Thomas et al. Trials 2011, 12:131
http://www.trialsjournal.com/content/12/1/131
STUDY PROTOCOL
TRIALS
Open Access
Study protocol: ICONS: Identifying continence
options after stroke: A randomised trial
Lois H Thomas1*, Caroline L Watkins1, Beverley French1, Christopher Sutton1, Denise Forshaw1, Francine Cheater2,
Brenda Roe3, Michael J Leathley1, Christopher Burton4, Elaine McColl5, Jo Booth6 and for
The ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups
Abstract
Background: Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in
hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence
after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g.
bladder training, pelvic floor muscle training and prompted voiding) have been shown to have some effect with
participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients.
Methods/Design: A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster
randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic
voiding programme for the management of continence after stroke. Stroke services will be randomised to receive
the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual
care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm). The primary outcome is
presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of
incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for
participants recruited in the first three months) twelve months after stroke. Process data will include rates of
recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted
in order to describe implementation and assist in explaining the potential mediators and modifiers of the process.
Trial Registration: ISRCTN: ISRCTN08609907
Background
Urinary incontinence following acute stroke is common,
affecting between 40%-60% of people in hospital after a
stroke; 25% at hospital discharge and 15% after one year
[1]. In longer term stroke survivors, the prevalence has
been reported as 17% [2]. Urge incontinence is the most
common type after stroke [3], but the cerebral lesion
may also lead to practical difficulties with bladder control
caused by, for example, motor impairment, depression
and aphasia [4] (termed functional incontinence). Despite
the availability of clinical guidelines for the management
of urinary incontinence in general [5] and urinary incontinence after stroke [6], national audit data [7] suggest
incontinence is often poorly managed.
* Correspondence: lhthomas@uclan.ac.uk
1
School of Health, University of Central Lancashire, Preston, PR1 2HE, UK
Full list of author information is available at the end of the article
Our systematic review [8] found no rigorously conducted studies evaluating interventions designed to manage urinary incontinence after stroke in secondary care.
The intervention in our programme will focus on conservative strategies shown to have some effect with participants in studies included in Cochrane systematic reviews
[9-13], but which have not had their effectiveness
demonstrated with stroke patients. These strategies are a
combined package of bladder training and (where possible) pelvic floor muscle training, and prompted voiding.
Available conservative interventions for urinary incontinence include bladder training, timed voiding, prompted
voiding, habit retraining and pelvic floor muscle training.
Bladder training is generally used for urge incontinence
and aims to increase the time interval between voids so
continence is regained. It involves patient education, scheduled voiding, and positive reinforcement, but can also
include self-monitoring and urge suppression techniques.
© 2011 Thomas et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited
Thomas et al. Trials 2011, 12:131
http://www.trialsjournal.com/content/12/1/131
Prompted voiding and timed voiding have mainly been
used with people who have cognitive deficits. They
are based on a system of scheduled voids, with prompted
voiding including reminders and reinforcement for selfinitiation of toileting. To date, trials of prompted voiding
have mainly taken place in United States nursing homes;
however there is no a priori reason why this approach
should not be introduced into the care of stroke patients in
secondary care in the UK.
Pelvic floor muscle training may also be effective in
assisting the individual to manage urge, stress or mixed
incontinence [10], and has been shown to be effective as
a combined intervention with bladder training [14,15].
The effectiveness of conservative interventions has
been systematically reviewed in adults. In the review of
bladder training [11], trials tended to favour bladder
training and there was no evidence of adverse effects.
The review of prompted voiding [9] found evidence of
increased self-initiated voiding and decreased incontinent episodes in the short-term.
Despite a growing evidence-base, existing evidence has
not been widely implemented in clinical practice, even by
stroke specialist teams working on recognised stroke
units [16]. This lack of implementation in stroke clinical
practice is in keeping with a recent and growing recognition that the implementation of research in practice is
influenced not only by individual clinicians but also by
the organisational context in which they operate [17-22].
Organisational context has been defined as “the environment or setting in which the proposed change is to be
implemented” [23]. At its simplest level, context may
refer to the physical environment where health care takes
place. However, Rycroft-Malone et al. concluded from
their concept analysis that contexts conducive to research
implementation included a range of less tangible process
elements: “clearly defined boundaries; clarity about decision-making processes; clarity about patterns of power
and authority; resources; information and feedback systems; active management of competing “force fields” ...
and systems in place that enable dynamic processes of
change and continuous development.’ [23].
Theories underpinning organisational influence include
those of learning organisations (with characteristics
encompassing hierarchical structure, information systems,
human resource practices, organisational culture and leadership [24]) and knowledge management (how organisational mechanisms affect knowledge uptake and use
[25-27]). Successful implementation of an intervention to
improve the management of post-stroke urinary incontinence is likely to be mediated not only by individual members of staff and availability of evidence-based guidance,
but also by the complexity of the intervention as well as
the interplay of patient, social and organisational factors
[28,29]. Careful attention needs to be paid to the specific
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barriers to change in any given setting, identified through
‘diagnostic analysis’ [30] at levels that may include the
individual, groups or teams, organisations and the wider
healthcare system [31]. Strategies then need to be ‘tailored’
to overcome barriers identified [32].
We therefore plan to evaluate whether supported
implementation, through targeted organisational development aimed at ‘normalising’ the intervention [33-35],
is more effective than introduction of the intervention
alone, as well as evaluating both in comparison to usual
care.
Aim
The trial aims to assess the feasibility of a full-scale clusterrandomised trial: to test the interventions for preliminary
evidence of clinical effect and to provide information
to enable estimates of the number of sites and patients
that would need to be recruited for a full-scale clusterrandomised trial to evaluate effectiveness.
Objectives
The trial objectives are to:
• assess feasibility in terms of rates of participant
recruitment and retention
• assess fidelity to the intervention
• conduct a qualitative assessment of feasibility from
the perspective of multiple stakeholders
• conduct a preliminary evaluation of supported
implementation compared with implementation
alone
• investigate patient-related factors affecting patient
outcome
• investigate stroke service-level factors potentially
affecting stroke service outcomes to estimate the
amount of unexplained variability in outcomes
between Trusts and between patients
• confirm the choice of primary and secondary outcome measures for a full-scale cluster-randomised
trial to evaluate effectiveness
• develop and test data collection tools for an
economic evaluation within a full-scale clusterrandomised trial
Design
A three arm, parallel, open, exploratory, pragmatic, cluster-randomised controlled trial of a systematic voiding
programme (including bladder training and pelvic floor
muscle training for patients who are cognitively able
and prompted voiding for patients with cognitive
impairments), with or without supported implementation, for the management of urinary incontinence after
stroke in secondary care.
Thomas et al. Trials 2011, 12:131
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Methods
Study setting
Twelve NHS stroke services in England and Wales. For
the purpose of the trial, a stroke service will comprise
both acute and rehabilitation stroke units. Stroke units
will be defined according to the definition provided by
the Royal College of Physicians of London for the
National Sentinel Stroke Audit [7].
Inclusion criteria for stroke services
Stroke services with specialist acute and rehabilitation
stroke services (either separate or combined units).
Access to appropriate Excess Treatment and Service
Support costs.
Exclusion criteria for stroke services
Stroke service without specialist acute and rehabilitation
stroke units (either separate or combined).
Inclusion criteria for patients
Patients aged 18 or over who have a diagnosis of stroke
based on the WHO criteria [36] will be included in the
study, with no upper age limit. Patients are required to
have urinary incontinence (UI) as defined by the International Continence Society [37] as “involuntary loss of
urine” and to have incontinence classified as stress UI,
urge UI, mixed UI or ‘functional’ UI OR to be catheterised in the acute phase of the stroke; to be conscious
(defined as either ‘alert’ or ‘drowsy’ on the ‘Clinical Status
on Admission’ item of the European Stroke Database),
and to be medically stable as judged by the clinical team.
Participants who had incontinence before the index
stroke will be included. Given the expected age range of
the population, there is likely to be a high prevalence of
pre-stroke incontinence among potential participants.
Furthermore, there is evidence to suggest patients with
longstanding incontinence may benefit from a programme of behavioural interventions [9,11].
Participants who are catheterised will be recruited; if
the catheter is removed, they will be assessed as per
protocol and begin the systematic voiding programme if
they are still incontinent. Participants who are continent
after catheter removal and those discharged with a
catheter still in situ will not be put onto the programme.
Data from these participants will be analysed separately
from participants who have taken part in the
programme.
Exclusion criteria for patients
Patients who refuse consent.
Patients unable to consent for whom a consultee does
not agree that the patient would wish to be included.
Centre recruitment process
The trial has been adopted onto the Stroke Research
Network (SRN) portfolio and was identified as open to
new sites using SRN procedures. The research team also
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made contact with all stroke services in the North West
of England and Wales and invited expressions of
interest.
Patient recruitment process
Patients who meet the inclusion criteria will be
approached as early as possible following admission to
the participating stroke unit. Patients who do not meet
the inclusion criteria early post-stroke will be approached
as soon as possible if they subsequently meet the inclusion criteria. Nursing staff will ask each eligible patient
whether his/her name can be given to the research team.
If the patient agrees, a member of the research team will
visit the patient, explain the project, answer any questions they may have and provide an information leaflet.
Patients will be given at least 24 hours to consider participation and will be visited by a member of the research
team after this period; patients choosing to participate
will sign the consent form at this stage.
For patients unable to consent for themselves, a person able to advise on the presumed wishes of the patient
will be approached to act in the role of consultee. This
is in line with the recommendations of the Mental
Capacity Act [38] and in line with the expressed wishes
of the study Patient, Public and Carer Involvement
groups, who would like everyone who is eligible to have
the opportunity to participate.
Recruitment rates in each cluster will be monitored on
a monthly basis to identify both quantitative (i.e. numbers of participants recruited) and qualitative (i.e. patient
characteristics) imbalance across clusters [39]. Should
identified imbalance be indicative of likely selection bias
(e.g. cluster with low proportion of stroke patients identified as eligible but high proportion of those eligible with
severe incontinence), we will review the recruitment process and address any issues identified.
Centre randomisation
Sequence generation
Stroke services will be placed into four strata based, in
order of priority, on (i) whether they have separate or
combined acute and rehabilitation units (ii) their average
performance on the ‘nine key indicators of stroke care’ in
the National Sentinel Stroke Audit Phase II (clinical
audit) [7] (iii) the number of stroke patients admitted per
year. Services will be randomly allocated to intervention
(n = 4), intervention plus supported implementation (n =
4) and usual care (n = 4) groups by the Clinical Trials
Unit at Newcastle University. After allocating hospitals to
the strata, the randomisation schedule will be generated
using block randomisation (block length of 3) to allocate
one site to each arm within every stratum. The software
package STATA (version 9) will be used.
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Allocation concealment Within each stratum, stroke
services will not be informed as to their intervention allocation until ALL stroke services within that stratum are
recruited to take part in the trial. However, services will
then be aware of their allocation, as will staff identifying
and recruiting trial participants from within that service.
Interventions
Systematic voiding programme
The intervention will comprise algorithm-driven individualised systematic voiding programmes tailored to the
physical and cognitive capabilities of each patient The
algorithm specifies two routes: a combined package
including bladder training and pelvic floor muscle training
for those patients who are cognitively able, and prompted
voiding for those with cognitive impairment. Bladder
training will include three main components: 1) focused
education for patients and carers (including information
on the anatomy and physiology of the lower urinary tract,
the rationale behind the programme and strategies to suppress the urge to void, for example distraction and relaxation [15,40]); 2) individualised voiding regimens designed
to restore normal voiding patterns by progressively lengthening the time interval between voids, based on assessment of participants’ normal voiding patterns and selfmonitoring; 3) patient-held voiding diary, a cognitive
intervention designed to promote self-awareness of voiding habits [41,42].
Pelvic floor muscle training is designed to strengthen
types I and II muscle fibres in the pelvic floor. Patients
will be instructed to perform 5 fast (3 seconds) and 1020 sustained (10 seconds) contractions with 10 second
relaxation periods between contractions twice a day.
For those patients with cognitive impairments, the programme will consist of elements traditionally classified as
prompted voiding: participants will be approached according to individualised schedules (for example every two
hours during waking hours), asked if they are wet or dry,
and prompted to use the toilet [43]. Verbal praise will be
offered for correct reporting of dryness/wetness and successful toileting. Participants with cognitive impairments
will be given the opportunity to participate in the education and patient-held diary components of the intervention.
Participants not able to walk to the toilet will be
assisted by nursing staff. Participants will be provided
with written information about their systematic voiding
programme to enable them to continue with it after discharge from hospital.
The intervention has been informed by the findings of
an evidence synthesis on the barriers and enablers to
successful implementation of conservative interventions
for UI completed during the programme’s Development
Phase, in line with the MRC Framework for developing
and evaluating complex interventions [44,45].
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The systematic voiding programme will be incorporated into routine practice by all staff in day-to-day contact with patients. All nursing staff (including health
care assistants, night staff and student nurses) will be
provided with an education programme of both theory
and practice. Training will be largely web-based to facilitate easy access and flexibility, but face-to-face sessions
will also be offered to cover the practical aspects of
intervention delivery and recording.
Systematic voiding programme plus supported
implementation
Services randomised to the supported implementation
arm of the trial will receive the systematic voiding programme together with supported implementation comprising: diagnostic analysis of context at the level of the
organisation and the individual, identification of barriers
(defined as “factors that impede the implementation of
change in professional practice” [32]) and facilitators to
the intervention, as well as targeted organisational development activities.
To support the process of implementing the systematic
voiding programme, we will use a form of facilitation, a
model that has been used successfully in secondary care
settings [46,47]. The process of facilitation involves supporting and enabling people to change their practice
[46-48]. Although approaches to facilitation vary, they are
based on the principle that ownership is with the group
[49]. The facilitator guides the group towards accomplishing a goal, helping members identify the obstacles that
may impede progress and enabling members to identify
strategies to overcome them [50]. While there will be a
focus on goal attainment (defined as the normalisation of
the systematic voiding programme [35]), our approach to
facilitation will primarily focus on ‘enabling’ rather than
‘doing for’ others [47] with an emphasis on developing
and empowering both individuals and teams. Experienced
external facilitators will work with nominated internal
facilitators in each site; further details of the supported
implementation intervention are available on request from
the lead author.
Usual care (control group)
Participants in this group will receive usual care provided by the stroke service. This may comprise: checking for urinary tract infection; checking for overflow
incontinence (bladder scanners will be provided); containment using a variety of devices (for example absorbent products) with regular changes and some form of
toileting schedule.
Outcomes
Effectiveness
The primary effectiveness outcome will be incontinence
(presence; absence). Measures will be taken at 6 weeks,
3 months and, for those recruited during the first three
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months, 12 months post stroke. The primary analysis
will be of the 6-week data as conservative interventions
for continence typically last six weeks [11,15], and an
effect is most likely to be seen at this time point.
Secondary effectiveness outcomes will be: quality of
life, frequency and severity of incontinence, urinary
symptoms, activities of daily living (ADLs), and death; at
6 weeks, 3 months and, for those recruited during the
first three months, 12 months post stroke.
Intervention fidelity
Intervention fidelity will be measured in terms of 1) percentage of occasions participants on the systematic voiding
programme either self-initiated toileting or were prompted
to toilet by ward staff within 30 minutes of the prescribed
voiding interval and 2) accuracy of programme implementation, assessed by percentage of episodes where there was
complete adherence to the elements of the protocol for
the relevant conservative intervention (bladder training,
prompted voiding and pelvic floor muscle training).
Data will be extracted from recording sheets specific
to each route on the programme.
Ascertainment of outcomes
Presence/absence of incontinence will be measured by
the International Consultation on Incontinence Questionnaire (ICIQ-UI Short Form) [51]. Absence of incontinence will be defined as the response ‘never’ to Question
3, ‘How often do you leak urine?’; presence of incontinence will be defined as any other response to Question
3 (ranging from ‘about once a week or less often’ to ‘all
the time’). The ICIQ-UI Short Form has received a grading of Anew - highly recommended from the International
Consultation on Incontinence Symptoms and Quality of
Life Committee indicating published reports of acceptable reliability, validity and responsiveness in at least one
study [52]. To our knowledge, the ICIQ-UI Short Form
has not been used in the post-stroke population. We
have conducted preliminary validation of the tool with
six stroke survivors from our Patient, Public and Carer
Involvement Group using the approach recommended by
the ICIQ developers (Dr Nikki Cotterill, personal communication); all thought the tool was appropriate for use
post-stroke and few problems were identified.
Quality of life will be measured using the Incontinence Quality of Life Instrument (I-QOL) [53,54] and
the EuroQol (EQ-5D) [55]. Frequency and severity of
incontinence will be ascertained using the Incontinence
Severity Index [56]. Urinary symptoms will be measured
using the Leicester Urinary Symptom questionnaire [57]
and activities of daily living via the Barthel Index [58].
In addition, the following baseline information about
the patient will be recorded following consent: date of
birth (age to be calculated*); sex; ethnicity; date of
admission; date of stroke onset; date baseline questionnaire completed; location when recruited into the study;
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consciousness level (defined as either ‘alert’ or ‘drowsy’
on the ‘Clinical Status on Admission’ item of the
European Stroke Database); side of body affected by
stroke; type of stroke; location of stroke (OCSP classification[59]); co-morbidities (Charlson Comorbidity Index
[60]; day seven Barthel Index [58]; pre-stroke Modified
Rankin Scale [61]*; pre-stroke living circumstances*; Leicester Urinary Symptom questionnaire [57]; type of UI
(urge UI, mixed UI, ‘functional’ UI or unclear); cognitive
ability (6 Item Cognitive Impairment Test [62]); fluid
intake; bowel function; relevant clinical investigations
(e.g. mid stream urine, bladder scan); medications; living
circumstances; verbal sub-section of the Glasgow Coma
Scale [63]*; ability to lift both arms off the bed*; ability
to walk independently*; ICIQ-UI Short Form [51];
Incontinence Severity Index [56]; EuroQol (EQ-5D) [55].
The six factors highlighted with a * above from the
Edinburgh stroke case mix adjuster [64] will be collected
to enhance patient-level adjustment for prognosis.
Data collection
Baseline data will be collected on entry to the trial by
the research nurse. Outcome data will be collected at
six weeks, three months and (for participants recruited
within the first three months of the trial) twelve months
post-stroke via postal questionnaires (or hand-delivered
questionnaires if participants are still in hospital at six
weeks). All participants with aphasia will be offered a
face-to-face interview with the research nurse to collect
outcome data; this will be conducted using appropriate
communication aids (e.g. pictorial cards with a ‘thumbs
up’ picture indicating ‘yes’ and a ‘thumbs down’ card
indicating ‘no’). Specialist help will be available from
Speech and Language Therapists and Speakeasy, a specialist aphasia charity based in Ramsbottom, Bury
(http://www.buryspeakeasy.org.uk/), if this is needed.
Postal and telephone reminders will be used if questionnaires are not returned within two weeks. Where
completion of postal questionnaires is not possible, participants (or carers if a proxy is needed) will be invited
to complete assessments over the telephone. If neither
postal or telephone completion is possible, a face-to-face
assessment in the participant’s home will be offered.
We will collect intervention fidelity data for all participants in the active intervention groups during three (for
sites with a nine month intervention period) or four (for
sites with a 12 month intervention period) randomly
selected weeks during each three-month period in
which the stroke service is recruiting participants into
the trial.
Blinding
It is not possible for the health professionals or patients
to be blinded to the intervention. However, data collectors will be blinded. The trial statistician will not be
blinded during the analysis, however the statistical
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analysis plan will be finalised prior to any outcome data
being available to the trial statistician.
Qualitative evaluation of implementation
An integrated qualitative evaluation will be conducted in
order to describe implementation and assist in explaining why the intervention and its components were or
were not successful. Semi-structured interviews will be
conducted with patients at discharge and will seek
patients’ experiences of their treatment for incontinence
and their views of the effectiveness of treatment.
We will use maximum variance sampling [65] to generate a range of participants (around 15-20 from each trial
arm, but with the numbers determined by data saturation) in terms of gender, age, ethnicity, type of incontinence and stroke severity. Patients will also be chosen to
reflect those with a range of outcomes at discharge
(defined in terms of the frequency of incontinent
episodes).
Qualitative, semi-structured interviews will be performed with health professionals (n = 15-20 per intervention group, but with the numbers determined by data
saturation) involved in the intervention to explore experiences of implementing the intervention and drivers and
barriers to successful implementation. Qualitative interviews (n = 15-20) will also be held with health professionals in the ‘usual care’ trial arm to facilitate comparison
in terms of continence management across trial arms.
Sample Size
The sample size is chosen pragmatically, rather than on
the basis of a formal power calculation; our aim is to
balance practicalities and the need for reasonable precision in the estimation of effects to inform the sample
size calculation for a full-scale trial to test effectiveness.
The use of four stroke services per arm (12 in total) will
provide a satisfactory indication of likely effectiveness and
help us address any feasibility issues relating to the delivery of the interventions. It will also provide some degree
of confirmation regarding the size of the intra-class correlation coefficient and will enable us to perform a review of
the number of sites (and the number of patients needed
per site) for each arm of the trial for a full-scale trial. It
will also provide some information on stroke service-level
factors which may help explain the variability in outcome
between stroke services in each arm, thus helping reduce
the intra-class correlation coefficient and hence achieve
efficiency in terms of the number of stroke services
required for a full-scale trial.
Twelve stroke services will admit around 4800 patients
per year, of whom we expect around 20% will meet the
trial inclusion criteria and consent to participate. To
achieve better balance in the number of participants
recruited per Trust, we will recruit for 12 months in
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services which admit 300 or less patients per year and
for 9 months in Trusts which admit more than 300
patients per year; we expect that this will enable us to
recruit 780 patients across the 12 services.
Data analysis
Patient baseline data
Baseline characteristics will be summarised using means
(with standard deviations), or median (inter-quartile
range) if quantitative (continuous or count) as appropriate,
or frequency (percentage) if dichotomous or categorical.
These will be summarised both within intervention groups
and within clusters (within intervention groups). All outcome data will be summarised in a similar manner.
Outcomes
The primary analysis set will be defined as the intentionto-treat population. All stroke services randomised will
be retained in the trial. Outcome data will be collected
from all consented patients whenever possible, whatever
their level of subsequent engagement with the allocated
intervention programme. If there is more than 10% loss
to follow-up overall or moderately differential loss to follow-up across stroke services, a secondary per-protocol
analysis will also be considered. The decision as to
whether a per-protocol analysis will be informative will
be made by the trial statistician in conjunction with other
members of the Trial Management Group; this decision
will be made without reference to the recorded values of
the outcome data.
To account for the cluster randomisation, we shall use
mixed effects modelling for continuous, ordinal and
dichotomous outcomes to compare the two groups on primary and secondary outcome data. Baseline measures of
the outcomes variables (where appropriate), stroke classification, type of incontinence and the other prognostic
patient-level information (from the Edinburgh case-mix
adjuster) will be included as individual-level covariates in
the models for outcome data.
Missing outcome data will be imputed according to the
particular outcome. For the primary analysis, dichotomous
and ordinal outcomes for those who withdraw, die or are
otherwise lost to follow-up will be imputed using a worstcase scenario (e.g. for the primary outcome variable, all
those for whom incontinence status is not recorded at
6-weeks post-stroke will be assumed to be incontinent).
For continuous outcomes, the primary analysis will use a
non-parametric multiple imputation approach [66].
The effect of stroke service-level factors will also be
explored in the modelling; this will enable appropriate
stratification to be used in the future larger scale trial, if
desired, and to potentially reduce the size of the intrastroke service correlation coefficient by reducing the
unexplained component of the variability between stroke
services. This analysis will be used to confirm the sample
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size necessary for the future trial and to provide estimates
(including 95% confidence intervals) of the effectiveness
of each intervention relative to usual care.
Various sensitivity analyses will be performed. These
will assess: the robustness of assumptions inherent in
the analyses (including the use of alternative analytical
approaches given the small number of clusters and of
alternative approaches to imputation of missing outcome data); the effect of excluding patients subsequently
found not to have had a stroke from analyses and the
impact on the estimate of effectiveness of including
patients with pre-stroke incontinence.
Recruitment
Each month, proportions of stroke patients meeting the
inclusion criteria for the trial and proportions of these
patients actually recruited will be presented and compared between clusters and between intervention groups,
both descriptively and inferentially using chi-square tests.
Every three months we will also investigate descriptively
whether there is an association between a cluster’s
reported eligibility rate and the percentage of recruited
patients with mild incontinence using a range of appropriate techniques, including graphical representation and
rank correlations.
Intervention fidelity data
For the intervention groups, fidelity measures will be
summarised using mean (with standard deviation) or
median (inter-quartile range), depending on the distributions of the percentage fidelity measures. Fidelity will
be compared across intervention groups and across different conservative interventions (i.e. bladder training,
prompted voiding and pelvic floor muscle training).
Qualitative data
Qualitative interviews will be audio taped, transcribed
and subject to thematic analysis using FRAMEWORK
[67] to identify emergent themes. FRAMEWORK method
permits identification and cross-classification of variables
from paper transcriptions. The analysis process consists
of identifying key concepts and mapping their range and
diversity, followed by a process of interpretation where
patterns of association are investigated and possible reasons for these explored. The validity of the interpretation
will be assessed through regular discussion by the project
team.
Economic evaluation
In this pilot trial, we will develop data collection tools to
record resource use which will be used in a future, definitive trial. Tools will include: proformas for staff to
record training and time spent on the intervention; a
structured staff-observation schedule to allow independent assessment of time spent on the intervention; proforma to record resources (e.g. tests and investigations,
length of stay) used in hospital (data will be obtained
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from the hospital information system); postal questionnaire about health and social service input, for self-completion by patients and carers. The postal questionnaires
will be based on a design used previously by the applicants when querying input after discharge in a cohort of
stroke patients.
Two measures will be used for the cost-utility analysis.
The EuroQol (EQ-5D)[55], a generic quality of life measure, will be used to facilitate comparison with other
studies and will allow us to estimate the benefit of the
intervention in terms of quality adjusted life years
(QALYs) gained. However, it has been suggested that
the EQ-5D has a large ceiling effect and poor responsiveness in a non-stroke sample of women with urinary
incontinence [68]. We will therefore also use a condition-specific measure, the Incontinence-Specific Quality
of Life instrument (I-QOL, [52,53]), which has been
shown to be the best continence-specific measure for
use in clinical trials in terms of reliability, validity and
responsiveness to change [67].
We will build on the cost-utility analysis by conducting an additional sensitivity analysis. We will review
published economic evaluations that have estimated
Quality Adjusted Life Years (QALYs) and extract the
utility (quality-of-life) values they used. We will tabulate
the basis for these figures in terms of the size of sample,
which patients were questioned, what technique was
used (EQ-5D or other), and how values were derived.
We will use the data which seem to have the most
validity in the sensitivity analysis.
Ethical aspects
The trial has been approved by Bradford Research
Ethics Committee (Reference number 10/H1302/60),
which has a lead responsibility for studies with Mental
Capacity issues, and by local Research and Development
departments.
Informed consent to participate in the trial will be
sought from participants themselves or from a consultee,
as outlined above. All patients will be informed that participation is voluntary and that they are able to withdraw
at any time. Urinary incontinence is a sensitive issue and
we believe the approach taken with participants needs to
reflect this. Our study has two dedicated Patient, Public
and Carer Involvement groups, and these have provided
advice on recruitment strategies as well as assisting in the
development of patient documentation.
Trial management and monitoring
The Management Group (comprising all programme
applicants) meets every 3 months to discuss the day to
day management and running of the programme. The
Trial Steering Committee meets every 6 months with a
remit including review of objectives and progress against
Thomas et al. Trials 2011, 12:131
http://www.trialsjournal.com/content/12/1/131
plans and objectives and monitoring the quality of the
research to help ensure it contributes to knowledge at a
national and international level.
The Data Monitoring Committee (DMC) will be
responsible for safeguarding the interests of trial participants, assessing the effect of the interventions during the
trial, and for monitoring the overall conduct of the clinical trial. The DMC will be advisory to the Trial sponsor
and the Trial Steering Group and will meet biannually.
Author details
1
University of Central Lancashire, Preston, UK. 2Glasgow Caledonian University, Cowcaddens Road, Glasgow,
UK. 3Edge Hill University, St Helens Road, Ormskirk,
UK. 4Bangor University, Gwynedd, UK. 5Newcastle University, Medical School, Newcastle upon Tyne, UK.
Abbreviations
ADLs: Activities of daily living; DMC: Data Monitoring Committee; EQ-5D:
EuroQol quality of life measure; ICIQ-SF: International Consultation on
Incontinence Questionnaire - Short Form; ICONS: Identifying Continence
OptioNs after Stroke study I-QOL: Incontinence Quality of Life instrument;
MRC: Medical Research Council; NHS: National Health Service; NIHR: National
Institute for Health Research; OCSP: Oxford Community Stroke Project; PPC
Groups: Patient, Public and Carer Involvement Groups; QALYS: Quality
Adjusted Life Years; SRN: Stroke Research Network; UI: Urinary incontinence;
UK: United Kingdom; WHO: World Health Organization
Acknowledgements
Members of the ICONS Project Team are: Lois H Thomas, Caroline L Watkins,
Beverley French, Christopher Sutton, Denise Forshaw, Michael Leathley,
Bernadette Carter (School of Health, University of Central Lancashire), Francine
Cheater (Institute for Applied Health Research, Glasgow Caledonian University),
Jo Booth (School of Health, Glasgow Caledonian University), Brenda Roe
(Evidence-Based Practice Research Centre, Edge Hill University), Christopher
Burton (Centre for Health-Related Research, Bangor University), Elaine McColl,
Helen Rodgers (Medical School, Newcastle University), Katie Brittain (Institute of
Health and Society & Institute for Ageing and Health, Newcastle University),
Andrew Walker (Robertson Centre for Biostatistics, Glasgow University), James
Barrett (Arrowe Park Hospital, Wirral) and Lin Nelson (Lancashire Teaching
Hospitals NHS Foundation Trust).
Members of the ICONS Patient, Public and Carer Involvement Groups are: Dave
and Pat Brand, Violet Birchall, David Britt, May Griffiths, Philip Helvin, Brian
James, Gill Pearl, Jane Whitewood, Jacqui Vella, Audrey and Richard Childs, Sean
Crosby, Steve Hall, Anj Lewin, Liz Royle, Carole Scott and Jean Wright.
This paper presents independent research commissioned by the National
Institute for Health Research (NIHR) under its Programme Grants for Applied
Research scheme (RP-PG-0707-10059). The views expressed in this
publication are those of the authors and not necessarily those of the NHS,
the NIHR or the Department of Health.
Author details
1
School of Health, University of Central Lancashire, Preston, PR1 2HE, UK.
2
Institute for Applied Health Research, Glasgow Caledonian University,
Cowcaddens Road, Glasgow, G4 0BA, UK. 3Evidence-Based Practice Research
Centre, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK. 4Centre
for Health-Related Research, Bangor University, Gwynedd, LL57 2EF, UK.
5
Medical School, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
6
School of Health, Glasgow Caledonian University, Cowcaddens Road,
Glasgow, G4 0BA, UK.
Authors’ contributions
All authors were responsible for the study design. LT and CW were
responsible for obtaining funding. LT is programme coordinator, responsible
for the ongoing management of the trial, assisted by DF, the trial manager.
Page 8 of 10
CS developed the statistical analyses. LT wrote the initial draft manuscript.
All authors have read and corrected the draft version and all authors
contributed to and approved the final manuscript.
Competing interests
The authors declare they have no competing interests.
Received: 18 February 2011 Accepted: 20 May 2011
Published: 20 May 2011
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doi:10.1186/1745-6215-12-131
Cite this article as: Thomas et al.: Study protocol: ICONS: Identifying
continence options after stroke: A randomised trial. Trials 2011 12:131.
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