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Diffusion of good practices of care and decline of the association with case volume: the example of breast conserving surgery
© Fedeli et al; licensee BioMed Central Ltd. 2007
Received: 16 April 2007
Accepted: 18 October 2007
Published: 18 October 2007
Several previous studies conducted on cancer registry data and hospital discharge records (HDR) have found an association between hospital volume and the recourse to breast conserving surgery (BCS) for breast cancer. The aim of the current study is to depict concurrent time trends in the recourse to BCS and its association with hospital volume.
Admissions of breast cancer patients for BCS or mastectomy in the period 2000–2004 were identified from the discharge database of the Veneto Region (Italy). The role of procedural volume (low < 50, medium 50–100, high > 100 breast cancer surgeries/year), and of individual risk factors obtainable from HDR was assessed through a hierarchical log-binomial regression.
Overall, the recourse to BCS was higher in medium (risk ratio = 1.12, 95% confidence interval 1.07–1.18) and high-volume (1.09, 1.03–1.14) compared to low-volume hospitals. The proportion of patients treated in low-volume hospitals dropped from 22% to 12%, with a concurrent increase in the activity of medium-volume providers. The increase over time in breast conservation (globally from 56% to 67%) was steeper in the categories of low- and medium-volume hospitals with respect to high caseload.
The growth in the recourse to BCS was accompanied by a decline of the association with hospital volume; larger centers probably acted as early adopters of breast conservation strategies that subsequently spread to smaller providers.
Breast conserving surgery (BCS) followed by radiotherapy to the residual breast tissue has been proved as an appropriate approach to the treatment of early-stage breast carcinoma since the early 1980s . Although a consensus on breast conservation has been reached since 1990 in the United States , mastectomy rates after the introduction of these recommendations have been higher than expected and unexplained by medical contraindication [3, 4].
Large centers are more likely to adopt innovative therapeutic modalities , and early studies from both Northern America and Europe showed a significant association between the surgical approach to breast cancer and hospital bed size or procedural volume (yearly number of breast cancer surgeries) [5–8]. More recent investigations conducted on data from cancer registries or hospital discharge records (HDR) continue to detect this pattern. For example, BCS was more frequently performed in high-volume hospitals in Los Angeles County and New York City in the period 1990–1998 [9, 10], as well as in an analysis of thirteen years (1988–2000) of the US Nationwide Inpatient Samples . Moreover, the finding of a significant association between the recourse to BCS and hospital volume has been replicated in analyses of HDR from some Italian regions [12–15].
In the Veneto Region located in northeastern Italy, breast cancer is a major public health problem, as the crude rate was 167 per 100,000 individuals in the period 1998–2001, with an estimated 1.96% annual percent increase in incidence from 1987 to 2001 . The aim of the present study is to examine HDR and assess time trends in the recourse to BCS in Veneto, as well as to investigate concomitant changes in the role -if any- played by hospital volume.
The total population of the Veneto Region was 4,699,950 on December 31, 2004 (ISTAT-National Institute of Statistics). There were approximately 950,000 discharges from Veneto hospitals each year; one primary and up to 5 secondary discharge diagnoses and one primary and up to 5 secondary procedures were registered in HDR.
All discharges of residents from Veneto hospitals with the International Classification of Diseases, 9th Revision-Clinical Modification (ICD9-CM) code 174 (cancer of the female breast) in all diagnostic categories, were identified for the period January 1, 2000 to December 31, 2004. Among these, admissions with BCS (ICD9-CM procedure codes 85.21–85.23) and mastectomy (85.41–85.48) were selected; patients who had already previous breast surgery in 1999 were excluded. In the case of repeated admissions for breast surgery in the years 2000–2004, only the first admission was considered. Lastly, we also included surgical biopsies (ICD9-CM procedure code 85.12) as BCS when no other breast surgery was performed in the study period, assuming that the biopsy resulted in complete excision of early breast cancer. A parallel analysis was also conducted examining the less conservative surgery identified in 2000–2004 among repeated admissions for breast surgery.
A hierarchical log binomial regression was applied in order to assess the influence of the above variables on the recourse to BCS while taking into account clustering of patients within providers. Since BCS is a common event, odds ratios estimated through conventional logistic regression depart from risk ratios (RR) of breast conservation. We therefore applied a model that directly estimates the RR . The analysis was performed through the gllamm procedure of the package Stata 8 by assuming a binomial distribution and a log link function. To investigate time changes in the association of breast conservation with hospital caseload, an additional analysis was conducted including, as well as age, severity and comorbidity, a dichotomized variable for volume of activity (large versus medium and small hospitals), a linear term for the calendar year, and an interaction term between the latter two variables.
Overall, 18,584 HDR with a diagnosis of female breast cancer had BCS or mastectomy procedure codes in the five years examined. Of the above records, 1,391 repeated admissions (7.5% of the hospitalizations for breast surgery) and 152 patients with breast surgery in 1999 (0.8%) were excluded; it is worth noting that 77.6% of the 1,391 repeated admissions occurred within 90 days from the first surgery. Lastly, 1,603 surgical biopsies with no other surgery recorded through the study period were added to the dataset, resulting in a total of 18,644 records (representing unique patients) submitted to statistical analyses.
The distribution of patients' age was unbalanced between hospitals groups: patients ≥70 years represented 40% of those treated in low-volume hospitals, while constituting only 33% and 25% in medium- and high-volume hospitals, respectively; only minor differences were evident for presence of comorbidities and stage of disease.
Discharges with breast surgery (n), percentage of breast conserving surgery (BCS), Risk Ratios for BCS (RR) with 95% Confidence Intervals (CI) estimated by hierarchical log binomial regression.
1.02 – 1.07
0.98 – 1.04
0.69 – 0.75
Severity of disease
0.69 – 0.77
0.85 – 0.96
1.07 – 1.18
1.03 – 1.14
1.01 – 1.08
1.03 – 1.11
1.09 – 1.17
1.11 – 1.19
Annual proportion of women treated by low (<50 surgeries), medium (50–100), and high volume hospitals (>100), and corresponding percentage of breast conservation (BCS%)
Proportion of women treated
Number of centers performing breast cancer surgery at the beginning and the end of the study period, and presence of a radiation therapy capability according to hospital volume
availability of radiation therapy (2004)
The age-severity-comorbidity adjusted RR for BCS (with 95% Confidence Interval) was 1.12 (1.09–1.14) for large versus small and medium institutions, 1.06 (1.05–1.07) for the linear trend through calendar years, and 0.98 (0.97–0.99) for the interaction term. This latter result confirms that the influence of hospital caseload diminishes over time.
The extent to which surgical treatments are adopted by clinicians must be assessed on a population basis, since studies on clinical or physician-based data are often flawed by bias due to referral patterns or patient selection . Cancer registries can accurately identify cancer cases providing additional information on stage and histology, although the delay in data availability and the coverage of restricted geographical area generally do not allow a timely capture of variability in patterns of care at a regional level. Because all types of breast surgery (including BCS) are performed in hospital settings and not in ambulatory care in Italy, the regional discharge database, which collects data from both public and private structures, ensures a complete coverage and allows proper evaluations of time-trends. The major drawback of this database is that it contains limited data on the stage of disease and comorbidity; improvement of accuracy and completeness of HDR may allow a better evaluation of appropriateness of surgical treatments . As a consequence, the increase in breast conservation may be due both to changing attitudes of patients and clinicians and to the diffusion of screening programs with an increased detection of early-stage cancers. However, this does not hamper the main finding of the present study that the decline of volume-associated differences between structures parallels the growing recourse to breast conservation.
A collaborative study of European tumor registries demonstrated that from 1990 to 1991 only 30.6% of breast cancer patients were treated conservatively in Italy, a proportion far lower than in Northern Europe. Out of the Italian registries, the lowest percentage was reported from Southern Italy . Since the early nineties, the recourse to BCS in some Italian regions was investigated by means of HDR. Overall, these studies were consistent in observing a greater proportion of BCS among younger women, with lower severity of disease, and in those treated in higher-volume hospitals [12–15]; more recent studies reported higher BCS rates than earlier papers, suggesting an increase in breast conservation over time in Italy. The first investigation was performed in the Lombardia Region on 1990–1991 discharges with a rate of breast conservation equal to 43% ; a study on 1997 HDR in the Latio Region found 52% conservative procedures ; lastly, the BCS reached 67% of total breast cancer surgeries in the Piedmont Region in 2000–2002 .
As well as age, stage of disease, and hospital case volume, other factors both at the patient and at the provider level have been reported to influence the choice of breast cancer treatment including socioeconomic status , proximity of residence to radiation therapy facilities , detection of the malignancy through screening programs , academic affiliation and breast surgery experience of individual physicians .
Hospital volume is usually defined as the average number of a specific type of surgery in a given hospital over a variable span of years . Our data show two possible intricacies with this approach: variation of hospital volume by calendar year, and time trends in the role played by hospital volume. Modern health care systems are characterized by rapid changes in the profile of providers including structures stop, transfer or begin activity, or sharply modify their activity over time (usually, but not necessarily, with an increase in volume – see Figure 1).
An investigation comparing treatment of early breast carcinoma before and after the introduction of clinical practice guidelines in Australia found an increased proportion of patients undergoing BCS; the analysis by surgeon's caseload showed an increase over time across all classes of activity level except for the least active surgeons . Surgeon's volume is not obtainable from HDR, but is only one facet of the complex association between pattern of care and hospital volume. In our database it was difficult to disentangle separate effects of case-volume, presence of radiation therapy facilities, academic affiliation. Centers with higher volumes may also have a greater capacity to disseminate information on new clinical practices and to assure better access to postoperative therapy.
The present study delineates an evolving scenario in the Veneto Region, with two coexisting trends: the decline in the proportion of breast cancer patients treated in low-volume hospitals, and the diffusion of breast conserving practices. Larger centers can act as early adopters of new therapeutic strategies and subsequently spread these strategies to other providers, a pattern consistent with the diffusion of innovation theory .
The work of Ugo Fedeli was partially supported by Master of Epidemiology, University of Turin.
- Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, Gallus G, Greco M, Luini A, Marubini E, Muscolino G, Rilke F, Salvadori B, Zecchini A, Zucali R: Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981, 305: 6-11.View ArticlePubMedGoogle Scholar
- NIH Consensus Conference: Treatment of early-stage breast cancer. JAMA. 1991, 265: 391-395. 10.1001/jama.265.3.391.View ArticleGoogle Scholar
- Morrow M, Bucci C, Rademaker A: Medical contraindications are not a major factor in the underutilization of breast conserving therapy. J Am Coll Surg. 1998, 186: 269-274. 10.1016/S1072-7515(97)00153-1.View ArticlePubMedGoogle Scholar
- Lazovich D, Solomon CC, Thomas DB, Moe RE, White E: Breast conservation therapy in the United States following the 1990 National Institutes of Health Consensus Development Conference on the treatment of patients with early stage invasive breast carcinoma. Cancer. 1999, 86: 628-637. 10.1002/(SICI)1097-0142(19990815)86:4<628::AID-CNCR11>3.0.CO;2-L.View ArticlePubMedGoogle Scholar
- Hebert-Croteau N, Brisson J, Latreille J, Blanchette C, Deschenes L: Variations in the treatment of early-stage breast cancer in Quebec between 1988 and 1994. CMAJ. 1999, 161: 951-955.PubMedPubMed CentralGoogle Scholar
- Grilli R, Mainini F, Penna A, Bertolini G, Scopiglione N, Torri V, Liberati A: Inappropriate Halsted mastectomy and patient volume in Italian hospitals. Am J Public Health. 1993, 83: 1762-1764.View ArticlePubMedPubMed CentralGoogle Scholar
- Kotwall CA, Covington DL, Rutledge R, Churchill MP, Meyer AA: Patient, hospital and surgeon factors associated with breast conservation surgery. A statewide analysis in North Carolina. Ann Surg. 1996, 224: 419-426. 10.1097/00000658-199610000-00001.View ArticlePubMedPubMed CentralGoogle Scholar
- Nattinger AB, Gottlieb MS, Hoffman RG, Walker AP, Goodwin JS: Minimal increase in use of breast-conserving surgery from 1986 to 1990. Med Care. 1996, 34: 479-489. 10.1097/00005650-199605000-00009.View ArticlePubMedGoogle Scholar
- Hiotis K, Ye W, Sposto R, Goldberg J, Mukhi V, Skinner K: The importance of location in determining breast conservation rates. Am J Surg. 2005, 190: 18-22. 10.1016/j.amjsurg.2004.12.002.View ArticlePubMedGoogle Scholar
- Hiotis K, Ye W, Sposto R, Skinner KA: Predictors of breast conservation therapy: size is not all that matters. Cancer. 2005, 103: 892-899. 10.1002/cncr.20853.View ArticlePubMedGoogle Scholar
- Guller U, Safford S, Pietrobon R, Heberer M, Oertli D, Jain NB: High hospital volume is associated with better outcomes for breast cancer surgery: analysis of 233,247 patients. World J Surg. 2005, 29: 994-999. 10.1007/s00268-005-7831-z.View ArticlePubMedGoogle Scholar
- Grilli R, Repetto F: Variation in use of breast-conserving surgery in Lombardia, Italy. Int J Technol Assess Health Care. 1995, 11: 733-740.View ArticlePubMedGoogle Scholar
- Schifano P, Scarinci M, Borgia P, Perucci CA: Analysis of the recourse to conservative surgery in the treatment of breast tumours. Tumori. 2002, 88: 131-136.PubMedGoogle Scholar
- Rosato R, Baldi I, Bona C, Bordon R, Di Cuonzo D, Pagano E, Ponti A, Sacerdote C, Segnan N, Vineis P, Ciccone G: L'assistenza alle pazienti affette dal carcinoma della mammella in Piemonte: un sistema di indicatori per la valutazione della qualità sulla base dei dati correnti. Proceedings of the XXVIII Annual meeting of the Italian Epidemiological Association, 15–17 settembre. 2004, , TorinoGoogle Scholar
- Russo A, Autelitano M, Bellini A, Ghilardi S, Giubelli C, Bovini A, Filipazzi L, Cervasio E, Bisanti L: Determinanti dell'accesso alla chirurgia conservativa per carcinoma mammario. Proceedings of the XXVIII Annual meeting of the Italian Epidemiological Association, 15–17 settembre. 2004, , TorinoGoogle Scholar
- Veneto Tumour Registry: I tumori nel Veneto. Trend temporali. [http://www.registrotumoriveneto.it/registro/trend/trend_f.pdf]
- Gonnella JS, Louis DZ, Gozum ME, Eds: Clinical Criteria for Disease Staging. 1994, Ann Arbor: The MEDSTAT Group, 4Google Scholar
- National Cancer Institute: SEER-Medicare: Calculation of Comorbidity Weights. [http://healthservices.cancer.gov/seermedicare/program/comorbidity.html]
- Pagano E, Ponti A, Gelormino E, Merletti F, Mano MP: An economic evaluation of the optimal workload in treating surgical patients in a breast unit. Eur J Cancer. 2003, 39: 748-754. 10.1016/S0959-8049(02)00808-0.View ArticlePubMedGoogle Scholar
- Barros AJ, Hirakata VN: Alternatives for logistic regression in cross-sectional studies: an empirical comparison of models that directly estimate the prevalence ratio. BMC Med Res Methodol. 2003, 20: 21-10.1186/1471-2288-3-21.View ArticleGoogle Scholar
- Wingo PA, Guest JL, McGinnis L, Miller DS, Rodriguez C, Cardinez CJ, Morrow B, Thun MJ: Patterns of inpatient surgeries for the top four cancers in the United States, National Hospital Discharge Survey, 1988–95. Cancer Causes Control. 2000, 11: 497-512. 10.1023/A:1008944209648.View ArticlePubMedGoogle Scholar
- Schifano P, Papini P, Agabiti N, Scarinci M, Borgia P, Perucci CA: Indicators of breast cancer severity and appropriateness of surgery based on hospital administrative data in the Lazio Region, Italy. BMC Public Health. 2006, 6: 25-10.1186/1471-2458-6-25.View ArticlePubMedPubMed CentralGoogle Scholar
- Sant M, Eurocare Working Group: Differences in stage and therapy for breast cancer across Europe. Int J Cancer. 2001, 93: 894-901. 10.1002/ijc.1408.View ArticlePubMedGoogle Scholar
- Celaya MO, Rees JR, Gibson JJ, Riddle BL, Greenberg ER: Travel distance and season of diagnosis affect treatment choices for women with early-stage breast cancer in a predominantly rural population (United States). Cancer Causes Control. 2006, 17: 851-856. 10.1007/s10552-006-0025-7.View ArticlePubMedGoogle Scholar
- Zorzi M, Puliti D, Vettorazzi M, De Lisi V, Falcini F, Federico M, Ferretti S, Moffa IF, Mangone L, Mano MP, Naldoni C, Ponti A, Traina A, Tumino R, Paci E, IMPACT Working Group: Mastectomy rates are decreasing in the era of service screening: a population-based study in Italy (1997–2001). Br J Cancer. 2006, 95: 1265-1268. 10.1038/sj.bjc.6603405.View ArticlePubMedPubMed CentralGoogle Scholar
- Chagpar AB, Studts JL, Scoggins CR, Martin RC, Carlson DJ, Laidley AL, El-Eid SE, McGlothin TQ, Noyes RD, McMasters KM: Factors associated with surgical options for breast carcinoma. Cancer. 2006, 106: 1462-1466. 10.1002/cncr.21728.View ArticlePubMedGoogle Scholar
- White V, Pruden M, Giles G, Collins J, Jamrozik K, Inglis G, Boyages J, Hill D: The management of early breast carcinoma before and after the introduction of clinical practice guidelines. Cancer. 2004, 101: 476-485. 10.1002/cncr.20401.View ArticlePubMedGoogle Scholar
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/7/167/prepub
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