Study design
We intend to design and perform a systematic review of CPGs on the palliative sedation of adults and to focus our analysis on the ethical challenges of all forms of this practice. The review will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [25].
This systematic review protocol is reported in accordance with to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols (PRISMA-P) [26] (see Supplementary File 1, for the checklist), and is registered on the International Prospective Register of Systematic Reviews (PROSPERO) as of 22 June 2021 (registration number: CRD42021262571).
Patient and Public Involvement
No patient involved.
Information sources and search strategy
Our systematic CPGs search will be conducted in three main steps by MT, a post-doctoral researcher in the ethics of palliative care, CJ, a medical librarian, and RJJ, a palliative care physician and researcher in the ethics.
In the first step, the following five electronic bibliographic databases will be searched: Medline (Ovid), Embase.com, CINAHL with Full Text, APA PsycInfo (Ovid), and Web of Science (All Databases). Strategies will include controlled vocabulary (if available) and free-text terms and will be peer reviewed by another librarian using the Peer Review of Electronic Search Strategies (PRESS) checklist [27] (see Supplementary File 2, for the draft Embase strategy). Citations will be integrated in citation management software (Endnote X9) for deduplication.
The following resources will be used for complementary searches: Trip Database, ECRI Guidelines Trust, Guidelines International Network, NHS Evidence Search, bibnet.org, CisMef, Society guideline links (UpToDate), Google Scholar, Google, and the websites of societies of palliative care, and medical ethics. If necessary, the corresponding authors will be contacted to obtain more detailed information about guidelines that emerged from these searches.
In complementary resources, search will be performed in English, as well as in French, German, Italian, and Polish, according to the list of translated terms (if translatable, translated according to usage). This list is presented in Table 1.
Table 1: Terms to be used in the Internet search
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English
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French
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German
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Italian
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Polish
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‘Palliative sedation’
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‘Sédation palliative’
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‘Palliative sedierung’
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‘Sedazione palliativa’
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‘Sedacja paliatywna’
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‘Terminal sedation’
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‘Sédation terminale’
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‘Terminale sedierung’
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‘Sedazione terminale’
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‘Sedacja terminalna’
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‘Sedation in palliative care’
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‘Sédation en soins palliatifs’
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‘Sedierung in der palliative care’
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‘Sedazione in cure palliative’
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‘Sedacja w opiece paliatywnej’
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‘Sedation in palliative medicine’
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‘Sédation en médecine palliative’
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‘Sedierung in der palliativmedizin’
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‘Sedazione in medicina palliativa’
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‘Sedacja w medycynie paliatywnej’
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‘Continuous sedation’
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‘Sédation continue’
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‘Kontinuierliche sedierung’
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‘Sedazione continua’
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‘Sedacja ciągła’
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‘Continuous deep sedation until death’
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‘Sédation profonde et continue jusqu’au décès’
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‘Tiefe kontinuierliche sedierung bis zum tod‘
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‘Sedazione profonda e continua fino alla morte’
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‘Sedacja głęboka ciągła utrzymywana do śmierci’
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‘Recommendations’/ ‘guidelines’
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‘Recommandations’/
‘guide’
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‘Empfehlungen’/ ’Leitlinien’
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‘Linee guida’ / ‘Raccomandazioni’
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‘Rekomendacje’/
‘Wytyczne’/‘Zalecenia’
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‘Practice guidelines’
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‘Recommandations / Guide pratique(s)’
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‘Praxisempfehlungen’/ ‘Praxisleitlinien’
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‘Linee guida /
Raccomandazioni pratiche’
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‘Rekomendacje /
Wytyczne / Zalecenia praktyczne’
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‘Clinical guidelines’
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‘Recommandations / Guide clinique(s)’
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‘Klinische empfehlungen’/ ‘Klinische leitlinien’
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‘Linee guida / Raccomandazioni
cliniche’
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‘Rekomendacje/
Wytyczne / Zalecenia kliniczne’
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‘Clinical practice guidelines’
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‘Recommandations / Guide de pratique clinique’
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‘Klinische praxisleitlinien’
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‘Linee guida / Raccomandazioni di pratica clinica’
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‘Rekomendacje / wytyczne / Zalecenia dotyczące praktyki klinicznej’
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In the second step, citation chasing will be carried out on included papers, in order to identify guidelines that may not have appeared through the database search. Individual and collective members of a palliative care society will then be asked about the guidelines used in their country. Prominent experts in palliative care will be contacted, if a country does not have a society for palliative care. Finally, a call will be published on LinkedID (online professional network).
Inclusion and exclusion criteria
The inclusion and exclusion criteria are presented in Table 2.
Table 2: Inclusion and exclusion criteria
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|
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Inclusion criteria
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Exclusion criteria
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1
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Type of
document
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Explicit statement identifying the document as a ‘practice guideline’ in line with the definition in MEDLINE. According to this definition, a ‘practice guideline’ is a ‘work consisting of a set of directions or principles to assist the health care practitioner with patient care decisions about appropriate diagnostic, therapeutic, or other clinical procedures for specific clinical circumstances’ [28].
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All documents contrary to the definition of the ‘practice guideline’ published in MEDLINE, such as documents not validated by a national authority, results of studies, study protocols, systematic literature reviews, description of the procedure, expert opinion without a consensus conference, commentaries, letters, and editorials.
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2
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Subject of
document
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Palliative sedation for adults (without explicitly specifying, such as cancer or geriatric patients), in all contexts of palliative care, such as a palliative care unit, inter-hospital palliative care mobile team, intra-hospital palliative care mobile team, or patient’s home.
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Sedation in other contexts (e.g., anaesthesia, intensive medicine, emergency medicine, or radiology) and/or for other populations (e.g., neonatology and paediatrics) or explicitly specified (e.g., cancer patients).
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3
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Source
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Texts developed by government agencies, associations, organizations, such as professional societies or governing boards, or by the convening of expert panels.
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Texts developed by institutions, such as a hospital.
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4
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Scope
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Texts validated at the international, national, or regional level.
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Texts not validated at the international, national, or regional level, such as internal hospital practice guidelines.
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5
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Target
audience
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Medical and paramedical staff.
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Other than medical and paramedical staff.
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6
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Language of publication
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English, German, French, Italian, or Polish (as native languages or used fluently by the authors of this paper).
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Published in a language other than English, German, French, Italian, or Polish.
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7
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Year of publication
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From 2000 to the date of the searches.
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Before 2000.
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8
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Version
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If there is more than one version of a specific guideline, only the latest and most up-to-date version. If a short and long version exist, only the long version.
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All versions not in force currently and/or a short version.
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9
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Availability
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Only full text.
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No full text accessible.
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10
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Definition of sedation
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Explicit or implicit definition (two items required: duration and depth of sedation).
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Lack of definition, or lack of one or both of the two items required (duration and depth of sedation).
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Guidelines selection
In the first step, the titles and abstracts of all CPGs identified will be screened by MT. Relevant CPGs will be retrieved and assessed for potential inclusion in accordance with the inclusion and exclusion criteria (1-9) presented in Table 2. Where it is unclear how to apply the inclusion/exclusion criteria, discussions between the two researchers involved at this stage (MT and RJJ) will be held and a consensus procedure applied. The corresponding author of the CPGs will be contacted if further information is required.
In the second step, the eligibility of each full text will be assessed and a final decision made regarding whether it will be included in the analysis. This final selection of full texts will be based on all the inclusion and exclusion criteria (1-10) presented in Table 2. Potential disagreements will be resolved by discussion between the two researchers.
Data extraction and analysis
Given the lack of methodological best practice standards for the extraction and analysis of data regarding ‘ethical challenges’, original content analysis will be performed in accordance with the objectives of this study by one reviewer (MT) in collaboration with RJJ (for adjudication on unresolved differences). If deemed necessary, corresponding authors will be contacted to resolve any uncertainties.
In the first step, vertical analysis (text by text) will be carried out in accordance with the analysis grid presented in Table 3.
Table 3: Grid for vertical analysis
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Formal characteristics of the CPGs
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Title and subtitle
|
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Scope (international / national / regional)
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|
Source
|
|
Language of publication
|
|
Year of publication
|
|
Number of pages
|
|
Number and affiliations of authors
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|
Availability (journal / website)
|
|
Importance of ethical considerations in the CPGs
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Chapter(s) and/or paragraphs explicitly focused on ethical considerations
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Yes/No
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Title(s)
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|
Placement(s) in the text
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|
Participation of a society for medical ethics
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|
Participation of ethicists
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Spectrum of ethical challenges of all forms of palliative sedation
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Palliative sedation
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Items: depth and duration of sedation, target patients, artificial hydration and nutrition, indications.
Example:
I. ‘X’: ......................................................................................
II. ‘XY’: ..................................................................................
III.‘XYZ’: ..........................................................................
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Ethical challenges
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I. Ethical challenges of ‘X’
Ethical challenge no. 1/2:.......................................................
a) Cancer and/or non-cancer patients:....................................
b) Disciplinary components:...................................................
c) Cultural influence:..............................................................
Ethical challenge no. 2/2:.......................................................
a) Cancer and/or non-cancer patients:....................................
b) Disciplinary components:...................................................
c) Cultural influence:.............................................................
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II. Ethical challenges of ‘XY’
Ethical challenge no. 1/1:......................................................
a) Cancer and/or non-cancer patients:....................................
b) Disciplinary components:...................................................
c) Cultural influence:..............................................................
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III. Ethical challenges of ‘XYZ’
Ethical challenge no. 1/1: ......................................................
a) Cancer and/or non-cancer patients:....................................
b) Disciplinary components:...................................................
c) Cultural influence:.............................................................
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In the second step, transversal analysis of all texts will be undertaken in accordance with the analysis grid presented in Table 4.
Table 4: Grid for transversal analysis
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CPGs no. 1
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CPGs no. 2
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CPGs no. 3
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Formal characteristics
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Title and subtitle
|
|
|
|
Scope
|
|
|
|
Source
|
|
|
|
Language of publication
|
|
|
|
Year of publication
|
|
|
|
Number of pages
|
|
|
|
Number and affiliations of authors
|
|
|
|
Availability
|
|
|
|
Importance of ethical considerations
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Chapter(s) and/or paragraphs explicitly focused on ethical considerations
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|
|
|
Title(s)
|
|
|
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Placement(s) in the text
|
|
|
|
Participation of a society for medical ethics
|
|
|
|
Participation of ethicists
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|
|
|
Spectrum of ethical challenges of all forms of palliative sedation
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Palliative sedation
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Items: depth and duration of sedation, target patients, artificial hydration and nutrition, indications.
Example:
I. ‘X’:.......................................
II. ‘XY’:...................................
III. ‘XYZ’:...............................
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Items: depth and duration of sedation, target patients, artificial hydration and nutrition, indications.
Example:
I. ‘X’: .......................................
II. ‘XY’:...................................
III. ‘XYZ’:...............................
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Items: depth and duration of sedation, target patients, artificial hydration and nutrition, indications.
Example:
I. ‘X’:.......................................
II. ‘XY’: ..................................
III. ‘XYZ’:...............................
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Ethical challenges
|
I. Ethical challenges of ‘X’
Ethical challenge no. 1/2:.........
a) Cancer and/or non-cancer patients:.....................................
b) Disciplinary components:.....
c) Cultural influence:...............
Ethical challenge no. 2/2:
a) Cancer and/or non-cancer patients:....................................
b) Disciplinary components:.....
c) Cultural influence:................
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I. Ethical challenges of ‘X’
Ethical challenge no. 1/1:.......
a) Cancer and/or non-cancer
patients:...................................
b) Disciplinary components:....
c) Cultural influence:..............
|
I. Ethical challenges of ‘X’
Ethical challenge no. 1/1:.......
a) Cancer and/or non-cancer
patients:.................................. b) Disciplinary components:....
c) Cultural influence:..............
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II. Ethical challenges of ‘XY’ and the rest
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II. Ethical challenges of ‘XY’ and the rest
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II. Ethical challenges of ‘XY’ and the rest
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III. Ethical challenges of ‘XYZ’ and the rest
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III. Ethical challenges of ‘XYZ’ and the rest
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III. Ethical challenges of ‘XYZ’ and the rest
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All analysis will be performed at the textual, linguistic, and thematic levels. Two opposite analysis methods – with and without a framework – will be used.
Textual analysis with a pragmatic framework will be performed to identify the formal characteristics of the CPGs and to determine the importance of ethical considerations in these texts (1-2); a range of types of information chosen in advance will be extracted from the CPGs (see below).
Linguistic analysis with a list of the items chosen in advance will be applied to identify all forms of palliative sedation and analyse their definitions. In contrast, thematic analysis with continuous theming (without a framework) and line-by-line coding of the text will be used to identify possible ethical challenges of palliative sedation. This method will also be used to determine whether CPGs specify ethical challenges in respect of cancer and non-cancer patients and, if so, how exactly they do this. According to this method, the majority of the themes will not be identified in advance; they will be inductively derived from the texts, without attempting to validate a particular theory or hypothesis [29]. All identified themes will then be grouped and organized into descriptive categories. It is important to be precise in the way the conceptual framework is developed (see below) for thematic analysis and applied to all texts. We chose this method because of the lack of research on this topic and to enable us to explore our material in depth. Our plan for data extraction and analysis is summarized in Figure 1.
Textual analysis
Identification of the formal characteristics of the CPGs
The following general characteristics will be searched for and noted: title and subtitle, scope (i.e., international, national, or regional), source, language, year of publication, number of pages, number and affiliations of authors, and availability (i.e., published in a journal or on a website).
Determination of the importance of ethical considerations in the CPGs
To determine the place of ethical considerations in the texts, the chapters and paragraphs that focus explicitly on ethical considerations will be searched for (e.g., a title containing the word ‘ethical’/‘ethics’ or with an obvious relation to ethics, such as euthanasia). The exact titles and placement in the text will be noted. In addition, the list of authors will be analysed, in order to determine whether and what kind of ethics expertise has been integrated into the CPGs (e.g., the participation of a society for medical ethics or ethicists in the development of the CPGs).
Linguistic analysis
Our linguistic analysis will aim to identify diverse forms of palliative sedation and to explore the terminology and definitions conceptually. In order to incorporate as many types of palliative sedation as possible, a working definition of this practice will not be employed. Initially, a linguistic analysis will be performed to identify all forms of palliative sedation presented in the CPGs. Their definitions, if available in the text, will be analysed according to the several items issued in a previous linguistic study [5]: depth and duration of sedation, sedating drugs, target patients, withdrawal or withholding of artificial nutrition and hydration, and indications. In the next step, ethical challenges of each type of sedation identified will be searched for in the full text.
Thematic analysis
Our thematic analysis will aim to identify the full spectrum of possible ethical challenges of all forms of palliative sedation. The analysis will also aim to determine whether the CPGs identified specify the ethical challenges of this therapy in respect of cancer and non-cancer patients and, if so, how exactly they do this.
Conceptual framework
Medical ethics can be defined in several ways. In the specialist literature, several terms are used to refer to ethical questions, such as ‘ethical issues’, ‘ethical aspects’, ‘ethical challenges’, ‘ethical dilemmas’, ‘ethical considerations’, ‘ethical reflection’, and ‘ethical risks’; often without explicit definition. Thus, in research ethics, the most basic (and paradoxical) question would always be ‘which is an ethical question, which is not?’. We understand ‘ethics’ as rational reflection, both individually and collectively, on moral issues. Moral issues are those that refer to the norms and values that apply to human beings as human beings [30].
For the purpose of our study, the term ‘ethical challenges’, which is borrowed from Kahrass et al. [31], is chosen and its working definition is elaborated by our research team (MT, CB, and RJJ). We did not adopt the definition proposed by Kahrass et al. [31] because it has a limited focus on principlism. This ethical approach has been elaborated by Beauchamp and Childress [32] and is based on four general principles: beneficence, non-maleficence, respect for autonomy, and justice. Currently, this approach is largely and explicitly used in theoretical academic literature and in clinical ethics. However, these principles always have to be adapted to the specific medical and personal context of the individual patient. According to the definition in MEDLINE, CPGs are ‘work[s] consisting of a set of directions or principles to assist the health care practitioner with patient care decisions about appropriate diagnostic, therapeutic, or other clinical procedures for specific clinical circumstances’ [28]. Thus, it is not certain that the four ethical principles will be explicitly presented in CPGs. If they are implicitly presented in CPGs, their identification and qualitative analysis may be very imprecise, subjective, and even erroneous. In addition, the systematic review performed by Schofield et al. [33], which focuses on the ethical challenges reported by specialist palliative care practitioners in their clinical practice, shows that practitioners use different approaches for ethical reflections, not only the ‘four principles’ of Beauchamp and Childress [32].
In our study, an ‘ethical challenge’ is defined as a relevant difficult situation (purely clinical or not) with regard to palliative sedation that provokes a question, an uncertainty, a controversy, or a risk that ethical norms will be transgressed. This situation may also require making a choice between two or more possibilities and needs great mental effort, in order to be conducted successfully. According to this working definition, the following questions can be considered as an ‘ethical challenge’: ‘Should we accede to a patient’s request to induce CDSUD for existential distress?’ and ‘Should we induce palliative sedation in response to requests for assisted dying, such as euthanasia or assisted suicide?’.
Analysis
In accordance with the conceptual framework, ethical challenges will be considered using an interdisciplinary approach, but the disciplinary components of each challenge (e.g., medical, moral, legal, and communicational) will be identified and analysed. Potential cultural influences, such as the legal and social contexts of a country, will also be explored. The ethical challenges of palliative sedation for cancer and/or non-cancer patients will then be searched for in the whole text. If they are identified for both populations, their potential similarities and differences will be analysed.
Data synthesis
At the time of writing this study protocol, and to the best of our knowledge, there are no specific methodological standards for the data synthesis of CPGs analysis that is focused on the ethical challenges of a medical procedure. In the literature, authors have proposed a very interesting and useful model for the data synthesis of CPGs analysis focused on ethical issues in line with a disease [31, 34, 35]. Despite its usefulness, however, we opted not to adopt this approach because it is not fully applicable to a data synthesis that is focused on the ethical challenges of a medical procedure, such as palliative sedation.
Our narrative synthesis will explore the findings within and the relationship between the CPGs included. The ethical challenges of palliative sedation, including their potential comparison in the care of cancer and non-cancer patients, will be presented according to the types of palliative sedation previously identified in the CPGs. As our systematic review is purely descriptive, we do not intend to carry out theory development.