This document provides the “clinical perspective” beyond the context of the National TB Program processes and procedures, addressing specific clinical questions and issues encountered in various health care settings in the country where resources and expertise may be available, and which cannot be addressed by the NTP Manual of Procedures. This hopes to serve as standard reference for clinicians, training programs for specialty and sub-specialty care, and the academe for the overall management of TB in adults.
This is a joint initiative led by the Philippine Coalition Against Tuberculosis (PhilCAT), Philippine Society of Microbiology and Infectious Diseases (PSMID), and the Philippine College of Chest Physicians (PCCP) in collaboration with other specialty professional societies and the Department of Health (DOH).
Methodology
A Task Force composed of TB experts, clinicians, epidemiologists, academicians and program implementers was created, headed by a Steering Committee for overall technical and administrative direction. An orientation and training workshop on the objectives, context and processes was done to all members of the Task Force using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.
Clinical questions on diagnosis, treatment, drug-resistance, TB-HIV and other high risk clinical groups, prevention and control were identified, approved in plenary and assigned to Technical Writing Committees (TWCs) who appraised available published or unpublished local and foreign medical evidence from 2005 to 2015. Quality of evidence was assessed to be high, moderate, low, and very low based on the study design and estimate of effect as shown in Table 1.
Statements were initially developed through a series of small group discussions (SGDs) in consultation with relevant experts and respective technical advisers at the committee level. Strength of recommendations was assessed by a 27-member Voting Consensus Panel based on the balance between desirable and undesirable effects, quality of evidence, patients values and preferences, cost and access to tests or interventions, largely guided by its potential implications to patients, clinicians and policy makers (Table 2).
TABLE 1
Quality of Evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Framework
QUALITY OF EVIDENCE STUDY DESIGN LOWER IF: HIGHER IF:
High Further research is very unlikely to change confidence in the estimate of effect Randomized controlled studies (RCTs) Study quality: Poor quality of implementation of RCT Inconsistency of results: Indirectness: Different population, intervention, outcomes Imprecise results: High probability of reporting bias Stronger association: Large magnitude of effect, no plausible confounders Very large magnitude of effect, no major threats to validity Dose response gradient
Moderate Further research is likely to have impact on the confidence in the estimate of effect Downgraded RCTs or upgraded observational studies Low Further research
is very likely to have an important impact on the confidence in the estimate of effect Observational studies
Very Low Any estimate of effect is very
uncertain
Case series or expert opinion
Reference: Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336:924-926
Voting was done as follows: A=accept completely; B=accept with some reservations; C=accept with major reservations; D= reject with some reservations; and E= reject completely. Statements reached consensus if 80% voted A or B; rejected if less than 80% was reached or at least one (1) member voted D or E.
The First Draft was presented last February 6-7, 2015 to the Voting Consensus Panel for initial inputs and approval. Statements that reached consensus were presented at the Annual Convention of the Philippine College of Chest Physicians (PCCP) last March 6-7, 2015 for feedback and comments; while those that were not accepted were sent back to the Technical Writing Committees for either revision or further literature review as recommended by the Voting Panel. The Second Draft was finalized in a write shop by the TWCs with their respective technical advisers last June 19-20, 2015, and presented for final voting in the Final Consensus Panel meeting last July 18, 2015. Statements that did not reach consensus but were not rejected
TABLE 2 Implications of Strength of Recommendations (GRADE Approach) to Patients, Clinicians and Policy Makers
STRENGTH OF
RECOMMENDATION IMPLICATIONS OF THE RECOMMENDATIONS
TO PATIENTS TO CLINICIANS TO POLICY MAKERS
Strong The benefits outweighed the harm. There are no cost or access issues for the general population
Most people in the situation would want the recommended course of action and only very few would not; request for discussion if the intervention is not offered Most patients should receive the recommended course of action The recommendation can be adopted as a policy in most situations
Weak Best available evidence is very low to low quality; Magnitude of benefits or risks is uncertain or closely balanced for the general population and applicable to a specific group, population or setting; Benefits may not warrant the cost or resource requirements in all settings
Most people in the situation would want the recommended course of action, but many would not
Different choices are appropriate for different patients, and clinician must help patients arrive at a management decision consistent with patient’s values and preferences
Policy making will require substantial debate and involvement of any stakeholders
Reference: Guyatt GH et al. Going from evidence to recommendations. BMJ. 2008 May 10; 336(7652):1049- 1051.
by the Voting Consensus Panel were reviewed, revised and elevated to the Steering Committee for final approval. The first public dissemination was done at the 22nd PhilCAT Annual Convention last August 13-14, 2015. An Advisory Committee represented by previous and current heads of participating professional medical societies assisted the Task Force. Dissemination of this document requires development of standard modules by trained pool of speakers selected among the members of the participating societies for standardized structured dissemination to their members.