Republic ofthe PhilippinesDepartment of Health

OFFICE OF THE SECRETARYFEB 26 2021

ADMINISTRATIVE ORDERNo. 2021 -_0020

II.

HI.

SUBJECT: Revised Guidelines on National Practice Guideline Development,Adoption and Dissemination

BACKGROUND

Practice guidelines are evidence-based recommendations used to optimizepatient care by reducing inappropriate variations and ensuring efficient use of limitedresources.

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

The development of clinical care standards and the establishment of amechanism for the development, adoption, and dissemination of practice guidelines arein line with the Department’s mandate as the lead agency in ensuring the quality ofhealth care through policy formulation, standards development, and regulations inaccordance with Executive Order No. 102, s. 1999 and Sections 27.7 and 27.8 ofRepublic Act No. 11223, or the Universal Health Care Act.

The development of these guidelines, and the complementary Manual forNational Practice Guideline (NPG) Development, were informed by a previousAdvancing Health for Evidence Assisted Decision-making with Health Policy SystemsResearch project entitled, “Scoping of Current Practices in National Practice GuidelineDevelopment” in addition to operational issues encountered since the issuance ofAdministrative Order No. 2018-0019, “Guidelines on the Institutionalization andImplementation of the National Practice Guidelines Program.”

OBJECTIVES

1. To set the operational frameworkfor practice guideline development, adoption, anddissemination.

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

SCOPE OF APPLICATION

This Ordershall apply to all DOH Central Office Bureaus and Services, DOH Centersfor Health and Development, Ministry of Health-Bangsamoro Autonomous Region in

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 8651-7800 local TTO8, WITT, 1112, T1713

Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh_gov.ph; e-mail: fiduque@doh.gov.ph

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Muslim Mindanao, DOH Hospitals and Treatment Rehabilitation Centers, DOHattached agencies, and all other public andprivate entities involved in practice guidelinedevelopment including but not limited to health care providers, academe, researchersand research institutions, and professional societies.

DEFINITION OF TERMS

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

A. Appraisal of Guidelines for Research & Evaluation II (AGREEI) - refers to aninternational tool used to assess the quality and reporting ofpractice guidelines

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

Conflict of Interest (COD - refers to a set of situations that creates a risk thatprofessional judgmentor actionsin relation to a primary interest are/may be undulyinfluenced by a secondary interest (IOM, 2011)

. Grading of Recommendations, Assessment, Development and Evaluations(GRADE)- refers to “a transparent framework for developing and presentingsummaries of evidence and provides a systematic approach for making clinicalpractice recommendations” (BMJ, 2020)

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

Interim National Practice Guidelines (Interim NPGs) - refer to DOH-endorsedNational Practice Guidelines, standard treatment guidelines, evidence-basedguidelines, or any equivalent standard that sets how individuals should be givencare and meets the minimum requirement for the AGREEII domain of “Rigor ofDevelopment”

Manual for National Practice Guidelines Development- refers to handbook that setsthe standards and prescribed methods set by the Department of Health ondeveloping practice guidelines

National Practice Guideline Clearinghouse (NPG Clearinghouse) — an ad hoc panelor committee convened by the National Practice Guidelines Program to appraise aPractice Guideline and recommend on its endorsement by the DOH

National Practice Guidelines Program (NPGP) - previously referred to as theNational Clinical Practice Guidelines Program

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J. National Practice Guidelines (NPGs) - refer to DOH-endorsed National PracticeGuidelines, standard treatment guidelines, evidence-based guidelines, or anyequivalent standard that sets how individuals should be given care and that meetsall quality requirements as stipulated in AGREE IPractice guidelines (PGs)- refer to National Practice Guidelines, standard treatmentguidelines, evidence-based guidelines, or any equivalent standard that sets howindividuals should be given care, regardless of the care provider (ex. clinician orbarangay health worker), the setting (clinical or community), or the care componentbeing addressed (ex. screening, diagnosis, treatment, etc.). These consist ofrecommendations that are intended to optimize patient care, and are informed by asystematic review of evidence and an assessment of the benefits and harms ofalternative care options (IOM,2011)

Rigor of Development - relates to the process used to gather and synthesize theevidence, 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 PGdevelopment are responsive to the information needs of clinicians, other healthcare providers in non-clinical settings, DOH units, and PhilHealth while takinginto consideration the patient’s values and preferences in decision-making.

. PGs for funding by the DOHshall be prioritized according to the needs ofPhilHealth and the HTAU primarily in light of the need to expand PhilHealthbenefit packages in support of Universal Health Care. Other criteria forprioritization shall be set by the NPGP as necessary in consultation withstakeholders, including DOH units and PhilHealth. These criteria shall be madeknownto the public for their guidance in applying for DOH funding.

. PG generation shall adhere to the Manual for CPG Development (First Edition2018) and its updates. In addition, apart from the full text/manuscript, pocketguides and laymanized versions of the PG shall also be developed by Lead PGDevelopers in collaboration with relevant units in the DOH.

PGs for endorsement by the Secretary of Health as NPGs must meet the qualitystandards as appraised by the National Practice Guideline Clearinghouse usingAGREEII. PGs that do not meet all the quality standards but attain a minimumrating of “Satisfactory” for the domain “Rigor of Development” shall be endorsedas Interim National Practice Guidelines.

PGs that are endorsed as NPGsor Interim NPGs shall be used by healthcareproviders, academe, and payersof healthcare (including the DOH and PhilHealth)to guide clinical practice, policy development, and benefit package development.

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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 overseePG developmentin the Philippines, and to develop and periodically reviewand update the approaches, strategies, and processes to improve the quality,timeliness, or overall responsiveness of PG development (ex. adoption of‘living guidelines’ approach, developmentof integrated care PGs, creationof additional committees or working groups as needed, etc.); and

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

2. The National Practice Guideline Clearinghouse shall:

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

b. ensure that PGs approved by the Secretary of Health meet the minimumquality standards using AGREEII; and

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

3. The Lead PG Developershall:

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

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

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

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

e. be a DOH Program Manager, content expert, methods expert, or anycombination of the three, or representatives of medical societies or otherstakeholder institutions;

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

g. befree from potential intellectual and financial COIs that are relevant to thecontent of the PG;provide administrative and technical support to the project team;engage additional content and technical experts as necessary; andcollect, assess, and manage COIs.+.

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4. The Consensus Panelshall:

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

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

5. The Evidence Review Experts shall:

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

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

B. Management of Conflicts of Interest

1. Declaration and managementof conflicts of interest shall be mandatory forallgroups and persons involved in PG development, and shall primarily be led byLead PG developers and overseen by the NPGP.

2. All stakeholders involved in PG development shall comply with the guidanceprovided in the Manual for National Practice Guideline Development (FirstEdition 2018) and its updates or forthcoming DOH guidelines on managementof COIs.

3. All PGs submitted by Lead PG Developers shall undergo an assessment of COIas part of the PG appraisal process. PGs that are rated unfavorably for thedomain “Editorial Independence” of AGREE II shall be recommended fordisapproval 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 thereview process (as a memberof the NPG Clearinghouse) and vice versa.

C. Practice Guideline Appraisal and Approval

1. PG manuscripts submitted to the NPGP for documentary review shall adhere tothe reporting criteria listed in the most updated version of the AGREE ReportingChecklist available at https://tinyurl.com/AGREEReportingChecklist prior toendorsement to the NPG Clearinghouse for appraisal. (Annex IT)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: Rigorof Development.

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

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

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

D. Practice Guideline Dissemination

1. The NPGPshall ensure that there is a dissemination plan for DOH-endorsedPGs 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), resultsof the appraisal by the NPGPshall be made publicly available for the guidanceand information of end-users.

E. Monitoring and Evaluation

1. Monitoring and evaluation of PG development, adoption, and disseminationshall be led by the NPGPin collaboration with Lead PG Developers. Lead PGDevelopers shall identify key quality of care indicators to be monitored for eachPG.

2. Monitoring and evaluation shall be done based on the logical framework to bedeveloped by the NPGPin consultation with stakeholders.

VII. ROLES AND RESPONSIBILITIES

A. Disease Prevention and Control Bureau shall:

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

2. develop internal capacity for PG development amongits Program Managers, apartfrom the NPGP, to encourage their participation as Lead PG Developers;

3. through the NPGP, ensure the development of the NPGP’s logical framework andthe operational guidelines for PG_ prioritization, reviews/appraisals,dissemination, and monitoring and evaluation; updating of the Manual for CPGDevelopment; 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 technicalassistance to the NPGPas needed.

C. Health Technology Assessment Unit, Health Facilities Development Bureau, andthe Health Human Resource Development Bureau shall:1. participate in the PG prioritization and generation process;

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2. utilize NPGs/Interim NPGs in health technology assessments, competencyframework development, resource and service flow identification, and otherprogram or policy development (ex. service package development, clinicalpathway development, etc.);

3. contribute toward efforts at dissemination; ensuring utilization of PGs amongnon-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 itsplan 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; and5. provide supplemental funding for PG guideline development.

E. Lead PG Developers shall:

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

2. comply with COI policies stipulated in this issuance; and3. develop internal capacity in their respective organizations/institutions/agencies

for PG development.

VII. REPEALING CLAUSE

This Order repeals Administrative Order No. 2018-0019, “Guidelines on theInstitutionalization and Implementation of the National Practice Guidelines Program.”

IX. SEPARABILITY CLAUSE

If any provision of this Orderis declared unauthorized or rendered invalid by any courtof law or competent authority, those provisions not affected thereby shall remain validand effective.

X. EFFECTIVITY

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

Secretary/g¢f Health

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ANNEXI. Program Governance Structure and Responsibilities

Program Governance Structure and Responsibilities

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ANNEXII. AGREEReporting Checklist

AGREE Reporting Checklist

A G R E E This checklist is intended to guide the reporting of clinical practice guidelines.REPORTING CHECALISE

CHECKLIST ITEM AND DESCRIPTION

—_|REPORTING CRITERIA Page

DOMAIN 1: SCOPE AND PURPOSE1. OBJECTIVES © Heaith intent(s) (i.e., prevention, screening,Report the overall objective(s) of the diagnosis, treatment, etc.)guideline. The expected health benefits O Expected benefit(s) or outcome(s)from the guideline are to be specific to the O) Target{s) (e.9., patient population, society)clinical problem or health topic.2. QUESTIONS O Target populationReport the health question(s) covered by ©) intervention(s) or exposure(s)the guidekine, particutarty for the key 0 Comparisons (if appropriate)recommendations. OO Outcome(s)

OO Heatth care setting or context3. POPULATION O Target population, sex and ageDescribe the population (i.e., patients, (J Clinica! condition (if relevant)public, etc.) to whom the guideline is meant | Severity/stage of disease (if relevant)to apply. OO Comorhidities (if relevant)

O Excluded poputations (if retevant)DOMAIN 2: STAKEHOLDER INVOLVEMENT

4. GROUP MEMBERSHIP O Nameof participantReport ail individuats who were involved in|( Discipline/content expertise (e.g., neurosurgeon,the development process. This may include methodologist)members ofthe steering group, the DC institution (e.g., St. Peter's hospital)research team involved in selecting and © Geographical location (e.g., Seattle, WA)reviewing/rating the evidence and © A description of the member's rolein theindividuals involved in formulating the finalrecommendations.

guideline development group

5. TARGET POPULATION © Statement of type of strategy used to capturePREFERENCES AND VIEWS patients'/publics’ views and preferences (e.g.,Report how the views and preferences of participation in the guideline development group,the target population were literature review of values and preferences)sought/considered and what the resulting © Methods by which preferences and views wereoutcomes were. sought (e.g., evidence from literature, surveys,

focus groups)© Outcomes/information gathered on patient/public

information© How the information gathered was used to inform

the guideline development process and/orformation of the recommendations

6. TARGET USERS © The intended guideline audience (e.g.Report the target (or intended) users of the specialists, famity physicians, patients, clinical orguideline. institutional leaders/administrators)

© How the guideline may be used by its targetaudience (e.g., to inform clinical decisions, toinform policy, to inform standards of care)

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DOMAIN 3: RIGOUR OF DEVELOPMENT

7, SEARCH METHODS O Named electronic database(s) or evidenceReport details of the strategy used to source(s) where the search was performed (e.g.,search for evidence. PMEOUNE, EMBASE, PsychINFO, CINAHL)

© Time periods searched (e.g., January 1, 2004 toMarch 31, 2008)

© Search terms used (e.9., text words, indexingterms, subheadings)

© Full search strategy included (e.9., possiblyfocated in appendix)

8. EVIDENCE SELECTION CRITERIA © Target population (patient, public, etc.)Report the criteria used to select (i.e., characteristicsinclude and exclude) the evidence. Provide |C) Study designrationale, where appropmiate. © Comparisons(if relevant)

© Outcomes© Language (if relevant)O Context (if retevant)

9. STRENGTHS & LIMITATIONS OF THE |() Study design(s) included in body of evidenceEVIDENCE 2) Study methodology limitations (sampling,Describe the strengths and limitations of blinding, allocation concealment, analyticalthe evidence. Consider from the methods)perspective of the individual studies and © Appropristeness/relevance of primary andthe body of evidence eggregated across all secondary outcomes consideredthe studies. Tools exist that can facilitate O Consistency of results across studiesthe reporting of this concept. ©) Direction of results across studies

© Magnitudeof benefit versus magnitude of harm© Applicabitity to practice context

10. FORMULATION OF O Recommendation development process (e.9.,RECOMMENDATIONS steps used in modified Deiphi technique, votingDescribe the methods used to formutate procedures that were considered)the recommendations end how final O Outcomes of the recommendation developmentdecisions were reached. Specify any areas process (e.g., extent to which consensus wasof disagreement and the methods used to reached using modified Delphi technique,resolve them. outcomeof voting procedures)

© How the process influenced therecommendations (e.g., results of Delphitechnique influence final recommendation,alignment with recommendations and the finalvote)

11. CONSIDERATION OF BENEFITS AND |) Supporting data and report of benefitsHARMS ©) Supporting data and report of harms/sideReport the health benefits, side effects, effects/risksand risks that were considered when © Reporting of the batanceftrade-off betweenformulating the recommendations. benefits and hamms/side effects/risks

© Recommendations refiect considerations of bothbenefits and hamns/side effects/risks

12. LINK BETWEEN OC) How the guideline development group linked andRECOMMENDATIONS AND EVIDENCE used the evidence to inform recommendationsOescribe the explicit link between the ©) Link between each recommendation and keyrecommendations and the evidence on evidence (text description and/or reference fist)which they are based. © Link between recommendations and evidence

summaries and/or evidence tables in the resultssection of the quidefine

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13. EXTERNAL REVIEWReport the methodology used to conductthe extemal review.

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Purpose and intent of the external review (e.g., toimprove quality, gather feedback on draftrecommendations, assess applicability andfeasibility, disseminate evidence)Methods taken to undertake the extemal review(e.g., rating scale, open-ended questions)Description of the extemal reviewers (e.g.,number, type of reviewers, affiliations)Outcomes/information gathered from the extemalreview (e.9., summary of key findings)How the information gathered was used to informthe guideline development process and/orformation of the recommendations (e.9.,guidefine panel considered results of review informing fina! recommendations)

14. UPDATING PROCEDUREDescribe the procedure for updating theguidetine.

ooA statement that the guideline will be updatedExplicit time interval or explicit criteria to guidedecisions about when an update will occurMethodology for the updating procedure

DOMAIN 4: CLARITY OF PRESENTATION

15. SPECIFIC AND UNAMBIGUOUSRECOMMENDATIONSDescribe which options ere appropriate inwhich situations and in which population

oOA statementof the recommended actionintent or purpose of the recommended action(€.g., to improve quality of life, to decrease sideeffects)

groups, as informed by the body of O Relevant population (e.g., patients, public)evidence. OO Caveats or quatifying statements, if relevant

(e.g., patients or conditions for whom therecommendations would not apply)

C if there is uncertainty about the best careoption(s), the uncertainty should be stated in thequideline

16. MANAGEMENT OPTIONS ©) Description of management optionsDescribe the different options formanaging|0 Poputation or clinical situation most appropriatethe condition or health issue. to each option17. IDENTIFIABLE KEY (1 Recommendations in a summarized box, typedRECOMMENDATIONS in boid, underlined, or presented as flow chartsPresent the key recommendations so that of algorithmsthey ore easy to identify. © Specific recommendations grouped together in

one section

DOMAWN 5: APPLICABILITY

18, FACILITATORS AND BARRIERS TO © Typesof facilitators and barriers that wereAPPLICATION consideredDescribe the facilitators and barriers to the |() Methods bywhich information regarding theguidetine's application. facilitators and barriers to implementing

recommendations were sought(e.g., feedbackfrom key stakeholders, plot testing of guddetinesbefore widespread implementation)

© Information/description of the types of facilitatorsand barriers that emerged from the inquiry (e.g.,practitioners have the skills to deliver therecommended care, sufficient equipment is notavaiable to ensure all eligible members of the

population receive mammography)How the information influenced the guidelinedevelopment process and/or formation of therecommendations

19. IMPLEMENTATION ADVICE/TOOLSProvide advice and/or tools on how therecommendations can be appfed inpractice.

Additional materiafs to support theimplementation of the guideline in practice. Forexample:

Guideline summary documentsLinks to check lists, algorithmsLinks to how-to manualsSolutions kinked to barrier analysis (see Item18)

Go Tools to capitalize on guideline facilitators(see Item 18)

O Outcomeof pilot test and lessons leamed

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20. RESOURCE IMPLICATIONSDescnbe any potential resourceimpkcations of applying therecommendations.

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Types of cost information that were considered(e.g., economic evatuations, drug acquisitioncosts)Methods by which the cost information wassought (e.g., a health economist was part of theguideline devetopment panel, use of healthtechnology assessments for specific drugs,etc.)information/description of the cost informationthat emerged from the inquiry (e.9., specific drugacquisition costs per treatment course)How the information gathered was used to informthe guideline development process and/orformation of the recommendations

21. MONITORING/ AUDITING CRITERIAProvide monitoring and/or auditing criteriato measure the application of guidelinerecommendations. 0000

Criterta to assess guideline implementation oradherence to recommendationsCriteria for assessing impact of implementing therecommendationsAdvice on the frequency and interval! ofmeasurementOperationa! definitions of how the criteria shouldbe measured

DOMAIN 6: EDITORIAL INDEPENDENCE

22. FUNDING BODY © The nameofthe funding body or source ofReport the funding body's influence on the funding (or explicit statement of no funding)contentof the guideline. C A statement that the funding body did not

influence the contentof the guideline23. COMPETING INTERESTS © Types of competing interests consideredProvide an explicit statement that el group |) Methods by which potential competing interestsmembers have declared whether they have were soughtany competing interests. DC A description of the competing interests

© How the competing interests influenced theguideline process and development ofrecommendations

From:Brouwers MC, Kerkviiet K. Spithoff K, on behalf of the AGREE Next Steps Consortum. The AGREE Reporting Chechiist: a tool toimprove reporting of clinical practice guidelines, BACJ 20167352:41 152. doi: 10.1 136/bmp.i 152.

For more information about the AGREE Reporting Checklist. please vist the AGREE Enterprise website at www.agreetrust.org.

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