Rationale: A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection.

Aim and hypothesis To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data.

Sample size estimates: Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial.

Methods and design: Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended.

Study outcome: The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life.

Discussion: Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke

Fiona Ellery

Helen Dewey

Janice M Collier

Julie Bernhardt

Kiu Tay-Teo

Lauren Sheppard

Leonid Churilov

Marj Moodie

null null

Olivia Wu

English

Sheppard, Lauren

Dewey, Helen

Bernhardt, Julie

Collier, Janice M.

Ellery, Fiona

Churilov, Leonid

Tay-Teo, Kiu

Wu, Olivia

Moodie, Marj

Enlighten

     Sheppard, L., Dewey, H., Bernhardt, J., Collier, J. M., Ellery, F., Churilov, L., Tay-Teo, K., Wu, O., and Moodie, M. (2016) Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care. International Journal of Stroke, 11(4), pp. 492-494.   There may be differences between this version and the published version. You are advised to consult the publisher’s version if you wish to cite from it.     http://eprints.gla.ac.uk/117754/            Deposited on: 03 June  2016                       Enlighten – Research publications by members of the University of Glasgow http://eprints.gla.ac.uk  Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): an international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilisation) within 24 hours of stroke onset with usual stroke unit care  Lauren Sheppard1,2, Helen Dewey3, Julie Bernhardt2, Janice M Collier2, Fiona Ellery2, Leonid Churilov2, Kiu Tay-Teo1, Olivia Wu4, Marj Moodie1; on behalf of The AVERT Trial Collaboration Group. 1. Deakin University, Population Health Strategic Research Centre, Deakin Health Economics; 2. The Florey Institute of Neuroscience and Mental Health, University of Melbourne; 3. Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University; 4. Institute of Health and Wellbeing, University of Glasgow. Corresponding author: lauren.sheppard@deakin.edu.au; Deakin University, 221 Burwood Hwy Burwood Victoria Australia 3125. KEYWORDS: economic evaluation; acute; clinical trials; early mobilisation; rehabilitation; stroke. Word Count: 1207 words AVERT Phase III (ACTRN12606000185561; NCT01846247; ISRCTN98129255) is an international, assessor blinded, multicentre randomised controlled trial of very early mobilisation (VEM) following stroke. The 2,104 participants were recruited at 56 acute stroke units across three geographic regions: Australia (Australia and New Zealand), Asia (Malaysia and Singapore) and the United Kingdom (England, Scotland, Northern Ireland and Wales). Efficacy and safety outcomes at 3 months have been published [1] and the collection of 12-month follow up data will be complete at the end of October 2015.   Resource utilisation data are being collected for one year following stroke for the purpose of undertaking cost-effectiveness analysis, with a view to informing efficient allocation of resources. These data are being collected prospectively alongside the trial outcomes on safety, efficacy and quality of life [2, 3]. Resource use data collection tools were piloted and refined in a smaller pilot study [4] and adapted to suit local service provision as the trial expanded to other countries. In addition, exploratory analysis of the resource use data is intended to consider the relationship between patterns of service use and health outcomes collected during the trial, including quality of life. A further objective will be to explore key economic impacts of stroke on the health sector, patients, families and the broader community. The exploratory analysis is intentionally broad in scope to enable in depth consideration of resource use data.  The Statistical Analysis Plan detailing the methods for assessing trial outcomes on safety, efficacy and quality of life has been published [5].  The EEP details how the economic evaluation will be conducted.  The EEP was finalised prior to the 12 month data collection being completed and before unblinding of the trial management team or steering committee to 12 month data. There are few examples where the economic evaluation methods have been published prior to data analysis (see [6-9] for recent examples). This approach has been taken for AVERT in order to pre-specify methods that were used to collect resource use data and to ensure à priori specification of analyses that will be reported in publications of cost-effectiveness outcomes. Our plan for prior publication of the EEP is to ensure precision of the analysis plan and to avoid bias from data-dependent analyses. Section A of the EEP reports key study parameters for the economic evaluation. Section B summarises the primary cost-effectiveness analysis of AVERT and Section C details intended exploratory analyses. Development and format of the EEP has been guided by using the Consolidated Health Economic Evaluation Reporting Standards where applicable [10]. The outcomes of the main economic evaluation analysis will satisfy the primary trial objective to determine if VEM is cost-effective. More broadly, the main findings will contribute a greater understanding of stroke rehabilitation practices that deliver value-for-money and how support services can be organised to optimise patient outcomes following stroke. The systematic and comprehensive way in which information has been collected is a major standalone achievement of AVERT and will ensure the economic analysis is underpinned by rigorous resource use data.  Acknowledgements: We are grateful to Dr Mohammadreza Mohebbi, Deakin University, Faculty of Health, Biostatistics Unit, for his input to the planned statistical analysis. Funding The economic evaluation component of the AVERT study was initially funded by the National Health and Medical Research Council (NHMRC) of Australia (grant numbers 386201 and 1041401). Additional funding was received from Singapore Health (SHF/FG401P/2008), Chest Heart and Stroke Scotland (Res08/A114), Northern Ireland Chest Heart and Stroke, and the Stroke Association UK (TSA2009/09). NHMRC fellowship funding was provided to HD (336102) and JB (1058635). JB was also supported by an Australia Research Council Future Fellowship (IFT0991086) and the National Heart Foundation. The Florey Institute of Neuroscience and Mental Health acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme. The content of the publication is solely the responsibility of the authors and does not reflect the views of the funders.  Conflicts of interest None declared Author contributions: Lauren Sheppard wrote the manuscript; Helen Dewey, Julie Bernhardt, Marj Moodie and Kiu Tay-Teo contributed to the protocol for data collection and economic evaluation plan; Leonid Churilov provided statistical review of the paper; all co-authors reviewed the draft manuscript. Appendix 1. Economic Evaluation Plan References 1. The AVERT Trial Collaboration Group: Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. The Lancet 2015, 386:46–55. 2. Bernhardt J, Dewey H, Collier J, Thrift A, Lindley R, Moodie M, Donnan G: A Very Early Rehabilitation Trial (AVERT). Int J Stroke 2006, 1:169-171. 3. Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G: A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. Stroke 2008, 39:390-396. 4. Tay-Teo K, Moodie M, Bernhardt J, Thrift AG, Collier J, Donnan G, Dewey H: Economic evaluation alongside a phase II, multi-centre, randomised controlled trial of very early rehabilitation after stroke (AVERT). Cerebrovasc Dis 2008, 26:475-481. 5. Bernhardt J, Churilov L, Dewey H, Lindley RI, Moodie M, Collier J, Langhorne P, Thrift AG, Donnan G: Statistical analysis plan (SAP) for A Very Early Rehabilitation Trial (AVERT): an international trial to determine the efficacy and safety of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset vs. usual stroke unit care. Int J Stroke 2015, 10:23-24. 6. Fowler RA, Mittmann N, Geerts WH, Heels-Ansdell D, Gould MK, Guyatt G, Krahn M, Finfer S, Pinto R, Chan B, et al: Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): study protocol for a randomized controlled trial. Trials 2014, 15:502. 7. Khowaja AR, Mitton C, Bryan S, Magee LA, Bhutta ZA, von Dadelszen P: Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol. Implementation Science: IS 2015, 10:76. 8. Ride J, Rowe H, Wynter K, Fisher J, Lorgelly P: Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers. BMJ Open 2014, 4: e006226. 9. Udsen FW, Lilholt PH, Hejlesen O, Ehlers LH: Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial. Trials 2014, 15:178. 10. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E: Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ 2013, 346:f1049. 

Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care

Rationale A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. Aim and hypothesis To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. Sample size estimates Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. Methods and design Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. Study outcome The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. Discussion Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke. </jats:sec

Crossref

International Journal of Stroke

Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care

RATIONALE: A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. AIM AND HYPOTHESIS: To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. SAMPLE SIZE ESTIMATES: Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. METHODS AND DESIGN: Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. STUDY OUTCOME: The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. DISCUSSION: Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke

Sheppard, L

Dewey, H

Bernhardt, J

Collier, JM

Ellery, F

Churilov, L

Tay-Teo, K

Wu, O

Moodie, M

University of Melbourne Institutional Repository

Enlighten: Publications

 
 
 
 
 
Sheppard, L., Dewey, H., Bernhardt, J., Collier, J. M., Ellery, F., Churilov, L., Tay-
Teo, K., Wu, O., and Moodie, M. (2016) Economic Evaluation Plan (EEP) for A 
Very Early Rehabilitation Trial (AVERT): An international trial to compare the 
costs and cost-effectiveness of commencing out of bed standing and walking 
training (very early mobilization) within 24 h of stroke onset with usual stroke unit 
care. International Journal of Stroke, 11(4), pp. 492-494. 
 
 
There may be differences between this version and the published version. You are 
advised to consult the publisher’s version if you wish to cite from it. 
 
 
 
 
http://eprints.gla.ac.uk/117754/ 
     
 
 
 
 
 
 
Deposited on: 03 June  2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enlighten – Research publications by members of the University of Glasgow 
http://eprints.gla.ac.uk 
 Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial 
(AVERT): an international trial to compare the costs and cost-
effectiveness of commencing out of bed standing and walking training 
(very early mobilisation) within 24 hours of stroke onset with usual 
stroke unit care 
 
Lauren Sheppard1,2, Helen Dewey3, Julie Bernhardt2, Janice M Collier2, Fiona Ellery2, Leonid 
Churilov2, Kiu Tay-Teo1, Olivia Wu4, Marj Moodie1; on behalf of The AVERT Trial Collaboration Group. 
1. Deakin University, Population Health Strategic Research Centre, Deakin Health Economics; 2. The 
Florey Institute of Neuroscience and Mental Health, University of Melbourne; 3. Eastern Health 
Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University; 4. Institute 
of Health and Wellbeing, University of Glasgow. 
Corresponding author: lauren.sheppard@deakin.edu.au; Deakin University, 221 Burwood Hwy 
Burwood Victoria Australia 3125. 
KEYWORDS: economic evaluation; acute; clinical trials; early mobilisation; rehabilitation; stroke. 
Word Count: 1207 words 
AVERT Phase III (ACTRN12606000185561; NCT01846247; ISRCTN98129255) is an international, 
assessor blinded, multicentre randomised controlled trial of very early mobilisation (VEM) following 
stroke. The 2,104 participants were recruited at 56 acute stroke units across three geographic 
regions: Australia (Australia and New Zealand), Asia (Malaysia and Singapore) and the United 
Kingdom (England, Scotland, Northern Ireland and Wales). Efficacy and safety outcomes at 3 months 
have been published [1] and the collection of 12-month follow up data will be complete at the end 
of October 2015.  
 
Resource utilisation data are being collected for one year following stroke for the purpose of 
undertaking cost-effectiveness analysis, with a view to informing efficient allocation of resources. 
These data are being collected prospectively alongside the trial outcomes on safety, efficacy and 
quality of life [2, 3]. Resource use data collection tools were piloted and refined in a smaller pilot 
study [4] and adapted to suit local service provision as the trial expanded to other countries. 
In addition, exploratory analysis of the resource use data is intended to consider the relationship 
between patterns of service use and health outcomes collected during the trial, including quality of 
life. A further objective will be to explore key economic impacts of stroke on the health sector, 
patients, families and the broader community. The exploratory analysis is intentionally broad in 
scope to enable in depth consideration of resource use data.  
The Statistical Analysis Plan detailing the methods for assessing trial outcomes on safety, efficacy 
and quality of life has been published [5].  The EEP details how the economic evaluation will be 
conducted.  The EEP was finalised prior to the 12 month data collection being completed and before 
unblinding of the trial management team or steering committee to 12 month data. 
There are few examples where the economic evaluation methods have been published prior to data 
analysis (see [6-9] for recent examples). This approach has been taken for AVERT in order to pre-
specify methods that were used to collect resource use data and to ensure à priori specification of 
analyses that will be reported in publications of cost-effectiveness outcomes. Our plan for prior 
publication of the EEP is to ensure precision of the analysis plan and to avoid bias from data-
dependent analyses. 
Section A of the EEP reports key study parameters for the economic evaluation. Section B 
summarises the primary cost-effectiveness analysis of AVERT and Section C details intended 
exploratory analyses. Development and format of the EEP has been guided by using the 
Consolidated Health Economic Evaluation Reporting Standards where applicable [10]. 
The outcomes of the main economic evaluation analysis will satisfy the primary trial objective to 
determine if VEM is cost-effective. More broadly, the main findings will contribute a greater 
understanding of stroke rehabilitation practices that deliver value-for-money and how support 
services can be organised to optimise patient outcomes following stroke. The systematic and 
comprehensive way in which information has been collected is a major standalone achievement of 
AVERT and will ensure the economic analysis is underpinned by rigorous resource use data.  
Acknowledgements: We are grateful to Dr Mohammadreza Mohebbi, Deakin University, Faculty of 
Health, Biostatistics Unit, for his input to the planned statistical analysis. 
Funding The economic evaluation component of the AVERT study was initially funded by the 
National Health and Medical Research Council (NHMRC) of Australia (grant numbers 386201 and 
1041401). Additional funding was received from Singapore Health (SHF/FG401P/2008), Chest Heart 
and Stroke Scotland (Res08/A114), Northern Ireland Chest Heart and Stroke, and the Stroke 
Association UK (TSA2009/09). NHMRC fellowship funding was provided to HD (336102) and JB 
(1058635). JB was also supported by an Australia Research Council Future Fellowship (IFT0991086) 
and the National Heart Foundation. The Florey Institute of Neuroscience and Mental Health 
acknowledges the support received from the Victorian Government via the Operational 
Infrastructure Support Scheme. The content of the publication is solely the responsibility of the 
authors and does not reflect the views of the funders. 
 
Conflicts of interest None declared 
Author contributions: Lauren Sheppard wrote the manuscript; Helen Dewey, Julie Bernhardt, Marj 
Moodie and Kiu Tay-Teo contributed to the protocol for data collection and economic evaluation 
plan; Leonid Churilov provided statistical review of the paper; all co-authors reviewed the draft 
manuscript. 
Appendix 1. Economic Evaluation Plan 
References 
1. The AVERT Trial Collaboration Group: Efficacy and safety of very early mobilisation within 24 
h of stroke onset (AVERT): a randomised controlled trial. The Lancet 2015, 386:46–55. 
2. Bernhardt J, Dewey H, Collier J, Thrift A, Lindley R, Moodie M, Donnan G: A Very Early 
Rehabilitation Trial (AVERT). Int J Stroke 2006, 1:169-171. 
3. Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G: A very early rehabilitation trial for stroke 
(AVERT): phase II safety and feasibility. Stroke 2008, 39:390-396. 
4. Tay-Teo K, Moodie M, Bernhardt J, Thrift AG, Collier J, Donnan G, Dewey H: Economic 
evaluation alongside a phase II, multi-centre, randomised controlled trial of very early 
rehabilitation after stroke (AVERT). Cerebrovasc Dis 2008, 26:475-481. 
5. Bernhardt J, Churilov L, Dewey H, Lindley RI, Moodie M, Collier J, Langhorne P, Thrift AG, 
Donnan G: Statistical analysis plan (SAP) for A Very Early Rehabilitation Trial (AVERT): an 
international trial to determine the efficacy and safety of commencing out of bed standing 
and walking training (very early mobilization) within 24 h of stroke onset vs. usual stroke unit 
care. Int J Stroke 2015, 10:23-24. 
6. Fowler RA, Mittmann N, Geerts WH, Heels-Ansdell D, Gould MK, Guyatt G, Krahn M, Finfer S, 
Pinto R, Chan B, et al: Economic evaluation of the prophylaxis for thromboembolism in 
critical care trial (E-PROTECT): study protocol for a randomized controlled trial. Trials 2014, 
15:502. 
7. Khowaja AR, Mitton C, Bryan S, Magee LA, Bhutta ZA, von Dadelszen P: Economic evaluation 
of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African 
countries: a study protocol. Implementation Science: IS 2015, 10:76. 
8. Ride J, Rowe H, Wynter K, Fisher J, Lorgelly P: Protocol for economic evaluation alongside a 
cluster-randomised controlled trial of a psychoeducational intervention for the primary 
prevention of postnatal mental health problems in first-time mothers. BMJ Open 2014, 4: 
e006226. 
9. Udsen FW, Lilholt PH, Hejlesen O, Ehlers LH: Effectiveness and cost-effectiveness of 
telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster 
randomized controlled trial. Trials 2014, 15:178. 
10. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, 
Briggs AH, Mauskopf J, Loder E: Consolidated Health Economic Evaluation Reporting 
Standards (CHEERS) statement. BMJ 2013, 346:f1049. 


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Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care

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