Heart Arrest Clinical Trial
Official title:
Evolution of European Ethical Resuscitation and End-of-Life Practices From 2014 to 2019: A Survey-based Comparative Evaluation
In 2014, the authors conducted a survey of key opinion leaders on ethical resuscitation
practices in 31 European Countries. The authors administered a comprehensive questionnaire to
1-2 ʺexpertsʺ from each country; subjectivity-related bias could not be excluded; however,
the questionnaire was actually administered twice over a 6-month period to all participants,
in order to confirm results' reproducibility. The questionnaire spanned across the following
4 domains: A: ethical practices (41 questions); B: access to best available care (39
questions); C: death diagnosis and organ donation (22 questions); and D: emergency care
organization (40 questions). Accordingly, a 142-point scoring system of the responses of the
participants was developed. Country-specific scores varied widely [e.g. score range of 1-41
for the ethical practices (domain A), and of 9-32 for emergency care organization (domain
D)]. The authors also found a significant association between domain A and domain D scores
(r2 = 0.42, P < 0.001).
The results of the 2014 survey highlighted variability across European countries in their
approach to the ethics of resuscitation/end-of-life care. Results also indicated the presence
of substantial need for improvements in all the aforementioned domains of practice and
emergency care organization On the other hand, such evolution should be substantially
augmented and accelerated by the above-described combination of new guidelines, RCT-based
support of ACP, legislation / governmental policies, and educational activities.
With this study the authors undertake a methodologically improved version of the 2014 survey,
in order to test the following hypotheses: 1) compared to 2014, there may be significant
improvements in overall domain A to D scores for 2019, reflecting improved quality of ethical
practice in the field of resuscitation/end-of-life care; 2) such progress, may be more marked
in countries with ʺlowʺ (i.e. below-average) domain A to D scores for 2014.
Background and Rationale Recently published ethical practice guidelines focus on shared
decision-making, patient-centred care, family-centred care, and prevention of patient
distress after withdrawal of life-sustaining treatments (LSTs). Furthermore, several, recent
randomized controlled trials (RCTs) have provided a robust evidence-base for complex and
resource-demanding interventions such as advance care planning (ACP). ACP is also recommended
by authors of major opinion articles. In addition, new laws, governmental statements, and
educational activities across Europe support an autonomy-oriented end-of-life care.
In 2014, the authors conducted a survey of key opinion leaders on ethical resuscitation
practices in 31 European Countries. The authors administered a comprehensive questionnaire to
1-2 ʺexpertsʺ from each country; subjectivity-related bias could not be excluded; however,
the questionnaire was actually administered twice over a 6-month period to all participants,
in order to confirm results' reproducibility. The questionnaire spanned across the following
4 domains: A: ethical practices (41 questions); B: access to best available care (39
questions); C: death diagnosis and organ donation (22 questions); and D: emergency care
organization (40 questions). Accordingly, a 142-point scoring system of the responses of the
participants was developed. Country-specific scores varied widely [e.g. score range of 1-41
for the ethical practices (domain A), and of 9-32 for emergency care organization (domain
D)]. We also found a significant association between domain A and domain D scores (r2 = 0.42,
P < 0.001).
The results of the 2014 survey highlighted variability across European countries in their
approach to the ethics of resuscitation/end-of-life care. Results also indicated the presence
of substantial need for improvements in all the aforementioned domains of practice and
emergency care organization On the other hand, such evolution should be substantially
augmented and accelerated by the above-described combination of new guidelines, RCT-based
support of ACP, legislation / governmental policies, and educational activities.
With this study the authors undertake a methodologically improved version of the 2014 survey,
in order to test the following hypotheses: 1) compared to 2014, there may be significant
improvements in overall domain A to D scores for 2019, reflecting improved quality of ethical
practice in the field of resuscitation/end-of-life care; 2) such progress, may be more marked
in countries with ʺlowʺ (i.e. below-average) domain A to D scores for 2014.
METHODS Ethics Committee Approval The study protocol will be submitted for approval to the
Regional Ethics and Scientific Committee of Evaggelismos General Hospital of Athens, the
Athens Eye Clinic, and the Athens Polyclinic.
An eventually obtained approval will be used to support the conduct of the survey study in at
least 31 European countries, which are listed as follows: Austria, Belgium, Bosnia &
Herzegovina, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Republic of Northern
Macedonia, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, The Netherlands, Turkey, and the United Kingdom. Respondents from additional
European countries (e.g. Ireland) may also be invited to participate.
The informed consent procedure
The following text for potential study participants is proposed (text will be presented in
informed consent format):
According to the Helsinki declaration], participation in research has the essential
prerequisite of free and voluntary informed consent of the participant.
According to Regulation 679/2016 {or General Data Protection regulation (GDPR) of the
European Parliament and of the Council}, ʺʺconsentʺ of the data subject means any freely
given, specific, informed and unambiguous indication of the data subject's wishes by which he
or she, by a statement or by a clear affirmative action, signifies agreement to the
processing of personal data relating to him or her.ʺ Participation in the current survey
study means that the participant accepts to share his/her knowledge on ethical practices
(domain A), on access to best-quality care (domain B), on death diagnosis and organ donation
(domain C), and on emergency care organization (domain D) in their country.
According to GDPR, ʺpseudonymization means the processing of personal data in such a manner
that the personal data can no longer be attributed to a specific data subject without the use
of additional information, provided that such additional information is kept separately and
is subject to technical and organizational measures to ensure that the personal data are not
attributed to an identified or identifiable natural person.ʺ A set of 50 consecutive random
numbers (range, 50-99) will be generated using ʺResearch Randomizer (www.randomizer.org).
Each one of the aforementioned numbers will be assigned to a European country (country code)
drawn according to alphabetic order from the list of participating European countries. Next
to the 2 digits of the country code, a third digit corresponding to the participant's
temporal order of participation relative to other participants from the same country;
participant's temporal order will be determined according to the exact time of completion of
the study questionnaire. This will form the participant's personal, 3-digit, code.
Data on ethical practices and emergency care organization will be stored next to the
participant's personal code in Microsoft Excel format. This electronic Masterfile will be
stored onto the password-protected hard disk of the principal investigator's personal
computer. In addition, next to the participant's personal code, the investigators will enter
the following personal data 1) name; professional qualification(s) (e.g. physician, nurse,
paramedic, other); 2) highest academic or professional rank (e.g. professor, lead clinician,
lead nurse, etc.); 3) professional occupation-more than one possible (e.g. academic teaching,
academic research; hospital emergency department, intensive care unit, emergency medical
service, etc.); and 4) years of professional experience as healthcare provider, academic, or
both. Subsequently, personal codes and names will be copied in a second Excel file, the
Decoding file. Finally, all names will be removed from the Masterfile, whereas the personal,
3-digit codes will be retained. Consequently, the Masterfile will fulfill the criterion of
ʺpseudonymization.ʺ The Masterfile data will be used for statistical analyses aimed at
testing the study hypotheses. In this context, and within the next 3-4 months, the authors
will resend to the participants the data corresponding to their responses in Excel format so
that they may be able to confirm data accuracy. In addition, the authors will also send to
participants the data corresponding to other respondents from the same country so that the
participant may be able to state whether he/she agrees with others' responses. In the event
of disagreement(s) the authors may request that a participant attempts to reach consensus
with the other respondents from his/her country. However, participants should note that the
reaching of such consensus should not in anyway be considered as ʺmandatoryʺ.
According to the above, the authors request the participant's free and voluntary consent for
1. Collection and storing of the above-mentioned data under password protection
2. Inclusion of the above-mentioned data (at least in part) in an Acknowledgment section of
a published article reporting on the results of the survey study
As essential prerequisites for consent validity we ask you to respond to the following
questions:
A) Has the participant read / understood the above-presented information? B) Has the
participant had adequate time to consider granting their consent for the use of their
personal data? C) If the participant asked any questions about any aspect of the survey
study, did they receive satisfactory replies from the study investigator? D) Does the
participant understand that he/she may withdraw their consent at any time until the
publication of the survey study results? E) Does the participant understand that after
publication of the study results and dissemination of their personal data, it may become not
possible to reverse such dissemination? F) Does the participant agree with the aforementioned
procedure of pseudonymization and subsequent dissemination of their personal data?
Methods Potential study participants from the European countries will be contacted via e-mail
and invited for an investigators meeting during the 2019 Resuscitation Congress, September
19-21, Ljubljana, Slovenia.
Participant inclusion criteria are presented in the relevant section To reduce the risk of
subjectivity-related bias, there will be a minimum of 3 and a maximum of 5 participants from
each one of the aforementioned European countries; responses will not be excluded from the
analyses if originating from less than 3 participants. Following obtainment of consent,
participants will be able to electronically access the questionnaire through Typeform
(www.typeform.com). As an example, the 2014 questionnaire is still accessible at
https://erc.typeform.com/to/dZjrOQ. The study questionnaire is summarized in Table 1.
As in the authors' 2014 survey study, respondents will have to choose either among 4 options,
i.e. never, sometimes, usually and always or between no and yes. Respondents will also be
asked to comment on domain subsections. Subsequently, responses of never/sometimes and
usually/always will be respectively grouped as no and yes, because never/sometimes does not
and usually/always does reflect common/everyday practice. All data will be entered in an
Excel Masterfile. Participants from each country will be asked to reconfirm their answers
after a period of approximately 3-4 months (procedure detailed above); they will also be
asked whether they agree or disagree with answers provided by other participants of the same
country. In cases of disagreement, the authors will encourage resolution through consensus.
For data analysis, the authors will use a dichotomous quantitizing approach by grading a
positive response with 1 and a negative response with 0.
As stated above, the authors will encourage consensus-based resolution of discrepancies among
respondents from each country. Full details of each case of discrepant responses will be
recorded. Subsequently, for each survey question and country, mean response grades will be
calculated and used in the data analyses. In the absence of discrepant responses, or
following a consensus, response grades will either have the value of 1 or 0. In cases of
failure to reach consensus, response grades will have non-integer, positive values below the
value of 1.
Study outcomes For the 2019 survey, Domain A, B, C, and D subcomponent and total scores will
by calculated by summing up the corresponding response grades; this specific, summation
procedure will not take into account the grades of responses to ʺnewʺ questions included only
in the 2019 questionnaire (Table 1).
The primary outcome will be the presence / absence of statistically significant differences
between 2014 and 2019 in Domain A to D total scores of all participating countries.
The secondary outcome will be the presence / absence of statistically significant differences
between 2014 and 2019 in Domain A to D total scores of countries with ʺlowʺ Domain total
scores in 2014. The latter ʺlowʺ 2014 scores will be defined as Domain total scores lower
than the corresponding, overall mean score values of 2014; more specifically, ʺlowʺ 2014
total scores for Domain A, B, C, and D will be those not exceeding the values of 18, 7, 12,
and 23, respectively.
According to the above, ʺhighʺ (or above-average) 2014 total scores for Domains A, B, C, and
D will be those exceeding the values of 18, 7, 12, and 23, respectively.
The tertiary outcome will be the presence / absence of statistically significant differences
between changes in ʺlowʺ 2014 Domain total scores from 2014 to 2019, and changes in ʺhighʺ
2014 Domain total scores from 2014 to 2019.
Plan of Statistical analyses As previously, the normalities of the distributions of domain
and subcomponent scores will be determined by Kolmogorov-Smirnov test. Data will be reported
as number, number (percentage), and mean±SD or median (interquartile range), as appropriate.
Comparisons pertaining to the primary, secondary, and tertiary outcome will be conducted
using an independent samples t-test or the Mann Whitney exact U test as appropriate.
As previously, bivariate linear regression will be performed to explore possible associations
between the 2019 Domain A and D total scores. These analyses will include 1) the 2019 total
scores calculated as reported above; and 2) the 2019 total scores after the addition of the
grades of the responses to the ʺnew - 2019-onlyʺ questions. All analyses will be performed
using SPSS version 24.
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