Very Elderly Patients' Treatment Preferences and Participation in Shared Decision-making in the Event of Acute Life-threatening Illness
Conditions: Aged, 80 and Over, Critical Illness
Sponsor: Haukeland University Hospital

Intensive Care of Elderly: What do They Wish for Themselves?
NCT05149040
Study protocol and Statistical Analysis Plan
06.06.2021 (version 3, IBM approval)

 
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Project Description 
 
1. Project Title 
 
Treatment preferences of very elderly Norwegians in the event of acute life-threatening 
illness, and family members’ ability to predict these treatment preferences: A self-
administered survey.  
 
2. Background 
Very elderly patients (aged 80 years and older) are a large and steeply increasing patient population 
in western intensive care units (ICUs), but the overall benefit of intensive care for these patients 
remains controversial [1, 2]. Will ICU admission improve survival and quality of life, or will it prolong 
suffering and delay natural death? In case of medical uncertainty, crucial significance is attached to 
the patient's treatment preferences, but less than 1 in 4 very elderly ICU patients retain decision 
making capacity [3]. Therefore, information about the patient's likely will is frequently sought 
through a family conference. 
Knowledge regarding the very elderlies' life sustaining treatment (LST) preferences is scarce and has 
recently been rated as number two of top-ten research-topics by a broad panel of experts [4-6]. To 
our knowledge, so far no survey instrument for this purpose exists.  
Research addressing the accuracy of proxy statements by family members has only shown low to 
moderate correlation [7, 8]. Both internal and external validity of the existing research addressing 
proxy accuracy is limited. 
 
3. Study design 
The overall goal of this project is to improve critically ill very elderly patients’ ICU trajectories by 
bringing forth knowledge about their treatment preferences, their family members’ ability to predict 
their wishes, and by directing attention to confounders of shared decision-making under uncertainty.  
3.1. Research questions:  
 Which preferences do very elderly people have regarding LST in the event of acute illness 
warranting ICU admission?  
 How accurate can close family members predict the treatment preferences of a temporarily 
incapacitated very elderly patient with acute life-threatening illness? 
 Are there factors that impact on very elderly patients’ LST preferences, and on the ability of a 
close family member to predict these preferences?  
3.2. Preregistration:  
We plan to preregister the proposed study on www.CinicalTrials.gov. 
3.2. Protocol:  
Choice of method: This study has an exploratory design and aims to investigate decision-making 
processes regarding choices where the informants can’t be exposed to an experimental decision due 
to both the nature of the choice and seriousness of the consequences. Despite its well-acknowledged 
weaknesses, hypothetic scenario-based survey research emerged as a suitable approach based on a 
mapping review of the medical literature and on transferred knowledge derived from decision-

 
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making research in other fields where decisional stakes are high as for example in criminology, 
economy, and politics [9-12].  
We plan to develop and  to validate a survey instrument and to conduct a self-administered survey of 
Norwegian residents aged 80 and older and a close family member who likely would act as a proxy in 
an event of acute illness.  
Target population and sampling frame:  Due to ethical concerns regarding exposure of very elderly 
patients to hypothetical treatment choices which they in real life would not be offered, we attempt 
to exclude patients who are not regarded potential ICU candidates in Norway owing to low physical 
and/or cognitive function. Furthermore, we have limited knowledge on whether very elderly people 
in Norway might experience a questionnaire addressing critical illness and risk of dying as a burden. 
We prefer therefore a sampling method where the informants have a short face-to-face encounter 
with one of the investigators followed by the offer to re-contact by phone or e-mail in case of 
emotional distress related to completing the questionnaire. For these two reasons, we abandoned 
the idea of a mailed survey to a random generated population-based sample and decided to study a 
purposive sample of potential ICU candidates aged 80 years or more.  
We plan to recruit study participants by approaching all patients ≥ 80 years at the orthopedic, 
ophthalmologic and ear, nose and throat outpatient clinics at Haukeland University Hospital 
consecutively. We will exclude patients who are blind, not fluent in Norwegian, or are not able to 
meet for the consultation without assistance as a rough surrogate measure of markedly reduced 
physical and / or cognitive function. We deem the patient populations of these outpatient clinics to 
be least skewed towards underlying comorbidities and chronic organ impairment compared to other 
medical or surgical outpatient clinics. The patients will receive an information sheet about the study 
upon registration, and if they are interested in participating they will receive a pair of cover letters, 
questionnaires and stamped return envelopes; one of each for the very elderly patient him- or 
herself, and one for the most likely designated proxy in the event of acute critical illness. The very 
elderly respondents, with age < 18 years being the only exclusion criterion, identify the potential 
proxy respondents. The participants are asked to complete the questionnaires by themselves and 
without consulting each other, and to return them by mail in the provided stamped envelope. No 
incentives or compensation will be offered, and no reminders will be sent. Patients having several 
outpatient appointments during the study period will only be approached once.  
We will account for age and gender of very elderly patients approached, but not enrolled, as well as 
age and gender of the very elderly non-respondents. Will we not be able to account for any 
characteristics of non-respondents among potential proxies.  
Sample size: We will use a sample size of at least 400 pairs of participants. We expect a response rate 
of more than 50%, and we plan to continue inclusion until we have reached at least 200 elderly 
respondents. For more details on the sample size calculations, see the ‘Analysis’ section below. 
Survey construction: Table 1 summarizes the structure of the questionnaires. They start with a short 
summary of background information regarding intensive care in general, and expected risks and 
benefits for very elderly patients in particular. Then the participant is asked to make a treatment 
choice regarding four clinical vignettes; the very elderly person is asked only about his or her own 
preferences, while the proxy is asked to both indicate the likely whish of the very elderly person, and 
his or her own preference. Three response options are provided: wishing admission to intensive care, 
not wishing admission to intensive care, and wishing to not engage in the decision.  
 
 
 

 
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Very elderly person          
(potential patient) 
Potential proxy 
Cover / instructions / contact information (p.1) Background information (p.2) 
Paragraph no. 
Questions 
Paragraph no. 
Questions 
Vignettes/scenarios 1–4 
1-4 
4 x 3 
1-4 
4 x 6 
Family involvement in 
medical decision-making 
5 
5 
5 
3 
Experiences with 
intensive care and 
advanced care planning 
6 
5 
6 
6 
Demographics 
7 
7 
9 
7 
Health / frailty 
8 
5 
7 
5 
EuroQuol 
 
6 
8 
6 
Comments  
9 
1 
10 
1 
Re-contact permission 
10 
1 
 
 
Pages / questions (total) 
15 / 42 
18 / 53 
Table 1: questionnaire structure 
 
The vignettes are randomly chosen among 20 hypothetical patient histories of acute life-threatening 
illness causing a higher degree of acute organ failure (equaling > 2 SOFA points) [13]. 
All vignettes are built up in a similar way, containing three paragraphs, following the same template: 
1. 2–3 sentences regarding the current diagnosis and acute organ failure. The type and 
frequency of diagnoses is representative for ICU admission diagnosis in elderly patients in 
Norway and Europe (table 2). For each questionnaire, there will be four vignettes – two 
framed as a history of a male patient, and two framed as a female patient. The vignettes will 
be presented in a random order. 
2. 3-4 sentences describing dichotomous therapeutic options as either intensive care with 
sedation requirements and some kind of invasive organ support or ward care with 
conservative treatment and the possibility for symptom alleviation. 
3. 3 sentences on the consequences of the choice. The survival outcome estimates are based 
on short- and long-term outcome data from the VIP2- study data-set (table 2). The estimated 
quality of life regarding physical and cognitive function of ICU survivors aged ≥ 80 years is 
based on published data from Norway, Finland, the Netherlands and Canada [14-17], and a 
systematic review on cognitive impairment after intensive care [18]. Outcomes are identical 
for all vignettes, but in 50% of the questionnaires, the expected outcome is framed as 
mortality and in 50% as survival. The same framing is used for all four vignettes in each 
questionnaire. 

 
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VIP-2 (May 2018-May 2019)  
NIR (May 2018-May 2019) 
ICU admission diagnosis 
N (%) 
Survival (%) 
N (%) 
Survival (%) 
ICU 
30 d 
6 m 
ICU 
30 d 
1 y 
Overall 
3921 
(100) 
73 
75 
40 
3069 
(100) 
86 
67 
47 
ARF 
941 (24) 
75 
76 
34 
951 (31) 
84 
Sepsis 
392 (14) 
68 
70 
33 
338 (11) 
86 
Shock 
540 (14) 
72 
71 
34 
737 (24) 
88 
Acute surgery 
541 (14) 
80 
82 
45 
614 (23) 
86 
Trauma  
233 (6) 
69 
70 
30 
215 (7) 
85 
Neuro 
190 (5) 
68 
68 
30 
153 (5) 
87 
Table 2: Main admission diagnosis and survival of very elderly (≥ 80 år) ICU patients in Europe (VIP-2 data set, personal 
communication, Hans Flaatten, April 2021) and in Norway (NIR (Norwegian Intensive Care Registry), personal 
communication, Reidar Kvåle, April 2021) 
 
Furthermore, the survey covers items that may influence treatment preferences and proxy accuracy 
including: demographics, education, religion, previous experience with and / or communication 
about serious illness, comorbidity (Charlson Comorbidity Index, [19]), frailty (Clinical Frailty Scale, 
version 2, [20]), quality of life (EuroQol-5D-5L, registration ID: 30864, [21]) and projection (i.e. the 
proxy’s own treatment preferences, [8]). Items were generated by a mapping review of the existing 
literature on elderly patients’ treatment and end-of-life preferences and on proxy accuracy in 
general. Additional items where identified by discussions within the research group.  
The questionnaires ask for the following free-text comments: 
- 
Elaborating the treatment choice made after each scenario 
- 
Expectations regarding family members contribution into the decisional process 
- 
General comments 
 
In order to allow for a longitudinal follow-up survey aiming at assessing very elderlies’ treatment 
preferences and proxy accuracy stability over time, the respondents are asked to provide their name 
and address at the end of the questionnaire. The respondents are informed that providing name and 
address for follow-up is voluntary, about their right to withdraw at any time and that taking part in a 
longitudinal cohort will impact on data handling, i.e. data will be stored pseudonymously instead of 
anonymously.   
 
The longitudinal follow-up will be a separate study with revised questionnaires and revised protocol 
according to the findings of the cross-sectional study. New ethical approval for the longitudinal 
follow-up will be sought.  

 
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The layout of the questionnaire was created in compliance with the guidelines for visual design of 
paper questionnaires by Statistics Norway [22]. 
Face / Content validity: The draft of the questionnaire has been evaluated by 9 health care 
professionals (4 senior ICU consultants, 2 junior anesthetists, 2 ICU nurse specialists, 1 research 
nurse, 2 geriatricians, 1 public health specialist) and 6 laymen (2 elderly, 4 possible proxy decision 
makers, of those 2 with higher education, but no health care professionals).  
Pre-testing: (February/March 2020): We pre-tested a preliminary version of the questionnaire 
containing only one vignette and no questions regarding demographic or health-related information 
among 20 grandparent/parent pairs of medical students. Completed questionnaires were returned 
anonymously by mail. The response rate was 45% with 8 complete pairs and may have been 
adversely affected by the coincidental society lock-down due to the CoVID-19 outbreak.  
We assessed whether the case vignette was feasible, and produced responses with sufficient data 
dispersion to assess proxy accuracy and factors that might impact on the choices made. 
 
Elderly’s 
preference 
N 
Son’s / daughter’s prediction 
 
Wants 
ICU 
admission 
Does not want 
ICU admission 
Wants the doctor 
to decide 
Unsure about the 
elderly’s preference 
Wants ICU 
admission 
3 
1 
1 
1 
 
Does not want 
ICU admission 
1 
 
1 
 
 
The doctor 
should decide 
4 
1 
 
2 
1 
Unsure 
0 
 
 
 
 
Table 3: Pre-test results (cases of apparent assumed similarity in red) 
 
We reduced and adjusted the “uncertain” and “the doctor should decide” answer categories to 
“wishing to not engage in the decision” after the pre-test in order to more precisely match the 
Norwegian regulations, where patient preferences are an important information into the medical 
decision process, but the ultimate decisional authority remains with the treating physician(s). 
Additional space for free-text comments is provided, and the respondents are asked to elaborate the 
reason for their preference. Moreover, we abstracted confidence into the choices made as an 
independent item and ask the participant to indicate for each scenario how certain they feel about 
their answer regarding treatment preference on a five-point Likert scale.   
The pretest also revealed cases of assumed similarity, where the son/daughter apparently decided 
according to his/her own preferences which were different from the preferences of their elderly 
mother / father (red numbers in table 2). None of the respondents commented on unpleasant 
feelings when confronted with a question regarding life-threatening illness, but several both elderly 
persons and their adult children volunteered that they perceived the question to be relevant, 
important, and not sufficiently addressed yet.  
An interesting observation from the pre-test was that respondents who opted for their physician to 
decide had less or no free text comments, compared to respondents who made a clear choice. 

 
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Pilot testing: We plan to assess the penultimate versions of the questionnaires (one for the very 
elderly person, and one for the potential proxy) for face validity, and clinical sensibility as well as to 
pilot them regarding relevance, flow, arrangement and time to complete.  
Validation method: We aim to recruit 10 very elderly people (≥ 80 years) and 10 family members of 
very elderly people (≥ 80 years) who likely would act as a designated proxy in case of an acute health 
related event through user representatives, the interest organization “Senior Norge”, the volunteer 
service at Haukeland University Hospital and advertisements in public spaces, social media and local 
print media. We aim for balance regarding gender, educational and cultural background. Potential 
participants will get information about the project by phone, and upon verbal consent receive the 
questionnaire validation package by mail. The package contains an information letter with written 
consent, the respective questionnaire (vey elderly person or proxy, version 2), and an evaluation 
sheet comprising items regarding practical aspects, sensibility and validity of the questionnaire, 
alongside with an invitation to a group interview.  
The participants are asked to complete the questionnaire and the evaluation sheet before the 
interview. They may keep the questionnaire and the evaluation sheet as an aid memoire during the 
interview, but are encouraged to not change their written answers. The evaluation forms will be 
collected after the interview. They do not contain any personal identifiable data.  
The interviews will take place at Haukeland University Hospital, and will follow a standardized 
template. Two investigators will meet approximately 5 participants. The group interview will be 
chaired by the principal investigator (GLS), assisted by a co-investigator, who also will write minutes 
(MAS). An experienced intensive care nurse (BÅS) will be available during all interviews in case any 
participant requires assistance or comfort. 
The content, wording and lay-out of the questionnaire and cover letter will be revised according to 
the data from the evaluation sheets and a synthesis of the focus group interviews. Data regarding 
validity and clinical sensibility of the questionnaire will be reported as numbers / percentages in the 
method chapter of the main study. Input from the focus group interview will also be used to inform 
about any possible additional ethical concerns not yet known to the investigators.  
Analysis: We will report basic descriptive statistics (e.g., frequencies, means, and standard 
deviations) for the items included in the questionnaire. 
To estimate the participants’ preferences regarding life-sustaining treatment, we will calculate the 
proportion of responses in each category (‘wants ICU admission’, ‘does not want ICU admission’, 
‘does not want to engage in the decision’), along with 95% confidence intervals. With responses from 
200 patients, we can estimate the preference proportions with an absolute margin of error less than 
7%, based on 95% confidence intervals, which we deem sufficient. For example, if 50% of the 
respondents wanted ICU admission, the corresponding 95% confidence interval would be approx. 
43%–57%. 
To investigate factors associated with the participants’ LST preference, we will use (mixed-effects) 
logistic regression analysis. The response variables will be a) having a preference (‘wants ICU 
admission’ or ‘does not want ICU admission), b) wanting ICU admission (for the subset who have a 
preference), or c) ‘does not want to engage in the decision’. Alternatively, we will use multinomial 
regression for the three preference categories. We will fit two types of models, with the following 
explanatory variables. 
Model 1 (experimental variables): 
Gender of vignette patient (two levels), survival vs. mortality framing (two levels). 
Model 2 (experimental + observed variables): 
Variables from model 1, and additionally age (continuous), gender (two levels), religion (three levels), 
comorbidity (continuous; Charlson Comorbidity Index), frailty score (continuous; Clinical Frailty 

 
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Scale), health-related quality of life (continuous; EQ-5D VAS), and experience with intensive care (two 
levels). 
We will only have statistical power to detect large effects. For example, the effect of a binary 
predictor with a prevalence of 50% (e.g., the survival vs. mortality framing predictor) must 
correspond to an odds ratio of at least 2.33 (outcome 50% vs. 70%) for the power to be 80% or 
greater (with 200 participants). For continuous predictors, an odds ratio of 1.5 for the event rate at 
one standard deviation above the mean compared to the event rate at the mean, will be sufficient. 
The above calculations are based on simple logistic regression, i.e., assuming that only one 
preference (from one patient vignette) is expressed for each participant. In practice, there will be 
four (correlated) preferences for each participant, and we will use statistical methods that take this 
into account (mixed-effects logistic regression instead of logistic regression). This will increase the 
statistical power; i.e., we will be able to detect lower odds ratios. 
To assess the proxies’ ability to predict their family member’s preference, we will estimate the 
overall percentage agreement. Again, the absolute margin of error will be less than 7% (based on a 
95% confidence interval). We will also estimate the agreement stratified by the family member’s 
preference. Other measures of agreement (e.g., chance-corrected agreement) may also be 
calculated. 
Furthermore, we will attempt to use (mixed-effects) logistic regression to examine variables 
associated with ‘correct prediction’ (and additionally stratified by the elderly’s preference [23]). Only 
responses where the elderly has a preference (‘wants ICU admission’ or ‘does not want ICU 
admission’) will be included [24]. The analysis will only be carried out if enough elderly patients have 
a preference (we aim to have at least 5, and preferably 10 preferences, for each predictor variable 
that is included). The following predictors may be included: 
Proxy’s prediction, elderly’s and proxy’s certainty in the proxy’s prediction of elderly’s preference, 
proxy’s preference, proxy’s experience with intensive care, communication about end of life 
decisions, elderly’s gender, proxy’s gender, interaction between elderly’s and proxy’s gender, 
absolute difference in age between the elderly and the proxy, and proxy’s assessment of elderly’s 
frailty. (Predictors with high multicollinearity may be excluded.) 
In all analyses where multiple responses are included for each participant or pair, we will use 
statistical methods that take this into account (e.g., mixed-effects logistic regression instead of 
ordinary logistic regression). 
If free-text comments result in rich data, they will be analyzed by Systematic Text Condensation (STC) 
[25] and published separately. 
 
4. Project organization 
4.1. Research group: 
Principal investigator:  
Gabriele Leonie Schwarz, MD, SSAI and European Diploma of Intensive Care. Senior consultant at the 
Department of Surgical Services, Intensive Care Unit, Haukeland University Hospital.  
Co-investigators:  
Margrethe Aase Schaufel, MD, PhD, Associate Professor in Pain Medicine and Palliative Care, senior 
researcher and consultant, Department of Thoracic Medicine, Haukeland University Hospital.  
Prof. Hans Flaatten, MD, PhD, Professor in Anaesthesia and Intensive care, Department of Clinical 
Medicine, University of Bergen. Coordinator of the European VIP network and principal investigator of 
the VIP study group, investigating outcomes and prognostic factors in very elderly intensive care 
patients.  

 
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Prof. Reidar Kvåle, MD, PhD, Professor in Anaesthesia and Intensive care, Department of Clinical 
Medicine, University of Bergen. Senior consultant, Department of Surgical Services, Intensive Care 
Unit, Haukeland University Hospital. Special research interest in very elderly patients’ outcomes after 
ICU admission. 
Prof. Ingrid Miljeteig, MD, PhD, Associate Professor in Medical Ethics, Department of Clinical Science, 
University of Bergen. Experienced researcher in priority setting and decision making.  
Karl Ove Hufthammer, PhD, Biostatistician, Centre for Clinical Research, Haukeland University Hospital.  
Elisabeth Skaar, MD, PhD, Specialist in Geriatric Medicine and Cardiology, Department of Heart 
Disease, Haukeland University Hospital. 
 
Local Collaborators: 
Prof. Roger Strand, Professor, Centre for the Study of the Sciences and Humanities, University of 
Bergen. Special research interest in “Uncertainty and complexity in the science-society interface”.  
Britt Ågot Sjøbø, Nurse specialist in Intensive Care and research nurse, Haukeland University Hospital, 
Master in Evidence Based Medicine.  
Randi Hag, User representative, Senior Norge.  
 
International Collaborator: 
Karen E.A. Burns, MD, FRCPC, MSc, Staff Physician, Critical Care Medicine, St. Michael's Hospital. 
Clinician Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital. Associate Professor, 
Department of Medicine, University of Toronto, Canada. Leader of a Canadian research program to 
characterize the unique aspects of the consent process in critical care. 
4.2. Founding: 
The project receives founding from Helse-Vest (the Western Norway Regional Health Authority), to 
cover 50% redemption of the principal investigator from clinical duties from March 2021 to 
December 2021, as well as user representative fees, and expenses for printing and postage.  
None of the investigators have other bindings to declare or disclosures to make. 
4.3. Plan / Milestones 
Timeline 
completed 
completed 
completed 
Mai / June 
2021 
Juli / August 
2021 
September/ 
October  2021 
November / 
December 
2021 
Survey 
develop-
ment steps 
Item 
generation 
Item 
reduction 
Face / 
content 
validity 
assessment 
Vignette 
feasibility 
(data 
dispersion) 
Protocol 
write-up 
REC 
application 
Pilot testing: 
- Relevance 
- Flow 
- Arrangement 
Clinical 
sensibility testing 
Survey 
administration  
Data collection 
Analysis 
Write-up 
Approach 
Mapping 
review 
Expert / 
laymen 
interviews 
Expert / 
laymen 
interviews 
Pre-test 
 
Focus-groups 
(public 
engagement 
events) 
- Very elderly 
- Potential 
proxies 
Recruitment of 
at least 400 
outpatients  
 
Instrument 
version 
0  
1 
1 
2 
2 
3 
 
Table 4: study progress plan 
 
 

 
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4.3. Dissemination: 
We plan to publish the results in a peer reviewed scientific medical journal.  
Suggested authorship:  G.L. Schwarz, E. Skaar, I. Miljeteig, K.O. Hufthammer, K.E.A. Burns, R. Kvaale, 
H. Flaatten, M.A. Schaufel 
 
4.4. Plans for Implementation 
The results of this project will be used to develop a clinical decision aid to guide intensivists when 
assessing very elderly patients with acute life-threatening illness, also incorporating illness severity 
scoring, frailty scoring, and assessment of capacity. The questionnaire if proven feasible in the 
proposed study will also serve as a template for further development of a European questionnaire 
for the conduction of an already proposed multinational survey [4].  
 
5. User Involvement 
Collaboration with the Norwegian Senior Advisory Organization, Senior Norge, has been formalized 
by cooperation with Randi Hag who will assist at all steps of the research process, especially by 
checking comprehension and wording during survey and interview guide construction and by input 
from a lay perspective during data collection and dissemination of the results. The protocol has been 
presented to the user advisory board of the Western Norway Regional Health Authority, too, and we 
aim to recruit one more user representative into the research group.  
The contribution by the user representative(s) and the public engagement events, i.e. focus group 
interviews during the questionnaire validation process, will be reported according to the GRIPP2-SF 
checklist [26]. 
 
6. Ethical considerations and data security 
The project will be conducted in coherence with the principles for medical research as described by 
the Helsinki Declaration [27]. Ethical approval will be sought from The Regional Committee for 
Medical and Health Research Ethics. The Regional Ethical Committee as well as the data protection 
officer at Haukeland University Hospital have already assessed the questionnaire validation project 
(focus group interviews) and waived consent, since no patients are involved and no identifiable,  
health related or otherwise sensitive data of the informants will be stored (REK-ID: 276403, 
25.5.2021). 
Written informed consent will be obtained from all participants of the focus group interviews before 
pilot and clinical sensibility testing.  
Informed consent by the respondents of the survey will be regarded implicit by completing and 
returning the questionnaire. Personal data from anonymously returned questionnaires will be stored 
anonymously in a designated closed domain on a research server kept at Helse-Vest IKT. Data 
provided by respondents who consent to a longitudinal follow-up by entering their name and 
address, will be stored pseudonymously and the identification keys will be stored separately on 
another designated closed domain on a research server kept at Helse-Vest IKT. The identification 
keys will be deleted no later than five years after the responses given by the same respondent from 
the first and second survey are aligned. The participants will be explicitly informed about the 
possibility for either anonymous or pseudonymous data storage in the surveys cover letters.  
Discussing end-of-life issues can be experienced as a burden and this will be addressed in the 
survey’s cover letters and handled with special attention during the focus group interviews. Contact 

 
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details (phone and e-mail) of the principal investigator (GLS) will be provided not only for questions 
regarding the study but explicitly also for emotional support. In addition, an experienced intensive 
care and research nurse will be available in during the focus group interviews to take care of 
participants who might require an individual conversation or comfort. Notwithstanding, a recent 
study where 33 Norwegian nursing home residents and their next-of-kin where interviewed 
regarding end-of-life communication and shared decision making, revealed that a majority of the 
informants welcomed these conversations, and none withdrew due to emotional distress [28].  
The study does not imply any additional blood samples or imaging and potential adverse effects are 
considered low.   
 
7. References 
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Care Med, 2007. 33(7): p. 1252. 
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Laake, J.H., et al., Impact of the post-World War II generation on intensive care needs in 
Norway. Acta Anaesthesiol Scand, 2010. 54(4): p. 479-84. 
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Ferrand, E., et al., Decision-making capacity and surrogate designation in French ICU patients. 
Intensive Care Med, 2001. 27(8): p. 1360-4. 
4. 
Flaatten, H., et al., The status of intensive care medicine research and a future agenda for 
very old patients in the ICU. Intensive Care Med, 2017. 43(9): p. 1319-1328. 
5. 
McPherson, K., et al., Limitation of Life-Sustaining Care in the Critically Ill: A Systematic 
Review of the Literature. J Hosp Med, 2019. 14(5): p. 303-310. 
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Ditto, P.H., et al., Stability of older adults' preferences for life-sustaining medical treatment. 
Health Psychol, 2003. 22(6): p. 605-15. 
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Shalowitz, D.I., E. Garrett-Mayer, and D. Wendler, The accuracy of surrogate decision makers: 
a systematic review. Arch Intern Med, 2006. 166(5): p. 493-7. 
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Fagerlin, A., et al., Projection in surrogate decisions about life-sustaining medical treatments. 
Health Psychol, 2001. 20(3): p. 166-75. 
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Kühberger, A.S.-M., M.; Perner, J., Framing Decisions: Hypothetical and real. . Organizational 
Behaviour and Human Decision Process, 2002. 89(2): p. 1162-1175. 
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Exum, M.L.B., J.A., Testing Theories of Criminal Decision Making: Some Empirical Questions 
about Hypothetical Scenarios, in Handbook of Quantitative Criminology, A.R.W. Piquero, D., 
Editor. 2010, Springer Science+Business Media: New York, USA. p. 581-594. 
11. 
Vlaev, I., How different are real and hypothetical decisions? Overestimation, contrast and 
assimilation in social interaction. . Journal of Economic Psychology, 2012. 33: p. 963-972. 
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Wiseman, D.B.L.I.P., Comparing Risky Decision Making Under Conditions of Real and 
Hypothetical Consequences. Organizational Behaviour and Human Decision Process, 1996. 
66: p. 241-250. 
13. 
Vincent, J.L., et al., The SOFA (Sepsis-related Organ Failure Assessment) score to describe 
organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the 
European Society of Intensive Care Medicine. Intensive Care Med, 1996. 22(7): p. 707-10. 
14. 
Andersen, F.H., et al., Long-term survival and quality of life after intensive care for patients 80 
years of age or older. Ann Intensive Care, 2015. 5(1): p. 53. 
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Kaarlola, A., V. Pettila, and P. Kekki, Quality of life six years after intensive care. Intensive 
Care Med, 2003. 29(8): p. 1294-9. 
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de Rooij, S.E., et al., Cognitive, functional, and quality-of-life outcomes of patients aged 80 
and older who survived at least 1 year after planned or unplanned surgery or medical 
intensive care treatment. J Am Geriatr Soc, 2008. 56(5): p. 816-22. 
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Heyland, D.K., et al., Recovery after critical illness in patients aged 80 years or older: a multi-
center prospective observational cohort study. Intensive Care Med, 2015. 41(11): p. 1911-20. 

 
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