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

September 14, 2026 updated by: Peda Kovacevic, MD, Ph.D. FCCP,FCCM, University Clinical Centre of Republic of Srpska

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pedja Kovacevic, MD,PhD
Phone Number: 051342507
Email: peko051@yahoo.com

Study Locations

Bosnia and Herzegovina
- The Repblic of Srpska
  - Banja Luka, The Repblic of Srpska, Bosnia and Herzegovina, 78000
    - University Clinical Centre of the Republic of Srpska
    - Contact:
      
      Pedja Kovacevic
      
      Phone Number: 051342507
      
      Email: peko051@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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. -

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and proportion of candidate statements rated 7-9 on the 9-point Likert scale Time Frame: From the first Delphi round through completion of the final Delphi round, up to 12 months	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and proportion of candidate statements with stable ratings between consecutive Delphi rounds Time Frame: From completion of the first Delphi round through completion of the final Delphi round, up to 12 months	Stability of ratings will be assessed among panelists who participate in consecutive Delphi rounds. Ratings assigned using the 9-point Likert scale will be compared between consecutive rounds using the Wilcoxon signed-rank test. The outcome will be reported as the number and proportion of candidate statements for which no statistically significant change in ratings is observed between consecutive rounds.	From completion of the first Delphi round through completion of the final Delphi round, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinical Centre of Republic of Srpska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)