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Observed differences in treatment outcome between populations suggest that opportunities for improvement are available.³ Moreover, potentially important variations in clinical practice are well documented in Australia and elsewhere.^4-6 Treatment practice which appears to be informed by evidence, for example greater use of breast-conserving surgery, has been observed more frequently among clinicians who regularly treat patients with breast cancer.⁷ Furthermore, congruence of treatment practice with published guidelines has been directly associated with improved patient survival;⁸ improved treatment practice has the potential to improve survival by up to 10%.^8,9 Therefore, enhanced implementation of soundly developed, evidence-based treatment guidelines is an appropriate goal for health services and individual clinicians.

In 1996, clinicians and consumers involved in breast cancer diagnosis and treatment in the Australian Capital Territory (ACT) and South Eastern New South Wales (SE NSW) formed a cooperative group aimed at improving breast cancer management and facilitating implementation of treatment guidelines. A prospective, longitudinal, community-based study of breast cancer treatment was established to assist with guidelines implementation. Our report describes the results of the first 14 months of this ongoing project.

The 1998 estimated populations of the ACT and South Eastern NSW were 311 000 and 118 000 respectively (source: Australian Bureau of Statistics, Estimated Residential Populations, 30 June 1998).

• Women with operable invasive breast cancer should undergo some form of axillary surgery sufficient to develop a prognosis based on axillary node status;

• Women undergoing less than total mastectomy for operable invasive breast cancer should receive postoperative adjuvant radiotherapy;

• Women with a completely resected invasive breast cancer tumour greater than two centimetres in diameter or with involved axillary lymph nodes should receive adjuvant systemic therapy (either chemotherapy, endocrine therapy or both); and

• Women under the age of 50 years with completely resected axillary lymph node positive breast cancer should receive adjuvant chemotherapy.

All clinicians involved specifically with the care of patients with breast cancer were invited to participate in the study. Participating clinicians agreed to approach all of their patients presenting with newly diagnosed breast cancer requesting permission to include them in the study. Eligible patients were women or men with newly diagnosed invasive or in-situ breast cancer. For each eligible patient a brief notification form was completed and submitted by mail to the study centre at the Women's Health Program of ACT Community Care. Written informed consent was obtained from the patient by the notifying clinician, and subsequently a detailed data form was completed giving details of presentation, clinical and pathological staging, and treatment. The dataset was based on a prior survey conducted by the Provincial Surgeons of Australia (Dr David Adamthwaite, President of the Provincial Surgeons of Australia, personal communication). Additional data relating to enrolled patients were obtained from treatment units in the region.

Information from the audit forms, supplemented where necessary from pathology reports and treatment facility records, was entered into a secure database developed by the project officer. As well as facilitating project management, the database allows individualised, confidential reports to be produced for each participating clinician, providing detailed feedback about each clinician's practice, with comparisons across the group and against the agreed criteria.

Aggregated data across the whole clinician group are presented at regular meetings of the treatment group.

Data collected during the first 14 months of the project, and analysed to provide an initial report to contributing clinicians, form the basis of our report. Accrual of patients to the project is ongoing.

Some 123 new cases of invasive breast cancer (excluding male patients and patients with in-situ disease only) were registered with ACT addresses. In comparison, the observed mean annual incidence of breast cancer in the ACT during 1993-1996 was 134.¹ Thus, during the 14-month study period, about 156 incident cases would be expected. The project therefore detected 79% of predicted ACT incident cases during the study period.

Of the 221 registered patients, there were 10 with distant metastases, 16 with carcinoma-in-situ only and four men, leaving 191 women with primary, localised, invasive breast cancer. It is to these women that the treatment guidelines apply. In five women with bilateral synchronous tumours, details are given of the tumour judged by the treating clinician to have the worse prognosis. Eighty-one per cent of tumours were oestrogen receptor (ER) positive or progesterone receptor (PgR) positive by immunohistochemical analysis done in routine diagnostic histopathology laboratories. The pathological characteristics of the tumours in these 191 women are presented in Box 2.

Only two of 87 women who underwent breast-conserving surgery did not also receive postoperative radiotherapy. Of the 191 patients with invasive breast cancer, 103 (54%; 95% CI, 47-61) underwent mastectomy.

The overall concordance of treatment with the practice indicators relating to systemic adjuvant therapy was strong. Of 33 women with tumours greater than 2 cm in diameter and negative or unknown axillary lymph node status, 32 (97%) received either tamoxifen (18), chemotherapy (4), or both (10). Of 66 women with axillary lymph node involvement, 63 (95%) received systemic adjuvant therapy with either tamoxifen (14), chemotherapy (19) or both (30). Thus, only four of 99 women for whom adjuvant systemic therapy was considered appropriate under the guidelines did not receive such therapy.

All 27 women under 50 years of age with axillary lymph node involvement received adjuvant chemotherapy.  

Given the degree of involvement of clinicians in establishing the data collection and practice indicators, the strong concordance with actual practice observed is not surprising. The practice indicators chosen were not particularly controversial, enabling rapid consensus among the group members. Indicators relating to the use of breast-conserving surgery for early breast cancer and to the use of adjuvant chemotherapy for node-negative disease, although more contentious, are appropriate further areas for local consensus and audit. Observed concordance with guidelines for adjuvant chemotherapy in node-negative breast cancer has been relatively low, presumably because of the more modest benefits of treatment (in absolute terms) in this group.¹¹

Implementing guidelines successfully can be difficult. Just producing and publishing guidelines for breast cancer treatment does not ensure their uptake into clinical practice.¹² Over time clinical practice may adhere more closely to published guidelines, although a causal relationship cannot be easily proven.¹³ In a survey of clinicians in Sydney, most respondents supported the NHMRC Clinical Practice Guidelines, but only 20% believed the guidelines had influenced clinical practice.¹⁴

The introduction of guidelines has been a stimulus for institutionally focused audits of surgical practice.¹⁵ Audits incorporating structured feedback to clinicians may be a critical strategy in implementing guidelines. Organisations such as the Royal Australasian College of Surgeons have recognised audit as an important tool in the treatment of breast cancer, and Clinical Indicator 7.1 of the Australian Council of Healthcare Standards Internal Medicine Indicators, version 2, measures the proportion of premenopausal women with node-positive early breast cancer receiving chemotherapy.¹⁶

Many factors affect treatment decisions in primary breast cancer. Women bring to the process their own preferences and needs. Many of the treatment decisions require trade-offs between long term gain and unpleasant treatments, such as chemotherapy. We did not examine the decision-making processes followed by these patients and their attending health professionals.

Entry of any individual patient into the audit was voluntary, both for the clinician and for the patient. Participating clinicians undertook to offer enrolment to all of their patients, and every effort was made to enhance compliance. Nevertheless, complete enrolment was not achieved and this may have introduced bias, with patients receiving multimodality care possibly being more likely to be enrolled.

An advantage of our audit was that it was community based and prospective. Surgical audits have generally been based on retrospective casenote review and, as such, have sometimes been hampered by missing data.¹⁷ Some community-based studies assessing the process of treatment have relied on the secondary analysis of administrative data with linkage to population-based cancer registries.¹⁸ In Canada, a population-based cancer registry has been linked to clinical records to obtain treatment details and allow comparisons with treatment guidelines.¹⁹

Successful collection of community-based audit data requires both enthusiasm and trust on the part of the treating clinicians voluntarily submitting information about their own practice. We believe this may be best achieved within a framework of agreed treatment guidelines and indicators. An enthusiastic project officer and involvement of practice staff and institutional data managers is crucial. As new ways of managing breast cancer (and other diseases) become available, an ongoing implementation process with agreed, clinically relevant indicators and guidelines, and a regionally based audit, can be an effective tool.

1. Australian Institute of Health and Welfare. Breast and cervical cancer screening in Australia 1996-1997. Canberra: AIHW, 1998: 33. (Cancer Series no. 8.)
2. National Health and Medical Research Council. Clinical practice guidelines. The management of early breast cancer. Canberra: NHMRC, 1995.
3. Richards M, Sainsbury R, Kerr D. Inequalities in breast cancer care and outcome. Br J Cancer 1997; 76: 634-638.
4. Craft PS, Primrose JG, Lindner JA, McManus PR. Surgical management of breast cancer in Australian women in 1993: analysis of Medicare statistics. Med J Aust 1997; 166: 626-629.
5. Nattinger AB, Goottlieb MS, Veum J, et al. Geographic variation in the use of breast-conserving treatment for breast cancer. N Engl J Med 1992; 326: 1102-1107.
6. Samet JM, Hunt WC, Farrow DC. Determinants of receiving breast-conserving surgery. The surveillance, epidemiology and end results program 1983-1986. Cancer 1994; 73: 2344-2351.
7. Hill DJ, White VM, Giles GG, et al. Changes in the investigation and management of primary operable breast cancer in Victoria. Med J Aust 1994; 161: 110-122.
8. Sainsbury R, Haward B, Rider L, et al. Influence of clinician workload and patterns of treatment on survival from breast cancer. Lancet 1995; 345: 1265-1270.
9. Gillis CR, Dole D. Survival outcome of care by specialist surgeons in breast cancer: a study of 3786 patients in the west of Scotland. BMJ 1996; 312: 145-148.
10. Elston CW, Ellis IO. Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology 1991; 19: 403-410.
11. Sawaka C, Olivotto I, Coldman A, et al. The association between population-based treatment guidelines and adjuvant therapy for node-negative breast cancer. Br J Cancer 1997; 75: 1534-1542.
12. Chouillet AM, Bell CM, Hiscox JG. Management of breast cancer in southeast England. BMJ 1994; 308: 168-171.
13. Ray-Coquard I, Philip T, Lehmann M, et al. Impact of a clinical guidelines program for breast and colon cancer in a French cancer center. JAMA 1997; 278: 1591-1595.
14. Ward JE, Boyages J, Gupta L. Local impact of the NHMRC early breast cancer guidelines: where to from here? Med J Aust 1997; 167: 362-365.
15. McCarthy DO, Blamey RW, Robertson JF, Mitchell AK. A one-year audit of 255 operable breast cancers. Eur J Surg Oncol 1997; 23: 399-402.
16. Australian Council on Healthcare Standards. Clinical indicators in summary. Revised edition. Sydney: ACHS, 1998.
17. Clamp SE. Management of breast cancer. Incomplete case notes hamper research. BMJ 1994; 308: 715.
18. Hillner BE, McDonald MK, Penberthy L, et al. Measuring standards of care for early breast cancer in an insured population. J Clin Oncol 1997; 15: 1401-1408.
19. Olivotto IA, Coldman AJ, Hislop TG, et al. Compliance with practice guidelines for node-negative breast cancer. J Clin Oncol 1997; 15: 216-222.

Women's Health Program, ACT Community Care, Canberra, ACT.
Yanping Zhang, Project Officer;
Jennifer Brogan, Director.

The Calvary Clinic, Canberra, ACT.
Noel Tait, FRACS, Consultant Surgeon;
John M Buckingham, FRACS, Consultant Surgeon.

Reprints: Dr P S Craft, Medical Oncology Unit, The Canberra Hospital, PO Box 11, Woden, ACT 2606.
Paul_CraftATact.gov.au

©MJA 2000
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