Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy

Journal article


Erin Godecke, Tapan Rai, Dominique Cadihac, Elizabeth Armstrong, Sandy Middleton, Natalie Ciccone, Anne Whitworth, Miranda L Rose, Audrey Holland, Fiona Ellery, Graeme J Hankey and Julie Bernhardt. (2018) Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy. International Journal of Stroke. 13(8), pp. 863-880. https://doi.org/10.1177/1747493018790055
AuthorsErin Godecke, Tapan Rai, Dominique Cadihac, Elizabeth Armstrong, Sandy Middleton, Natalie Ciccone, Anne Whitworth, Miranda L Rose, Audrey Holland, Fiona Ellery, Graeme J Hankey and Julie Bernhardt
Abstract

Background
Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care.

Objective
To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms.

Results
The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting.

Conclusions
Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses.

Keywordsaphasia; stroke rehabilitation; statistical analysis plan; randomised controlled trial
Year2018
JournalInternational Journal of Stroke
Journal citation13 (8), pp. 863-880
PublisherSAGE Publications
ISSN1747-4949
Digital Object Identifier (DOI)https://doi.org/10.1177/1747493018790055
Scopus EID2-s2.0-85055076769
Publisher's version
File Access Level
Controlled
Publication process dates
Deposited22 Apr 2021
Permalink -

https://acuresearchbank.acu.edu.au/item/8vxqv/statistical-analysis-plan-sap-for-the-very-early-rehabilitation-in-speech-verse-after-stroke-trial-an-international-3-arm-clinical-trial-to-determine-the-effectiveness-of-early-intensive-prescribed

Restricted files

Publisher's version

  • 1
    total views
  • 0
    total downloads
  • 0
    views this month
  • 0
    downloads this month
These values are for the period from 19th October 2020, when this repository was created.

Export as

Related outputs

The prevalence and impact of unprofessional behaviour among hospital workers : A survey in seven Australian hospitals
Westbrook, Johanna, Sunderland, Neroli, Li, Ling, Koyama, Alain, McMullan, Ryan, Urwin, Rachel, Churruca, Kate, Baysari, Melissa T., Jones, Catherine, Loh, Erwin, McInnes, Elizabeth C., Middleton, Sandy and Braithwaite, Jeffrey. (2021) The prevalence and impact of unprofessional behaviour among hospital workers : A survey in seven Australian hospitals. Medical Journal of Australia. 214(1), pp. 31-37. https://doi.org/10.5694/mja2.50849
Measuring organizational context in Australian emergency departments and its impact on stroke care and patient outcomes
Schadewaldt, Verena, McElduff, Benjamin, D'Este, Catherine, McInnes, Elizabeth, Dale, Simeon, Fasugba, Oyebola, Cadilhac, Dominique A., Considine, Julie, Grimshaw, Jeremy M., Cheung, N. Wah, Levi, Chris, Gerraty, Richard, Fitzgerald, Mark and Middleton, Sandy. (2021) Measuring organizational context in Australian emergency departments and its impact on stroke care and patient outcomes. Nursing Outlook. 69(1), pp. 103-115. https://doi.org/10.1016/j.outlook.2020.08.009
Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study
Ouyang, Menglu, Zhang, Yao, Wang, Xia, Song, Lili, Billot, Laurent, Robinson, Thompson, Lavados, Pablo M., Arima, Hisatomi, Hackett, Maree L., Olavarría, Verónica V., Muñoz-Venturelli, Paula, Middleton, Sandy, Watkins, Caroline L., Pontes-Neto, Octavio M., Lee, Tsong-Hai, Brunser, Alejandro M. and Anderson, Craig S.. (2020) Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study. Journal of the Neurological Sciences. 419, p. 117187. https://doi.org/10.1016/j.jns.2020.117187
Prognostic significance of early urinary catheterization after acute stroke : Secondary analyses of the international HeadPoST trial
Ouyang, Menglu, Billot, Laurent, Song, Lili, Wang, Xia, Roffe, Christine, Arima, Hisatomi, Lavados, Pablo M., Hackett, Maree L., Olavarría, Verónica V., Muñoz-Venturelli, Paula, Middleton, Sandy, Pontes-Neto, Octavio M., Lee, Tsong-Hai, Watkins, Caroline L., Robinson, Thompson G. and Anderson, Craig S.. (2020) Prognostic significance of early urinary catheterization after acute stroke : Secondary analyses of the international HeadPoST trial. International Journal of Stroke. 16(2), pp. 200-206. https://doi.org/10.1177/1747493020908140
Process evaluation of an implementation trial to improve the triage, treatment and transfer of stroke patients in emergency departments (T3 trial) : A qualitative study
McInnes, Elizabeth, Dale, Simeon, Craig, Louise, Phillips, Rosemary, Fasugba, Oyebola, Schadewaldt, Verena, Cheung, N. Wah, Cadilhac, Dominique A., Grimshaw, Jeremy M., Levi, Chris, Considine, Julie, McElduff, Patrick, Gerraty, Richard, Fitzgerald, Mark, Ward, Jeanette, D’Este, Catherine and Middleton, Sandy. (2020) Process evaluation of an implementation trial to improve the triage, treatment and transfer of stroke patients in emergency departments (T3 trial) : A qualitative study. Implementation Science. 15(1), p. 99. https://doi.org/10.1186/s13012-020-01057-0
No benefit of flat head positioning in early moderate–severe acute ischaemic stroke : A HeadPoST study subgroup analysis
Brunser, Alejandro M., Ouyang, Menglu, Arima, Hisatomi, Lavados, Pablo M., Robinson, Thompson, Muñoz-Venturelli, Paula, Olavarría, Verónica V., Billot, Laurent, Hackett, Marre L., Song, Lili, Middleton, Sandy, Pontes-Neto, Octavio, Lee, Tsong-Hai, Watkins, Caroline and Anderson, Craig S.. (2020) No benefit of flat head positioning in early moderate–severe acute ischaemic stroke : A HeadPoST study subgroup analysis. Stroke and Vascular Neurology. 5(4), pp. 406-409. https://doi.org/10.1136/svn-2020-000387
Increased fluid intake for the prevention of urinary tract infection in adults and children in all settings : A systematic review
Fasugba, O., Mitchell, B. G., McInnes, E., Koerner, J., Cheng, A. C., Cheng, H. and Middleton, S.. (2020) Increased fluid intake for the prevention of urinary tract infection in adults and children in all settings : A systematic review. Journal of Hospital Infection. 104(1), pp. 68-77. https://doi.org/10.1016/j.jhin.2019.08.016
Review article: A primer for clinical researchers in the emergency department: Part VIII. Implementation science: An introduction
Emma Tavender, Franz Babl and Sandy Middleton. (2019) Review article: A primer for clinical researchers in the emergency department: Part VIII. Implementation science: An introduction. Emergency Medicine Australasia. 31(3), pp. 332-338. https://doi.org/10.1111/1742-6723.13296
Predicting functional outcomes after stroke: An observational study of acute single-channel EEG
Rogers, Jeffrey M., Middleton, Sandy, Wilson, Peter H. and Johnstone, Stuart J.. (2019) Predicting functional outcomes after stroke: An observational study of acute single-channel EEG. Topics in Stroke Rehabilitation. 27(3), pp. 161 - 172. https://doi.org/10.1080/10749357.2019.1673576
Outcomes for patients with in-hospital stroke: A multicenter study from the Australian stroke clinical registry (AuSCR)
Cadihac, Dominique, Kilkenny, Monique, Lannin, Natasha, Dewey, Helen M., Levi, Chris, Hill, Kelvin, Grabsch, Brenda, Grimley, Rohan, Blacker, David, Thrift, Amanda, Middleton, Sandy, Anderson, Craig and Donnan, Geoffrey. (2019) Outcomes for patients with in-hospital stroke: A multicenter study from the Australian stroke clinical registry (AuSCR). Journal of Stroke and Cerebrovascular Diseases. 28(5), pp. 1302 - 1310. https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.01.026
Implementing a protocol for a research impact assessment of the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery
Shanthi Ramanathan, Penny Reeves, Simon Deeming, Julie Bernhardt, Michael Nilsson, Dominique Cadihac, Frederick Rohan Walker, Leeanne Carey, Sandy Middleton, Elizabeth A. Lynch and Andrew Searles. (2018) Implementing a protocol for a research impact assessment of the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery. Health Research Policy and Systems. 16(1), pp. 1-10. https://doi.org/10.1186/s12961-018-0349-2
Barriers and outcomes of an evidence-based approach to diagnosis and management of chronic obstructive pulmonary disease (COPD) in Australia: a qualitative study
Dennis, Sarah, Reddel, Helen K., Middleton, Sandra Jane, Hasan, Iqbal, Hermiz, Oshana, Phillips, Rosemary, Crockett, Alan J., Vagholkar, Sanjyot, Marks, Guy B. and Zwar, Nicholas. (2017) Barriers and outcomes of an evidence-based approach to diagnosis and management of chronic obstructive pulmonary disease (COPD) in Australia: a qualitative study. Family Practice. 34(4), pp. 485 - 490.
Multi-morbidity, frailty and self-care: important considerations in treatment with anticoagulation drugs. Outcomes of the AFASTER study
Ferguson, Caleb, Inglis, Sally C., Newton, Phillip J., Middleton, Sandra Jane, Macdonald, Peter S. and Davidson, Patricia M.. (2017) Multi-morbidity, frailty and self-care: important considerations in treatment with anticoagulation drugs. Outcomes of the AFASTER study. European Journal of Cardiovascular Nursing. 16(2), pp. 113 - 124.
Multimorbidity, frailty and self-care: Important considerations in anticoagulation. Outcomes of the AFASTER study
Ferguson, Caleb, Inglis, Sally, Newton, Phillip, Middleton, Sandra Jane, Macdonald, Peter and Davidson, Patricia M.. (2017) Multimorbidity, frailty and self-care: Important considerations in anticoagulation. Outcomes of the AFASTER study. European Journal of Cardiovascular Nursing. 16(2), pp. 113 - 124. https://doi.org/10.1177/1474515116642604
A randomized controlled trial of very early rehabilitation in speech after stroke
Godecke, Erin, Armstrong, Elizabeth A., Middleton, Sandra Jane, Whitworth, Anne, Ciccone, Natalie, Rai, Tapan, Rose, Miranda, Holland, Audrey, Ellery, Fiona, Hankey, Graeme J., Cadilhac, Dominique A. and Bernhardt, Julie. (2016) A randomized controlled trial of very early rehabilitation in speech after stroke. International Journal of Stroke. 11(5), pp. 586 - 592. https://doi.org/10.1177/1747493016641116
How has the profile of Australian Nurse practitioners changed over time?
Middleton, Sandra Jane, Gardner, Anne, Della, Phillip R., Lam, Lawrence, Allnutt, Nissa and Gardner, Glenn. (2016) How has the profile of Australian Nurse practitioners changed over time? Collegian. 23(1), pp. 69 - 77. https://doi.org/10.1016/j.colegn.2014.10.004
A behaviour change program to increase outings delivered during therapy to stroke survivors by community rehabilitation teams : The Out-and-About trial
McCluskey, Annie, Ada, Louise, Kelly, Patrick J., Middleton, Sandy, Goodall, Stephen, Grimshaw, Jeremy M., Logan, Pip, Longworth, Mark and Karageorge, Aspasia. (2016) A behaviour change program to increase outings delivered during therapy to stroke survivors by community rehabilitation teams : The Out-and-About trial. International Journal of Stroke. 11(4), pp. 425-437. https://doi.org/10.1177/1747493016632246
A survey of acute care clinicians views on factors influencing hand hygiene practice and actions to improve hand hygiene compliance
Jammali-Blasi, Asmara, McInnes, Elizabeth Catherine and Middleton, Sandra Jane. (2016) A survey of acute care clinicians views on factors influencing hand hygiene practice and actions to improve hand hygiene compliance. Infection, Disease and Health. 21(1), pp. 16 - 25. https://doi.org/10.1016/j.idh.2016.01.004
Better outcomes for hospitalized patients with TIA when in stroke units: An observational study
Cadilhac, Dominique A., Kim, Joosup, Lannin, Natasha A., Levi, Christopher R., Dewey, Helen M., Hill, Kelvin, Faux, Steven, Andrew, Nadine E., Kilkenny, Monique F., Grimley, Rohan, Thrift, Amanda G., Grabsch, Brenda, Middleton, Sandy, Anderson, Craig S. and Donnan, Geoffrey A.. (2016) Better outcomes for hospitalized patients with TIA when in stroke units: An observational study. Neurology. 86(22), pp. 2042-2048. https://doi.org/10.1212/WNL.0000000000002715
Stroke unit Nurse Managers’ views of individual and organisational factors liable to influence evidence-based practice : A survey
Drury, Peta, McInnes, Elizabeth, Hardy, Jennifer, Dale, Simeon and Middleton, Sandy. (2015) Stroke unit Nurse Managers’ views of individual and organisational factors liable to influence evidence-based practice : A survey. International Journal of Nursing Practice. 22(2), pp. 169-178. https://doi.org/10.1111/ijn.12396
Triage, treatment and transfer : Evidence-based clinical practice recommendations and models of nursing care for the first 72 hours of admission to hospital for acute stroke
Middleton, Sandy, Grimley, Rohan and Alexandrov, Anne. (2015) Triage, treatment and transfer : Evidence-based clinical practice recommendations and models of nursing care for the first 72 hours of admission to hospital for acute stroke. Stroke. 46(2), pp. e18-e25. https://doi.org/10.1161/STROKEAHA.114.006139
Health service management study for stroke : A randomized controlled trial to evaluate two models of stroke care
Chan, Daniel K.Y., Levi, Chris, Cordato, Dennis, O'Rourke, Fintan, Chen, Jack, Redmond, Helen, Xu, Ying-Hua, Middleton, Sandy, Pollack, Michael and Hankey, Graeme. (2014) Health service management study for stroke : A randomized controlled trial to evaluate two models of stroke care. International Journal of Stroke. 9(4), pp. 400-405. https://doi.org/10.1111/ijs.12240
Stroke management : Updated recommendations for treatment along the care continuum
Wright, Leah, Hill, Kelvin M., Bernhardt, Julie, Lindley, Richard, Ada, Louise, Bajorek, Beata V., Barber, P. Alan, Beer, Christopher, Golledge, Jonathon, Gustafsson, L., Hersh, D., Kenardy, J., Perry, L., Middleton, S., Brauer, S. G. and Nelson, M. R.. (2012) Stroke management : Updated recommendations for treatment along the care continuum. Internal Medicine Journal. 42(5), pp. 562 - 569. https://doi.org/10.1111/j.1445-5994.2012.02774.x
Doing the simple things well
Middleton, Sandy. (2012) Doing the simple things well. Royal College of Nursing Australia. 19(2), pp. 65-66. https://doi.org/10.1016/j.colegn.2012.04.001
Improving quality of life by increasing outings after stroke : Study protocol for the Out-and-About trial
McClusky, Annie, Ada, Louise, Middleton, Sandy, Kelly, Patrick J., Goodall, Stephen, Grimshaw, Jeremy M., Logan, Pip, Longworth, Mark and Karageorge, A.. (2012) Improving quality of life by increasing outings after stroke : Study protocol for the Out-and-About trial. International Journal of Stroke. 8(1), pp. 54-58. https://doi.org/10.1111/j.1747-4949.2012.00966.x