Kris McGill, Jon Godwin, Catherine Sackley, Marian C Brady Efficiency of recruitment to stroke rehabilitation RCTs Secondary analysis of recruitment data Kris McGill, Jon Godwin, Catherine Sackley, Marian C Brady CSO funded research department Don’t mention supervisors

Stroke Incidence Rates Over 152,000 people suffer from a stroke each year Over 1.2 million stroke survivors in the UK Survivors experience varying degrees of impairments and rehabilitation needs Stroke Association. State of a Nation Stroke Statistics. 2016

Stroke Impairment Impairment % Upper limb weakness 77% Aphasia 33% Lower limb weakness 72% Slurred speech 50% Visual problems 60% Depression Facial weakness 54% Bowel control Bladder control Dementia 30% Swallowing These % are from soon after stroke. But many impairments continue to have an affect indefinitely. Stroke Association. State of a Nation Stroke Statistics. 2016

Stroke Rehabilitation Rehabilitation is key for recovery and return to life after stroke (Stroke unit Trialists’ Collaboration, 1997) RCTs are used to test the effectiveness of rehabilitation interventions RCTs adopt formal methods that reduce the chances of bias RCTs have high internal validity We all know that RCTs… Stroke unit Trialists’ Collaboration. (1997). BMJ, 314(7088).

Recruitment Successful recruitment to RCTs is essential for effective evaluation of treatment effects Power: Adequate sample sizes essential for confidence in statistics Research waste: inadequate recruitment key contributor Poor estimations: Informed estimates of recruitment efficiency lead to more cost efficient trials

Haidich et al. BMC medical research methodology, 2001. Foy et al. Family Practice, 2003. 20(1). McDonald et al. Trials, 2006. 7(1). Treweek et al. BMJ open, 2013. 3(2).

Recruitment speed for stroke trials Elkins et al (2006) recruitment of acute (up to 1 month after stroke) stroke survivors for pharmacological trials Recruitment speed: 0.79 participants per site per month Trials conducted in one country were more efficient than international trials Elkins, J.S. Stroke, 2006. 37(1).

Research aims Extent of the problem with recruitment rate, speed and dropout in stroke rehabilitation trials Effects of trial features potentially associated with recruitment CONSORT reporting standards

Methods Stroke RCTs (2005 to 2015) No language restrictions Cochrane Stroke Trials Register Inclusion criteria: Stroke survivors only Non-pharmacological Rehabilitation interventions - Reflective of clinical practice - Administered by stroke rehabilitation team - Targeting stroke related impairment Cochrane stroke trials register comprehensive. Includes 35 electronic databases, most trial register, hand searching of grey literature

Data Extraction Country of recruitment Funding support Year of publication Ethical approval Trial size Type of intervention Stroke survivor’s living context Targeted impairment Control condition Recruitment strategy Stage of stroke rehabilitation Profession of the recruiter Number of recruiting staff

Recruitment Efficiency Rate of recruitment = 𝑛 𝑅𝑎𝑛𝑑𝑜𝑚𝑖𝑠𝑒𝑑 𝑛 𝑆𝑐𝑟𝑒𝑒𝑛𝑒𝑑 Speed of recruitment per site= ( 𝑛 𝑅𝑎𝑛𝑑𝑜𝑚𝑖𝑠𝑒𝑑 𝑅𝑒𝑐𝑟𝑢𝑖𝑡𝑚𝑒𝑛𝑡 𝑡𝑖𝑚𝑒 (𝑀𝑜𝑛𝑡ℎ𝑠) ) 𝑛 𝑆𝑖𝑡𝑒𝑠 Dropout rate = 𝑛 𝐷𝑟𝑜𝑝𝑜𝑢𝑡 𝑛 𝑅𝑎𝑛𝑑𝑜𝑚𝑖𝑠𝑒𝑑

Secondary Outcomes CONSORT diagram adherence Coded with a traffic light system Not reported Partially reported Reported

PRISMA Diagram

Countries Included (N=47)

CONSORT diagram reporting

Recruitment efficiency - participants, rate, speed, dropouts   RCTs =512 Mean (n) SD min-max Stroke survivors Screened 321 320.88 536.87 8 - 4909 Randomised 512 56.26 86.02 4 - 1209 Mean Recruitment Time (months) 305 21.87 17.8 1 - 152 Rate .40 .28 .02 - 1 Speed 242 3.03 4.93 .08 - 40 Dropout 414 .09 .11 .00 - .83 Sites 363 2.55 5.69 1 - 71

RATE: Trial features that have had a significant effect Kruskal- Wallis p RCTs Rate Stroke survivor living context X2(3)= 10.11 p= .018 239 Recruitment strategy X2(2)= 10.34 p= .006 167 Number of recruiters X2(2)= 6.06 p= .048 133 Stage of rehab X2(5)= 16.82 p= .005 300    

RATE: Trial features that have not had a significant results Kruskal-Wallis p RCT RATE Publication date X2(1)= .1 p= .318 321 Continent of recruitment X2(2)= 5.06 p= .08 283 Trial size X2(4)= 5.5 p= .240 Profession of recruiter X2(3)= 2.02 p= .568 171 Recruiters per site X2(3)= 1.78 p= .620 116 Type of intervention X2(1)= 2.19 p= .139 315 Funding support X2(6)= 6.42 p= .378 257 Ethical approval X2(2)= 1 p= .606 248 Targeted impairment X2(3)= 5.62 p= .132 Control condition X2(2)= .98 p= .612

(p= .035) (p= .001)

(p= .025)

(p= .001) (p= .003) (p= .03)

SPEED: Trial features that have had a significant effect Kruskal- Wallis p RCTs Speed Trial size X2(4)= 15.07 p= .005 242 Continent of recruitment X2(2)= 24.21 p= > .001 283 Recruiters per site X2(3)= 15.97 p= .001 122 Targeted impairment X2(3)= 14.97 p= .002 241  

SPEED: Trial features that have not had a significant results Kruskal-Wallis p RCT SPEED Publication date X2(1)= .208 p= .648 242 Living context X2(2)= 1.495 p= .474 221 Recruitment strategy X2(2)= .49 p= .782 157 Profession of recruiter X2(3)= 2.02 p= .232 151 Recruiters per site X2(2)= 2.92 122 Type of intervention X2(1)= .01 p= .917 241 Funding support X2(6)= 9.97 p= .126 206 Ethical approval 193 Stage of stroke rehab X2(5)= 9.98 p= .076 226 Control condition X2(2)= 2.9 p= .235

(p= .008) (p= >.001) (p= .019) (p= .008)

(Both p= >.001)

(p= .001) (p= .008) (p= >.001)

Dropout: Trial features that have had a significant effect   Dropout: Trial features that have had a significant effect Trial feature Kruskal- Wallis p RCTs Dropout Publication date X2(1)= 10.73 p= .001 414 Trial size X2(4)= 25.38 Continent of recruitment X2(2)= 11.91 p= .003 354 Recruitment Strategy X2(2)= 6.09 p= .048 205  

Dropout: Trial features that have not had a significant results Kruskal-Wallis p RCT Dropout Living context X2(2)= .237 p= .888 344 Profession of recruiter X2(3)= 3.62 p= .306 198 Number of recruiters X2(2)= 1.34 p= .511 149 Recruiters per site X2(3)= .98 p= .805 128 Type of intervention X2(1)= .96 p= .327 395 Funding support X2(6)= 6.14 p= .407 310 Ethical approval X2(2)= 1.24 p= .537 309 Targeted impairment X2(3)= 3.94 p= .268 396 Stage of stroke rehab X2(5)= 9.41 p= .094 373 Control condition X2(2)= 1.67 p= .433

Make sure and say published not conducted.

(p= .002) (p= .005)

(p= .015)

RATE of recruitment Higher recruitment rate for studies recruiting stroke survivors living at home Higher recruitment rate when using 2 or 3 recruiters Higher recruitment rate when screening chronic (6 months after stroke and above) stroke survivors

SPEED of recruitment Small trials recruit slower One recruiter covering multiple sites appears much slower recruitment Trials in Asia recruit faster

Dropout Trials published more recently experience higher dropout Smaller trials retain participants more effectively Less dropout in trials conducted in Asia Higher dropout for studies screening admissions

Study strengths Extensive inclusion of stroke rehabilitation RCTs Large sample sizes for analysis Two authors screened and data extracted independently High degree of trialists participation (>40%)

Limitations Reliant on authors descriptions of trial feature Missing data due to lack of reporting of recruitment details Despite limitations, this study will hopefully improve recruitment through more accurate estimations of recruitment Rate, Speed, and Dropout

Kris McGill Email: kris.mcgill@gcu.ac.uk Twitter: @krismcgil