These guidelines are intended for use of primary care providers.
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This guideline is intended to be used by general practitioners, specialists and health professionals who are primary care providers. Although adherence to this guideline is encouraged, it should not restrict the primary care providers in using their sound clinical judgment in handling individual cases. Payors and policymakers, including hospital administrators and employers, can also utilize this CPG, but this document should not be the sole basis for evaluating insurance claims. Recommendations from the PHEX app and the guidelines therein should also not be treated as strict rules on which to base legal action.
Program Leaders Leonila F. Dans, M.D., M.Sc Marissa M. Alejandria, M.D., MSc Central Steering Committee Members Antonio Miguel L. Dans, M.D., M Sc Dante D. Morales, M.D. Beverly C. Ho, M.D Aileen Espina, M.D. Maria Vanessa V. Sulit, RN, M Sc Diana Lachica Tamondong M. D. Project Managers Ian Theodore G. Cabaluna, R.Ph., M.D., Gdip(ClinEpi) Josephine T. Sanchez, RN Administrative Staff Maria Pamela A. Tagle Lailanie Ann C. Tejuco Jorge Romero OVERSIGHT COMMITTEE (OC) Chair: Dr. Dante D. Morales Co-Chair: Antonio Miguel L. Dans Angela Abanilla-Du, MD Camilo G. Te, MD Maria Vanessa Villaruz-Sulit, RN, MSc
Preventive health screening has been advocated as a means to improve health outcomes and quality of life, and avoid preventable deaths. However, despite its perceived benefits, it may also bring harm to a patient such as physical, emotional and financial consequences of false positive results and more importantly, overdiagnosis. The “Philippine Guidelines on Periodic Health Examination (PHEX): Effective Screening for Diseases Among Apparently Healthy Filipinos†was developed in 2004 to guide health providers and patients on preventive health screening. As new evidence on preventive screening emerges and the enactment of the Universal Healthcare law, there is an urgent need to update the existing outdated guidelines. Due to the large scope of the guideline, its updating was carried in 3 phases. Phase 1 entailed evaluation of select screening strategies that are currently being implemented by the Department of Health. Phase 2 and 3 involved evaluation of additional screening strategies, that are considered novel, controversial, or misused. Phase 2 also involved the development of an online and mobile app that will allow users to generate a patient-specific plan based on age, sex, risk factors, and other patient characteristics. It covered screening recommendations for cardiovascular, neoplastic, congenital disorders, mental health & substance abuse, lifestyle advice and immunizations. The recommendations in this website covers Phase 1 & 2 of the project.
The general CPG methodology used for the entire update was the GRADE approach, following the recommended process in the DOH Manual on Practice Guideline Development. The target users of the CPG would be primary care providers and policymakers. The target population of the screening test and interventions was the apparently healthy asymptomatic Filipinos. Guideline Preparation PHEX Phase 1 & 2 convened a Central Executive Committee comprised of a Steering Committee (SC), Oversight Committee (OC) and Central administrative staff. Phase 1 : Konsulta Package screening interventions Phase 2: Six task forces (TF) were convened to develop their respective guidelines namely: 1. Task force on Screening for Cardiovascular Disease 2. Task Force on Screening for Neoplastic Diseases 3. Task force on Screening for Congenital and Developmental Disorders 4. Task Force on Screening for Mental Disorders and Substance Abuse 5. Task Force on Immunization – Pediatric & Adult 6. Task Force on Screening on Lifestyle Advise Task Force chairs were identified to lead each TF. They identified and recruited the working committees namely: 1) Task force SC, 2) Technical Working Group (technical coordinator, evidence review experts, technical writer, technical meeting facilitator, and an administrative officer) 3) Consensus Panel (CP) members. Each task force Steering Committee prioritized and finalized the guideline questions to be addressed, 2) convened the ERE and 3). convened the CP. 4). supervised the entire CPG process. Additional methods done by each task force are found in their respective manuscripts. Due to the number of task forces involved in the project, a Central Executive Committee, led by Dr. Leonila F Dans and Dr. Marissa A Alejandria, was created. The team was composed of the central steering committee, project leaders (LFD, MMA), project managers and administrative staff. The team oversaw and coordinated with all task forces. The Central Executive Committee provided continuous administrative and technical support to the task forces including the collection of declaration of Conflict of Interest, Curriculum Vitae (CVs), preparation, collection and processing of contracts and other salary/honorarium documents, training of task force members, and technical guidance throughout the whole CPG development process. The central team ensured that the CPG methodology as recommended in the DOH Manual for CPG Development was followed. The team guided and reviewed the development of research questions and evidence summaries. Lectures, instruction modules, technical resource and templates were prepared to guide the task force in developing the research questions, evidence synthesis, and facilitation of CP meetings. Online orientation on CPG methodology tasks, specific steps were given to the task force steering committee, technical writers, evidence reviewers, technical coordinators, and facilitators. Prioritizing the Guideline Research Questions The task forces identified, prioritized and finalized the scope and the guideline research questions. Each question included details on population, intervention, comparator, and outcomes. Additional relevant specifics such as subgroup to be considered and frequency of intervention were also included. They consulted different stakeholders in prioritizing and developing their respective guideline questions. The Central Steering Committee reviewed and approved the guideline questions prior to evidence synthesis. Identification and prioritization of questions were mostly based on the following criteria 1. disease burden 2. public contention 3. cost-effectiveness 4. new evidence 5. potential impact 6. interest of public or care providers 7. variation in care 8. sufficiency of evidence and 9. timeliness. Evidence Synthesis Each task force then convened their technical working group composed of a technical coordinator, evidence review experts (ERE) and technical writer. . At least one ERE was assigned a guideline question to work on supervised and guided by a technical coordinator that also functioned as second reviewer. For each guideline question, the GRADE Adolopment process was used in gathering the evidence. It involved extracting and appraising evidence summaries of high-quality CPGs and adapting them into our own local setting by constructing an Evidence to Decision framework. A systematic search of international CPGs that directly answered the guideline question were done. We included guidelines developed by international guideline developing bodies such as the World Health Organization, the United States Prevention Task Force, the Canadian Task Force on Preventive Healthcare, National Institute for Health Care and Excellence and United Kingdom National Screening Committee Recommendations. Two independent reviewers appraised the CPG using AGREE II tool. Evidence summaries of CPG done from 2015 onward and were deemed to have high quality (AGREE II score > 75) were included. Evidence for questions that were not covered by the above CPGs were systematically searched and appraised. The results of the appraisal of existing CPGs and their evidence summaries determined the need for a systematic search in electronic databases (MEDLINE via PubMed, CENTRAL, Google Scholar) to do de-novo systematic reviews and meta-analysis for each question. Relevant local databases and websites of medical societies were also utilized in the search. Keywords were based on PICO (MeSH and free text) set for each question. The ERE also contacted authors of related articles to verify details and identify other research studies for appraisal, if needed. The ERE appraised the directness, methodological validity, results, and applicability of each relevant article included. The ERE generated evidence summaries for each of the questions. Each evidence summary included evidence on the burden of the problem, and diagnostic performance, benefits, harm, and social and economic impact of the screening test/intervention. RevMan, STATA, and GRADEPro were used for the quantitative synthesis of important clinical outcomes for each question. Source of the evidence would include evidence summaries from pre-identified CPG, systematic reviews, health technology assessment reports, and primary studies such as clinical trials, diagnostic accuracy studies, qualitative studies and cost-effectiveness analysis studies whenever possible or available. The certainty of evidence for the benefit and harm of an intervention was assessed according to Table 1. Over-all certainty of evidence per research question will be the lowest level based on the critical outcomes included in the decision-making. The ERE systematically and exhaustively searched for and provided evidence on the following criteria whenever applicable: • Burden of the problem • Diagnostic performance of the screening test • Benefits and harm of the screening test and/or subsequent management • Economic impact and cost of the screening test • Social and health systems impact of the screening test and/or subsequent management. Relevant evidence that would facilitate in the decision (i.e., cost of screening test, cost-effectiveness studies, qualitative studies for patient values and preferences, accessibility, feasibility, and equity issues) were also included in the evidence summaries. The evidence gathered for each guideline question were also incorporated into the GRADE EtD framework to facilitate the decision-making process. A draft recommendation was formulated prior to the panel meeting. The draft recommendations were formulated based solely on the evidence on the balance between benefits and harm of the screening test and the certainty of the evidence. During this stage of development, each task force had a technical coordinator with expertise on CPG development, Evidence-Based Medicine and Evidence synthesis. The TC supervised the retrieval and appraisal of evidence, ensured methodologic rigor of the process and the accuracy and reliability of data extraction, and the construction of the draft recommendations. They also functioned as second reviewer to ERE. Practice presentations with their respective TF SC and the Central Executive Committee were organized to ensure the validity and quality of the evidence summaries prior to the consensus panel meeting. A technical writer (TW) per task force took charge of collating the ES into an evidence base, ensuring the continuity and flow of the manuscript, standardizing the manuscript format and documenting the Consensus meeting to be included in the CPG manuscript. The TW was also responsible for incorporating the agreed recommendation and consensus issues into the final manuscript. Formulation of Recommendations Prior to CP Meeting Each task force convened a 10-15 multisectoral Consensus panel and identified a technical facilitator who oversaw the deliberation and the consensus process. An online orientation session for the panelists and technical facilitators was conducted to introduce the GRADE CPG methodology, interpretation of evidence summaries, the EtD approach and the formal consensus process. The panelists were asked to study the evidence base of the guideline research questions and asked to answer a set of questions based on the EtD framework for each guideline question. Their answers were summarized and presented during the CP meeting. Outcomes were also rated according to whether they were critical, important but not critical or of low importance for decision making by health care providers and consumers. Only important and critical outcomes were included in the evidence summaries to be considered in the decision-making. A maximum of 7 outcomes were considered and presented. During CP Meeting During the facilitated en banc consensus panel meetings, the key findings of the evidence summaries and draft recommendations were presented for deliberation. The criteria on Evidence to Decision framework on diagnostic tests by the GRADE working group were used. Upon clarification and discussions, the panel voted and arrived at a recommendation. If consensus (75% of total votes) was reached before or on the third round, voting on the strength of the recommendation commenced. The CP arrived at a consensus in recommendations for all 16 questions. The CP considered the balance between harm and benefit, certainty of evidence, costs, acceptability, feasibility, appropriateness, and equity in making the recommendation and its strength. The CP needed to decide on the direction of the recommendation [whether to recommend for or against] and the strength of recommendation [whether weak or strong]. Usually high or moderate certainty of evidence will result into a strong recommendation and low or very low certainty of evidence will lead to a weak recommendation. All meetings were done remotely via Zoom. When no consensus was reached during the remote meetings, modified Delphi approach was used to extend the voting process if additional evidence or issues were introduced that might change the votes to reach a consensus. Strong recommendation means that desirable effects of intervention clearly outweigh undesirable effects, or clearly do not while weak recommendations means that trade-offs are less certain, either because of low quality evidence or because evidence suggests desirable and undesirable effects are closely balanced. In case of discrepant decisions with the certainty of evidence, the CP was asked to explicitly justify the recommendations and this was documented under consensus issues in the final manuscript of the CPG.
Management of Conflict of Interest The Central Executive Committee convened an COI Committee (COIC) whose task was to thoroughly review the declaration of conflict of interest (DCOI) of each of the Task Force members particularly the Consensus Panelists (CP) and make recommendations on how to manage the COI. For TF members with potential significant COIs, the members of the COIC conducted additional investigations with due diligence to ensure the integrity of the CPG process and the final recommendations. All task force members submitted a DCOI and their curriculum vitae (CV) prior to the initiation of guideline development process. The disclosure included a 4-year period of personal potential intellectual and/or financial conflicts of interest (COI). Management of the COI of the Consensus Panel, Technical Coordinators, and Task Force Steering Committees were deliberated and decided by the COI Committee, using the pre-agreed criteria. The COIC decision was then forwarded to the Task Force Steering Committee for appropriate action. The COIC members were invited to attend the CP meetings for due diligence if their recommendations were actually being followed.
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