Management of Sepsis in Resource Limited Settings Using a Delphi Method.

Sponsor

Oxford University Clinical Research Unit, Vietnam (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05909384

Collaborator

Asia Pacific Sepsis Alliance (Other)

Enrollment

Location

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rapid evolution of sepsis syndromes means that timely diagnosis and treatment are critical in improving outcomes but this may be difficult to achieve in many low- and middle- income countries (LMICs) and there is a lack of high quality clinical evidence to guide diagnosis and management in LMIC settings. The wide variability in health systems in LMICs means that additional areas of guidance may be required where staff or facilities are lacking. In the absence of clinical data, to address some of these issues, the investigators aim to use Delphi methodology to obtain experts consensus statements on some specific aspects of sepsis management in LMICs.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: Survey

Detailed Description

The investigators aim to use a Delphi process to generate expert consensus practice statements in the context of diagnosis and management of sepsis in LMICs, including identification of aspects of sepsis diagnosis and management in LMICs not covered by existing guidelines. The questions will undergo several iterative rounds and will be in multiple-choice or Likert scale format. A study steering group will review the results of each round via video conference and design the questionnaire for the next survey. Summary results of each round will be presented to experts, along with the survey questionnaire for the next round. The survey process will be repeated with the modified questionnaire. The Delphi rounds will continue until the desired consensus and stability are achieved.

Study Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Expert Consensus Statements for the Management of Sepsis in Resource Limited Settings Using a Delphi Method

Actual Study Start Date :

May 16, 2023

Anticipated Primary Completion Date :

Jul 15, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Expert group Clinical expertise in adult sepsis management, AND Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities	Other: Survey Multiple rounds of surveys collecting information on sepsis diagnosis and management in resource-limited settings.

Arm

Intervention/Treatment

Expert group

Clinical expertise in adult sepsis management, AND Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

Other: Survey

Multiple rounds of surveys collecting information on sepsis diagnosis and management in resource-limited settings.

Outcome Measures

Primary Outcome Measures

Questionnaire statements which have reached pre-defined consensus [2 weeks]
Descriptive analysis of questionnaire statements which have reached pre-defined consensus. Consensus will be defined as >70% participants in favour of agree/disagree statements (Likeart scale 1-3 means disagree or 5-7 means agree), or >80% in favour of single option in a single stem question with multiple responses (yes/no answers).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Recognized experts meeting pre-defined criteria (below) from a wide geographical distribution with approximately 70% from LMICs.

Clinical expertise in adult sepsis management, AND
Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities