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

Completed

• Conditions: Sepsis
• Interventions: Other: Survey

• Registration Number: NCT05909384
• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

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.

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 Timeline

• Study Start: 2023-05-16
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Primary Completion: 2023-08-21
• Study Completion: 2023-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Expert group	Survey	1. Clinical expertise in adult sepsis management, AND 2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

Primary Outcome Measures

Name	Time	Method
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 (Likert 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).

Trial Locations

Locations (1)

Oxford University Clinical Research Unit; 🇻🇳 Ho Chi Minh City, Vietnam