Book
Bronchial Asthma
- Methodology
• A comprehensive search for guidelines was undertaken to identify the most relevant guidelines to consider for adaptation.
• Inclusion/exclusion criteria were applied: only evidence-based guidelines (with systematic literature searches and explicit links between recommendations and supporting evidence); national and/or international guidelines; within the last 3 years; peer-reviewed publications; guidelines written in English; excluding single-author guidelines not on behalf of an organization; and excluding guidelines published without references.
• All retrieved guidelines were screened and appraised using the AGREE II instrument (www.agreetrust.org) by at least three members.
• The GDG adapted the GINA 2026 Strategy Report and the GINA 2025 guide on difficult-to-treat and severe asthma for the diagnostic, assessment and multimorbidity sections; pharmacological management is aligned with the Egyptian MoH Asthma Management Protocol for Adolescents and Adults (2023). Content on children aged less than 12 years, and content not addressed by the national Protocol, were excluded from this edition.
Evidence assessment
In accordance with the WHO handbook for guideline development, the GDG used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess the quality of a body of evidence and to develop and report recommendations. GRADE methods are used by WHO because they represent internationally agreed standards for making transparent recommendations. Detailed information on GRADE is available through the WHO Guidelines Review Committee (GRC) secretariat and on the following sites:
GRADE Working Group: https://www.gradeworkinggroup.org
GRADE online training modules: http://cebgrade.mcmaster.ca/
Table 1. Quality and significance of the four levels of evidence in GRADE
|
Quality |
Definition |
Implications |
|
High |
The GDG is very confident that the true effect lies close to the estimate of the effect. |
Further research is very unlikely to change confidence in the estimate of effect. |
|
Moderate |
The GDG is moderately confident in the effect estimate: the true effect is likely close to the estimate but may be substantially different. |
Further research is likely to have an important impact on confidence and may change the estimate. |
|
Low |
Confidence in the effect estimate is limited: the true effect may be substantially different. |
Further research is very likely to have an important impact and is likely to change the estimate. |
|
Very low |
The group has very little confidence in the effect estimate: the true effect is likely substantially different. |
Any estimate of effect is very uncertain. |
Table 2. Factors that upgrade or downgrade the quality of evidence
|
Factor |
Effect on evidence rating |
|
Study limitations |
− 1 serious; − 2 very serious |
|
Inconsistency |
− 1 important inconsistency |
|
Indirectness |
− 1 some uncertainty; − 2 major uncertainty |
|
Imprecision |
− 1 imprecise data |
|
Reporting bias |
− 1 high probability of reporting bias |
|
Dose-response gradient |
+ 1 evidence of a gradient |
|
Plausible confounding |
+ 1 confounders would have reduced the effect |
|
Magnitude of effect |
+ 1 strong; + 2 very strong, no major threats to validity |
Strength of the recommendation
Strong recommendations communicate that the desirable effects of adherence outweigh the undesirable effects; in most situations the recommendation can be adopted as policy.
Conditional (weak) recommendations are made when there is greater uncertainty, when local adaptation must account for variability in values and preferences, or when resource use makes the intervention suitable in some settings but not others; these require stakeholder involvement before adoption as policy.
When not to make a recommendation: where there is a lack of evidence on the effectiveness of an intervention, it may be appropriate not to make a recommendation.
Good practice statements: where the GDG judged that the benefit of an action is unequivocal and that collecting and grading evidence would not be a productive use of resources, a good practice statement is made. Good practice statements are not graded for strength or level of evidence.
Wording of recommendations: “We recommend” and “We do not recommend” denote strong recommendations; “We advise” and “We advise against” denote conditional recommendations. Each recommendation is followed by its supporting references (superscript) and, in parentheses, its strength and level of evidence. Remarks below a recommendation give implementation detail and are not graded.
Table 3. Implications of recommendations by stakeholder
|
Stakeholder |
Strong recommendation |
Conditional recommendation |
|
Patient |
Most patients would want the recommended course of action; only a small number would not. |
Many would prefer it, but a substantial number may not; this is an opportunity for shared decision-making. |
|
Clinician |
Most individuals should receive the recommended action; adherence may serve as a quality criterion. |
Different choices suit different patients; decision aids and shared decision making are appropriate. |
|
Policymaker |
Can be adopted as policy and used for performance indicators. |
Requires substantial debate and stakeholder involvement; regional variance is more likely. |
Standard of care and resource-stratified implementation
These recommendations define the recommended standard of asthma care in Egypt. They are a decision-support framework and do not replace the judgment of the treating physician; any deviation should be clinically justified and documented. Because services are not uniform across Egypt, where a recommended medicine, investigation or service is not available at the point of care, this does not lower the standard; it activates a duty to substitute safely and to refer.
• Provide the best available evidence-based alternative of equivalent safety; never withhold ICS-containing treatment, and never revert to SABA-only therapy, because of unavailability.
• Refer or escalate along the referral ladder (Table 4) without undue delay, within the indicated time frame.
• Record the unavailable item, the safe alternative provided, and the referral made.
A patient with red-flag (near-fatal) features or a severe exacerbation must receive immediate emergency care and is never delayed pending routine referral.
Table 4. Referral and escalation ladder
Tiers describe capability, not a specific building; a facility providing a higher-tier capability may discharge that role. Timeframes are maximum, not targets.
|
Tier |
Setting (Egypt) |
Expected to provide |
Refer / escalate when |
Timeframe |
|
Primary care |
GP, family medicine, primary chest clinic |
Diagnosis; ICS-containing controller; inhaler training; written action plan; first response to exacerbations |
Diagnostic uncertainty; uncontrolled despite correct Step 3–4 therapy with good adherence/technique; ≥2 exacerbations/year; any red-flag feature; suspected occupational, severe or Type 2 disease |
Routine 2–4 weeks; urgent same week |
|
Secondary care |
Chest / internal-medicine outpatient; district or general hospital |
Spirometry and lung function; structured assessment; ICS-LABA (± LAMA) optimization; inpatient exacerbation care |
Difficult-to-treat asthma after optimization; need for phenotyping/biomarkers; possible biologic candidate; recurrent severe exacerbations |
Routine 2–4 weeks; urgent 24–72 h |
|
Tertiary / specialist |
University or specialist severe-asthma service |
Severe-asthma work-up; Type 2 biomarkers; biologic therapy; induced sputum; allergen-immunotherapy assessment; complex multimorbidity |
Apex of the ladder, accepts referrals from secondary care |
Severe/near-fatal: same-day; otherwise expedited |
Before adoption as a binding standard, this document should undergo formal review and endorsement by the Ministry of Health and Population. It sets minimum expected standards and a referral framework; it does not remove the individual clinical responsibility of the treating physician and does not constitute legal advice. The wording of individual recommendations and local availability thresholds remain the responsibility of the GDG.
