International Care Of the Dying Evaluation (CODE): Quality of Care for Cancer Patients as Perceived by Bereaved Relatives
Conditions: Neoplasms, Bereavement, Quality of Life
Sponsor: University of Bergen

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
1 
 
 
 
 
International ‘Care Of the Dying Evaluation’ (CODE):  
quality of care for cancer patients as 
perceived by bereaved relatives 
 
Protocol Version 1.1 
 
International protocol 
adjusted for Norway 
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
2 
 
Protocol writing committee:  
Dr Catriona Mayland 
Professor Dagny Faksvåg Haugen 
Dr Katrin Sigurdardottir 
 
Statistical advisor: 
Karl Ove Hufthammer, PhD  
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
3 
 
Table of contents 
PROTOCOL WRITING COMMITTEE.............................................................................. 
2 
ABSTRACT…………………………………………………………………………………………………………………… 
5 
 
LAY SUMMARY………………………………………………………………………………………………………….. 
7 
INTRODUCTION............................................................................................................ 
8  
BACKGROUND…………………………………………………………………………………………………………… 
8 
‘Care Of the Dying Evaluation’ questionnaire……………………………………………………………. 
9 
Questionnaire translation............................................................................................. 
10 
Pre-testing survey methods.......................................................................................... 
10 
AIMS AND OBJECTIVES……………………………………………………………………………………………… 
11 
 
METHODS…………………………………………………………………………………………………………………... 
12 
Wp1 – Preparation and Piloting.................................................................................... 
12 
Translation of CODE questionnaire.................................................................... 
12 
Pilot testing of translated questionnaire............................................................ 
13 
Establishing a common, core international version of CODE (i-CODE)...............  
15 
Part 2 – CODE International Survey.................................................................................. 
16 
Study sites..................................................………………………………………………………. 16 
Study participants…………………………………………………………………………………………..... 16 
Data collection……………………………………………………………………………………………….... 18 
Data analysis......................................................................................................... 21 
PROJECT MANAGEMENT AND WORK PLAN…....………………………………………………………..... 22 
Time line and deliverables.............................................................................................. 
23 
END OF STUDY................................................................................................................ 
23 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
4 
 
SPONSORSHIP AND BUDGET.......................................................................................... 
24 
ETHICAL APPROVAL AND GOVERNANCE........................................................................ 
24 
PATIENT AND PUBLIC INVOLVEMENT............................................................................. 
24 
CONFIDENTIALITY AND DATA MANAGEMENT................................................................ 
24 
 
DISSEMINATION AND PUBLICATIONS................………………………………………………………….. 25 
 
REFERENCES…………………………………………………………………………………………………………………. 26 
APPENDICES..................................................................................................................... 
29 
Appendix 1: Overview of ERANet-LAC CODE Consortium, including PIs and national 
funding agencies............................................................................................................... 
29 
Appendix 2: Overview of participating hospitals and responsible persons, Norway....... 
29 
List of further appendices, provided in or as separate documents.................................. 
30 
Amendment 1, February 2018: Additional participating hospitals and responsible 
persons, Norway…………………………………………………………………………………………………………… 31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
5 
 
ABSTRACT 
Background: In order to ensure the highest quality of care provisions for dying patients and their 
families, we need to first be able to robustly evaluate the current quality of care. One identified 
method is to assess this from the user-perspective by conducting bereaved relatives’ surveys. ‘Care 
Of the Dying Evaluation’ (CODE) is a recognised, validated post-bereavement questionnaire which 
has been extensively used within the United Kingdom. The ERANet-LAC CODE project aims to use 
CODE on a wider, international level.  
Aims: The present project aims to advance the international evidence in care for dying patients by 
undertaking an observational study of bereaved relatives’ views across seven participating countries. 
The overall aims of the project are to:  
 
Refine and revise the CODE questionnaire so that it is ready for international use (Work 
Package 1; WP1) 
 
Conduct an international survey of bereaved relatives of cancer patients dying in hospitals, 
using the CODE questionnaire (WP2) 
 
Use the CODE data to provide feedback about the quality of care and level of family support 
at an international and national level, allowing for cross-country comparisons   
 
Conduct a web survey of all participating institutions to be able to interpret the survey data 
in view of the organisation and level of palliative care provision at each site / in each country  
Methods:  WP1: Using the principles of the EORTC translation procedure, the CODE questionnaire 
will be translated into the relevant languages for each country. Piloting with volunteers and pre-
testing cognitive ‘think aloud’ interviews will be conducted with bereaved relatives. Using a 
consensus procedure, the final version of the international CODE (i-CODE) questionnaire will be 
developed. 
WP2: Bereaved adult relatives, to adult cancer patients who had an ‘expected’ death in hospital,   
will be approached face to face, by telephone or in writing and invited to complete the CODE 
questionnaire. The CODE questionnaire pack will be sent out 6-8 weeks after bereavement. CODE 
may be completed on paper, on tablet, online, or in a telephone or face to face interview, according 
to what is feasible and acceptable in each country. The aim is at least 100 completed questionnaires 
per country. Basic demographics will be recorded for all potential participants and for the patients 
who died.       
Analysis of results: WP1: Feedback from volunteers and bereaved relatives will be analysed 
thematically and collated into a Standardised Feedback Form. This will detail aspects of feedback 
about clarity, content, sensitivity, and response options, as well as general feedback about the 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
6 
 
layout and formatting of the i-CODE.  
WP2: Data will be analysed using SPSS and according to the CODE user guide, to present a common 
international report, individual country reports and cross-country comparisons. Data will be 
interpreted in the context of knowledge about the individual sites/countries.   
Conclusions: The expected outcomes are: a translation of CODE for each country / language, a 
common, core, international version of i-CODE established, and an international survey and cross-
country comparisons about the current quality of care for dying cancer patients as perceived by 
bereaved people, including key areas where care needs to be improved. The next phase of the 
project will use the results of the international survey to implement changes to improve the care.  
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
7 
 
LAY SUMMARY  
Providing high quality care for dying patients and their families is very important. One way we can 
assess the care provided is to ask bereaved relatives to complete a questionnaire after their family 
member has died. The questionnaire can ask about their experiences and their thoughts about the 
care provided to their family member.  
One such questionnaire is the ‘Care Of the Dying Evaluation’ (or CODE). CODE has been developed 
with the help and support of bereaved relatives and has been used extensively within the United 
Kingdom. In this project we want to use the CODE questionnaire to look at bereaved relatives’ views 
about care provided in seven different countries within Europe and Latin America. Firstly, though, 
we need to ensure that CODE is understood and appropriate for use in these other countries.  
In the first part of the project CODE will be translated into other languages using a recognized 
procedure. Then we will ask volunteers their views about whether or not the CODE questionnaire is 
easy to understand and sensitive. After that, we will ask a small group of bereaved relatives to 
complete CODE and be interviewed about their experience of completing the questionnaire. They 
will also be asked to provide feedback about whether they found the questionnaire easy to 
understand and complete and whether it is sensitively worded. We will use all this feedback to form 
a common version of CODE that is suitable for use across all the countries.   
In the next stage of the project, relatives who have recently experienced a bereavement where one 
of their family members has died from cancer in a hospital, will be invited to complete the CODE 
questionnaire about two months after the patient’s death. The relatives may complete CODE on 
paper, using a computer, or by interview. The aim is to have at least 100 completed CODE 
questionnaires from each of the seven countries. The data from the questionnaires will be used to 
make a report on the current quality of care for dying cancer patients in hospitals across the seven 
countries. It will also be possible to compare the care between the countries and identify areas 
needing improvement.  
In the next phase of the project, health care professionals, researchers and bereaved relatives 
together will use their knowledge and experience to find effective ways to improve the weak areas 
identified, and assess the results of putting these changes into practice.         
 
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
8 
 
INTRODUCTION 
In 2012, 2.35 million people died from cancer in European and Latin American (EU-LAC) countries. 
Patients with advanced cancer generally experience a number of distressing symptoms and face 
problems of a psychological, social and spiritual nature as well as physical ones. Care for dying 
patients is an important part of comprehensive cancer care and a central responsibility for health 
care on the whole. Evidence has identified challenges and disparities in the quality of care for 
seriously ill and dying patients, both within and across EU-LAC countries. An international project 
which engaged both EU and LAC countries (OPCARE9) already identified areas of common research 
interest and potential learning between continents. 
The present project was proposed in response to the ERANet-LAC 2nd Joint Call on Research and 
Innovation and approved for funding under the European Commission’s 7th framework program. 
The aim of the project is to inform and develop an evidence based approach to systematically 
standardize assessment and care of dying cancer patients, using relative generated outcomes. The 
project will be conducted in four European and three South American countries three years starting 
from January 2017. The project contains three Work Packages (parts). This protocol describes the 
work to be undertaken in Work Packages 1 and 2.      
BACKGROUND  
The delivery of appropriate care for dying cancer patients remains a key medical, social, economic 
and political issue. However, the quality of care for the dying is diverse both within and between EU-
LAC countries. The Quality of Death Index 2015 (1) ranges 80 countries around the world based on 
20 quantitative and qualitative indicators across five categories: the palliative and healthcare 
environment, human resources, the affordability of care, the quality of care, and the level of 
community engagement. The European countries of the present proposal all fall within the top 30 of 
this ranking, ranging from positions 1-26, while the South American countries have positions 32, 39 
and 42 respectively. Several reports on the current state of palliative and end-of-life care in South 
America have been published in recent years (2, 3). They show that 80 % of Latin American countries 
do not acknowledge specialist palliative care as a discipline, and consequently do not include it in 
public health services. Only 51 % of patients in terminal stages of disease receive palliative care. 
Even in the United Kingdom, however, ranked as number 1 in the Quality of Death Index 2015, 
recent reports have shown significant variations in the care of the dying across hospitals in England 
(National care of the dying audit – hospitals, England 2014) (4). In Norway, ranked as number 13 
overall, but number 9 in the availability of care category and 7 in the human resources category, 
there is a lack of robust indicators to evaluate the care given to dying patients, hampering audit and 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
9 
 
comparisons between services. Henceforth, this indicates the need and importance for good process 
and outcome indicators to be in place within healthcare settings.    
Based on the international evidence base, a set of core principles for care of the dying has been 
defined (5). These principles are applicable to the care of dying cancer patients, as well as other 
patients, worldwide. Several of the partners of the present consortium have led local, regional or 
national initiatives to improve care for dying cancer patients, especially by the use of integrated care 
plans applying these core international principles for care.  
In order to ensure the highest quality of care provisions, we need to first be able to robustly evaluate 
the current quality of care. One method, as recommended by the End of Life Care Strategy (6) within 
the United Kingdom, is to assess this from the user-perspective by conducting bereaved relatives’ 
surveys. As such, bereaved relatives’ evaluations (both by surveys and telephone interviews) have 
formed a key aspect in evaluation of end-of-life care in many countries, especially within North 
America, and parts of Europe (7-9).  
‘Care Of the Dying Evaluation’ Questionnaire 
One such post-bereavement questionnaire is ‘Care Of the Dying Evaluation’ (CODE). This is a 42-item 
self-completion questionnaire, developed within the UK, and focused on the quality of care and the 
level of support provided to individuals and their families in the last days of life and the immediate 
post-bereavement period (10). In the UK, the NHS Friends and Family Test has also been included as 
an additional question within this questionnaire (11). 
CODE represents a shortened and more user-friendly version of the original instrument, ‘Evaluating 
Care and Health Outcomes - for the Dying’ (ECHO-D). ECHO-D has been used with over 700 bereaved 
relatives within a hospice and hospital setting and shown to be valid, reliable and sensitive in 
detecting inequalities in care and areas of unmet need (10,12-13). Both these instruments are 
unique from other post-bereavement questionnaires as they specifically link with the key 
components representing best practice for ‘care of the dying’ in the last days of life (14).  
ECHO-D was revised and shortened, and the ‘key quality indicator’ questions (based on validity and 
reliability measures as well as clinical importance) were used to form CODE. These questions include: 
aspects of symptom control; communication; nursing and medical care; provision of fluids; place of 
death; emotional and spiritual support. CODE has been used and validated with bereaved relatives to 
patients who died in their own home (15). The validation process included: undertaking cognitive 
’think aloud’ interviews to assess face and content validity; assessing CODE’s stability over time by 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
10 
 
conducting test-retest reliability analysis; and assessing the construct validity and internal 
consistency of three key composite scales within CODE.   
Subsequently, CODE has been used within the context of the National Care of the Dying Audit – 
Hospitals which was led by the Royal College of Physicians (16); and within Merseyside and Cheshire 
as part of a quality assurance and benchmarking process to evaluate Care of the Dying across 
hospices, hospitals and community settings (17). Additionally, prior to the present project, there 
have been six requests for CODE to be used internationally, and over 40 requests for use within the 
UK healthcare setting. In order to ensure that CODE is suitable for use in all participating countries 
where English is not the first language, appropriate methods of translation and further pre-testing of 
the questionnaire is most pertinent prior to use. 
Questionnaire translation 
When undertaking the translation of a questionnaire from English into another native language, the 
process as described within the EORTC Quality of life group translation procedure is recommended 
(18). In essence this has the following steps:  
1. Undertake two forward translations of the English version of CODE  
2. Form reconciled translation 
3. Translate the reconciled version back into English 
4. Preliminary translation read by an external proof-reader 
5.  Linguistic validation, or pilot testing   
Pre-testing survey methods 
Questionnaire pre-testing is generally defined as ‘testing a set of questions or the whole 
questionnaire on members of the target population’ to help improve the quality of the 
questionnaire (19). It helps test the respondents’ comprehension and interest, and also assesses 
whether the questionnaire has a logical flow. One comprehensive and innovative method used for 
‘pre-testing’ includes the technique of cognitive interviewing.  There are two main techniques used 
in cognitive interviews, the ‘think aloud’ method and the use of ‘probes’. Cognitive interviews enable 
both overt and covert problems to be identified and are qualitative and flexible in nature (20).    
The ‘think aloud’ method 
One form of cognitive pre-testing is the ‘think aloud’ interview. This method entails training 
respondents to think aloud, or articulate their thoughts as they read a question, recall from their 
memories the information required, and turn the information they have into an answer (21). The 
‘think aloud’ process helps gain an understanding of the cognitive processes respondents use to 
formulate their answers and checks whether questions have been understood correctly (19).  

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
11 
 
The ‘probing’ method 
Probes are specific pre-prepared and spontaneous questions used to elicit reports from respondents 
about their thinking (22).They help identify difficulties at the different stages of the question and 
answer model e.g. comprehension or information retrieval problems (19). Probes can be categorised 
as follows: 
General probes (‘How did you go about answering that question?’) 
Comprehension probes (‘What does the term ‘x’ mean to you?) 
Recall probes (‘How did you remember that?’) 
Response probes (‘How did you feel about answering that question?’) 
Confidence judgement probes (‘How sure of your answer are you?’) 
Attitude probes (‘How did you decide on your answer to that question?’)   
AIMS & OBJECTIVES 
The present project aims to advance the international evidence in care for dying patients by 
undertaking an observational study of bereaved relatives’ views across seven participating countries, 
by use of the CODE questionnaire.  
The overall aims of the project are to:  
 
Refine and revise CODE so that it is ready for international use (WP1) 
 
Conduct an international survey of bereaved relatives of cancer patients dying in hospitals, 
using the CODE questionnaire (WP2) 
 
Conduct a web survey of all participating institutions to aid in the interpretation of the 
survey data (WP2)   
 
Use the CODE data to provide feedback about the quality of care and level of family support 
at an international and national level, allowing for cross-country comparisons   
The aims will be achieved by the following objectives: 
WP1:    
 
Translation of CODE into the languages used within each of the seven countries according to 
the principles of the EORTC Quality of life group translation procedure (18).  
 
Undertake specific pre-testing of CODE using volunteer involvement and established pre-
testing survey methods with bereaved relatives  
 
Collate all feedback from the pre-testing survey methods to establish a common, core 
international version of CODE (i-CODE) 
WP2:  

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
12 
 
 
Recruit the sufficient number of hospitals caring for adult cancer patients as study sites   
 
Recruit at least 100 bereaved relatives as study participants in each country. (Due to 
expected response rates for these types of bereaved surveys, we are anticipating that up to 
3-4 times as many questionnaires will need to be disseminated to bereaved relatives. 
However, the expected response rate is depending on the method of recruitment, as 
generally more persons respond to a personal invitation than to a letter in the post.)  
 
Establish feasible and effective procedures for CODE data collection in each country 
 
Establish safe and effective methods for transfer of study data to a common database 
 
Develop an online survey for mapping of all participating hospitals  
 
Analyse the CODE data using the CODE user guide and appropriate statistical methods 
 
Interpret the data in view of the organisation and level of palliative care provision at each 
site / in each country  
METHODS 
WP1 – Preparation and piloting 
Translation of CODE questionnaire  
All partners will sign a Material Transfer Agreement for the use of CODE in the present project, as 
stated in the Consortium Agreement. A copy of the most recent version of the CODE questionnaire 
(version January 2015) will be given to the project lead in each country. The project lead will 
facilitate the translation process, based on the principles of the EORTC Quality of life group 
translation procedure (18), using the following steps:   
Forward translation 
A forward translation will be conducted by two independent individuals operating separately from 
each other. The translation will be from English into the target language. The translations should be 
conducted by native speakers of the native language who also have a good command of English (18).   
Reconciliation 
A third translator is used to reconcile the two forward translations according to a recognised 
standard process (18). The outcome of this process may include the following options: using one of 
the forward translations without changes; to slightly change one of the translations; to make a new 
translation by adapting from the previous two; or to prepare a completely new translation.  

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
13 
 
Back translation 
The reconciled translation is translated back into English again by two translators, working 
independently from each other. These individuals should ideally be native speakers of English, but 
alternatively can be those with a good command of English.  
All of the five versions (two forward translations; the reconciled translation; the two back 
translations) of the CODE questionnaire should be sent to the project lead for each language, with 
each change marked and explained. The project lead will clarify any queries, reach a consensus 
regarding the specific wording and prepare the preliminary translation. 
Proof reading  
An external proof reader will read through the preliminary translation and report any further 
changes needed along with an explanation about why they are needed.  
Pilot testing of translated questionnaire    
The pilot testing will be undertaken in two stages:  
 
The first stage will involve volunteers or representatives from patient and public 
involvement (PPI) groups 
 
The second stages will involve cognitive pre-testing interviews with bereaved relatives  
A: Volunteers 
Each country will identify potential suitable volunteers who may include individuals who are 
currently working as volunteers within the hospital; or representatives from patient and public 
forums (ideally n=5 where possible). The volunteers should not have experienced a bereavement 
within the last 6-8 weeks.   
This stage will be facilitated as part of a group discussion forum (see Appendix 3, Guidance Template 
One). Ahead of the meeting, potential volunteers will be given a copy of the CODE questionnaire.  
Within the meeting, they will be asked to feedback about the following:  
What do they think about CODE, overall as a questionnaire, in terms of the:  
 
Format and layout 
 
Clarity to follow and complete the questionnaire 
Specifically, they will also be asked about each of the individual questions in terms of the:  
 
Clarity 
 
Sensitivity 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
14 
 
 
Use of the response options  
Optimally, the group interview will be audiotaped after gaining the participants’ permission.  
Feedback from the volunteers will be collated into a Standardised Feedback Form for each country 
(Appendix 5).   
To describe the sample, age, gender, nationality and professional background will be noted. 
B: Cognitive pre-testing interviews with bereaved relatives 
Eligibility criteria 
Potential participants will be selected according to the following eligibility criteria.   
Inclusion criteria 
 
Next-of-kin to a patient who died from cancer  
 
Are over 18 years of age 
 
Patient was over 18 years of age at the time of death 
 
Are able to give informed consent  
Exclusion criteria  
 
Patient had a sudden and unexpected death  
 
Next-of-kin experienced a bereavement within the last 6-8 weeks  
 
Research team perceive the individual would be unduly distressed by participating in the 
pilot  
Recruitment 
For each language, a minimum of 5 bereaved relatives would be included. This is with the exception 
of the UK English version, where extensive pre-testing cognitive interviews have already been 
undertaken as part of the development and validation of both the original instrument ECHO-D and 
CODE (10, 15, 23). Depending on the set-up of each country, potential participants may be identified 
from existing bereavement support groups; by liaison with bereavement support teams who may be 
used to disseminate information about the study; or via patient and public involvement groups 
whose membership may contain bereaved relatives.  
An opt-in method of approach will be adopted for this part of the study. Potential participants will 
either be sent or given an information sheet informing about the study and asking if they would be 
willing to participate. For those willing to participate, they will be asked to return a response form 
providing a contact telephone number.  A member of the research team will then contact this 
individual and discuss further details about what participation would involve and provide the 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
15 
 
opportunity for any questions to be addressed. Alternatively, the individual will phone the member 
of the research team directly.  
Cognitive think-aloud interviews 
For those willing to be interviewed, the researcher will arrange a suitable time and place for this to 
occur. Following written informed consent, a structured cognitive ‘think aloud’ interview will be 
conducted. Initially the following example will be used to practice the ‘think aloud’ method: 
‘I would like you to visualise the place where you live, and think about how many windows are in that 
place. As you count up the windows, tell me what you are seeing and thinking about.’ (24) 
The interview schedule (example provided in Appendix 4, Guidance Template Two) will consist of:  
 
General questions asking about the layout or structure of the CODE questionnaire 
 
In-depth questions using the ‘think aloud’ method supported by ‘probes’  
 
Opportunities for the participant to raise any other issues that hadn’t been discussed 
The aim of these interviews is to help improve the quality of the questionnaire as well as provide 
additional support for the face and content validity of CODE. Each interview will be audio taped after 
gaining the participant’s permission and will last approximately an hour. The interviews will be 
transcribed verbatim. Comments about each question will be collated into the Standardised 
Feedback Form to provide a summary of the views for each question. This will subsequently be 
assembled with the previous feedback from the volunteers to form a summary of all the feedback 
from each country.   
To describe the sample, age, gender, nationality, professional background and time since 
bereavement will be noted.  
Establishing a common, core international version of CODE (i-CODE) 
Each country will return copies of their final Standardised Feedback Form (incorporating all feedback 
from the volunteers and bereaved relatives) and the copy of their ‘back translation into English’ 
questionnaire to the WP1 Lead, Dr Catriona Mayland and the Chief Investigator, Professor Dagny 
Haugen. Where there are unresolved issues or concerns regarding the content or wording of the 
CODE questionnaire, these will be collated. A consensus process will be conducted using a tele-
conference meeting. Where 4 or more countries agree that the individual question should form part 
of i-CODE, that particular question will be included in the final version of the i-CODE questionnaire. 
Where 4 or more countries think the individual question should not form part of i-CODE, then that 
question becomes optional. In circumstances where consensus can’t be reached within the 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
16 
 
teleconference, a final decision will be made by the WP1 Lead, Dr Catriona Mayland, the Chief 
Investigator, Professor Dagny Haugen and one of the Leads from the Latin American countries, Dr 
Vilma Tripodoro. Following this meeting, the final version of i-CODE, representing the questions that 
all countries will ask in their post-bereavement survey will be completed.  
 
WP2 – CODE International Survey 
Study sites  
The necessary number of hospitals caring for adult cancer patients will be recruited as study sites.  
The study will only be performed in institutions defined as hospitals (not hospices, nursing homes or 
other care institutions, nor home care services). Any type of hospital caring for adult cancer patients 
may be used: local, central, or regional hospitals, providing secondary and/or tertiary care, with or 
without a palliative care inpatient unit, with public or private funding. 
The following hospitals will be used for the study: 
Norway: Haukeland University Hospital and Haraldsplass Deaconess Hospital, Bergen; St Olavs 
Hospital, Trondheim University Hospital; Bærum Hospital, Vestre Viken Hospital Trust 
Poland: Hospital J. Biziel in Bydgoszcz; Pulmonological Hospital in Bydgoszcz; D. Wladyslaw  Biegański 
Regional Specialist Hospital in Grudziądz; F. Dłutek Autonomic Public Healthcare Centre in Rypin; 
Provincial Specialist Hospital in name of the blessed priest Popiełuszko in Włocławek   
Uruguay: Hospital Evangelico Montevideo; Hospital Evangelico Colonia; possibly also Servicio Médico 
Integral Hospital in Montevideo (agreement pending). 
Argentina: Institute for Medical Research Alfredo Lanari, University of Buenos Aires; Hospital of 
Gastroenterology Carlos B Udaondo, Buenos Aires City; Private Hospital of Córdoba,  Córdoba City.  
Germany: University Medical Centre of the Johannes Gutenberg University of Mainz 
Brazil: Sumare State Hospital Dr Leandre Francheschini; Campinas State University Hospital De 
Clinicas  
UK: Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, England        
Study participants  
Eligibility criteria 
Potential participants will be selected according to the following eligibility criteria:  

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
17 
 
 Inclusion criteria 
 
Next-of-kin to a patient who died an ‘expected’ death from cancer in hospital 
 
Over 18 years of age 
 
Has been present at the hospital together with the patient at least some of the time during 
the patient’s last two days. (This might not always be known or recorded, therefore the 
participant may have the option to pass the questionnaire on to somebody better placed to 
complete it.)   
 
Patient was over 18 years of age at the time of death 
 
Patient had been admitted to the hospital (not any specific ward) at least three calendar 
days (e.g., admission August 1st, died August 3rd) 
 
Able to give written informed consent, which might be implied when the participant 
completes and returns the questionnaire, in keeping with the ethical stipulations for each 
country  
Exclusion criteria  
 
Patient had a sudden and unexpected death  
 
Unable to complete the questionnaire due to language abilities or reduced cognitive 
functioning (in some countries the offer of a translator would be provided  if someone 
wanted to complete the questionnaire but had difficulty due to languages) 
Definitions:  
Next-of-kin: Defined by the patient and recorded in the patient’s hospital record. It may be any 
family relation or friend, neighbour, warden, etc. 
Expected death: If not possible to check with attending physician: any cancer patient who died in 
hospital and was not resuscitated  
Cancer patient: Any patient with a cancer diagnosis (histologically or radiologically verified), not 
necessarily dying from the cancer. Solid tumours as well as haematological malignancies count as 
cancer.   
Recruitment 
The relative / next-of-kin must be approached after the patient’s death. We will approach the person 
recorded as next-of-kin in the patient’s hospital record.  
Only one completed questionnaire will be included per deceased patient, but it may be completed 
by more than one relative, or by somebody else than the one recorded as next-of-kin.  
Recruitment will be done prospectively. However, in the UK recruitment will also be done 
retrospectively to be able to reach the desired number of participants, but will be limited to 8 weeks 
post bereavement.  

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
18 
 
The method of recruitment will be adapted as to what is feasible and in the individual country. 
Potential participants will be approached face to face, by telephone or in writing and invited to 
complete the CODE questionnaire.  
Each country will insert details about their recruitment process, including how informed consent will 
be obtained. 
Norway:  
Next-of-kin are in a vulnerable situation after the patient’s death. The approach must be considerate 
and flexible. We see three possible scenarios: 
1. Information about the study is given to the next-of-kin during a conversation with the ward nurse 
or doctor before they leave the ward after the death of the patient. This will include both oral and 
written information. If more details are wanted by the next-of-kin, they will be referred to a member 
of the research team. 
2. Written information about the study is handed out to the next-of-kin as part of the bereavement 
pack, before they leave the hospital. 
3. In case written information has not been handed out on the ward, it is sent to the next-of-kin by 
post after they have left the hospital.     
Data collection  
CODE International Survey 
 
Data to be collected 
The CODE questionnaire is the common data collection tool of the study. It is described in the 
Background section above and included in the Appendix (Appendix 6). The demographic data 
included in CODE are the following (all information provided by the participant): 
Participant:  
 
Relation to the patient 
 
Age (in groups) 
 
Ethnic group  
 
Gender 
 
Religious affiliation 
Patient: 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
19 
 
 
Illnesses in the last days and hours of life 
 
Age (in groups) 
 
Ethnic group  
 
Gender 
 
Religious affiliation 
In addition, the following information will be included for all cases, as part of the inclusion 
procedure: 
 
The patient’s length of stay in the hospital 
 
Type of ward the patient died on (general medical or surgical ward, oncology ward, ICU, 
emergency ward, palliative care unit) 
 
The patient’s cancer type (predefined groups) 
Length of stay, type of ward, cancer type and age (groups) and gender of the patient and next-of-kin 
will be recorded for all eligible cases, included and non-included, to be able to subsequently judge 
whether the sample is representative of the population as a whole. Depending on national 
regulations, this may require special permission.  
If any of the partners want to include additional items or questionnaires, they are free to do so, 
provided the necessary approvals are obtained and the add-ons do not negatively influence 
participation in the main study.  
In Norway, we will include three items about advance care planning, as this has been a focus on our 
end-of-life care research the last years and also is a hot topic internationally.  
 
Method of data collection  
The CODE questionnaire will be sent to the participants 6-8 weeks post bereavement. If not 
returned, one reminder will be sent, four weeks after the first attempt. CODE International Survey 
was intended as a postal survey. However, due to poorly functioning postal services, illiteracy, lack 
of experience with postal questionnaires or very low response rates in several of the participating 
countries (South America), other data collection methods (data entry online, face to face interviews 
and telephone interviews) will also be accepted. Poland intends to use computer-assisted personal 
interviewing using tablets (CAPI; the computer displays the questions on screen, the interviewer 
reads them to the respondent, and then enters the respondent's answers). 
  

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
20 
 
If CODE is to be completed by the participant in writing, they may have the choice between paper 
and an electronic version. They will receive a letter with the paper version of CODE and a fully 
prepared return envelope, but the letter may also say where they can log on to complete the 
electronic version, depending on the ethical and data protection stipulations in each country. The 
paper questionnaire will be marked with the unique identifier code when sent out. When answering 
online, the participants themselves must enter their identifier code.   
Each country will insert details about how they will perform the data collection. 
Norway: 
The survey will only be conducted as a postal survey. The paper questionnaire will be sent to next-
of-kin together with an information sheet and a fully prepared return envelope. Informed consent is 
implied when the relative fills in and returns the questionnaire. 
One reminder will be sent to non-responders, four weeks after the first postage.  
Sample estimation  
The aim is to have at least 100 completed CODE questionnaires per country. 
Sample estimation: Minimum acceptable number of questionnaires per country is 100  
(with this number, a 95% confidence interval will give an error margin of +/- 10% of the primary 
outcome).  
There is no maximum acceptable number of questionnaires per country; the more, the better.  
Data transfer  
The electronic version and database for CODE for each country/language will be developed in 
Norway using the Corporate Surveyor software. There will be one database for each country. 
Participants entering their data online will enter them directly into the database. For paper 
questionnaires, either filled in by the participants themselves or by interview, the CODE data will be 
entered into the database by local project coworkers. 
The databases will be merged in Norway for the final common analyses.  
Data from Corporate Surveyors may be transferred directly to SPSS or other statistics tools. 
As some analyses of the survey data may be conducted by other consortium partners, 
consent/approval for data transfer is included in the information sheet for survey participants and 
the ethics application.       

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
21 
 
Web survey of study sites 
Data to be collected 
In order to provide contextual information for the results of CODE International Survey of bereaved 
relatives, information will be gathered about each organisation (hospital) and their palliative care 
provision. The following information will be collected:  
 
Type of hospital – categories  
 
Number of beds in hospital; number of beds in included wards 
 
Public/private; if private, profit-oriented or idealistic 
 
Deaths per year  
 
Deaths from cancer per year  
 
Palliative care unit in the hospital – yes/no 
 
Advisory palliative care team – yes/no 
 
Outpatient palliative care clinic – yes/no 
 
Palliative care daycare unit – yes/no 
 
Structured bereavement service – yes/no 
 
Chaplaincy – yes/no 
 
Physicians, nurses, physiotherapists specialized in palliative care 
 
EOL care implemented in hospital’s ‘mission statement’ 
 
Integrated care plan for the dying implemented – yes/no 
 
Level of oncological expertise (comprehensive cancer centre, oncological centre; clear 
definitions must be given) (‘not applicable’ included as answer option) 
 
Code status defined/identified 
 
Opioid access / policy 
Method of data collection and transfer 
The web survey of study sites will be developed using the Corporate Surveyor software.  
There will be one questionnaire to be used by all participating institutions across all seven countries, 
and the answers will be entered into one common database. The questionnaire will be developed 
and answered in English.  
 
Data analysis  
Data will be analysed using the SPSS statistical package. Initial data analysis of response rates and 
demographic details will be conducted using descriptive statistics (proportions (%) for categorical 
data; means and standard deviations for continuous parametric data and medians and interquartile 
range for continuous non-parametric data).   
A comparison of demographic details for participants and non-respondents will be conducted to 
assess how representative our sample is compared to the potential population as a whole. We will 
use Pearson X2 statistic for categorical data, independent sample t-testing for continuous parametric 
data and Mann-Whitney U for continuous non-parametric data 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
22 
 
The dataset, anonymised at patient, site and country level, will be aggregated at international level 
to enable an international report. The two key (primary) outcomes will be the proportion of 
bereaved relatives who perceived that:  
 
the deceased patient was treated with dignity and respect (two separate questions: by 
doctors, and by nurses); and   
 
they themselves were adequately supported in the patient’s last days of life 
The secondary outcomes will be the results of each of the composite and variable scales (means), 
and the total score, as outlined in the CODE User Guide (25). Finally, results for the individual items 
will be presented. Results will be summarised in tabular and graphical format, as appropriate.  
Missing data: If <10% missing data: For single questions, means of what has been answered for other 
questions will be used, based on composite scales.  
With higher degrees of missing data, multiple imputation will be used.  
Descriptive statistics will be used to compare the characteristics of included and non-included cases, 
to see whether the final sample is representative for the population as a whole.  
For each country, similar reports as described for the international level will be developed. National 
data will be reported back to each partner.  
Data from the web survey of study sites will be analysed with descriptive statistics using SPSS.    
Where appropriate, responses to CODE will be compared with hospital characteristics and level of 
palliative care provision using regression analyses.   
Free text comments will be analysed using qualitative methods (text condensation). 
 
Additionally, the three key composite scales within the CODE questionnaire, the CARE, the 
COMMUNICATION and the ENVIRONMENT scales would be assessed for their internal consistency 
and construct validity. These three scales represent question items which have been grouped 
together for their conceptual similarity. Cronbach’s alpha will be used to assess the internal 
consistency of these scales and factor analysis techniques to assess the construct validity.  
PROJECT MANAGEMENT AND WORK PLAN  
An overview of the ERANet-LAC CODE consortium is included in the Appendix (Appendix 1). 
All partners have signed the consortium agreement. The PIs are responsible for the CODE 
international survey in their respective countries. The group of PIs constitute the project General 
Assembly and decision-making body. Important decisions concerning both WP1 and WP2 of the 
present project were made at the project Initiation Meeting in Mainz, Germany, in February 2017.  
Project management will be handled by the Coordinator.      

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
23 
 
WP1 (Preparation and Piloting) is designed to run from month 1 to month 7 of the project, i.e. from 
January to August 2017. Group discussion with volunteers may be carried out as soon as the 
translation process is completed. Cognitive interviews with bereaved relatives may be conducted 
when ethical approval is obtained.   
WP2 is designed to run from month 8 to month 22 of the ERANet-LAC CODE project, i.e. from 
September 2017 to November 2018. Recruitment of participants for the international survey may 
start when the following factors are in place: 
 
Approval from ethics committee and other relevant agencies  
 
i-CODE ready for use in all relevant languages and presented as fully developed, tested and 
web-accessible data collection tools 
 
Study office with the necessary infrastructure in each country 
Time line and deliverables 
Confirmation of ethical approval for CODE International Survey in each country   
month 6 (July 2017) 
Web survey of institutions ready for use 
 
 
 
 
   
month 6 (July 2017) 
Fully developed, tested and web-accessible data collection tools 
 
 
month 6 (July 2017) 
i-CODE ready for use 
 
 
 
 
 
 
 
month 7 (Aug 2017) 
Completed web survey of inclusion sites 
 
 
 
 
 
month 10 (Nov  2017) 
Completed international survey with at least 600 completed CODE questionnaires 
month 22 (Nov 2018) 
Report on CODE International Survey data  
 
 
 
 
month 22 (Nov 2018) 
END OF STUDY 
 
WP1: The end of WP1 will occur when the following outcomes are achieved:  
 
A translation of CODE for each country / language 
 
A report on the translation and pilot testing for each country / language 
 
Results from the pre-testing in each country collated and compared, to establish a common, 
core international version of CODE (i-CODE) 
 
International CODE ready for use, in all relevant languages 
WP2: The end of WP2 will occur when the following outcomes are achieved:  
 
A common international report on CODE survey data 
 
Individual country reports and cross-country comparisons 
 
Identification of the two main concerns, across the countries and in the individual countries   

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
24 
 
SPONSORSHIP AND BUDGET 
Financial support for the project was granted from national research funding agencies in the 
participating countries, except in the UK. The University of Liverpool, UK, takes part in the project as 
self-financed partner. Details on the agencies are provided in Appendix 1.  
No commercial interests are involved in the study. No conflicts of interest have been declared. 
Participants receive no financial benefit for participation. 
ETHICAL APPROVAL AND GOVERNANCE 
The Project Lead (PI) for each country will seek the necessary approvals for CODE International 
Survey, from their local/regional ethics committee, and from their institutional review board as 
needed. The research project will adhere fully to the Declaration of Helsinki and to the requirements 
set out in the Health Research Governance Framework for each participating country.  
As regards WP1 of the project, we do not think ethical approval is required for the pilot testing with 
volunteers, but each country needs to clarify their own stipulations. We will seek ethical approval for 
the cognitive ‘think aloud’ interviews and the international survey.  
All potential participants will be given a Participant Information Sheet detailing the aims of the 
study. This information sheet emphasizes that participation is fully voluntary and that they may 
withdraw at any time, up to the time when the final analysis and reporting have been completed. 
They will be given time to consider whether they wish to participate. In addition, the full contact 
details for a member of the research team will be provided so that the opportunity to ask questions 
and request additional information is available. These measures should ensure that participation is 
based on fully informed consent.     
PATIENT AND PUBLIC INVOLVEMENT 
Seeking patient and public views is an important component of WP1 of this study. Both volunteers 
and bereaved relatives will be deeply involved in developing i-CODE to be used for the international 
survey. They will also be consulted on how to approach the participants in the survey.  
After the survey has been performed, bereaved relatives will be involved in the action planning on 
how to address the main areas of concern identified. 
 
CONFIDENTIALITY AND DATA MANAGEMENT  
The Project Lead for each country will preserve the confidentiality of participants taking part in the 
study. All participants will be allocated a unique identifier number, both for transcription of 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
25 
 
interviews, inputting of data and completion of the CODE questionnaire. The code list will be 
securely locked up and only available to the responsible personnel/contact person recruiting 
participants at each study site/ward. The list will not be available for researchers analysing the data. 
The code list will be destroyed by the end of the study.  
All data will be anonymised and individual participants will not be identifiable from published data. 
Any quotations from interviews or free text comments that may lead to a participant being 
identifiable will be edited prior to publication of subsequent reports and publications.  
Any audio recordings will be transferred immediately after the interview onto a transcription 
system. Electronic transcripts and all data will be stored on a secure, password protected research 
server. Consent forms and other paper documents will be locked in filing cabinets. Data will be 
stored for up to five years after the completion of the project before being confidentially shredded 
or deleted.  
DISSEMINATION AND PUBLICATIONS  
A website for the project will be established with the purpose of providing general information 
about the study. The website has one public part and one part with restricted access, open for the 
PIs and study personnel. This part will contain all common project documents and templates. 
Summary results from the project will be published on the open part.  
The dissemination activities will be directed towards health care professionals and researchers, the 
general public, and health care authorities and politicians. Publications reporting results from the 
study will be submitted to international peer review medical journals, and presented at international 
meetings. Authorship will be defined according to the Vancouver Guidelines. The PI and study 
coordinator in each country will be co-authors on the main publication from WP2, as long as they 
fulfil the requirements in these guidelines. National data may be published in local reports for 
individual organisations and national journals by the study group in each country. Plans for 
additional publications including authorship must be decided or approved by the Project General 
Assembly. 
The last project meeting with presentations and discussions of the project findings will be arranged 
as an open international conference.      

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
26 
 
REFERENCES 
1. The 2015 Quality of Death index. Ranking palliative care across the world. The Economist  
Intelligence Unit. A report by The Economist Intelligence Unit. Lien Foundation 2015. 
2. Pastrana T, De Lima L, Wenk R, et al. Atlas de Cuidados Paliativos de Latinoamérica. Houston,
TX: IAHPC Press, 2012.  
3. Pastrana T, Eisenchlas J, Centeno C et al. Status of palliative care in Latin America: looking 
through the Latin America Atlas of Palliative Care. Curr Opin Support Palliat Care 2013; 
7:411-5.  
4. National care of the dying audit for hospitals, England. National report, Royal College of 
Physicians, May 2014  
https://www.rcplondon.ac.uk/projects/outputs/national-care-dying-audit-hospitals (last 
accessed 28 Feb 2017)  
5. The International Collaborative for Best Care for the Dying Person. Supporting Care in the 
Last Hours or Days of Life. May 2014.  
http://www.mcpcil.org.uk/media/33890/international%20model%20documentation.pdf   
(last accessed 28 Feb 2017) 
6. Department of Health (2008). End of life care strategy. Promoting high quality care for all 
adults at the end of life. Department of Health: London.  
7. Burge F, Lawson B, Johnston G et al. Bereaved family member perceptions of patient-
focused family-centered care during the last 30 days of life using a mortality follow-back 
survey: does location matter? BMC Palliat Care 2014; 13:25. 
8. Office of National Statistics (2014). National Survey of Bereaved People (VOICES) 2014. 
Office of National Statistics.  
https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthcares
ystem/bulletins/nationalsurveyofbereavedpeoplevoices/2015-07-09 (last accessed 28 Feb 
2017)  
9. van der Heide A, de Vogel-Voogt E, Visser AP, van der Rjt CC, van der Maas PJ. Dying at home 
or in an institution: perspectives of Dutch physicians and bereaved relatives. Support Care 
Cancer 2007; 15:1413-21.  
10. Mayland CR, Williams EMI, Ellershaw JE. Assessing quality of care for the dying: the 
development and initial validation of a postal self-completion questionnaire for bereaved 
relatives. Pall Med 2012; 26:897-907. 
11. Department of Health (2013) The NHS Friends and Family Test: Publication Guidelines. 
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/141446/Fr

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
27 
 
iends-and-Family-Test-Publication-Guidance-v2-FOR-PUBLIC_E2_80_A6.pdf.pdf (last 
accessed 28 Feb 2017) 
12. Mayland CR, Williams EMI, Addington-Hall J, Cox TF and Ellershaw JE. Does the ‘Liverpool 
Care Pathway’ facilitate an improvement in quality of care for dying cancer patients? Br J 
Cancer 2013; 108:1942-8. 
13. Mayland CR, Williams EMI, Addington-Hall J, Cox TF and Ellershaw JE. Assessing the quality of 
care for dying patients from the bereaved relatives’ perspective: further validation of 
‘Evaluating Care and Health Outcomes – for the Dying’. J Pain Symp Manage 2014; 47 (4): 
687-696 
14. Mayland CR, Williams EMI and Ellershaw JE. How well do we care for dying patients? A 
review of instruments using bereaved relatives to assess the quality of end-of-life care. 
Palliat Med 2008; 22: 133-144.  
15. Mayland CR, Lees C, Germain A et al. Caring for those who die at home: the use and 
validation of ‘Care Of the Dying Evaluation’ (CODE) with bereaved relatives. BMJ Support 
Palliat Care 2014; 4:167-74. 
16. Mayland CR, Mulholland H, Gambles M, Ellershaw J, Stewart K. How well do we currently 
care for our dying patients in acute hospitals: the views of bereaved relatives? BMJ Support 
Palliat Care 2017 doi: 10.1136/bmjspcare-2014-000810. [Epub ahead of print]. 
17. Quality Assurance for Care of the Dying: Cheshire & Merseyside Strategic Clinical Network. 
Network 
Report. 
October 
2015. 
http://www.nwcscnsenate.nhs.uk/strategic-clinical-
network/our-networks/palliative-and-end-life-care/education-reso/care-dying-evaluation 
(last accessed 28 Feb 2017) 
18. Kulis D, Bottomley A, Velikova G et al. on behalf of the EORTC Quality of life group. EORTC 
Quality of life group translation procedure 4th edition. May 2016 
19. Czaja R. Questionnaire pre-testing comes of age. Marketing Bulletin 1998; 9:52-66. 
20. Campanelli P, Collins D. How to do cognitive interviewing. CASS course in pre-testing survey 
questionnaires. London: Royal Statistical Society 2005. 
21. Fowler FJ, Coppola KM, Teno JM. Methodological challenges for measuring quality of care at 
the end of life. J Pain Sympt Manage 1999; 17 (2): 114-119. 
22. Van der Veer K, Hak T, Jansen H. The Three-Step test-Interview (TSTI): An observational 
instrument for pre-testing self-completion questionnaires. Paper for the International 
Conference of Questionnaire development, Evaluation, and Testing Methods. Charleston, 
South Carolina, Nov 2002. 
23. Germain A, Mayland CR, Jack B. The potential therapeutic value for bereaved relatives 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
28 
 
participating in research: An exploratory study. Palliat Support Care 2016;14:479-87.  
24. Willis GB. Cognitive interviewing. A ‘How to’ guide. Short course presented at the 1999 
meeting of the American Statistical Association.  
25. Mayland C. User-guide for ‘Care of the Dying Evaluation’ (CODETM). The Marie Curie Palliative 
Care Institute Liverpool, 2015.   
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
29 
 
APPENDICES  
Appendix 1: Overview of ERANet-LAC CODE Consortium, including PIs and national 
funding agencies  
 
Organisation  
Country 
Principal Investigator 
Funding Organisation 
University of Bergen 
Norway 
Prof Dagny Faksvåg Haugen 
dagny.haugen@uib.no 
The Research Council of Norway 
(RCN / NFR) 
Sue Ryder House 
administered by Pallmed 
Poland 
Prof Wojciech Leppert 
wojciechleppert@wp.pl 
National Centre for Research and 
Development (NCBR) 
Mutualista Asociaciόn 
Hospital Evangélico 
Uruguay 
Dr Eduardo Garcia Yanneo 
eduardouruguay@hotmail.com 
National Research and 
Innovation Agency of Uruguay 
(ANII) 
Pallium Latinoamérica 
N.G.O. 
Argentina 
Dr Vilma Adriana Tripodoro 
vilma.tripodoro@gmail.com 
Ministry for Science, Technology 
and Productive Innovation 
(MINCyT) 
University Medical Center 
of the Johannes 
Gutenberg University of 
Mainz 
Germany 
Prof Martin Weber 
martin.weber@unimedizin-
mainz.de 
Federal Ministry of Education 
and Research (BMBF/DLR) 
State University of 
Campinas 
Brazil 
Prof, Dr Lair Zambon 
lair.zambon@hes.unicamp.br 
Research Support Foundation of 
the State of Sao Paulo (FAPESP) 
University of Liverpool 
UK 
Dr Catriona Mayland 
catriona.mayland@liverpool.ac.uk 
No funding agency 
Appendix 2: Overview of participating hospitals and responsible persons, Norway 
 
Sykehus 
Kontaktperson 
Haraldsplass Diakonale Sykehus 
Overlege, forsker Katrin Sigurdardottir 
katrin.sigurdardottir@haraldsplass.no 
Haukeland unversitetssjukehus 
Seksjonsoverlege, professor  
Dagny Faksvåg Haugen 
dagny.haugen@uib.no  
St Olavs Hospital 
Overlege Morten Thronæs og overlege, 
førsteamanuensis Anne Kvikstad 
morten.thrones@ntnu.no 
anne.kvikstad@ntnu.no 
Bærum Sykehus 
Overlege Eva Gravdahl 
eva.gravdahl@vestreviken.no 
 
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
30 
 
List of further appendices, provided in or as separate documents 
 
Appendix 3: Guidance Template One: Part 1 Volunteers 
Appendix 4: Guidance Template Two: Part 2 Cognitive interviews  
Appendix 5: Interview briefing sheet 
Appendix 6: Standardised feedback form from questionnaire pre-testing 
Appendices 3-6 in common document 
 
Appendix 7: CODE questionnaire (English original) (separate document) 
Appendix 8: CODE User Guide (separate document) 
Appendix 9: Norwegian translation of CODE questionnaire (separate document) 
Appendix 10: Information flyer, questionnaire pre-testing with cognitive think-aloud interviews 
(separate document) (Informasjon om forskningsprosjektet – uttesting av spørreskjema) 
Appendix 11: Information sheet and consent form, questionnaire pre-testing with cognitive think-
aloud interviews (Forespørsel om deltakelse – uttesting av spørreskjema) 
Appendix 12: Information flyer, CODE international survey (separate document) (Informasjon om 
forskningsprosjektet – utfylling av spørreskjema) 
Appendix 13: Information sheet, CODE international survey (separate document) (Forespørsel om 
deltakelse – utfylling av spørreskjema) 
Appendix 14: Screening and registration of information at inclusion (separate document) (Screening 
og opplysninger ved inklusjon) 
Appendix 15: Additional questions, Norway (Tilleggsspørsmål til spørreskjemaet i Norge) 
 
 

ERANet-LAC CODE Protocol version 1.1 25th March 2017; Amendment 1 included 15th February 2018 
 
 
31 
 
 
Amendment 1, 15th February 2018: Additional participating hospitals and 
responsible persons, Norway 
 
Sykehus 
Kontaktperson 
Haugesund Sjukehus, Helse Fonna 
Overlege Carmen Julia Bratke 
carmen.julia.bratke@helse-fonna.no 
Førde Sentralsjukehus, Helse Førde 
Studiesykepleier Kristin Vassbotn Guldhav  
kristin.vassbotn.guldhav@helse-forde.no 
Stavanger universitetssjukehus, Helse 
Stavanger  
Fagansvarlig sykepleier Janet Bakken 
janet.bakken@sus.no