The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
Conditions: COVID-19, Psychological Distress, Depression, Anxiety, Post-traumatic Stress Disorder, Post Intensive Care Syndrome
Sponsor: Royal Liverpool University Hospital

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THE PSYCHOLOGICAL IMPACT OF SURVIVING AN INTENSIVE CARE ADMISSION DUE TO 
CORONAVIRUS DISEASE 2019 (COVID-19) ON PATIENTS IN THE UNITED KINGDOM 
 
 
SHORT STUDY TITLE / ACRONYM 
Psychological Impact of COVID-19 on Intensive Care Survivors / PIM-COVID 
 
PROTOCOL VERSION NUMBER & DATE 
Version 1.7, 19 November 2023 
 
SPONSOR 
Liverpool University Hospitals NHS Foundation Trust 
 
RESEARCH REFERENCE NUMBERS 
IRAS: 282400 
Sponsor: SP0316 
 
Funders: Intensive Care Society, Mersey School of Anaesthesia 
 
 
 
  
 
      
 
 

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Sponsor & NHS R&D Department 
Name of Organisation:  
Liverpool University Hospitals NHS Foundation Trust 
Name of Representative:    
Heather Rogers        
Address:   
Research Development and Innovation, Royal Liverpool University Hospital, L7 8XP                          
Phone:  
+44 (0)151 705 3754                                
Email:   
heather.rogers@liverpoolft.nhs.uk                        
  
Co-Chief Investigators: 
Name:           Dr Alicia Waite, Intensive Care Medicine Trainee & Clinical Research Fellow (TRIC 
Network) 
Address:        Intensive Care Unit, Royal Liverpool University Hospital, L7 8XP 
Phone:   
+44 (0)151 706 2410 
Email:       
alicia.waite@liverpool.ac.uk 
  
Name:  
Professor Ingeborg Welters, Intensive Care Consultant  
Address:        Institute of Life Course and Medical Sciences, University of Liverpool, L7 8TX 
Phone:   
+44 (0)151 706 2410  
Email:  
i.welters@liverpool.ac.uk 
 
Name and Address of Co-Investigators 
Name:           Dr Brian Johnston, NIHR Academic Clinical Fellow (TRIC Network) 
Address:        Intensive Care Unit, Royal Liverpool University Hospital, L7 8XP  
Phone:  
+44 (0)151 706 2410 
Email:  
brian.johnston@liverpool.ac.uk 
 
Name: 
 Dr Andrew Boyle, Clinical Fellow & Trainee Representative for NIHR Clinical Research 
Network Clinical Care Specialty Group (TRIC Network) 
Address: 
Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, BT12 6BA 
Phone:            +44 (0)28 9615 0751 
Email:  
boyle.andrewj@gmail.com 
 
Name:  
Dr Gemma Cherry, Lecturer in Clinical Health Psychology 
Address: 
Institute of Population Health, University of Liverpool, L69 3BX  
Phone:  
+44 (0)151 795 5364 
Email:   
M.G.Cherry@liverpool.ac.uk 

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Name:  
Dr Peter Fisher, Senior Lecturer in Clinical Psychology 
Address:  
Institute of Population Health, University of Liverpool, L69 3BX 
Phone:        
+44 (0)151 794 4160 
Email:           Peter.Fisher@liverpool.ac.uk 
 
Name:  
Dr Steve Brown, Academic Health Psychologist 
Address: 
7 Markey Street, Eastwood, South Australia, 5063 
Phone:  
+61 (0) 478 926 250 
Email:   
slbrown@liverpool.ac.uk 
 
Name:         
Dr Christina Jones, ICUsteps Research Manager  
Address:  
ICUsteps, Kemp House, 152 City Road, London, EC1V 2NX 
Email:   
christina.jones@icusteps.org 
Phone:  
+44 (0) 300 302 0121   

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 Signature Page 
 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written consent 
of the Sponsor 
 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this protocol 
will be explained. 
 
 
For and on behalf of the Study Sponsor: 
 
Signature: ..................................................................................... 
 
 
Date: ..... /..... /..... 
 
Name:   Heather Rogers 
 
 
 
Position: Research Governance Manager 
 
 
 
Chief Investigators: 
 
Signature: …………………………………………………………….. 
  
 
Date: ..... /..... /..... 
Name:   Alicia A C Waite 
 
 
Signature: …………………………………………………………….. 
 
Name:   Ingeborg D Welters 
 
 
 
 
 
 
Date: ..... /..... /..... 
 
 
 

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Table of Contents 
 
LIST OF ABBREVIATIONS 
7 
1.  STUDY SUMMARY 
8 
2.  INTRODUCTION 
10 
3.  STUDY OBJECTIVES, DESIGN AND STATISTICS 
12 
3.1 Study Aim 
12 
3.2 Study Objectives 
12 
3.3 Study Outcomes 
12 
3.4 Study Design 
15 
3.5 Study Statistics 
15 
3.6 Sample size 
16 
4.  RECRUITMENT AND WITHDRAWAL OF PARTICIPANTS 
16 
4.1 Recruitment 
16 
4.2 Inclusion criteria 
17 
4.3 Exclusion criteria 
17 
4.4 Criteria for Premature Withdrawal 
17 
5.  STUDY PROCEDURES 
17 
5.1 Screening Procedures 
17 
5.2 Consent, Enrolment and Participant Follow-up Procedures 
17 
5.3 Schedule of study procedure 
21 
5.4 Accessing locally held data 
22 
5.5 Missing observations 
22 
5.6 End of Study Definition 
23 
6.  ASSESSMENT OF SAFETY 
23 
6.1 Safety outcomes 
23 
6.2 Ethics Reporting 
23 
6.3 Data Safety and Monitoring Board 
23 
6.4 Ethics & Regulatory Approvals 
23 
7.  DATA HANDLING 
24 
7.1 Confidentiality 
24 
7.2 Case Report Form 
24 

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7.3 Record Retention and Archiving 
25 
7.4 Compliance 
25 
7.5 Clinical Governance 
25 
7.6 Non-Compliance 
25 
7.7 Protocol Amendments 
26 
7.8 Study Management 
26 
8.  FINANCE AND PUBLICATION POLICY 
26 
8.1 Finance 
26 
8.2 Publication Policy 
26 
9.  REFERENCES 
27 
10.  APPENDICES 
30 
APPENDIX 1: INFORMATION WITH REGARDS TO SAFETY REPORTING IN NON-CTIMP 
RESEARCH 
30 
APPENDIX 2: STUDY FLOWCHART 
32 
APPENDIX 3A: STUDY GANTT CHART 
33 
APPENDIX 3B: INTERVIEWS & SURVEY GANTT CHART 
34 
APPENDIX 4: INVITATION LETTER, PATIENT INFORMATION SHEET AND CONSENT FORM 
35 
APPENDIX 5: WELSH INVITATION LETTER, PATIENT INFORMATION SHEET AND CONSENT 
FORM 
42 
APPENDIX 6A: FOLLOW-UP INTERVIEWS - PARTICIPANT INFORMATION SHEET 
43 
APPENDIX 6B: FOLLOW-UP INTERVIEWS – CONSENT FORM 
47 
APPENDIX 7: INTERVIEW GUIDE 
48 
APPENDIX 8: SURVEY OF INTENSIVE CARE FOLLOW-UP SERVICES 
51 
APPENDIX 9: STUDY TEAM SURVEY 
54 
 
 
 

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List of Abbreviations  
 
ARDS  
 
Acute Respiratory Distress Syndrome 
APACHE II 
 
Acute Physiologic Assessment and Chronic Health Evaluation II  
ASR 
 
 
Annual Safety Report 
CA                        
Competent Authority 
CAS-1R 
 
Cognitive Attentional Syndrome Scale-1 (Revised) 
CI                         
Chief Investigator 
COVID-19 
 
Coronavirus Disease 2019 
CRF                   
Case Report Form 
HADS  
 
Hospital Anxiety and Depression Scale 
HRQoL 
 
Health-Related Quality of Life 
ICU 
 
 
Intensive Care Unit 
ICM 
 
 
Intensive Care Medicine 
IES-6  
 
Impact of Event Scale-6  
IES-R  
 
Impact of Events Scale-Revised  
Main REC                
Main Research Ethics Committee 
NHS 
                   
National Health Service 
NIHR  
 
National Institute for Health Research 
PI                              Principle Investigator 
PICS  
 
Post-Intensive Care Syndrome 
PTSD  
 
Post Traumatic Stress Disorder 
R&D                   
Research & Development  
RD&I  
 
Research, Development and Innovation 
REC                          Research Ethics Committee 
REDCap 
 
Research Electronic Data Capture 
SAE                          Serious Adverse Event 
SARS  
 
Severe Acute Respiratory Syndrome 
SARS-CoV-2  
Severe Acute Respiratory Syndrome Coronavirus 2  
SOFA  
 
Sequential Organ Failure Assessment  
SOP 
 
 
Standard Operating Procedure 
TRIC   
 
Trainee Research in Intensive Care 
 
 
 
 
 

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1.  Study Summary 
Title 
The psychological impact of surviving an intensive care 
admission due to coronavirus disease 2019 (COVID-19) on 
patients in the United Kingdom 
Protocol short title / 
Acronym 
Psychological Impact of COVID-19 on Intensive Care Survivors /  
PIM-COVID 
Protocol 
Version 
number and Date 
Version: 1.6 
8 April 2022 
IRAS 
 282400 
Is the study a Pilot? 
No 
Study Duration 
24 months 
Methodology / Study 
Design 
Mixed methods: multicentre longitudinal observational study, 
longitudinal 
semi-structured 
interviews 
and 
observational 
structured survey. 
Sponsor 
Liverpool University Hospitals NHS Foundation Trust 
Co-Chief Investigators 
Dr Alicia Waite 
Professor Ingeborg Welters 
Medical 
conditions 
under investigation 
1) Anxiety, 2) depression and 3) trauma symptoms 
Purpose of study 
To assess the short- and long-term psychological impact on 
patients who have survived an admission to intensive care due 
to COVID-19, and identify possible predictors of anxiety, 
depression and trauma symptoms in this patient group.  
Primary objective 
To identify the proportion of patients surviving an admission to 
intensive care due to COVID-19 who experience anxiety, 
depression and/or trauma symptoms in the 6 months post-
discharge, assessed using the Hospital Anxiety and Depression 
Scale (HADS) and the Impact of Event Scale-6 (IES-6), 
respectively.  
Secondary objectives 
1. Identify 
demographic, 
clinical, 
physical 
and/or 
psychosocial predictors of depression, anxiety and/or 
trauma symptoms at 3-, 6- and 12-months post discharge 
from ICU.  

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2. Assess the feasibility of using a self-reported online 
questionnaire to assess anxiety, depression and/or trauma 
symptoms in patients following ICU admission.  
3. Explore the experiences of critical care survivors following 
COVID-19 infection during their recovery phase, including 
perceptions about the care received and support available 
to them, using semi-structured interviews 
4. Assess geographical differences in the availability and 
structure of follow-up services offered to patients with 
critical COVID-19 after hospital discharge.  
5. Gain feedback from the study team members on their 
involvement in the study.  
Main 
Inclusion 
and 
Exclusion Criteria 
Inclusion criteria: 
1.  Adult patients ≥18 years 
2.  Survived to intensive care / high dependency unit discharge 
following an admission of ≥24 hours 
3.  Diagnosed positive for COVID-19 
  
Exclusion criteria: 
1. Unable to complete questionnaires 
2. Unable or unwilling to consent 
3. Unable to speak, understand or communicate in English 
4. Patients with diagnosed pre-existing cognitive impairment (at 
the time of ICU admission) 
5. Patients with no fixed abode, at which postal questionnaire 
might be not received, and who have no access to a personal 
email address. 
Randomisation 
Not applicable 
Statistical Methodology 
and Analysis 
Trajectories of anxiety, depression, and trauma symptoms will be 
estimated using growth curve analysis. We will estimate and 
predict individual survivors’ slope and intercept scores. We will 
then regress predictor variables onto intercept and slope scores 
for all outcomes to identify variables likely to determine trajectories 
of anxiety, depression and trauma symptoms. Feasibility will be 
assessed using descriptive analyses.  
  
 

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2.  Introduction 
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was first reported in Wuhan, China in 
December 2019 (1). SARS-CoV-2 was later termed coronavirus disease 2019 (COVID-19) by the World 
Health Organisation (WHO).  On March 12, 2020 a pandemic was declared, which continues to emerge 
globally (2). At the time of writing, COVID-19 infections number over one million and have been 
responsible for over 123,000 deaths worldwide (3).  
 
COVID-19 is responsible for a spectrum of clinical presentations, ranging from asymptomatic or mild 
disease in the majority of patients, to pneumonia and acute respiratory distress syndrome (ARDS) in 
those more severely affected (1).  Initial reports suggested 5% of 1099 patients in China with confirmed 
COVID-19 were admitted to an intensive care unit (ICU) (4). Meanwhile, 12% of positive cases required 
ICU admission in Lombardy, Italy, accounting for 16% of all hospitalised patients (5). Based on recent 
UK-wide data from 258 ICUs where at least one patient has had COVID-19, the ICU mortality rate 
amongst patients with confirmed COVID-19 is 41.1% (6). 
 
In a 5 year longitudinal study of patients who developed ARDS not caused by COVID-19, prolonged 
symptoms of anxiety, depression and post-traumatic stress disorder (PTSD) were found to affect 23-38% 
of patients, with a median duration of symptoms of between 33 and 39 months (7). Not all patients 
admitted to ICU with COVID-19 will have ARDS, but admission to ICU is itself associated with a significant 
burden of post-ICU psychological sequelae. Symptoms of anxiety, depression and PTSD have been 
reported to affect up to 73% of survivors (8-10). Furthermore, symptoms of anxiety, depression and PTSD 
persist in 34% (8), 29% (9) and 34% (10) of ICU survivors respectively at 12-14 months following ICU 
admission.  
 
The severe acute respiratory syndrome (SARS) pandemic in 2002-2003 was also caused by a 
coronavirus, but affected significantly fewer individuals despite having a higher case fatality rate (10.9% 
(11) vs 3.2% (4)). At the peak of the SARS outbreak, patients reported significantly higher stress levels 
than healthy controls (12), with similar symptoms reported up to 1 year later, with 64% of patients 
reporting symptoms suggesting psychiatric morbidity (13). Furthermore, amongst SARS survivors, 
females were more likely to have symptoms of anxiety, depression, stress and trauma, and were three 
times more likely than males to have psychiatric morbidity (13). Female gender was also found to be an 
independent risk factor for chronic PTSD up to 30 months after the SARS outbreak (14). These results 
contrast with pre-existing data for ICU survivors, in whom gender is not a significant risk factor for anxiety, 
depression or PTSD (8-10). Instead, recognised risk factors for emotional distress following ICU 

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admission include previous psychiatric morbidity, receipt of benzodiazepines in ICU and psychiatric 
symptoms during admission (8-10). Furthermore, psychological symptoms may be part of Post Intensive 
Care Syndrome, which also includes cognitive and physical impairments that are new or have worsened 
following ICU admission and persist on discharge from hospital (15, 16). 
 
Whilst data emerges about the short-term impact of COVID-19 (17), the long-term implications to patients 
and healthcare systems remain unclear. With population-wide social distancing and societal lockdown 
enacted in many countries, the mental health of the general public is under strain(18). Data from previous 
pandemics suggests that pandemic-related factors such as quarantine may also have an impact on the 
psychological wellbeing of ICU survivors (19). It is plausible that this heightened anxiety primes patients, 
who subsequently require treatment in ICU for COVID-19, to develop psychological distress (17).  
 
We anticipate that there will be a significant burden to healthcare systems as a result of psychological 
distress. Current national guidelines state that at-risk ICU survivors who have had an admission of more 
than 4 days should be invited to a follow up clinic 2-3 months after discharge from ICU (20). However, 
hospital and community based services to support ICU survivors in their recovery were limited before 
COVID-19, with some hospitals not even offering an ICU follow up clinic (21). The number of patients 
expected to require admission to ICU during COVID-19 is far beyond existing UK critical care capacity, 
and in the context of enhanced baseline societal anxiety, the potential volume of patients with post-ICU 
psychological distress could far exceed existing healthcare capacity overwhelming current services. In 
order to be able to expand services as necessary and support ICU survivors properly to help them regain 
their quality of life, and return to working and contributing to society, we must first identify how many, and 
to what extent patients are affected.   
 
In this study, we aim to: 1. identify the proportion of COVID-19-positive critical care survivors who 
experience anxiety, depression and/or trauma symptoms up to 12 months after discharge from ICU, using 
validated tools; 2. identify predictors of post-ICU anxiety, depression and/or trauma in COVID-19 ICU 
survivors; 3. explore the experiences of critical care survivors following COVID-19 infection during their 
recovery phase, including perceptions about the care received and support available to them and 4. 
assess geographical differences in the availability and structure of follow-up services offered to critical 
COVID-19 survivors. This information may be used to inform healthcare systems about the psychological 
support required for survivors of this pandemic, and may inform healthcare planning for future pandemics. 

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3.  Study Objectives, Design and Statistics 
3.1 Study Aim 
To assess the short- and long-term psychological impact on patients who have survived an admission 
to intensive care due to COVID-19 in the United Kingdom, and identify possible predictors of anxiety, 
depression and trauma symptoms in this patient group. 
  
3.2 Study Objectives 
Primary objective: 
To identify the proportion of patients who survive ICU admission following treatment for COVID-19 that 
experience anxiety, depression and/or trauma symptoms at 6 months, assessed using the Hospital 
Anxiety and Depression Scale (HADS) and the Impact of Event Scale-6 (IES-6), respectively.  
 
Exploratory objectives: 
1. Identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety 
and/or trauma symptoms at 3-, 6- and 12-months after ICU discharge in patients being treated 
for COVID-19 within the ICU. 
2. Assess the feasibility of using a self-reported questionnaire to assess anxiety, depression and/or 
trauma symptoms in patients following ICU admission with COVID-19.  
3. Explore the experiences of critical care survivors following COVID-19 infection during their 
recovery phase, including perceptions about the care received and support available to them, 
using semi-structured interviews. 
4. Assess geographical differences in the availability and structure of follow-up services offered to 
patients with critical COVID-19 after hospital discharge.  
5. Gain feedback from the study team members on their involvement in this trainee-led study.  
 
3.3 Study Outcomes 
Primary outcome: 
Prevalence and incidence of: 
1. Anxiety 
2. Depression 
3. Trauma  
 
Anxiety and depression will be assessed using the HADS. The HADS is a 14-item self-report measure in 
which participants rate the presence of symptoms of anxiety (7 items) and depression (7 items) over the 

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preceding week using a 4-point Likert scale, with options from 0 (absence) to 3 (extreme presence). 
Responses are summed to produce two subscale scores, ranging from 0-21, with higher scores indicative 
of higher anxiety and depression levels, respectively. The HADS is widely used to assess anxiety and 
depression in people with physical health difficulties and demonstrates good psychometric properties 
when used in an intensive care setting.  Cut-off scores of ≥8 on anxiety and depression subscales of the 
HADS were used to define caseness (22, 23). A recent meta-analysis (24) showed the anxiety cut-off to 
predict structured interview diagnoses of either anxiety or depression with a sensitivity of 73% and 
specificity of 65%, and the depression cut-off to predict diagnosed depression with a sensitivity of 86% 
and specificity of 81%.  
 
Trauma will be assessed using the IES-6. The IES-6 is a validated tool in survivors of ARDS for screening 
for post-traumatic stress disorder. It is an abbreviated version of the IES-R test and contains six questions 
(25). We have chosen the IES-6 over the IES-R because it is shorter, is validated in a very similar patient 
population, will provide similar information, and is likely to have a higher completion rate by patients 
because it is shorter. Furthermore, in collaboration with ICU steps it was felt that this was the best 
approach for this cohort of ICU survivors.  
 
Exploratory outcomes: 
1. Identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety and/or 
trauma symptoms at 3-, 6- and 12-months post discharge from ICU.  
 
a. Demographic and clinical predictors.  
(See Schedule of Study Procedure for specific data that will be collected.) 
 
b. Physical predictors.  
 
The EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L) is a five-domain, self-report measure 
assessing mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are 
asked to rate each question, indicating no problems, slight problems, moderate problems, severe 
problems or extreme problems. In addition, participants are invited to rate their health on a visual 
analogue scale from 0-100, where zero represent the worst health imaginable and 100 represents the 
best health imaginable. EQ-5D-5L is the recommended questionnaire to assess the HRQoL of critically 
ill patients (26). In this study, EQ-5D-5L will be used as a subjective assessment of the physical function 
of participants. 

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c. Psychosocial predictors (metacognitive beliefs and processes). 
Metacognitive beliefs and processes will be assessed using the Cognitive Attentional Syndrome Scale-1 
(Revised; CAS-1R (27)). The CAS-1R is a 10-item self-report measure assessing positive and negative 
metacognitive beliefs, frequency of worry/rumination and the use of a range of counterproductive coping 
strategies used in response to negative thoughts and feelings. Participants are asked to rate the degree 
to which they have engaged in a particular coping strategy or thought process during the previous week. 
Responses are scaled from 0%-100% and are summed to produce a total score. Higher scores indicate 
greater conviction in metacognitive beliefs and greater use of maladaptive coping strategies to manage 
distress. The CAS-1R has demonstrated good psychometric properties in physical health populations.  
 
2. Assess the feasibility of using a self-reported online questionnaire to assess anxiety, depression 
and/or trauma symptoms in patients following ICU admission.  
 
Outcomes:  
● Recruitment number (total number of patients recruited per month) 
● Recruitment rate (proportion of those deemed eligible recruited) 
● Retention rate (proportion of participants who provide data at subsequent data capture points) 
● Rate of missing key data 
● Estimation of quantities needed for an accurate sample size calculation (e.g. HADS standard 
deviation) 
 
3. Explore the experiences of critical care survivors following COVID-19 infection during their recovery 
phase, including perceptions about the care received and support available to them, using semi-
structured interviews. The central study team will conduct semi-structured interviews in a 
representative sample of 40 patients. (See Schedule of Events for additional information.) 
 
4. Assess geographical differences in the availability and structure of follow-up services offered to 
patients with critical COVID-19 after hospital discharge.  
 
5. Explore the factors influencing the involvement of study team members in the study.  
 
 

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3.4 Study Design 
This is a multicentre longitudinal study. Exploratory outcomes will be address through mixed methods, 
including longitudinal, semi-structured interviews and observational structured surveys. 
 
3.5 Study Statistics 
This study is planned as a descriptive study in an effort to quantify the psychological impact on ICU 
survivors of COVID-19. It is anticipated that the study will report its findings using descriptive methods in 
the absence of a comparator group. 
 
Trajectories of anxiety, depression, and trauma symptoms will be estimated using growth curve analysis. 
To improve power, we will use the full range of anxiety, depression and trauma symptom scores (not cut-
off scores). Growth modelling is latent variable covariance modelling to estimate the intercept (value of 
the initial observation) and slope (the rate of change from this observation over time) of a time series of 
mean scores. We will estimate full sample single class models (eg, assuming homogeneity across the 
sample) for each outcome. Initial fixed parameters will be; error variance constrained to equality across 
observations, mean intercept and slope constrained to zero, intercept and slope constrained to equality, 
and intercept and slope covariance constrained to zero. Parameters will be systematically relaxed in that 
order until good fitting models (CFI > .95, RMSEA .05) are identified with maximum fixed parameters. 
Linear and quadratic slope models will be tested; linear models being defined as slope parameters 0, 1, 
4, and 12 and quadratic slopes as 0, 1, 8 and 24.  
 
We will estimate and predict individual survivors’ slope and intercept scores. Scores will be calculated 
using the regression method, setting intercepts for observed variables to 0 and imposing equality of 
variance. We will then regress predictor variables onto intercept and slope scores for all outcomes to 
identify variables likely to determine trajectories of anxiety, depression and trauma symptoms. 
 
Semi-structured interviews 
Analysis will use the principles of the constant comparative method and interpretive thematic analysis. 
One member of the research team will lead a process of iterating between the developing analysis and 
new data, and other members of the research team will develop and test the analysis by periodic 
discussion. The analysis will be interpretive and consider both latent and manifest aspects of the data, 
thereby acknowledging both the manner that participants talk as well as the explicit content. Analysis will 
progress in parallel with recruitment and will end when theoretical saturation is reached. Systematic data 
coding will be performed; exceptional case analysis will be discussed within the research team; and data 

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will be triangulated with quantitative data from the PIM-COVID study to enriching findings and 
interpretation. Analysis will be assisted by qualitative analysis software.  
 
3.6 Sample size 
There is no formal sample size required.  Overall we aim to recruit until September 2022 or when 1000 
patients have answered the questionnaire at all three time points, whichever occurs first. We will initially 
approach 20 intensive care units for participation. If necessary we will extend the number of recruiting 
units to facilitate reaching this recruitment target. We have factored in a 40% return rate, so we will have 
to send out 2500 questionnaires in order to achieve our target.  
 
With the semi-structured interviews, based on previous experience of qualitative evaluation of 
psychological effects on patients, we anticipate theoretical saturation with about 40 participants. 
 
 
4.  Recruitment and Withdrawal of Participants 
4.1 Recruitment 
Recruitment will take place at hospitals across the UK, and be conducted by junior doctors who are either 
training, or have a specialist interest, in intensive care medicine; and/or allied health professionals 
working in intensive care (including Advanced Critical Care Practitioners). Therefore, recruitment will be 
balanced within the demands of the clinical workload. It is intended that all patients discharged from a 
recruiting ICU, that were admitted and treated for COVID-19, will be given an information sheet explaining 
the study to them and explaining the possibility of receiving three questionnaires during the year following 
discharge. Where this is not feasible, every reasonable effort will be made to contact these patients prior 
to hospital discharge. All ICUs with members in the Trainee Research in Intensive Care (TRIC) will be 
invited to participate. 
 
For the semi-structured interviews, identification of participants will be performed by the central research 
team by accessing the PIM-COVID REDCap database. Where patients have agreed to be contacted by 
phone or email, these contact details will be available within the REDCap database. Patients who have 
provided consent to be contacted will be approached by telephone or email to discuss their potential 
participation in the study. A written information sheet will be sent via email or post as per participants’ 
preferences. Participants have been asked whether or not they are happy to be contacted as part of the 
3, 6 and 12 month questionnaires; participants who have indicated they would not like to be contacted 
will not be approached.  

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4.2 Inclusion criteria 
1. Adult patients ≥18 years 
2. Survival to intensive care / high dependency unit discharge following an admission of ≥24 
hours 
3. Treated for COVID-19 
  
4.3 Exclusion criteria  
1. Unable to complete questionnaires 
2. Unable or unwilling to consent 
3. Unable to speak, understand or communicate in English 
4. Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission) 
5. Patients without a fixed abode, at which postal questionnaires might be received, and who 
have no access to a personal email address. 
 
4.4 Criteria for Premature Withdrawal 
A patient may request to be withdrawn from the study at any time, for any reason, without prejudice and 
without an impact on their clinical care. A patient may also be withdrawn from the study at the request of 
his/her legal representative or clinical team, for any reason.   
 
5.  Study Procedures 
5.1 Screening Procedures 
All patients discharged from the ICU will be screened against inclusion and exclusion criteria prior to 
enrolment. A screening and enrolment log will be kept with site files and will be archived following the 
end of the study (see section 7.3). 
  
For the semi-structured interviews, a purposive sample of about 40 participants will be selected aiming 
for a sample that is diverse, representative of the cohort (in terms of ethnicity, sex, geographical location, 
degree of deprivation based on postcode, length of stay in ICU, etc), and inclusive of participants with 
and without evidence of psychological distress, based on answers to the 3 and 6 month questionnaires.  
 
5.2 Consent, Enrolment and Participant Follow-up Procedures 
On ICU discharge, where possible, patients will be provided with an information sheet outlining the study. 
A member of the research team with a valid GCP certificate will provide verbal information about the 

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study and answer any questions. Patients will be given the option to opt out of the study at this point, and 
thenceforth. Patients will also be given the option to opt in and be contacted by phone, email and/or post.  
Even if a patient opts in, and provides their contact details, they can choose to not participate in the study, 
and when they receive the invitation to participate in the first survey they can actively decline to participate 
or just not respond to the invitation. If the patient indicates that they do not wish to participate, they will 
be withdrawn from the study. If they do not indicate that they do not want to be contacted, and do not 
reply to the first survey, they will still be sent subsequent surveys and invited to participate in those. 
Critically ill patients often have impaired capacity as a result of their underlying illness and/or sedating 
medications, but usually regain capacity prior to being discharged home.  It is important that only patients 
with capacity participate in the study.  A patient will only be provided with an information leaflet in hospital 
once they have regained capacity.  If a patient has not been given an information leaflet prior to being 
discharged home, they will be sent an information sheet by post along with an invitation to participate. If 
after receiving the information sheet and unique login details, the patient has not yet indicated via the 
REDCap database that they either consent to participating in the study or decline to participate, they will 
be contacted by telephone by the study team (unless they have previously opted out of being contacted 
by phone).  There are three possible outcomes of this telephone contact: i) the patient consents to 
participating in the study; ii) the patient asks to be contacted again for re-discussion of consent; iii) the 
patient declines to participate in the study.  There are three methods for patients to provide their consent, 
via i) an online consent form in the REDCap database; ii) witnessed telephone consent; iii) a written 
consent form, which the patient can request. Verbal agreement to participate in the study will be obtained 
by a member of the study team and will be recorded in the patient notes. Verbal agreement must be 
witnessed by another member of the site study team or site medical staff.  The patient may withdraw 
consent at any stage. Upon withdrawing their consent, a study participant will be given the option for i) 
any previously collected data to still be included in the data analysis; or ii) all of their data to be removed 
from the REDCap database, and as such none of their data to be included in the analysis. 
 
Where patients consent to taking part in the study using the online consent form, they will be asked to 
enter their name and email address, and whether they are happy to be contacted by email, post and/or 
phone.  If patients decide not to provide an email address or their name, the study team will still be able 
to identify which patient has responded as the link to that consent form is unique to the patient and the 
REDCap record identifier can be cross referenced with the screening log. Where patients do not consent 
to taking part in the study, no personal information will be requested.  
 

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Eligible patients, who have not already opted out, will be invited to participate in an online questionnaire 
at 3, 6 and 12 months following discharge from ICU, or alternatively a paper copy of the questionnaire 
can be sent to them at the relevant time points or they may choose to answer the questionnaire over the 
phone with a member of the study team documenting their responses on REDCap. Prior to patient 
contact, electronic healthcare records will be accessed, and/or contact made with the patient’s registered 
general practitioner, to confirm the patient’s survival status. This is intended as a pre-contact check to 
minimise distress caused to families/relatives by making contact in the event a patient has died following 
discharge from the ICU. 
 
For patients who have provided their email address, an email will be sent at 3, 6 and 12 months with a 
unique link to their survey. The link to their survey at each timepoint will expire after 1 month. At the 
beginning of the questionnaire, the study information will be repeated.  Patients will be able to leave the 
study by contacting their local study team at any point during the study.  If patients indicate they would 
prefer to complete a paper version, they will be provided with a pre-paid envelope to return their 
completed questionnaire.  If patients indicate they would like to complete their questionnaire over the 
phone, this can be arranged with a study team member.  
 
No patient identifiable information will be entered into REDCap prior to gaining patient consent. Patient 
information that is analysed will be pseudo-anonymised and each patient will have a unique study 
identifier assigned for use in REDCap.  When the patient consents to be part of the study, their name 
and email address where provided will be stored in the REDCap database. Only the local study team will 
have access to this.  The REDCap database will be used for the study duration and closed when all data 
has been acquired.  Patient contact details will be kept during the study period only and will not be stored 
on the REDCap database without the patient’s consent. In the event that the patient dies after having 
consented to participating in the study, then they will remain in the study and their data will be included 
in the final analysis. 
  
Semi-structured interviews 
At the end of the 3, 6 and 12 month questionnaires there is a question asking if we can contact participants 
for feedback about the questionnaires. For the semi-structured interviews, we will approach patients (by 
phone or email) who have indicated that they agree to being contacted, and invite them to participate in 
interviews to provide further information about their experiences after ICU discharge. Participants will be 
invited to take part in an interview, at around 12 months after discharge from intensive care. A written 

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patient information sheet will be provided by email or post, and consent to participate can be provided 
verbally or in writing. 
 
Using open-ended questions we will explore physical and psychological consequences patients may face 
during their recovery phase; including physical sequelae such as loss of smell, breathlessness, fatigue, 
and psychological issues such as isolation, anxiety, flashbacks, or sleeping problems. We would like to 
learn about the follow-up services offered to participants by their GPs, the hospital and patient support 
groups, whether they chose to engage with services offered and how the support available influenced 
their way of coping. We also plan to explore what aspects of their recovery and any support they received 
they considered beneficial, and what aspects they felt could have been improved. The patient will be 
invited to share their experience without interruption, and only where topics of interest have not been 
covered, the Interview Guide (Appendix 7) will be used to provide prompts. 
 
The interviews will be conducted by a medically qualified research fellow trained in conducting qualitative 
interviews, over the telephone, online (via a secure platform such as MS Teams or Zoom) or in person, 
to ensure equitable access for prospective study participants. Interviews will be audio recorded, 
anonymised and transcribed. Recordings will be held in accordance with GDP regulations. Should 
patients become distressed during the interview, the one-on-one nature of the interviews should provide 
the opportunity for the interview to be postponed and to advise on additional support offered by locally 
available follow-up services, ICUsteps or other local support groups or their GP. Where patients describe 
psychological distress, a letter will be written to their GP and a copy sent to the patient, outlining what 
the patient has reported in the interview. We also have psychological support available within our study 
team to support patients who experience distress whilst recalling their experiences. 
 
Survey of Follow-up Services 
All intensive care units within the UK will be approached via email and invited to complete an online 
survey about follow-up services available for patients having been discharged from hospital after critical 
illness (See Appendix 7). ICUs will be contacted via the clinical ICU directors and through study teams, 
where sites are already involved in the PIM-COVID study. Invitations and information about the survey 
will be distributed through research network mailing lists and cascaded via social media. 
 
Survey of Study Team Members 
Study team members at all PIM-COVID sites will be invited to complete an online survey, which will 
explore the following:  

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• 
Socio-demographic characteristics of study team members 
• 
Previous academic experience 
• 
Feedback on involvement in the PIM-COVID study 
• 
Attitudes towards health research 
• 
Barriers and motivators to contributing to health research 
• 
Future research plans 
 
Questions evaluating participants attitudes, opinions and subjective feedback will be answered using a 
5-point Likert scale.  (See Appendix 8) 
 
 
5.3 Schedule of study procedure 
Following screening and enrolment after ICU discharge, the following will be collected: 
Patient data from medical records:  
1. Age 
2. Gender 
3. Laboratory diagnosis of COVID-19 
4. Physical health co-morbidities 
5. Mental health comorbidities 
6. Socioeconomic status (deprivation index calculated from postcode) 
 
Patient data from self-reported questionnaire:  
1. Highest educational level obtained (first questionnaire only) 
2. Prior and current experience of, and treatment for, mental health difficulties  
3. Current employment status 
 
ICU-acquired data: 
1. ICU date of discharge 
2. ICU length of stay * 
3. APACHE II score 
4. Mechanical ventilation received ** 
5. Delirium during ICU admission *** 
6. Benzodiazepine requirement during ICU admission 
* Defined as the length of stay recorded on the ICNARC database 

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** Defined as invasive mechanical ventilation via an endotracheal tube or tracheostomy using PEEP ≥ 
5cmH2O 
*** Defined as present if recorded in the medical notes during ICU admission or discharge 
 
Psychological assessment via self-reported questionnaire:   
The following four self-report questionnaires will be administered at 3, 6 and 12 months following ICU 
discharge:  
1. HADS 
2. IES-6 
3. CAS-1R 
4. EQ-5D-5L 
  
Semi-structured interviews:  
The interview guide that will be used to help conduct the interviews is outlined in Appendix 7. 
 
Survey of Follow-up Services: 
The survey questions are outlined in Appendix 8.  
 
Survey of study team members: 
The survey questions are outlined in Appendix 9.  
 
5.4 Accessing locally held data 
Where possible, locally collected data that contributes to the ICNARC database will be used rather than 
directly accessing patient notes. Accessing this data minimises error and bias in this study. Prior to study 
commencement, an agreement will be sought to access ICNARC data. Where additional information may 
be made available through large existing databases, including but not limited to ISARIC-CCP and 
GenOMICC, application will be made for data linkage and the necessary permissions sought.   
 
5.5 Missing observations 
Every effort will be made to minimise missing baseline and outcome data in this study. Reasonable efforts 
will be made to obtain complete datasets. Where this is not possible, data will be reported as missing in 
the presentation of the results. In the event that participants are non-responders to the 3- and 6-month 
questionnaires, the 12-month questionnaire will still be sent to participants (unless consent has previously 

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been withdrawn). This will be accompanied by a telephone call to confirm the patient’s willingness to 
continue as a study participant. 
 
5.6 End of Study Definition 
The study end date is deemed to be the date of the last data capture.  Reasonable attempts will be made 
to contact non-responders. The CI has the right at any time to terminate the study for clinical or 
administrative reasons. The end of the study will be reported to the Sponsor and REC within the required 
timeframe if the study is terminated prematurely. Investigators will inform patients of any premature 
termination of the study. Following the end of the study a summary report of the study will be provided to 
the REC within the required timeframe. 
 
6.  Assessment of Safety 
6.1 Safety outcomes 
Whilst we do not anticipate any adverse events or safety risks for patients or members of the research 
team from participation in this study, it is possible that patients engaging with this study may be 
experiencing psychological distress.  With each online or paper questionnaire, information will be 
provided about ICUsteps, a national support group network who are aware of and support this study. 
Participants will also be encouraged to engage with their local ICU follow up clinic if available locally (e.g. 
at 3 months) or contact their GP if they feel they need additional support.  
 
6.2 Ethics Reporting 
Approval from a Research & Ethics Committee (REC) will be sought. The REC will be informed about 
any changes according to the official National Research Ethics System regulations. Local site 
investigators will be responsible for ensuring appropriate approvals from local research committees, audit 
committees or R&D centres are obtained as required to ensure compliance with local policies.   
 
6.3 Data Safety and Monitoring Board 
This is a longitudinal study with no change in clinical practice. A data safety and monitoring board will not 
be established. 
 
6.4 Ethics & Regulatory Approvals 
The study will be submitted centrally for consideration by a NRES approved Research Ethics Committee 
and by the HRA, as well as local RD&I approvals. 
 

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7.  Data Handling 
7.1 Confidentiality 
● All local sites will maintain an enrolment and recruitment log, which will include patient hospital 
identification number, name and contact details and will be held in a locked office at the local site. 
Only members of the local study team will have access to this list. 
● Patient confidentiality will only be breached if a participant discloses information which may 
indicate harm to themselves or others. We will take every opportunity to discuss any possible 
breaches of confidentiality with patients before informing any appropriate agencies (e.g. patient’s 
registered general practitioner). 
● All enrolled patients will be allocated a unique study number which will be used for referencing 
data recorded and entered into the REDCap database. This study number will be used as the 
patient identifier to link to clinical variables. 
● To avoid the possibility of identifying patients via their postcode, study members will be looking 
up the deprivation index using government data specific to England, Northern Ireland, Scotland 
and Wales. This deprivation index will then be entered into the REDCap database.  The 
patient’s postcode will be found in the patient’s records and not be recorded in the REDCap 
database.  
● All online questionnaires, and online generated data, will be held in a secure server. If necessary, 
paper copies of questionnaire results will be printed and stored at local sites. Printed 
questionnaires will be entered into the REDCap database by local study team members, so as to 
merge all data together for analysis.  
● All paper documents (including participants’ written consent forms and returned paper 
questionnaires) will be held securely at the study site in a restricted access area, in line with data 
protection regulations.   
● The Chief Investigator will act as ‘Custodian’ for all data collected. 
● No patient identifiable details will be included in the published study reports. 
● No information regarding the study will be released to or by a third party without the prior written 
consent of the sponsoring institution. 
● Representatives of the sponsoring institute may inspect all documents and records required to be 
maintained by the investigators. 
 
7.2 Case Report Form 
Data will be recorded via individual electronic case report forms (eCRF) through the REDCap 
(https://www.project-redcap.org/) online database tool. Local investigators will be responsible for 

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individual hospital data input into REDCap. Local investigators are responsible for data collection, input 
and accuracy. 
  
7.3 Record Retention and Archiving 
All research and relevant documents will be stored confidentially and securely for 10 years following the 
end of the study as per the Sponsor’s standard operating procedure on research archiving. The members 
of the study management team will have access to stored data. Upon request, investigators can get 
access to data from their own site. 
  
7.4 Compliance 
The study will be conducted in compliance with the principles of the Declaration of Helsinki (1996), and 
in accordance with all applicable regulatory requirements including but not limited to the Research 
Governance Framework, Trust and Research Office policies and procedures and any subsequent 
amendments. Personal patient data will be pseudo-anonymised and will be held in compliance with EU 
General Data Protection Regulations (GDPR) and the UK Data Protection Act (2018).  
  
7.5 Clinical Governance 
The study may be selected for audit by any method listed below: 
● The project may be identified via the risk assessment process. 
● An individual investigator or department may request an audit. 
● A project may be identified via an allegation of research misconduct or fraud or a suspected 
breach of regulations. 
● Projects may be selected at random. The Department of Health states that Trusts should be 
auditing a minimum of 10% of all research projects. 
● Projects may be randomly selected for audit by an external organisation. 
● Internal audits will be conducted by a sponsor’s representative 
  
7.6 Non-Compliance 
Non-compliances may be captured from a variety of different sources including eCRFs, communications 
and updates. The sponsor will maintain a log of the non-compliances to ascertain if there are any trends 
developing which require to be escalated. The sponsor will assess the non-compliances and action a 
timeframe in which they need to be dealt with. Each action will be given a different timeframe dependent 
on the severity. If the actions are not dealt with accordingly, the R&D team will agree to an appropriate 
action, including an on-site audit. All protocol and GCP deviations will be reported to the Sponsor and 

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serious non-compliance will be reported to REC, in line with the SAE/protocol deviation SOPs of the 
Sponsor.  
 
7.7 Protocol Amendments 
Any changes in research activity will be reviewed and approved by the Chief Investigator and submitted 
in writing to the appropriate REC and local research site for approval prior to being included in an 
amended protocol.  
 
7.8 Study Management 
The Co-Chief Investigators, Dr Alicia Waite and Professor Ingeborg Welters, will have managerial 
oversight of the project. The day-to-day management and data collection will be coordinated by the TRIC 
network, with junior doctors at each site performing patient identification, data collection and appropriate 
participant contact, in conjunction with allied health professionals working with the TRIC network. The 
analysis will be led by Dr Steve Brown, with clinical input provided by the TRIC network. 
 
 
8.  Finance and Publication Policy 
8.1 Finance 
Funding is provided by the Intensive Care Society and the Mersey School of Anaesthesia.  
   
8.2 Publication Policy 
It is planned to publish the study results, in mutual agreement with the investigator team, in a scientific 
journal and present the findings at international congresses. Publication of the results of the study as a 
whole is intended. Requirements for authorship will follow American Medical Association (AMA) 
guidance. Any publication will take account of the International Committee of Medical Journal Editors 
(ICMJE) relevant policies and guidelines. The study will also be registered in a public register in 
accordance with the recommendations of the ICMJE. Any published data will observe data protection 
legislation covering the study subject and investigators. Individual findings at individual study sites are 
known only to the responsible institution. A lay summary of the results will be made available to 
participants upon their request. 
 
Publications or lectures presenting findings of the study (either as a whole or at individual investigation 
sites) must be approved by the chief investigator in advance, and the responsible institution reserves the 

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right to review and comment on such documentation before publication. Publication should include details 
of the sponsor and other major study contributors, but with no patient identifiable details.  
 
 
9.  References 
1. 
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 
2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center 
for Disease Control and Prevention. JAMA. 2020. 
2. 
Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. 
Lancet Infect Dis. 2020. 
3. 
Organization WH. Coronavirus disease 2019 (COVID-19) Situation Report – 86 2020 [Available 
from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200415-sitrep-86-covid-
19.pdf?sfvrsn=c615ea20_4. 
4. 
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical Characteristics of Coronavirus 
Disease 2019 in China. N Engl J Med. 2020. 
5. 
Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in 
Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020. 
6. 
Intensive Care National Audit & Research Centre (ICNARC) report on COVID-19 in critical care -  
19 
June 
2020 
 
[Available 
from: 
https://www.icnarc.org/Our-Audit/Audits/Cmp/Our-National-
Analyses/2020/05/08/Report-On-9623-Patients-Critically-Ill-With-Covid-19. 
7. 
Bienvenu OJ, Friedman LA, Colantuoni E, Dinglas VD, Sepulveda KA, Mendez-Tellez P, et al. 
Psychiatric symptoms after acute respiratory distress syndrome: a 5-year longitudinal study. Intensive 
Care Med. 2018;44(1):38-47. 
8. 
Nikayin S, Rabiee A, Hashem MD, Huang M, Bienvenu OJ, Turnbull AE, et al. Anxiety symptoms 
in survivors of critical illness: a systematic review and meta-analysis. Gen Hosp Psychiatry. 2016;43:23-
9. 
9. 
Rabiee A, Nikayin S, Hashem MD, Huang M, Dinglas VD, Bienvenu OJ, et al. Depressive 
Symptoms After Critical Illness: A Systematic Review and Meta-Analysis. Crit Care Med. 
2016;44(9):1744-53. 
10. 
Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. 
Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 
2015;43(5):1121-9. 
11. 
Organization WH. Summary table of SARS cases by country, 1 November 2002 - 7 August 2003 
2003 [updated 15 August 2003. Available from: https://www.who.int/csr/sars/country/2003_08_15/en/. 

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28 
12. 
Chua SE, Cheung V, McAlonan GM, Cheung C, Wong JW, Cheung EP, et al. Stress and 
psychological impact on SARS patients during the outbreak. Can J Psychiatry. 2004;49(6):385-90. 
13. 
Lee AM, Wong JG, McAlonan GM, Cheung V, Cheung C, Sham PC, et al. Stress and 
psychological distress among SARS survivors 1 year after the outbreak. Can J Psychiatry. 
2007;52(4):233-40. 
14. 
Mak IW, Chu CM, Pan PC, Yiu MG, Chan VL. Long-term psychiatric morbidities among SARS 
survivors. Gen Hosp Psychiatry. 2009;31(4):318-26. 
15. 
Stam HJ, Stucki G, Bickenbach J. Covid-19 and Post Intensive Care Syndrome: A Call for Action. 
J Rehabil Med. 2020;52(4):jrm00044. 
16. 
Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, et al. Improving long-
term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care 
Med. 2012;40(2):502-9. 
17. 
Bo HX, Li W, Yang Y, Wang Y, Zhang Q, Cheung T, et al. Posttraumatic stress symptoms and 
attitude toward crisis mental health services among clinically stable patients with COVID-19 in China. 
Psychol Med. 2020:1-7. 
18. 
Holmes EA, O'Connor RC, Perry VH, Tracey I, Wessely S, Arseneault L, et al. Multidisciplinary 
research priorities for the COVID-19 pandemic: a call for action for mental health science. Lancet 
Psychiatry. 2020;7(6):547-60. 
19. 
Ahmed H, Patel K, Greenwood DC, Halpin S, Lewthwaite P, Salawu A, et al. Long-term clinical 
outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome 
coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J 
Rehabil Med. 2020;52(5):jrm00063. 
20. 
National Institute for Health and Care Excellence. Rehabilitation after critical illness in adults. 
Clinical guideline [CG83]: NICE; 2009 [Available from: https://www.nice.org.uk/guidance/cg83. 
21. 
Connolly B, Douiri A, Steier J, Moxham J, Denehy L, Hart N. A UK survey of rehabilitation following 
critical illness: implementation of NICE Clinical Guidance 83 (CG83) following hospital discharge. BMJ 
Open. 2014;4(5):e004963. 
22. 
Jutte JE, Needham DM, Pfoh ER, Bienvenu OJ. Psychometric evaluation of the Hospital Anxiety 
and Depression Scale 3 months after acute lung injury. J Crit Care. 2015;30(4):793-8. 
23. 
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression 
Scale. An updated literature review. J Psychosom Res. 2002;52(2):69-77. 
24. 
Vodermaier A, Millman RD. Accuracy of the Hospital Anxiety and Depression Scale as a 
screening tool in cancer patients: a systematic review and meta-analysis. Support Care Cancer. 
2011;19(12):1899-908. 

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25. 
Hosey MM, Leoutsakos JS, Li X, Dinglas VD, Bienvenu OJ, Parker AM, et al. Screening for 
posttraumatic stress disorder in ARDS survivors: validation of the Impact of Event Scale-6 (IES-6). Crit 
Care. 2019;23(1):276. 
26. 
Needham DM, Sepulveda KA, Dinglas VD, Chessare CM, Friedman LA, Bingham CO, 3rd, et al. 
Core Outcome Measures for Clinical Research in Acute Respiratory Failure Survivors. An International 
Modified Delphi Consensus Study. Am J Respir Crit Care Med. 2017;196(9):1122-30. 
27. 
Wells A. Metacognitive Therapy for Anxiety and Depression. London: Guilford Press; 2009. 
 
 

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10.  Appendices 
Appendix 1: Information with regards to Safety Reporting in Non-CTIMP Research 
  
  
Who 
When 
How 
To Whom 
SAE 
Chief 
Investigator 
Report to sponsor 
within 24 hours of 
learning of the 
event 
  
Report to the MREC 
within 15 days of 
learning of the 
event 
SAE report form for 
non-CTIMPs, available 
from NRES website. 
Sponsor and MREC 
Urgent 
Safety 
Measures 
Chief 
Investigator 
Contact the sponsor 
and MREC 
immediately 
  
Within 3 days 
By phone 
  
  
Substantial amendment 
form giving notice in 
writing setting out the 
reasons for the urgent 
safety measures and 
the plan for future 
action. 
Main REC and 
sponsor 
  
Main REC with a 
copy also sent to the 
sponsor. The MREC 
will acknowledge this 
within 30 days of 
receipt. 
Progress 
Reports 
Chief 
Investigator 
Annually (starting 
12 months after the 
date of favourable 
opinion) 
Annual progress report 
form (non-CTIMPs) 
available from the 
NRES website 
Main REC 
Declaration 
of the 
conclusion 
or early 
termination 
of the study 
Chief 
Investigator 
Within 90 days 
(conclusion) 
  
Within 15 days 
(early termination) 
  
The end of study 
should be defined in 
the protocol 
End of study 
declaration form 
available from the 
NRES website 
Main REC with a 
copy to be sent to the 
sponsor 

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Summary of 
final Report 
Chief 
Investigator 
Within one year of 
conclusion of the 
research 
No standard format 
However, the following 
Information should be 
included: 
Where the study has 
met its objectives, the 
main findings and 
arrangements for 
publication or 
dissemination including 
feedback to 
participants 
Main REC with a 
copy to be sent to the 
sponsor 
 
 

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Appendix 2: Study Flowchart 
 
 
 
 
Ward admission post-ICU
Home
STUDY FLOWCHART
Admitted to ICU with COVID-19
Day 1
3 months
6 months
12 months
Investigator Action
Study information sheet and 
invitation letter provided to patient
Option to opt 
out
Check hospital records 
Patient Action
Screening log of patients ≥18 
years discharged from ICU 
following an admission of ≥24 
hours with COVID-19
Option to opt 
in
No response
Survived?
Yes
No
Exclude from study
Contact details obtained 
in compliance with 
GDPR. Email address for 
survey where possible. 
Exclude from study
Send study invitation by post 
unless patient has already 
opted in and provided their 
email address.
Where permission already 
given, can contact patient to 
remind about survey.
Reponses within 1 month of 
study time point.
No response
Check hospital records 
Check hospital records 
Survived?
No
Do not send 
further surveys
Survived?
No
Do not send 
further surveys
Yes
Yes
Agrees to be 
contacted for future 
surveys
Declines to be 
contacted for this or 
future surveys
Do not send further surveys
Patient Journey
Send study invitation by email unless 
no response to first letter
Send study invitation by email unless no 
response to first letter
Where permission already given, can contact 
patient to remind about survey.
Reponses within 1 month of study time point.
No response
Legend:
S
Task performed by 
member of Study Team
S
D
S
S
S
D
S
D
S
D
S
D
Task checked and/or 
reminder sent to Study 
Team by Data Manager
D
S
D
S
D
S
D
S
D
S
D
S
D
S
D
S
D
S

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19 November 2023 
33 
Appendix 3a: Study Gantt Chart 
 
 
 
 
 
 
Tasks
2020
2021
2022
2023
J
F
M
A
M
J
J
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
N
D
J
F
M
A
M
J
J
A
S
O
N
D
Award
Ethics 
REC/HRA
Preparation/set 
up
Site 
enrollment
Patient 
Recruitment
PPI 
Engagement
Analysis
Analysis of 6-
month data
Interim report
Final analysis
Journal writeup
Journal 
submission
and editing
Poster 
presentation
ISICEM
ESICM
ICS

PIM-COVID Study Protocol Version 1.7  
 
 
 
 
 
 
IRAS 282400 
19 November 2023 
34 
Appendix 3b: Interviews & Survey Gantt Chart 
 
 
 
Phase
Year
Month Sep Oct Nov Dec Jan Feb Mar Apr May Jun
Jul
Aug Sept Oct Nov Dec Jan Feb
Mar
Apr May
Work Package
Patient interviews
ICU follow-up service survey
Study team survey
Activity
PPI Involvement
Interviews - First patient recruited
Patient Interviews
Interview Transcription
Interviews - Final patient recruited
ICU follow-up service & study team survey
Data cleaning
Data analysis
Journal writeup
Journal submission
Conference Presentation
ICS
ISICEM
Presentation
2023
Recruitment & data collection
Data analysis & write-up
2021
2022

<INSERT LOCAL TRUST HEADER> 
 
PIM-COVID Patient Information Sheet Version 1.3 08/04/2022.                     IRAS 282400. Study No. 
SP0316. 
35 
 
Appendix 4: Invitation Letter, Patient Information Sheet and Consent Form 
 
< ENTER PATIENT ADDRESS> 
 
<ENTER DATE> 
 
 
Dear <ENTER  PATIENT NAME> 
 
Psychological Impact of COVID-19 on Intensive Care Survivors Study  
AN INVITATION TO PARTICIPATE 
 
We are conducting a research study investigating the psychological impact of surviving an 
intensive care admission due to COVID-19 on patients in the UK. You have been sent this 
invitation to participate because you were a patient in the <ENTER HOSPITAL NAME> 
intensive care unit where you were treated for COVID-19 infection.  
 
Please read the patient information sheet provided carefully. If you have any questions or 
concerns in relation to the study, the local research team or the chief investigators will be 
happy to discuss these with you.  
 
If the study team do not hear from you through the online survey system (a link and password 
is provided for you on a separate page), they will contact you by telephone to see whether or 
not you would like to take part in the study. There is no obligation for you to participate.   
 
By following the link provided, you can let us know whether or not you would like to participate.  
If you indicate that you would like to take part, you will be asked to provide some basic 
information about yourself. Once you have answered these questions, you will be contacted 
via email or telephone to participate in the survey 3, 6, and 12 months after you were 
discharged from intensive care. 
 
Thank you for your time in considering this request. 
 
Yours sincerely,  
 
 
<ENTER TRAINEE/CONSULTANT PI NAME> 
 

 
 
PIM-COVID Patient Information Sheet Version 1.3 08/04/2022.                     IRAS 282400. Study No. SP0316. 
36 
 
Psychological Impact of COVID-19 on Intensive Care Survivors 
PATIENT INFORMATION SHEET 
 
What is the purpose of the study? 
We are investigating the psychological impact of having been treated for Coronavirus disease 2019 
(COVID-19). The purpose of this study is to improve our understanding of the psychological impact on 
patients of being diagnosed with COVID-19 and receiving treatment in intensive care. We are planning 
to ask you questions to assess symptoms of anxiety, depression and trauma that you may be 
experiencing. We will also ask you some questions which will enable us to identify potential risk factors 
for anxiety, depression and trauma following an intensive care admission due to COVID-19. We hope 
that by learning more about the psychological impact on people who have survived intensive care, we 
can improve our understanding and use the information to help inform healthcare planners about the 
number of intensive care survivors who might need psychological support once they go home.  
 
Why have you been chosen? 
You have been chosen because you had COVID-19 and were treated in intensive care. 
 
Do I have to take part? 
No, it is up to you to decide whether or not to take part. You are still free at any time to withdraw your 
consent without giving a reason. If you decide not to take part the standard of care you will receive will 
not be affected. 
 
What happens if I agree to take part? 
If you do decide to participate you will be given this information sheet to keep and will be asked to sign 
a consent form. The consent form can be completed online, over the telephone or on a paper form that 
we can post to you. If we have sent you this Invitation to Participate in the post and we do not hear back 
from you, a member of the local hospital team will contact you by telephone to see whether or not you 
are willing to participate in the study.  
 
We will then ask you to complete questionnaires that ask you about symptoms relating to anxiety, 
depression and trauma. These questionnaires will be sent to you by the study team at the intensive care 
unit where you were a patient, at 3, 6 and 12 months after your ICU stay, where applicable.  
 
 

 
 
PIM-COVID Patient Information Sheet Version 1.3 08/04/2022.                     IRAS 282400. Study No. SP0316. 
37 
 
You will be invited to complete these questionnaires online, but if you would prefer to complete a paper 
version of the questionnaire, or give your answers over the telephone to one of the study team members 
you can contact your local study team and they will organise this <ENTER LOCAL STUDY TEAM 
CONTACT DETAILS>. 
 
We may contact your general practitioner to check your condition before sending out questionnaires. In 
addition to the questionnaires we send you, your local study team will collect information from hospital 
records about your past medical history and the support you received during your intensive care 
admission (e.g. whether you were on a ventilator).  
 
What are the possible advantages and disadvantages of taking part? 
Taking part in this study may contribute to improved treatment of patients with COVID-19 who are 
discharged from intensive care.  The potential complications that may arise from this study are rare. We 
will be asking you questions about anxiety, depression and trauma symptoms. Sometimes, when people 
are asked to complete questionnaires about these topics, they can find this distressing. You may find 
that completing the questionnaire increases your level of anxiety, depression and trauma related to 
COVID-19, but this is uncommon. Should you be interested in support from others who have experience 
of what it is like to being a patient in intensive care, you can find a local support group and access other 
resources at the ICUsteps website: www.icusteps.org. 
 
What if something goes wrong? 
It is unlikely that anything will go wrong as a result of taking part in this study. If you have any concerns 
about this study you should contact the Chief Investigators (contact details below) who will do their best 
to answer your questions. 
 
Would my taking part in this study be kept confidential? 
Any information collected about you during the study will be kept strictly confidential and only be seen 
by staff involved in the study from the hospital trust where you were a patient in intensive care, the 
University of Liverpool, and people from regulatory authorities who ensure that studies such as this are 
carried out correctly. All of them will have a duty of confidentiality to you as a research participant.  
 
 
 
 

 
 
PIM-COVID Patient Information Sheet Version 1.3 08/04/2022.                     IRAS 282400. Study No. SP0316. 
38 
Your contact details will only be held at the hospital where you were a patient in intensive care. We will 
keep your contact details for the duration of the study (2 years) in case we need to contact you.  
 
Patient confidentiality will only be breached if you disclose information that may indicate harm to yourself 
or to others. We will try to contact you first and discuss this with you prior to contacting relevant agencies 
(e.g. your registered general practitioner) to inform them of concerns raised through this study. 
 
What happens to the questionnaires completed during this survey? 
Questionnaires will be completed online, via a system called REDCap; or by telephone with one of the 
study team members at the site where you were a patient recording your responses; or we can send 
you a paper version of the questionnaire.  
 
REDCap is a secure online platform that is commonly used for surveys and study databases.  The online 
questionnaires will be accessed via a link and password that is specific to you. Your responses will be 
stored using a unique participant number. Only the local study team will be able to tell that your 
participant number is linked to you, and when the study is finished and the data is analysed your 
responses will be anonymous.  If you choose to complete the questionnaire online, we will ask you to 
enter your name and email address. These personal details will only be visible to the local study team, 
and will be deleted at the end of the study or if you decide to withdraw from the study.  
 
If you request a paper version of the questionnaire, when you return the questionnaire one of the study 
team members will enter your responses into the online REDCap database, so that the information can 
be stored in the same format as questionnaires completed online.  
 
All relevant documents related to the study will be stored confidentially and securely for 10 years 
following the end of the study.  Members of the study management team will have access to stored data, 
and members of the study team at each site will be granted access to the data collected at their own 
site.  
 
 
 

 
 
PIM-COVID Patient Information Sheet Version 1.3 08/04/2022.                     IRAS 282400. Study No. SP0316. 
39 
 
 
What will happen to the results of the study? 
This study will take 2 years to complete. Publication of the results will follow shortly after this, through 
medical publications, websites and press releases.  Results of the study will be made available to study 
participants. Anonymised results and updates on the study will be published regularly on the study 
website. 
 
The data collected in this study may be used to support future research, but any data shared with third 
parties will be fully anonymised and cannot be traced back to the participant.  
 
Who is organising and funding the study? 
This study is being organised by a group of doctors and scientists led by Dr Alicia Waite who is a trainee 
and researcher in intensive care medicine at the University of Liverpool, and Professor Ingeborg 
Welters, who is an intensive care consultant, Research Lead at the Royal Liverpool University Hospital 
and a researcher at the University of Liverpool.  The funding for this study comes from the Intensive 
Care Society and the Mersey School of Anaesthesia.  The Sponsor of the study is the Liverpool 
University Hospitals NHS Foundation Trust. 
 
Who has reviewed the study? 
This research study has been reviewed by an independent group of people, called a Research Ethics 
Committee, to protect your safety, rights, wellbeing and dignity. This study has been given a favourable 
opinion by the East Midlands – Derby Research and Ethics Committee. 
 
What happens if I have any questions, concerns or complaints about the study? 
If you have any questions about your participation in this study you should contact your hospital’s 
Principal Investigator or a member of the research team. If you want to complain about how researchers 
have handled your information, you should contact the research team. If you are not happy after that, 
you can contact the Data Protection Officer. The research team can give you details of the right Data 
Protection Officer. If you wish to complain formally, you can contact the Patient Advice and Liaison 
Service at your hospital: <INSERT TELEPHONE NUMBER FOR LOCAL PALS>.   
 
We may ask you for feedback on the questionnaire itself, but this will be voluntary and will not be part 
of the study data. 
 

 
 
PIM-COVID Patient Information Sheet Version 1.3 08/04/2022.                     IRAS 282400. Study No. SP0316. 
40 
 
 
What happens if I don’t want to carry on with the study? 
You are free to withdraw from the study at any time and without giving a reason. This will not affect the 
standard of care you receive. If you decide you don’t want to continue in the study you will be given two 
options regarding any data already collected about you: 1) you can decide that any data already 
collected can be included in the study, or 2) you can decide that all data about you should be removed 
from the study.  Removing your data from the study will only be possible before the data is analysed.  
 
There are two timepoints at which the data will be analysed: the first analysis will be 6 months into the 
study, and the second will be at 18 months.  
 
Any other questions? 
If you have any questions that remain unanswered, the local study team member will be happy to answer 
these for you.  If you require any further information you may contact the Chief Investigators (details 
below). 
 
Chief Investigators: 
Name:  
Dr Alicia Waite 
Address:  
Intensive Care Unit, Royal Liverpool University Hospital, L7 8XP 
Phone:  
0151 706 2410 
Email:   
alicia.waite@liverpool.ac.uk 
 
Name:  
Professor Ingeborg Welters 
Address:  
Institute of Life Course and Medical Sciences, University of Liverpool, L7 8TX 
Phone:  
0151 706 2410 
Email:   
i.welters@liverpool.ac.uk 
 
To find your nearest ICUsteps support group for intensive care survivors visit www.icusteps.org. 
 
 
Thank you for taking the time to read this Patient Information Sheet. 
 
 

 
 
PIM-COVID Consent form Version 1.3 08/04/2022.  
IRAS 282400. Study No. SP0316. 
41 
 
 
CONSENT FORM 
 
 
Title of Project: Psychological Impact of COVID-19 on Intensive Care Survivors  
Chief Investigators: Dr Alicia Waite, Professor Ingeborg Welters 
Centre Number:  
 
 
 
 
Participant ID:  
 
1. 
I confirm that I have read the Patient Information Sheet dated 08/04/2022 (version 1.3) for the 
above study (or have had it read to me). I have had the opportunity to consider the information, 
ask questions and have had these answered satisfactorily.  
 
2. 
I understand that my participation is voluntary and that I am free to withdraw at any time, without 
giving any reason and without my medical care or legal rights being affected. 
 
3. 
I understand that relevant sections of my medical notes and data collected during the study may 
be looked at by individuals from regulatory authorities and from the NHS Trust, where it is relevant 
to my taking part in this research. I give permission for these individuals to have access to my 
records.  
 
4. 
I understand that the information collected about me will be used to support other research in the 
future and may be shared anonymously with other researchers.  
 
5. 
I agree to my General Practitioner being contacted, including any necessary exchange of 
information about me between my GP and the research team.  
 
6. 
I agree to my contact details being held by the study team in order for the results of the study to 
be shared with me. 
 
7. 
I agree to participate in the above study. 
 
 
 
 
 
 
 
Name of participant 
 
Signature of Participant 
 
Date 
 
 
 
 
 
 
 
 
 
 
Name of person taking consent 
 
Signature of person taking consent 
 
Date 
 

 
 
Taflen Wybodaeth i Gleifion PIM-COVID Fersiwn 1.2 02/02/2021.     IRAS 282400. Rhif Astudiaeth SP0316. 
42 
 
 
Appendix 5: Welsh Invitation Letter, Patient Information Sheet and Consent Form 
 
<Welsh translation available. English language only permitted by Clinicaltrials.gov

 
 
 
PIM-COVID Interview PIS - Version 1.2 08/04/2022.                                     IRAS 282400. Study No. SP0316. 
43 
 
 
Appendix 6a: Follow-up Interviews - Participant Information Sheet 
 
Psychological Impact of COVID-19 on Intensive Care Survivors –  
Follow-up Interviews 
PARTICIPANT INFORMATION SHEET 
 
What is the purpose of the study? 
We are investigating the psychological impact of having been treated for Coronavirus disease 2019 
(COVID-19). The purpose of this study is to improve our understanding of the psychological impact on 
patients of being diagnosed with COVID-19 and receiving treatment in intensive care. In addition to the 
questionnaires that you have completed, we would like to learn more about your experience since 
leaving intensive care, particularly about your recovery and factors that may influence this.  We hope 
that by learning more about your experience after leaving intensive care we can make recommendations 
to improve services for other patients in their recovery phase. 
 
Why have you been chosen? 
You have been chosen because you had COVID-19 and were treated in intensive care. You have been 
taking part in the PIM-COVID study and indicated that you would be happy to be contacted for more 
feedback. 
 
Do I have to take part? 
 
No, it is up to you to decide whether or not to take part. You are free at any time to withdraw your consent 
without giving a reason. If you decide not to take part, the standard of care you will receive will not be 
affected. 
 
What happens if I agree to take part? 
If you do decide to participate you will be given this information sheet to keep and will be asked to sign 
a consent form. We will arrange an interview with you, 12 months after your ICU stay. In this interview 
we will ask you about your experience since leaving intensive care. The interview will be arranged at a 
time convenient for you and will be conducted by one of the central study team members. You can 
choose whether you would like to conduct the interview via telephone, online via video chat (e.g. MS 
Teams or Zoom), in person at the Royal Liverpool University Hospital, or at your home (government 

 
 
 
PIM-COVID Interview PIS - Version 1.2 08/04/2022.                                     IRAS 282400. Study No. SP0316. 
44 
restrictions permitting). The interview will be audio recorded and anonymised to maintain your 
confidentiality.  
 
 
What are the possible advantages and disadvantages of taking part? 
Taking part in this study may contribute to improved treatment of patients with COVID-19 who are 
discharged from intensive care.  We will be asking you questions about your mental and physical health 
after leaving intensive care. Sometimes, when people are asked about these topics, they can find it 
distressing. You will be able to pause or stop the interview if this happens or rearrange the interview for 
another day. Should you feel that you require further support during or after the study, we can direct you 
to other resources and support options. 
 
What if something goes wrong? 
It is unlikely that anything will go wrong as a result of taking part in this study. If you have any concerns 
about this study you should contact the Chief Investigators (contact details below) who will do their best 
to answer your questions. 
 
Would my taking part in this study be kept confidential? 
Any personal information you provide us will be kept confidential and only seen by staff involved in the 
study. The only other group who will have access to your details are people from regulatory authorities 
who ensure that studies such as this are carried out correctly. All of them will have a duty of 
confidentiality to you as a research participant. Your contact details will be held on a secure computer, 
in a password protected file at the Royal Liverpool University Hospital, where the central study team are 
based.  We will keep your details for the duration of the study in case we need to contact you.  
 
Patient confidentiality will only be breached if you disclose information that may indicate harm to yourself 
or to others. We will try to contact you first and discuss this with you prior to contacting relevant agencies 
(e.g. your registered general practitioner) to inform them of concerns raised through this study. 
 
What happens to my answers given in the interview?  
The interviews will be conducted by a medically qualified researcher, trained in undertaking interviews. 
The audio recording of your interview will be anonymised and then transcribed for analysis by a third 
party (www.uktranspcription.com). Your recording will be stored using a unique participant number that 
is linked to you, but when the study is published your responses will be anonymous. Only the central 

 
 
 
PIM-COVID Interview PIS - Version 1.2 08/04/2022.                                     IRAS 282400. Study No. SP0316. 
45 
study team will be able to link your answers to you. Your personal details will only be visible to the study 
team and will be deleted at the end of the study or if you decide to withdraw from the study.  
 
All relevant documents related to the study will be stored confidentially and securely for 10 years 
following the end of the study.  Members of the study management team will have access to stored data, 
and members of the study team at each site will be granted access to the data collected at their own 
site.  
 
What will happen to the results of the study? 
This study will take approximately one year to complete. Publication of the results will follow shortly after 
this, through medical publications, websites and press releases. Results of the study will be made 
available to study participants. Anonymised results and updates on the study will be published on the 
study website www.pim-covid.com. 
 
The data collected in this study may be used to support future research, but any data shared with third 
parties will be fully anonymised and cannot be traced back to the participant.  
 
Who is organising and funding the study? 
This study is being organised by a group of doctors and scientists led by Dr Alicia Waite who is a trainee 
and researcher in intensive care medicine at the University of Liverpool, and Professor Ingeborg 
Welters, who is an intensive care consultant, Research Lead at the Royal Liverpool University Hospital 
and a researcher at the University of Liverpool.  The funding for this study comes from the Intensive 
Care Society and the Mersey School of Anaesthesia.  The Sponsor of the study is the Liverpool 
University Hospitals NHS Foundation Trust. 
 
Who has reviewed the study? 
This research study has been reviewed by an independent group of people, called a Research Ethics 
Committee, to protect your safety, rights, wellbeing and dignity. This study has been given a favourable 
opinion by the East Midlands – Derby Research and Ethics Committee. 
 
What happens if I have any questions, concerns or complaints about the study? 
If you have any questions about your participation in this study you should contact a member of the 
research team. If you want to complain about how researchers have handled your information, you 
should contact the research team. If you are not happy after that, you can contact the Data Protection 

 
 
 
PIM-COVID Interview PIS - Version 1.2 08/04/2022.                                     IRAS 282400. Study No. SP0316. 
46 
Officer. The research team can give you details of the right Data Protection Officer. If you wish to 
complain formally, you can contact the Patient Advice and Liaison Service on 0151 706 4903.   
 
We may ask you for feedback on the questionnaire itself, but this will be voluntary and will not be part 
of the study data. 
 
What happens if I don’t want to carry on with the study? 
You are free to withdraw from the study at any time and without giving a reason. This will not affect the 
standard of care you receive. If you decide you don’t want to continue in the study you will be given two 
options regarding any data already collected about you: 1) you can decide that any data already 
collected can be included in the study, or 2) you can decide that all data about you should be removed 
from the study.   
 
Any other questions? 
If you have any questions that remain unanswered, the Chief Investigators (details below) will be 
happy to answer these for you. 
 
Chief Investigators: 
Name:  
Dr Alicia Waite 
Address:  
Intensive Care Unit, Royal Liverpool University Hospital, L7 8XP 
Phone:  
0151 706 2410 
Email:   
alicia.waite@liverpool.ac.uk 
 
Name:  
Professor Ingeborg Welters 
Address:  
Institute of Life Course and Medical Sciences, University of Liverpool, L7 8TX 
Phone:  
0151 706 2410 
Email:   
i.welters@liverpool.ac.uk 
 
To find your nearest ICUsteps support group for intensive care survivors visit www.icusteps.org. 
 
 
Thank you for taking the time to read this Patient Information Sheet. 

 
 
 
PIM-COVID Interview Consent Form - Version 1.2  08/04/2022.                       IRAS 282400. Study No. SP0316. 
47 
 
Appendix 6b: Follow-up Interviews – Consent Form  
 
CONSENT FORM 
 
 
Title of Project: Psychological Impact of COVID-19 on Intensive Care Survivors – Follow-up Interview 
Chief Investigators: Dr Alicia Waite, Professor Ingeborg Welters 
Participant ID:  
 
1. 
I confirm that I have read the Participant Information Sheet dated 08/04/2022 (version 1.2) for the 
above study (or have had it read to me). I have had the opportunity to consider the information, 
ask questions and have had these answered satisfactorily.  
 
2. 
I understand that my participation is voluntary and that I am free to withdraw at any time, without 
giving any reason and without my medical care or legal rights being affected. 
 
3. 
I understand that the interview will be audio recorded and although the recording will be 
anonymised, it will be shared with a third party company in order to be transcribed. 
 
4. 
I understand that the information collected about me will be used to support other research in the 
future and may be shared anonymously with other researchers.  
 
5. 
I agree to my General Practitioner being contacted if there are concerns about my well-being, 
including any necessary exchange of information about me between my GP and the research 
team.  
 
6. 
I agree to my contact details being held by the study team in order for the results of the study to 
be shared with me. 
 
7. 
I agree to participate in the above study. 
 
 
 
 
 
 
 
Name of participant 
 
Signature of Participant 
 
Date 
 
 
 
 
 
 
 
 
 
 
Name of person taking consent 
 
Signature of person taking consent 
 
Date 
 

 
 
 
PIM-COVID Interview Guide - Version 1.0 10/01/2022.                                     IRAS 282400. Study No. SP0316. 
48 
 
 
 
Appendix 7: Interview Guide 
 
Interviews will be arranged at a time convenient for the participant and will be conducted via telephone, 
an online secure platform (e.g. MS Teams or Zoom), or in person at the Royal Liverpool University 
Hospital, James Cook University Hospital or the participant’s home, as per the participant’s preference 
and current government guidance regarding lockdowns.  
 
Closed questions are to be avoided as much as possible. To ensure that the research questions are 
addressed, a semi-structured approach should be used. Interruptions from the interview should be kept 
to a minimum, with the interviewer reflecting, prompting and summarising, with open or closed questions 
and probing where appropriate. Participants should be encouraged to speak about their specific 
experience.  
 
Before the interview commences, ensure that the participant has read the information sheet. Questions 
and prompts below are resources on which the interviewer can draw and only relevant questions should 
be asked.  
 
1. Introduction  
 
2. Reassurance of confidentiality  
Ensure the participant that their answers will be treated confidentially, and their interview will be 
anonymised before being analysed. Confidentiality will only be broken if they say something that 
indicates risk to themselves or others.  
 
3. Clarification of research aims and the interview purpose 
 
4. Time for questions from the participant about the interview and/or information sheet 
Remind participants that the interview will be recorded. 
 
5. Interview questions  
The format and sequencing will be guided by the patient’s responses.  
 

 
 
 
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49 
• 
What has your experience been since leaving intensive care? 
 
• 
What psychological and/or physical symptoms have you experienced, including:  
- 
Difficulty concentrating 
- 
Breathlessness 
- 
Coughing 
- 
Difficulties sleeping 
- 
Nightmares 
- 
Pain 
- 
Weakness 
- 
Fatigue 
- 
Intrusive thoughts 
- 
Seeing insects 
 
• 
Have your psychological and/or physical symptoms changed over the course of your recovery? 
• 
If so, how? 
 
• 
Do you think your physical symptoms (e.g. breathlessness, pain, weakness) have affected 
your mental well-being? 
 
• 
How do you think that COVID-19 has affected your recovery, if at all? 
 
• 
How have any of the following COVID-19 related factors influenced your recovery: 
- 
Restricted family/friend visiting whilst in hospital 
- 
Staff wearing PPE  
- 
Difficulty getting face to face appointments with your GP 
- 
Reminders about COVID-19 in the media.  
- 
Family support. Limits on family/friends visiting when at home because of lockdown. Or 
more family support because of furlough.  
 
• 
What follow-up services have you been offered? 
 
• 
Have you attended ICU follow-up clinic?  
o If no, why not?  

 
 
 
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o If yes, did you find it helpful and what services were offered as part of that (ICU doctor, 
physio, dietician, respiratory physician) 
 
• 
Were you given a phone number to contact for advice?  
• 
Did you use it?  
o If no, why not?  
 
• 
Is there any other support that you would have liked to have been offered?  
 
• 
Were you contacted to attend a follow-up clinic? Would you have preferred to have been 
contacted once you got home (at an earlier time point that being invited for follow-up clinic)?  
• 
At what time frame would you have found that helpful?  
 
• 
What support do you think you would have benefitted from? 
 
• 
Did you feel you knew what to expect during your recovery? 
• 
Were you given any information regarding what experiences to expect during your recovery e.g. 
timespan / symptoms?  
o If so what information was given? 
o Where you satisfied with the information given? 
• 
Specifically - were you given information about ICU recovery / ICUsteps / locally available 
support services? 
 
6. Close 
• 
Is there anything else you would like to share? 
 
Thanks for taking part. 
 
 
 
 

 
 
 
PIM-COVID Follow-Up Services Survey - Version 1.0 10/01/2022.   IRAS 282400. Study No. SP0316. 
51 
 
Appendix 8: Survey of Intensive Care Follow-Up Services 
 
Thank you very much for agreeing to provide the information included in this survey. We 
appreciate your contribution.  
 
The COVID-19 pandemic has put significant strain on the NHS, not only in direct provision of 
acute care, but also on follow-up services. At the same time, patients who survive critical 
COVID-19 often suffer from long-term psychological sequelae, including anxiety, post 
traumatic distress syndrome and prolonged functional recovery (‘long COVID’). In this survey 
we wish to evaluate the existing follow-up care provided by intensive care units within the UK 
to address the needs of patients after discharge from hospital. 
 
Instructions:  
Please complete the questions in the survey below.   
• 
The survey software will enable or disable some questions depending on your 
responses.  
• 
Based on validation testing we estimate it will take no more than 10 minutes to 
complete the survey.  
• 
Please answer all questions as accurately as possible.  
• 
Although for brevity we use the terms ‘ICU’, ‘intensive care’ and ‘critical care’ 
interchangeably, please also consider in your responses all high-dependency beds 
for which your service is responsible. 
• 
Patients with COVID-19 are defined as patients with a positive PCR test and organ 
failure requiring treatment.  
 
BACKGROUND INFORMATION 
 
1 
Which of the following answers most accurately 
describes your hospital?  
• 
District General Hospital 
• 
Teaching Hospital 
• 
Tertiary referral centre or University 
Hospital 
2 
What’s the name of your trust and hospital? 
 
• 
Trust name:  
• 
Hospital name: 
3 
How many staffed Intensive Care beds (level 2 and 
level 3) does your Department have (excluding any 
surge areas)? 
 
4 
Was your capacity increased during COVID-19? 
 
• 
Yes (If yes, go to Q5) 
• 
No 
5 
By what number of beds was your unit’s capacity 
increased during COVID-19? 
 
6 
Can you estimate the number of patients with COVID-
19 admitted to your unit during the pandemic? 
 

 
 
 
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FOLLOW-UP SERVICES 
7 
Do you currently run an ICU follow-up clinic for 
patients with COVID-19? 
• 
Yes (If yes, go to Q2) 
• 
No (If no, go to Q13) 
8 
Was the ICU follow-up clinic running prior to COVID-
19? 
• 
Yes (If yes, go to Q3) 
• 
No (If no, go to Q4) 
9 
Have any changes been made to the way your ICU 
clinic is run for COVID-19 patients? 
• 
Yes (Please specify) 
• 
No 
10 
Have any changes been made to the way you run ICU 
clinics for non-COVID-19 patients? 
• 
Yes (Please specify) 
• 
No 
11 
If you had surge areas within your hospitals, where 
high flow oxygen/CPAP was provided but patients 
were cared for by medical teams, were these patients 
also invited to ICU follow-up clinic? 
• 
Yes 
• 
No  
• 
Followed up by other specialties 
(Respiratory/ID) 
12 
How soon after hospital discharge do you contact 
patients? 
• 
Within a week 
• 
Within 2 weeks  
• 
Within a month 
• 
Within 2 months 
• 
Within 3 months 
• 
Other (please specify) 
13 
In addition to the ICU follow-up service, are there any 
alternative arrangements for follow-up for COVID-19 
patients? 
• 
Yes: 
• 
Respiratory team led 
• 
GP led 
• 
ID led 
• 
Other (please specify) 
• 
No 
14 
Which MDT professionals are part of your ICU follow-
up clinic? (Please select all that apply) 
• 
ICU consultant 
• 
Critical Care Nurse / Specialist 
Nurse 
• 
Physiotherapist 
• 
Psychologist 
• 
Dietician 
• 
Respiratory physician 
• 
Infectious Diseases physician 
• 
Other (Please specify) 
15 
Which patients do you invite to attend the ICU follow-
up clinic? 
 
• 
All patients admitted to the ICU 
• 
All patients treated on the ICU for 
24hrs or longer 
• 
All patients treated on the ICU for 3 
or 4 days or longer 
• 
Other (Please specify) 
16 
At what time points do you invite patients to the clinic 
for their first visit?  
 
• 
3 months post ICU or hospital 
discharge 
• 
6 months post ICU or hospital 
discharge 
• 
Other (please specify) 
17 
If patients are invited to attend more than one follow-
up clinic, please indicate all relevant times:  
 
• 
3 months post ICU or hospital 
discharge 
• 
6 months post ICU or hospital 
discharge 
• 
12 months post ICU or hospital 
discharge 
• 
Other (please specify) 
18 
What tools are used to determine a patients’ 
functional recovery?  (Please select all that apply) 
 
• 
SF-36 (any version)  
• 
HADS 
• 
Locally derived questionnaire 
• 
EQ-5D 

 
 
 
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• 
PTSD screening tool (please 
specify) 
• 
Others (please specify) 
19 
Does the clinic have pre-negotiated access to any of 
the following services (not simply referral letters), if 
they are not already integral to the ICU follow-up 
clinic? (Please select all that apply) 
 
• 
Clinical psychologist 
• 
Occupational therapist 
• 
ENT 
• 
Physiotherapy 
• 
Urology/Sexual Health Medicine 
• 
Other (Please specify) 
20 
How is the follow-up clinic funded?  
 
• 
Not funded 
• 
ICU budget 
• 
Primary Care Trust 
• 
Other (please specify) 
• 
Don’t know 
21 
In your opinion, is there a reason for your ICU having 
no follow-up clinic? (Please select all that apply) 
• 
Financial constraints 
• 
Lack of clinical need 
• 
Lack of current evidence of benefit 
• 
Other (please specify) 
• 
No 
22 
Please feel free to add any additional comments here: 
 
 
 
 
 
 
 
 
 

 
 
 
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Appendix 9: Study Team Survey 
 
The PIM-COVID study is the first trainee-led study facilitated by the Trainee Research in 
Intensive Care (TRIC) Network. We are interested in your feedback on the study and finding 
out about your views on research.  The results will be analysed and interpreted for future 
presentation and publication and will inform future activities of the TRIC network.  
 
You have been asked to participate as you were a contributor to the PIM-COVID study. The 
survey will take you about five minutes to complete. Your responses will be stored 
confidentially and securely for 10 years.  
 
For further information please contact PIM-COVID@liverpoolft.nhs.uk. 
 
 
DEMOGRAPHICS 
We would like to know a little bit more about the demographics and previous research 
experiences of those involved in the PIM-COVID study teams. 
 
Question 1 
What is your role?  
(Please select one option from the list below) 
 
Foundation trainee 
¨ 
Core trainee 
¨ 
Specialist Registrar 
¨ 
Junior doctor not in training 
¨ 
Consultant 
¨ 
Research nurse 
¨ 
Advanced critical care practitioner 
¨ 
Psychologist 
¨ 
Allied healthcare professional (please specify) 
¨ 
 
 
Other (please specify) 
¨ 
 
 
 
  
 
 

 
 
 
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Question 2 
What is your gender? 
 
Female 
¨ 
Male 
¨ 
Non-binary 
¨ 
Prefer not to say 
¨ 
 
Question 3 
What is your ethnicity? 
 
Asian or Asian British 
¨ 
Black, African, Caribbean or Black British 
¨ 
White 
¨ 
Mixed or multiple ethnicities 
¨ 
Other (please specify) 
¨ 
 
 
Prefer not to say 
¨ 
 
 
Question 4 
Are you currently employed in, or have previously been employed in, a position with 
protected research time as part of your job plan? 
(Please select all that apply) 
 
 
If yes: 
Current role 
Previous role 
Academic Foundation Programme 
¨ 
¨ 
Academic Clinical Fellow 
¨ 
¨ 
Academic Clinical Lecturer 
¨ 
¨ 
Research Fellow 
¨ 
¨ 
Associate Principal Investigator (of another study) 
¨ 
¨ 
Principal Investigator (of another study)  
¨ 
¨ 
 
 
 
If no: 
 
 
No previous research experience 
¨ 
 
Previous research experience but in my own time whist 
not employed in a research role (i.e. recruiting patients, 
data collection, research publication, research 
presentation) 
¨ 
 
Other (please specify) 
¨ 
¨ 
 
 
 

 
 
 
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SITE TEAM 
The following questions are about your experience of joining the study and the day-to-day 
running at your site.  
 
Question 5 
How did you hear about the PIM-COVID study? 
(Please select all that apply) 
 
From the Senior PI 
¨ 
From the Trainee PI 
¨ 
From an ICU consultant (not the Senior PI) 
¨ 
TRIC network mailing list 
¨ 
Twitter 
¨ 
Other (please specify) 
¨ 
 
 
 
Question 6 
What role did you have on the PIM-COVID delegation log? 
(Please select one) 
 
Trainee PI 
¨ 
Senior PI 
¨ 
Sub-investigator / co-investigator 
¨ 
Not sure 
¨ 
 
Question 7 
Were you involved with the study set up at your hospital? 
 
Yes 
¨ 
No 
¨ 
 
If you answered Yes to Question 7, please proceed to Question 8. 
If you answered No to Question 7, please proceed to Question 9. 
 
 
 
 

 
 
 
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Question 8 
To what extent do you agree with the following? 
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
Setting up the study 
at my site was easy 
 
¨ 
¨ 
¨ 
¨ 
¨ 
It was clear what was 
expected of the site 
team 
 
¨ 
¨ 
¨ 
¨ 
¨ 
The site team were 
well supported by the 
central study team 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I knew who to contact 
if advice was needed 
 
¨ 
¨ 
¨ 
¨ 
¨ 
 
Question 9 
What duties did you undertake during the study? 
(Please select all that apply) 
 
Identifying patients 
¨ 
Recruiting participants 
¨ 
Data collection and/or participant follow up 
¨ 
Supporting other staff on the delegation log 
¨ 
Managing site paperwork / screening log 
¨ 
 
Question 10 
Who was involved in the day-to-day running of the study at your site? 
(Please select all that apply) 
 
Trainee PI 
¨ 
Research nurse 
¨ 
Junior doctor 
¨ 
Allied health professional (please specify) 
¨ 
 
 
Senior PI 
¨ 
Don’t know 
¨ 
 

 
 
 
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Question 11 
On average how much time did you dedicate to the PIM-COVID study per week? 
(Please select one) 
 
Up to 1 hour 
¨ 
1-2 hours 
¨ 
2-4 hours 
¨ 
4+ hours 
¨ 
 
Question 12 
How long were you actively involved in the PIM-COVID project? 
(Please select one) 
 
Up to 3 months 
¨ 
3-6 months 
¨ 
6-12 months 
¨ 
Participation still ongoing 
¨ 
 
If ‘Participation still ongoing’ selected, proceed to Question 14.  
 
Question 13 
If you stopped your involvement in the PIM-COVID study what was the reason? 
(Please select all that apply) 
 
Moved to a different job or department 
¨ 
Demands on time or other commitments 
¨ 
Did not want to continue 
¨ 
Site stopped collecting data 
¨ 
Other (please specify) 
¨ 
 
 
 
 
 

 
 
 
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Questions 14-24 are for junior doctors and allied health professionals only (not research nurses or 
Consultants), as indicated in Question 1. 
 
MOTIVATION AND BARRIERS TO PARTICIPATING 
We are looking to identify factors that influence trainee and allied health participation in 
clinical research. Please consider the following questions:  
 
Question 14 
How important were the following aspects in your decision to participate in PIM-COVID? 
 
 
Not at all 
important 
Unimportant 
Neither 
important 
nor 
unimportant 
 
Important 
Very 
important 
Interest in the 
subject matter 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Desire to enhance 
patient care 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Career progression 
(i.e. to enhance CV 
or publication 
record) 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Desire to pursue a 
career in academic 
medicine 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Gain experience in 
research 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Develop new or 
transferable skills 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Job variety 
 
¨ 
¨ 
¨ 
¨ 
¨ 
 
 
Question 15 
Please specify anything you were hoping to achieve being involved in PIM-COVID, if not 
mentioned above. 
 
 
 
 
 

 
 
 
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Question 16 
Did any of the following concerns or barriers impact your ability to undertake work on PIM-
COVID?  
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
Lack of protected 
research time 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Already involved in 
other research 
projects 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Other non-clinical 
commitments (i.e. 
exams, quality 
improvement, 
teaching) 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Other clinical 
commitments 
 
¨ 
¨ 
¨ 
¨ 
¨ 
No previous 
research experience 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Only based in 
department for a 
limited amount of 
time (e.g. trainee 
rotation) 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Lack of academic 
culture at my local 
site 
¨ 
¨ 
¨ 
¨ 
¨ 
 
Question 17 
Did you have any other concerns about participating in PIM-COVID that are not listed above? 
 
 
 
 

 
 
 
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FEEDBACK ON THE PIM-COVID STUDY 
PIM-COVID is the first UK-wide intensive care trainee-led study. We are interested in feedback 
on the study design, support provided for local site teams and the individual experiences of 
those involved. 
 
Question 18 
Regarding time commitments, to what extent do you agree with the following statements: 
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
PIM-COVID work was 
flexible and could be 
done around my 
clinical commitments 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I was able to carry out 
PIM-COVID work 
during my work hours 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I needed to do work 
for PIM-COVID in my 
own time 
¨ 
¨ 
¨ 
¨ 
¨ 
 
 
Question 19 
Were you involved in conducting questionnaires with participants over the telephone? 
 
Yes 
¨ 
No 
¨ 
 
If you answered Yes to Question 19 please answer the following question. 
If you answered No to Question 19 please proceed to Question 21. 
 
 
 

 
 
 
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Question 20 
To what extent do you agree with the following statements? 
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
The number of 
questions made it 
difficult to complete 
questionnaires over 
the phone 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I found the personal 
and emotive 
questions unpleasant 
to ask over the phone 
 
¨ 
¨ 
¨ 
¨ 
¨ 
Emotional support for 
staff carrying out 
questionnaires over 
the phone is important 
due to the nature of 
the study 
questionnaire.  
¨ 
¨ 
¨ 
¨ 
¨ 
 
 
Question 21 
Regarding your experience in PIM-COVID to what extent do you agree with the following 
statements? 
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
Not 
applicable 
I learnt about the 
study design 
process and 
seeking research 
approval 
 
¨ 
¨ 
¨ 
¨ 
¨ 
¨ 
I learnt about 
study set up at my 
site  
 
¨ 
¨ 
¨ 
¨ 
¨ 
¨ 
I learnt about data 
management at a 
study site 
 
¨ 
¨ 
¨ 
¨ 
¨ 
¨ 

 
 
 
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I learnt about the 
role of other 
members of a site 
team (including 
research nurses) 
 
¨ 
¨ 
¨ 
¨ 
¨ 
¨ 
I learnt about 
difficulties in 
recruitment to 
studies 
 
¨ 
¨ 
¨ 
¨ 
¨ 
¨ 
I was involved in 
communication 
with the Research 
Development and 
Innovation team at 
my site 
 
¨ 
¨ 
¨ 
¨ 
¨ 
¨ 
 
 
FUTURE PARTICIPATION IN RESEARCH 
We would like to understand trainee’s plans regarding research and academic opportunities 
they would like to be involved in. 
 
 
Question 22 
Do you intend to pursue a career in clinical academia? 
 
Yes 
¨ 
No 
¨ 
Undecided 
¨ 
 
 
Question 23 
Regarding future research involvement to what extent do you agree with the following 
statements? 
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
Research 
opportunities that are 
flexible around my 
clinical commitments 
are important to me 
 
¨ 
¨ 
¨ 
¨ 
¨ 

 
 
 
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Leadership 
opportunities within 
research are 
important to me 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I would like to learn 
more about study set 
up and management  
 
¨ 
¨ 
¨ 
¨ 
¨ 
I feel confident using 
research in my clinical 
practice 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I would be involved in 
research like PIM-
COVID again 
 
¨ 
¨ 
¨ 
¨ 
¨ 
 
 
Question 24 
Regarding current expectations of healthcare professionals in UK training schemes to what 
extent do you agree with the following statements? 
 
 
Strongly 
disagree 
Disagree 
Neither 
agree nor 
disagree 
 
Agree 
Strongly 
agree 
It is important for 
trainees to gain 
research experience  
 
¨ 
¨ 
¨ 
¨ 
¨ 
I am aware of what 
research studies are 
happening in my local 
hospital 
 
¨ 
¨ 
¨ 
¨ 
¨ 
I would use protected 
development time to 
contribute to further 
research 
¨ 
¨ 
¨ 
¨ 
¨ 
I prefer quality 
improvement projects 
/ audit to research 
¨ 
¨ 
¨ 
¨ 
¨ 
 
Thank you for completing this survey.