The Return to Work Experiences of People With Communication Disorders Post-stroke: a Qualitative Study
Conditions: Stroke
Sponsor: NHS Grampian

IRAS ID: 308674 ConQueSt/Protocol/ V2.0 5th October 2022 
 
 
Version
Date
Changes
2.0
05/10/22
6.2; 6.3; 6.4, 6.5, 6.7, 9.1, 
11.2, 12.1 
 
 
 
 
 
 
 
 
 
 
Study Protocol 
 
Full Title:  
The return to work experiences of people with 
communication 
disorders 
post-stroke: 
a 
qualitative study 
Study Acronym:  
 
 
ConQueSt 
Sponsor:  
 
 
 
NHS Grampian 
Sponsor Reference Number:  
1-017-22 
 
Funder: 
NHS Grampian Research and Development 
Endowment Research Grant  
Chief Investigator:   
 
Emma Coutts 
REC Reference Number: 
 
22/PR/0604 
R&D Reference Number: 
 
2022SP001E 
Version Number and Date:   
V2.0 5th October 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
IRAS ID: 308674 ConQueSt/Protocol/ V2.0 5th October 2022 
 
 
 
 
 
 

 
 
IRAS ID: 308674 ConQueSt/Protocol/ V2.0 5th October 2022 
 
 
 
Protocol Approval 
The return to work experiences of people with communication disorders post-stroke: a 
qualitative study – ConQueSt 
 
Signatures 
By signing this document I am confirming that I have read, understood and approve the 
protocol for the above study. 
 
 
Emma Coutts 
 
 
 
5th October 2022 
Chief Investigator 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
IRAS ID: 308674 ConQueSt/Protocol/ V2.0 5th October 2022 
 
 
 
1.0 Title 
The return to work experiences of people with communication disorders post-stroke: a 
qualitative study 
 
2.0 Summary 
With an estimated incidence of 15 000 in Scotland every year, stroke is the most common 
cause of severe physical disability among adults in Scotland. As approximately a quarter of 
stroke survivors are of working age, a significant proportion of the considerable financial 
burden of stroke can be attributed to difficulties to returning to work because of the ensuing 
disabilities. Stroke-related disabilities may be obvious and physical, such as reduced mobility 
or limited movement in the upper limb on the affected side. However, other disabilities such 
as communication disorders including aphasia (language processing difficulties) and 
dysarthria (speech articulation difficulties) may be less apparent but equally significant, 
because of the importance of communication across a vast range of work activities. There 
has been little research into the barriers and facilitators affecting people with post-stroke 
communication disorders endeavoring to return to work. This study aims to address this 
issue by conducting semi-structured interviews with people with post-stroke communication 
disorders to explore their experiences of returning or attempting to return to the workplace. 
This study will generate important knowledge that will help inform the development of a 
targeted intervention for this population, which will be evaluated in a future study. It therefore 
represents the vital first step in understanding the problem (return to work for people with 
post-stroke communication disorders), which is key to the development of complex health 
interventions.1  
 
 

 
 
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3.0 Background and rationale 
 
Approximately a quarter of stroke survivors are of working age,2 and while estimates of 
return to work rates following stroke vary considerably, ranging from around 11% to 85%,3 it 
has been estimated that over 9 million workdays are lost in the UK alone each year because 
of stroke, with 26% of the total annual cost of stroke being due to loss of productivity.4 In 
addition to the economic cost, being out of the workplace due to disability has major 
psychosocial costs for the individual, causing reduced social capital, sense of purpose, 
quality of life and standard of living.5-6 Return to work following illness or injury is therefore 
an important factor in reducing these economic, social and personal consequences.7 
Communication disorders resulting from a stroke are very common: an estimated 21-38% of 
stroke survivors are affected by aphasia (which can affect comprehension of the spoken and 
written word, as well as the production of speech and writing),8 and 20-30% by dysarthria.9 
Because of the importance of spoken and written communication in work activities, such 
impairments can cause considerable barriers to return to work.10 One review found that the 
return to work rate for people with post-stroke aphasia averaged 28% across the included 
studies, a significantly lower rate than that for the general population of working-aged stroke 
survivors, which was 45%.8   
 
We recently carried out a scoping review11 which found that while there has been a 
significant amount of research in the last ten years on factors, barriers and facilitators 
impacting on return to work for people following a stroke, there has been little research 
specific to people with post-stroke communication disorders: only two records were identified 
in the scoping review, one of which was a narrative review on rates of return to work8 and 
one of which was a single case study on a person with aphasia’s experiences of return to 
work.12 Therefore, there is a need to carry out research in this area, to explore issues which 
are unique or particularly pertinent to people with post-stroke communication disorders. This 

 
 
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is especially important, given the necessity of effective communication in a wide range of 
work-related activities, for example as a means to engage with colleagues, to share 
information in order to solve problems and resolve conflicts,13 and as a means to ensure 
health and safety.14 
 
4.0 Public involvement 
People with lived experience were engaged in the design of this study and will continue to be 
engaged throughout its implementation. This will help to ensure that the study is relevant, 
the design is acceptable, the information is understandable and the results are effectively 
communicated at the end of the study.15 For the design stage of the project, three people 
from across Scotland who were known to the Chief Investigator (CI) as having the 
experience of attempting to return to work with post-stroke communication disorders were 
contacted by letter and invited to contribute to development of this proposal. An outline of the 
study including the proposed research questions and methodology, written in accessible 
language, was sent by post or email to the two people who responded. A  video call (via 
Microsoft Teams) was arranged with each person at least 5 days later in order for them to 
give their comments and make further suggestions from the perspective of their lived 
experience of the issue. These comments and suggestions were subsequently incorporated 
into the design of the study which is described below. Specific examples include explicit 
mention that communication refers to reading/writing as well as speech, and the inclusion of 
National Stroke Voices as a vehicle for recruitment. These two advisors also participated in 
further stages of the design, as described in the relevant sections below.  
 
 
 

 
 
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5.0 Aims and research questions 
This proposed research aims to investigate the experiences of people with post-stroke 
communication disorders who are attempting or have attempted to return to work. The 
specific questions are:  
i) 
What are people with post-stroke communication disorders’ experiences of 
attempting return to work? 
ii) 
What barriers and facilitators are experienced by people with post-stroke 
communication disorders when attempting to return to work?  
iii) 
What do people with post-stroke communication disorders perceive their 
informational and support needs to be in relation to return to work? 
iv) 
How and by whom do people with post-stroke communication disorders perceive 
that any informational and support needs could be met? 
 
6.0 Methodology and methods 
6.1 Study design 
A qualitative descriptive study design will be used. This methodology seeks to discover and 
understand a phenomenon from the perspectives of those experiencing it.16 It falls within the 
naturalistic approach16 and attempts to interpret findings while staying close to the surface of 
the data.17 It is appropriate to this study because it offers the opportunity to gather rich 
descriptions of a phenomenon about which little is currently known,16 and the use of 
knowledge gained may influence interventional approaches aimed at the participant 
population.16 Interviews will be carried out using a semi-structured format in order to allow 
flexibility to explore aspects of importance to the participants while having focus maintained 
by the guide questions.18   
 

 
 
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6.2 Setting 
The study will take place within Scotland. The focus will be the area covered by NHS 
Grampian, NHS Greater Glasgow and Clyde, and NHS Highland health boards. Participants 
can also take part from elsewhere in Scotland where they are recruited via social media or 
through public adverts. This cohort is of sufficient size to make recruitment viable and 
feasible, and it also represents a range of geographical areas in terms of urban/rural 
classification to allow for generalizability of the findings to elsewhere in Scotland and 
beyond.  
 
6.3 Participants  
Adults (aged 18 years of age and over) will be eligible for inclusion if: 
 
they have had an ischaemic or haemorrhagic stroke (excluding Transient Ischemic 
Attacks, or mini strokes) within the last 3 years 
 
they self-identify as having communication difficulties as a result of the stroke 
 
they were in paid employment or actively seeking work at the time of their stroke 
 
they are attempting or have attempted (whether or not successfully) to return to paid 
employment since their stroke. 
 
Individuals will be excluded if: 
 
they lack the capacity to consent 
 
they are considered to have insufficient English language skills to be able to engage 
effectively in an interview, given that this is a small-scale study which will not have 
the resources to fund interpreter services 

 
 
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 
they have a diagnosis of a learning disability, dementia or another comorbidity 
deemed to be as or more significant than the stroke in their experience of return to 
work.     
6.4 Recruitment  
Sampling will be purposive and include more than one pathway in order to recruit a wide 
range of participants. In one pathway, individuals will be recruited through Speech and 
Language Therapy services in NHS Grampian, NHS Greater Glasgow and Clyde, and NHS 
Highland. Speech and Language Therapists (SLTs) will identify potential participants, 
discuss the project with them, and give them the information pack. This pack, which was 
designed in consultation with the two advisors with lived experience mentioned above 
(Section 4.0), will include an invitation letter, Participant Information Sheet (PIS), and reply 
slip with a stamped addressed envelope. In a second pathway, advertising notices (again 
designed in consultation with the advisors mentioned in Section 4.0) will be given to groups 
for stroke survivors run by organisations such as the Chest Heart and Stroke Scotland and 
the Stroke Association across Scotland, inviting individuals to contact the research team if 
they wish to be considered for the study. They will then be sent an information pack 
including a PIS, and a reply slip with a stamped addressed envelope. In either pathway, the 
individual can then reply to the research team by post, email or telephone if they wish to 
proceed with involvement.   
 
We will aim for a total sample size of 18 participants. We will aim to recruit 12 participants 
initially. If data saturation has not been reached, a further three participants will be recruited, 
then further groups of three until data saturation has been reached. If data saturation has 
been reached before 18 participants have been recruited, we will close the study early. This 
number is based on evidence that a sample size of 12 has been found to be the minimum for 
data saturation in an interview study19 and also for pragmatic reasons (e.g. the predicted 

 
 
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availability of eligible participants within the region, and the time and resource limitations of 
the study.)  If recruitment numbers are low, a third recruitment pathway will utilise the vehicle 
of the National Stroke Voices public involvement group and/or social media 
(Twitter/Facebook accounts for relevant NHS Grampian and Robert Gordon University 
(RGU) departments and professional contacts of the research team). Participants will be 
recruited via advertisements and will be asked to contact the research team in the same way 
as the first and second recruitment pathways.   
 
6.5 Eligibility screen and informed consent 
A member of the research team will make contact with each potential participant who has 
consented to the initial contact or responded to an advertisement to screen against the 
inclusion and exclusion criteria for eligibility, discuss the study further and answer any 
questions about it. If the person still wishes to be involved in the study, a member of the 
research team will arrange to meet them at a mutually agreed venue or, where a face to face 
meeting is not possible, via a digital interface such as NearMe or Microsoft Teams (in the 
case of people recruited from the NHS Greater Glasgow and Clyde and NHS Highland 
areas, all meetings would be conducted via a digital interface rather than face to face). 
Written informed consent will be obtained before conducting the interview. The participant 
will initial, sign and date two copies of the consent form, one of which they will keep, the 
other being retained by the researcher team. Where the meeting is conducted via  a digital 
interface,. the participant will be provided with a copy of the consent form by email or post, 
according to their preference, and each point will be read aloud to the participant for them to 
indicate their consent to participate verbally. The researcher will initial each point of the 
consent form as the participant agrees, and will retain this hard copy. A copy of this will be 
sent to the participant. This meeting would be recorded, and the recording stored (see 
section below on data protection).  

 
 
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6.6 Ineligible and non-recruited patients 
Participants recruited via SLTs will have been identified as eligible by the SLTs, so it is 
unlikely that they will then be found to be ineligible for inclusion when screened by a member 
of the research team. It is possible however that individuals who respond to advertisements 
may be found to be ineligible when screened. In this event, they will be thanked for their 
interest and their time, and it will be explained to them why the current study is not 
appropriate for them. They will be directed to sources of support as appropriate. A screening 
log will be kept, recording how many individuals have been approached about the study; 
how many individuals have contacted the research team to request an interest in 
participating; and how many of these have been screened as eligible for inclusion.  
 
As involvement will entail a single interview, it is highly unlikely that a participant would have 
to be withdrawn by the research team. If a participant chooses to withdraw when data 
collection has already begun (e.g. when the interview has commenced), they will be asked if 
they consent to the data already collected being retained by the research team for analysis. 
Their wishes in this regard will be respected.    
 
6.7 Data collection 
In the case of face to face interviews, these will be arranged with participants in a venue 
suitable for them (e.g. in their own home or in a clinic or a mutually convenient community 
location). The sponsor’s Lone Working Policy will be adhered to, with risk assessments 
carried out as appropriate, in order to reduce the risk of harm to members of the research 
team. While it would be more beneficial to carry out face to face interviews because of 
participants’ communication problems and the potential barriers caused by digital 

 
 
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technology, interviews could be carried out using digital interfaces such as Microsoft Teams 
or NearMe if necessary. As noted above, in the case of participants recruited from NHS 
Greater Glasgow and Clyde and NHS Highland areas, although it would be ideal to conduct 
face to face interviews, this is not practical outside of the Grampian area, therefore all 
interviews will be conducted via a digital interface. The interview will be informed by a topic 
guide with items probing the overarching research questions (e.g. questions about pre-
stroke employment/job seeking activity; feelings on considering returning to work/job seeking 
after stroke (especially with regard to communication problems); support from health 
services/third sector; discussions with employer/employment services; nature of return and 
adjustments made; feelings about return (especially with regard to communication 
problems). The topic guide questions were informed by consultation with the advisors with 
lived experience mentioned above (Section 4.0). In addition, they were piloted with a 
colleague.   
 
The interviews will last approximately 60 minutes, but the time will vary depending on the 
individual and their communication needs and skills (e.g. how much information they are 
able to provide; whether additional time is required for them to respond to questions). 
Additional communication support will be given if necessary (e.g. use of writing, drawing and 
gesture, and communication technology). If a participant would like to take a break from the 
interview it can be paused, as necessary, and a further session can be arranged to complete 
the interview at a convenient time for the participant. Participants will be given a shopping 
voucher as a thank-you for taking part in the study.  
 
The interviews will be digitally recorded on a password-protected NHS iPad (with automatic 
cloud storage having been disabled). The recordings will be immediately transferred onto an 
NHS password-protected computer and deleted from the portable device.  

 
 
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6.8 Data analysis 
The audio-recordings will be transcribed by an NHS Grampian-approved transcription 
service.  Thematic analysis will be undertaken, using the procedure outlined by Braun and 
Clarke.20 The CI will generate the initial codes on the basis of content pertinent to the 
research questions. A research fellow will assist with the coding process. In order to ensure 
rigour, The CI, one of the collaborators (a research professor), and the research fellow will 
code 2-3 transcripts independently and review agreement/disagreement. This may result in 
refinement of the coding index and further coding and reviewing agreement, until agreement 
is sufficiently high for coding to be conducted by the CI or the research fellow. 
 
An audit trail will be kept in the form of Microsoft Word documents recording discussions and 
decisions that are made. The data management software system NVivo will be used to 
facilitate data analysis. Participants will be sent a summary of the initial findings and asked if 
they have anything further to add.  They will be able to provide this by filling in a feedback form 
supplied with a stamped addressed envelope. This will be an optional activity and all 
responses will be fully anonymous. Any additional information provided by the participants in 
this feedback will be incorporated into the final analysis.  
 
7.0 Project management 
The project will be overseen by a steering group comprised of the research team, 1-2 
healthcare professionals with specialist knowledge of return to work (e.g. a vocational 
rehabilitation specialist and/or a physiotherapist or occupational therapist with relevant 
expertise) and 2-3 lay advisors with lived experience (invited from the pool of advisors who 
participated in the design stage, as discussed above in section 4.0). This group will meet 
every 3 months to discuss progress and to agree on any further decisions that require to be 

 
 
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made during the course of the project.  In keeping with current guidance, lay members will 
be reimbursed for their time and travel.  
 
A study-specific Delegation Log will be prepared, detailing the responsibilities of each 
member of staff working on the study. 
 
 
8.0 Inspection of records  
The CI, collaborators and all institutions involved in the study shall permit study related 
monitoring, audits, and Research Ethics Committee (REC) review. The CI agrees to allow 
the Sponsor or, representatives of the Sponsor, direct access to all study records and source 
documentation. 
 
9.0 Good clinical practice  
9.1 Ethical issues 
The study will be conducted in accordance with the principles of good research practice 
(GRP). In addition to Sponsorship approval, a favorable ethical opinion will be obtained from 
the appropriate REC, and appropriate  Research and Development (R&D) approvals will be 
obtained prior to commencement of the study. 
 
Potential participants will be given clear verbal and written information in an accessible 
format (for example large font size, pictorial support) as appropriate to the nature of their 
communication disorders. This information will highlight that participation is entirely voluntary 

 
 
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and participants can withdraw at any point without needing to give a reason and without it 
affecting any healthcare or return to work support they may be receiving. 
 
We believe that there is a low burden or risk of harm to participants. Any unexpected 
distress experienced when describing the emotional impact of the stroke or any difficulties 
that ensued will be minimised by sensitive and sympathetic listening, acknowledging the 
distress and offering to discontinue the interview. In addition, the participant information 
sheet will signpost people to sources of support, for example Chest Heart & Stroke Scotland, 
or the Stroke Association. 
9.2 Confidentiality  
All data will be identified in a manner designed to maintain participant confidentiality. All 
records will be kept in a secure storage area with limited access to study staff only. Clinical 
information will not be released without the written permission of the participant, except as 
necessary for monitoring and auditing by the Sponsor or its designee. The CI and study staff 
involved with this study will not disclose or use for any purpose other than performance of the 
study, any data, record, or other unpublished, confidential information disclosed to those 
individuals for the purpose of the study. Prior written agreement from the Sponsor or its 
designee will be obtained for the disclosure of any said confidential information to other 
parties. 
 
9.3 Data protection 
The CI and study staff involved with this project will comply with the requirements of the 
General Data Protection Regulations (GDPR) and the Data Protection Act 2018. The Health 
Research Authority (HRA) recommended wording to fulfil transparency requirements under 
the GDPR for health and care research has been included in the PIS.  

 
 
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The CI and study staff will also adhere, if appropriate, to the current version of the NHS 
Scotland Code of Practice on Protecting Patient Confidentiality.  Access to collated participant 
data will be restricted to the CI and appropriate study staff. 
 
Computers used to collate the data will have limited access measures via user names and 
passwords. 
 
Published results will not contain any personal data that could allow identification of individual 
participants. 
 
Participants will be assigned a code in order to de-identify them for the purposes of 
transcription and analysis. A separate file containing the participants’ names and contact 
details will be stored separately and accessed only by the research team if necessary, e.g.  
for sending the summary of initial findings or final report.  All identifiable study data (i.e. 
signed consent forms, the coding information with participants’ details), will be stored on 
password-protected NHS computers (electronic data) and/or locked filing cabinets (hard 
copies consent forms) on NHS premises that are only accessible to members of the 
research team and destroyed at the end of the study. 
 
Anonymised data may be analysed on university computers as well as NHS computers 
during the course of the study. This anonymised data will be transferred between institutions 
using a dedicated Microsoft Teams page. Anonymised transcriptions may be printed out to 
facilitate the process of data analysis. These hard copies will be stored in a locked filing 
cabinet in NHS or university offices which are locked outwith working hours. Audio 

 
 
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recordings will be destroyed at the end of the study. Anonymised research data will be 
stored for ten years in an NHS-approved storage facility.  
 
Consent procedures will seek permission to use direct quotations from respondents. Any 
identifying material (e.g. names of people/employer) will be removed from the quotation. 
 
10.4 Insurance and indemnity 
Grampian Health Board is sponsoring the study. 
 
10.4.1 Insurance – Grampian Health Board will maintain its membership of the Clinical 
Negligence and Other Risks Insurance Scheme (“CNORIS”) which covers the legal liability of 
Grampian in relation to the study. 
 
10.4.2 Indemnity: Grampian Health Board does not provide study participants with indemnity 
in relation to participation in the study but has insurance for legal liability as described above. 
 
11.0 Output and dissemination 
11.1 Authorship policy 
Ownership of the data arising from this study resides with the study team and their 
respective employers. Following the analysis of the study data described above in section 
6.7, a final report will be prepared. 
 
11.2 Dissemination 

 
 
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The findings from the study will be presented via the following channels:  
Academic: a peer-reviewed manuscript in high-impact journal aimed at rehabilitation 
professionals and academics; a presentation at a relevant international or national 
conference such as the UK Stroke Forum Conference.  
Lay:  a summary of findings provided to the study participants.  
Professional: presentations to relevant NHS Grampian, NHS Greater Glasgow and Clyde, 
and NHS Highland rehabilitation professionals involved in managing post-stroke 
communication disorders and/or return to work, e.g. Occupational Therapists, 
Physiotherapists, Speech and Language Therapists, Vocational Rehabilitation specialists.  
As indicated above (section 2.0), the findings will be used to progress a programme of 
research that will benefit people who have had a stroke. It will be combined with the findings 
from our earlier scoping review11 to provide important knowledge about barriers and 
facilitators to return to work for people with post-stroke communication disorders. This 
knowledge will then be used in a co-production that will follow on from this study. In this co-
production, based on the facilitators identified and using strategies to overcome the barriers, 
a targeted intervention will be developed to support people with post-stroke communication 
disorders attempting to return to work.  
 
12.0 Study conduct responsibilities  
12.1 Protocol amendments, deviations and breaches 
The CI will seek approval for any amendments to the protocol or other study documents from 
the Sponsor (in the first instance), REC and NHS R&D Office(s). Amendments to the 
protocol or other study documents will not be implemented without these approvals.  

 
 
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In the event that the CI needs to deviate from the protocol, the nature of and reasons for the 
deviation will be recorded in the Clinical Report Form, documented and submitted to the 
Sponsor. If this necessitates a subsequent protocol amendment, this will be submitted to the 
Sponsor for approval and then to the appropriate REC and NHS R&D Office(s) for review 
and approval. 
  
In the event that a serious breach of GCP is suspected, this will be reported to the Sponsor 
immediately using the form “Breach Report Form”.  
 
12.2 
Study record retention 
Archiving of study documents will be on NHS Grampian premises in line with the Sponsor’s 
Standard Operating Procedure (SOP). At the end of the study the NHS Grampian archivist will 
be contacted to arrange appropriate archiving.   
 
12.3 
End of study 
The end of study is defined as the last participant interview. The Sponsor, CI and/or the 
steering group have the right at any time to terminate the study for clinical or administrative 
reasons. The end of the study will be reported to the Sponsor and REC within 90 days, or 15 
days if the study is terminated prematurely. The CI will ensure that any appropriate follow up 
is arranged for all participants. A summary report of the study will be provided to the Sponsor 
and REC within 1 year of the end of the study. 
 
References   

 
 
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1. O'Cathain A, Croot L, Duncan E, et al. Guidance on how to develop complex 
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19. Guest G, Bunce A, Johnson L. How Many Interviews Are Enough?: An Experiment 
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