Existing guidelines
Data extracted from the rapid review of 11 included guides are summarized in Table 2. Contents were extracted into the following key themes: guiding principles, target patients, prioritization criteria, decision maker and process, and implementation.
Table 2 Data extraction of existing guidelines on critical care resource allocation
Country
|
Guiding principles
|
Target Patients
|
Prioritization criteria
|
Decision making process
|
Implementation conditions
|
Austria(35)
|
-Ethical principles of justice, non-damage, well-being, autonomy.
|
All patients needing critical care
|
Comorbidities
|
Decision maker: Intensive care specialist
Process: Consultation with ddesignated experts and patients and relatives
Time of decision making: -
|
Health resource demand exceeds supply
|
Belgium(11)
|
- First come first serve
- Randomization
|
All patients needing critical care
|
First-come, first served; Medical urgency; Cognitive impairment; Patient age; Comorbidities
|
Decision maker: Team of healthcare professionals
Process: Consultation with experts (technical, nursing etc.) / patient’s general practitioner
Time of decision making: Upon admission with daily reassessment
|
Health resource demand exceeds supply
|
Germany(12)
|
Clinical success
|
All patients needing critical care
|
Comorbidities
|
Decision maker: Team of healthcare professionals
Process: Consultation with experts (technical, nursing etc.) / patient’s general practitioner. Time of decision making: Upon admission
|
Health resource demand exceeds supply
|
Italy(22)
|
Greatest life expectancy
|
All patients needing critical care
|
Patient age; Comorbidities
|
Decision maker: Healthcare staff with patients, proxies + Others (Ethics committees)
Process: Consultation with Designated experts and Patients / Relatives
Time of decision making: Upon admission with daily reassessment
|
Health resource demand exceeds supply
|
Switzerland(9)
|
- Beneficence
- Non-maleficence
- Respect for autonomy
- Equity
|
All patients needing critical care
|
Patient age; Comorbidities
|
Decision maker: Team of healthcare professionals
Process: Consultation with Ethics committee / team
Time of decision making: Upon admission with reassessment every 2-3 days
|
|
UK (NHS)(10)
|
Clinical success
|
All patients needing critical care
|
Clinical Frailty; Comorbidities
|
Decision maker: Team of healthcare professionals
Process: Consultation with experts (technical, nursing etc.) / patient’s general practitioner . Time of decision making: Upon admission
|
|
UK (BMA)(36)
|
Promote safe and effective patient care as far as possible in the circumstances
|
All patients needing critical care
|
|
Decision maker: Team of healthcare professionals
Time of decision making: Upon admission
|
|
USA (Hasting Center)(37)
|
Promote equality and equity in distribution of the risks and benefits in society
|
All patients needing critical care
|
|
Decision maker: Healthcare staff with patients, proxies and others (Ethics committees)
Process: Consultation with designated experts and patients / relatives
Time of decision making: Upon admission
|
|
USA (New York)(23)
|
-Save the most lives
|
All patients needing critical care
|
First-come, first served; Randomization; Social usefulness; Patient age; Comorbidities; Sequential Organ Failure Assessment
|
Decision maker: Nominated triage officer or triage committees
Process: Consultation with experts (technical, nursing etc.) / patient’s general practitioner. Time of decision making: Upon admission with reassessment after 48 and 120 hours
|
Health resource demand exceeds supply
|
USA (Pittsburgh)(24)
|
- Duty to care
- Duty to steward resources to optimize population health
-Distributive and procedural justice - Transparency.
|
All patients needing critical care
|
Patient age; Comorbidities
|
Decision maker: Nominated triage officer or triage committees
Process: Consultation with ddesignated experts
Time of decision making: Upon admission
|
Health resource demand exceeds supply
|
International (WHO)(38)
|
Utility and equity, on the basis of health-related considerations
|
All patients needing critical care
|
|
Decision maker: Intensive care specialist
Time of decision making: Upon admission
|
Health resource demand exceeds supply
|
Guiding Principles and Prioritization Criteria
The prioritization criteria and tools applied for each guide was positioned by the authors on a scale ranging from social function, which promotes and rewards instrumental value or benefits to others, to clinical prognosis, which gives value to clinical success, the number of lives and life years that can be saved (See Figure 1). Social usefulness, such as patient’s occupation, was applied only for the New York guide. Italy and Pittsburgh both utilized patient age, and it was indirectly assessed in the guides from Switzerland, Belgium and New York. Clinical frailty which involves assessing status of cognitive and physical function is applied in the United Kingdom, Belgium and Germany. Cognitive impairment assessment, measuring brain function and the patients’ medical urgency were criteria only applied in the Belgium guide. Sequential Organ Failure Assessment (SOFA), a tool used to estimate and quantify the number and severity of potential organ failure, was used in New York, Pittsburg, Germany and Austria. Comorbidities, such as prior medical conditions were stated as criteria in the guides from Switzerland, Belgium, New York and Germany, and indirectly considered for United Kingdom, Italy, Pittsburgh and Austria guides. Additionally, first-come, first served method applied in New York and Belgium, as well as randomization, utilized in New York, were excluded from the scale. This wide-ranging scale obtained from the rapid literature review reflects differing societal and cultural values given on allocation criteria.
Target Patients and Guideline Application
All guides indicated the prioritization criteria was to be applied to all patients requiring critical care resources, which includes both COVID-19 and non COVID-19 patients, to ensure that everyone had the same chance of accessing to the scarce resources. The prioritization criteria for most guides was recommended to be applied on admission to intensive care units (ICU). Additionally, some guides recommended reassessment following ICU admission: daily for the Belgian and Italian guides, every 2-3 days for the Swiss guide, and every 48 to 120 hours for the New York ventilator allocation guide.
Decision making process
The recommendation for the primary decision maker for the guidelines differed. Decisions to be made by a team of healthcare professionals involved in the patient’s care was suggested in Switzerland, United Kingdom, Belgium and Germany. While United States guides from Pittsburgh and New York recommended the formation of a triage committee or nominating a triage officer to make decision, sparing those involved in direct patient care. Similarly, the Austrian and WHO guide suggested the nomination of an intensive care specialist as the decision maker. In addition to the primary decision maker, most guides recommended consultations to be made with an ethics committee (Switzerland, Germany, Austria and United States), technical or designated experts (United Kingdom, Belgium, Germany, New York, Pittsburgh, Italy) or with patients and/or relatives (Italy, Austria, United States). Three out of the 11 guides also provided information regarding the process of appeals against decisions made for the patient. The WHO guidance stated that mechanisms to resolve disputes are necessary. The Pittsburgh guide recommended the formation of a Triage Review Committee to review the appeal using majority vote, while the Italian guide suggested appeals be reviewed by a designated experts or regional health centers. Decision-making processes varied between settings reflecting diverse medico-legal and clinical practices across the world.
Implementation
Although all guidelines were developed for the pandemics or outbreaks, only the guides from Belgium, Germany, Pittsburgh, New York, Italy, Austria and WHO, clearly specified its application only upon demand exceeding supply. No guides stated legal mechanisms for enforcement; instead all were voluntary and non-binding recommendations. This ensured the guides could be flexible and adapted to suit the situation and context of each health facility and the changes in clinical data. However, the New York guideline discussed the concern of lack of statutory protection for healthcare workers and institutions.
Current Practices in Thailand
The key informant interview confirmed that no protocols or guidelines on allocating critical care resources currently exist or are being applied in Thailand though they agreed that such guideline would be useful to ensure consistent approach across patients and facilitate patient referral across hospitals during public health emergency. The decisions on allocating critical care resources are primarily made by ICU doctors, usually in consensus and based on several qualitative and quantitative factors including medical urgency, SOFA score and comorbidities such as Charlson Comorbidity Index etc. In addition to clinical prognosis, patients’ cognitive function may be evaluated through relatives; examples provided included the Modified Informant Questionnaire on Cognitive Decline in the Elderly (modified IQ CODE) and Function Assessment Staging Test (FAST). It was maintained that cognitive impairment assessments are not usually undertaken by patients themselves given their critical conditions; though discussions with relatives and caregivers may be utilized by physicians to assess patients cognitive function. While re-assessment following initial admission may be necessary, many doctors are reluctant to step down treatment or withdraw care except upon patient’s prior consent not to treat.
In addition to lack of allocation protocols, advanced care plans are not routinely practiced, and as attending ICU physicians are on rotation, adequate communication between ICU doctors and patient relatives is lacking. Overall, key informants expressed the need for the development of a national guideline especially in the public health emergency and also stressed the importance of the guideline being endorsed by the Thai Medical Council and various Royal Colleges of physicians to ensure successful implementation.
Proposed Draft Guideline
Based on the rapid review and key informant interviews, a draft guideline was developed by the technical team to be proposed at the stakeholder consultations. At both rounds of consultations, the technical team proposed four areas for discussion 1) Criteria for patient assessment in allocating resources, 2) Decision maker and decision-making process, 3) Appeal and documentation mechanisms, and 4) Process of implementation and enforcement.
Prioritization Criteria
The proposed criteria comprised of three-orders to be applied sequentially to break ties in decisions between patients with the same level of priority. In the context of limited critical care resources, the first order criteria aimed to assess patients based on short-term clinical prognosis and maximize the health outcomes. Four assessment tools, that would be chosen based on applicability for each health facility setting, were put forward including; 1) Charlson Comorbidity Index, 2) SOFA, 3) Clinical Frailty Scale (CFS) and 4) Cognitive Impairment Assessment. The second order criteria was the number of potential life years saved, favoring long term survival. Lastly, the third order criteria would prioritize those with higher social utility, such as health care and social service workers.
Decision maker and process
In Thailand, according to the Medical Profession Act 1982 (2525 BE), the decisions on a patient’s prognosis and treatment can only be made by the patients’ attending physician. However, in the situation of scare critical care resources, to alleviate stress and ethical dilemmas faced by physicians, the formation of a Triage Committee was proposed to assist physicians on allocation decisions. The committee of three healthcare professionals, such as a physician, nurse and/or technical expert, has the primary responsibility to apply the prioritization criteria to each patient upon consideration of ICU admission and reassessment every 48 hours and advise physicians on the decision to give, to continue critical care or step-down care, such as to palliative care facilities (Figure 2a).
Appeal and documentation mechanisms
The documentation of all patients’ assessment results and decision allocation during the pandemic is necessary for transparency. In addition, a two-step mechanism for appeals to be made by patients, relatives or legal representatives, were proposed for the stakeholders to consider. Firstly, an immediate appeal of prior allocation decisions for cases where a decision is disputed by the health facility. Followed by the review by an established review committee to verify disputed decisions through a majority vote.
Implementation and Enforcement
To ensure the guideline is utilized in appropriate circumstances, the guideline was proposed to be triggered when only 10-20% of critical care resources remain available and to be applied to all patients requiring critical care resources, both patients affected by the pandemic or those with unrelated conditions. The guideline was proposed to be endorsed and issued as a legal document by Medical Council of Thailand, to ensure consistent application across all public and private facilities in Thailand and to provide legal protection to medical doctors who adhere to it.
Key Stakeholder Concerns and Considerations
During the consultations, five major concerns were identified 1) Ethical principles, 2) Criteria to be used for prioritization, 3) Decision makers and decision-making process, 4) Transparency and process of appeal and 5) Implementation and enforcement.
Ethics
At both rounds of expert consultations, considerable time was spent discussing the ethical principles that the Thai guideline should comply with. Experts compared the COVID-19 pandemic with war time where field resources were scarce, and the military goal was for the greatest utility of the society. Applying this utilitarian ideology can be at direct odds with the medical ethics, beneficence and non-maleficence principles that health workers practiced in normal situations with sufficient resource. Without clear and motivated communication between doctors and patients, the application of ‘rationing’ resources may trigger high levels of stress in some health staff as well as the patients and their relatives. Both stakeholder groups emphasized the need for citizen awareness initiatives to accompany the guideline. Pre-counselling and informing citizens of the necessity to potentially allocate critical care resources, prior to the implementation of the guide was recommended to gain high level of acceptance and limit distrust by the population.
Prioritization criteria
The inclusion of age and social values as prioritization criteria was highly contentious in the consultations. Unlike many countries, including Belgium, Italy, and USA (11,22–24), which use patient age as a prioritizing criterion, most Thai stakeholders did not support an age criterion, even in the form of number of life years saved. Number of life years saved, calculated by life expectancy at birth minus patient age, was seen as linked directly to patient age and also gender given females has higher average life expectancy at birth than males(25). Therefore, the second-order criterion was rejected on the basis that it would contradict the non-discriminatory basis that health professionals are required to adhere to.
Similarly, the third order criterion on social usefulness greatly concerned both groups of stakeholders. Many argued that while the criterion itself carries good justification, to compare social values of individuals is not feasible, decision can be arbitrary which may lead to public distrust. Stakeholders from the Buddhist and Muslim communities felt that all individuals hold their own intrinsic value (either for their own family or to the society) and this cannot be compared to one another. It is worth noting that stakeholders preferred all criteria to be objective and quantifiable to enable a transparent and verifiable decision-making process.
Decision makers
A fundamental reason behind establishing a rationing protocol is to alleviate the psychological burden placed on frontline health workers who would be otherwise tasked with deciding who receives potentially lifesaving resources(26,27). While stakeholders acknowledged that most guidelines spare attending physicians from making allocation decisions and assign that role to a designated staff or a triage team; stakeholders agreed that in accordance with the Thai medico-legal context, decisions on diagnosis and treatment for patients are to be made by attending physicians. Stakeholders also agreed with the need for a committee to play an advisory role to the attending physicians. However, the ‘triage team’, originally proposed was amended to ‘Patient Review Committee’ as the word ‘triage’ may carry a negative connotation in the Thai society. Medical stakeholders suggested the committee consist of five other healthcare professionals (such as physicians, nurses or relevant experts). The civil society and religious group highlighted that a trusted religious or community leader in the Patient Review Committee would also increase the likelihood of patients and relatives accepting the decisions made; though a counterargument was made that a religious leader in the committee may not be applicable to multi-religious communities. It was agreed that a highly respected member of the community should be selected as a committee member.
Appeal mechanisms
Whether or not to establish an appeal mechanism was diligently discussed. On the one hand, allowing patients or representatives to appeal immediately should they disagree with the decision was seen as recognizing patients’ voice and helping ensure objectivity. On the other hand, stakeholders found that an established appeal process could result in delays in decisions, decrease trust in the process and may add an element of unfairness. Stakeholders raised a concern that patients’ ability to appeal is also linked to socio-economic class. Civil society and social science stakeholders were in favour of having an appeal committee; while the law stakeholders and medical experts were not due to the added pressure put on attending physicians. A consensus was finally reached not to establish an appeal committee. Instead, clear and motivated communication between physicians and patients or their relatives about the process and decisions must be actively practised. Together with regular review and a transparent patient registry of what decisions are made to allow for future evaluation of the guide to ensure the guide fits its purpose was decided.
Implementation and enforcement
Although existing guidelines state that guides should be implemented only when demand exceeds supply, stakeholders stressed that it is difficult for frontline health staff to know exactly when surge capacities are fully mobilized and all needed resources in the country have been occupied. Therefore, medical stakeholders suggested the guideline should only be triggered after all efforts have been made to mobilize resources and demand for the resources continue to exceed the supply capacity. Stakeholders added that only when a national public health emergency has been declared and critical resource have been exhausted, should the guideline implementation be prompted. This requires higher-level public health officers to routinely monitor and update the resource situation during a public health emergency.
Another matter relating to guideline implementation is enforcement. Similar to the New York Ventilator Allocation Guideline which flaged a concern that there was no legal protection for health staff who adhered to its guideline (23), stakeholders from the medical field emphasized that a legally binding mechanism would be necessary to support and protect healthcare workers in their decisions. A consensus was reached among all stakeholder groups that the endorsement of the guide by the Medical Council should be sought to ensure harmonized implementation nationwide, and adherence with existing laws and practices.
Guideline Finalization
Following two rounds of consultations, a revised guideline was developed by the technical team and circulated to all stakeholders for confirmation and suggested revisions via email if needed. Table 3 summarizes the guideline evolution at different steps of development and Figure 2 compares the proposed and final version of decision-making steps.
Table 3 Summary of guideline evolution at each development step
Key Contents
|
Step 1: Rapid Review
(First draft)
|
Step 2: Key Informant Interview
(Second draft)
|
Step 3: Multi-Stakeholder Consultation (Final draft)
|
Guideline Principle
|
· Save the most lives
· Save the most live years
· Benefit to others
|
· Save the most lives
· Save the most live years
· Benefit to others
|
· Utilitarianism – saving the most lives
|
Prioritization Criteria
|
· Apply three-order criteria:
1) Clinical prognosis e.g. Sequential Organ Failure Assessment (SOFA); Clinical Frailty Scale (CFS); Cognitive impairment assessment
2) Number of live years saved
3) Social usefulness
· Allocation decisions are based on relative scores.
· No cut-off score is applied.
|
· Apply three-order criteria:
1) Clinical prognosis using one or more of the following tools:
o Charlson comorbidity index
o Sequential Organ Failure Assessment (SOFA)
o Frailty assessment such as Clinical Frailty Scale (CFS)
o Cognitive impairment assessment
2) Number of live years saved
3) Social usefulness
· Allocation decisions are based on relative scores.
· No cut-off score is applied.
|
· Assess patients based on clinical prognosis using at least 2 of the following tools:
1) Charlson comorbidity index
2) Sequential Organ Failure Assessment (SOFA)
3) Frailty assessment such as Clinical Frailty Scale (CFS)
4) Cognitive impairment assessment
· Allocation decisions are based on relative scores.
· No cut-off score is applied.
· Each health facility must apply the same sequence of tools consistently across all cases.
|
Application
|
· Applicable to all patients requiring critical care resources
· Prior to ICU admission
· Reassessment every 48 hours during ICU stay
|
· Applicable to all patients requiring critical care resources
· Prior to ICU admission
· Reassessment every 48 hours during ICU stay
|
· Applicable to all patients requiring critical care resources
· Prior to ICU admission
· Reassessment as appropriate during ICU stay
|
Decision Making
|
· Triage committee of three healthcare professionals advises an attending physician on allocation
|
· Attending physician is a decision maker
· Triage committee of three healthcare professionals advises an attending physician on allocation
|
· Attending physician is a decision maker
· Patient review committee of five health and non-health experts advises an attending physician on allocation decision and communication with patient and families
|
Review Process
|
· Document assessment result and allocation decisions in a registry
· Registry information can be reviewed by a staff/team in the hospital who are not involved in the first decision or external expert(s)
· Appeal mechanism was proposed to be considered
|
· Document assessment results and allocation decisions in a registry
· Registry information can be reviewed by a staff/team in the hospital who are not involved in the first decision or external expert(s)
· Appeal mechanism was proposed to be considered
|
· Document assessment results and allocation decisions in a registry
· Registry information can be reviewed by a staff/team in the hospital who are not involved in the first decision or external expert(s)
|
Implementation
|
· When only 10-20% of critical care resources remain available
|
· When only 10-20% of critical care resources remain available
|
· National public health emergency AND
· All efforts have been made to mobilize resources and demand still exceeds supply
|
Enforcement
|
· The guideline is to be endorsed by the Medical Council of Thailand
|
· The guideline is to be endorsed by the Medical Council of Thailand
|
· The guideline is to be endorsed by the Medical Council of Thailand. Current status of endorsement is unclear due to the pandemics changing situation.
|
Upon finalization of the guideline’s contents, the guide was presented at a high-level governmental meeting of decision makers and academics, including executive board members of the Medical Council of Thailand. The importance and necessity for the guide was acknowledged. However, the favourable outcomes of COVID-19 containment in the country leading to an average of less than 3 new daily cases of COVID-19 between June 6th and June 25th 2020, resulted in the announcement of the third and final phase marking the end of lock down measures in Thailand in July 1st, 2020. This has made the endorsement of the guideline no longer a matter of urgency, and therefore it was decided that commencing legal process with the Medical Council should be put on hold. However, recognizing looming threats of new waves of infection after the unlocking phase, the guide can be adopted should the necessary situation arises.