Annals of the Royal College of Surgeons of (1991) vol. 73, 364-372

Breast cancer data collection for surgical audit

W G A Woods DM Senior Surgical Registrar

R J Earlam MChir Consultant Surgeon The Royal Hospital, Whitechapel, London

Key words: Breast; Carcinoma; Audit; Survival

Data are available about the mortality, the incidence, the breast cancer. A huge body of information exists about the stage, the survival, and the treatment of breast cancer. In disease which should form a valuable database. The poor this country mortality data are published by the OPCS and quality of this information reduces its usefulness. It is the HIPE and evidence exists to show that there is a consider- responsibility of doctors to agree on a data set and to ensure able shortfall in both these sources. The incidence of breast its collection. They do it in Scandinavia. cancer is recorded by the Regional Cancer Registries and published by OPCS. The registries supply OPCS with a minimum data set which does not include the stage of the disease, which is important, and does include the quadrant, In England and Wales, carcinoma of the breast is the which is not. Audit shows marked regional variations in commonest malignant tumour in women, the commonest completeness of registration. International comparisons with cause of cancer death in women, and the commonest Scandinavia are unfavourable and show what can be cause of all death in women between the ages of 30 and 59 achieved. years. In this article the sources of epidemiological data Patients who develop breast cancer but do not die from it for the disease and their accuracy are reviewed, deficien- may be cured. The discrepancy between incidence and mortality, which varies both geographically and historically, cies in data collection identified, ana! the implications for should therefore provide a valuable insight into changing surgical practice discussed. survival, but does not do so because the data are unreliable. Wide variations in survival figures in the medical literature are probably due to variations in staging conventions rather than different treatments. It is clear that r ;r stages carry a Mortality—England and Wales more favourable prognosis, but it <;rU cannot be proved that earlier diagnosis in a particular individual prolongs the life of Figures published by the Registrar General (1) and the that individual. This unproven hypothesis is the rationale for Office of Population Censuses and Surveys (OPCS) (2) mammographic screening. show a steady rise in the number of deaths from breast Data on treatment in hospitals do not link diagnosis to cancer (Fig. 1). This is due to an increase in the operation, so that it is impossible to separate operations for population, a change in the age profile of that population, benign breast disease from those for cancer. The OPCS and also a true increase as shown by the age-specific classification of operations is complex with many open- ended choices. Doctors do not participate in the coding mortality rates. The latest available figures record 13 723 process and clerks cannot make up for this. Radiotherapy women having died of the disease in 1988. and chemotherapy data are not collected nationally and the four regional registries who do collect it also rely on their clerks' interpretation of medical notes. Data on the use of Comment tamoxifen are consistent and of high quality. An extensive data gathering mechanism is in place for The mortality statistics for England and Wales derive from information on death certificates (3). There are four diagnostic categories which may be completed on a death Correspondence to: Mr R J Earlam, The Royal London certificate. Category la is the 'disease or condition Hospital, Whitechapel, London El IBB directly leading to death'. Ib is 'other disease or con- Breast cancer data collection for surgical audit 365 dition, if any, leading to la'. Ic is denned as 'other disease Comment or condition leading to Ib\ Finally, category II is 'other significant conditions contributing to the death but not 'All patients diagnosed as suffering from cancer in related to the disease or condition causing it'. However, England and Wales have been, or should have been, information from only one of these appears in the official registered with a cancer registry. This system has statistics and 'where more than one cause of death is covered the whole of England and Wales since 1962' (9). mentioned on the medical certificate the choice of the Regional Cancer Registries have to collect a minimum assigned cause is in accordance with international pro- data set required by the OPCS. In practice they collect cedure . . .' (2,3). Because there are cases in which breast much more information, which they then make available carcinoma contributes to death but is not the sole cause in the form of regular reports or in response to individual thereof the figures underestimate breast cancer-related enquiries. Of the 12 registries in England and Wales, 10 sent us copies of their registration forms. All 10 obtain mortality. Errors of diagnosis in death certification are common histological confirmation of the diagnosis and details of and have been quantified in the following studies. Of 191 the subject's occupation. All the registries record certificates reviewed in 1978, 21% contained major dis- patients' deaths and most receive notification of deaths from OPCS for every patient with a mention of cancer on crepancies between the cause of death on the certificate and the cause as derived from the hospital notes, consul- the death certificate as well as deaths from any cause for tant's opinion, and autopsy findings (4). In a further 29% those patients already registered. Of the 10 registries, six there was 'a 'minor but epidemiologically important record full death certificate details (Sections la, b, c and II) but only two have any more detailed follow-up. difference'. A more detailed analysis revealed that only The figures for England and Wales are classified 51% of certificates were in agreement with post-mortem according to the International Classification of Disease findings (5). A total of 148 deaths were certified as due to (9th revision) (10). This subdivides carcinoma of the breast cancer; in 12 cases this was an error, while in a female breast (174) according to one of nine possible further 21 cases the diagnosis of breast cancer had been anatomical sites. In 1983, 24% of registered breast overlooked, thus giving an overall error rate of 21%. cancers were classified by site (nipple and areola 1%, Brinkley el al. (6) reviewed the death certification of 193 central portion 2%, upper inner quadrant 4%, lower patients registered with breast cancer and found six (3%) inner quadrant 2%, upper outer quadrant 12%, lower who had died of breast cancer but were certified as outer quadrant 2%, or axillary tail 1%); 3% were classi- having died of another cause. They also found a 24% fied as 'other' (174.8) and 74% as 'breast unclassified' error rate in the completion of Part II of the certificate. (174.9) (9). There is evidence that the site of a breast The number of patients dying in hospital from breast cancer has no bearing on survival (11), but there can be cancer can be calculated from OPCS data. Comparison of no reliable information on this subject from centrally these figures with those from Hospital Activity Analysis collected data when the majority are unclassified. (HAA) published as the Hospital Inpatient Enquiry Two British registries have assessed the completeness (HIPE) show a consistent shortfall of between 35% and of registration. A total of 203 breast cancer cases were 40% in the HAA data for the years 1982-1985 (7). This registered out of 233 patients treated in the Southampton figure represents about 2500 unrecorded deaths each district in 1985, representing an 87% registration year. The report of the Confidential Enquiry into (personal communication, Wessex Cancer Intelligence Perioperative Deaths found similar deficiencies in HAA Unit). The Oxford-FPA contraceptive study found an mortality data (8). Death certificates cannot be accepted as an accurate source of epidemiological data, but the mortality statis- tics derived from them are the best we have.

Thousands

Incidence—England and Wales

Universal cancer registration is the responsibility of the regional cancer registries (1). Crude incidence figures have shown a progressive increase over the last 22 years (Fig. 1) (1,9). The Standardised Registration Ratio (SRR), which allows for changes in the age profile of the population, rose steadily between 1961 and 1975 reflect- ing a rise in the incidence of breast cancer not accounted for by an increase in the proportion of elderly people in the population. Between 1975 and 1983 the crude inci- 1965 1970 1975 1980 Year dence and the SRR have changed little. The registered incidence of breast cancer in 1984 in England and Wales Figure 1, Incidence and mortality figures for breast cancer in was 21 363. women in England and Wales (1,2,9). 366 W G A Woods and R J Earlam overall 87% registration rate for all cancers, although the 35%. In Sweden the discrepancy between the incidence rate for breast cancer was 92% (12). Of the unregistered and subsequent mortality from the disease has risen from cancers, 18% had been treated in private hospitals and 50% in 1960 to 64% in 1982-1984 (16). If these data are there were variations in under-registration between reliable, patients with breast cancer in Sweden now have different regional registries. A comparison of the ratio of a two out of three chance of surviving compared with a cancer registrations to total deaths from cancer showed a one in two chance 30 years ago, and a one in three chance wide variation between regions from 1.89 in Wales to in England and Wales in the 1980s. However, in view of 0.9t in NE Thames in 1981 (9). If the accuracy of death inconsistencies and inaccuracies in data collection high- registration and the efficacy of treatment are assumed to lighted above this interpretation is suspect. be the same, then this wide variation reflects a twofold difference in the completeness of cancer registration Comment between these two regions. In Sweden a 4% under-registration of cancer (13) is There is undoubtedly a percentage of patients with breast now thought to be less than 1% (14). Both clinicians and cancer who do not die from the disease. This percentage pathologists in Sweden are required to send separate varies historically and geographically. Several factors reports of each cancer so that 95% of cases now have may account for this variation, (1) staging at presen- reports from both. A similar system operates in Norway, tation, which may have changed over the years and varies where 98% of registered breast cancer patients also had between countries, (2) treatment, whether by surgery, pathological reports of their axillary node status available radiotherapy, chemotherapy or other adjuvant therapy, (IS). and (3) variations in practice and accuracy in the report- Registration of cancer patients in the United Kingdom ing of cause of death and the diagnosis and registration of underestimates the incidence by 5-10%. No staging is the disease. The epidemiological data concerning staging collected routinely and information on the anatomical and treatment will be examined. If the discrepancy site is incomplete and useless. between incidence and survival does indeed represent a proportion of patients who are cured then factors asso- ciated with a change in this proportion would be of great Discrepancy between incidence and importance. Unfortunately, as has been shown, the mortality registration of breast cancer and the diagnosis of cause of death is variable and inaccurate. A total of 21 000 patients were registered with breast cancer in England and Wales in 1981. Four years later (the median survival) 13 000 died of the disease. The Staging at presentation (Table I) remaining 8000 might represent 35% who have been cured. There is evidence that this is an overestimate due There are no centrally collected data on staging at to errors in death certification (4%) and failure to include presentation. Only four of the ten cancer registries who those patients with symptomatic breast cancer at the time replied to our enquiries collected such data and they had of their death from another cause (15%) (6). The true to extract it from the medical notes. The discrepancy for England and Wales must be less than registry had sufficient information for TNM staging in

Table I. Staging at presentation—percentages

Stage

Author Years II III IV Comment

Bloom et al. (19) 1805-1933 0 2 53 74 Untreated patients McWhirter (20) 1941-47 31 26 13 30 Donegan and Lewis (21) 1940-65 41 31 17 12* *'Undisseminated cases only' Rutqvist et al. (22) 1953-67 46 36 7 15 Mueller et al. (23) 1956-75 51 40 8 No 'locally advanced' category Ferguson et al. (24) 1945-78 39 38 2 0 Operable cases only 17 51 14 18 Same patients restaged according to AJC 1977 convention Haybittle (25) 1947-50 27 25 31 18 1960-71 36 21 31 12 Chu et al. (26) 1963-72 49 34 12 6 HIP control patients 56 32 6 5 HIP screened patients Andersson et al. (27) 1976-86 48 39 6 7 Malmo control patients 67 25 4 4 Malmo screened patients 29 39 14 19 j. T on-atten^ers ior screening Breast cancer data collection for surgical audit 367 only 16% of registered patients (17). There is no worth- An estimate from the available studies (Table I) while epidemiological staging data available in the UK. suggests that in the USA and Scandinavia the staging at Published staging data in the medical literature have a presentation is 45% stage I, 35% stage II, 10% stage III, population bias according to the practice of the author and 10% stage IV. An estimate for the UK figures is 30% whether surgeon, radiotherapist, or oncologist. The best stage I, 30% stage II, 20% stage III, and 20% stage IV. It selection of publications is shown in Table I (19-27). may well be that differences in attitudes to disease and The wide range of percentages for the different stages health education explain these differences (17). In a makes it difficult to estimate the true figures. The data of screened population it is possible to attain figures of 60% McWhirter (20) Rutqvist el al. (22) and Haybittle (25) stage I, 30% stage II, 5% stage III and 5% stage IV. are derived from unselected populations and the control These facts alone may explain why cancer mortality in data from screening programmes (26,27) are probably the UK is the highest in the world, despite the fact that the best available. we do not have the highest incidence in the world. There Part of the problem lies with the staging methodology. is no evidence that our treatment is inferior. On the other Two of the original systems, the Manchester Classifica- hand, with such inaccurate data to argue from and the tion (28) and the Columbia Clinical Classification (29), possibility that screening per se increases the incidence of divided the disease into four stages on the basis of clinical diagnosed breast cancer this is impossible to prove. findings, with node negative, node positive, locally advanced and metastatic stages. The TNM system was originally clinically based (30) until pathological lymph Staging and survival (Table II) node staging was added in 1977. There have been several modifications by the Union International Centre le OPCS figures suggest a recent improvement in crude and Cancer (UICC) and the American Joint Commission on relative survival from breast cancer (9) (Table II). Cases Cancer (AJCC). As a resulr, series staged by different registered in 1975 have better survival than those regis- versions of the same system are not comparable (24). The tered between 1964 and 1966, who in turn fared better most recent version (31) has some 26 different TNM than those registered in 1959. This improvement may stages with four major groupings akin to the Manchester have been due to an earlier stage at presentation or better and Columbia systems. It is ideally suited for clinical treatment. OPCS does not collect staging data and until trials but has been shown to be unworkable in population the use of tamoxifen and adjuvant chemotherapy (32) studies (17). However, the most important factors are there was no evidence that any treatment conferred a whether or not the axillary nodes are involved and survival benefit over any other, so it seems unlikely that whether or not metastases are present. The collection of improved treatment resulted in improved survival. this data should be relatively simple for clinicians and Given the limitations of our staging data, only an pathologists. estimate of survival by stage can be made from the best

Table II. Survival by stage at presentation—percentages

Stage

Author Year II III IV Comment

McWhirter (20) 5 58 30 4 Stages I and II together 10 39 15 0 Donegan and Lewis (21) 5 77 57 52 22 Radical mastectomy patients only 10 70 43 30 7 Stage IV 'undisseminated cases only' Ferguson el al. (24) 10 63 51 18 — Operable cases only 10 75 55 37 18 Same patients restaged by AJC 1966 convention Chu el al. (26) 18 77 29 7 0 HIP control patients 18 78 39 8 0 HIP screened patients Thames Registry 5 75 61 39 14 (Personal communication) 10 62 44 29 8 Yorkshire Registry (17) 5 91 69 47 12 16% of cases registered were staged • 10 66 49 40 12 East Anglia Registry (33) 5 70-85 58-63 26-41 7-11 Figures are the ranges for 1976-82 patients OPCS (9) All stages 1959 5 yr relative survival 42 All stages 1959 10 yr relative survival 32 All stages 1959 15 yr relative survival 28 All stages 1964-6 5 yr relative survival 5 1 All stages 1975 5 yr relative survival 57 368 W G A Woods and R J Earlam

percent survival 100 (HIPE) (7). About 50 000 'mastectomies' (condensed operation code 036) were recorded in 1985, a year in which some 21 000 patients were registered with breast 80 - stage I cancer. There were 270 radical mastectomies and 80 extended radical mastectomies. i staae i mI ' 60 - stage II j In the 3rd edition of the OPCS classification of operations, there are five possible codes for breast cancer ft 9 ^ operations, one of which is open-ended (34) (Table III). 40- stage 11 stage III I ' ' A total of 19% of cases were coded using the open-ended j v 71 6 stage III and clinically meaningless code 382, 'mastectomy not 20- elsewhere classified (NEC)'. The condensed code 036 is I ') stage IV * } misleading because, although called 'mastectomy', it 4 stage IV includes all cases recorded under codes 381 to 385. In 0- 5 years 10 years 1985, 74% of these were 'partial mastectomy' (381) which Figure 2. Percentage survival by stage for cancer of the female includes all operations less than mastectomy but not breast at 5 and 10 years from diagnosis. Data from refs recorded as 387 (biopsy of breast). Many of these (17,20,21,24,26,33) and the Thames Registry. operations are for benign disease, which accounts for there being more than twice as many 'mastectomies' (036) as registered breast cancers that year. available data (17,20,21,24,26,33) (Table II), This is Up to 30% of operations carried out fail to appear in shown graphically in Fig, 2. Five-year survival is 80% for the HAA statistics (35). These errors arise because of stage I, 60% for stage II, 40% for stage III, and less than poor record keeping by doctors (36) and clerical errors 20% for stage IV. The 10-year survival figures for each (37,38). In 1983 a postal survey of the breast cancer stage are approximately 10% less than the 5-year rates. practice of 766 British consultant surgeons was carried For reasons explained above, inferences about survival out (39). Seven out of ten replied and indicated that they derived from the discrepancy between incidence and saw some 17 000 new cases of breast cancer each year, mortality are suspect. Survival figures are the best way of suggesting that there might have been about 24 000 if all measuring survival and there is some evidence that this surgeons had replied. This compares with 21 297 regis- has improved. It seems common sense that if patients trations that year (9). Of these patients, 70% underwent with early stages of breast cancer survive longer than mastectomy rather than a more limited excision, which those with late stages then earlier diagnosis will improve represents a minimum of 11 900 (70% of 17 000) or a prognosis. Although this has not been proved, it is the maximum of 14 900 (70% of 21 297) mastectomies. HAA rationale for screening programmes. figures for that year recorded 10 860 mastectomies, a shortfall of between 8% and 27%. HAA data are not only of poor quality but also incomplete. Treatment Only six of the 10 regional registries who answered our enquiries record any details of the treatment of registered Operations (Fig. 3.) cases. Four record the type of operation carried out. Registry clerks rely on information which can be Hospital Activity Analysis (HAA) data used to be extracted from medical notes, but in only 40% operated obtained for all operations and a 10% sample was upon between 1964 and 1980 was the type of breast published yearly as the Hospital Inpatient Enquiry operation clear from the notes available (personal com- munication, Thames Cancer Registry). The cancer regis-

HAA 10% sample tries try their best but they are not helped by doctors. 3000 In an attempt to improve the data on surgical opera- tions that will be collected under the Korner system, a new edition of the OPCS classification of operations was published in 1988 (40). There are 18 possible breast 2000- operations of which six are open-ended (eg 'other exci- 1500 sion of breast—unspecified') in addition to 20 possible plastic surgery procedures (Table III). It is extremely

1000 unlikely that any more accurate data collection will arise from this new coding system. Such a complex nomencla- ture with so many non-specific and open-ended choices Invites the use of the non-specific options by overworked or confused doctors and clerical staff. In Table III, six 1979 1980 1981 1982 1983 1984 1985 year possible 'mastectomies' without alternatives are offered as a 'concise coding system'. All the conventionally used Figure 3. Hospital Activity Analysis data for breast operations operations are included and the loss of detail is more than from 1979 to 1985. compensated for by omitting meaningless open-ended Breast cancer data collection for surgical audit 369 codes. Similarly, there are only four ways of dealing with therapy alone with an increase in other multimodality the axillary lymph nodes—biopsy, sample, block dissec- treatments. This probably represents the increased use of tion, or performed as part of a simple, Patey or radical tamoxifen and adjuvant chemotherapy. mastectomy. Histology of the axillary nodes should always be obtained and should be in the original notes, although not coded with the Korner data. Tamoxifen (Fig. 5) The number of prescriptions for and the volume of sales of tamoxifen have increased exponentially. These data Radiotherapy and chemotherapy (Fig. 4) are made available by the Department of Health and Data on the use of radiotherapy are not collected nation- International Medical Statistics Ltd and data from the ally. Only four of the cancer registries collect radiother- two sources are in close agreement. Only three of the apy data and the figures for the Thames Cancer Registry regional registries collect data on tamoxifen or chemo- may not be representative of the rest of England and therapy. The figures suggest that between 25 000 (if Wales. The data suggest a trend away from single all were taking 40 mg a day) and 50 000 patients (if all modality treatment and surgery combined with radio- were taking 20 mg a day) are being treated with the drug.

Table 777.,,-OPCS classification of operations, 4th edition, with corresponding codes from the suggested concise coding system and the OPCS, 3rd edition

OPCS classification (4th edition) Concise coding OPCS classification (3rd edition)

B27 Total excision of breast 036 All mastectomies—shortened code B27.1 Total mastectomy and excision of both pectoral 385 Extended radical mastectomy muscles and part of chest wall B27.2 Total mastectomy and excision of both pectoral Mastectomy, radical, Halstead 384 Radical mastectomy muscles NEC B27.3 Total mastectomy and excision of pectoralis minor Mastectomy, Patey 383 Extended simple mastectomy muscle B27.4 Total mastectomy NEC Mastectomy, simple B27.5 Subcutaneous mastectomy Mastectomy, subcutaneous B27.8 Other specified B27.9 Unspecified (includes mastectomy NEC) 382 Mastectomy not elsewhere classified B28 Other excision of breast B28.1 Quadrantectomy of breast B28.2 Partial excision of breast NEC Mastectomy, sector 381 Partial mastectomy (includes wedge excision NEC) B28.3 Excision of lesion of breast (includes lumpectomy) Mastectomy, lumpectomy B28.8 Other specified B28.9 Unspecified B32 Biopsy of breast B32.1 Percutaneous biopsy of lesion of breast Percutaneous biopsy of breast 380 Incision of breast B32.2 Biopsy of lesion of breast NEC B32.8 Other specified B32.9 Unspecified B33 Operations on nipple B33.2 Excision of nipple B33.3 Extirpation of lesion of nipple T87.3 Axillary lymph nodes, biopsy Axillary lymph nodes, biopsy T86.2 Axillary lymph nodes, sampling, high, low, or both Axillary lymph nodes, sampling T85.2 Axillary lymph nodes, block dissection Axillary lymph nodes, block dissection

NEC = Not elsewhere classified 370 W G A Woods and R J Earlam

percent turn be due either to improvements in treatment or earlier stage at presentation. Alternatively, the figures may be explained by regional and historical variation in the accuracy of collection of incidence and mortality data. These deficiencies have been reviewed above. The epidemiological data which might show an effect of treatment on mortality do not exist, but there is evidence of a trend to earlier staging at presentation (Table I) associated with an improvement in survival (Table II). Patients are presenting with earlier disease in Sweden (Table I). Similar improvements in survival relative to incidence have been recorded by the 1963 1983 Connecticut Tumor Registry (43). How have these improvements been achieved? Screening programmes Figure 4. Percentage of patients undergoing different primary using mammography have shown a higher proportion of treatments for cancer of the female breast in the South East and early stages at presentation. This effect is also seen in the South West Thames regions. unscreened control patients who probably benefit from the educative effect of a mass screening programme in prescriptions (thousands) 10 mg equivalents (millions) their community. However, much of the apparent : 70 improvement in prognosis predates mammographic screening, and this may well be due to increased public awareness of the importance of early presentation. Again inconsistencies and inadequacies in the data leave such interpretation open to question. Settlement of the contro- versy as to which is the best method for increasing the proportion of favourable stage cancers is beyond the scope of this article. It is clear from this study that the present data

1973 1975 1977 1979 1981 1983 1985 1987 collection system is inadequate because it is incomplete year and inaccurate. Clinicians and epidemiologists should -~ 10mg tabs (IMS) —**- 10mg tabs (DH) -£- prescriptions (DH) agree on a national data set. Acceptable levels of accuracy Figure S. Sales and dispensed prescriptions for tamoxifen. Data will only be attained if the diagnosis, operation, and from the Department of Health (DH) and Intercontinental complications are coded by the surgical staff. These data Medical Statistics Ltd (IMS). will be required anyway for surgical audit and must be coded according to the OPCS Classification of Surgical Operations and Procedures (40) and the International Discussion Classification of Disease (10). Staging for cancer regis- tration must be simplified. Three codes to indicate We have attempted to bring together epidemiological whether nodes were involved, not involved, or their data about breast cancer from different sources to give an status was unknown, and three codes giving the same overall picture of diagnosis, treatment, and survival. One information about metastases are suggested (44). of the authors has previously studied oesophageal cancer Independent data collection to audit registration is (41) and pancreatic cancer (42) in this way. Although needed. Computer-based in-house surgical audit is ideal these data may satisfy the epidemiologist they are lacking and can be cross-checked with hospital activity data. in two important areas which affect the prognosis of the Only when accurate data have been collected about individual patient: (1) the staging of the disease at breast cancer, its pathology, staging, treatment, and presentation and its effect on survival, and (2) the survival, can the question be answered as to which epidemiology of treatment and its effect on survival. In treatment is best. The information available at the this paper the available sources of these facts for cancer moment suggests that staging at presentation is the most of the breast have been examined and found to be important factor for long survival and that this is much incomplete. more important than treatment. It seems good sense to The discrepancy between incidence and mortality in aim for early diagnosis by whatever method this can be this disease, although not representing a cured popula- achieved, although firm evidence even for this is lacking. tion (6,18), may be used to make historical and geo- graphical comparisons of the fate of patients with breast We would like to thank the Cancer Registries who sent us cancer. The figure for England and Wales is 35% and has details of their data collection. The Thames Registry increased since 1961, but not greatly in the last 10 years Information Officer was particularly helpful. The Department (Fig. 1). In Sweden the discrepancy has risen from 50% of Health and Intercontinental Statistics Ltd supplied data on in 1960 to about 64% between 1982 and 1984 (21). This the prescription and sales of tamoxifen. may be explained by improved survival, which may in Breast cancer data collection for surgical audit 371

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