhagic or ischemic major adverse cardiovascular events [MACE]) over a median of 2.0 years; an independent adjudication committee verified outcomes using medical records and brain imaging. We obtained ICD10-coded HCSD on hospital admissions and deaths in England and Scotland to identify primary and secondary outcomes. We compared HCSD with a reference standard of adjudicated outcomes. We estimated the effects of antiplatelet therapy using HCSD alone in a Cox proportional hazards model adjusted for minimisation variables.ResultsIn the original RESTART trial, 31 people experienced a primary outcome event. HCSD had sensitivity of 84% (95% CI 66 to 95%) and positive predictive value of 68% (51 to 82%) for recurrent ICH. HCSD estimated an effect of antiplatelet therapy (adjusted hazard ratio [aHR] 0.51, 95% CI 0.27 to 0.98; p = 0.044) that was almost identical to adjudicated outcomes (aHR 0.51, 95% CI 0.25 to 1.03; p = 0.060). HCSD had sensitivity of 84% (76 to 91%) and positive predictive value of 78% (69 to 85%) for MACE, on which HCSD estimated an effect of antiplatelet therapy (aHR 0.81, 95% CI 0.56 to 1.16; p = 0.247) that was similar to adjudicated outcomes (aHR 0.65, 95% CI 0.44 to 0.95; p = 0.025).ConclusionsIn a RCT of antiplatelet therapy for people with ICH, HCSD was reasonably accurate and provided similar estimates of treatment effect compared with adjudicated outcomes.

KW - Healthcare systems data

KW - Intracerebral haemorrhage

KW - Trial outcome adjudication

U2 - 10.1186/s13063-024-08631-7

DO - 10.1186/s13063-024-08631-7

M3 - Article

C2 - 39550597

AN - SCOPUS:85209401325

SN - 1745-6215

VL - 25

JO - Trials

JF - Trials

IS - 1

M1 - 774

ER -

Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom

Abstract

Keywords

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