Philippine COVID-19 Living Clinical Practice Guidelines
Institute of Clinical Epidemiology, National Institutes of Health, UP Manila
In cooperation with the Philippine Society for Microbiology and Infectious Diseases
Funded by the DOH AHEAD Program through the PCHRD
LIVING CPG DEVELOPMENT METHODS
The development process of the Philippine Living CPG follows the Philippine Department of Health’s Manual for Clinical Practice Guideline Development [DOH 2018] and the Grading of Recommendations, Assessment, Development and Evaluation or GRADE Approach [Schünemann et al 2013].
The specific phases of the CPG development process are as follows:
Guideline Preparation – The Steering Committee identified and convened members of the Living CPG task force: Lead CPG Developer (Steering Committee), Evidence Review Experts or Technical Working Group (TWG) and the Consensus Panel. A total of 20 specialty societies and stakeholders are represented in the task force.
The Steering Committee, together with the TWG and other key stakeholders, finalized the health questions to be addressed in the CPG. The Steering Committee selected the members of the Consensus Panel based on their knowledge and experience, and potential conflicts of interest in consultation with the heads of the professional medical societies and stakeholder organizations. The Consensus Panel is composed of multi-sectoral representatives such as practitioners, both specialists and non-specialists, and patient advocates. The panel members were selected from the designated representatives of the relevant specialty groups. Some stakeholders, such as nurses, acted as patient advocates to reflect patients’ and public’s views and preferences.
Several orientation sessions were conducted for the technical reviewers and consensus panel members on the COVID CPG development process. Technical reviewers were re-trained on evidence synthesis and the GRADE methodology. Consensus panel members were oriented on how to interpret the evidence summaries and generate the GRADE evidence-to-decision framework.
Evidence Synthesis – Evidence Review Experts reviewed and appraised existing CPGs and published literature, prepared evidence summaries, and drafted evidence-based recommendations. They are composed of members with one or more of the following expertise: methodologists, clinical epidemiologists, evidence-based practitioners, etc. They ideally have attended previous training on CPG development and evidence synthesis, or have previous experience on CPG development.
For each health question, a systematic literature search was done. All eligible studies were critically appraised independently by the assigned reviewers.
Evidence tables and evidence summaries were generated by the TWG using the GRADE approach. Draft recommendations were formulated based on the quality of the evidence. All these steps were done by at least two independent reviewers.
During this stage of development, several technical coordinators with expertise on CPG Development and Evidence-Based Medicine oversee the retrieval and appraisal of evidence and the creation of the draft recommendations. A writer ensured that the draft recommendations are uniform, concise and clear. The Steering Committee organized several practice sessions for the ERE to finalize their presentations, and discuss them with other EREs, Steering Committee and technical experts. Evidence summaries were collated, formatted and prepared for presentation to the consensus panel.
Evidence to Decision – Upon completion of the evidence summaries by the ERE, several en banc meetings with the Consensus Panel were conducted wherein the evidence summaries and draft recommendations were presented for discussion and consensus voting. The Consensus Panel ranked the outcomes for each set of clinical questions according to whether they were critical, important but not critical or of low importance for decision making. Critical outcomes were primary factors that should influence a recommendation, while those with lower importance did not bear on these recommendations. In a scale of 1-9, those rated 7-9 were critical outcomes, 4-6 were important but not critical outcomes and 1-3 were outcomes of limited importance. Grading of the strength of recommendations are based on the overall quality of the evidence, trade-offs between benefits and harms, values and preferences of patients, resource implications and impact on equity. A skilled facilitator moderated the discussions during this meeting.
Each member voted on the draft recommendation as follows: yes, no, or abstain. Consensus was defined as at least 75% agreement among the members for both the direction and strength of recommendation. If consensus was not reached, members discussed the reasons in support of their votes for or against the recommendation. The voting was repeated, up to three times, until a consensus is reached. Any issues left unsettled after the en banc meeting were finalized through a modified Delphi activity.
Living CPG Process – From standard guideline development process above, several recommendations were prioritized to a living status according to the following: priority for decision making, reasonable chance that new evidence changes the existing recommendation, and likelihood of new research evidence [Akl et al, 2020]. Members of the EREs working on living recommendations (1) performed continual surveillance of literature to update the living systematic review with new evidence and (2) updated the Evidence Summary tables and draft recommendations for panel discussion. The Steering Committee reviews the updated evidence summary and determines if the update will be presented to the Consensus Panel again. If so, the Consensus Panel is convened in an online meeting to discuss the new evidence and any changes in the living recommendation.
The Living CPG Development Process is summarized in the figure below:
This Living CPG tackles six central themes in COVID-19, and each theme is represented by a separate CPG Consensus Panel:
- Screening and diagnosis
- Critical care and respiratory management
- Non-pharmacologic interventions
- Vaccines and prophylactic interventions
- Adjunct interventions
MANAGEMENT OF CONFLICT OF INTEREST
All members involved in the creation of this Clinical Practice Guideline, including the Steering Committee, Technical Working Group and Consensus Panel, declared any conflicts of interest within the last 4 years, using a uniform Declaration of Conflict of Interest (DCOI) form. These were reviewed by the central project team and the Steering Committee, to screen and manage the COIs declared. Those without significant COIs were selected to be members of the consensus panel. Those with COIs which were not significant could participate, as long as their COIs are declared in meetings and documented in reports. Finally, those with significant personal and financial COIs related to COVID-19 were not selected to be involved in any part of the CPG project.
The Consensus Panel evaluated the direction and strength of recommendation using the GRADE approach, based on the (1) over-all quality of evidence for each question, (2) balance between benefits and harms, (3) values, preferences and burden on patients, (4) cost and resource use, and (5) other considerations.The quality of evidence is one of the bases of the Consensus Panel in making the final recommendation. The following table shows the definition and implication of each:
The implications of strong and conditional recommendations are as follows [Schünemann et al 2013]:
There are three reasons where the consensus panels were unable to make a recommendation:
- confidence in effect estimates is so low that the panels feel a recommendation is too speculative
- trade-offs are so closely balanced, and the values and preferences and resource implications not known or too variable
- management options have very different undesirable consequences, and individual patients’ reactions to these consequences are likely to be variable
A strong recommendation is usually stated as “We recommend/ We recommend against…”, while a conditional recommendation is worded “We suggest/ We suggest against…”. Finally, when there is no recommendation that can be made, the sentence starts with “There is no/ insufficient evidence to recommend…”