The rate of breast-conserving surgery for early breast cancer is not influenced by the surgical strategy of excisional biopsy followed by the definitive procedure.

Increased emphasis on breast conservation and the primacy of the patient's preferences has led to the promotion and increased use of a two-step surgical strategy (definitive operation only after a final tissue diagnosis from a biopsy done on a previous visit) in the treatment of early breast cancer, with the assumption being that this is more conducive to the performance of breast-conserving surgery (BCS). We sought to test this by examining the effect of the surgical strategy (one-step versus two-step) on the operation performed (BCS versus mastectomy). A random sample of women with node-negative breast cancer diagnosed in 1991 in Ontario was drawn from the Ontario Cancer Registry database and matched to the Canadian Institute of Health Information and Ontario Health Insurance Plan databases (n = 643). This provided information on the timing and nature of all surgical procedures performed as well as patient, tumor, hospital, and surgeon characteristics. The surgical strategy was defined as either a one-step procedure (biopsy and definitive surgery performed at the same time) or a two-step procedure (surgical biopsy and pathologic diagnosis, followed by definitive surgery at a later date). The axillary lymph node dissection was used to define the definitive procedure. BCS was employed in 68% of patients, and this did not differ significantly between the one-step and two-step groups (66% versus 70%). Patients with palpable lesions had a significantly lower rate of breast conservation than those with nonpalpable lesions. Other variables associated with a lower rate of BCS were larger tumor size, presence of extensive ductal carcinoma in situ (DCIS), and central or multifocal tumors. The use of a one-step procedure was associated with a patient age of more than 50 years, a palpable mass, tumor size larger than 1 cm, previous fine needle aspiration (FNA) biopsy, absence of extensive DCIS, and surgery in an academic setting. Breast conservation was not affected by the surgical strategy used or the timing of the decision, but was associated with several accepted tumor factors. This study shows that, contrary to the opinion of some, there is a group of breast cancer patients in whom treatment in a one-step manner is appropriate.

Quality of hospital discharge and physician data for type of breast cancer surgery.

OBJECTIVE: The quality of coding for breast surgical procedures was examined by comparing hospital discharge abstracts and physician claims with data abstracted from records of women diagnosed with node-negative breast cancer from April 1, 1991, to December 31, 1991. METHODS: The node-negative breast cancer cohort was linked with a population registry file. Hospital discharge abstracts and physician billing claims were retrieved for matched subjects. Overall agreement between two data sets was defined as the number of cases for which there was a match by specific type of procedure out of all eligible cases that were matched with the health care utilization file. Specific agreement was assessed by the kappa statistic, using only those records in the administrative data set that were coded for mastectomy or breast-conserving surgery. RESULTS: Of 735 eligible cases in the node-negative breast cancer cohort, 655 (89.1%) were linked to a health care utilization file. Overall agreement between surgeon billing claims and charts was 95.4% (CI = 93.5, 96.9) for most definitive procedure. Agreement for breast surgery type was 98.1% (kappa = 0.96; CI = 0.87,1.0) for cases coded as breast-conserving surgery or mastectomy. When hospital discharge and chart data were compared, overall agreement was 86.2% (CI = 83.4, 88.8), whereas agreement for breast surgery type was 93.2% (kappa = 0.86; CI = 0.77, 0.94). CONCLUSION: Overall, definitive surgical procedure in the two administrative databases accurately reflected information recorded in patients' charts. Physician claims appeared to provide more accurate information than did hospital discharge data.

Case selection and appropriateness of coronary angiography and coronary artery bypass graft surgery in British Columbia and Ontario.

OBJECTIVES: To compare the types of patients selected for coronary angiography (CA) and coronary artery bypass graft (CABG) surgery, and the appropriateness of the procedures performed on these patients in a random sample of cases in British Columbia and Ontario. DESIGN: Retrospective randomized medical record review. SETTING: All hospitals performing CA and/or CABG in British Columbia and Ontario in fiscal year 1989/90. PATIENTS: For CA, 395 randomly selected patients in Ontario and 139 randomly selected patients in British Columbia; for CABG, 431 randomly selected patients in Ontario and 125 randomly selected patients in British Columbia. MAIN OUTCOME MEASURES: Case selection was measured in terms of the demographic and clinical characteristics of patients undergoing the procedures. Appropriateness was measured by comparing the clinical characteristics of patients undergoing the procedures with explicit criteria established by a panel of Canadian physicians. The yield from CA was measured as the proportion of patients who were found to have insignificant anatomical disease. RESULTS: Analysis of patients selected for CA showed that sample patients from Ontario were less likely than those from British Columbia to be female (25% versus 37%, respectively, P = 0.012) and less likely to have undergone a previous revascularization (12% versus 24%, respectively, P = 0.005). The distribution of main indications for CA differed between the two provinces (P = 0.002), with Ontario patients more likely to have chronic stable angina (45% versus 24%) and less likely to have unstable angina (16% versus 26%). For CABG, sample patients from Ontario were less likely to be 65 years of age or older (32% versus 45%, P = 0.016) and more likely to have an ejection fraction less than 35% (14% versus 5%, P = 0.006). The distribution of the main indications for CABG differed (P < 0.001), with Ontario patients more likely to have chronic stable angina (68% versus 38%) and less likely to have unstable angina (20% versus 43%). There was no statistically significant difference in CA cases rated as inappropriate (8.4% in Ontario versus 10.8% in British Columbia, P = 0.396) or CABG cases rated as inappropriate (3.9% in Ontario versus 2.4% in British Columbia, P = 0.393). There were no statistically significant differences in the proportion of CA that yielded insignificant anatomical disease (17.5% in Ontario versus 18.4% in British Columbia, P = 0.355). CONCLUSIONS: There were differences between Ontario and British Columbia in the demographic and clinical characteristics of patients selected for CA and CABG. This may indicate differences in the referral process in the two provinces. Despite these differences the rates of inappropriate procedures and the yield from CA were similar.

Physicians' opinions about decision aids for patients considering systemic adjuvant therapy for axillary-node negative breast cancer.

PURPOSE: To examine variations in physicians' opinions about the appropriateness and content of decision aids for women with breast cancer and criteria for their evaluation. METHODS: Cross-sectional survey of all 144 Ontario oncologists by Dillman's mailed survey design. The response rate was 87%. RESULTS: The predominant current practice pattern was to spontaneously inform patients about the treatment recommendations, degree of certainty regarding the recommendations, treatment regime, benefits and side effects. Most respondents (94%) endorsed patient decision aids, particularly when there was high uncertainty about providing adjuvant treatment. Over three-quarters endorsed measuring the following outcomes of decision aids: patients' clarity of trade-offs involved (e.g. survival vs. side effects); comprehension of treatment alternatives, risks and benefits; accuracy of expectations; decision satisfaction; anxiety; commitment to the decision; length of time to complete the decision aid; and decision uncertainty. The least support was for the use of the decision itself as an outcome measure. CONCLUSIONS: There is considerable consensus regarding the indications for, content and criteria for evaluating decision aids which should be considered when developing aids relevant to the needs of clinicians and patients.

Appropriateness of adjuvant systemic therapy for axillary node-negative breast cancer: a physician opinion survey.

PURPOSE: To examine variations in physicians' recommendations for systemic adjuvant therapy in the treatment of women with node-negative breast cancer (NNBC) and to determine factors used in making specific recommendations. MATERIALS AND METHODS: A questionnaire was sent by mail to all 149 Ontario physicians who actively treated breast cancer in 1993. The questionnaire described 48 clinical scenarios of women with NNBC, which included all possible combinations of the following factors: menopausal status, tumor size, hormone receptor status, histologic and nuclear grade, and lymphatic and/or vascular invasion. Respondents rated the appropriateness of administering tamoxifen, combination chemotherapy, or both tamoxifen and combination chemotherapy on a nine-point scale from extremely inappropriate to extremely appropriate. Respondent agreement and disagreement were tabulated for each scenario, and factors associated with specific treatment ratings were analyzed by logistic regression. RESULTS: The response rate was 87%. Agreement for the appropriateness of specific therapies was most evident where clinical trials have demonstrated efficacy, whereas disagreement was observed in scenarios in which support for a specific treatment is not available in the current literature. Relevant tumor- and patient-specific factors were used in decision-making; personal characteristics of the respondents had no statistically significant impact on appropriateness ratings. CONCLUSION: The physicians surveyed had good knowledge of NNBC prognostic factors, but had a range of opinion on optimal therapy for many clinical scenarios, which reflects current knowledge of the benefits of adjuvant therapy for NNBC.

Coronary angiography and revascularization: defining procedural indications through formal group processes. The Canadian Revascularization Panel, the Canadian Coronary Angiography Panel.

OBJECTIVES: To summarize the process and extent of interphysician agreement within two panels convened to derive indications for the appropriate use of coronary angiography and for coronary revascularization procedures. PARTICIPANTS: Two panels, each with nine practitioners. METHODS: Panelists rated the appropriateness of intervention for a comprehensive set of indications for each procedure. Indications were brief profiles created by combining and permuting clinical characteristics pertinent to case selection for intervention. Ratings were first made at home, with a second round at the panel meeting following open discussion. Final rankings of indications as 'appropriate', 'uncertain' or 'inappropriate' were based on the pattern of panelists' responses on a nine-point scale, including the median rating and extent of agreement among panelists. Agreement was defined as at least seven panelists' ratings within the three-point region containing the median rating. Panelists were later mailed a much-reduced list of indications for which there was agreement on appropriateness. These were re-rated on a necessity scale. A procedure was rated 'necessary' only if a physician was ethically obligated to recommend it as the preferred treatment option. RESULTS: For appropriateness of angiography, agreement occurred in 38.2% of indications in round 1 and 64.4% in round 2 (P < 0.0001). For coronary artery bypass graft (CABG) versus medical therapy, the corresponding increase was from 43.5 to 54.0% (P < 0.0001). Agreement on necessity of angiography occurred for 44.3% of scenarios. For indications where CABG alone was appropriate, agreement on necessity was 56%. However, for indications where percutaneous transluminal coronary angioplasty (PTCA) could be regarded as the first-line intervention, agreement on necessity was only 5%. CONCLUSIONS: A two-step panel process permitted considerable convergence of panelists' ratings, highlighting the importance of formal panel methods in setting utilization management criteria. However, the extent of continuing disagreement on ratings underscores the need to avoid a forced consensus; instead, divergent opinions should be taken as indicative of uncertainty about the appropriateness of intervention. Interpanelist agreement on necessity ratings was modest, but may help in setting benchmarks to assess possible underprovision of invasive cardiac services in Canada.

Pulmonary artery catheterization. Can there be an integrated strategy for guideline development and research promotion?

OBJECTIVES: To review the evidence regarding indications for pulmonary artery catheterization (PAC) in critically ill patients, and to propose a guideline-generating process that would encourage randomized controlled trials of PAC. DATA SOURCES: Computerized and manual search for randomized trials involving PAC as an integral part of the protocol, published as of October 1992. Manual search for guidelines endorsed by specialty societies and/or proposed by expert panels following an explicit group process. DATA SYNTHESIS: Four trials suggest benefit from PAC for pre- or perioperative management of high-risk surgical patients. Two others indicate that PAC for low-risk aortic aneurysm surgery confers no advantages. Use of PAC to guide therapy aimed at improved mixed venous oxygen saturation was beneficial compared with usual care with PAC in two small trials among patients with septic shock and severe trauma. Other PAC indications are either untested or inadequately tested by small trials. Large trials are needed, but trials to date have been impeded by clinicians' uncertainty about PAC and unwillingness to randomize critically ill patients. No published guidelines for PAC have used a formal group process and/or a hierarchical review of evidence to demarcate proven from unproven indications. CONCLUSIONS: We propose a research-promoting expert panel on indications for PAC. Aided by a critical literature review, experts would rate case scenarios on the need for routine PAC with or without a specified intervention strategy. Future trials should test indications where there is either consensus about the uncertainty of need for PAC, or interpanelist disagreement owing to inconclusive evidence. This process could facilitate practice guideline development, utilization management, and large trials of PAC and related interventions.

Links between passive smoking and disease: a best-evidence synthesis. A report of the Working Group on Passive Smoking.

We reviewed the toxicologic, clinical, and epidemiologic evidence on the health effects of environmental tobacco smoke (ETS). For each type of exposure to environmental tobacco smoke we have sought articles in the English language reporting studies of effects on human health. Formal criteria that stressed study design, quality of execution and generalizability of results were used to select 116 scientifically admissible reports from over 2,900 articles. We concluded that: (a) there is strong evidence of an association between residential exposure to environmental tobacco smoke and both respiratory illness and reduction of lung function, and also between maternal smoking and reduced birth weight; (b) the weight of evidence is compatible with an association between active maternal smoking during pregnancy and increased infant mortality, and also between residential exposure to environmental tobacco smoke (primarily spousal smoking) and the risk of lung cancer; (c) there is evidence consistent with a relationship between exposure to environmental tobacco smoke in the workplace and respiratory symptoms, (d) the evidence is insufficient to implicate residential exposure to environmental tobacco smoke in relation to other forms of malignant disease or congenital malformations; (e) there is no evidence in the literature of an association between nonresidential exposure to environmental tobacco smoke and any form of cancer. Further studies are required to address the effects of exposure to environmental tobacco smoke, especially nonresidential exposure, in carcinogenesis and as a risk factor for atherosclerosis. Further work is also needed to improve measurement of exposure in such studies and to assess the importance of confounding factors.