EUROIMPACT PALLIATIVE SEDATION STUDY CHECKLIST on Palliative Sedation Guidelines Version 31 July 2013 Title of document.................................................... ……………………………………………………….. 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 3 4 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 5 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 4 7 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 5 8 9 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 ...................................................... 7 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 ............................. ………………………………………………………………… ………………………………………………………………… ……………………………………………............................ ............................... minutes Additional remarks: …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………… 8