euroimpact palliative sedation study

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EUROIMPACT PALLIATIVE SEDATION STUDY
CHECKLIST on Palliative Sedation Guidelines
Version 31 July 2013
Title of document....................................................
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Serial Nr __ _____ _____
Reviewer’s initials……………..
Language ……………………..
A. GENERAL SECTION
Part 1: BACKGROUND INFORMATION
1.
Complete the sentences /anwer the follwoing questions as appropriate (see instruction sheet for details):
This guideline is …….
 A separate document
(more than 1 option possible)
 Part of a broader guideline on
2.
Is it a framework?
3.
Does it include a flow chart?
4.
What is its country of origin?
5.
What is its coverage?
6.
Which of the following correctly describes the document?
(more than 1 option possible)
7.
Who initiated or authorized its development?
(more than 1 option possible)
8.
Does it have any relationship with the EAPC framework?
9.
What is its length?
o Palliative Care
o Medical end-of-life decisions
o Pain management
o Cancer care
o Refractory symptom management
o Other, specify
 A summarizing decision tree, flowchart or a check list
 Other format, specify ......................................................
 No
 Yes
 No
 Yes
 ......................................................
 Not explicitly stated
 Not applicable
 Country-wide
 Region- or state-wide
 International
 Other, specify ……………………
 Not explicitly stated
 Scientific peer-reviewed paper(s) – journal: ……………
 Printed document or report
 Web document
 Other, specify …………………………………
 Medical association: specify …………………………….
 Scientific /Research group: specify ……………………..
 International: …………………………………………………
 Organisation or Network: …………………………………..
 Patient /Carer group: ………………………………………..
 Other, specify …………………………………………………
 Not explicitly stated
 None
 Unclear / not explicitly stated
 Yes: it refers to EAPC Framework
 Yes: it is built around /based on EAPC framework
 Other, specify ………………………………………….
…………………… pages / words (delete as appropriate)
10. When was the year of last publication?
…………………… (year)
11. Is it an update of an earlier version? If so, when was the
previous version published?








12. For which professional body /group was it developed?
(more than 1 option possible)
1
Yes: ………………….. (specify year if known)
No (i.e. this is the first version)
Not stated/ not applicable
Physicians
Nurses or care assistants
Multidisciplinary team
Health care professionals
Not explicitly stated
13. For which care settings /institution was it developed?
(more than 1 option possible)







Part 2: TERMS, DEFINTIONS AND TYPES
14. What term is used to depict EOL sedation practice in this
guideline? (more than 1 option possible)
15. Is this term defined?
(more than 1 definition possible)
16. Is the term “refractory” defined?
17. Are other terms referring to this practice of sedation
likewise applied– i.e. outside the Introduction Section?
18. Does it mention different types of EOL sedation? If yes,
select those mentioned
Not applicable (i.e. it is not a setting-specific guideline)
Home
Care home or equivalent
Hospital
Hospice or specialized palliative care unit
ICU
Other, specify .....................................
Palliative sedation
Palliative sedation therapy
Terminal sedation
Continuous deep sedation
Continuous palliative sedation
Continuous palliative sedation therapy
Making ‘patient comfortable’
Other, specify ..........................................................
No
Yes: state below
.......................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
........................................................................................................
.........................................................................................................
 No
 Yes: state below
.......................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
........................................................................................................
 No
 Yes: select as appropriate
o Palliative sedation
o Palliative sedation therapy
o Terminal sedation
o Continuous deep sedation
o Continuous palliative sedation
o Continuous palliative sedation therapy
o Making ‘patient comfortable’
o Other, specify ..........................................................
 No, it does not
 Yes: intermittent /transient /respite /temporary sedation
 Yes: continuous sedation










B. COMPARABILITY WITH THE EAPC’S 10-POINT FRAMEWORK (Cherny & Radbruch 2009)
Select the most appropriate responses (see instructions):
1.
Does it mention anything about pre-emptive planning or
discussing potential sedation with the patient upfront?
1.1 Are the following items mentioned in the plans?
a.
Addressing EOL care preferences / needs with patients
at risk of dying
b.
Addressing the option of sedation, if appropriate
d.
Addressing contingency plans for catastrophic events, if
appropriate
Documenting the outcomes of EOL care discussions
e.
Revisiting EOL care plans periodically
c.
2.
Does it mention indications for which sedation may or
should be considered?
2

No  question 2

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No question 3a

Yes
2.1 Are any of the following explicitly or implicitly mentioned?
a. Symptom /suffering should be intolerable
(unbearable)
b. Symptom /suffering should be refractory
2.2 Do the indications include non-physical symptoms?
2.3 Are any of the following explicitly/ implicitly mentioned
with respect to ‘non-physical’ or existential symptoms?
a. Continuous sedation should be considered only
when patient is in the terminal stage of illness
b. Continuous sedation should initiated for respite
reasons, with plans to reduce sedation after the
problematic symptom is controlled
c. Continuous sedation should be considered only
after repeated respite sedation, combined with
intensive intermittent therapy
d. Respite sedation may be indicated earlier in
the patient’s trajectory, for temporary relief
whilst awaiting treatment benefit from other
therapeutic approaches
e.
A symptom should be labeled ‘refractory’ only
after a period of repeated assessment by
clinicians skilled in psychological care
f.
Patient evaluation should be made within the
context of a multidisciplinary team
2.4 Does it mention a specific life expectancy in the
patient’s illness trajectory?
2.4.1 If yes, which of these is mentioned?
a. Hour to days
b.
≤ 1 week
c.
1- 2 weeks
d. Other, specify ………………………………….
2.5 Does it explicitly mention the possibility of using
temporary sedation earlier on in the treatment process
(i.e. before the terminal phase of illness)
3. a. Does it mention necessary evaluation (assessment)
procedures for the patient, prior to sedation?
3.1 Who should (ideally) evaluate patient?
a.
b.
c.

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No question 2.5

Yes

No

Yes

No question 3b

Yes

No question 4

Yes
Not explicitly stated
A clinician with sufficient experience in
palliative care
A multidisciplinary team
d. Other, specify ............................................
3.2 What does the evaluation include?
(more than 1 option possible)
a. Medical history
b. Relevant investigations
c. Physical examination of patient
d. Psycho-social and existential issues
e. Life expectancy
f. Decision-making capacity
g. Other, specify………………………………….
3b. Does it mention a consultation procedure, pre-sedation?
3.3 When should a PC expert be consulted?
(more than 1 option possible)
a. In case of uncertainty
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b. In case of extreme distress
c. Always
d. Not explicitly stated
e. Other, specify....................................................
Does it secifically mention requirements for patient consent
before the sedation is performed?
4.1 Who can give consent?
(more than 1 option possible)
a. Patient, if competent
b. A legally recognized proxy, if patient is not
competent
c. A family member, if patient is not competent
d.
Other, specify ……………………………………
e.
Not explicitly stated

No question 5

Yes

No question 6

Yes

No

Yes

No

Yes

No

Yes

No question 7a

Yes

No

Yes

No

Yes
4.2 If patient is not competent, and does not have legally
recognized proxy or family member, who should give it?
a. Physician
b. Not explicitly stated
c. Other, specify …………………………………
……………………………………………………
4.3 Which of the following should inform the discussion
about consent?
(more than 1 option possible)
a. Patient’s general condition
b. Rationale (that sedation is the only method
available means of achieving symptom relief
witihn an acceptale time)
c. Aim of sedation
d. Method of sedation, including depth
e. Anticipated effects
f.
Potential uncommon risks
g. Ongoing treatment and nursing care
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6
h. Expected outcomes, incl. other treatment
options, and expected survival if sedation is
not performed
i. Commitment to patient’s wellbeing and care
irrespective of patient’s treatment choices
j. Other, specify .....................................
Mentions discussing decision-making process with patient’s
family?
5.1 Select from the under-listed items:
a. If family was not part of the decision-making,
permission should be sought from the patient
to update them of patient’s condition
b. Permission sought to discuss the decision to
sedation with them
c. In the case of a disagreement, patient should
be strongly encouraged to reconsider the
position not to discuss
Presents direction for selecting the sedation method?
6.1 Select from the under-listed items: it recommend that
the sedation
a. Is begun with the lowest level required to
adequately relieve suffering
b. Is begun on a mild or intermittent level, before
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graduating to higher doses (except in
emergency)
c. Deep sedation should be considered only when
lower doses are ineffective
d. Deep sedation should be considered if there is
an emergency (massive hemorrhage) and it is
the patient’s explicit wish
a. Provides direction for dose titration during the sedation?

No

Yes

No

Yes

No question 7b

Yes

No

Yes

No question 7b

Yes

No question 8

Yes
7.5 What should be monitored?
(more than 1 option possible)
a. Severity of suffering
b. Level of consciousness
c. Adverse effects related to sedation
d. Other, specify ……………………………..
7.6 Does it mention frequency of patient monitoring?

No question 7.8

Yes
7.7 If yes, select which of the following options are
mentioned about patient monitoring (more than 1 option)
a. Should be done based on the goal of care
b. Regarding short term sedation, physiological
stability should be preserved within the preagreed treatment constraints
c. Regarding continuous sedation, the only critical
parameters for ongoing observation are those
pertaining to comfort
d. Other, specify ………………………………..
7.8 How should the monitoring be done?
(more than 1 option possible)
a. Observation
b. Physical signs e.g. response to pain, facial
expression
c. Use of assessment scales
d. Other, specify ……………………………………
7c. Provides direction for patient care during the sedation?

No question 8a

Yes
7.1 Does it mention the drugs for appropriate sedation
7.2 Select which drugs can be used:
(more than 1 option possible)
a. Benzodiazepines (e.g. midazolam)
b.
Neuroleptics /antipsychotics
c.
Barbiturates
d.
General anesthetics (e.g. propofol)
e.
Other, specify ……………………………
7.3 Does it mention who should start the sedation?
7.3.1 If yes, who should preferable start the sedation?
a. Physician
b. Nurse
c. Physician and nurse
d. Other, specify ……………………………..
7b. Provides direction for patient monitoring during sedation?
7.9 The level of dignified care provided by the team during
sedation, depending on patient’s wishes and estimated harm
should include: (more than 1 option possible)
a. Talking to the patient
b. Adjusting the environment
c. Oral care
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d. Eye care
e. Toilet hygiene
f. Pressure wound care
g. Other, specify ……………………………………
a. Provides guidance for decisions regarding the use of
artificial hydration /nutrition during sedation?
8.1 Regarding artificial hydration/nutrition:
a. The decision to use artificial hydration/nutrition
during the sedation is independent of the decision to
sedate
b. The decision to use artificial hydration/nutrition
during the sedation depends on wishes and
perspectives of those involved
c. If adverse effects occur from artificial hydration
/nutrition, then reducing the amount or withdrawal
should be considered
d. Other, specify
……………………………………………………
8b. Provides guidance for decisions regarding the use of
concomitant medications?
8.2 Regarding medication:
a. Medication for symptom palliation that were used
before sedation should be continued, unless found
ineffective or to have a distressing effect
b. Medications that are inconsistent / irrelevant to the
goal of care may be withdrawn
c. Other, specify
…………………………………………………
8.3 Regarding Opioids
a. In most cases opioids should be
continued, possibly with dose modification
b. Opioids should be withdrawn if there are
signs of adverse effects or overdose
(respiratory distress or myoclonus)
c. If symptoms are well palliated and
overdose signs are observed opioid doses
should be reduced
d. Opioids should not be withdrawn rapidly to
avoid precipitating withdrawal symptoms
e. Other, specify,
…………………………………….
a. Mentions the care needs of the patient’s family?
9b. Mentions the informational needs of the patient’s family?
9.1 Care team must provide supportive care in the form of
(more than 1 option possible)
a. Physical care needs
b. Psychological care needs
c. Spiritual care needs
d. Other, specify ..................................................
9.2 Select most appropriate options regarding care needs
a. Families should be allowed to be with the patient
during sedation
b. Families should be allowed and encouraged to say
goodbye
c. If patient is hospitalized, every effort should be
made to provide privacy for emotional and physical
intimacy
d. To promote family’s wellbeing and peacefulness,
considerations should be paid to aesthetics of the
environment and basic support (i.e. place to sleep)
e. Other, specify
……………………………………………….
6

No question 8b

Yes

No

Yes

No

Yes

No

Yes

No  question 9a

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes



No question 9b
No question 10

Yes
Yes

No

Yes

No

Yes

No

Yes

No

Yes
9.3. Select most appropriate options regarding the family’s
information needs:
a. Families should be informed of patient’s state of
wellbeing
b. Families should be informed that other methods were
sufficiently tried, but were considered ineffective
c. Families should be informed of what to expect during the
sedation (i.e. drug reactions, adverse effects etc.)
d. Families should be informed that the sedation is unlikely
to shorten patient’s life
e. Families should be informed that the sedation can be
reduced or discontinued if needed
f. Other, specify …………………………………
10 Includes the care for the medical professionals?
10.1 What does it cover?
(more than 1 option possible)
a. Physical needs
b. Psychological /emotional needs
c. Spiritual needs
d. Information needs
e. Training needs
f. Other, specify.........................................................
10.2 Select most appropriate options:
a. Team should recognize the potential for staff distress
b. All participating staff need to understand the goals of
care
c. All participating staff need to understand the rationale for
sedation
d. Whenever possible, issues should be addressed before
and after the event, to discuss professional and
emotional issues related to such decisions
e. When, issues should be addressed after the event, to
improve local procedures where possible
f. Other, specify
…………………………………………………………
11 Mentions anything about documenting the build-up to the
actual sedation?
11.1 What should such a report contain?
(more than 1 option possible)
a. Medical rationale for sedation
b. Decision-making process
c. Aim of care
d. Depth of sedation
e. Duration of sedation
f. Other, specify .......................................................
12 Non-EAPC: Mentions other end-of-life decisions?
12.1 If yes, specify………………………………………….
12.2 In what context are these mentioned?
(more than 1 option possible)
a. For purpose of clarification
b. For purpose of comparison
c. Other, specify ......................................................
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
No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No question 11

Yes


No
No


Yes
Yes

No

Yes

No

Yes

No

Yes

No

Yes

No question 12

Yes

No question C1

Yes
C. APPRAISAL OF GUIDELINE: using the AGREE II INSTRUMENT (Browers et al).
Select the most appropriate responses (see instructions): KEY: SD=strongly disagree; SA= strongly agree; LPQ=lowest possible quality; HPQ=
highest possible quality
D. IMPLEMENTATION & DISSEMINATION
Select the most appropriate responses (see instructions):
1.
Does it include dissemination plans? If so, select the
proposed methods (more than 1 option possible)


2.
What measures are proposed for implementing its
recommendations in clinical practice?



3.
Briefly state what is /has been done regarding
implementing the stated recommendation(s)?
Estimated time needed to fill in this checklist
No plans explicitly stated
Yes
o Via publication
o Via targeted websites
o On-line
o Other, specify .....................
None mentioned
A checklist
Other, specify .............................
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Additional remarks:
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