Using the Barthel Index and modified Rankin Scale as outcome measures for stroke rehabilitation trials; A comparison of minimum sample size requirements

Journal article

McGill, Kris, Sackley, Catherine, Godwin, Jon, Gavaghan, David, Ali, Myzoon, Ballester, Belen Rubio, Brady, Marian C., Ashburn, A., Barer, D., Barzel, A., Bernhardt, J., Bowen, A., Drummond, A., Edmans, J., English, C., Gladman, J., Godecke, E., Hiekkala, S., Hoffman, T., ... Whiteley, W.. (2022). Using the Barthel Index and modified Rankin Scale as outcome measures for stroke rehabilitation trials; A comparison of minimum sample size requirements. Journal of Stroke and Cerebrovascular Diseases. 31(2), p. Article 106229. https://doi.org/10.1016/j.jstrokecerebrovasdis.2021.106229
AuthorsMcGill, Kris, Sackley, Catherine, Godwin, Jon, Gavaghan, David, Ali, Myzoon, Ballester, Belen Rubio, Brady, Marian C., Ashburn, A., Barer, D., Barzel, A., Bernhardt, J., Bowen, A., Drummond, A., Edmans, J., English, C., Gladman, J., Godecke, E., Hiekkala, S., Hoffman, T., Kalra, L., Kuys, S., Langhorne, P., Laska, A. C., Lees, K., Logan, P., Machner, B., Mead, G., Morris, J., Pandyan, A., Pollock, A., Pomeroy, V., Rodgers, H., Shaw, L., Stott, D. J., Sunnerhagen, K. S., Tyson, S., van Vliet, P., Walker, M. and Whiteley, W.
Abstract

Objectives
Underpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes.

Methods
We conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS.

Results
We secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure.

Conclusions
Stroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.

Keywordsstroke rehabilitation; sample size calculations; Barthel Index; modified Rankin Scale; recruitment; simulations; randomised controlled trials
Year2022
JournalJournal of Stroke and Cerebrovascular Diseases
Journal citation31 (2), p. Article 106229
PublisherElsevier Inc.
ISSN1052-3057
Digital Object Identifier (DOI)https://doi.org/10.1016/j.jstrokecerebrovasdis.2021.106229
PubMed ID34871903
Scopus EID2-s2.0-85120453553
Open accessPublished as green open access
Page range1-7
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Output statusPublished
Publication dates
Online03 Dec 2021
Publication process dates
Accepted14 Nov 2021
Deposited24 Nov 2023
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Preston, Elisabeth, Dean, Catherine M., Ada, Louise, Stanton, Rosalyn, Brauer, Sandy, Kuys, Suzanne and Waddington, Gordon. (2017). Promoting physical activity after stroke via self-management: A feasibility study. Topics in Stroke Rehabilitation. 24(5), pp. 353 - 360. https://doi.org/10.1080/10749357.2017.1304876
The effect of aerobic exercise on brain-derived neurotrophic factor in people with neurological disorders: A Systematic Review and Meta-Analysis
Mackay, Christopher P., Kuys, Suzanne S. and Brauer, Sandra G.. (2017). The effect of aerobic exercise on brain-derived neurotrophic factor in people with neurological disorders: A Systematic Review and Meta-Analysis. Neural Plasticity. 2017, pp. 1 - 9. https://doi.org/10.1155/2017/4716197
Accelerometer and global positioning system measurement of recovery of community ambulation across the first 6 months after stroke : An exploratory prospective study
Mahendran, Niruthikha, Kuys, Suzanne S. and Brauer, Sandra G.. (2016). Accelerometer and global positioning system measurement of recovery of community ambulation across the first 6 months after stroke : An exploratory prospective study. Archives of Physical Medicine and Rehabilitation. 97(9), pp. 1465-1472. https://doi.org/10.1016/j.apmr.2016.04.013
Poor mobility in hospitalized adults of all ages
Mudge, Alison, McRae, Prue, McHugh, Kirstie, Griffin, Lauren, Hitchen, Andrew, Walker, James, Cruickshank, Mark, Morris, Norman R. and Kuys, Suzanne Shanelle. (2016). Poor mobility in hospitalized adults of all ages. Journal of Hospital Medicine. 11(4), pp. 289 - 291. https://doi.org/10.1002/jhm.2536
General versus spinal anaesthesia and postoperative delirium in an orthogeriatric population
Ilango, Sivarajah, Pulle, Ranjeev Chrys, Bell, Jack J. and Kuys, Suzanne Shanelle. (2016). General versus spinal anaesthesia and postoperative delirium in an orthogeriatric population. Australasian Journal on Ageing. 35(1), pp. 42 - 47. https://doi.org/10.1111/ajag.12212
Direct inpatient burden caused by foot-related conditions: A multisite point-prevalence study
Lazzarini, Peter A., Hurn, Sheree E., Kuys, Suzanne Shanelle, Kamp, Maarten C., Ng, Vanessa, Thomas, Courtney, Jen, Scott D., Kinnear, Ewan, d'Emden, Michael C. and Reed, Lloyd. (2016). Direct inpatient burden caused by foot-related conditions: A multisite point-prevalence study. BMJ Open. 6(6), pp. 1 - 15. https://doi.org/10.1136/bmjopen-2015-010811
Balance self-efficacy in older adults following inpatient rehabilitation
Kuys, Suzanne S., Donovan, Jacquelin, Mattin, Sarah and Low Choy, Nancy L.. (2015). Balance self-efficacy in older adults following inpatient rehabilitation. International Journal of Rehabilitation Research. 38(2), pp. 167-172. https://doi.org/10.1097/MRR.0000000000000106
Demographics and discharge outcomes of dysvascular and non-vascular lower limb amputees at a subacute rehabilitation unit : A 7-year series
Batten, Heather, Kuys, Suzanne, McPhail, Steven, Varghese, Paulose and Nitz, Jennifer. (2015). Demographics and discharge outcomes of dysvascular and non-vascular lower limb amputees at a subacute rehabilitation unit : A 7-year series. Australian Health Review. 39(1), pp. 76-84. https://doi.org/10.1071/AH14042
A systematic review of axillary web syndrome (AWS)
Yeung, W. M., McPhail, Steven M. and Kuys, Suzanne Shanelle. (2015). A systematic review of axillary web syndrome (AWS). Journal of Cancer Survivorship. 9(4), pp. 576 - 598. https://doi.org/10.1007/s11764-015-0435-1
Comparison of sit-to-stand strategies used by older adults and people living with dementia
Dolecka, Urszula, Ownsworth, Tamara and Kuys, Suzanne. (2015). Comparison of sit-to-stand strategies used by older adults and people living with dementia. Archives of Gerontology and Geriatrics. 60(3), pp. 528 - 534. https://doi.org/10.1016/j.archger.2014.12.007
Prevalence of foot disease and risk factors in general inpatient populations: A systematic review and meta-analysis
Lazzarini, Peter A., Hurn, Sheree E., Fernando, Malindu E., Jen, Scott D., Kuys, Suzanne S., Kamp, Maarten C. and Reed, Lloyd F.. (2015). Prevalence of foot disease and risk factors in general inpatient populations: A systematic review and meta-analysis. BMJ Open. 5(11), pp. 1 - 15. https://doi.org/10.1136/bmjopen-2015-008544
Clinically important improvements in motor function are achievable during inpatient rehabilitation by stroke patients with severe motor disability : A prospective observational study
Hayward, Kathryn, Kuys, Suzanne, Barker, Ruth and Brauer, Sandra. (2014). Clinically important improvements in motor function are achievable during inpatient rehabilitation by stroke patients with severe motor disability : A prospective observational study. NeuroRehabilitation. 34(4), pp. 773 - 779. https://doi.org/10.3233/NRE-141076
Gait speed in ambulant older people in long term care : A systematic review and meta-analysis
Kuys, Suzanne, Peel, Nancye, Klein, Kerenaftali, Slater, Alexandra and Hubbard, Ruth. (2014). Gait speed in ambulant older people in long term care : A systematic review and meta-analysis. Journal of the American Medical Directors Association (JAMDA) (print). 15(3), pp. 194 - 200. https://doi.org/10.1016/j.jamda.2013.10.015
The Queensland High Risk Foot Form (QHRFF) - Is it a reliable and valid tool for foot disease?
Lazzarini, Peter A., Ng, Vanessa, Kinnear, Ewan M., Kamp, Maarten C., Kuys, Suzanne S., Hurst, Cameron and Reed, Lloyd F.. (2014). The Queensland High Risk Foot Form (QHRFF) - Is it a reliable and valid tool for foot disease? Journal of Foot and Ankle Research. 7(7), pp. 1 - 18. https://doi.org/10.1186/1757-1146-7-7
The Queensland high risk foot form (QHRFF) - is it a reliable and valid clinical research tool for foot disease?
Lazzarini, Peter A., Ng, Vanessa, Kinnear, Ewan, Kamp, Maarten C., Kuys, Suzanne Shanelle, Hurst, Cameron and Reed, Lloyd. (2014). The Queensland high risk foot form (QHRFF) - is it a reliable and valid clinical research tool for foot disease? Journal of Foot and Ankle Research. 7(1), pp. 1 - 18. https://doi.org/10.1186/1757-1146-7-7
Use and validation of the balance outcome measure for elder rehabilitation in acute care
Kuys, Suzanne, Crouch, Tom, Dolecka, Urszula, Steele, Michael and Low Choy, Nancy. (2014). Use and validation of the balance outcome measure for elder rehabilitation in acute care. New Zealand Journal of Physiotherapy. 42(1), pp. 16 - 21.
Factors affecting the ability of the stroke survivor to drive their own recovery outside of therapy during inpatient stroke rehabilitation
Eng, Xue Wen, Brauer, Sandra, Kuys, Suzanne, Lord, Matthew and Hayward, Kathryn. (2014). Factors affecting the ability of the stroke survivor to drive their own recovery outside of therapy during inpatient stroke rehabilitation. Stroke Research and Treatment. https://doi.org/10.1155/2014/626538
Factors affecting the ability of the stroke survivor to drive their own recovery outside of therapy during inpatient stroke rehabilitation
Eng, Xue Wen, Brauer, Sandra, Kuys, Suzanne Shanelle, Lord, Matthew and Hayward, Kathryn. (2014). Factors affecting the ability of the stroke survivor to drive their own recovery outside of therapy during inpatient stroke rehabilitation. Stroke Research and Treatment. https://doi.org/10.1155/2014/626538
Development and preliminary validation of the Acute Brain Injury Physiotherapy Assessment (ABIPA)
Gesch, Janelle, Low Choy, Nancy, Weeks, Benjamin, Passier, Leanne, Nascimento, Margarida, Haines, Terry and Kuys, Suzanne. (2014). Development and preliminary validation of the Acute Brain Injury Physiotherapy Assessment (ABIPA). Brain Impairment. 15(2), pp. 132 - 145. https://doi.org/10.1017/BrImp.2014.13
Activity limitations experienced by people with stroke who received inpatient rehabiliation: Differences between 2001, 2005, and 2011
Kuys, Suzanne Shanelle, Bew, Paul, Lynch, Mary and Brauer, Sandy. (2014). Activity limitations experienced by people with stroke who received inpatient rehabiliation: Differences between 2001, 2005, and 2011. Archives of Physical Medicine and Rehabilitation. 95(4), pp. 741 - 746. https://doi.org/10.1016/j.apmr.2013.12.008
The health outcomes and costs of people attending an interdisciplinary chronic disease service in regional Australia: protocol for a longitudinal cohort investigation
Tyack, Zephanie, Frakes, Kerrie-Anne, Cornwell, Petrea, Kuys, Suzanne, Barnett, Adrian and McPhail, Steven. (2013). The health outcomes and costs of people attending an interdisciplinary chronic disease service in regional Australia: protocol for a longitudinal cohort investigation. BMC Health Services Research. 13(410), pp. 1 - 7. https://doi.org/10.1186/1472-6963-13-410
Physiotherapy students find guided journals useful to develop reflective thinking and practice during their first clinical placement : A qualitative study
Constantinou, Maria and Kuys, Suzanne. (2013). Physiotherapy students find guided journals useful to develop reflective thinking and practice during their first clinical placement : A qualitative study. Physiotherapy (print). 99(1), pp. 49 - 55. https://doi.org/10.1016/j.physio.2011.12.002
Feasibility of an interdisciplinary early intervention for patients with low levels of responsiveness following an acquired brain injury
Seeto, Treena, Kuys, Suzanne Shanelle, Budden, Cassandra, Griffin, Erin, Kajewski, Haylee and McPhail, Steven. (2013). Feasibility of an interdisciplinary early intervention for patients with low levels of responsiveness following an acquired brain injury. Brain Impairment. 14(2), pp. 213 - 221. https://doi.org/10.1017/BrImp.2013.20
Frequency of urinary incontinence in people with chronic heart failure
Hwang, Rita, Chuan, Francine, Peters, Robyn and Kuys, Suzanne. (2013). Frequency of urinary incontinence in people with chronic heart failure. Heart & Lung: the journal of acute and critical care. 42(1), pp. 26 - 31. https://doi.org/10.1016/j.hrtlng.2012.08.003
Feasibility of an interdisciplinary early intervention for patients with low levels of responsiveness following an acquired brain injury
Seeto, Treena, Kuys, Suzanne, Budden, Cassandra, Griffin, Erin, Kajewski, Haylee and McPhail, Steven. (2013). Feasibility of an interdisciplinary early intervention for patients with low levels of responsiveness following an acquired brain injury. Brain Impairment. 14(2), pp. 213 - 221. https://doi.org/10.1017/BrImp.2013.20
Frequency of urinary incontinence in people with chronic heart failure
Hwang, Rita, Chuan, Francine, Peters, Robyn and Kuys, Suzanne Shanelle. (2013). Frequency of urinary incontinence in people with chronic heart failure. Heart & Lung: the journal of acute and critical care. 42(1), pp. 26 - 31. https://doi.org/10.1016/j.hrtlng.2012.08.003
Feasibility of gaming console exercise and its effect on endurance, gait and balance in people with an acquired brain injury
McClanachan, Nelson, Gesch, Janelle, Wuthapanich, Nampech, Fleming, Jennifer and Kuys, Suzanne Shanelle. (2013). Feasibility of gaming console exercise and its effect on endurance, gait and balance in people with an acquired brain injury. Brain Injury. 27(12), pp. 1402 - 1408. https://doi.org/10.3109/02699052.2013.823654
Feasibility of gaming console exercise and its effect on endurance, gait and balance in people with an acquired brain injury
McClanachan, Nelson, Gesch, Janelle, Wuthapanich, Nampech, Fleming, Jennifer and Kuys, Suzanne. (2013). Feasibility of gaming console exercise and its effect on endurance, gait and balance in people with an acquired brain injury. Brain Injury. 27(12), pp. 1402 - 1408. https://doi.org/10.3109/02699052.2013.823654
What are the key conditions associated with lower limb amputations in a major Australian teaching hospital?
Lazzarini, Peter, O'Rourke, Sharon, Russell, Anthony, Clark, Damien and Kuys, Suzanne Shanelle. (2012). What are the key conditions associated with lower limb amputations in a major Australian teaching hospital? Journal of Foot and Ankle Research. 5(12), pp. 1 - 9. https://doi.org/10.1186/1757-1146-5-12
What are the key conditions associated with lower limb amputations in a major Australian teaching hospital?
Lazzarini, Peter, O'Rourke, Sharon, Russell, Anthony, Clark, Damien and Kuys, Suzanne. (2012). What are the key conditions associated with lower limb amputations in a major Australian teaching hospital? Journal of Foot and Ankle Research. 5(1), pp. 1 - 9. https://doi.org/10.1186/1757-1146-5-12
Activity level of hospital medical inpatients: An observational study
Kuys, Suzanne S., Dolecka, Urszula E. and Guard, Amanda. (2012). Activity level of hospital medical inpatients: An observational study. Archives of Gerontology and Geriatrics. 55(2), pp. 417 - 421. https://doi.org/10.1016/j.archger.2012.02.008
Can Wii work it out?
Cyarto, Elizabeth V., Kuys, Suzanne, Henwood, Tim R. and Blackberry, Irene. (2011). Can Wii work it out? Telecommunications Journal of Australia. 61(3), pp. 37.1 - 37.12.
Higher-intensity treadmill walking during rehabilitation after stroke in feasible and not detrimental to walking pattern or quality: A pilot randomized trial
Kuys, Suzanne S., Brauer, Sandra G. and Ada, Louise. (2011). Higher-intensity treadmill walking during rehabilitation after stroke in feasible and not detrimental to walking pattern or quality: A pilot randomized trial. Clinical Rehabilitation. 25(4), pp. 316 - 326. https://doi.org/10.1177/0269215510382928
Higher-intensity treadmill walking during rehabilitation after stroke in feasible and not detrimental to walking pattern or quality : A pilot randomized trial
Kuys, Suzanne, Brauer, Sandra and Ada, Louise. (2011). Higher-intensity treadmill walking during rehabilitation after stroke in feasible and not detrimental to walking pattern or quality : A pilot randomized trial. Clinical Rehabilitation. 25(4), pp. 316 - 326. https://doi.org/10.1177/0269215510382928
Appropriate seating for medical patients: An audit
Kuys, Suzanne, Dolecka, Urszula and Morrison, Carol. (2011). Appropriate seating for medical patients: An audit. Australian Health Review. 35(3), pp. 316 - 319. https://doi.org/10.1071/AH10943
Changes in falls risk factors for geriatric diagnostic groups across inpatient, outpatient and domiciliary rehabilitation settings
Morrison, Gregory, Lee, Huang-Ling, Kuys, Suzanne, Clarke, Jane, Bew, Paul and Haines, Terry. (2011). Changes in falls risk factors for geriatric diagnostic groups across inpatient, outpatient and domiciliary rehabilitation settings. Disability and Rehabilitation. 33(11), pp. 900 - 907. https://doi.org/10.3109/09638288.2010.514019
Trial of an allied health workload allocation model
Simmons, Nadine and Kuys, Suzanne. (2011). Trial of an allied health workload allocation model. Australian Health Review. 35(2), pp. 168 - 175. https://doi.org/10.1071/AH09860
Test-retest reliability of the GAITRite system in people with stroke undergoing rehabilitation
Kuys, Suzanne, Brauer, Sandra and Ada, Louise. (2011). Test-retest reliability of the GAITRite system in people with stroke undergoing rehabilitation. Disability and Rehabilitation. 33(19-20), pp. 1848 - 1853. https://doi.org/10.3109/09638288.2010.549895
Appropriate seating for medical patients: An audit
Kuys, Suzanne S., Dolecka, Urszula E. and Morrison, Carol A.. (2011). Appropriate seating for medical patients: An audit. Australian Health Review. 35(3), pp. 316 - 319. https://doi.org/10.1071/AH10943
Gaming console exercise and cycle or treadmill exercise provide similar cardiovascular demand in adults with cystic fibrosis : A randomised cross-over trial
Kuys, Suzanne, Hall, Kathleen, Peasey, Maureen, Wood, Michelle, Cobb, Robyn and Bell, Scott. (2011). Gaming console exercise and cycle or treadmill exercise provide similar cardiovascular demand in adults with cystic fibrosis : A randomised cross-over trial. Journal of Physiotherapy. 57(1), pp. 35 - 40. https://doi.org/10.1016/S1836-9553(11)70005-4
Trial of an allied health workload allocation model
Simmons, Nadine and Kuys, Suzanne Shanelle. (2011). Trial of an allied health workload allocation model. Australian Health Review. 35(2), pp. 168 - 175. https://doi.org/10.1071/AH09860
Dose-response relationship between physiotherapy resource provision with function and balance improvements in patients following stroke : A multi-centre observational study
Haines, Terry, Kuys, Suzanne, Clarke, Jane, Morrison, Gregory and Bew, Paul. (2011). Dose-response relationship between physiotherapy resource provision with function and balance improvements in patients following stroke : A multi-centre observational study. Journal of Evaluation in Clinical Practice. 17(1), pp. 136 - 142. https://doi.org/10.1111/j.1365-2753.2010.01380.x
Higher-intensity treadmill walking during rehabilitation after stroke in feasible and not detrimental to walking pattern or quality: A pilot randomized trial
Kuys, Suzanne, Brauer, Sandra and Ada, Louise. (2011). Higher-intensity treadmill walking during rehabilitation after stroke in feasible and not detrimental to walking pattern or quality: A pilot randomized trial. Clinical Rehabilitation. 25(4), pp. 316 - 326. https://doi.org/10.1177/0269215510382928