EVIDENCE RELEVANT TO GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS SECOND EDITION FEBRUARY 2006 PREPARED BY THE NATIONAL BREAST CANCER CENTRE FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING Evidence Relevant to Guidelines for the Investigation of Breast Symptoms. Second Edition. was prepared and produced by: The National Breast Cancer Centre 92 Parramatta Road, Camperdown NSW, Australia Locked Bag 16, Camperdown NSW 1450 Telephone: +61 2 9036 3030 Fax: +61 2 9036 3077 Website: www.nbcc.org.au Email: [email protected] © National Breast Cancer Centre 2006 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part might be reproduced by any process without prior written permission from the National Breast Cancer Centre. Requests and enquiries concerning reproduction and rights should be addressed to the Communications Manager, National Breast Cancer Centre, Locked Bag 16, Camperdown NSW 1450 Australia. Recommended citation National Breast Cancer Centre. Evidence Relevant to Guidelines for the Investigation of Breast Symptoms. Second Edition. National Breast Cancer Centre, Camperdown, NSW, 2006. DISCLAIMER The National Breast Cancer Centre does not accept any liability for any injury, loss or damage incurred by use of or reliance on the information. The National Breast Cancer Centre develops material based on the best available evidence, however it cannot guarantee and assumes no legal liability or responsibility for the currency or completeness of the information. Copies of this report can be downloaded from the National Breast Cancer Centre website: www.nbcc.org.au or ordered by telephone: 1800 624 973 The National Breast Cancer Centre is funded by the Australian Government Department of Health and Ageing. Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 2 CONTENTS List of tables 5 List of figures 6 Acknowledgements 7 Executive summary 8 Introduction 11 Methods 13 Searching the literature 13 Appraising quality and validity 15 Objective 1: Appraisal of international guidelines 17 Objective 2: The accuracy and clinical utility of the triple test in women presenting with a breast lump or asymmetrical prominence 19 The accuracy of a positive and negative triple test 20 The accuracy of combinations of components of the triple test 21 The accuracy of combined results for mammography and fine needle aspiration cytology 21 Objective 3: The value of core biopsy versus fine needle aspiration cytology as a component of the triple test in diagnosing breast cancer in women presenting with a breast lump or asymmetrical prominence 24 Diagnostic performance 25 Choosing between core biopsy and fine needle aspiration cytology 25 Objective 4: The value of ultrasound in diagnosing breast cancer in women presenting with a breast lump or asymmetrical prominence 28 Study quality 29 Diagnostic performance 29 Age-specific results 31 Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 3 Objective 5: The clinical significance of nipple discharge and the utility of cytology in diagnosing breast cancer 33 The clinical significance of nipple discharge 33 The diagnostic accuracy of cytology of discharge smears in the diagnosis of breast cancer 35 Conclusions 36 References 37 List of abbreviations 39 APPENDIX A: Search strategies 40 APPENDIX B: Websites 41 APPENDIX C: List of Included Studies 42 APPENDIX D: Second-stage Exclusions 43 APPENDIX E: Tables for ultrasound section 83 Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 4 LIST OF TABLES Table 1. Electronic databases used in the search of the primary literature 13 Table 2. Entry criteria used to assess eligibility of published material 14 Table 3. Structure and content of the AGREE Instrument 16 Table 4. Items used to assess the quality of diagnostic test studies 17 Table 5. Standardised domain scores for clinical practice guidelines according to AGREE criteria 19 Table 6. True positive rate and false positive rate for the triple test and each component 21 Table 7. Distribution of results for clinical examination, mammography and fine needle aspiration with women with and without cancer 22 Table 8. Distribution of results for mammography and fine needle aspiration of women with and without cancer 24 Table 9. Reported diagnostic performance of studies examining the accuracy of core biopsy versus FNAC 26 Table 10. Reported diagnostic performance of mammography and ultrasonography in the diagnosis of breast cancer 31 Table 11. True and false positive rates for mammography with or without ultrasonography by age group from Zonderland and colleagues 32 Table 12. Studies examining the association between nipple discharge and breast cancer 33 Table 13. Distributions of nipple discharge characteristics as percentages of all discharges and of those cases found to have cancer 34 Table 14. Probability of cancer by age and characteristic of discharge 34 Table 15. Reported diagnostic performance of cytology of nipple discharge in the diagnosis of breast cancer 35 Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 5 LIST OF FIGURES Figure 1. The probability of breast cancer based on results of the triple test 21 Figure 2. The probabilities of breast cancer based on results of individual components of the triple test 23 Figure 3. The probabilities of breast cancer based on results of mammography and fine needle aspiration cytology 24 Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 6 ACKNOWLEDGEMENTS The National Breast Cancer Centre gratefully acknowledges the support of all the individuals and groups who contributed to the development of this report. Working Group This report was developed with input from a multidisciplinary Working Group: Dr Jane Armes (The Royal College of Pathologists of Australasia) Dr Kathleen Burns (Australian Divisions of General Practice) Dr Bronwyn Kennedy (The Royal Australian College of General Practitioners) Dr Marjorie Kossoff (The Royal Australian and New Zealand College of Radiologists) Ms Ros Lawson (Breast Cancer Network Australia) Dr Warwick Lee (radiologist with expertise in breast imaging) Mr David Oliver (Royal Australasian College of Surgeons) Dr Wendy Raymond (The Royal College of Pathologists of Australasia) Dr Julie Thompson (general practitioner with expertise in rural health) This report was developed by Dr Elmer V Villanueva. Dr Adele Weston of Health Technology Analysts P/L provided technical input into the systematic review of evidence on ultrasonography. Ms Caroline Nehill and Dr Helen Zorbas contributed to the conception and design of the report and provided substantial critical comments on its intellectual content. Funding Funding for the development of this report was provided by the Australian Government Department of Health and Ageing. Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 7 EXECUTIVE SUMMARY This report builds, replicates and extends the findings of the National Breast Cancer Centre (NBCC) review Evidence Relevant to Guidelines for the Investigation of Breast Symptoms, First Edition released in 1997. The review was used to support a number of NBCC publications, including The Investigation of a New Breast Symptom: A Guide for General Practitioners (the Guide). The present edition has the following specific objectives: 1. To assess guidelines produced by international agencies for the quality of their evidence base. 2. To examine the evidence of the accuracy and clinical utility of the triple test in women presenting with a breast lump or asymmetrical prominence. 3. To evaluate the value of core biopsy versus fine needle aspiration cytology (FNAC) as a component of the triple test in women presenting with a breast lump or asymmetrical prominence. 4. To evaluate the value of ultrasound in diagnosing breast cancer in women presenting with a breast lump or asymmetrical prominence. 5. To examine the clinical significance of nipple discharge in terms of the crude and age- specific probabilities of breast cancer and the use and interpretation of clinical features and cytology in the assessment of cancer risk. Standard techniques of systematic reviewing were applied to evaluate the evidence published since 1996, while retaining as much as possible of the approach used in the first edition. APPRAISAL OF INTERNATIONAL GUIDELINES Three guidelines on the diagnosis of breast disease were identified. These were released by the following organisations: NHS Cancer Screening Programmes (Cancer Research UK), Institute for Clinical Systems Improvement (USA) and the Brigham and Women’s Hospital (USA). While each showed strengths in specific areas, none adequately described the guidelines development process or provided sufficient coverage of issues relevant to the Australian setting. Guideline development groups focusing on the management of women with breast symptoms in the general practice setting should consider these guidelines in the light of local patterns of care, differences in health and financing systems, and end user and patient behaviour. Evidence relevant to GUIDELINES FOR THE INVESTIGATION OF BREAST SYMPTOMS 8 THE ACCURACY AND CLINICAL UTILITY OF THE CLASSIC TRIPLE TEST The triple test result may significantly modify the pre-test probability of a patient. The triple test is considered positive if any one of its component tests results in a positive result (i.e. “indeterminate”, “suspicious” or “malignant”). A positive finding on one of the components