journal of Epidemiology and Community Health 1991; 45: 112-116 J Epidemiol Community Health: first published as 10.1136/jech.45.2.112 on 1 June 1991. Downloaded from Practice ofbreast self examination: disease extent at diagnosis and patterns of surgical care. A report from an Italian study GIVIO (Interdisciplinary Group for Cancer Care Evaluation) Abstract women; (b) patients' compliance over time; (c) the Study objective-The aim was to possible psychological effects and cost7 8; and (d) determine whether breast self examination the overall yield of screening programmes when leads to earlier diagnosis and whether this aggressive surgical procedures are still widely translates into a larger utilisation of practiced. At least some of these issues will be conservative surgical procedures. clarified by a trial currently in progress in the Design-The study was a survey of a USSR.9 cohort of breast cancer patients diagnosed In Italy there is not much information on the over the period September 1986-July 1988. diffusion of breast self examination and no Subjects-Participants were 1315 women organised educational programme is offered enrolled in a clinical trial testing the country wide. Our group has reported the results effectiveness of two follow up regimens by of a study in 1984 on the relationship between 30 general hospitals throughout Italy. premorbid breast self examination practice and Measurements and main results- the extent of disease at diagnosis.'o Overall, Overall, 511 patients (39%) reported some results indicated a low prevalence of self breast self examination practice, but only examination and a small beneficial effect limited 109 (8%) did this regularly and in a way to women performing it on a regular (monthly) deemed correct by their physicians. Breast basis. In this study we collected more detailed self examination practice was positively information on breast self examination and, as an associated with patients' education and past indirect measure of its contribution to better history of benign breast disease and quality care, we looked at how many women with negatively with age. Self examiners were small tumours (ie, <2 cm) do in fact receive found to have a significantly greater chance limited surgery. of being diagnosed with a primary tumour coded as pT1 according to the 1982 TNM classification (odds ratio = 1P42, 95% Methods CI= 1P13-1V79). This protective effect was The study was conducted in the framework of a mostly evident in the subgroup of optimal randomised control trial. l lAll patients performers (odds ratio= 1P54, CI= 1-01- consecutively admitted at the 30 participating 2 34). Nearly half the patients (3191655) hospitals were eligible provided they were 70 http://jech.bmj.com/ eligible for conservative surgery still had an years old or younger and had histologically unnecessary radical procedure. confirmed primary breast cancer classified as Conclusions-Premorbid breast self T1-3, N 0-2, M 0 according to the 1982 TNM examination seems to have a modest effect system. In situ tumours, second malignancies on the extent ofdisease at diagnosis. The still other than cutaneous basalioma, age over 70, and widespread use of radical surgery suggests geographical constraints which might prevent that a careful reanalysis ofpriorities among women from complying with regular follow up on September 27, 2021 by guest. Protected copyright. possible public interventions is needed were considered exclusion criteria. A before launching massive educational comprehensive view of the selection scheme is campaigns targeted exclusively at given in fig 1; 1315 women with newly diagnosed consumers. breast cancer represented the study base. During their first hospital stay for diagnosis and primary surgery, all patients were GIVIO Coordinating Centre: Different screening methods for early detection of interviewed about their past breast self AA Alexanian breast cancer, which is usually discovered by examination practice by medically qualified R Fossati patients themselves,' have been tested over the investigators, using a standardised questionnaire, G Apalone A Liberati last few years.23 Breast self examination has in order to assess time of first performance and P Zola potential as a screening test, but it is still debated frequency of examination (classified as monthly Clinicians participating whether screening programmes should include it or irregular). At the end of the interview, women in the survey are listed 5 were also asked to show how did the at the end of the article as a major detection method.4 they Over the last 20 years several observational examination in order to assess the quality of their Correspondence to: studies have looked at the relationship between performance (classified by their attending Dr Alessandro Liberati, Laboratory of Clinical breast self examination practice and extent of physicians, according to their implicit judgement, Epidemiology, Istituto di disease at diagnosis. Recently, a meta-analysis of as correct or incorrect). Ricerche Farmacologiche "Mario Negri", Via Eritrea most of these studies6 concluded that regular Then, to test the hypothesis of a "dose- 62, 20157 Milan, Italy practice may lead to earlier diagnosis.7 Some response effect" of breast self examination, we still remain about its divided women into three formed by Accepted for publication major questions, however, categories June 1990 intrinsic efficacy: (a) the best method for training pooling information collected on both frequency Breast self examination practice in Italy 113 and quality of the procedure: group A, those comparing observed and expected numbers of J Epidemiol Community Health: first published as 10.1136/jech.45.2.112 on 1 June 1991. Downloaded from practising the examination monthly and correctly; events. The significance of the linear trend, when group B, those practising with an irregular appropriate, was assessed using the Mantel- frequency and/or doing it in an incorrect way; and Haenszel test. Differences in diagnostic delay group C, those not reporting any self examination between performers and non-performers were practice. assessed using the Mann-Whitney test. Information on diagnostic delay was also gathered through face to face interview to quantify the lag time between first symptom and Results first visit (patient dependent delay) and the time A nodule was the first presentation of the disease between first seeking care and surgery (system in 9300 of cases (detected by patients themselves dependent delay). in 90% of cases). Quantitative estimates of the effect of self A total of 511 women (390O) said they examination on extent of disease were obtained performed self examination; their socio- using odds ratios (OR) and their 95% confidence demographic characteristics are reported in table intervals (CI). Patients with pTl lesions, node I. As expected, breast self examination was negative and pathological stage I were the negatively associated with age (p<0 001) and reference categories. Women reporting any kind positively associated with education (p<0-001) of breast self examination practice (ie, group A and history of benign breast disease (p < 0-00 1). and group B) were compared to women who No association emerged between selfexamination reported no self examination. All OR estimates and either family history of breast cancer or were adjusted by age and/or education. marital status. The practice of self examination is Tests of statistical significance of differences classified in table II according to its frequency, between proportions were based on x2 values, quality, the combination ofthe two, and duration. 2010 Patients admitted to GIVIO hospitals and eligible for the study L 40 Physicians' positive preference for 63 Excluded for either one or different follow up regimens clinical reasons 23 Physicians' preferences for post surgical treatment different from those foreseen by the protocol 506 Excluded for ~ 15 Psychiatric problems http://jech.bmj.com/ non-clinical reasons 43 Patient's refusal 189 Participation to other trials 259 1441 Organisational problems Patients randomised in the trial of the effectiveness of follow up on September 27, 2021 by guest. Protected copyright. 40 Rlandomised in two hospitals that selectively iricluded only node negative patients 571niconsistency in clinical charts 25-prT and/or stage data unavailable A PIISE practice unknown 1315 Patients evaluable for Figure 1 Flow chart of patients' entry into the the BSE study study (GIVIO, 1989). BSE=breast self examination 114 GIVIO (Interdisciplinary Group for Cancer Care Evaluation) J Epidemiol Community Health: first published as 10.1136/jech.45.2.112 on 1 June 1991. Downloaded from Table I Total Some evidence of a "dose-response effect" Sociodemographic Yes No (o/o) emerged when we considered self examination characteristics of 1315 n (%) n (%) n breast cancer patients Agea practice according to frequency and quality of according to breast self (39 60 (12) 60 (7) 120 (9) performance (table IV). A statistically significant 40-59 334 (65) 458 (57) 792 (60) examination (BSE) trend that women practice (yes or no) ,60 117 (23) 286 (36) 403 (31) emerged, suggesting (GIVIO, 1991). Total 511 804 1315 performing the examination regularly and Educationb correctly (group A) experienced slightly greater (5 259 (52) 505 (65) 764 (58) benefit than women in group B. The OR estimates >6 240 (48) 267 (35) 507 (39) Not evaluable 12 32 44 (3) were statistically significant, indicating a 54% Total 499 772 1315 greater likelihood