Guideline development

Question 1

What are accept statements

Answer 1

Australasian CREI consensus Expert Panel on trial evidence

Question 2

What are ACCEPT guidelines (name and year)

Answer 2

Fibroids (2011)
Endometriosis (2012)
Diagnosis and detection of Ovarian Hyperstimulation syndrome (2015)
Treatment of Ovarian hyperstimulation syndrome (2015)
Elective Oocyte cryopreservation (2019)

Question 3

How is an ACCEPT guideline developed

Answer 3

• Evidence reviewed – search of relevant databases performed
• Level of evidence assessed
• Uses NHMRC Evidence Hierarchy
• Recommendations/consensus statements generated
• Review of recommendations through consensus process
• Unanimous = alpha, unanimous with caveat = B, majority – gamma, no consensus = delta
• Guideline published and disseminated

Question 4

Agree II - what is it?

Answer 4

Appraisal of guidelines for research and evaluation (II)
Agree II is a tool that assesses the methodological rigour and transparency in which a guideline is developed.
Agree II is used to :
Assess the quality of guidelines.
Provide a methodological strategy for the development of guidelines.
Inform what information and how information ought to be reported in guidelines.

Question 5

Domains of Agree II tool

Answer 5

1. Scope and purpose
   a) overall objectives of the guideline are specifically described
   b) health questions covered by the guideline are specifically described
   c) the population to whom the guideline is meant to apply is specifically described
2. Stakeholder involvement
   a) the guideline development group includes individuals from all relevant professional groups
   b) the view and preferences of the target population have been sought.
   c) the target users of the guideline are clearly defined.
3. Rigor and development
   a) systematic methods were used to search for evidence
   b) criteria for selecting the evidence are clearly described
   c) strengths and limitations of the body of evidence clearly described
   d) methods for formulating the recommendations are clearly described
   e) health benefits, side effects, and risks have been considered in formualting the recommendations
   f) there is an explicit link between the recommendations and the supporting evidence
   g) the guideline has been externally reviewed by experts prior to its publication
   h) a procedure for updating the guideline is provided
4. Clarify of presentation
   a) the recommendations are specific and unambiguous
   b) the different options for management of the condition or health issue are clearly presented.
   c) key recommendations are easily identifiable
5. Applicability
   a) the guideline describes the facilitators and barriers to its application
   b) the guideline provides advice and/or tools on how the recommendations can be put into practice
   c) the potential resource implications of applying the recommendations have been considered
   d) the guideline presents monitoring and/or auditing criteria.
6. Editorial independence
   a) views of the funding body have not influenced the content
   Competing interestes of guideline development group members have been recorded and addressed.
7. Overall guideline assessment

Question 6

Steps in developing a guideline

Answer 6

Question 7

trustworthiness checklist for RCTs (TRACT)

Answer 7

Question 8

GRADE

Answer 8

Grading of Recommendations, Assessment, Development, and Evaluation
- Transparent framework for developing and presenting summaries of evidence and provides a systematic approach for making clinical practice recommendations.

Considers the following and then puts into a grade (image)
- number and design of studies addressing the outcome
- quality of the studies and/or synthesised evidence such as risk of bias, inconsistency, indirectness, imprecision, publication bias and any other considerations that may influence the quality of evidence.
RCTs tend to start high level and observational studies low level.
Once quality of evidence grade is determined then assess for the strength of the recommendations (done variably across different guidelines as below)

Question 9

Grade/strength of the recommendation - PCOS

Answer 9

• Conditional recommendation against the option
  ** Conditional recommendation for with the option or the comparison
  *** Conditional recommendation for the option
  ** Strong recommendation for the option

Question 10

Grade of the recommendation ESHRE

Answer 10

Strong recommendation (includes patient, clinician and policy makers)
Weak recommendation (includes patient, clinician and policy makers)
Good practice point - information of the advice of the GDG regarding a certain recommendation
Research only recommendation - the test or intervention should only be considered within the setting of a research trial for which appropriate approvals and safety precautions have been established.

Question 11

Grade of recommendation RANZCOG

Answer 11

Evidence-based recommendation (with quality alongside)
Consensus-based (evidence sought but none identified)
WG opinion/good practice note - (outside scope of the evidence search and based on consensus from working group).

Question 12

Grade of recommendation RCOG

Answer 12

Does not use grade framework

Question 13

Grade of recommendations ASRM

Answer 13

Does not use grade framework

Question 14

GRADE acronym stands for

Answer 14

Grading of recommendations assessment, development and evaluation

Question 15

NHMRC standards for guidelines

Answer 15

Be relevant and useful for decision making
Be transparent
Be accessible
Be up to date
Be evidence informed
Be focussed on health and related outcomes
Make actionable recommendations
Identify and manage conflicts of interest
Be overseen by a guideline development group

Question 16

Appropriate members of a guideline development group

Answer 16

Consumers
Researchers
Clinicians - included expected users of the guideline
Policy-makers
Indigenous representation

Question 17

three aspects to interpreting guideline recommendation

Answer 17

Category
Quality of evidence
Direction and strength of recommendations

Question 18

NHMRC levels of evidence

Answer 18

I - Evidence obtained from a systematic review of all relevant randomised
controlled trials
II - Evidence obtained from at least one properly–designed randomised
controlled trial
III-1 - Evidence obtained from well–designed pseudo–randomised
controlled trials (alternate allocation or some other method)
III-2 - Evidence obtained from comparative studies (including systematic
reviews of such studies) with concurrent controls and allocation not
randomised, cohort studies, case–control studies, or interrupted time
series with a control group
III-3 - Evidence obtained from comparative studies with historical control, two
or more single arm studies, or interrupted time series without parallel
control group
IV – case studies

Question 19

reporting guidelines for main study types

Answer 19

Question 20

CONSORT-IMPRINT checklist

Answer 20