Understanding the Patient Experience of Day-case Bladder Tumour Resection, and Prostate Resection or Enucleation: Qualitative Patient Interviews.
Conditions: Bladder Cancer, Bladder Outflow Obstruction
Sponsor: Royal Devon and Exeter NHS Foundation Trust

Protocol/V3/161023 
IRAS 327246 
1
Understanding the patient experience of day-case bladder tumour resection, 
and prostate resection or enucleation: Qualitative patient interviews. 
 
Current Protocol Number: 
V3 16.10.23                                     IRAS no – 327246 
 
Chief Investigator: 
• Mr John McGrath - Consultant Urologist and GIRFT Urology co-chair, Royal Devon 
University Healthcare NHS Foundation Trust and Getting It Right First Time. 
Principal Investigator:  
• Mr Joseph John – Urology Registrar and Research Fellow, Royal Devon University 
Healthcare NHS Foundation Trust and Getting It Right First Time.  
Co- Investigators: 
• Mr Kieran O’Flynn - Consultant Urologist and GIRFT Urology co-chair, Northern Care 
Alliance NHS Foundation Trust and Getting It Right First Time. 
• Mr William Keith Gray, Researcher and analyst, Getting It Right First Time. 
• Professor Sir Tim Briggs, Director for Clinical Improvement and Elective Recovery, 
NHS England 
Sponsor: 
• Royal Devon University Healthcare NHS Foundation Trust 
 
Independent Scientific review:  
Dr Bethany Treadgold, Research Fellow & Qualitative Advisor 
Primary Care Research Group & NIHR Research Design Service, South West 
 
Funder: 
• Getting It Right First Time (GIRFT) 
Infra structure support: 
• NIHR Peninsula Clinical Research Network 
• 
Royal Devon University Healthcare NHS Foundation Trust 
 
 

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SIGNATURE PAGE FOR CHIEF AND PRINCIPAL INVESTIGATOR 
For Protocol No.: V2 14.02.23                                      
 
 
Understanding the patient experience of day-case bladder tumour resection, 
and prostate resection or enucleation: Qualitative patient interviews. 
 
I have read this protocol (xxxxx) and agree to conduct this trial in accordance with all 
stipulations of the protocol and in accordance with the principles of Good Clinical Practices 
(GCP), the Declaration of Helsinki (2000 Edinburgh), and applicable legal and regulatory 
requirements.   
 
 
 
 
 
Chief Investigator  
 
Signature 
 
Date 
 
 
 
 
 
Principal Investigator  
 
Signature 
 
Date 
 
 
 

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Title of Study 
Understanding the patient experience of day-case bladder tumour 
resection, and prostate resection or enucleation: Qualitative patient 
interviews. 
Protocol Number 
3 (16/10/23) 
Sponsor R&D No: 
TBC 
Number of Study Sites 
6+ 
Number of participants  
15, with plans to expand in increments of 3 until thematic saturation is 
reached 
Study Design 
Semi-structured qualitative interviews 
Participant population 
Patients who have recently undergone day-case transurethral resection 
of bladder tumour, transurethral resection of prostate, or transurethral 
enucleation of the prostate. 
Aim 
To understand patient experiences following day-case transurethral 
resection of bladder tumour (TURBT), transurethral resection of 
prostate (TURP), and transurethral enucleation of prostate (TUEP). 
Main Criteria for 
Inclusion 
Inclusion Criteria: 
● Adults aged >18 who have recently undergone day-case TURBT or 
TURP or TUEP 
● Able and willing to provide informed consent 
Exclusion Criteria: 
● Patients who had surgery that was not performed as a day-case 
Study Duration 
 18 Months 
Study Period  
 April 2023 – October 2024 
Study Summary  
A qualitative research study interviewing patients treated in hospitals 
across England. We will interview patients who have recently undergone 
one of the following operations as a day-case; transurethral bladder 
tumour resection (TURBT), transurethral resection of prostate (TURP) or 
transurethral enucleation of the prostate (TUEP). We are interested to 
find out about the experience for patients who go home on the day of 
surgery after they have had one of these operations. We hope that the 
findings will tell us about how to improve the experience for patients in 
future. 
 
Patients undergoing day-case surgery at a range of different hospitals 
from across England with varying day-case rates will be interviewed. 
Hospitals in large city and more rural areas will be included. Interviews 
are anticipated to take place over a six month period between December 
2023 and May 2024. The study will end when “saturation” is achieved, 
whereby no new themes are identified through interviews. Saturation 

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will be sought for each individual operation of interest. Analysis and write 
up will take place from May 2024 – October 2024.  

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Table of Contents 
Amendment History/Changes from previous version ........................................................ 7 
Scientific Summary .......................................................................................................... 8 
Plain English Summary..................................................................................................... 9 
Research Question ........................................................................................................... 9 
Aims and Objectives .......................................................................................................10 
Aim: ...................................................................................................................................... 10 
Objectives:............................................................................................................................. 11 
Methods .........................................................................................................................11 
Study Population ............................................................................................................11 
Inclusion criteria .............................................................................................................11 
Exclusion Criteria ............................................................................................................12 
Participant Identification:....................................................................................................... 12 
Screening and identification ................................................................................................... 12 
Recruitment ........................................................................................................................... 12 
Informed consent................................................................................................................... 13 
Participant withdrawal: .......................................................................................................... 14 
Schedule of events ..........................................................................................................16 
Primary outcome measure: .................................................................................................... 16 
Study management ........................................................................................................17 
Budget Summary and costings ........................................................................................18 
Project development and user involvement .....................................................................18 
Data Management .........................................................................................................20 
Data monitoring:.................................................................................................................... 20 
Data Confidentiality: .............................................................................................................. 20 
Data Storage and Archiving: ................................................................................................... 21 
Ethical considerations .....................................................................................................21 
Adverse event recording and reporting ...........................................................................23 
Participant feedback .......................................................................................................24 
Dissemination/implementation of research.....................................................................24 
Potential impact and benefit of the proposed research: ...................................................25 
End of Study ...................................................................................................................25 

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References ......................................................................................................................25 
Appendix 1. Question guide ............................................................................................27 
 
 
 

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Amendment History/Changes from previous version 
Amendment 
Number 
Revised Protocol 
Version Number 
and date 
Details of key changes made (including 
justification if required) 
Amendment 1 
Version 1 
(15.11.22) revised 
based on 
feedback to 
produce version 2 
(17.02.23) 
 Changes based on PPIE meeting 14.02.2023 
- 
Remove assumptions around recovery in 
own home being preferable in PLS. 
- 
Wording modifications to questions for 
clarity. 
- 
Have telephone interviews as an available 
option as well as video conferencing. 
- 
Specify that study is within NHS hospitals. 
- 
Question about information provided for 
patients. 
Based on supervision from qualitative 
researcher 
- Increase introductory questions. 
- re-frame questions in more open format. 
- reduce overall number of questions in 
order to achieve “semi-structured” 
interview aim. 
Amendment 2 
 
 
 
 
 

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Scientific Summary 
Safe day-case surgery pathways offer to reduce pressure on hospitals by avoiding overnight 
inpatient admission. This is particularly relevant given the intense pressures on hospital 
resources in the United Kingdom. Urological surgery includes a number of frequently 
performed operations for which safe day-case surgery pathways have been demonstrated, 
but for which day surgery is routine widespread routine practice. These include bladder 
tumour resection (TURBT), and prostate resection or enucleation using diathermy or laser 
(TURP and TUEP). All of these operation types involve endoscopic access to the bladder via 
the urethra, and do not involve skin incisions. They can be performed under general or 
spinal anaesthesia.  
 
For 12 months from December 2021, the national average day-case rate for transurethral 
resection of bladder tumour In England was 21.1%, and ranged from 0% to 87.3% at 
different hospitals, with an interquartile range (IQR) of 10.5% to 37.7%, and 23,071 cases 
performed in total. For bladder outflow obstruction surgery the median day-case rate was 
7.7% (range 0% to 82.4%, IQR 4.4% to 19.1%, 18,912 cases), and this includes TURP and 
TUEP. This demonstrates that for these common operations there is significant variation in 
practice across England.  
 
The Getting It Right First Time (GIRFT) Urology programme advocates for a “day-case by 
default” approach to TURBT, and that day-case surgery should ideally be offered for 
prostate resection and enucleation. As well as reducing pressure on inpatient services, 
greater day-case adoption offers to reduce financial costs, shorten waiting lists by allowing 
greater access to day-case theatres away from the acute hospital, and reduce 
environmental impact by adopting a less resource-intensive approach. It also offers a more 
standardised patient experience, however we do not understand a great deal about the 
lived patient experience after discharge.  
 
National day-case rates for of TURBT, and bladder outflow obstruction surgery using TURP 
or TUEP, have increased over the past five years. Many hospitals have well-established 
pathways, whilst others are newly adopting this approach, or not yet adopting day-case 
surgery for these operation types at all. There is an opportunity to understand the patient 
experience of different day-case surgery pathways for these operations of interest, so that 
we might understand factors contributing to a favourable or unfavourable experience. This 
knowledge could inform future day-case pathway development and modification is a way 
that is more acceptable for patients.  
 
To explore this area, we intend to perform qualitative research involving patients. We will 
interview patients who were treated at a range of different hospitals with differing day-case 
performances.  
 

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Plain English Summary 
Safely performing day-case surgery is a way of easing pressure on hospitals. This is because 
it avoids an overnight stay. It allows patients to recover in their own home. This is likely to 
be cheaper and better for the environment because it uses less resource. 
 
In healthcare, urology deals with problems with the urinary and sex organs. Urology 
includes some common operations that can safely be performed as a day-case. These 
include treating bladder tumours and removing part or all of the prostate to treat a 
blockage. All of these involve treating the patient through their natural orifice (urethra) 
instead of making any cuts to the skin.  
 
In England, the Getting It Right First Time (GIRFT) programme suggests that these 
operations should be performed as a day-case. Even so, there is wide variation in day-case 
rates across England. Most of these operations still involve an overnight hospital stay. 
 
We want to know what it is like for patients who go home on the day of surgery. We hope 
that this will tell us how to improve the process for patients in future. 
 
We will perform the study through hospitals that do a lot of day-case surgery for bladder 
tumours or prostates. Before or after surgery the doctor will ask their patient if they would 
be happy to be interviewed. This would take place in the future after they have fully 
recovered. Patients will be given an leaflet explaining the study. This will have an email 
address and phone number to contact if they would like to take part.  
 
Willing patients will be interviewed one-to-one on the internet or phone. Each patient will 
be asked about their experience of having day-case surgery. The interviews will be recorded. 
After, the research team will listen to them to find common patient experiences. They will 
look for ways that future patient’s experiences could be made better.  
Research Question 
What is the patient experience of day-case TURBT, TURP and TUEP?  
 
Rationale and background 
Resource constraints and evolving patient demographics mean that the waiting lists for 
elective surgery in the NHS are greater than ever. Nationally, the median average 
percentage of patients receiving transurethral resection of bladder tumour (TURBT) 
treatment within 62 days of referral is only 13.1% (1). For patients requiring surgical 
treatment for acute urinary retention, the median average national hospital wait time 
exceeds five months (1).   
 

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Solutions are required to improve timely patient access to surgery. The approach will need 
to be multi-factorial, and increasing day-case rates by configuring safe and effective 
pathways is one proposed method (2). Performing common endourology operations as a 
day-case when possible, could take pressure off inpatient resources and allow these 
inpatient beds to be used for other purposes (3). It also means that these endourology 
operations could proceed without a reliance on inpatient bed availability, and this would 
open opportunities to perform surgery in peripheral day-case units without inpatient beds 
(4). Furthermore, by utilising less resource intensive day-case pathways there would be cost 
savings, and potentially reduced associated greenhouse gas emissions (5). There is 
additionally reason to suppose that patients might have a superior experience by recovering 
at home instead of as a hospital inpatient, although this has not yet been demonstrated in 
academic literature.  
 
The Getting It Right First Time (GIRFT) programme is an expert clinician-led and data-driven 
national quality improvement programme aiming to improve standards and decrease 
unwarranted variation in clinical care (6). Separate GIRFT workstreams exist for each 
medical and surgical specialty. The GIRFT urology programme advocates for increased day-
case rates for common endourology operations and recommends a “day-case by default” 
approach to TURBT. The GIRFT programme recommended day-case adoption in the 2018 
GIRFT Urology National Report and their GIRFT academy service delivery guides (7)(8)(9). At 
the intensive deep dive visits that GIRFT perform to every single urology unit in England, 
day-case pathways are commonly discussed as a target for quality improvement. In the five 
years since the 2018 report, trends towards increasing day-case rates have been observed, 
however there remains significant nationwide variation in the rates of day-case surgery 
performed for TURBT, and bladder outflow obstruction operations such as TURP and TUEP.  
 
A fundamental question that remains largely unanswered is what the experience is like for 
patients who undergo day-case endourology operations. There is a common assumption 
that patients would prefer to recover at home as part of a safe day-case pathway, however 
this assumption is untested. This question is particularly relevant for TURBT, TURP and TUEP 
because practice with respect to adoption of day-case surgery remains divergent across 
England. It is important to understand whether and how we can facilitate an acceptable 
patient experience of day-case TURBT, TURP and TUEP, so that our findings can inform 
future GIRFT recommendations around optimising day-case surgery pathways. We intend to 
utilise a semi-structured qualitative interview format to explore the patient experience of 
day case urology operations, and understand what contributes to a positive or negative 
experience (10). 
Aims and Objectives  
Aim:  

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To understand patient experiences following day-case transurethral resection of bladder 
tumour (TURBT), transurethral resection of prostate (TURP), and transurethral enucleation 
of prostate (TUEP). 
 
Objectives: 
- 
Interview patients who have had day-case TURBT, TURP or TUEP to identify common 
themes with respect to patient experience. 
- 
Identify factors that positively or negatively affect the patient experience after day-
case TURBT, TURP and TUEP. 
 
Hypothesis: 
We hypothesise that the patient experience of day-case TURBT, TURP and. TUEP is 
acceptable when delivered as part of a well-designed treatment pathway. 
 
Choice of study design: 
A semi-structured qualitative interview design has been adopted in order to identify key 
themes.  
 
We see it as important to interview a range of patients having undergone TURBT, TURP or 
TUEP, at different hospitals in different parts of England. This is so we can gain a broad 
range of perspectives about different care pathways that have been developed, and to gain 
a broad representation of the patient experience. We will conduct interviews with patients 
who have had surgery at hospitals with different day-case rates because it is possible that 
factors relevant in one hospital that performs a certain volume of day-case endourology 
surgery might not be the same in other hospitals. 
Methods 
Study Population 
Patients who have recently undergone day-case transurethral resection of bladder tumour 
(TURBT), transurethral resection of prostate (TURP), or transurethral enucleation of the 
prostate (TUEP) at an NHS hospital in England.  
Inclusion criteria 
• Adults aged 18 
• Experienced day-case TURBT, TURP or TUEP within the past 6 weeks 
• Willing and able to provide informed consent 
• English speaking 

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Exclusion Criteria 
• Experienced surgery that was not performed as a day-case 
 
Potential participants will not be excluded on unfair grounds, however participants will be 
selected from a pool of willing individuals such that a representative cross section of 
different individuals are interviewed based on demographics and location. 
 
Participant Identification: 
Screening and identification:  
Study sites of interest will be identified by analysing Hospital Episode Statistics (HES) data 
using the Model Hospital information dashboard. A representative selection of hospitals 
performing high, intermediate and low rates of day-case surgery for the operations of 
interest will be selected for potential recruitment. Representation of urban and rural areas, 
and patient population demographics will be considered to gain a representative cross 
section of English hospitals.  
 
Clinicians who perform any of the operations of interest as a day-case will be contacted and 
consented to assist with participant identification. This will involve discussing the study with 
patients on the day of their operation, after standard preoperative consenting has taken 
place and before any anaesthetic or preoperative psychoactive medications are 
administered. Expression of interest will be noted and a study information leaflet provided 
for patients who are interested in participation.  
 
The individuals gaining the expressions of interest from patients will be considered as local 
collaborators rather than investigators, and the recruitment sites as participant 
identification centres (PICs) rather than formal study sites.  
 
Potential participant’s details will be sent from their treating clinician/local collaborator to 
the sponsor site Principle Investigator (PI) via secure encrypted NHS email. The following 
details will be included; operation type and date, contact details, age, sex, ethnicity, and 
whether the patient has a carer. Potential participant contact details will be stored at the 
sponsor site on a database on a secure server and screened in order to gain interviews with 
a diverse patient population.  
 
Potential participants will then be screened based on their demographics, operation type, 
and hospital, and contacted by telephone to discuss participation in further detail. 
 
Recruitment:  
The research team will then be responsible for the recruitment process. This will include a 
telephone call from a member of the research team to identified potential participants, and 

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providing an electronic study-specific participant information sheet (PIS). A physical PIS will 
be offered by post if preferable. Potential participants will be provided with the opportunity 
to discuss the project in detail with a member of the research team. These discussions will 
include the nature and purpose of the study, participant involvement and potential risks. All 
potential participants will be given the time they deem necessary to make the decision to 
participate. The anticipated time commitment associated with undertaking the interview 
will be explained. Data on numbers of participants expressing interest to take part, invited 
to take part, and those actually taking part, will all be recorded.  
 
Informed consent:   
The participant information sheet contains sufficient detail in order for individuals to be 
able to make an informed decision about participation. Participants will be offered 
opportunities to ask any further questions that they might have either by email or over the 
telephone, with the sponsor site PI. If necessary, a physical PIS copy will be posted to 
potential participants if they are unable to access email.  
 
Willing participants will be routinely contacted by telephone on a date ahead of the 
interview to answer any questions, confirm their willingness to participate, and arrange a 
suitable date and time for interview.  
 
Since the interviews are largely planned to take place remotely either using video 
conferencing (MS teams) or over the telephone, verbal consent will be obtained and 
recorded prior to the interview. This will be on the day of the interview, after permission to 
record has been granted and before the interview questions commence.  
 
On the day of the interview, before commencing the interview, the consent form will be 
read out to the participant. Each point will be read out in turn and ticked when the 
participant agrees to them. Opportunities to ask further questions will be offered after each 
point. The participant will be asked to provide verbal consent and this will be recorded on 
audio. The audio files of participation consent will be stored on a password protected 
secure server at the sponsor site, separate from the main body of their interview but linked 
via a pseudonymised participant identification number. On providing their verbal consent, 
the interviewer will also sign the consent form and send a copy via e-mail to the 
interviewee.  
 
Recordings of consent will be saved and stored as separate files on a password protected 
encrypted server at the sponsor site (Royal Devon University Healthcare NHS Foundation 
Trust). A delegated member of the research team will maintain a record of all documented 
consent. 
 

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Only patients with capacity to consent to participate will be interviewed for the study. 
When verbal consent is gained before the study, capacity to consent will be informally 
assessed based on the participant's understanding about the reason to conduct the study, 
and their ability to articulate their willingness to be involved. The PI is a doctor and 
understands the principles pertaining to capacity to consent. A delegated member of the 
research team will maintain a record of all documented consent. Patients who lack capacity 
to consent will not be recruited. Local collaborators at PICs who are assisting with 
participant identification will be informed about this.  
  
Participant withdrawal: 
Participants will be informed that they are free to withdraw from the study at any time. If a 
participant withdraws from the study the reason will be recorded anonymously. 
Criteria for discontinuing participation in the study are: 
● Participant withdrawal of consent 
● Participant unwilling to undergo audio recording of interview 
● Investigator’s discretion that it is in the best interest of the participant to withdraw 
● Termination of the study by the sponsor or funding body  
 
Interviews 
Participants will be provided with the following options for interviews, being able to select 
the option of their preference: 
• 
Video conferencing using Microsoft Teams 
• 
Telephone call 
Interviews will all be recorded after informing the participant and gaining their consent for 
this, and the audio file stored on an encrypted computer. For interviews conducted using 
Microsoft Teams, the integrated recording and transcription function will be used. For 
interviews conducted over the phone, the Voice Memo iPhone app will be used on a 
password protected and encrypted iPhone. The audio and transcription files will be stored 
on an encrypted, password protected server with regular file back up. Interviews will last 
between 45 and 60 minutes.  Participants will be informed of their right to terminate the 
interview at any time. Interviews will all be carried out by the PI (JJ).  
 
Interviewees will be asked to situate themselves in a quiet room on their own and free from 
distraction for remote interviews, and the interviewer will also locate himself in a 
distraction-free environment. Open questions will be asked about the patient’s experience 
of day-case surgery, with the nature of follow up questions depending on the initial 
answers. The feasibility of the question guide will be tested during an internal pilot study 
performed at the Royal Devon and Exeter Hospital (sponsor site). 
 
Timing:  

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Within the study timeline, interviews will be arranged at a time and date that is convenient 
for the interviewee.  
 
Questions:  
A semi-structured interview format will be utilised. This involves using a pre-designed 
question guide, with themes explored in greater depth depending on the interviewee’s 
answers. The questions are designed to signpost areas of fundamental importance, as 
established following consultation with clinicians, academics, and a patient and public 
involvement group. The study question guide is included in Appendix 2.  
 
Descriptive data collection:  
A limited set of descriptive data will be collected alongside the interviews. This will describe 
the following; participant age, sex, ethnicity, hospital, region, operation experienced, 
comorbidities, disabilities, and whether they require social care.  
 
Interview transcription:  
For interviews conducted using Microsoft Teams, the integrated recording and transcription 
function will be used. For interviews recorded using the phone, the Voice Memos iphone 
app will be used to record audio. Third party transcription service will be utilised to 
transcribe interview audio into text (Bristol Transcription and Translation Service). They are 
an ISO:9001 (quality) and ISO: 27001 (information security) and Cyber Essentials certified 
business. I attach a document describing their data security and management.  
 
The audio files provided to this service will be in a pseudonymised format using a unique 
study number for each participant. A password protected spreadsheet stored at the sponsor 
site will contain the complete participant details.  
 
Pilot study:  
Over two weeks a pilot study will be conducted with participants at the Royal Devon and 
Exeter hospital. As well as broadly assessing study feasibility, particular attention will be 
paid to the length of interviews and the degree to which it is feasible to interview 
participants about multiple different operation types. Generic feedback regarding the 
feasibility of the study will be gained during the pilot study. Transcription and thematic 
analysis will not be performed immediately following these interviews, however if the 
interview format remains similar after the pilot study then these interviews will be included 
in subsequent analysis. 
 
Recruiting centres: 
For the purposes of the study, centres from whom participants will be identified will be 
considered to be Participant Identification Centres (PICs). They will not be a requirement for 

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PIC’s involvement in the running of the study beyond the initial identification of potential 
participants.  
  
Schedule of events 
 
TIME POINT 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 (6 
MONTHS) 
Hospital 
identification 
X 
 
 
 
 
 
 
 
 
 
 
Consent clinical 
leads 
 
X 
 
 
 
 
 
 
 
 
 
Candidate 
interviewee 
identification 
 
X 
 
 
 
 
 
 
 
 
 
Interviewee 
expression of 
interest 
 
 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
 
 
 
X 
 
 
 
 
 
 
 
Consent 
 
 
 
 
X 
 
 
 
 
 
 
Interview 
 
 
 
 
 
X 
 
 
 
 
 
Demographic data 
 
 
 
 
 
X 
 
 
 
 
 
Transcription 
 
 
 
 
 
 
X 
 
 
 
 
Interim thematic 
analysis 
 
 
 
 
 
 
 
X 
 
 
 
Study conclusion 
(when thematic 
saturation is 
reached) 
 
 
 
 
 
 
 
 
X 
 
 
Analysis 
 
 
 
 
 
 
 
 
 
X 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
X 
 
Primary outcome measure: 
• Patient’s descriptions of their experience of day-case TURBT, TURP and TUEP 
 
Statistical planning 
Since this is a qualitative study no prospective power calculation will be performed. After 15 
interviews, audio transcription will be performed. Thematic analysis of these transcripts will 
be carried out. If thematic saturation and a representative sample of hospital sites and 
operations is achieved then the study will be ended. If not, then a further extension of the 
study will be registered with the HRA using IRAS, and interviews will be continued. Every 3 

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interviews further transcription and interim thematic analysis will be performed. Interviews 
will be discontinued and the study closed at whichever point that saturation of themes is 
reached, and a representative sample of hospital sites and operations is achieved. For the 
purposes of this research saturation is defined as when only repeated themes are observed 
during analysis of subsequent interviews. Themes will be characterised using inductive 
thematic analysis as described by Braun and Clarke.  
 
Representative sampling:  
In addition to achieving thematic saturation, interviews will be carried out for patients with 
experiences of hospitals with the following characteristics:  
• Units with endourology day-case rates in the top quartile nationally for any of 
bladder tumour resection or prostate resection or enucleation 
• Units that are not in the top quartile nationally for these operations. 
The aim will be to achieve roughly 50:50 representation from patients who have undergone 
surgery in each of these two categories. 
 
Further target characteristics are: 
• Large city hospital (population > 500,000) 
• Hospital serving low population density area 
• Hospital serving population with higher-than-average ethnic minority population 
This is to gain a representative understanding of patient experiences across a range of 
different NHS hospitals in England.  
 
Thematic analysis:  
Transcripts will be coded and inductive thematic analysis performed, in accordance with the 
six step process described by Braun and Clarke. A validation subset of transcripts (10-20%) 
will be analysed additionally by a second researcher as well as the PPIE representative to 
assess for agreement about interpretation. Analysis will be performed using NVivo software. 
Study management 
The day-to-day management of the study will be undertaken by the PI (JJ) with 
infrastructure and supervisory support from the GIRFT programme team and the NIHR 
Qualitative Research Design Service, and the sponsor site R&D team. 
 
Monitoring and audit of the research conduct will take place using regular research 
meetings within study working group and will be compliant with the usual governance 
processes involved with all research conducted at the sponsor site (Royal Devon University 
Healthcare NHS Foundation Trust).   
 

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Time scale 
The intended time scale involves study completion over a ten-month period, ending 
February 2024.  
 
 
 
 
 
 
 
 
 
 
Budget Summary and costings 
This is a study being undertaken principally by the PI (JJ), who is a funded research fellow for 
the Getting It Right First Time Urology programme.  
Items that require funding are:  
• Transcription service; estimated cost £1000 – 2000  
• Patient and Public Involvement, priced at NIHR recommended rate of £75 per half 
day activity. Estimated total time and associated cost being 
o Two hour meeting with four PPI participants with pre-reading (£300 total, 
£75pp), two whole further days of input from a designated PPI member 
providing ongoing oversight and input (£300).  
Estimated upper total cost = £2600 
 
The funding will be provided by the GIRFT programme, which is part of NHS England.  
Project development and user involvement 
The project was designed by the study team in recognition of the fact that, whilst day-case 
surgery is perceived as a desirable option for numerous reasons, the patient experience 
remains uncharacterised. This is therefore a research priority, so that best practice can be 
understood and shared by the GIRFT urology programme. 
 
The study could provide understanding necessary to be able to support further clinical 
transformation across England. It is also viewed as important by the GIRFT programme to 
understand whether any adverse patient outcomes or experiences occur because of action 
on GIRFT recommendations. The study therefore is a component of a wider evaluation 
process taking place for the GIRFT urology programme.  
Milestones 
0 –2m 
3–4m 
4–6m 
6–10m 
Ethical/Governance approvals 
 
 
 
 
Recruitment    
 
 
 
 
Data collection 
 
 
 
 
Data analysis 
 
 
 
 
Write-up 
 
 
 
 

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The study group recognised a need to understand more about the patient experience in the 
context of GIRFT recommended practices. Patient’s experiences of day-case surgery was felt 
to be a priority area because GIRFT urology and other GIRFT workstreams advocate for day-
case surgery across a range of different high volume operations. Increasing day-case surgery 
is a nationally defined clinical priority which is feasible for many endourology operations, 
and the operations of interest in this study are high volume operations with difficult to 
manage waiting lists. There is therefore scope to gain new understanding about important 
areas of clinical care that could result in improved care in the future. The project team were 
all involved in defining the scope of the study.  
 
Protocol review: 
Independent external review has been conducted by an NIHR post-doctoral qualitative 
researcher working for the Southwest Peninsula NIHR qualitative research unit. The Royal 
Devon University Healthcare NHS Foundation Trust’s Research and Development team have 
reviewed the protocol and provided verbal and written feedback.  
 
The protocol has been reviewed within the research team which is a multi-centre 
researching group involving the following; consultant urologists at the Royal Devon and 
Exeter Hospital and Salford Royal Hospital, GIRFT urology national co-chairs, data analyst for 
GIRFT. 
 
Patient and Public Involvement and Engagement (PPIE):  
A draft protocol and plain English summary were discussed at an initial PPIE meeting 
involving three PPIE representatives. A subsequent meeting was then held with four PPIE 
representatives, at which a draft study question guide was also reviewed, along with further 
logistical elements (as defined within this protocol and described within the amendment 
history). Participant facing documents have been in line with PPIE recommendations. 
 
Areas where the PPIE group provided input leading to changes in study design included: 
- Changes to question order and wording in order to reduce ambiguity and appear non 
judgemental 
- When to schedule interviews 
- How to conduct the interviews (to include telephone as an option and confirming that 
video conferencing is acceptable) 
- Proof-reading the participant facing information 
- Discussing the broad study concept and agreeing that this could be a practice changing 
study 
 

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A PPIE representative will be included in the study team throughout the duration. Their 
involvement will include:  
 
- 
Screening of potential participants will be undertaking with PPIE input 
- 
Analysis: The retained PPIE member will review 3-5 transcripts and perform thematic 
analysis to determine the degree or agreement with the other two researcher's 
interpretations. Any differences will be discussed with the wider study team to form 
agreement around thematic interpretation.  
- 
Dissemination of findings: The PPIE member will review any materials produced as 
part of dissemination, including abstracts, presentations and publications. The PPIE 
member will be given opportunity to present the study at relevant meetings that 
they might wish to attend. 
PPIE time will be reimbursed in accordance with NIHR-defined standards. 
Data Management 
All participants will be assigned a unique Study ID number. All data collected will be 
recorded and stored under this ID number. Descriptive data will be initially recorded onto 
an electronic study specific Case Report Form and transferred onto a password-protected 
study specific database. Data files (spreadsheet, audio files, transcription files) will be stored 
on a password protected Royal Devon and Exeter Hospital computer in the Urology 
Department.   All paper and electronic data will be collected and stored in compliance with 
data protection guidelines, good clinical practice in research guidance and Trust clinical 
governance policy. 
 
Data monitoring:  
The research team will undertake regular audits of raw data for both accuracy and 
completeness and research data will be cleansed before analysis is undertaken.   
 
Data Confidentiality:  
All participant data will be held in a link-anonymised format, with personal identifiable data 
only accessible to personnel with training in data protection who require this information to 
perform their duties. Participants’ research and sample data will be identified by unique 
study ID numbers and all data will be held on password-protected computers. Only the CI 
and delegated members of the research team will have access to personal identifiable data. 
To comply with the Data Protection legislation information will be collected and used fairly, 
stored safely and not disclosed to any unauthorised person. This will apply to both manual 
and electronically held data. The CI will preserve the confidentiality of participants taking 
part in the study and ensure the EU General Data Protection Regulations (GDPR) in 
conjunction with the UK Data Protection Act 2018. 
 
The following individuals will have access to participant's personal data during the study: 

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- 
Chief investigator – access to all data 
- 
Principle investigator at sponsor site – access to all data 
- 
Research associates x 3 at sponsor site – access to complete set of pseudonymised 
data 
- 
Local collaborator / site clinical lead at participant identification centres – access to 
participant contact data for their site only 
- 
PPIE representative – access to complete set of pseudonymised data 
- 
Qualitative research supervisor – access to complete set of pseudonymised data 
 
Data will be analysed on password protected NHS computers at the sponsor site by the 
principle investigator and a further research associate. A small subset of pseudonymised 
transcripts will be emailed to the PPIE representative's university of Exeter email account for 
analysis on a University of Exeter computer. 
Data Storage and Archiving:  
All electronic documentation of consent, electronic data collection forms, and audio/video 
files will be stored on an encrypted, password protected server at the Royal Devon and 
Exeter Hospital, with regular file backup. The server is stored in a dedicated secure facility. 
Data transfer to this server will be via password protected encrypted NHS email, or using a 
password protected encrypted USB storage device. Any paper copies of data will be stored 
in lockable filing cabinets within the Royal Devon University Healthcare NHS Foundation 
Trust (RDUH) Urology Department offices. Archiving will be undertaken as per current 
standard RDUH R&D protocols and procedures. Study data will be stored at the sponsor site 
for 5 years, in keeping with sponsor site research and development standard operating 
procedures.  
Ethical considerations  
We have identified the potential ethical considerations and addressed them below: 
 
Altered or impaired mental state: Only adults with capacity to consent to participation 
will be approached for potential involvement. Expressions of interest will be obtained in a 
comfortable environment before any anaesthetic is delivered. Formal consent will only be 
obtained once the patient has fully recovered from anaesthetic, approximately one week 
after surgery. We have discussed this matter with our PPIE group and it was felt to be 
acceptable to gain expressions of interest from patients on the day before their operation, 
after they had been consented for surgery.  
 
Concerns about quality of medical care: Patients will be reassured by the team 
providing their care that no alterations to their usual standard of care will take place. The 
PIS will help to explain this. 
 

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Time burden: Participants will be reassured that their involvement in the study is voluntary 
and that they are able to withdraw at any time. A convenient interview time will be 
arranged for each study participant.  
 
Confidentiality: Caldicott principles will be followed throughout and only data directly 
relevant to the study will be obtained. Personal data will be stored in a link-anonymised 
format on a password protected encrypted server at the sponsor site and only accessed by 
trained individuals when necessary. Results will not be presented in a manner that could 
allow individual participants to be identified by inference. The recorded audio files will be 
transcribed, and after this point audio and video will be deleted except for the audio file 
documenting participant consent, which will be stored separately and securely. The 
transcripts will be stored using the participant's study ID number, with the corresponding 
personal details held separately. 
 
If at the time of the interview there is a reason to believe that the participant is at risk of 
serious harm then confidentiality would be broken if necessary in order to ensure the 
participants safety. This might relate to severe psychological distress or physical symptoms. 
If at all possible participants would be encouraged to seek medical attention independently. 
 
Scrutiny: Before commencing the interview, it will be re-affirmed to participants that the 
interview is exploratory in nature, that there are no correct or incorrect answers, and that 
participants will not be judged nor treated adversely based on their responses to questions. 
 
Sensitive subject matter: 
It is possible that patients could find it distressing talking about their experience of their 
treatment, or their condition which required treatment. Sensitivity and care will be taken 
during the interview, and the questions have been designed in conjunction with the PPIE 
group in such a way as to be open and inviting, and not overtly negative or anxiety-
provoking. 
 
The PI (interviewer) is an experienced medically trained urology surgery registrar who with 
extensive experience of providing care for patients who are distressed. This is both in 
emergency and elective (clinic) based settings, and includes patients who have undergone  
or are going to undergo surgery. As such, he is adequately resourced to provide appropriate 
support for patients who become distressed during the course of the interview. In such an 
event, the following steps will be followed:  
1. Stop the interview when signs of distress are identified. 
2. Provide time for the participant to be able to think and reflect. 
3. Explore and acknowledge the participant’s emotional state. This includes providing an 
invitation to discuss how they are feeling in further detail. The interview should only be 

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resumed if the level of distress is low and the participant is judged to be fully able to do so 
without experiencing excess distress compared with if the interview were stopped.  
4. Discuss an action plan with the participant that is suitable to them. 
5. Where judged to be necessary based on the assessment of the participant’s emotional state, 
encourage them to contact their GP or mental health/care provider (if applicable) 
6. If necessary and with the participant’s consent, offer to contact their GP/mental health/care 
provider on their behalf. 
7. Follow the participant up at an appropriately timed later date to establish their wellbeing 
and support. 
Helplines and support services available to patients requiring additional help are as follows: 
- 
The patient’s urology care team, with a designated study-specific point of contact at each 
participant identification centre.  
- 
The patient’s GP 
 
Conflicts of interest:  
The principle investigator (JJ) will be conducting the interviews. Joseph is a urology specialty 
trainee. No conflicts of interest have been identified and the study is intended to be 
exploratory, with the aim of uncovering new themes.  
 
Counteracting researcher bias:  
The interviews will be conducted by one researcher, who is a urology specialty trainee. In 
order to ensure that the interviews remain appropriately interviewee-led and that the 
interviewer is not directing the interview towards specific themes, anonymised audio 
footage will be reviewed by a trained NIHR qualitative researcher who is providing project 
supervision. This will be conducted for three initial pilot interviews performed with 
professionals working at the sponsor site. Subsequent feedback will be provided in 
interview technique. When performing thematic analysis of transcripts, 20% of transcripts 
will be analysed by an additional researcher, and a further small subset analysed by a PPIE 
representative. This is to ensure consistent interpretation of the data and identify any bias. 
Adverse event recording and reporting 
We do not anticipate adverse events associated with these non-interventional qualitative 
interviews, however it is possible that discussing their care could trigger upset for patients. 
In the event of psychological harm experienced during the interview, immediate verbal 
support will be offered to the participant and the interview ended if necessary. Such 
adverse events will be recorded and discussed with the study team. With participant 
consent, arrangements will be made for local support to be offered at their hospital by way 
of contact with the hospital clinical lead and/or their general practitioner. The study sponsor 
will be notified within 24 hours as per local NHS R&D procedures. An electronic copy of any 
adverse event form will be stored in the project specific site file.  

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It is possible that during the interview a patient could report symptoms in keeping with a 
potential ongoing complication that requires medical attention. In such instances, the 
interview would be terminated and a minimum set of relevant questions asked in order to 
be able to give advice to the patient about how to seek medical attention. Advice would 
involve one of the following, depending on the potential severity of the underlying problem; 
arranging a GP review, patient-arranged emergency department attendance, or the 
interviewer calling emergency services for emergency paramedic assessment and transport 
to hospital.  
 
It is also possible that descriptions of medical malpractice could be described by a 
participant during their interview. In such an instance, relevant detail would be obtained 
and the matter discussed within the study team to develop an appropriate strategy. As a 
minimum this would involve feeding concerns back to the hospital’s urology clinical lead in 
order for the matter to be addressed. If felt to be necessary, escalation of concerns to the 
GIRFT urology programme, NHS England for the General Medical Council would be 
considered, depending on the nature of the issue.  
 
Benefits to participants: 
There are no financial incentives for participation. Participants will hopefully appreciate the 
opportunity to discuss their observations about their experiences of a real-world health 
service. There is an opportunity for them to provide detailed insights that could drive wide 
service improvement. On this basis, it is hoped that they will find the process an 
empowering one, in particular knowing that their input will contribute to a larger research 
project which could inform future practice through a quality improvement programme 
taking place on a national scale (the GIRFT programme).  
 
Risks to researchers: 
There are no anticipated risks to the researchers. Any interviews will be conducted virtually 
or in public areas. 
Participant feedback 
An opportunity for anonymous participant feedback will be offered following the interview 
using Survey Monkey. Feedback will be stored in the study file on the Royal Devon and 
Exeter Hospital encrypted server.  
Dissemination/implementation of research 
Results will be written up and submitted for publication in a peer-reviewed journal. 
Abstracts will be submitted to national and international conferences. Results will be 
presented to clinical colleagues at regular in-house meetings. Results will be shared as part 

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of future GIRFT reports and the findings might influence future GIRFT recommendations. 
Written information in the form of a summary report outlining the key findings of the study 
will be sent to all participants and any stakeholders including PPIE representatives who were 
involved in the study design and implementation. This will be in electronic format with an 
option of a hard copy on request. 
Potential impact and benefit of the proposed research: 
There is significant scope for the study findings to influence future patient care. New 
understanding about scope for improvement of patient experience might be obtained, in 
which case this could inform future GIRFT recommendations and interventions to positively 
impact patient experience of day-care surgery. Unexpected outcomes associated with day-
case surgery might be identified in such a way that positive outcomes could be maximised 
and negative outcomes mitigated. Elective surgery recovery is a significant NHS priority and 
it is possible that these research findings could benefit the elective surgery recovery 
process. Lastly, because GIRFT workstreams exist for every specialty, if this qualitative study 
design is successful it can be implemented across other GIRFT specialty areas to maximise 
impact.   
 
End of Study 
The study will finish when data and interview has been completed for all participants (when 
thematic saturation is observed) and when analysis of data has been undertaken as 
timetabled on the Gantt chart. 
 
References 
1.  
GIRFT. Model Hospital [Internet]. Model Health Website. 2022 [cited 2022 May 21]. 
Available from: https://model.nhs.uk/home 
2.  
GIRFT Urology. Urology : the path to recovery. GIRFT website. 2022;(April).  
3.  
National Health Service, British Association of Day Surgery. National day surgery 
delivery pack. 2020;(September):1–54.  
4.  
GIRFT. Urology: towards better care for patients with bladder outlet obstruction 
[Internet]. GIRFT website. 2022 [cited 2022 Jan 10]. Available from: 
https://gettingitrightfirsttime.co.uk/wp-content/uploads/2021/12/Urology_2021-12-
10_Guidance_Bladder-outlet-obstruction.pdf 
5.  
Wise J. ENT surgery: increasing day cases could save money, release beds, and benefit 
patients. BMJ. 2019;367(November):l6440.  
6.  
GIRFT. Getting It Right First Time (GIRFT) [Internet]. GIRFT website. 2022 [cited 2022 
May 21]. Available from: https://www.gettingitrightfirsttime.co.uk 

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7.  
Harrison S. Urology: GIRFT programme national specialty report. GIRFT website. 2018.  
8.  
GIRFT. Urology: towards better care for patients with bladder cancer. GIRFT website. 
2022;(January).  
9.  
GIRFT. Urology: towards better care for patients with acute urinary tract stones. 
GIRFT website. 2022;(January):1–42.  
10.  
Kiger ME, Varpio L. Thematic analysis of qualitative data : AMEE Guide. Med Teach. 
2020;0(0):1–9.  
 
 
 
 

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Appendix 1. Question guide 
 
Understanding the patient experience of day-case bladder tumour resection, 
and prostate resection or enucleation: Qualitative patient interviews. 
 
Question guide / script. 
 
Introduction 
“Thank you for agreeing to this interview. It is kind of you to offer your time for 
it. We have asked you to talk to us because you recently had an operation 
involving your [bladder/prostate/kidney stones], and you went home on the 
same day as the operation. We want to understand what this was like for you. 
 
We will record the interview so that we can re-visit it later, and we will 
transcribe the interview in to text for analysis. The transcript will be 
anonymised. You can pause or end the interview at any time and there is no 
obligation to answer any of the questions.  
 
Before we start, do you have any questions? 
 
Are you happy for me to start recording and begin the interview?” 
 
Opening questions (4 questions) 
“To start off, can you tell me about the operation that you recently had?” 
 
Day-case endourology questions (9 questions) 
“Tell me what you understand by the term “day-case surgery.” 
[If 23 hour stay is included in answer, clarify that for this study we will specifically be considering 
instances where the patient leaves the hospital on the same day as the surgery, before midnight.] 
 
“How did you feel knowing that you were going to go home on the same day?”  
 
“Can you tell me about any particular advantages or disadvantages to going 
home on the same day after your operation?” 
 
“Tell me about the information you received about your operation.” 
 

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“Can you tell me what it was like going home on the same day as your 
operation?” 
 
“Tell me about your experience of travelling home after your operation.” 
 
“Were you able to manage at home after your operation?” 
 
“If you or a member of family needed to have this operation, would you be 
happy to have it as a day-case?” 
 
“Have you had this operation before?” 
 
“Is there anything else that you would like to tell us based on your 
experience?”