Our meeting in Bergen: Preparation to start the different studies in 2020

Updated: Jan 14



In 2020, the iLIVE Project will start the three main activities in our research programme: the cohort study, the medication study and the volunteer study. During this year, all teams worked to prepare the different instruments and questionnaires that will be used during this new phase and in the last meeting for the iLIVE Project, held in Bergen (Norway) in November, it was time to work on the last details to make the studies a reality.


This preliminary work is of the utmost importance. Who will be eligible to take part in the study? What kind of questions are we going to ask the different subjects? What will be the method to analyse the outcomes? All these questions need to be answered before anything starts. All of the instruments, be it surveys, questionnaires or strategies, have been carefully prepared and assessed by the different teams. The wellbeing of all participants in the study, with a welcoming and warm approach to all of them, has been the main concern in this phase of our work.


The cohort Study

This is probably the most important aspect of the research. In the end, 2200 patients will be included in this part of the work from the different countries taking part in the study. In Bergen the team worked to ensure that all patients are comfortable during the recruitment and fully understand what the study entails, so they can make an informed decision. That is why ethical procedures for the study have been started in some countries already, and for the rest they will start shortly, as the complete study has to be approved by the different ethic research committees of each country.


The procedures will be fine-tuned by the ethics committees to ensure that all participating countries follow the same precautions and methods. Understanding the cultural differences and how they may affect this part of the work is one of the main tasks that are being worked on. Also, the teams need to assess how to work on especially sensitive matters, such as those regarding end of life preferences and worries. That is why pilot testing will be an important part of this phase, and will start at the beginning of next year.


As explained by team leader, Agnes van der Heide: "We have worked hard to finalize the protocol for the cohort study and the questionnaires that will be used in this study. The protocol now needs approval from research ethics, after which the study can actually start".

For her, this is a very "inspiring and exciting work". "I hope that we can contribute to best personalized care for dying patients and their families by providing better understanding of their cross-cultural concerns, expectations and preferences", she explains.


This enthusiasm is shared by Simon Allan, from the Arohanui Hospice in New Zealand: "This is an exciting project with a lot of future potential for ongoing research. To be part of delivering a global standard expectation from our patients and families is a great outcome".


The medication study

In the medication study, the focus is about creating an electronic instrument to help physicians evaluate the use of medications. In Bergen the teams agreed on important details of the challenging iLIVE medication optimisation study and on the related Delphi study.

Also, about the alarm system on medication management, it will not be treated as a binding procedure, but as an advice to reconsider a patient's current use of medication, and the physician will always have the last word. This deprescription alerts will be discussed on a Delphi Study to validate rules. The next step will deal with finalizing the study protocol and sending the Delphi study to participants for the first round.


This is, of course, a group effort, as explained by team leader Carole Van Zuylen from the Erasmus Medical Center: “It is great to work with a diverse group of very skilled members. I learned to better use all these talents by asking their help”.


With this work, Van Zuylen would like to achieve an integrated device on giving advice to doctors on medication optimisation. “Moreover, I hope that the discussion about medication between doctors and their patients and the relatives contributes to advance care planning and especially to appropriate care in the last phase of life”.


The volunteer study

The volunteer study is also ready to move on. A Delphi on the core curriculums for volunteers training has been already conducted successfully and a report has been written.

As for the design of this stage of the study, some changes were made to improve the final results. A group of patients accepting volunteer support will be compared with a group of patients not accepting such support.


This work package is lead from the University of Liverpool that will now develop a curriculum for training palliative care volunteers and plan a three day training course for Volunteer Co-ordinators in January 2020 that will be an important part of the study. For team leader, Professor John Ellershaw, work is progressing satisfactorily. The desired achievement for his work on this project would be to promote palliative care volunteer services in hospitals across Europe.


Cost effectiveness

The team working on cost effectiveness is working now on systematic review on methodological aspects on performing economic evaluations in the end of life care setting. Quite an important challenge.


Qualitative interviews, ethics and culture

The protocol for this study deals with three groups of interviews: with five patients, five family members and five health care professionals. The aim is to have a representative group, with an even number of men and women and of patients over and under 65.

As the wellbeing of the patients and their comfort during the study is an important matter, interviewers will be specially elected to be capable and sensitive to the goals and target group.


The first meeting to start analysing this part of the work will be held in January. Different smaller groups, with the same language and a similar expertise will be formed to discuss procedures and contents of interviews.


The questionnaires will be adapted to each language to get the best results. The method for analysis will be thematic, following the work of Braun and Clarke.


A topic guide for interviews with family members and health care professionals is currently being prepared; these will include topics that are comparable to the patient interview guide, but adapted to the relevant perspective.


This group is also working with a junior researchers questionnaire and a questionnaire for experts on status of palliative care, policy, attitudes beliefs of patients and family, etc. that will help complete work on this aspects.





Data Collection

The data collection group is working on technical aspects about the instruments. How do you translate a questionnaire to different languages to maintain its effectiveness? The method used varies depending on the type of instrument.


For the key questions on concerns and preferences, the back and forward method, developed by the WHO, will be used. This method works making a translation that is then translated again to the original language by a third party that does not know the original text. If both texts are similar, then a good translation has been made. It is a popular method to ensure that all nuances of the language have been fully understood.


This Work Package also deals with the data management, an important task to ensure the privacy that all participants need and expect. The system used will be Alea & Mijn CTC (in English: My CTC, Clinical Trial Centre). Alea is for the content of the data, My CTC for the logistics. Alea team will develop system and codebook in collaboration with WP1 and WP6 leads.


The Core Outcome Set (COS)

This Work package deals with the procedures to create the Core Outcome Set, the desired outcomes for this study. A Delphi study will be conducted for this after one year of data recollection in the cohort study. The group is now working on a systematic review to identify studies on patient wishes for the last days and hours of life.


Previously, this group worked with the leads of the cohort study to include questions regarding core outcomes into cohort study questionnaires. This group has been working with BMCPallCare for the submission of a protocol COS. Also there is a summary report of the Swiss pilot study on core outcomes (focus groups with patients and family members), submitted to the Bernese cancer league.


This team is being lead from Switzerland, by Professor Steffen Eychmüller from the University of Bern. For him, the objectives he wants to achieve in the end with this work include:

- coming out in the end with potentially two sets of core outcomes: one of a metalevel (e.g. providing space and peace), another measureable (e.g. low symptom burden for dying patient; low distress levels for family carers).


-A series of publications adressing the different levels of outcomes and perspectives; adding expertise for more meaningful and effective care for the dying;

-Contribute to current best practice in care for the dying and her/his family.


Communication and Dissemination

WP8 was also able to present to the rest of the team all the communication and dissemination tools that are already prepared. Mainly the website, social media profiles (in Facebook, Twitter and Linkedin) and the newsletter. But also ideas for leaflets, posters and roll ups that will be used by all participating teams. “This is our challenge now. This first year was for preparation. And for next year this WP wants, through this website, engage society and recollect their opinion about our work in this project. We are really excited. We have an important challenge to make this website an instrument not only to reach the scientific community, but to really reach the citizens. And to be able to recollect the opinion from a lot of anonymous people that are, in the end, protagonists of our work”, says Marisa Martin, in charge of this Work Package.

In conclusion, a lot of work has been covered to reach the next stage in 2020, that will start bringing results and valuable data. The team is ready to go for it!

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