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AGREE-Ethics. A working model
(The AGREE instrument modified for the application on ethical guidelines)
SCOPE AND PURPOSE
1. The overall objective(s) of the guideline is (are) specifically described
Guidelines on ethically relevant questions are influential regarding the behaviour of healthcare professionals and have an impact on the health of patients covered by the respective guidance. The overall objective(s) of the guideline with respect to ethically relevant aspects of clinical practices should be described in detail.and the expected benefit from the guideline should be specific to the clinical-ethical problem. For example specific statements would be:
• Support of healthcare providers with respect to end of life decision making in intensive care
• Assistance of physicians with respect to disclosing bad news to patient with a life limiting disease
· The statement should be answered with “1”, “strongly disagree”, either if there is unclarity about the purpose of the guideline or if no objectives have been named.
· A rating of “2” requires the naming of objectives in general (e.g. optimization of care at the level of process quality, structural quality or quality of results, support of doctors, patients or family members in dealing with certain illnesses and situations; assistance in the training of those beginning their careers or seeking continuing education).
· A rating of “3” requires the naming of specific objectives
· For the rating “4”, “strongly agree”, the objectives of the guideline should be distinguished from related objectives which are not pursued by this guideline or the reasons why a further specification of the objectives would not be productive should be explained
Examples for a 4 rating
Example: Renal Physicians Association and American Society of Nephrology (1999). Clinical Practice Guideline on Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis.
See A GUIDE TO THIS DOCUMENT (p. 5): “This document, Clinical Practice Guideline on Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis, addresses recommendations concerning withholding or withdrawing dialysis in adult patients with either acute renal failure (ARF) or end-stage renal disease (ESRD).”
See also SECTION 2: BACKGROUND. Scope and Intended Use (p. 13.14): […] The guideline provides recommendations on the targeting, timing, and content of discussions related to either withholding or withdrawing dialysis, and the care of patients who forgo dialysis. The guideline also provides recommendations on when it is appropriate to withhold or withdraw dialysis. The recommendations are not mandatory, but rather flexible guides that warrant tailoring based on particular patient, provider, and geographic circumstances. They allow the renal care team discretion in their application to individual patients.
See also SECTION 2: BACKGROUND. Guideline Objectives (p. 14): The following are the objectives of this guideline:
· Synthesize available research evidence on patients with ARF and ESRD as a basis for making recommendations about withholding and withdrawing dialysis;
· Enhance understanding of the principles and processes useful for and involved in making decisions to withhold or withdraw dialysis;
· Promote ethically as well as medically sound decision-making in individual cases;
· Recommend tools that can be used to promote shared decision-making in the care of patients with ARF or ESRD; and
· Offer a publicly understandable and acceptable ethical framework for shared decision-making among health care providers, patients, and their families.
2. The ethical question(s) covered by the guideline is (are) specifically described
A detailed description of the ethically relevant questions covered by the guideline should be provided, particularly for the key recommendations (see item 17). Following the examples provided in question 1:
• Which are the ethically relevant aspects of end of life decision making in intensive care?
• Which are the ethical and communication challenges when disclosing bad news to patients with life limiting diseases?
· The statement should be answered with “1”, “strongly disagree”, if the guideline does not specify any ethically relevant questions/problems underlying the key recommendations.
· A rating of “2” means that the guideline only specifies underlying ethically relevant questions/problems for some of the key recommendations.
· A rating of “3” requires specification of underlying ethically relevant questions/problems for most key recommendations.
· A rating of “4”, “strongly agree”, requires that the guideline specifies the underlying ethically relevant questions/problems for all key recommendations. The key recommendations must have a clear (conceptual) connection to the background information.
Examples for a 4 rating
Example: Renal Physicians Association and American Society of Nephrology (1999). Clinical Practice Guideline on Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis.
See SECTION 1: FOREWORD AND RATIONALE FOR GUIDELINE. Ethical Considerations in Dialysis Decision-Making (p. 9-12). This chapter specifies four dimensions of the ethical problem: medical indications, patient preferences, quality of life, and contextual features, that is, the social, economic, legal, and administrative context in which the decision occurs.
See also SECTION 2: BACKGROUND. Scope and Intended Use (p. 13): Shared decision-making--the process by which physicians and patients agree on a specific course of action based on a common understanding of the treatment goals and risks and benefits of the chosen course compared with reasonable alternatives--is recommended. Shared decision-making recognizes the importance of both patient preferences and medical indications. In shared- decision-making, the health care provider is the expert in diagnosis, prognosis, and treatment alternatives, and the patient is the expert in his or her own history, values, preferences, and goals. The two work together to reach decisions that are individualized to the patient’s particular circumstances and preferences. There are limits, however, to the shared decision-making process that protect the rights of patients and the professional integrity of health care professionals. The patient has the right to refuse dialysis even if the renal care team disagrees with the patient’s decision and wants the patient to undergo dialysis. Similarly, the renal care team has the right to refuse to offer dialysis when the expected benefits do not justify the risks. Recognizing that there are circumstances in which patients and renal care teams might disagree about decisions to start, continue, or stop dialysis, this guideline provides recommendations for how to resolve such conflicts.
3. The patients/other relevant group to whom the guideline is meant to apply are specifically described.
There should be a clear description of the target population which is covered by a guideline. The age range,
sex, clinical description and other criteria relevant to the ethical questions covered by the guideline may be provided.
For example:
• A guideline on end-of-life decision making only includes the group of patients in the intensive care setting who lack legal capacity
• A guideline on the management of disclosing bad news to adult patients for whom there is no curative treatment option available
There should be an explicit statement if the aforementioned or other characteristics are not relevant for the ethical guideline
· The statement should be answered with “1”, “strongly agree”, if the target patient population has not been named or can only be indirectly inferred from the text of the guideline.
· A rating of “2” requires a simple statement of the target patient population.
· A rating of “3” requires the additional description of the characteristics of inclusion or exclusion, such as the relevant area of care (ambulant or stationary treatment, age, degree of severity).
· A rating of “4”, “strongly agree”, requires an explanation of the reasons why a further specification of the target patient population would not be productive.
Examples for a 4 rating
Example: American Thoracic Society (2007). Clinical Policy Statement: Palliative Care for Patients with Respiratory Diseases and Critical Illnesses
See „Executive Summary“ (p. 912): Although originally conceived and practiced as end-of-life care, palliative care may be applied to all stages of illness, whether terminal or not. Because its members commonly care for children and adults and their families in need of palliative care due to chronic respiratory diseases or critical illnesses, the American Thoracic Society (ATS) approved formation of an ad hoc End-of-Life Care Task Force whose purpose was to develop this statement that focuses on how to better integrate palliative care into standard clinical management (curative and/or restorative care).
See also „Introduction“ (p. 913): Although this statement primarily describes providing palliative care for children and adults with advanced respiratory diseases and critical illnesses, the same professional values and principles and many of the same recommendations also apply to the care of neonates and of patients in intensive care units (ICUs) due to trauma or for perioperative care.
See also: Goals, Timing, and setting for palliative care“ (p. 914): Clearly, palliative care should be available near the end of life. However, it should also be available at any point during the course of a progressive or chronic respiratory disease or critical illness when the patient becomes symptomatic. An important concept is that, in general, palliative care should be available when curative/restorative care begins, while curative/restorative care continues, after life-prolonging treatments are withheld or withdrawn, and, for the patient’s family, after the patient’s death..
STAKEHOLDER INVOLVEMENT
4. The guideline development group includes individuals from all the groups relevant to the ethical issue at stake.
This item refers to all groups relevant to the ethical issue at stake who were involved at some stage of the development process.
This may include members of the steering group, the research team involved in selecting and
reviewing /rating the evidence and individuals involved in formulating the final recommendations.
This item excludes individuals who have externally reviewed the guideline (see Item 13). Information
about the composition, discipline and relevant expertise of the guideline development group should
be provided.
· The statement should be answered with “1”, “strongly disagree”, if there is no reference to the composition of the guideline development group or if authors are only mentioned by name and it is not possible to classify them by professional group or function.
· A rating of “2” requires, alongside the names of the authors, an unambiguous statement of the professional and interest groups that each represent.
· For a rating of “3”, this statement should make it clear that all professional and patient groups addressed by the guideline were actively represented in the guideline development group (e.g., for end-of-life decisions this should generally include: doctors, patients, caregivers).
· A rating of “4”, “strongly agree”, requires additional information about how those professional and interest groups not directly addressed by the guideline (e.g. patients’ family, hospital management, additional medical care professions) were involved. This can occur in the guideline itself or in the guideline report (see criterion 29), whereby the existence of a guideline report must be clearly stated in the guideline itself.
Examples for a 4 rating
Example: Clayton M et al. (2007) Clinical practice guidelines for communicating prognosis and end-of-life issues with adults in the advanced stages of a life-limiting illness, and their caregivers
See „Methods of guideline development“, „Expert advisory panel“ (p. S85): An expert panel was convened, comprising 35 Australian and New Zealand health care professionals and consumers (nine palliative care medical specialists, three medical oncologists, three palliative care nurses, three consumers [including two cancer patients and one caregiver], two general practitioners, two psychosocial experts, two ethicists, two linguists, one oncology nurse, one cardiology nurse, one aged care nurse, one research nurse, one geriatrician, one respiratory physician, one radiation oncologist, one intensive care specialist, and one lawyer).
5. The views and preferences of patients or other groups affected by the guideline have been sought
Information about experiences, preferences and expectations of patients or other groups affected by the guideline should inform the development of ethical guidelines. There are various methods for ensuring that these perspectives inform guideline development. For example, the development group could involve representatives of patients, relatives or other relevant groups, information could be obtained from interviews with relevant representatives, literature reviews on relevant socio-empirical research could be considered by the group. There should be evidence that on eliciting preferences and views by patients or other groups affected by the guideline either within the guideline or as part of a separate report on the production of the guideline.
· The statement should be answered with “1”, “strongly agree”, if patients or other groups affected by the guideline were not involved or if how and to what extent they were involved can only be guessed at from the statements (not) made.
· A rating of “2” requires that representatives of patients or other groups affected by the guideline were indirectly involved (e.g. through a review procedure, with reference to empirical social research in certain key recommendations, or a public discussion of the guideline including modification of its content prior to its going into effect).
· A rating of “3” requires direct participation in developing the guideline and reference to empirical social research for all key recommendations. If the relevant external evidence is not available, this must be explicitly explained.
· A rating of “4”, “strongly agree”, requires an explanation of how the selection of patient or other groups involved is representative as well as a systematic search of the external evidence. This can occur in the guideline itself or in the guideline report, whereby the existence of a guideline report must be clearly stated in the guideline itself.
Examples for a 4 rating
Example: Clayton M et al. (2007) Clinical practice guidelines for communicating prognosis and end-of-life issues with adults in the advanced stages of a life-limiting illness, and their caregivers
With respect to the explanation of how the selection of the patient groups involved is representative see „Methods of guideline development“, „Expert advisory panel“ (p. S85): The panel members were selected to reflect the multidisciplinary nature of care for patients with advanced progressive life-limiting illnesses. Representatives were selected on the basis of either their clinical expertise or a track record of publications on this topic. Consumer bodies, such as Carers NSW and Cancer Voices NSW, were approached and provided consumer representation.
With respect to the systematic search of the external evidence see „Methods of guideline development“ (p. S85): The guidelines were developed using the following process: Literature review: Systematic review of the best available evidence regarding discussion of prognosis and end-of-life issues with patients with a progressive life-limiting illness, and their caregivers; and review of previous related guidelines and expert opinions.