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The Taking Charge after Stroke (TaCAS) study protocol: A multicentre, investigator-blinded, randomised controlled trial comparing the effect of a single Take Charge session, two Take Charge sessions and control intervention on health-related quality of life 12 months after stroke for non-M? ori, non-Pacific adult New Zealanders discharged to community living

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Abstract

Introduction Stroke is one of the leading causes of disability worldwide. Recent data support the possibility that person-centred, self-management interventions can reduce dependence after stroke. However, there is limited information on the generalisability and optimum dose of these interventions. Methods The Taking Charge After Stroke (TaCAS) study is a multicentre, investigator-blinded, randomised controlled trial recruiting 400 participants following acute stroke from seven hospitals in New Zealand. All patients discharged to community living who have ongoing symptoms at time of discharge (modified Rankin scale>0) will be eligible. Participants will be randomly assigned to one Take Charge session, two Take Charge sessions 6 weeks apart or control. Outcomes The primary outcome will be the Physical Component Summary score of the Short-Form 36 at 12 months post stroke. Secondary outcomes will include dependence (modified Rankin scale), performance in activities of daily living (Barthel Index) and carer strain (Caregiver Strain Index), at 6 and 12 months post stroke. All analyses will be conducted on an intention-to-treat basis. Ethics and dissemination The TaCAS study is funded by a Health Research Council of New Zealand grant. It has been approved by the Central Health and Disability Ethics Committee (15/CEN/115). Results will be published and presented at relevant stroke meetings within New Zealand and internationally, informing the use of a self-management intervention after stroke. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12615001163594. Date registered 02-11-2015. Medical Research Institute of New Zealand Registry TCS01. Universal trial number U1111-1171-4127.
1
Fu VWY, etal. BMJ Open 2017;7:e016512. doi:10.1136/bmjopen-2017-016512
Open Access
The Taking Charge After Stroke
(TaCAS) study protocol: a multicentre,
investigator-blinded, randomised
controlled trial comparing the effect of a
single Take Charge session, two Take
Charge sessions and control
intervention on health-related quality of
life 12 months after stroke for non-
Māori, non-Pacic adult New
Zealanders discharged to
community living
Vivian Wai Yin Fu,1 Mark Weatherall,2 Harry McNaughton1
To cite: FuVWY, WeatherallM,
McNaughtonH. The Taking
Charge After Stroke (TaCAS)
study protocol: a multicentre,
investigator-blinded,
randomised controlled trial
comparing the effect of a
single Take Charge session,
two Take Charge sessions
and control intervention on
health-related quality of life
12 months after stroke for
non-Māori, non-Pacic adult
New Zealanders discharged to
community living. BMJ Open
2017;7:e016512. doi:10.1136/
bmjopen-2017-016512
Prepublication history and
additional material are available.
To view these les please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2017-
016512).
Received 20 February 2017
Accepted 6 March 2017
For numbered afliations see
end of article.
Correspondence to
Dr Vivian Wai Yin Fu;
vivian. fu@ mrinz. ac. nz
Protocol
AbstrAct
Introduction Stroke is one of the leading causes of
disability worldwide. Recent data support the possibility
that person-centred, self-management interventions can
reduce dependence after stroke. However, there is limited
information on the generalisability and optimum dose of
these interventions.
Methods The Taking Charge After Stroke (TaCAS) study is
a multicentre, investigator-blinded, randomised controlled
trial recruiting 400 participants following acute stroke from
seven hospitals in New Zealand. All patients discharged
to community living who have ongoing symptoms at time
of discharge (modied Rankin scale>0) will be eligible.
Participants will be randomly assigned to one Take Charge
session, two Take Charge sessions 6 weeks apart or control.
Outcomes The primary outcome will be the Physical
Component Summary score of the Short-Form 36 at 12
months post stroke. Secondary outcomes will include
dependence (modied Rankin scale), performance in
activities of daily living (Barthel Index) and carer strain
(Caregiver Strain Index), at 6 and 12 months post stroke. All
analyses will be conducted on an intention-to-treat basis.
Ethics and dissemination The TaCAS study is funded
by a Health Research Council of New Zealand grant. It
has been approved by the Central Health and Disability
Ethics Committee (15/CEN/115). Results will be published
and presented at relevant stroke meetings within New
Zealand and internationally, informing the use of a self-
management intervention after stroke.
Trial registration Australia and New Zealand Clinical
Trials Registry ACTRN12615001163594. Date registered
02-11-2015. Medical Research Institute of New Zealand
Registry TCS01. Universal trial number U1111-1171-4127.
INTRODUCTION
Stroke is a sudden, devastating clinical event
that affects 15 million people worldwide each
year, leaving 5 million people permanently
Strengths and limitations of this study
This is a trial of a low-cost, practical intervention in
the community phase of stroke with the potential to
make a signicant difference to important outcomes
for people with stroke.
Few exclusion criteria and multicentre design with
relatively large number of participants will provide
good basis for generalisability of the results.
Our methodology has stringent safeguards for
data quality including a centralised randomisation
system, blinded outcomes assessment and an
electronic database that tracks all entries and locks
data.
Outcome measurements are obtained by an
assessor blinded to allocation; however participants
and research clinicians are unable to be blinded,
potentially leading to bias.
The 12–month follow-up limits the study to shorter-
term outcomes.
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disabled.1 Some current therapies may modify the acute
phase of stroke but their use is inappropriate for a large
proportion of patients and their effectiveness is limited.2 3
Despite early interventions, a high proportion of people
have substantial impairment, activity limitation and
participation restriction after routine stroke care. At least
half of stroke survivors remain dependent on others one
year after the stroke.4 Currently, there is little evidence
supporting the effectiveness and efficacy of communi-
ty-based therapies after stroke. Family support workers
and goal-setting strategies are examples of two partic-
ular interventions that have been tested in randomised
controlled trials but shown no benefit.5 6 Systematic
reviews of therapy-led interventions have shown a positive
effect on activities of daily living although with a small
effect size.7
Self-management intervention studies in stroke and
other conditions suggest that there is a positive effect
on patient outcomes.8–10 Self-management programmes
differ from education or skills training because they
emphasise enablement of individuals to take an active role
in managing their condition. This includes management
of psychosocial problems and lifestyle changes needed to
enhance quality of life.
A successful self-management programme is the 'Take
Charge Session' (TCS) intervention, which is a low-cost,
person-centred intervention undertaken after discharge
from an acute or rehabilitation hospital into the commu-
nity following acute stroke. This was tested against a
DVD-delivered educational intervention and control in
the Māori and Pacific Stroke study (MaPSS).11 In New
Zealand, 9000 people suffer stroke every year. Although a
relatively small proportion (15%) of those in New Zealand
who have a stroke are of Māori or Pacific ethnicity,
compared with other ethnic groups in New Zealand,
Māori and Pacific stroke patients are more likely to have
stroke at a younger age and have poorer outcomes after
12 months, even when adjusted for case-mix.4
In more detail MaPSS was a multicentre, randomised
controlled trial in which participants were randomised
to one of four arms: a TCS (delivered by an ethnic-ap-
propriate, trained layperson), a professionally produced
DVD of Māori and Pacific stroke survivor stories, both
the TCS and the DVD, or a control group who received
written stroke educational material. Outcomes were
assessed after 12 months for 80% of the 172 participants.
The TCS improved physical health-related quality of life,
dependence and caregiver strain. Those who received
the TCS session had a Physical Component Score of the
Short-Form 36 (PCS) of 6.0 (95% CI 2.0 to 10.0, p=0.004)
higher than those who did not. The TCS also reduced
dependence on others (modified Rankin scale (mRS) >2)
for activities of daily living, OR 0.42 (95% CI 0.2 to 0.89),
p=0.023. The number needed to treat to prevent one
person becoming dependent was 10.
We hypothesise that the TCS could improve physical
outcomes in New Zealand stroke survivors of all ethnici-
ties, and that two exposures to TCS may be more effective
than one. This target population for the intervention
includes all stroke survivors discharged to community
living after inpatient hospital care. This represents about
60% of all patients with acute stroke in New Zealand,
which is >5000 people per year. To test this hypothesis, the
present study (TaCAS) will determine whether the TCS
session improves outcomes in New Zealand stroke survi-
vors who are non-Māori and non-Pacific, and whether two
TCS episodes are more effective than one. This paper
outlines the study protocol for the TaCAS study and
follows the SPIRIT guidelines see online supplementary
table.12
METHODS
TaCAS is proposed to be a prospective, single-country,
multicentre, parallel-group, blinded outcome assessed,
randomised controlled trial of 400 patients with a new
diagnosis of acute stroke. Patients will be screened for eligi-
bility by local researchers in seven New Zealand hospitals
using the inclusion and exclusion criteria listed in box 1.
The screening researcher will be either the stroke nurse
or doctors of the stroke team, or the principal investigator
depending on the centre. In hospital, this researcher will
explain the study and provide a participant information
sheet to eligible patients and determine their stroke
severity using Barthel Index (BI) at days 3–5 after stroke.
In the presence of conditions such as aphasia or cogni-
tive impairment, the patient’s ability to understand the
study—and therefore to consent—will be determined by
the screening researcher. The hospitals are geograph-
ically dispersed and range from semirural (secondary)
to regional (quaternary) units. The trial study sites are
listed in table 1. Māori and Pacific stroke patients have
been excluded from TaCAS as it would be unethical to
Table 1 Trial sites
Principal
investigator Centre City
District
Health
Board
Dr Harry
McNaughton
Wellington
Regional Hospital
Wellington Capital and
Coast
Dr Harry
McNaughton
Dr Tom
Thomson
Hutt Hospital Lower Hutt Hutt Valley
Dr Carl
Hanger
Princess Margaret
Hospital/Burwood
Hospital
Christchurch Canterbury
Anna McRae Auckland City
Hospital
Auckland Auckland
Dr Geoff
Green
Middlemore
Hospital
South
Auckland
Counties
Manukau
Dr Anna
Ranta
Palmerston North
Hospital
Palmerston
North
MidCentral
Dr John
Gommans
Hawkes Bay
Hospital
Hastings Hawkes
Bay
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randomise these patients to a control arm when MaPSS
demonstrated that they benefit from the intervention.
Patients will receive diagnostic procedures, treatment
and rehabilitation as per local practice, not influenced
in any way by the study. Patients who express interest in
participating will be followed until their date of discharge.
Those discharged into community living (not rest home
or hospital-level care) will be telephoned within two weeks
to arrange a baseline home visit with a research clinician.
This research clinician may be a nurse, physiotherapist
or occupational therapist, who is trained in the delivery
of the TCS. The research clinician must complete this
visit within a 16-week window from date of stroke, which
allows for time spent in inpatient rehabilitation.
Randomisation
At the baseline home visit, the research clinician will
explain the study to the participant. Informed consent will
be obtained based on the International Conference on
Harmonisation Good Clinical Practices guidelines prior
to randomisation. No one will consent on behalf of partic-
ipants in TaCAS, that is, proxy consent is not permitted.
Once consented, the research clinician randomises the
participant to one of the two interventions or to control
by opening a sealed, opaque envelope containing allo-
cation. An independent statistician (MW) is responsible
for the computer-generated allocation sequence used to
create the envelopes, which are consecutively numbered
and delivered to each site in blocks of 18.
Prior to randomisation, all participants undergo a base-
line assessment, which includes patient demographics,
poststroke dependence measured by the mRS,13 activi-
ties of daily living by the BI,14 extended activities of daily
living by the Frenchay Activities Index (FAI),15 health-re-
lated quality of life by the Short-Form 12 (SF-12v2)16 and
EuroQOL EQ-5D (EQ-5D),17 depression by the Patient
Health Questionnaire-2 (PHQ-2),18 activation by the
Patient Activation Measure (PAM),19 as well as stroke-re-
lated risk factors and medications. Current support,
outpatient rehabilitation service involvement and work
situation will all be recorded.
After the baseline assessment, but at the same visit,
participants receive their allocated intervention: either
a TCS or control. The study flow chart is presented in
figure 1.
Intervention arms
Prior to their involvement in TaCAS, all research clini-
cians undergo training focused on the rationale and
delivery of the TCS. Research clinicians are trained to
encourage participants to ask and answer their own ques-
tions, and to form their own ideas. Time spent listening to
participants is emphasised, in particular allowing them to
consider and express their hopes, fears and priorities. By
gently reflecting the participant’s own thoughts, the TCS
attempts to avoid shaping the patient’s goals, a process
that can occur in therapist-led goal-setting.20 Research
clinicians are discouraged from suggesting goals so that
the focus remains on what the participant wants, rather
than what is perceived to be doable. Using a structured
workbook allows participants to write down any forth-
coming goals and intermediate steps, and to see this as an
ongoing process that they can review in their own time; in
essence, ‘Taking Charge’ of their own recovery. The inter-
vention takes between 60 and 80 min to complete. The
headings within the workbook include Who I Really Am,
Hopes and Aspirations, Main Fears, My Best Day, Physical
Needs, Communication, Emotional Issues, Information
Needs, Financial Issues, My Support Network and Stroke
Prevention. The two intervention arms are distinguished
in box 2.
Control arm
After the baseline assessment, these participants will
receive educational pamphlets produced by the Stroke
Foundation of New Zealand. All aspects of routine stroke
care, in particular contact with rehabilitation services, will
be unchanged by participation.
Outcomes
The primary outcome is physical functioning as deter-
mined by the PCS of SF-36 at 12 months after stroke.21
Participants will be followed 6 months after stroke with a
questionnaire which will be delivered by telephone, post
or by the internet. A blinded outcomes assessor, who will
attempt to confirm incomplete responses by a telephone
call, will gather all the questionnaire information. At 12
months after stroke, the blinded outcomes assessor will
visit participants in person to complete follow-up. Box 3
describes the primary and secondary outcomes as well as
the predefined subgroup analyses.
The SF-36 is a psychometrically robust self-reported
measure of health status that is validated in multiple
conditions, including stroke. The PCS assigns weights to
responses about physical ability, the impact of physical
health, pain and general health perceptions to give a
composite score. The PCS score has an observed mean of
between 38 and 39, 12 months after stroke in Australasian
stroke studies.22 It was responsive to the TCS in the MaPSS
study, in which the difference between mean-adjusted
12-month PCS scores exceeded the Minimal Clinically
Important Difference of 5 points.
Table 2 summarises timing of the assessments.
Research clinicians will write data from their visits onto
paper forms, which are then scanned and sent to the
data management team for entry onto a secure, online
database. Each participant is identified by a unique iden-
tifier with only the central site at the Medical Research
Institute of New Zealand (MRINZ) holding the master
log of names.
Attempts will be made to obtain mRS and SF-36 data at
12 months by telephone from participants who discon-
tinue or deviate from the intervention protocol. If this
is not possible, data about living situation and level of
disability (mRS) will be obtained from the participant’s
general practitioner.
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Risks to internal validity
The main risks to internal validity are threats to the
fidelity of the intervention and unblinding. Site initiation
and subsequent site training visits by the Coordinating
Investigator, as well as 6-monthly teleconferences between
research clinicians and the study team, will allow moni-
toring of the fidelity of the TCS. Research clinicians are
encouraged to document specific problems encountered
Figure 1 TaCAS study ow chart depicting interventions and outcome measurements. BI, Barthel Index; CSI, Caregiver Strain
Index; EQ-5D-5L, EuroQol 5-Dimensional, 5 Levels; FAI, Frenchay Activities Index; mRS, modied Rankin scale; PAM, Patient
Activation Measure; PHQ-2, Patient Health Questionnaire 2; SF-12v2, Short Form 12 version 2; SF-36, Short Form 36; TCS,
Take Charge Session.
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during the TCS although the participant keeps the TCS
workbook as part of the intervention. Due to the personal
nature of its contents, the workbook will not be collected
or analysed. A central email account is checked daily for
questions from research clinicians, and the principal
investigator will answer urgent questions immediately by
telephone. These queries form a Frequently Asked Ques-
tions section in a monthly newsletter to all the sites.
Blinding is maintained by employing a single-blinded
outcomes assessor who will visit participants at each site.
The blinded outcomes assessor will have an office that is
physically separate from the office of the local research
clinicians, and the specific online database user profile
allows access only to demographic and outcomes data.
Participants are asked not to disclose details of home
visits to the blinded outcomes assessor, and intervention
participants are asked to hide the TCS workbook when
the blinded outcomes assessor visits.
Sample size calculation and statistical analysis
In MaPSS, the root mean square error for the PCS was
10.8. The clinically significant difference for PCS is five.
A total sample size of 360, 120 in each of three arms, has
90% power to detect this difference. With provision for
10% drop out, we plan to recruit 400 participants. Expe-
rience in MaPSS has allowed prediction that TaCAS will
complete recruitment in mid-2017.
All outcomes will be analysed using the intention-to-
treat principle. Our primary analysis of the difference in
mean PCS (between both Take Charge groups and control,
and between high-dose Take Charge and low-dose Take
charge) will be by analysis of variance. We will use analysis
of covariance (ANCOVA) to analyse the Take Charge dose
response as a continuous predictor. A further analysis will
adjust for baseline variables including baseline PCS, age
and gender. We will use also ANCOVA for our prespeci-
fied subgroup analyses using an interaction term between
randomised treatment and each of stroke severity, site, age,
gender, living situation, type of stroke, thrombolysis and
fluoxetine use. The mRS will be analysed as dichotomous
(0–2 compared with 3–5) and by ordinal logistic regression.
We plan to undertake a meta-analysis of individual
patient data from TaCAS and the MaPSS study to compare
the TCS against control, using PCS at 12 months after
stroke in a linear mixed model meta-analysis. We will also
assess combined dependency based on mRS in a gener-
alised linear mixed model.
Finally, we will undertake a cost-utility analysis of the
TCS using employment and earning information, cost to
the carer and health-related quality of life.
Box 1 Inclusion and exclusion criteria
Inclusion criteria
Non-Māori, non-Pacic adults>16 years of age with acute ischaemic
stroke or intracerebral haemorrhage (WHO denition)
Discharged from hospital to non-institutional, community living
situation
Modied Rankin score>0
Exclusion criteria
Inability to provide informed consent
Unlikely to survive beyond 12 months
Box 2 Interventions
1 TCS
A person-centred, self-directed session designed to engage the
participant in the process of recovery, guided by a workbook. The
research clinician is trained to facilitate the process by listening and
supporting any forthcoming ideas.
2 TCS second arm
The initial TCS will be undertaken, followed by a second TCS
approximately six weeks after. The second ‘dose’ of the session
allows time for the participant to express new, interim ideas that
may have formed, and to reect upon their progress.
Box 3 Primary and secondary outcomes and proposed
subgroup analyses for theTaking Charge After Stroke
study
Primary outcome
Physical Component Summary score of Short-Form 36 at 12 months
after stroke
Secondary outcomes
At 6 months after stroke
Telephone-based, written postal or internet-administered
questionnaire assessment of
Physical Component Summary score of the Short-Form 12 version
2 (PCS of SF-12v2)
Activities of daily living: Barthel Index (BI)
Instrumental activities of daily living: Frenchay Activities Index (FAI)
Level of function: modied Rankin scale (mRS)
Depression: Patient Health Questionnaire-2 (PHQ-2)
Level of activation: Patient Activation Measure (PAM)
Health-Related Quality of Life: WHO Quality of Life Assessment and
euroQol Five-Dimensional scores (EuroQOL EQ-5D)
Carer strain: Caregiver Strain Index (CSI)
Contact with rehabilitation service
Hospitalisations
At 12 months after stroke
Face-to-face assessment of
BI, FAI, mRS, PHQ-2, PAM, EuroQOL EQ-5D, CSI, rehabilitation
contact or hospitalisations
Predened subgroups
Stroke severity: patients with BI at 3–5 days after stroke grouped
severe (0–7), moderate (8–13) and mild (14–20)
Sites (all centres and tertiary centre vs not)
Age (<75 years vs 75+ years)
Patients taking uoxetine at baseline
Patients with signicant communication disorder (vs none/mild)
Patients with signicant cognitive disorder (vs none/mild)
Self-reported purpose/autonomy/mastery/connectedness level
Patients with different levels of patient activation based on PAM
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Data collection and study management
The baseline data will be collected on paper forms by
research clinicians at the initial home visits. These forms
are scanned and sent to the data management team
based at MRINZ for entry into a secure, online database.
This database is designed to maintain complete blinding
of the outcomes assessor. The data management team at
MRINZ performs double data entry of the baseline visit
data. Participants undertaking the 6-month questionnaire
online will enter their data directly onto this database.
The blinded outcomes assessor will enter the 6-month
data obtained by telephone or posted questionnaire. The
blinded outcomes assessor will also enter the 12-month
data onto the database by an electronic tablet at the final
home visit. This web-based data management system
allows allocation concealment, locking of completed
entries and ad hoc consistency checks by study monitors.
The TCS has no known harms associated. We plan to
report the following serious adverse events (SAEs): death,
life-threatening event, permanently disabling or incapac-
itating event, hospitalisation and any significant medical
event considered serious by the study investigator.
All SAEs will be reported to the New Zealand Central
Health and Disability Ethics Committee of New Zealand
(HDEC) in accordance with current guidelines, as well
as to the MRINZ within 24 hours of the study investiga-
tors becoming aware of the event. AE data are collected
at each follow-up and during the study period if the
participant or their next-of-kin notify the research team.
No interim analysis, for either effectiveness or harm, is
planned prior to completion of the study. There are no
current data available for data sharing.
There are no specific plans for independent auditing
of this study; however, MRINZ research staff and online
database will ensure there is a complete audit trail for
external auditing, in the event this is required.
ETHICS AND DISSEMINATION
TaCAS will be conducted in compliance with relevant
New Zealand legislation including the Health Informa-
tion Privacy Code, the Health and Disability Code and
the New Zealand Bill of Rights Act. Ethics approval has
been provided by the HDEC, reference 15/CEN/115 and
at the research office at each local site. Protocol amend-
ments will first be approved by the HDEC and then by
local ethics committees before implementation. The
current approved protocol version is version 9.1, dated
20 February 2017.
Research clinicians will obtain informed consent from
the participant when understanding of the study’s under-
takings has been demonstrated. The participant ‘making
a mark’ on the consent form will be accepted. Proxy
consent by a surrogate will not be accepted.
To maintain confidentiality, participant information
will be kept in the locked, central data office at MRINZ as
well as at each local site in locked offices. The online data-
base is password-protected and located on an encrypted
server belonging to REDCap. Source data from TaCAS
will be kept in secure premises for 15 years after comple-
tion of the study, then it will be destroyed.
The day-to-day management of the trial is undertaken
by a management committee comprised of the principal
investigator, Dr Harry McNaughton, the study coordinator,
Dr Vivian Fu, project manager, Tanya Baker, and a team
of researchers based at MRINZ. These individuals, as well
as our statistician, Dr Mark Weatherall, will have access to
the final trial dataset. The TaCAS Study Group meets on
an ‘as-required’ basis with regular updates via newsletters
and email. The majority of members meet regularly for
national stroke and rehabilitation working groups, study
days and conferences where progress and issues with the
trial are discussed. Neither the principal investigator nor
site investigators have competing interests.
Table 2 Timing of assessments
Randomisation (visit 1) 1/3 have 2 TCS (visit 2) Follow-up 1 Follow-up 2
Time since stroke 6–12 weeks 6 weeks after
randomisation
6 months 12 months
Clinical examination and
risk factors*
X X X
Current medications X X X
Medication adherence X
Rehabilitation, support,
work information
X X X X
SF-36v2 X
SF-12v2 X X X
mRS, BI, FAI, PHQ-2,
EuroQOL EQ-5D, PAM,
CSI
X X X X
*Includes heart rate, heart rhythm, blood pressure, height and weight, smoking status, diabetes, anticoagulation status.
BI, Barthel Index; CSI, Caregiver Strain Index; EQ-5D, euroQol Five-Dimensional scores; FAI, Frenchay Activities Index; mRS, modied Rankin
scale; PAM, Patient Activation Measure; PHQ-2, Patient Health Questionnaire-2; SF-12v2, Short-Form 12 version 2; SF-36v2, Short-Form 36
version 2; TCS, Take Charge Session.
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All members of the TaCAS Study Group will contribute
to, and be acknowledged in, the primary trial manuscript.
The HRC funding will be acknowledged in all publi-
cations. Results will also be presented at national and
international stroke meetings, including the National
Stroke Rehabilitation Working Group and National
Stroke Clinical Working Group meetings. Those partici-
pants who have indicated their desire to receive results of
the study will have these sent to them.
Trial status
The first patient was randomised on 24 October 2015 and
recruitment is expected to complete by June 2017. Study
recruitment is continuing as planned.
Author afliations
1Medical Research Institute of New Zealand, Wellington, New Zealand
2University of Otago, Wellington, New Zealand
Contributors HM conceived the study. HM, VF and MW contributed to the study
design. VF collected the data. HM, VF and MW will be responsible for data analysis
and interpretation. VF drafted this protocol, and HM and MW contributed equally
to its critical review. VF, MW and HM have given nal approval of this version to be
published.
Funding This work was supported by the Health Research Council (HRC) of New
Zealand (grant 15/297). The HRC had no role in the preparation or decision to
publish of this protocol.
Competing interests None declared.
Ethics approval New Zealand Health and Disability Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Open Access This is an Open Access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited and the use is non-commercial. See: http:// creativecommons. org/
licenses/ by- nc/ 4.0/
© Article author(s) (or their employer(s) unless otherwise stated in the text of the
article) 2017. All rights reserved. No commercial use is permitted unless otherwise
expressly granted.
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discharged to community living
non-Maori, non-Pacific adult New Zealanders
quality of life 12 months after stroke for
and control intervention on health-related
Charge session, two Take Charge sessions
trial comparing the effect of a single Take
investigator-blinded, randomised controlled
study protocol: a multicentre,
The Taking Charge After Stroke (TaCAS)
Vivian Wai Yin Fu, Mark Weatherall and Harry McNaughton
doi: 10.1136/bmjopen-2017-016512
2017 7: BMJ Open
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Supplementary resource (1)

Article
Stroke can cause significant disability and impact quality of life. Multidisciplinary neurorehabilitation that meets individual needs can help to optimise recovery. Rehabilitation is essential for best quality care but should start early, be ongoing and involve effective teamwork. We describe current stroke rehabilitation processes, from the hyperacute setting through to inpatient and community rehabilitation, to long-term care and report on which UK quality care standards are (or are not) being met. We also examine the gap between what stroke rehabilitation is recommended and what is being delivered, and suggest areas for further improvement.
Article
Objective To undertake an economic analysis of the Take Charge intervention as part of the Taking Charge after Stroke (TaCAS) study. Design An open, parallel-group, randomised trial comparing active and control interventions with blinded outcome assessment Setting Community. Participants Adults ( n = 400) discharged to community, non-institutional living following acute stroke. Interventions The Take Charge intervention, a strengths based, self-directed rehabilitation intervention, in two doses (one or two sessions), and a control intervention (no Take Charge sessions). Measures The cost per quality-adjusted life year (QALY) saved for the period between randomisation (always post hospital discharge) and 12 months following acute stroke. QALYs were calculated from the EuroQol-5D-5L. Costs of stroke-related and non-health care were obtained by questionnaire, hospital records and the New Zealand Ministry of Health. Results One-year post hospital discharge cost of care was mean (95% CI) $US4706 (3758–6014) for the Take Charge intervention group and $6118 (4350–8005) for control, mean (95% CI) difference $ −1412 (−3553 to +729). Health utility scores were mean (95% CI) 0.75 (0.73–0.77) for Take Charge and 0.71 (0.67–0.75) for control, mean (95% CI) difference 0.04 (0.0–0.08). Cost per QALY gained for the Take Charge intervention was $US −35,296 (=£ −25,524, € −30,019). Sensitivity analyses confirm Take Charge is cost-effective, even at a very low willingness-to-pay threshold. With a threshold of $US5000 per QALY, the probability that Take Charge is cost-effective is 99%. Conclusion Take Charge is cost-effective and probably cost saving.
Article
Objective: To develop a cross-professional model framing the concept and practice of Person-Centered Rehabilitation (PCR) in adult populations, based on a scoping review and thematic analysis of the literature. Data sources: Key databases (PubMed, Scopus, CINAHL), snowballing searches, and experts' consultation were the data sources for English-language empirical or conceptual papers, published from January 2007 to February 2020. Study selection: Two independent reviewers selected adult-based papers addressing at least one of the six categories of PCR-related content, a priori specified in the published review protocol. From 6527 unique references, 147 were finally included in the analysis. Of those, 26 were exclusively conceptual papers. Data extraction: Two independent reviewers extracted textual data on what PCR entails conceptually or as a practice. No quality appraisals were performed as is typical in scoping reviews. Data synthesis: A thematic analysis produced thematic categories that were combined into an emergent model (the PCR Model), which was reviewed by five external experts. PCR was framed as a way of thinking about and providing rehabilitation services "with" the person. PCR is embedded in rehabilitation structures and practice across three levels: 1) the person-professional dyad, 2) the micro-system level (typically an interprofessional team, involving significant others) and 3) a macro-system level (organization within which rehabilitation is delivered). Thematic categories are articulated within each level, detailing both the conceptual and practice attributes of PCR. Conclusion: The PCR model can inform both clinical and service organization practices. The PCR Model may benefit from further developments including obtaining wider stakeholders' input, determining relevance in different cultural and linguistic groups, and further operationalization and testing in implementation projects.
Article
The term 'embolic stroke of undetermined source' (ESUS) is used to describe patients with a non-lacunar ischaemic stroke without any identified embolic source from the heart or the arteries supplying the ischaemic territory, or any other apparent cause. When the ESUS concept was introduced, covert atrial fibrillation was conceived to be the main underlying cause in the majority of ESUS patients. Another important embolic source in ESUS is the atherosclerotic plaque in the carotid, vertebrobasilar, and intracranial arteries, or the aortic arch-collectively described as supracardiac atherosclerosis. There is emerging evidence showing that the role of supracardiac atherosclerosis is larger than it was initially perceived. Advanced imaging methods are available to identify plaques which high embolic risk. The role of novel antithrombotic strategies in these patients needs to be assessed in randomized controlled trials. This review presents the evidence which points towards a major aetiological association between atherosclerotic plaques and ESUS, summarizes the imaging features which may aid to identify plaques more likely to be associated with ESUS, discusses strategies to reduce the associated stroke risk, and highlights the rationale for future research in this field.
Article
Full-text available
Background and purpose: "Take Charge" is a novel, community-based self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. In a previous randomized controlled trial, a single Take Charge session improved independence and health-related quality of life 12 months following stroke in Māori and Pacific New Zealanders. We tested the same intervention in three doses (zero, one, or two sessions) in a larger study and in a broader non-Māori and non-Pacific population with stroke. We aimed to confirm whether the Take Charge intervention improved quality of life at 12 months after stroke in a different population and whether two sessions were more effective than one. Methods: We randomized 400 people within 16 weeks of acute stroke who had been discharged to institution-free community living at seven centers in New Zealand to a single Take Charge session (TC1, n = 132), two Take Charge sessions six weeks apart (TC2, n = 138), or a control intervention (n = 130). Take Charge is a "talking therapy" that encourages a sense of purpose, autonomy, mastery, and connectedness with others. The primary outcome was the Physical Component Summary score of the Short Form 36 at 12 months following stroke comparing any Take Charge intervention to control. Results: Of the 400 people randomized (mean age 72.2 years, 58.5% male), 10 died and two withdrew from the study. The remaining 388 (97%) people were followed up at 12 months after stroke. Twelve months following stroke, participants in either of the TC groups (i.e. TC1 + TC2) scored 2.9 (95% confidence intervals (CI) 0.95 to 4.9, p = 0.004) points higher (better) than control on the Short Form 36 Physical Component Summary. This difference remained significant when adjusted for pre-specified baseline variables. There was a dose effect with Short Form 36 Physical Component Summary scores increasing by 1.9 points (95% CI 0.8 to 3.1, p < 0.001) for each extra Take Charge session received. Exposure to the Take Charge intervention was associated with reduced odds of being dependent (modified Rankin Scale 3 to 5) at 12 months (TC1 + TC2 12% versus control 19.5%, odds ratio 0.55, 95% CI 0.31 to 0.99, p = 0.045). Conclusions: Confirming the previous randomized controlled trial outcome, Take Charge-a low-cost, person-centered, self-directed rehabilitation intervention after stroke-improved health-related quality of life and independence. Clinical trial registration-url: http://www.anzctr.org.au . Unique identifier: ACTRN12615001163594.
Conference Paper
Full-text available
This research aims to apply the Bluetooth technology to control home electrical appliances by using facial gestures for patients with severe paralysis or the absence of arms and legs. This system used the EMG Muscle Sensor Module to measure the electrical signalgenerated by the muscles of facial expressions. After that, the Arduino micro-controller board is used to process electrical signals and to control the operation of home electrical appliances. From the experiment, we found that in the case when sender and receiver have no obstacle. The system has a full capability at 100% in the transmission distance about 1-7 meters. But when the system has some obstacles between sender and receiver, the performance is dropped down to only 1-4 meters. This research will be of great benefit to disabled or elderly people who are unable to move their arms and legs, as well as those who may be insecure if used directly with electrical equipment such as quadriplegia. In addition, the system can record muscle signal patterns to apply signal data in other fields in the near future.
Conference Paper
Full-text available
The purpose of this research was to develop measurement and recording instruments for facial electrical signal detection. The signal can be measured through the pattern of facial muscles changes due to different facial expressions. The difference in facial electrical signal is converted into a command to control the mechanism of electronic devices or home appliances. The microcontroller Arduino board is used in the process of electrical signal processing, and then sends commands to control the work process according to user requirements. The system or equipment developed will be very useful for patients with severe paralysis, which cannot move certain organs of the body such as not being able to use both arms and legs. In this experiment, we used two facial expressions: closing left eye and closing right eye. Therefore, the facial muscle's electrical signal measuring and recoding system will help people with disabilities or patients to have the ability to live close to ordinary people with only facial expression.
Article
Full-text available
Abstract Background There is considerable policy interest in promoting self-management in patients with long-term conditions, but it remains uncertain whether these interventions are effective in stroke patients. Design Systematic meta-review of the evidence for self-management support interventions with stroke survivors to inform provision of healthcare services. Methods We searched MEDLINE, EMBASE, CINAHL, PsychINFO, AMED, BNI, Database of Abstracts of Reviews for Effectiveness, and Cochrane Database of Systematic Reviews for systematic reviews of self-management support interventions for stroke survivors. Quality was assessed using the R-AMSTAR tool, and data extracted using a customised data extraction form. We undertook a narrative synthesis of the reviews' findings. Results From 12,400 titles we selected 13 systematic reviews (published 2003-2012) representing 101 individual trials. Although the term ‘self-management’ was rarely used, key elements of self-management support such as goal setting, action planning, and problem solving were core components of therapy rehabilitation interventions. We found high quality evidence that supported self-management in the context of therapy rehabilitation delivered soon after the stroke event resulted in short-term (< 1 year) improvements in basic and extended activities of daily living, and a reduction in poor outcomes (dependence/death). There is some evidence that rehabilitation and problem solving interventions facilitated reintegration into the community. Conclusions Self-management terminology is rarely used in the context of stroke. However, therapy rehabilitation currently successfully delivers elements of self-management support to stroke survivors and their caregivers with improved outcomes. Future research should focus on managing the emotional, medical and social tasks of long-term survivorship. Link to PLOS ONE page: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0131448
Article
Full-text available
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Article
Full-text available
Few community interventions following stroke enhance activity, participation or quality of life. We tested two novel community interventions designed to promote self-directed rehabilitation following stroke. This was a randomized, controlled parallel group 2×2 trial. Community. Maori and Pacific New Zealanders, >15 years old, randomized within three months of a new stroke. A DVD of four inspirational stories by Maori and Pacific people with stroke and a 'Take Charge Session'--a single structured risk factor and activities of daily living assessment, designed to facilitate self-directed rehabilitation. Primary outcomes were Health-related Quality of Life (Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form 36 (SF-36)) 12 months from randomization. Secondary outcomes were Barthel Index, Frenchay Activities Index, Carer Strain Index and modified Rankin score. One hundred and seventy-two people were randomized with 139 (80.8%) followed up at 12 months post randomization. The effect of the Take Charge Session on SF-36 PCS at 12 months was 6.0 (95% confidence interval (CI) 2.0 to 10.0) and of the DVD was 0.9 (95% CI -3.1 to 4.9). Participants allocated to the Take Charge Session were less likely to have a modified Rankin score of >2 (odds ratio (OR) 0.42, 95% CI 0.2 to 0.89) and their carers had lower (better) Carer Strain Index scores (-1.5, 95% CI -2.8 to -0.1). A simple, low-cost intervention in the community phase of stroke recovery aiming to promote self-directed rehabilitation improved outcomes.
Article
Full-text available
Background: Many patients experience depression, social isolation and anxiety post stroke. These are associated with a poorer outcome. Ameliorating these problems may improve patient wellbeing. Objectives: To evaluate the impact of a healthcare worker or volunteer whose multi-dimensional roles have been grouped under the title 'stroke liaison worker'. Search strategy: We searched the Cochrane Stroke Group Trials Register (searched February 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2009), MEDLINE (1966 to 2009), EMBASE (1980 to 2009) and four other databases. We performed a cited reference search, searched conference proceedings and trials registers, checked reference lists and contacted authors and trial investigators. Selection criteria: Randomised controlled trials investigating the impact of a stroke liaison worker versus usual care. Data collection and analysis: We invited trialists to participate in a review of individual patient data. Primary outcomes for patients were subjective health status and extended activities of daily living. Primary outcomes for carers were subjective health status including measures of carer strain. Main results: We included 16 trials involving 4759 participants. Analysis did not show a significant overall difference for subjective health status (standardised mean difference (SMD) -0.03, 95% confidence interval (CI) -0.11 to 0.04, P = 0.34) or extended activities of daily living (SMD 0.04, 95% CI -0.03 to 0.11, P = 0.22). There was no overall significant effect for the outcome of carer subjective health status (SMD 0.04, 95% CI -0.05 to 0.14, P = 0.37). Patients with mild to moderate disability (Barthel 15 to 19) had a significant reduction in dependence (odds ratio (OR) 0.62, 95% CI 0.44 to 0.87, P = 0.006). This would equate to 10 fewer dependent patients (95% CI 17 fewer to 4 fewer) for every 100 patients seen by the stroke liaison worker. Similar results were seen for the outcome of death or dependence for the subgroup with Barthel 15 to 19 (OR 0.55, 95% CI 0.38 to 0.81, P = 0.002). This risk difference equates to 11 fewer dead or dependent patients (95% CI 17 fewer to 4 fewer) for every 100 patients seen by the stroke liaison worker. Authors' conclusions: There is no evidence for the effectiveness of this multifaceted intervention in improving outcomes for all groups of patients or carers. Patients with mild to moderate disability benefit from a reduction in death and disability. Patients and carers do report improved satisfaction with some aspects of service provision.
Article
Objectives: To evaluate the efficacy and safety of endovascular treatment, particularly adjunctive intra-arterial mechanical thrombectomy, in patients with ischaemic stroke. Design: Systematic review and meta-analysis. Data sources: Medline, Embase, Cochrane Central Register of Controlled Trials, Web of Science, SciELO, LILACS, and clinical trial registries from inception to December 2015. Reference lists were crosschecked. Eligibility criteria for selecting studies: Randomised controlled trials in adults aged 18 or more with ischaemic stroke comparing endovascular treatment, including thrombectomy, with medical care alone, including intravenous recombinant tissue plasminogen activator (rt-PA). Trial endpoints were functional outcome (modified Rankin scale scores of ≤2) and mortality at 90 days after onset of symptoms. No language or time restrictions applied. Results: 10 randomised controlled trials (n=2925) were included. In pooled analysis endovascular treatment, including thrombectomy, was associated with a higher proportion of patients experiencing good (modified Rankin scale scores ≤2) and excellent (scores ≤1) outcomes 90 days after stroke, without differences in mortality or rates for symptomatic intracranial haemorrhage, compared with patients randomised to medical care alone, including intravenous rt-PA. Heterogeneity was high among studies. The more recent studies (seven randomised controlled trials, published or presented in 2015) proved better suited to evaluate the effect of adjunctive intra-arterial mechanical thrombectomy on its index disease owing to more accurate patient selection, intravenous rt-PA being administered at a higher rate and earlier, and the use of more efficient thrombectomy devices. In most of these studies, more than 86% of the patients were treated with stent retrievers, and rates of recanalisation were higher (>58%) than previously reported. Subgroup analysis of these seven studies yielded a risk ratio of 1.56 (95% confidence interval 1.38 to 1.75) for good functional outcomes and 0.86 (0.69 to 1.06) for mortality, without heterogeneity among the results of the studies. All trials were open label. Risk of bias was moderate across studies. The full results of two trials are yet to be published. Conclusions: Moderate to high quality evidence suggests that compared with medical care alone in a selected group of patients endovascular thrombectomy as add-on to intravenous thrombolysis performed within six to eight hours after large vessel ischaemic stroke in the anterior circulation provides beneficial functional outcomes, without increased detrimental effects. Systematic review registration: PROSPERO CRD42015019340.
Article
Background: Stroke Unit care is now accepted as an effective service model for hospital care, but the effectiveness of outpatient care is less certain. This review focuses on therapy-based rehabilitation services targeted at stroke patients living at home. Objectives: To assess the effects of therapy-based rehabilitation services targeted towards stroke patient resident in the community within one year of stroke onset/ discharge from hospital following stroke. Search strategy: We searched the Cochrane Stroke Group Trials Register (last searched November 2001). In addition we searched the following electronic databases: the Cochrane Controlled Trials Register (Cochrane Library Issue 4, 2001), MEDLINE (1996 - Nov 2001), EMBASE (1980 - Nov 2001), CINAHL (1983 - Nov 2001), PsycINFO (1967 - Nov 2001), AMED (1985 - Nov 2001), Wilson Social Sciences Abstracts (1984-Nov 2001), Science Citation Index and Social Sciences Citation Index (1981-Nov 2001). Other strategies to ensure identification of all potentially relevant trials included scanning reference lists of relevant articles and original papers, personal communication and hand searching journals. Selection criteria: All unconfounded, truly randomised controlled trials of stroke patients resident in the community receiving a therapy service intervention, which was compared to conventional or no care. Therapy services were those provided by physiotherapy, occupational therapy, or multidisciplinary staff working with patients primarily to improve task-orientated behaviour (e.g. walking, dressing) and hence increase activity and participation. Data collection and analysis: Two reviewers independently selected trials and extracted data on a number of prespecified outcomes. The primary outcomes were the proportion of patients who had deteriorated or were dependent in personal activities of daily living and performance in personal activities of daily living at the end of follow-up. Main results: We identified a heterogeneous group of 14 trials including 1617 patients. Therapy-based rehabilitation services reduced the odds of a poor outcome (Peto odds ratio 0.72 (95% CI 0.57 to 0.92; P = 0.009) and increased personal activity of daily living scores (standardised mean difference 0.14 (95% CI 0.02 to 0.25; P = 0.02). For every 100 stroke patients resident in the community receiving therapy-based rehabilitation services, 7 (95% CI 2 to 11) patients would be spared a poor outcome, assuming 37.5% would have had a poor outcome with no treatment. Reviewer's conclusions: Therapy-based rehabilitation services targeted towards stroke patients living at home appear to improve independence in personal activities of daily living. However, the evidence is derived from a review of heterogeneous interventions and therefore further exploration of the interventions is justifiable.
Article
Goal setting is considered a key component of rehabilitation for adults with acquired disability, yet there is little consensus regarding the best strategies for undertaking goal setting and in which clinical contexts. It has also been unclear what effect, if any, goal setting has on health outcomes after rehabilitation. To assess the effects of goal setting and strategies to enhance the pursuit of goals (i.e. how goals and progress towards goals are communicated, used, or shared) on improving health outcomes in adults with acquired disability participating in rehabilitation. We searched CENTRAL, MEDLINE, EMBASE, four other databases and three trials registers to December 2013, together with reference checking, citation searching and contact with study authors to identify additional studies. We did not impose any language or date restrictions. Randomised controlled trials (RCTs), cluster-RCTs and quasi-RCTs evaluating the effects of goal setting or strategies to enhance goal pursuit in the context of adult rehabilitation for acquired disability. Two authors independently reviewed search results for inclusion. Grey literature searches were conducted and reviewed by a single author. Two authors independently extracted data and assessed risk of bias for included studies. We contacted study authors for additional information. We included 39 studies (27 RCTs, 6 cluster-RCTs, and 6 quasi-RCTs) involving 2846 participants in total. Studies ranged widely regarding clinical context and participants' primary health conditions. The most common health conditions included musculoskeletal disorders, brain injury, chronic pain, mental health conditions, and cardiovascular disease.Eighteen studies compared goal setting, with or without strategies to enhance goal pursuit, to no goal setting. These studies provide very low quality evidence that including any type of goal setting in the practice of adult rehabilitation is better than no goal setting for health-related quality of life or self-reported emotional status (8 studies; 446 participants; standardised mean difference (SMD) 0.53, 95% confidence interval (CI) 0.17 to 0.88, indicative of a moderate effect size) and self-efficacy (3 studies; 108 participants; SMD 1.07, 95% CI 0.64 to 1.49, indicative of a moderate to large effect size). The evidence is inconclusive regarding whether goal setting results in improvements in social participation or activity levels, body structure or function, or levels of patient engagement in the rehabilitation process. Insufficient data are available to determine whether or not goal setting is associated with more or fewer adverse events compared to no goal setting.Fourteen studies compared structured goal setting approaches, with or without strategies to enhance goal pursuit, to 'usual care' that may have involved some goal setting but where no structured approach was followed. These studies provide very low quality evidence that more structured goal setting results in higher patient self-efficacy (2 studies; 134 participants; SMD 0.37, 95% CI 0.02 to 0.71, indicative of a small effect size) and low quality evidence for greater satisfaction with service delivery (5 studies; 309 participants; SMD 0.33, 95% CI 0.10 to 0.56, indicative of a small effect size). The evidence was inconclusive regarding whether more structured goal setting approaches result in higher health-related quality of life or self-reported emotional status, social participation, activity levels, or improvements in body structure or function. Three studies in this group reported on adverse events (death, re-hospitalisation, or worsening symptoms), but insufficient data are available to determine whether structured goal setting is associated with more or fewer adverse events than usual care.A moderate degree of heterogeneity was observed in outcomes across all studies, but an insufficient number of studies was available to permit subgroup analysis to explore the reasons for this heterogeneity. The review also considers studies which investigate the effects of different approaches to enhancing goal pursuit, and studies which investigate different structured goal setting approaches. It also reports on secondary outcomes including goal attainment and healthcare utilisation. There is some very low quality evidence that goal setting may improve some outcomes for adults receiving rehabilitation for acquired disability. The best of this evidence appears to favour positive effects for psychosocial outcomes (i.e. health-related quality of life, emotional status, and self-efficacy) rather than physical ones. Due to study limitations, there is considerable uncertainty regarding these effects however, and further research is highly likely to change reported estimates of effect.
Article
Interobserver agreement for the assessment of handicap in stroke patients was investigated in a group of 10 senior neurologists and 24 residents from two centers. One hundred patients were separately interviewed by two physicians in different combinations. The degree of handicap was recorded by each observer on the modified Rankin scale, which has six grades (0-5). The agreement rates were corrected for chance (kappa statistics). Both physicians agreed on the degree of handicap in 65 patients; they differed by one grade in 32 patients and by two grades in 3 patients. Kappa for all pairwise observations was 0.56; the value for weighted kappa (with quadratic disagreement weights) was 0.91. Our results confirm the value of the modified Rankin scale in the assessment of handicap in stroke patients; nevertheless, further improvements are possible.