Table 10: Body of evidence assessment matrix A B C D Excellent Good Satisfactory Poor Evidence base several level I or II studies with low risk of bias one or two level II studies with low risk of bias or a SR/multiple level III studies with low risk of bias level III studies with low risk of bias, or level I or II studies with moderate risk of bias level IV studies, or level I to III studies with high risk of bias Consistency all studies consistent most studies consistent and inconsistency may be explained some inconsistency reflecting genuine uncertainty around clinical question evidence is inconsistent Clinical impact very large substantial moderate slight or restricted Generalizability population/s studied in body of evidence are the same as the target population population/s studied in the body of evidence are similar to the target population population/s studied in body of evidence different to target population for guideline but it is clinically sensible to apply this evidence to target population population/s studied in body of evidence different to target population and hard to judge whether it is sensible to generalise to target population Applicability directly applicable to Australian healthcare context applicable to Australian healthcare context with few caveats probably applicable to Australian healthcare context with some caveats not applicable to Australian healthcare context Adapted from () Expert advice An advisory panel was established to provide guidance to the evaluators to ensure that the assessment is clinically relevant and takes into account consumer interests. Membership of the advisory panel is provided at Appendix D.
Results of assessment Relevant studies for assessment The searches yielded 32 studies that were deemed relevant for this assessment. A summary of these studies is provided in Table 11. Table 11: Summary of studies included in the assessment Reviewed for assessment of : Study Study design Search 1 Are patients with breast cancer and taking aromatase inhibitors at high risk of fractures? (and related questions) Amir 2011 Becker 2012 Bell 2011 Eastell 2011 Edwards 2011 Goss 2013 Kalder 2013 Neuner 2011 Meta-analysis Meta-analysis Comparative study RCT Systematic review and case series RCT RCT Population study, retrospective Search 2 Are DXA scans safe and effective? (and related questions) Marshall 1996 Homik 1999 Rud 2007 Kanis 2009 Lim 2009 Cummins 2011 Hailey 1998 Meta-analysis HTA report Meta-analysis Meta-analysis Review and position statement Case control study, retrospective HTA report Search 3 Are anti-resorptives or other BMD treatments safe and effective? (and related questions) Brufsky 2012 (Z-FAST) Coleman 2013 (ZO-FAST) Llombart 2012 (E-ZO-FAST) Takahashi 2012 Nuzzo 2012 (HOBOE) Safra 2011 Lee 2011 Lester 2012 (ARIBON) Markopoulos 2010 (ARBI) Rhee 2013 Van Poznak 2010 (SABRE) Ellis 2009 Rastelli 2011 Martyn-St James 2009 RCT open label RCT open label RCT open label RCT open label RCT Phase III RCT Phase II Comparative study RCT RCT phase II open-label RCT RCT phase III RCT phase III RCT phase II Meta-analysis Search 4 Cost-effectiveness of DXA and treatment? (and related questions) Ito 2012 Logman 2010 Mueller 2009 Cost-utility analysis Cost-utility analysis Cost-utility analysis Sources: (, , , , , , , , , , , , , , , , , , , , , , , , , , , , , ) Are post-menopausal women with breast cancer on aromatase inhibitors at high risk of minimal trauma fractures? A summary of the key features, results and quality appraisal are provided in Tables 12 and 13. Additional information on these studies is provided in Appendix C.