Methods
Panel recruitment Delphi process Updating of the guidelines An expert panel was constituted and reviewed current evidence and compiled consensus-based recommendations for the minimum standards required for death determination, applicable in the SA context, using a modified Delphi process. All statements in this guideline are considered strong recommendations. In cases where evidence is less stron
An expert panel was constituted and reviewed current evidence and compiled consensus-based recommendations for the minimum standards required for death determination, applicable in the SA context, using a modified Delphi process. All statements in this guideline are considered strong recommendations. In cases where evidence is less strong, the term ‘suggested’ is used to indicate a lower level of evidence. Statements are intentionally similar to international documents in the interests of commonality of approach. Recommendations are aligned with the best interests of patients and their families.
Panel recruitment
Expert panel members were recruited through the Critical Care Society of Southern Africa (CCSSA) as experts in the field of death determination and end-of-life care representing a broad range of disciplines within critical care (neurosurgery, paediatrics, obstetrics and gynaecology, surgery, anaesthesiology, nursing, ethics). Informed consent was given by the expert panel with acknowledgement that they would be identifiable in the publication (Appendix 1 - 3: http:// samj.org.za/public/sup/15200-1.pdf). The study methodology was approved by the University of Cape Town Human Research Ethics Committee (HREC 476/2019).
Delphi process
A literature search of Pubmed, Web of Science, SCOPUS and the grey literature was conducted by the steering committee of the expert panel and a professional librarian to identify national and professional society guidelines in death determination, and their supporting evidence, for review (http://samj.org.za/public/sup/15200-2.pdf). A modified Delphi approach was used with adherence to the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument to compile the guidelines. [11]
Key questions related to current principles and practice regarding death certification were drafted by the meeting steering committee. During three rounds of a modified Delphi process [12] using Surveymonkey (SVMK Inc., USA), a web-based application, the expert panel progressively modified, deleted or added questions and components. Participants were asked to rate agreement with each component between 1 and 9 on a Likert scale, with 1 - 3 being ‘not important’, 3 - 6 being ‘important but not critical’ and 7 - 9 being critically important’, or state if they were unable to comment. This scale is recommended by the Grading of Recommendations Assessment, Development and Evaluation working group. [11,13] Participants were invited to suggest additional questions for consideration for the round table in each round using free-text responses. Although five to 10 experts are considered adequate for content validation, we used 18 to ensure a broadly representative group. [14]
Precise terminology was reviewed and finalised in order to improve clarity in death determination discussions and debate. We defined consensus for the Delphi a priori based on guidance in The COMET Handbook. [15] For inclusion in the consensus outcome statement (COS), outcomes required at least 70% of participants in each stakeholder group to score the outcome as critically important and <15% to score the outcome as not important. Outcomes excluded from the COS required at least 70% of participants in each stakeholder group to score the outcome as not important and <15% to score the outcome as ‘critical’. If outcomes did not meet either criterion, they were presented at the round-table for discussion. The expert panel members summarised the responses and the available evidence and formulated draft recommendations that were presented and discussed at a face-to-face round table meeting prior to the CCSSA national conference in Cape Town, SA, in 2019. The results were presented at a plenary meeting of the conference.
All questions and feedback from this meeting were then reviewed with the steering committee. The combined consensus statement and proposed guideline were circulated to all society members for comment over three months. All expert panel members approved the final document for publication. The guidelines were then submitted for external review and endorsement by other South African professional medical societies (Table 1).
Table 1. List of endorsing societies
| Trauma Society of Southern Africa |
| The Association of Surgeons of South Africa |
| Radiology Society of South Africa |
| Southern African Transplantation Society |
| Islamic Medical Association |
| South African Medical Association |
| Resuscitation Council of South Africa |
| South African Thoracic Society |
| Colleges of Medicine of South Africa - Committee of Critical Care |
| Neurological Association of South Africa |
| Society of Neurosurgeons of South Africa |
| South African Paediatric Association (Affirmation of Value) |
Updating of the guidelines
A review period of five years was set after publication of this document, the review to be undertaken by the guideline development group of the CCSSA, unless an earlier revision is mandated by emerging high-quality medical evidence or legislative changes.
Critical Care Society of Southern Africa: South African Guidelines on the Determination of Death_SAMJ/SAJCC_March 2021, Vol. 37, No. 1 (Part 2)