ClinicalTrials.gg
Not yet recruitingNCT07826819CLARITY-LRSUpdated Sep 17, 2026

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

An observational study in Resource-Limited Setting, Delphi Study and Consensus, sponsored by University Clinical Centre of Republic of Srpska. Not yet recruiting at 1 site in Bosnia and Herzegovina. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University Clinical Centre of Republic of Srpska · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • low-resource settings; resource-limited settings; Delphi study; consensus; critical care; acute care; global health; health systems
03

In context

Lead sponsor

University Clinical Centre of Republic of Srpska is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and participate in the Delphi process. Access to the internet and ability to complete electronic questionnaires. -

Exclusion criteria

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 . Failure to complete the initial Delphi questionnaire round.

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 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

    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.

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

07

Study locations

1 site
  • University Clinical Centre of the Republic of Srpska
    Banja Luka, The Repblic of Srpska 78000, Bosnia and Herzegovina
08

References and documents

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. PubMed 37642671 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2027; primary completion for Aug 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 17, 2026
StartEst.
Feb 1, 2027
Primary completionEst.
Aug 1, 2027
CompletionEst.
Feb 1, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07826819
Lead sponsor
University Clinical Centre of Republic of Srpska
Responsible party
Peda Kovacevic, MD, Ph.D. FCCP,FCCM (MD, PhD, FCCP, FCCM, University Clinical Centre of Republic of Srpska) — Principal investigator
First posted
Sep 17, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Pedja Kovacevic, MD,PhD
Contact
peko051@yahoo.com
051342507

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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