Clinical Guideline and Care Pathway Template (AGREE II, GRADE)

Local guideline or care pathway: scope and PICO questions, recommendations with GRADE strength, pathway, methods, audit criteria, AGREE II self-appraisal

医療フルAGREE II (2009, manual updated 2017); GRADEclinical guideline更新 2026/10/29

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使い方: Use it when you write or adapt a local clinical guideline or care pathway. Fill the scope, key questions and development group (sections 1 and 2) before any evidence work, and link every recommendation to a question and an evidence summary. The main pitfall is a weak methods section (AGREE II domain 3) and no implementation or audit plan, so the guideline neither scores well nor changes practice.

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Clinical Guideline: [Topic] ([Setting])

Template for a local clinical guideline or care pathway written by a hospital, health system, practice network or specialty group. Its sections are arranged so that the finished guideline addresses the six domains and 23 items of the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation II, AGREE Next Steps Consortium, 2009, manual updated December 2017), and it rates evidence and recommendations in the style of the GRADE approach. All wording is original to this collection. Replace every [bracketed] value and every row marked Example. Example recommendations are illustrative wording for the template, not clinical recommendations. This is a documentation format, not medical advice; base every recommendation on current evidence, check the official AGREE II and GRADE material, and follow your organisation's clinical governance process.

Document control

Field	Value
Document ID	[CG-2026-019]
Title	[Topic] in [setting]
Type	[Guideline / care pathway / protocol]
Development approach	[De novo / adapted from source guideline / adopted]
Version	[1.0]
Status	[Draft / Consultation / Approved / Superseded]
Owner (clinical lead)	[@clinical-lead]
Guideline development group chair	[@chair]
Approvers	[@clinical-guidelines-committee], [@medical-director]
Applies to	[Departments, staff groups, sites]
Date approved	YYYY-MM-DD
Next full review	[YYYY-MM-DD, normally within 3 years or earlier on new evidence]
Classification	[Internal / Public]

Approvals

Role	Name	Decision	Date
Guideline development group chair	[@name]	[Approved]	YYYY-MM-DD
Clinical guidelines committee	[Chair name]	[Approved]	YYYY-MM-DD
Pharmacy or medicines committee (if medicines are recommended)	[@name]	[Approved]	YYYY-MM-DD
Patient partner representative	[Name]	[Reviewed]	YYYY-MM-DD

Revision history

Version	Date	Author	Change summary
0.1	YYYY-MM-DD	[@name]	Scope and key questions agreed
0.5	YYYY-MM-DD	[@name]	Example: Evidence summaries and draft recommendations for consultation
1.0	YYYY-MM-DD	[@name]	Example: Approved after external review; REC-03 strength changed to conditional

Scope and purpose
Stakeholder involvement
Summary of recommendations
Care pathway
Recommendations with rationale
Methods
Implementation
Monitoring and audit criteria
Editorial independence
Equality, accessibility and patient information
Consultation and external review record
AGREE II self-appraisal
Glossary and references

1. Scope and purpose

1.1 Objectives

[State the overall objectives and the expected health benefit for the population, for example a reduction in a harm, faster access, or less unwarranted variation.]

Example: To reduce falls and fall-related injuries among adult inpatients at Halvermoor District Hospital (fictional) by setting a consistent approach to risk assessment, prevention and post-fall care across all adult wards.

1.2 Key questions

ID	Question (population, intervention, comparison, outcomes) (Example)
Q-01	In adult inpatients aged 65 or over, does a multifactorial falls risk assessment followed by tailored interventions, compared with usual care, reduce falls and injurious falls?
Q-02	In adult inpatients at high falls risk, do bed and chair sensor alarms, compared with no alarm, reduce falls?
Q-03	In adult inpatients who have fallen, which structured post-fall checks reduce missed injury?

1.3 Population and setting

Item	In scope (Example)	Out of scope (Example)
Patients	Adult inpatients aged 18 or over on general and specialist wards	Children; emergency department; outpatient clinics
Settings	All adult inpatient wards on both sites	Community hospitals run by other providers
Care covered	Risk assessment, prevention, post-fall assessment	Treatment of fractures after diagnosis

2. Stakeholder involvement

2.1 Guideline development group

Name	Role and discipline	Department	Role in group
[@name]	Example: Consultant geriatrician	Elderly care	Chair
[@name]	Example: Falls prevention nurse specialist	Patient safety	Clinical lead
[@name]	Example: Physiotherapist	Therapies	Member
[@name]	Example: Pharmacist	Pharmacy	Member (medicines review)
[@name]	Example: Ward manager	Acute medicine	Member
[Name]	Example: Patient partner	Patient partner programme	Member
[@name]	Example: Information specialist	Library service	Evidence searches

2.2 Patient and public views

[Describe how the views and preferences of patients and carers were sought: membership of the group, focus groups, surveys, published literature on patient experience, consultation responses. State what changed as a result.]

Example: A patient partner sat on the group, and a survey of 46 recently discharged patients asked about night-time help and bed alarms. Responses led to REC-04 on explaining night help on admission.

2.3 Intended users

[List who should use the guideline: staff groups, departments, and whether patients may use a public version.]

3. Summary of recommendations

ID	Recommendation (Example, illustrative wording)	Strength	Certainty
REC-01	Complete a multifactorial falls risk assessment for every inpatient aged 65 or over, and for adults aged 18 to 64 judged at higher risk, within 24 hours of admission	Strong for	Moderate
REC-02	Agree an individual prevention plan addressing each risk factor found, and review it after any change in condition or ward move	Strong for	Moderate
REC-03	Consider bed or chair sensor alarms only as part of an individual plan, not as a stand-alone measure	Conditional for	Low
REC-04	Explain to every patient on admission how to get help at night and demonstrate the call bell	Good practice statement	Not rated
REC-05	After any fall, check for injury before moving the patient and follow the post-fall checklist (appendix in section 7.2)	Strong for	Low

Strength and certainty follow the GRADE approach described in section 6.4. Good practice statements (section 5.2) are not rated for certainty.

4. Care pathway

The pathway reads top to bottom. Every patient receives REC-04; only patients who meet the REC-01 criteria go through the assessment and individual plan. After a fall, REC-05 applies and the plan is reviewed again through REC-02. If your pathway has more than about 12 steps, split it into linked pathways (for example admission and post-fall).

5. Recommendations with rationale

5.1 Recommendation detail

REC-01 (Example). [Full recommendation text.]

Field	Content (Example)
Question	Q-01
Evidence summary	EV-01: [systematic review or source guideline, number of studies, main effect in original words]
Certainty of evidence	Moderate: [reasons for any rating down, such as risk of bias or imprecision]
Benefits	[Expected reduction in falls, in absolute terms if available]
Harms and burdens	[Staff time per assessment; risk of restricting mobility if the plan is over-cautious]
Patient values and preferences	[What patients said in the survey]
Resource use	[Staff minutes per assessment, training time]
Options considered	[Single-tool risk score alone; rejected because (reason)]
Strength and direction	Strong for
Rationale	[Why the group judged that benefits outweigh harms for almost all patients]

REC-02 to REC-05. [Repeat the table for each recommendation. Keep the field names identical so readers can compare them.]

5.2 Good practice points

Example: REC-04 is a good practice statement: the group judged its benefit obvious and its cost negligible, so a formal evidence review would not change it.

[List any statements the group made without formal evidence review, labelled as good practice, with the reason no evidence review was needed.]

5.3 Changes from the source guideline (adapted guidelines only)

Source recommendation	Local recommendation	Change	Reason (Example)
[Source ID and number]	REC-01	Adds adults aged 18 to 64 judged at higher risk	Local audit found a third of injurious falls in this group
[Source ID and number]	REC-03	Unchanged in substance; wording made specific to local alarm models	Local equipment

6. Methods

6.1 Evidence search

[Describe the systematic search: databases, other sources such as guideline repositories, date limits, search terms or a link to the full strategy, and the date of the last search.]

Item	Details (Example)
Sources searched	MEDLINE, CINAHL, Cochrane Library, two national guideline repositories
Date range	[YYYY-MM-DD] to [YYYY-MM-DD]
Last search	[YYYY-MM-DD]
Full strategy	[Appendix or document ID]

6.2 Selection criteria

[State the inclusion and exclusion criteria for evidence (study types, populations, outcomes, languages) and how many records were screened and included. A flow diagram such as PRISMA can be referenced.]

6.3 Appraisal of the body of evidence

[Describe how the strengths and limitations of the evidence were assessed: risk of bias tools, the GRADE domains used, who did the assessment and how disagreements were resolved.]

6.4 Formulating recommendations

The group used the GRADE approach:

Certainty of evidence	Meaning in this guideline
High	The group is very confident that the true effect is close to the estimate
Moderate	The group is moderately confident: the true effect is probably close to the estimate but may differ substantially
Low	The group has limited confidence: the true effect may differ substantially from the estimate
Very low	The group has very little confidence: the true effect is likely to differ substantially from the estimate

Strength	How to read it
Strong (for or against)	The group is confident that desirable effects clearly outweigh undesirable effects, or the reverse, for almost all patients. Wording: "do" or "do not"
Conditional, also called weak (for or against)	Desirable effects probably outweigh undesirable effects, or the reverse, but the balance is close or uncertain; choices depend on patient values and context. Wording: "consider"

Decision method. [Describe the consensus method: for example, open discussion with a formal vote where agreement was not reached, with a threshold such as 70% agreement, and how dissent was recorded.]

Evidence-to-decision criteria considered. [List the criteria used: benefits and harms, certainty, values, resource use, equity, acceptability and feasibility.]

6.5 External review

[Describe the external review before approval: who reviewed (clinical experts, methodologists, patient groups, other departments), how they were selected, and how comments were handled. Section 11 records the comments.]

6.6 Updating procedure

[State when and how the guideline will be updated: the review date, triggers for early review (new evidence, safety alerts, changes in national guidance), and who is responsible.]

Example: Full review three years after approval. The clinical lead checks national guidance and runs an update search every 12 months, and calls an early review if new evidence or a safety alert may change a recommendation.

7. Implementation

7.1 Facilitators and barriers

ID	Type	Description (Example)	Response
IMP-01	Barrier	Assessment takes about 15 minutes, competing with admission workload	Built into the electronic admission record with prompts
IMP-02	Barrier	Too few low beds on some wards	Linked to equipment plan; interim loan process
IMP-03	Facilitator	Existing ward falls champions on 14 of 18 adult wards	Champions lead local launch

7.2 Tools and resources

Tool	Purpose	Location
[Electronic assessment form]	REC-01 and REC-02	[System name, form ID]
[Post-fall checklist]	REC-05	[Document ID]
[Patient leaflet on staying safe in hospital]	REC-04	[Document ID, languages available]
[Training module]	All recommendations	[Learning system link]

7.3 Resource implications

Item	Estimate (Example)	Basis
Staff time for assessment	[n] minutes per admission	Pilot on two wards
Equipment	[n] additional low beds	Ward equipment survey
Training	[n] hours per registered nurse	Training module length
Expected savings	[Fewer injurious falls; length of stay effect]	[Source]

8. Monitoring and audit criteria

ID	Criterion (Example)	Linked REC	Numerator and denominator	Target	Source and frequency
AUD-01	Risk assessment within 24 hours	REC-01	Eligible patients assessed within 24 hours / eligible admissions sampled	90%	Monthly sample of 20 records per ward
AUD-02	Individual plan matches identified risks	REC-02	Plans addressing every risk found / plans reviewed	85%	Quarterly audit
AUD-03	Post-fall checklist completed	REC-05	Falls with completed checklist / all reported falls	95%	Incident system, monthly
AUD-04	Outcome: falls per 1,000 occupied bed days	All	Reported falls / occupied bed days x 1,000	Downward trend on run chart	Incident system, monthly

Use healthcare/clinical-audit to run and report each audit cycle.

9. Editorial independence

9.1 Funding

[State who funded the development and confirm that the funder did not influence the content, or describe any influence.]

Example: Developed within the hospital's clinical governance budget. No external funding.

9.2 Competing interests

Member	Interest declared	Type	How managed
[@name]	Example: Paid lecture for a bed alarm manufacturer in the past 3 years	Financial, specific	Did not vote on REC-03
[@name]	None	Not applicable	Not applicable

Declarations were collected [at the first meeting and updated before the final vote].

10. Equality, accessibility and patient information

Question	Answer (Example)
Could any recommendation disadvantage a group with a protected or vulnerable characteristic?	Patients with cognitive impairment may not use a call bell; REC-02 asks for an individual plan including observation level
Are patient materials available in accessible formats and main local languages?	Leaflet in easy read and [n] languages
Does the guideline restrict patient freedom or mobility?	Prevention plans must balance falls risk with the harm of immobility; restrictive measures follow the organisation's policy

11. Consultation and external review record

ID	Reviewer group	Comment summary (Example)	Response	Change made
CON-01	Orthopaedic surgeons	Asked for a clear rule on not moving a patient with suspected hip fracture	Agreed	REC-05 and post-fall checklist updated
CON-02	Patient group	Asked for leaflet in large print	Agreed	Large-print version added
CON-03	External methodologist	Evidence for REC-03 is low certainty; strong wording not justified	Agreed	REC-03 changed to conditional

12. AGREE II self-appraisal

The scaled domain score is (obtained score minus minimum possible score) divided by (maximum possible score minus minimum possible score), times 100. With 2 appraisers, a 3-item domain has a maximum of 7 x 3 x 2 = 42 and a minimum of 1 x 3 x 2 = 6. AGREE II sets no pass mark; the group decides in advance what scores it expects before approval.

Domain	Items	Appraiser A total (Example)	Appraiser B total (Example)	Obtained	Max	Min	Scaled score
1 Scope and purpose	1 to 3	17	17	34	42	6	77.8%
2 Stakeholder involvement	4 to 6	14	13	27	42	6	58.3%
3 Rigour of development	7 to 14	38	35	73	112	16	59.4%
4 Clarity of presentation	15 to 17	19	18	37	42	6	86.1%
5 Applicability	18 to 21	18	17	35	56	8	56.3%
6 Editorial independence	22 to 23	13	12	25	28	4	87.5%

Example: Domain 1 worked through: (34 - 6) / (42 - 6) x 100 = 77.8%.

Overall assessment	Appraiser A	Appraiser B
Overall quality (1 to 7) (Example)	5	5
Recommend for use (Example)	Yes, with modifications	Yes, with modifications
Modifications noted (Example)	Strengthen patient involvement (domain 2) and resource estimates (item 20) before approval	Same, plus publish full search strategy (item 7)

13. Glossary and references

13.1 Glossary

Term	Meaning
AGREE II	Appraisal of Guidelines for Research and Evaluation II: an instrument with 23 items in 6 domains for assessing guideline quality
Care pathway	A sequence of care steps and decisions for a defined group of patients
Certainty of evidence	How confident the group is that the estimate of effect is close to the true effect (GRADE)
Conditional recommendation	A recommendation where the balance of benefits and harms is close or uncertain, so choices depend on context and patient values
GRADE	Grading of Recommendations Assessment, Development and Evaluation
PICO	Population, intervention, comparison, outcomes: the parts of a structured question
RIGHT	Reporting Items for practice Guidelines in HealThcare: a reporting checklist for guidelines

13.2 References

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L, for the AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182:E839-842.
AGREE Next Steps Consortium. The AGREE II Instrument and User's Manual, May 2009, updated September 2013 and December 2017: https://www.agreetrust.org/resource-centre/agree-ii/
GRADE Working Group: https://www.gradeworkinggroup.org/
Chen Y, Yang K, Marusic A, and colleagues, for the RIGHT Working Group. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med. 2017;166(2):128-132. Listed on the EQUATOR Network: https://www.equator-network.org/reporting-guidelines/right-statement/
[Source guideline, if adapted, with version and date]
[Evidence sources for each recommendation, EV-01 onwards]

Related templates in this collection: healthcare/clinical-audit for the audit criteria in section 8, healthcare/quality-improvement-report for an implementation project, healthcare/care-plan for the individual plans that follow REC-02, science/systematic-review for the evidence review behind section 6, and healthcare/root-cause-analysis when a serious event shows a gap in the guideline.

Standard and licence note

Structure aligned with the AGREE II instrument (AGREE Next Steps Consortium, May 2009, user's manual updated December 2017, copyright The AGREE Research Trust and AGREE Enterprise) and with the GRADE approach of the GRADE Working Group. This template uses the AGREE II domain names, item numbers and item counts only, and GRADE's category names; every explanation is original text and no instrument item wording is reproduced. Use the official AGREE II user's manual from agreetrust.org for appraisal and the GRADE Working Group's publications for evidence rating, and check both for their current versions. The RIGHT statement (2017) is cited as a related reporting checklist. The hospital, people, figures and recommendations in the examples are fictional and illustrative. This is a documentation format, not medical advice; recommendations must come from current evidence and qualified clinical judgement under your organisation's governance. Template licence: MIT.