Incorporating Ethics in Clinical Guidelines in Infectious Diseases: A Scoping Review

TL;DR

This study reviews if ethical issues are included in guidelines for treating infectious diseases.

Contribution

It is the first scoping review to assess the inclusion of ethics in infectious disease guidelines.

Findings

Many guidelines lack explicit ethical considerations.

Ethical issues are often addressed implicitly rather than formally.

There is a need for more structured integration of ethics in guideline development.

Abstract

This scoping review evaluates whether clinical practice guidelines in infectious disease include ethical considerations.

Tables

Table 1.. Characteristics of the Included Guidelines

Characteristic	Articles retrieved, No. (%) (N = 115)
Year of publication
2021	44 (38.2)
2022	58 (50.5)
2023	13 (11.3)
Scientific society
ESCMID	5 (4.4)
IDSA	21 (18.3)
NICE	10 (8.6)
WHO	18 (15.7)
Othera	61 (53.0)
Infectious disease topic
Infective syndromesb	19 (16.5)
COVID-19	18 (15.7)
Tropical/neglected diseasec	18 (15.7)
Hepatitis and STI	17 (14.8)
Bacterial infectionsd	15 (13.0)
HIV/AIDS	9 (7.8)
Hospital-acquired infections	6 (5.2)
Viral infectionse	5 (4.3)
Otherf	8 (7.0)
Guideline methodology
GRADE	49 (42.6)
Not reported	43 (37.4)
Other than GRADE	23 (20.0)
Target population
General	66 (57.4)
Paediatric	28 (24.3)
Immunocompromised	10 (8.6)
Health care workers	4 (3.6)
Otherg	7 (6.1)
Ethical consideration
Authorship reporting (n = 115)
Authorship clearly stated	64 (55.7)
COI reported	57 (50.0)
COI addressedh	2 (1.7)
Gender balance policies reported	1 (0.9)
Country balance policies reported	2 (1.7)
Women authors, median, % (IQR)i	41.4 (33-50)
Authors affiliated to pharma, median, % (IQR)	7.1 (0-44)
Included authors from LMICj	4 (3.6)
Ethics sections’ content (n = 32)k
Costs and equity	9 (28.1)
Decision sharing, patients’ education, community engagement	9 (28.1)
Patients’ needs-based decision (rather than efficacy)	6 (18.8)
Services tailored to families, specific groups, cultural barriers	5 (15.6)
Specific topic considerations (eg, drug addiction)	3 (9.4)
Reference to minority groups (n = 115)
Involvement in included trials reported	57 (49.6)
Retrieval of data on minority groups	55 (47.8)
Focused on minority groupsl	26 (22.6)
Discrimination addressed	20 (17.4)
Ethics issues addressed in guidelines
Costs
Diagnostics and treatment affordability	53 (46.1)
Cost or benefit centered on patient	41 (35.7)
Justice or access to care
Allocation of resources	35 (30.4)
Access to care	50 (43.5)
Patient autonomy addressed	44 (38.3)
Patient liberty assessed	6 (5.2)
Risks and benefits
Risk/benefit balance assessment	39 (33.9)
Off-label use recognized	8 (7.0)

Table 2.. Ethical Issue Details and Proposed Solutions in Guidelines

Ethical issues	Issue details (No. [%]) (N = 115)	Proposed solutions
Costs (affordability; patient cost-benefit analysis)	Lack of drugs in resource limited areas (40 [34.8]) High cost of tests, PPE, hand hygiene monitoring, vaccine, or informatic tools (29 [25.2]) Cost-effectiveness of different regimens (options limited by cost or insurance availability) (17 [14.8]) Subpopulations at high risk not able to afford costs (17 [14.8]) Indirect costs (disease related income loss, hospital stay) (12 [10.4])	Different costs in different countries, negotiations Oral therapy or OPAT Reduce unnecessary treatment Offer alternatives if costs too high Cost-benefit analysis Generic drugs, shorter treatments Point of care testing Scale up centered services Consider costs in each recommendation
Justice or access to care (allocation of resources; access to care)	Means in general (36 [31.3]) Treatment (30 [26.1]) Diagnostics, equipment, material (23 [20.0]) Community services (13 [11.3]) Hospital capacity (7 [6.1]) Workforce (7 [6.1]) Diagnostics (37 [32.2]) Facilities (37 [32.2]) Medication (25 [21.7]) Stigma (12 [10.4]) Information (5 [4.3])	Optimize screening Vaccination in rural areas and for vulnerable populations Allocation of equipment for IPC Identify gaps and inform models of care Prioritize antibiotics Support training Offer alternatives if limited resources Implement infrastructures and laboratories Access to dedicated funding for LMIC Patient centered policies Free of charge care
Autonomy (patient autonomy addressed)	Right to information (52 [45.2]) Refusal and decision making (23 [20.0]) Choice of health care facility (17 [14.8]) Referral of care (12 [10.4]) Privacy and confidentiality (12 [10.4])	Risk and benefit discussion with patients OPAT Education and multilingual leaflets Choice discussion with patients Provide updated information on safety and adverse effects Information about own health Involvement of families Patients’ active contribution in the decision Informed consent obtained and shared decision making MDT discussion Safeguard privacy Identify vulnerable groups Cultural and religious beliefs considered Confidentiality, empathy and a nonjudgemental approach Involve affected communities in the design and implementation of health care centers Sharing goals DOT
Public health (patient liberty assessed)	Isolation or contact precautions (35 [30.4]) Involvement in decision (35 [30.4]) Privacy (23 [20.0]) Education (23 [20.0])	Invite patients to comment on recommendations Right to refuse

Full text

Introduction

Infectious diseases raise numerous ethical issues. Yet, incorporating ethics in infectious diseases international clinical practice guidelines (CPGL) remains largely unregulated.^1^ We aimed to evaluate how ethical issues are addressed in CPGL in infectious diseases.

Methods

This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline for scoping reviews. We performed a systematic search for CPGL specific to infectious diseases published between January 2021 and December 2023 in 3 guideline databases. Four researchers (N.S., M.A., C.Z., and V.T.) extracted data from included CPGL characteristics and ethics considerations for guidelines authorship, dedicated ethics sections, approaches to disadvantaged or minoritized populations, costs, justice, access to care, autonomy, public health, and risk-benefit assessment. For study protocol and data extraction manual see eAppendix in Supplement 1.

Results

Overall, 115 CPGL were included. Characteristics of included CPGL are reported in Table 1. Guidelines authorship (64 [55.7%]), conflict of interest (57 [50.0%]), gender balance (1 [0.9%]), and country balance (2 [1.7%]) policies reporting was limited. Only 32 of 115 CPGL (27.8%) dedicated a section or paragraph to ethical considerations. Minority groups were addressed in approximately half of CPGL (57 [49.6%]), typically by reporting data from available studies (55 [47.8%]). Treatment and diagnostics affordability and costs (53 [46.1%]), access to care (50 [43.5%]), and autonomy (44 [38.3%]) were the most common ethics issues addressed, all in less than half of CPGL. Only 20 CPGL (17.4%) addressed discrimination and 6 (5.2%) discussed liberty.

Suggestions to address cost issues included the proposal of differential costs according to country and addressing costs in CPGL recommendations (Table 2). Regarding resource allocation and access to care, potential solutions included training, strengthening of laboratories and infrastructure, and offering alternatives where resources are limited. Discussion with patients and family involvement were advocated to promote autonomy, and incorporating patients’ views where appropriate was advised to promote ethically acceptable restrictions of individual liberty (eg, isolation).

Discussion

The explicit incorporation of ethical issues in infectious disease CPGL is limited. The aspects of ethics in treating infectious diseases are intrinsically multifaceted and often involve economically or socially disadvantaged populations, with implications for public health, resource allocation, discrimination, patient autonomy, justice, and more.^2^ The majority of retrieved CPGL came from high-income countries. Furthermore, infectious disease CPGL may present inadequate reporting of authorship and conflicts of interest, with underrepresentation of female and LMIC authors, despite addressing relevant topics (tuberculosis, HIV). Less than a third of CPGL dedicated a section or paragraph to ethical considerations, and only half of guidelines addressed minority populations. The most common ethical issues addressed were related to justice (including affordability and access to care). Complex ethical issues apply to the field of infectious diseases because of disproportionate disease burdens in vulnerable populations and the public health risks related to the spread of infection. Nevertheless, current literature regarding implementation of ethical aspects in infectious disease CPGL is limited. Strategies for inclusion of ethical issues in CPGL in general include defining disease-specific ethical issues (DSEI) and appropriate planning of CPGL development (eg, by including panel members with ethics expertise, incorporating the results of patient or public engagement, addressing the needs of vulnerable populations, and/or defining ethical issues as part of specifying outcomes).^3,4,5,6^ Limitations of this study is lack of quality assessment of included guidelines, as well as the subjectivity in data extraction concerning ethical issues.

Our study reveals that such planning and actual consideration of ethical issues in infectious disease CPGL are limited. This should arguably be improved, for example via guidance for incorporating ethics into future infectious disease CPGL and/or the development of a predefined checklist to ensure appropriate handling of ethical issues.