Development of the Guidelines: Focus on Availability, Feasibility, Affordability, and Safety of Interventions in Resource-Limited Settings
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Abstract
This chapter gives an overview of the organization and functioning of our working group on developing guidelines on “Sepsis in Resource-Limited Settings,” the methods used for the systematic reviews and for grading of the evidence.
2.1 Introduction
In 2014, the “Global Intensive Care Working Group” of the “European Society of Intensive Care Medicine” (ESICM) and the “Mahidol Oxford Tropical Medicine Research Unit” (MORU) in Bangkok, Thailand, decided to refine and rewrite the guidelines for sepsis treatment in resource-limited settings as published in 2012 [1]. This chapter describes the development of eight sets of recommendations for care of septic patients in resource-limited settings as published in Intensive Care Medicine [2, 3, 4, 5, 6, 7, 8] and the Transactions of Royal Society of Tropical Medicine and Hygiene [9] in 2016 and 2017.
2.2 Heads and Subheads
Group chairs, subgroup chairs, and subgroup members
| Group chairs | |||||||
|---|---|---|---|---|---|---|---|
| Marcus J. Schultz, Martin W. Dünser, and Arjen M. Dondorp | |||||||
| Group 1 ICU organization and structure | Group 2 Sepsis recognition | Group 3 Infection management | Group 4 Tropical sepsis | Group 5 Hemodynamic monitoring and support | Group 6 Ventilatory support | Group 7 General supportive care | Group 8 Pediatric sepsis |
| Subgroup chairs | |||||||
| Alfred Papali | Arthur Kwizera | Ganbold Lundeg | Mai Nguyen Thi Hoang | David Misango | Ary Serpa Neto | Mervyn Mer | Srinivas Murthy |
| Marcus J. Schultz | Emir Festic | Louise Thwaites | Arjen M. Dondorp | Timothy Baker | Marcus J. Schultz | Marcus J. Schultz | Ndidiamaka Musa |
| Martin W. Dünser | Martin W. Dünser | Arjen M. Dondorp | Mervyn Mer | Rajyabardhan Pattnaik | Emir Festic | Neill Adhikari | Niranjan Kissoon |
| Other members | |||||||
| Neill Adhikari | Rashan Haniffa | Arthur Kwizera | Sanjib Mohanty | Martin W. Dünser | Neill Adhikari | Arthur Kwizera | Rakesh Lodha |
| Janet Diaz | Neill Adhikari | Mervyn Mer | Marcus J. Schultz | Marcus J. Schultz | Arjen M. Dondorp | David Misango | Suchitra Ranjit |
| Arjen M. Dondorp | Ganbold Lundeg | Neill Adhikari | Louise Thwaites | Arjen M. Dondorp | Rajyabardhan Pattnaik | Sanjib Mohanty | |
| Shevin Jacob | Arjen M. Dondorp | Marcus J. Schultz | Martin W. Dünser | Louise Thwaites | Arjen M. Dondorp | ||
| Jason Phua | Derek Angus | Randeep Jawa | Jane Nakibuuka | Pedro Povoa | Ary Serpa Neto | ||
| Marc Romain | Ignacio Martin Loeches | Jane Nakibuuka | Ignacio Martin Loeches | Kobus Preller | |||
| Niranjan Kissoon | Srinivas Murthy | Luigi Pisani | |||||
| Binh Nguyen Thien | |||||||
2.3 Other Subgroup Members
The chairs of each subgroup recruited additional members for each set of recommendations (Table 2.1). Alike selection of subgroup chairs, recruitment of group members was based on interest in specific aspects of sepsis and hands-on experience in ICUs in resource-limited settings. Additional group members were appointed by the group heads to address content needs for the development process. Several group members had experience in “Grading of Recommendations, Assessment, Development and Evaluation” (GRADE) process and the use of the GRADEpro Guideline Development Tool [10].
2.4 Meetings
Initial Internet subgroup chair meetings established the procedures for literature review and drafting of tables for evidence analysis. Subgroup chairs continued work remotely via the Internet. Several meetings occurred at major international meetings, teleconferences, and electronic-based discussions among subgroup chairs and members from other subgroups.
In the first meetings, up to 10 clearly defined questions regarding specific aspects of care for sepsis patients were formulated, using the GRADEpro Guideline Development Tool [10]. These were reviewed for content and clarity by all subgroup members. After the approval by the subgroup members, the subgroup chairs split up, each one to seek for evidence for recommendations regarding three or four of the specific questions posed, seeking help from the subgroup members in identifying relevant publications where necessary. During this process, questions could be combined or adjusted—in some cases extra questions were added. The subgroup chairs summarized the evidence and formulated the recommendations after interactive telephone conferences. These were communicated among subgroup members. After their approval, the subgroup chairs summarized the evidence in a report, which was then sent for approval to all members of all eight subgroups.
2.5 Search Process
The search for literature followed the same methods as described for the development of the Surviving Sepsis Campaign guidelines [11]. In case a question was identical to one in those guidelines, the subgroup chairs searched for additional articles, specifically (new) investigations or meta-analyses related to the questions, in a minimum of one general database (i.e., MEDLINE, EMBASE) and the Cochrane Libraries. Furthermore, subgroup members paid specific attention to identify publication originating in low- and middle-income countries.
2.6 Grading of Recommendations
Quality of evidence
| A | Randomized controlled trials | High |
| B | Downgraded randomized controlled trial(s) or upgraded observational studies | Moderate |
| C | Observational studies | Low |
| D | Downgraded observational studies or expert opinion | Very low |
Strong versus weak recommendationsa
| What should be considered | Recommended process |
|---|---|
| High or moderate evidence | The higher the quality of evidence, the more likely a strong recommendation |
| Certainty about the balance of benefits vs. harms and burdens | The larger/smaller the difference between the desirable and undesirable consequences and the certainty around that difference, the more likely a strong/weak recommendation |
| Certainty in or similar values | The more certainty or similarity in values and preferences, the more likely a strong recommendation |
| Resource implications | The lower/higher the cost of an intervention compared to the alternative, the more likely a strong/weak recommendation |
| Availability and feasibility in LMICs | The less available, the more likely a weak recommendation |
| Affordability for LMICs | The less affordable, the more likely a weak recommendation |
| Safety of the intervention in LMICs | The less safe in an LMIC, the more likely a weak recommendation |
A strong recommendation was worded as “we recommend” and a weak recommendation as “we suggest.” Some recommendations remained as ungraded best practice statements, when in the opinion of the subgroup members, such recommendations were clear, clinically relevant, likely to result in benefit, supported by indirect evidence, and unsuitable for a formal evidence generation and review process (opportunity cost) [12].
2.7 Reporting
Each report was edited for style and form, with final approval by subgroup heads and then by the entire “Sepsis in Resource-Limited Settings” guidelines group.
Notes
Acknowledgments
All authors of this chapter are members of the “European Society of Intensive Care Medicine (ESICM) Global Intensive Care” Working Group and the Mahidol–Oxford Research Unit (MORU) in Bangkok, Thailand.
Conflicts of interest Group chairs, subgroup chairs, and subgroup members did not represent industry, and there was no industry input into the development of the recommendations. Group chairs, subgroup chairs, and subgroup members did not receive honoraria for any role in the guideline development process. Group chairs, subgroup chairs, and subgroup members provided a standard conflict of interest form, to be uploaded through the GRADEpro Guideline Development Tool website—none reported conflicts of interest.
References
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