# 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.

<!--
Guidance: How to use this template
- Decide first whether to adopt, adapt or write from scratch. If a
  high-quality national or society guideline exists, a local guideline
  usually adapts it and documents the local changes (section 5.3).
- Fill section 1 (scope and questions) and section 2 (who is involved)
  before any evidence work. AGREE II appraisers look for them first.
- Keep the evidence trail: each recommendation (REC-nn) links to a
  question (Q-nn), an evidence summary (EV-nn) and a strength and
  certainty rating.
- Section 12 lets the group appraise its own draft with AGREE II before
  approval. Two or more independent appraisers give a fairer result.
- Write recommendations as actions: who does what, for whom, when.
-->

## Document control

<!-- Guidance: A guideline is a controlled clinical document. Record the review date prominently; out-of-date guidelines are a common source of harm. -->

| 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| Status | [Draft / Consultation / Approved / Superseded] |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

<!-- Guidance: Record what changed and why, especially changes to recommendations. Readers need to know which advice is new. -->

| 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 |

## Contents

<!-- Guidance: Keep in sync with the headings below. Put the summary of recommendations near the top so busy readers find it. -->

1. [Scope and purpose](#1-scope-and-purpose)
2. [Stakeholder involvement](#2-stakeholder-involvement)
3. [Summary of recommendations](#3-summary-of-recommendations)
4. [Care pathway](#4-care-pathway)
5. [Recommendations with rationale](#5-recommendations-with-rationale)
6. [Methods](#6-methods)
7. [Implementation](#7-implementation)
8. [Monitoring and audit criteria](#8-monitoring-and-audit-criteria)
9. [Editorial independence](#9-editorial-independence)
10. [Equality, accessibility and patient information](#10-equality-accessibility-and-patient-information)
11. [Consultation and external review record](#11-consultation-and-external-review-record)
12. [AGREE II self-appraisal](#12-agree-ii-self-appraisal)
13. [Glossary and references](#13-glossary-and-references)

## 1. Scope and purpose

<!-- Guidance: AGREE II domain 1 (items 1 to 3): the overall objectives, the health questions and the population. Be specific enough that a reader can tell whether a given patient is in or out. -->

### 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

<!-- Guidance: AGREE II domain 2 (items 4 to 6): who was in the development group, how patient views were sought, and who the intended users are. Name disciplines, not just people. -->

### 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

<!-- Guidance: AGREE II item 17: key recommendations are easy to find. List each recommendation once, with its strength and certainty, and link to the detail in section 5. -->

| 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

<!-- Guidance: A pathway diagram shows the sequence of decisions and the recommendation that applies at each point. Keep it to the decisions a clinician makes; details belong in section 5. Every REC in the diagram must exist in section 3. -->

```mermaid
flowchart TD
  A["Adult admitted to ward"] --> B{"Aged 65 or over, or judged at higher risk?"}
  B -- "Yes" --> C["REC-01 Multifactorial risk assessment within 24 hours"]
  B -- "No" --> D["Standard care and REC-04 night help explained"]
  C --> E["REC-02 Individual prevention plan"]
  E --> F{"Sensor alarm useful for this patient?"}
  F -- "Yes" --> G["REC-03 Alarm as part of plan"]
  F -- "No" --> H["Plan without alarm"]
  G --> I["REC-04 Night help explained, call bell shown"]
  H --> I
  I --> J{"Fall occurs?"}
  D --> J
  J -- "Yes" --> K["REC-05 Post-fall checks before moving"]
  K --> E
  J -- "No" --> L["Review plan on change of condition or ward move"]
```

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

<!-- Guidance: AGREE II items 10 to 12 and 15 to 16: how recommendations were formed, benefits and harms considered, an explicit link to evidence, specific and unambiguous wording, and the options considered. Use one block per recommendation. -->

### 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

<!-- Guidance: AGREE II domain 3 (items 7 to 14) is the largest domain and the one most often weak. Describe each step clearly enough that another group could repeat it. -->

### 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

<!-- Guidance: GRADE defines four certainty levels and two strengths of recommendation, for or against. Explain how the group reached decisions (consensus method, voting rules) and how it weighed the evidence-to-decision criteria. -->

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

<!-- Guidance: AGREE II domain 5 items 18 to 20: facilitators and barriers, tools for putting recommendations into practice, and resource implications. A guideline without an implementation plan rarely changes practice. -->

### 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

<!-- Guidance: AGREE II item 21: give measurable criteria so that the guideline can be audited. Each criterion names its recommendation, numerator, denominator, target and data source. -->

| 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

<!-- Guidance: AGREE II domain 6 (items 22 and 23): state funding and its influence, and how competing interests of group members were recorded and managed. Say "none" explicitly when there are none. -->

### 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

<!-- Guidance: Not an AGREE II item, but committees and regulators expect it. Check whether recommendations could disadvantage any group and how information reaches patients with different needs. -->

| 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

<!-- Guidance: Record each comment and the group's response. This is the evidence for AGREE II item 13 and protects the guideline at approval. -->

| 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

<!-- Guidance: AGREE II rates each of 23 items on a 7-point scale (1 strongly disagree to 7 strongly agree), ideally by at least two and preferably four appraisers. Domain scores are summed across appraisers and scaled. Use the official AGREE II user's manual for the item wording and rating guidance; this table lists domains and item counts only. -->

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

<!-- Guidance: Define terms and list every source, including the evidence for each recommendation and the source guideline if adapted. -->

### 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

1. 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.
2. 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/
3. GRADE Working Group: https://www.gradeworkinggroup.org/
4. 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/
5. [Source guideline, if adapted, with version and date]
6. [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.