Revised Guidelines on National Practice Guideline Development, Adoption and Dissemination

February 26, 2021

DOH ADMINISTRATIVE ORDER NO. 2021-0020

 

I. BACKGROUND

Practice guidelines are evidence-based recommendations used to optimize patient care by reducing inappropriate variations and ensuring efficient use of limited resources. HTcADC

Standardizing the process of development, adoption, and dissemination is aimed at improving the overall availability of quality-assured practice guidelines.

The development of clinical care standards and the establishment of a mechanism for the development, adoption, and dissemination of practice guidelines are in line with the Department's mandate as the lead agency in ensuring the quality of health care through policy formulation, standards development, and regulations in accordance with Executive Order No. 102, s. 1999 and Sections 27.7 and 27.8 of Republic Act No. 11223, or the Universal Health Care Act.

The development of these guidelines, and the complementary Manual for National Practice Guideline (NPG) Development, were informed by a previous Advancing Health for Evidence Assisted Decision-making with Health Policy Systems Research project entitled, "Scoping of Current Practices in National Practice Guideline Development" in addition to operational issues encountered since the issuance of Administrative Order No. 2018-0019, "Guidelines on the Institutionalization and Implementation of the National Practice Guidelines Program."

II. OBJECTIVES

1. To set the operational framework for practice guideline development, adoption, and dissemination.

2. To update the standardized process of practice guideline prioritization, generation, appraisal and approval, dissemination, and monitoring and evaluation.

III. SCOPE OF APPLICATION

This Order shall apply to all DOH Central Office Bureaus and Services, DOH Centers for Health and Development, Ministry of Health-Bangsamoro Autonomous Region in Muslim Mindanao, DOH Hospitals and Treatment Rehabilitation Centers, DOH attached agencies, and all other public and private entities involved in practice guideline development including but not limited to health care providers, academe, researchers and research institutions, and professional societies.

IV. DEFINITION OF TERMS

The following terms are defined for the purpose of this Order:

A. Appraisal of Guidelines for Research & Evaluation II (AGREE II) — refers to an international tool used to assess the quality and reporting of practice guidelines

B. Appraisal of Guidelines for Research & Evaluation (AGREE) Reporting Checklist — refers to the reporting checklist to be complied with by Lead Practice Guideline (PG) Developers upon submission of their PGs for appraisal/review by the DOH

C. Conflict of Interest (COI) — refers to a set of situations that creates a risk that professional judgment or actions in relation to a primary interest are/may be unduly influenced by a secondary interest (IOM, 2011)

D. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) — refers to "a transparent framework for developing and presenting summaries of evidence and provides a systematic approach for making clinical practice recommendations" (BMJ, 2020)

E. Health Technology Assessment (HTA) — refers to the systematic evaluation of properties, effects, or impact of health-related technologies, devices, medicines, vaccines, procedures, and all other health-related systems developed to solve a health problem, and improve the quality of lives and health outcomes, utilizing a multidisciplinary process to evaluate the clinical, economic, organizational, social, and ethical issues of a health intervention or health technology (RA 11223)

F. Interim National Practice Guidelines (Interim NPGs) — refer to DOH-endorsed National Practice Guidelines, standard treatment guidelines, evidence-based guidelines, or any equivalent standard that sets how individuals should be given care and meets the minimum requirement for the AGREE II domain of "Rigor of Development"

G. Manual for National Practice Guidelines Development — refers to handbook that sets the standards and prescribed methods set by the Department of Health on developing practice guidelines

H. National Practice Guideline Clearinghouse (NPG Clearinghouse) — an ad hoc panel or committee convened by the National Practice Guidelines Program to appraise a Practice Guideline and recommend on its endorsement by the DOH

I. National Practice Guidelines Program (NPGP) — previously referred to as the National Clinical Practice Guidelines Program

J. National Practice Guidelines (NPGs) — refer to DOH-endorsed National Practice Guidelines, standard treatment guidelines, evidence-based guidelines, or any equivalent standard that sets how individuals should be given care and that meets all quality requirements as stipulated in AGREE II aScITE

K. Practice Guidelines (PGs) — refer to National Practice Guidelines, standard treatment guidelines, evidence-based guidelines, or any equivalent standard that sets how individuals should be given care, regardless of the care provider (ex. clinician or barangay health worker), the setting (clinical or community), or the care component being addressed (ex. screening, diagnosis, treatment, etc.). These consist of recommendations that are intended to optimize patient care, and are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options (IOM, 2011)

L. Rigor of Development — relates to the process used to gather and synthesize the evidence, the methods to formulate the recommendations, and to update them

V. GENERAL GUIDELINES

A. To maximize the utility of PGs, the NPGP shall ensure that processes for PG development are responsive to the information needs of clinicians, other health care providers in non-clinical settings, DOH units, and PhilHealth while taking into consideration the patient's values and preferences in decision-making.

B. PGs for funding by the DOH shall be prioritized according to the needs of PhilHealth and the HTAU primarily in light of the need to expand PhilHealth benefit packages in support of Universal Health Care. Other criteria for prioritization shall be set by the NPGP as necessary in consultation with stakeholders, including DOH units and PhilHealth. These criteria shall be made known to the public for their guidance in applying for DOH funding.

C. PG generation shall adhere to the Manual for CPG Development (First Edition 2018) and its updates. In addition, apart from the full text/manuscript, pocket guides and laymanized versions of the PG shall also be developed by Lead PG Developers in collaboration with relevant units in the DOH.

D. PGs for endorsement by the Secretary of Health as NPGs must meet the quality standards as appraised by the National Practice Guideline Clearinghouse using AGREE II. PGs that do not meet all the quality standards but attain a minimum rating of "Satisfactory" for the domain "Rigor of Development" shall be endorsed as Interim National Practice Guidelines.

E. PGs that are endorsed as NPGs or Interim NPGs shall be used by healthcare providers, academe, and payers of healthcare (including the DOH and PhilHealth) to guide clinical practice, policy development, and benefit package development.

VI. SPECIFIC GUIDELINES

A. National Practice Guideline Governance Structure (Refer to Annex I)

1. The National Practice Guideline Program shall:

a. be organized within the Disease Prevention and Control Bureau to oversee PG development in the Philippines, and to develop and periodically review and update the approaches, strategies, and processes to improve the quality, timeliness, or overall responsiveness of PG development (ex. adoption of 'living guidelines' approach, development of integrated care PGs, creation of additional committees or working groups as needed, etc.); and

b. be the main coordinating body for PG development in the Philippines, and convene and provide administrative and technical support to the NPG Clearinghouse; engage, liaise with, or commission Lead PG Developers; and ensure involvement of relevant end-user units from the DOH and PhilHealth during the PG generation phase. This includes collaborating with the HTAU to ensure that information is shared between the two units and that outputs, evidence used, and recommendations are consistent.

2. The National Practice Guideline Clearinghouse shall:

a. be convened by the NPGP for each PG that has been endorsed for the Clearinghouse's appraisal;

b. ensure that PGs approved by the Secretary of Health meet the minimum quality standards using AGREE II; and

c. be composed of one (1) DOH representative, two (2) content experts, and two (2) methodologists.

3. The Lead PG Developer shall:

a. be the overall technical lead in PG development that convenes the working groups, namely the Consensus Panel and Evidence Review Experts;

b. finalize the scope, research questions, and target users of the PG to be developed;

c. preferably be trained and experienced in PG development and/or Evidence-Based Medicine;

d. preferably be affiliated with an agency or institution that can provide adequate administrative and additional technical support;

e. be a DOH Program Manager, content expert, methods expert, or any combination of the three, or representatives of medical societies or other stakeholder institutions;

f. form a project team that has adequate project management, data management and analysis, and medical writing skills;

g. be free from potential intellectual and financial COIs that are relevant to the content of the PG;

h. provide administrative and technical support to the project team;

i. engage additional content and technical experts as necessary; and

j. collect, assess, and manage COIs.

4. The Consensus Panel shall:

a. prioritize outcome measures, review evidence summaries, and draft and vote on recommendations; and

b. be composed of 10-15 multi-sectoral representatives from health care providers (specialists, generalists, primary care providers); patients and/or patient advocates (at least 1); methodologists (at least 1) such as evidence-based practitioners, clinical epidemiologists, and economists; and other DOH representatives (at least 1) whose practice may be affected by the guidelines, who can influence the uptake of PG recommendations, or whose work would require information that can be obtained through the PG generation process (ex. costs of services for PhilHealth, service flow for HFDB). HEITAD

5. The Evidence Review Experts shall:

a. conduct the review of existing PGs, create evidence summaries, and formulate evidence-based draft recommendations; and

b. include at least one (1) PG/GRADE methods expert, one (1) clinical epidemiologist or evidence-based practitioner, and one (1) biostatistician.

B. Management of Conflicts of Interest

1. Declaration and management of conflicts of interest shall be mandatory for all groups and persons involved in PG development, and shall primarily be led by Lead PG developers and overseen by the NPGP.

2. All stakeholders involved in PG development shall comply with the guidance provided in the Manual for National Practice Guideline Development (First Edition 2018) and its updates or forthcoming DOH guidelines on management of COIs.

3. All PGs submitted by Lead PG Developers shall undergo an assessment of COI as part of the PG appraisal process. PGs that are rated unfavorably for the domain "Editorial Independence" of AGREE II shall be recommended for disapproval and shall not be endorsed by the DOH.

4. To ensure a clear delineation between the PG generation and review processes, an individual that participates in the PG generation shall not participate in the review process (as a member of the NPG Clearinghouse) and vice versa.

C. Practice Guideline Appraisal and Approval

1. PG manuscripts submitted to the NPGP for documentary review shall adhere to the reporting criteria listed in the most updated version of the AGREE Reporting Checklist available at https://tinyurl.com/AGREEReportingChecklist prior to endorsement to the NPG Clearinghouse for appraisal. (Annex II)

a. For consideration as National Practice Guidelines, submissions shall be 100% compliant with reporting requirements for all domains.

b. For consideration as Interim National Practice Guidelines, submissions shall be 100% compliant with reporting requirements for Domain 3: Rigor of Development.

2. The NPG Clearinghouse shall appraise PG manuscripts with the AGREE II tool. PG approval requires 4 out of 5 favorable ratings by the NPGC. A minimum rating of 75% for all domains is required for an overall favorable rating.

3. DOH-endorsed PGs (whether Interim NPGs or NPGs) must at least maintain their favorable ratings to be continually recognized as DOH-endorsed PGs. Appraisals shall be done in accordance with the schedule/plan for updating of such PGs.

4. Updating requirements and specific guidelines on the appraisal, approval, and appeal processes shall be developed and specified by the NPGP.

D. Practice Guideline Dissemination

1. The NPGP shall ensure that there is a dissemination plan for DOH-endorsed PGs and shall keep a repository of DOH-endorsed PGs.

2. DOH-endorsed PGs shall be made publicly available and accessible through, but not limited to, DOH web-based platforms.

3. Apart from the PGs (full text, pocket guide, and laymanized versions), results of the appraisal by the NPGP shall be made publicly available for the guidance and information of end-users.

E. Monitoring and Evaluation

1. Monitoring and evaluation of PG development, adoption, and dissemination shall be led by the NPGP in collaboration with Lead PG Developers. Lead PG Developers shall identify key quality of care indicators to be monitored for each PG.

2. Monitoring and evaluation shall be done based on the logical framework to be developed by the NPGP in consultation with stakeholders.

VII. ROLES AND RESPONSIBILITIES

A. Disease Prevention and Control Bureau shall:

1. establish a functional NPGP with adequate technical and administrative support that is independent of other program management functions of the Bureau;

2. develop internal capacity for PG development among its Program Managers, apart from the NPGP, to encourage their participation as Lead PG Developers;

3. through the NPGP, ensure the development of the NPGP's logical framework and the operational guidelines for PG prioritization, reviews/appraisals, dissemination, and monitoring and evaluation; updating of the Manual for CPG Development; and the implementation of the NPGP's activities; and

4. secure financing for priority PGs for development.

B. Health Policy Development and Planning Bureau shall provide technical assistance to the NPGP as needed.

C. Health Technology Assessment Unit, Health Facilities Development Bureau, and the Health Human Resource Development Bureau shall:

1. participate in the PG prioritization and generation process;

2. utilize NPGs/Interim NPGs in health technology assessments, competency framework development, resource and service flow identification, and other program or policy development (ex. service package development, clinical pathway development, etc.);

3. contribute toward efforts at dissemination; ensuring utilization of PGs among non-DOH stakeholders; and monitoring and evaluation activities of the PG; and

4. provide supplemental funding for PG guideline development.

D. Philippine Health Insurance Corporation shall:

1. conduct their own prioritization of PGs that need to be developed in line with its plan for benefit package development that is aligned with the UHC Act;

2. participate in the PG prioritization and generation process;

3. use NPGs/Interim NPGs only in its benefit package development (including costing);

4. contribute toward efforts at dissemination; ensuring utilization of PGs among non-DOH stakeholders; and monitoring and evaluation activities of the PG; and

5. provide supplemental funding for PG guideline development.

E. Lead PG Developers shall: ATICcS

1. comply with the requirements for PG appraisal as identified in the AGREE Reporting Checklist;

2. comply with COI policies stipulated in this issuance; and

3. develop internal capacity in their respective organizations/institutions/agencies for PG development.

VIII. REPEALING CLAUSE

This Order repeals Administrative Order No. 2018-0019, "Guidelines on the Institutionalization and Implementation of the National Practice Guidelines Program."

IX. SEPARABILITY CLAUSE

If any provision of this Order is declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected thereby shall remain valid and effective.

X. EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in the Official Gazette or a newspaper of general circulation. Copies of this Order shall be filed with the U.P. Law Center-Office of the National Administrative Register.

(SGD.) FRANCISCO T. DUQUE III, MD, MScSecretary of Health

ANNEX I

Program Governance Structure and Responsibilities

ANNEX II

AGREE Reporting Checklist