Consensus on Low-resource Setting Definition: An inteRnational Delphi sTudY (CLARITY-LRS)

NCT07826819 | Not Yet Recruiting

• 1 other identifier: 01-19-420-2/26
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The term "low-resource setting" (LRS) is widely used in global health and critical care, yet no universally accepted definition exists. World Bank income classifications are frequently used as proxies for healthcare resources but may not adequately reflect differences in healthcare capacity and delivery within and across countries. Resource limitations may also exist within high-income countries, emphasizing the need for a multidimensional, setting-specific approach. The Consensus on Low-resource setting definition: An inteRnational Delphi sTudY (CLARITY-LRS) aims to achieve international expert consensus on the limitations of country-level income classifications and to develop a context-sensitive framework for defining and characterizing resource-limited acute and critical care settings. CLARITY-LRS is an international modified Delphi study involving 40-50 multidisciplinary panelists from all inhabited continents, with deliberate representation from low-resource settings and inclusion of patient and caregiver perspectives. At least three anonymous electronic Delphi rounds will be conducted using 9-point Likert scales, multiple-choice and ranking questions, and qualitative feedback. Consensus will be predefined as ≥80% agreement, with response stability assessed across consecutive rounds. The study will follow ACCORD guidance for consensus-based research. The resulting consensus is expected to identify key structural, organizational, workforce-related, technological, and clinical dimensions of resource limitations, provide an operational framework applicable across and within countries, and recommend standardized terminology, including whether the term "low-resource setting" should be retained or replaced. This framework may improve comparability of research, interpretation of evidence, and context-sensitive implementation of interventions across diverse healthcare systems.

Conditions

Resource-Limited Setting; Delphi Study; Critical Care; Acute Care Medical; Global Health; Health Systems; Consensus

Keywords

low-resource settings; resource-limited settings; Delphi study; consensus; critical care; acute care; global health; health systems

Outcome Measures

Primary Outcomes (1)

• Number and proportion of candidate statements rated 7-9 on the 9-point Likert scale

  International Delphi panelists will rate each candidate statement on a 9-point Likert scale, where 1 indicates strong disagreement and 9 indicates strong agreement. Consensus for inclusion in the low-resource setting definition will be defined as at least 80% of respondents rating a statement from 7 to 9. The outcome will be summarized as the number and percentage of candidate statements meeting this prespecified consensus threshold after completion of the Delphi process.

  From the first Delphi round through completion of the final Delphi round, up to 12 months

Secondary Outcomes (1)

• Number and proportion of candidate statements with stable ratings between consecutive Delphi rounds

  From completion of the first Delphi round through completion of the final Delphi round, up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise an international and multidisciplinary panel of healthcare professionals, researchers, policymakers, health-system experts, patient representatives, and other relevant stakeholders with knowledge or experience related to healthcare delivery and resource limitations. Participants will be recruited from different geographic regions, professional backgrounds, healthcare settings, and national income categories to ensure broad representation. Particular attention will be given to adequate representation of participants working in or having direct experience with low-resource settings.

You may qualify if:

• Adults aged 18 years or older. Healthcare professionals, researchers, policymakers, health system experts, patient representatives, or other stakeholders with relevant knowledge or experience related to healthcare delivery, critical care, global health, health systems, or resource-limited healthcare environments.
• Ability to read and understand English. Willingness to provide informed consent and participate in the Delphi process. Access to the internet and ability to complete electronic questionnaires. -

You may not qualify if:

• Individuals younger than 18 years. Individuals without relevant professional, research, policy, health-system, or lived experience related to the study topic.
• Inability to understand the study information or complete the questionnaires in English.
• Refusal or inability to provide informed consent. Failure to complete the initial Delphi questionnaire round.

Sponsors & Collaborators

• University Clinical Centre of Republic of Srpska: lead

Study Sites (1)

University Clinical Centre of the Republic of Srpska

Banja Luka, The Repblic of Srpska, 78000, Bosnia and Herzegovina

Location

Related Publications (1)

• Kovacevic P. Can the terms "low resource setting" and "low-income country" be used interchangeably in the context of intensive care medicine? Intensive Care Med. 2023 Oct;49(10):1274-1275. doi: 10.1007/s00134-023-07203-8. Epub 2023 Aug 29. No abstract available.

  PMID: 37642671 BACKGROUND

Central Study Contacts

Pedja Kovacevic, MD,PhD

CONTACT

051342507; peko051@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FCCP, FCCM

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)