w12 research

What are clinical guidelines?

Systematically developed statements on disease management, based on best available research evidence, expert opinion, and patient experiences. They act as a comprehensive resource of high-quality information.

What is the purpose of clinical guidelines?

To assist practitioner and patient decisions about appropriate health care for specific circumstances, while acknowledging the patient's right to make decisions.

What is the role of the physiotherapist regarding clinical guidelines?

To provide information to facilitate decision making for the patient.

List 4 reasons clinical guidelines were developed.

1. Linked with development of EBP 2. Increase in literature difficult to keep up with — guidelines provide summaries 3. Government calls for consistency of care 4. Patient requests for information about treatment options

Where can clinical guidelines be found? (4 sources)

1. PEDro (pedro.org.au) — evidence-based practice guidelines only 2. England: NICE (nice.org.uk) 3. Australia: NHMRC (nhmrc.gov.au) 4. Specific organisations e.g. National Stroke Foundation, OARSI

What are the PEDro criteria for archiving a clinical guideline?

Must be evidence-based, based on a systematic review, include at least 1 RCT related to physiotherapy, and contain systematically developed statements/recommendations for healthcare decisions.

What is the focus of a systematic review vs a clinical guideline?

Systematic review: single clinical question / limited aspect of patient care Clinical guideline: several clinical questions / whole process of disease management

What are the conclusions of a systematic review vs a clinical guideline based on?

Systematic review: high-quality clinical research Clinical guideline: high-quality clinical research + expert opinion + patient experience + consensus views

Who are the stakeholders in a systematic review vs a clinical guideline?

Systematic review: small group of researchers (typically no patients) Clinical guideline: wide range of professionals including patients

How does the development process differ between a systematic review and a clinical guideline?

Systematic review: relatively shorter time Clinical guideline: relatively longer time

How does publication format differ between a systematic review and a clinical guideline?

Systematic review: journal article Clinical guideline: patient and clinician versions

What is the AGREE instrument?

Appraisal of Guidelines for Research and Evaluation — a 23-item tool with 6 quality domains used to appraise clinical guidelines. First published in 2003. Each item rated 1 (strongly disagree) to 7 (strongly agree).

Who uses the AGREE instrument?

1. Guideline developers 2. Policy makers, health administrators, program managers, professional organisations 3. Stakeholders: patients, health professionals, researchers, educators

List the 6 AGREE quality domains.

1. Scope and Purpose 2. Stakeholder Involvement 3. Rigour of Development 4. Clarity of Presentation 5. Applicability 6. Editorial Independence

AGREE Domain 1: Scope and Purpose — what does it assess?

The overall aim of the guideline, the specific health questions, and the target population (items 1–3).

AGREE Domain 2: Stakeholder Involvement — what does it assess?

The extent to which the guideline was developed by appropriate stakeholders and represents the views of its intended users, including who developed the guideline (items 4–6).

AGREE Domain 3: Rigour of Development — what does it assess?

How the evidence was chosen and the quality of the evidence; how recommendations were developed (items 7–14).

AGREE Domain 4: Clarity of Presentation — what does it assess?

The language, structure, and format of the guideline (items 15–17).

AGREE Domain 5: Applicability — what does it assess?

Likely barriers and facilitators to implementation, strategies to improve uptake, and resource implications of applying the guideline (items 18–21).

AGREE Domain 6: Editorial Independence — what does it assess?

Whether the formulation of recommendations is unduly biased by competing interests (items 22–23).

What is GRADE?

Grading of Recommendations, Assessment, Development and Evaluations. First published in 2004. An emerging consensus tool that clearly differentiates between quality of evidence and strength of recommendations.

List the 4 GRADE quality of evidence levels.

1. High — further research very unlikely to change confidence in the effect 2. Moderate — further research likely to impact confidence and may change estimate 3. Low — further research very likely to impact confidence and likely to change estimate 4. Very low — any estimate of effect is very uncertain

What factors might DECREASE quality of evidence in GRADE?

1. Study limitations 2. Inconsistency of results 3. Indirectness of evidence 4. Imprecision 5. Reporting/publication bias

What factors might INCREASE quality of evidence in GRADE?

1. Large magnitude of effect 2. Plausible confounding 3. Dose-response gradient

What are the GRADE strength of recommendation categories?

• Strong recommendation FOR: Do it • Strong recommendation AGAINST: Don't do it • Weak recommendation FOR: Probably do it • Weak recommendation AGAINST: Probably don't do it

What 4 factors determine the GRADE strength of a recommendation?

1. Quality of evidence 2. Balance between desirable and undesirable effects 3. Values and preferences 4. Costs (resource allocation)

What is a Good Practice Point (GPP) in clinical guidelines?

Recommended best practice based on clinical experience and expert opinion, rather than formal research evidence.

What are the 5 steps of Evidence-Based Practice (EBP)?

1. Frame patient scenario into a clinical question 2. Systematically search for best available evidence 3. Critically appraise the quality of the evidence 4. Implement findings by integrating evidence with clinical expertise and client values 5. Evaluate the effectiveness of the intervention

What are the 3 components of the EBP model?

1. Best Research Evidence 2. Clinical Expertise 3. Patient Values (All three overlap at EBP)

What are the 3 approaches to integrating evidence into clinical practice?

1. Passive diffusion — clinicians naturally incorporate trials into practice 2. Dissemination — targeting the message to defined groups 3. Implementation — identifying and overcoming barriers to use of knowledge

List 5 barriers to changing clinical practice.

1. Patient demand for treatment despite lack of evidence 2. Lack of time / workload pressure 3. Lack of skills 4. Lack of staff resources 5. Culture

List 6 strategies to address barriers to changing clinical practice.

1. Educational materials 2. Educational meetings (didactic, interactive, outreach visits) 3. Reminders (manual or computerised) 4. Audit and feedback 5. Local opinion leaders 6. Local consensus process

What is implementation research?

The scientific study of methods to promote the uptake of research findings to improve quality of care. It studies factors influencing behaviour of professionals and organisations, and interventions that enable effective use of research findings.

What are the 3 phases in the proposal for introduction of new therapies?

1. Development phase: clinical observation/laboratory studies, clinical exploration, pilot studies 2. Testing phase: RCT 3. Refinement and Dissemination phase: refinement, active dissemination

What should a clinical guideline's Rigour of Development explicitly report?

1. Quality/levels of evidence — based on high-quality, up-to-date systematic reviews 2. Strength of recommendations — including consideration of benefit and harm, and what the evidence means for patients