Guideline

Appendix A. Guideline review process

Osteoporosis management and fracture prevention in post-menopausal women and men > 50 years of age
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Appendix A. Guideline review process

This guide is an evidence update of the second edition of the clinical guideline Osteoporosis prevention, diagnosis and management in postmenopausal women and men over 50 years of age published in 2017 by the RACGP and approved by the NHMRC.

This review and updating sought to follow best practice guideline development, but due to limited resourcing some limitations were imposed. Key phases in this review process included:

  • establishment of the National Osteoporosis Guideline Review Committee and ongoing register of conflicts of interest (refer to Appendix D)
  • allocation of sections to review committee members according to their subspecialist bone expertise
  • identification of sections requiring additional subject matter advisers and the identification of these experts (refer to Appendix D)
  • agreement on the scope of work and approach with the RACGP, including use of the existing NHMRC guideline review process and evidence levels system (refer to Tables 4–6)
  • identification of priority and new subject areas for focused literature search strategies to be performed by the RACGP
  • systematic literature searches of these subject areas to identify the primary evidence and syntheses of primary evidence
  • appraisal and selection of this evidence by relevant bone experts
  • revision and updating of existing content in the guide, as well as drafting new content, sections and/or evidence statements
  • revision and updating of current recommendations, as well as the drafting of new recommendations
  • full review of final draft guide and agreement on recommendations by the National Osteoporosis Guideline Review Committee
  • endorsement of this guide by the RACGP.

Most recommendations in the 2017 second edition were based on critical analysis of peer-reviewed evidence published between 2006 and 2016, following a systematic review of available evidence to support these recommendations. Every section in this third edition has been reviewed and updated with relevant new peer-reviewed evidence published from 2017 by a bone expert with subspeciality expertise in that topic.

For subject areas identified as requiring new focused published literature searches, the review committee provided specific key words to the RACGP to conduct the search using the following databases: PubMed/Medline, National Institute for Heath and Care Excellence (NICE), Cochrane database of systematic reviews and Cochrane Central Register of Controlled Trials (CENTRAL), Scottish Intercollegiate Guidelines Network (SIGN), Trip database and Google. Filters were applied in Ovid Medline to identify RCTs, systematic reviews and meta-analyses.1,2 Other filters applied included men and women older than 45 years of age and studies reporting outcomes of fracture and/or BMD. As far as possible, evidence used to support recommendations covering pharmacological and other interventions for osteoporosis prevention and treatment was restricted to studies with fracture as a primary outcome. However, for some interventions, evidence meeting this criterion was sparse or of variable quality, and high-quality studies with BMD as a primary outcome have been used if, in the opinion of the review committee, the data could be used to support recommendations.

Evidence to support the recommendations was confined to papers complying with Levels I (systematic reviews of Level II studies) and II (RCT or prospective cohort study) of the NHMRC evidence hierarchy. Evidence from cohort and observational studies was used to support some recommendations concerning diagnostic investigations, monitoring, diet and lifestyle, and to update epidemiological and background information.

 
Table 4. NHMRC evidence hierarchy3
Study type Description
Level I A systematic review of Level II studies
Level II An RCT or prospective cohort study
Level III A pseudo-RCT, case-control study, retrospective cohort study, comparative study with concurrent controls or comparative study without concurrent controls
Level IV Case series, study of diagnostic yield, cohort study of persons at different stages of disease or cross-sectional study
Adapted from NHMRC additional levels of evidence and grades for recommendations for developers of guidelines.3
NHMRC, National Health and Medical Research Council; RCT, randomised controlled trial.

The body of evidence supporting each recommendation was rated according to the NHMRC body of evidence matrix (Table 5). This method is designed to allow for a mixture of components, taking into account the fact that although the body of evidence in any particular area may be small (therefore attracting a low evidence base component rating), a high clinical impact and applicability to the Australian population will merit a high overall rating.

Table 5. NHMRC body of evidence matrix3
Component A
Excellent		 B
Good		 C
Satisfactory		 D
Poor
Evidence base One or more Level I studies with a low risk of bias or several Level II studies with a low risk of bias One or two Level II studies with a low risk of bias or a systematic review of several Level III studies with a low risk of bias One or two Level III studies with a low risk of bias, or Level I or II studies with a moderate risk of bias Level IV studies or Level I–III studies/systematic reviews with a high risk of bias
Consistency All studies consistent Most studies consistent, and inconsistency can be explained Some inconsistency reflecting genuine uncertainty around the clinical question Evidence is inconsistent
Clinical impact Very large Substantial Moderate Slight or restricted
Generalisability Populations studied in body of evidence are the same as the target population for the guideline Populations studied in the body of evidence are similar to the target population for the guideline Populations studied in the body of evidence differ from the target population for the guideline, but it is clinically sensible to apply this evidence to the target population Populations studied in the body of evidence differ from the target population and it is hard to judge whether it is sensible to generalise to the target population
Applicability Directly applicable to the Australian healthcare context Applicable to the Australian healthcare context with few caveats Probably applicable to the Australian healthcare context with some caveats Not applicable to the Australian healthcare context
Adapted from NHMRC additional levels of evidence and grades for recommendations for developers of guidelines.3
NHMRC, National Health and Medical Research Council.

Each recommendation was given a final grading according to the NHMRC grades of recommendation (Table 6). The grading represents the overall strength of the evidence and reflects the confidence with which clinicians can apply a recommendation in a clinical situation. The final grades are based on a summation of individual components of the body of evidence assessment shown in Table 5. A recommendation cannot be graded A or B unless the volume and consistency of evidence components are both graded either A or B.

Table 6. NHMRC grades of recommendations
Grade Description
A Body of evidence can be trusted to guide practice
B Body of evidence can be trusted to guide practice in most situations
C Body of evidence provides some support for recommendation(s), but care should be taken in its application
D Body of evidence is weak and recommendation must be applied with caution*
*The review committee also applied a Grade D to recommendations where there is expert consensus in the absence of a strong body of evidence.
Adapted from NHMRC additional levels of evidence and grades for recommendations for developers of guidelines.3

Due to resource and time restrictions, the consultation period was focused on Healthy Bones Australia stakeholders and review by the main users of the guide, namely GPs. The National Osteoporosis Guideline Review Committee was particularly cognisant of the importance of clear and pragmatic advice for busy GPs in everyday clinical practice. This guide was reviewed by GP subject matter experts and the RACGP’s Expert Committee for Quality Care, and endorsed by the RACGP Board.

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