Understanding Enablers, Barriers, and Unexpected Outcomes Associated With Adoption of Routine Day-case Surgery Pathways for Common Endourology Operations: Qualitative Interviews With Healthcare Professionals.
Conditions: Bladder Cancer, Bladder Outlet Obstruction, Urolithiasis
Sponsor: Royal Devon and Exeter NHS Foundation Trust

Protocol/V2/140223 
IRAS: 326803 
1
Understanding enablers, barriers, and unexpected outcomes associated with 
adoption of routine day-case surgery pathways for common endourology 
operations: Qualitative interviews with healthcare professionals.  
 
Current Protocol Number: 
V2 14.2.23                                     IRAS no – 326803 
 
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 
 
 

Protocol/V2/140223 
IRAS: 326803 
2
SIGNATURE PAGE FOR CHIEF AND PRINCIPAL INVESTIGATOR 
For Protocol No.: V2 14.02.23                                      
 
 
Understanding enablers, barriers, and unexpected outcomes associated with 
adoption of routine day-case surgery pathways for common endourology 
operations: Qualitative interviews with healthcare professionals. 
 
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 
 
 
 

Protocol/V2/140223 
IRAS: 326803 
3
 
Title of Study 
Understanding enablers, barriers, and unexpected outcomes 
associated with adoption of routine day-case surgery pathways for 
common endourology operations: Qualitative interviews with 
healthcare professionals.  
 
Protocol Number 
2 (14/02/23) 
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 
Consultant urologists, urology specialty registrars, theatre nurses, 
anaesthetists, day-case unit nurses, ward-based nurses, cancer specialist 
nurses, managers. 
Aim 
To identify what enables or prevents urology units from adopting day-
case pathways for common endourology operations (transurethral 
resection of bladder tumour, prostate resection or enucleation, 
ureteroscopy and stone fragmentation), and understand unexpected 
outcomes associated with increasing day-case rates.  
Main Criteria for 
Inclusion 
Inclusion Criteria: 
● Healthcare professionals as outlined above, involved in delivering 
care for patients undergoing one or more of the operations of 
interest. 
● Able and willing to provide informed consent 
Exclusion Criteria: 
● Healthcare professionals involved with fewer than 10 of the 
operations of interest per year 
Study Duration 
 10 Months 
Study Period  
 May 2023 – February 2024 
Study Summary  
A qualitative research study conducted in hospitals across England, in 
which staff members will be interviewed. We will interview staff who are 
directly or indirectly involved in delivering care for patients undergoing 
the operations of interest; namely bladder tumour resection, prostate 
resection or enucleation, and ureteroscopy for upper urinary tract 
stones. We hope to find out the reasons why some hospitals can perform 
day-case surgery with very high rates, and why others do not. We also 
hope to find out about any unexpected outcomes observed when 
performing day-case surgery for the operations of interest.  
 

Protocol/V2/140223 
IRAS: 326803 
4
 
 
 
Staff working in 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 assessed. Interviews are anticipated to take 
place over a six month period between April 2023 and October 2023. The 
study will end when “saturation” is achieved, whereby no new themes 
are identified through interviews. Saturation will be sought for each 
individual operation of interest.  
 
Analysis and write up will take place from October 2023 – February 2024.  

Protocol/V2/140223 
IRAS: 326803 
5
Table of Contents 
Amendment History/Changes from previous version ........................................................ 7 
Scientific Summary .......................................................................................................... 8 
Plain English Summary..................................................................................................... 9 
Research Question ........................................................................................................... 9 
Aims and Objectives .......................................................................................................11 
Aim: ...................................................................................................................................... 11 
Objectives:............................................................................................................................. 11 
Methods .........................................................................................................................11 
Study Population ............................................................................................................11 
Inclusion criteria .............................................................................................................12 
Exclusion Criteria ............................................................................................................12 
Participant Identification:....................................................................................................... 12 
Screening and identification ................................................................................................... 12 
Recruitment ........................................................................................................................... 13 
Informed consent................................................................................................................... 13 
Participant withdrawal: .......................................................................................................... 14 
Schedule of events ..........................................................................................................16 
Primary outcome measure: .................................................................................................... 17 
Secondary outcome measures: ............................................................................................... 17 
Study management ........................................................................................................18 
Budget Summary and costings ........................................................................................19 
Project development and user involvement .....................................................................19 
Data Management .........................................................................................................21 
Data monitoring:.................................................................................................................... 21 
Data Confidentiality: .............................................................................................................. 21 
Data Storage and Archiving: ................................................................................................... 22 
Ethical considerations .....................................................................................................22 
Adverse event recording and reporting ...........................................................................24 
Participant feedback .......................................................................................................24 
Dissemination/implementation of research.....................................................................24 
Potential impact and benefit of the proposed research: ...................................................24 
End of Study ...................................................................................................................25 
References ......................................................................................................................25 

Protocol/V2/140223 
IRAS: 326803 
6
Appendix 1. Question guide ............................................................................................26 
 
 
 

Protocol/V2/140223 
IRAS: 326803 
7
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 
(14.02.23) 
 Changes based on PPIE meeting 14.02.2023 
- 
Remove assumptions around recovery in 
own home being preferable in PLS 
- 
Re-order questions in guide to help maintain 
rapport 
- 
Wording modifications to questions for 
clarity 
- 
Change wording from “unintended 
consequences” to “unexpected good or bad 
outcomes” 
- 
To include anaesthetists in study population 
- 
Nursing interviewees to include admissions 
ward, inpatient ward, day case unit, theatre 
nurses, and cancer specialist nurses who 
might field patient concerns post-
operatively 
- 
Have telephone interviews as an available 
options as well as video conferencing 
- 
Specify that study is within NHS hospitals 
- 
Discuss anaesthetic choice with 
anaesthetists 
- 
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 
 
 
 
 
 

Protocol/V2/140223 
IRAS: 326803 
8
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. 
These include bladder tumour resection (TURBT), prostate resection or enucleation using 
diathermy or laser (TURP and TUEP), and ureteroscopy and laser for upper urinary tract 
stones (URS). 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, although spinal anaesthesia is rarely used for ureteroscopy.  
 
For the 12 months from December 2021, the national median 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. For URS the median day case rate was 60.1% (range 0% to 87.9%, IQR 44.4% to 
69.7%, 23,130 cases). 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 URS, 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.  
 
National day-case rates for all of TURBT, TURP/TUEP and URS have increased over the past 
five years, however the wide variation in practice identifies a need to understand reasons 
underlying a significant observed divergence in practice. We want to understand why some 
hospitals have rapidly adopted day-case surgery whereas others have not. Furthermore, it is 
necessary to understand any positive and negative outcomes associated with the increased 
utilisation of day-case surgery. In order to explore this area we intend to perform qualitative 
research involving members of staff involved in the delivery of one or more of the 
operations of interest. We will interview staff from a range of different hospitals with 
differing day-case performances to further understand enablers and barriers associated 
with day-case adoption. We would also like to understand staff members’ experiences of 
any wider unexpected outcomes associated with day-case surgery adoption.  
 

Protocol/V2/140223 
IRAS: 326803 
9
Plain English Summary 
Safe day-case surgery can lower pressure on hospitals by avoiding an overnight stay. It means 
patients can recover in their own home. It is likely to be cheaper and better for the planet as it uses 
less resource. 
 
Urology is a branch of healthcare. It includes some common surgeries that can be performed as a 
day-case. These include bladder tumour treatment, prostate surgery to treat blockage, and 
ureteroscopy to treat stones. All of these involve treating the patient through their natural orifice 
(urethra). No cuts to the skin are made.  
 
In England, the Getting It Right First Time (GIRFT) programme makes healthcare guidance. It 
suggests that these operations are done as a day-case. Despite this, there is wide variation in 
England. Most of these operations still involve an overnight hospital stay. 
 
We want to know how some hospitals do lots of day-case bladder, prostate, and stone surgery. We 
also want to know why many hospitals do not do lots these as a day-case. Lastly, we want to know 
whether there are any unexpected outcomes when doing more day-case surgery. We will choose 
hospitals that do a lot or very little day-case surgery for bladder tumours or prostate resection. We 
will ask nurses, doctors, and mangers involved in the service if they would like to be interviewed.  
 
We aim to find themes that will help hospitals to do more day-case surgery in future. 
Research Question 
What are the enablers and barriers to performing day-case surgery for common 
endourology operations, and are there any unexpected outcomes associated with 
performing these operations as a day-case?  
 
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 male patients requiring surgical 
treatment for acute urinary retention, the median average national hospital wait time 
exceeds five months, and this wait is over three months for patients awaiting treatment 
following emergency admission for an upper urinary tract stone (1).   
 
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 

Protocol/V2/140223 
IRAS: 326803 
10
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, such as reduced opportunity to acquire an 
infection, although this has not yet been demonstrated in academic literature.  
 
The Getting It Right First Time (GIRFT) programme is an expert clinician-led ad data-driven 
national quality improvement programme aiming to improve standards and decreased 
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 and URS. The GIRFT programme have 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, TURP/TUEP and URS.  
 
For the 12 months from December 2021, the national median 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%. For 
bladder outflow obstruction surgery the median day-case rate was 7.7% (range 0% to 
82.4%, IQR 4.4% to 19.1%). For URS the median day case rate was 60.1% (range 0% to 
87.9%, IQR 44.4% to 69.7%). The factors underpinning the wide variation in adoption of day-
case pathways is unclear. It is possible that any of the following factors could contribute to 
this observed phenomenon; available hospital resource, geographic factors, staff values, 
beliefs and motivation, patient-related factors, available funding or expertise to support 
service development. By performing semi-structured qualitative interviews we plan to take 
an open approach to exploring the range of factors underpinning high or low degrees of 
day-case surgery adoption (10).  
 
Iterative evaluation forms an important part of the GIRFT programme, both at a local and 
national level. It is therefore important to understand whether there have been any positive 
or negative unexpected outcomes associated with the increased utilisation of day-case 
surgery pathways following GIRFT recommendations. It is therefore our intention to also 
interview staff from units with high endourology day-case rates about their perceptions of 
any such outcomes.  

Protocol/V2/140223 
IRAS: 326803 
11
 
Aims and Objectives  
Aim:  
To identify what enables or prevents urology units from adopting day-case pathways for 
common endourology operations, and understand unexpected outcomes associated with 
increasing day-case rates.  
 
Objectives: 
Interview urologists, anaesthetists, nursing staff, and managers TURBT, TURP/TUEP, and 
URS in order to: 
• 
Identify perceived patient and service factors that cause their urology service to deliver its 
current rate of day-case surgery.  
• 
identify perceived factors that have enabled or prevented the implementation of day 
surgery pathways as default care.  
• 
Identify unexpected outcomes experienced as a result of performing day-case surgery. 
 
Hypothesis:  
We hypothesise that there are likely to be key success factors necessary to establishing 
effective day-case endourology pathways. We also hypothesise that there are likely to be a 
range of different barriers to establishing day-case endourology pathways, some of which 
might not be currently known about. Lastly, we hypothesise that there are unexpected 
positive and negative outcomes associated with performing day-case endourology 
operations. 
 
Choice of study design: 
A multi-professional semi-structured qualitative interview design has been adopted in order 
to identify themes, some of which might not have been characterised previously. We see it 
as important to interview a range of professionals in different roles who are involved in 
delivering day-case endourology operations, so we can gain a broad range of perspectives. 
We will conduct interviews with professionals from a range of different hospitals with a 
range of different day-case rates because it is possible that factors affecting one hospital 
might not be the same in other hospitals. 
Methods 
Study Population 
Any of the following staff members from across a range of urology units:  
• 
Consultant and trainee urologists 
• 
Anaesthetists 

Protocol/V2/140223 
IRAS: 326803 
12
• 
Theatre nursing staff and healthcare assistants 
• 
Day-case unit nursing staff 
• 
Inpatient ward nursing staff 
• 
Cancer nurse specialists 
• 
Urology managers 
• 
Urology department clinical leads 
Inclusion criteria 
• Staff members who are routinely involved, either directly or indirectly, in the 
delivery of any of TURBT, TURP, TUEP, URS within NHS hospitals.  
• Willing and able to provide informed consent 
Exclusion Criteria 
• Staff who are not regularly involved in any of TURBT, TURP, TUEP or URS, defined as 
being involved in the operation less than 10 cases per year. 
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 role and location. 
 
Sampling and sample sizes: 
Urology units across England will be approached for participation and can be considered as 
fitting two broad categories: 
1) Units with endourology day-case rates in the top quartile nationally for any of bladder 
tumour resection or prostate resection or ureteroscopy 
2) Units that are not in the top quartile nationally for these operations 
Within each unit, the aim will be to interview a range of staff members as outlined above. 
Each type of professional will not necessarily be interviewed from each trust. Adequate 
sample size will be reached when saturation on thematic analysis is achieved, with thematic 
analysis and assessment for saturation being performed after 15 interviews.  
 
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. Clinical leads at the urology units of interest will be contacted 
and asked for consent for site study participation. Participating clinical leads or their 

Protocol/V2/140223 
IRAS: 326803 
13
nominated local collaborator will be asked to identify potentially willing interviewees based 
on the study population characteristics described above.  
 
Potential participant details will be sent from their unit’s clinical lead or local study 
collaborator to the Principle Investigator (PI) via secure encrypted NHS email. The following 
details will be included; hospital, region, demographics, and professional role and operations 
that they are involved with. Willing participant contact details will be stored on a database 
on a secure server, and screened in order to gain interviews from a broad population. 
 
Recruitment:  
The research team will then be responsible for the recruitment process. This will include 
providing potential recruits with an electronic study-specific participant information sheet 
(PIS). Expressions of interest from participants will be obtained by clinical leads or a 
nominated local collaborator at sites agreeable to study involvement. Willing potential 
participant's contact details (email address and telephone number) will be forwarded to the 
research team at the sponsor site, along with a very limited set of accompanying 
information (role, gender, operation types with which they are involved). Transfer of 
information will only take place with the potential participant's verbal consent. The sponsor 
site principle investigator will then contact potential participants in order to gain consent for 
participation and to arrange an interview time that is suitable for them. 
 
Potential participants will be provided with the opportunity to discuss the project in detail 
with a member of the research team at the sponsor site. 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 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.  
 

Protocol/V2/140223 
IRAS: 326803 
14
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.  
 
This same consent process will be carried out for participants being interviewed in a face to 
face capacity, for consistency of approach.  
 
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. 
 
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  
 

Protocol/V2/140223 
IRAS: 326803 
15
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 
• 
In person face-to-face interview 
Interviews will primarily be arranged to take place either using video-conferencing software 
or over the telephone. In certain circumstances in-person interviews will be arranged if 
remote options are not possible. Given that the interviews will be conducted by one 
researcher, and the study will take place in centres across England, it is neither practical not 
environmentally sustainable to conduct all interviews in person. 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. In-
person interviews will be arranged to take place in a pre-booked interview room to avoid 
distractions. 
 
Interviews will all be recorded after informing the participant and gaining their consent for 
this. For interviews conducted using Microsoft Teams, the integrated recording and 
transcription function will be used. For interviews conducted over the phone or in person, 
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 20 and 45 minutes, depending on the 
responses and the number of operations of interest with which the interviewee is involved 
in delivering.  Participants will be informed of their right to terminate the interview at any 
time. Interviews will all be carried out by the principal investigator (JJ).  
 
When relevant the interview will address all operations with which the interviewee is 
involved; TURBT, TURP, TUEP, URS. Questions broadly covering the participants views about 
day-case endourology operations will be asked and then explored in more detail. 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:  
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 

Protocol/V2/140223 
IRAS: 326803 
16
established following consultation with clinicians, academics, and a patient and public 
involvement group. The study question guide is included in Appendix 1.  
 
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, role, years in current role.  
 
Interview transcription:  
For interviews conducted using Microsoft Teams, the integrated recording and transcription 
function will be used. For interviews recorded using the phone or in person, the Voice 
Memos iphone app will be used to record audio. Third party transcription service will be 
utilised to transcribe interview audio into text. 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. Generic participant feedback on the study will be gained during the 
pilot study.  
 
 
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 
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 (6 
MONTHS) 
Hospital 
identification 
X 
 
 
 
 
 
 
 
 
 

Protocol/V2/140223 
IRAS: 326803 
17
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: 
• Enablers of successful day-case endourology surgery pathways 
 
Secondary outcome measures: 
• Barriers to successfully implementing day-case endourology surgery pathways 
• 
Unexpected outcomes associated with day-case endourology pathways 
 
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 
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.  
 
Representative sampling:  
Interviews will be carried out in hospitals with the following characteristics:  
• Top quartile day-case rate for each of the operations of interest 

Protocol/V2/140223 
IRAS: 326803 
18
• Bottom two quartiles for day-case rate for each of the operations of interest 
• Large city hospital (population > 500,000) 
• Hospital serving low population density/rural area 
• Hospital serving population with higher-than-average ethnic minority population 
This is to gain a representative understanding based on staff views and experiences from 
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). There will be 
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).   
 
Time scale 
The intended time scale involves study completion over a ten-month period, ending 
February 2024.  
 
 
 
 
 
 
 
 
 
 
Milestones 
0 –2m 
3–4m 
4–6m 
6–10m 
Ethical/Governance approvals 
 
 
 
 
Recruitment    
 
 
 
 
Data collection 
 
 
 
 
Data analysis 
 
 
 
 
Write-up 
 
 
 
 

Protocol/V2/140223 
IRAS: 326803 
19
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 a need to understand whether 
or not hospitals have the capacity to change in line with GIRFT recommendations, and 
whether there might be important underlying factors that warrant non-adoption of 
increased rates of day-case surgery. The study is seen as an important means of generating 
greater detailed understanding to supplement the observations made during routine GIRFT 
visits to hospitals. It 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 unexpected outcomes have occurred as a result of 
action on GIRFT recommendations. The study therefore is a component of a wider 
evaluation process taking place for the GIRFT urology programme.  
 
Starting with an initial broad remit of “qualitative evaluation of trusts’ ability to enact GIRFT-
recommended change”, the project focus was narrowed to focus on day-case surgery for 
endourology 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 

Protocol/V2/140223 
IRAS: 326803 
20
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: 
- 
Screening of potential participants will be undertaking with PPIE input 
- 
Changes to question order and wording 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) 
- 
Identified additional healthcare professionals to interview, who will have important 
insights into day surgery pathways; namely cancer nurse specialists who might be a 
first point of contact for patients at home following bladder tumour resection. 
- 
Proof-reading the participant facing information 
- 
Discussing the broad study concept and agreeing that this could be a practice 
changing study 
 
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. 

Protocol/V2/140223 
IRAS: 326803 
21
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 an encrypted, password protected Royal Devon and Exeter Hospital server. 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: 
- 
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. 

Protocol/V2/140223 
IRAS: 326803 
22
 
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 RD&E Urology Department offices. Archiving will be 
undertaken as per current standard RD&E R&D protocols and procedures.  
Ethical considerations  
We have identified the potential ethical considerations and addressed them below: 
 
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. The recorded audio files will be transcribed, and after 
this point audio and video will be deleted except for consent audio files. The transcripts will 
be stored using the participant's study ID number, with the corresponding personal details 
held separately. 
 
We will reassure participants that they will not be identifiable by their responses, and that 
the results will be presented in such a way that participants could not be indirectly 
identified. We are aware that the interview asks participants to comment on their hospital’s 
practice in a way that might feel uncomfortable for them. We will clarify that the questions 
are intended only to enhance understanding and will not be utilised in such a way as to 
positively or negatively impact on the participant or their hospital.  
 
 
Scrutiny:  
Whilst the GIRFT programme recommends day-case endourology surgery, it is accepted that 
their recommendations might be non-generalisable for reasons that are not understood. 
This forms the rationale for the study, and at the beginning of interview it will be explained 
to participants that the study is exploratory in nature and that negative judgement or 
scrutiny will not be applied with respect to their own or their hospital’s practices.  
 
Psychological distress:  

Protocol/V2/140223 
IRAS: 326803 
23
It is likely that professionals will feel a sense of ownership over the service to which they 
contribute. Asking questions about the performance of this service on a particular metric 
(day-case surgery rate) could therefore risk appearing judgemental if the questions are not 
handled sensitively. The interview guide has been addressed with this in mind. Some 
professionals might find it distressing to discuss their service, if they feel that the service 
does not meet their own desired standards that they would like to be able to deliver for 
their patients. 
 
In the event of psychological harm experienced during the interview, immediate verbal 
support will be offered to the participant and the interview ended. 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. 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. 
 
Concern about adverse treatment by employer:  
The interview responses will be anonymised and when we publish the study results, we will 
take care to avoid presenting the findings in a way that could identify individuals based on 
their answers and information provided. As such, it would not be possible for employers to 
identify individual interviewee's responses. 
 
Conflicts of interest:  
The principle investigator (Joseph John) 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. 

Protocol/V2/140223 
IRAS: 326803 
24
Adverse event recording and reporting: 
We do not anticipate adverse events associated with these non-interventional qualitative 
interviews. In the event of psychological harm experienced during the interview, immediate 
verbal support will be offered to the participant and the interview ended. 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 their hospital’s clinical lead/local study collaborator. 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.  
 
It is unlikely but possible that descriptions of medical malpractice could be described during 
an interview. In such an event, these concerns would be discussed within the study team, in 
particular with the GIRFT urology clinical leads, who would be able to raise with the relevant 
department’s clinical lead if necessary.  
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 
of future GIRFT reports and the findings might influence future GIRFT recommendations. 
Written information in the form of a letter 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.  
Potential impact and benefit of the proposed research: 
There is significant scope for the study findings to influence future patient care. New 
understanding about real-world implementation of day-case surgery pathways might be 
obtained, in which case this could inform future GIRFT recommendations and interventions 
in order to improve day-case surgery rates and overall access to 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 

Protocol/V2/140223 
IRAS: 326803 
25
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 
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.  
 
 
 
 

Protocol/V2/140223 
IRAS: 326803 
26
Appendix 1. Question guide 
 
Understanding enablers, barriers, and unexpected outcomes associated with 
adoption of routine day-case surgery pathways for common endourology 
operations: Qualitative interviews with healthcare professionals.  
 
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 are involved in delivering a 
service for patients with bladder cancer, bladder outflow obstruction, or upper 
urinary tract stones. We want to understand your views about, and 
experiences of, day-case surgery to resect bladder tumours or treat prostatic 
enlargement.  
 
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, tell me about your role at the X hospital.” 
 
“Can you tell me about your hospital?” 
 
“Tell me about your patient population.” 
 
“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.] 
 

Protocol/V2/140223 
IRAS: 326803 
27
Day-case endourology questions (9 questions) 
“What are your thoughts about performing endourology operations as a day-
case?” 
 
“Tell me about any benefits or disadvantages for patients by performing day-
case endourology operations.” 
 
“What are the potential advantages or disadvantages to performing day-case 
endourology operations for the hospital and its staff?” 
 
“What characteristics do your patients have that allows them to undergo day-
case surgery?”  
 
“What are the key aspects of a service which allows it to delivery day-case 
endourology?” 
 
“Looking at Model Hospital, I can see that over the last 12 months your 
hospital performed day-case surgery for; 
x% of its TURBTs 
y% of its TURPs / TUEPs 
z% of its ureteroscopies.  
w% of cystoscopy plus procedures, so that’s operations like bladder biopsies 
and urethral dilatation.  
 
“What are your views on each of these day-case rates?”  
 
“Tell me about any barriers you may have encountered to developing 
endourology services with a higher day-case rate?” 
 
“Can you tell me about any unexpected good or bad outcomes that you have 
noticed by performing day-case endourology operations?” 
 
“Is there anything else about day-case surgery that you think it would be useful 
for us to know?”