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

N/ANot Yet RecruitingNCT07826819

University Clinical Centre of Republic of Srpska50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Resource-Limited Setting Delphi Study

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. \-

Outcomes

Primary Outcomes

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

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