Resource-Limited SettingCLARITY-LRSNCT07826819
Consensus on Low-resource Setting Definition: An inteRnational Delphi sTudY (CLARITY-LRS)
An observational study of Resource-Limited Setting and Delphi Study, run by University Clinical Centre of Republic of Srpska at 1 site in Bosnia and Herzegovina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resource-Limited Setting, Delphi Study, Consensus
- How many people
- 50 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Feb 2027to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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. -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bosnia and Herzegovina1 site
University Clinical Centre of the Republic of Srpska
Banja Luka, The Repblic of Srpska, 78000
Pedja Kovacevic, 051342507, peko051@yahoo.com
About this study
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, Consensus, Critical Care, Acute Care Medical, Global Health
- Keywords
- low-resource settings; resource-limited settings; Delphi study; consensus; critical care; acute care; global health; health systems
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From completion of the first Delphi round through completion of the final Delphi round, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resource-Limited SettingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Republic of Srpska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peda Kovacevic, MD, Ph.D. FCCP,FCCM, University Clinical Centre of Republic of Srpska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826819
- Sponsor's protocol ID
- 01-19-420-2/26
- Acronym
- CLARITY-LRS
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consensus on Low-resource Setting Definition: An inteRnational Delphi sTudY (CLARITY-LRS)
- ClinicalTrials.gov ID
- NCT07826819
- Acronym / sponsor ID
- CLARITY-LRS / 01-19-420-2/26
- Conditions
- Resource-Limited Setting, Delphi Study, Consensus, Critical Care, Acute Care Medical, Global Health
- Keywords
- low-resource settings; resource-limited settings; Delphi study; consensus; critical care; acute care; global health; health systems
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Clinical Centre of Republic of SrpskaUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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. -
Key exclusion criteria (4 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 37642671Kovacevic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resource-Limited Setting and Delphi Study, run by University Clinical Centre of Republic of Srpska at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedja Kovacevic, MD,PhD (051342507, peko051@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07826819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.