Indicators based on registers and administrative data for breast cancer: routine evaluation of oncologic care pathway can be implemented.

RATIONALE, AIMS AND OBJECTIVES: Assuring the best standards of care - in a sustainable way - in chronic diseases as breast cancer is nowadays an important challenge for any health system. The aim of this study was to present the methodology used to define a set of quality indicators, computable from administrative data for the pathway of care of breast cancer, and its application at a population level. METHOD: The cohort of 2007-2009 incident cases of breast cancer was identified through a network of six cancer registers in Northern Italy. Cases of sarcoma and lymphoma, patients with multiple primary cancers and those metastatic at diagnosis were excluded; 9614 women were retained for the analysis. For each indicator, the sub-cohort of women eligible for the diagnostic/therapeutic procedures was identified and calculations were performed through record linkage between the cohort and sources of health information. Data on potential available confounders or prognostic factors were also collected. RESULTS: For a few indicators, such as cyto-histological assessment before surgery (62%) and intensive follow-up (79%), deviation from recommendations was evident. Younger patients (≤50 years) more frequently needed a short term re-intervention, while older patients less frequently underwent reconstructive surgery and received palliative care. Several indicators had a great variability across hospitals. In some cases, this heterogeneity appeared to be related to the hospital size, with high-volume hospitals being more compliant to guidelines. CONCLUSION: It is possible to evaluate the quality of cancer care delivered in clinical practice in recent years, in order to implement interventions aimed to improve adherence to international standards of care.

[A set of indicators to monitor the adherence to the guidelines for the diagnosis and treatment of breast cancer]. / Indicatori per il monitoraggio dei percorsi diagnostico-terapeutici del tumore della mammella.

OBJECTIVES: to present a set of indicators developed from six Local Health Authorities of the Lombardy Region to monitor the diagnostic and therapeutic pathway of breast cancer patients, applied to 2007-2009 incident cases. DESIGN: retrospective cohort study. SETTING AND PARTICIPANTS: all subjects with primary breast cancer, incident in the period 2007-2009, and collected by cancer registries of Milano 1, Bergamo, Cremona, Milano, Milano 2 and Monza-Brianza (5,320,272 inhabitants) were included. MAIN OUTCOME MEASURES: through the use of combined current health databases (health registry, hospitalizations, outpatient, pharmaceutical prescription and specific database for anticancer drugs), for each incident case 34 different indicators have been developed to measure the appropriateness of the procedures provided for diagnosis, treatment (surgical and medical) and follow-up. For each indicator, we analyzed the relationship with age, stage, deprivation index, type of treatment, volume of the specific procedure of the hospital where primary surgery was performed. Estimates were adjusted using multilevel regression models. RESULTS: 12,988 incident cases, without metastatic diseases and other cancers, were included in the cohort: 62% were localized to the breast, 33% to the axillary lymph-nodes, 3% metastatic ab initio, and 2% with unknown stage. Deviations from the expected value of different magnitude depending on the type of indicator were observed: the most important differences were detected for the follow-up indicators. There was, in fact, an excess of several procedures in the first year of follow-up: 75% of the cases performed a dosage of a tumor marker, 67% an ecography or a CT scan or an MR, and 37% a bone scan. On the other hand, the access to neoadjuvant and adjuvant treatments in older women was far below the expected values. CONCLUSIONS: the study presents data derived from a large cohort of population cases; the set of indicators was validated by a board of oncologists. The use of indicators calculated by linking the cancer registries (that provide staging) and administrative databases allows the assessment of compliance to the guidelines for diagnosis and treatment of tumours. This experience shows that it is possible to develop a methodology, shared with clinicians, to define indicators that measure the distance between guidelines and current clinical practice in order to decrease variability, to limit inappropriateness, and to reduce unnecessary diagnostic tests for patients (and, consequently, hospitals organizational overload). In order to be sustainable and equitable, a health care system must be able to ensure implementation of protocols/procedures based exclusively on the best available scientific evidences.

[«Bridge Coding¼ ICD-9, ICD-10 and effects on mortality statistics]. / Il passaggio da ICD-9 a ICD-10 per le statistiche di mortalità.

OBJECTIVE: This study evaluates the impact of the introduction of ICD-10 on mortality statistics in Italy. DESIGN: «Bridge-Coding¼ analysis carried out by a working group that has coded a number of death certificates using both ICD-9 and ICD-10 versions. In 2006, a training project was launched in order to allow the group to standardize the coding procedures. SETTING: The study was carried out by professionals from the following regions: Emilia-Romagna, Veneto, Tuscany, Liguria; and from the towns of Biella and Milan. The analysis included 74,525 Death Certificates produced in the aforementioned areas. RESULTS: A limited variability was observed for the most important groups of diseases (diseases of the circulatory system and neoplasms), with low impact on mortality statistics. The variability was higher for "minor" diseases like infectious and respiratory diseases, and dementia. The variability was similar but not identical to that observed in other national and international studies. The «Bridge-Coding¼ analysis has a local impact. Furthermore, changes depending on the variation in the selection rules are impossible to predict or to correct with the trans-coding procedure. CONCLUSIONS: In some cases, the changes determined by the implementation of ICD-10 are not completely corrected by the transcoding procedure, even applying appropriate Comparability Ratios (CR) from «Bridge Coding¼ analysis like this. Studies on respiratory diseases, or dementia and some neoplasms require new coding procedures in only one ICD version. Quality and accuracy of the compilation of death certificates have more effect than a correct coding, though more casual and less evaluable by means of comparability studies like this one.

Cancer incidence in people with AIDS in Italy.

People with HIV/AIDS (PWHA) have increased risk of some cancers. The introduction of highly active antiretroviral therapies (HAART) has improved their life expectancy, exposing them to the combined consequences of aging and of a prolonged exposure to cancer risk factors. The aim of this study was to estimate incidence rates (IR) in PWHA in Italy, before and after the introduction of HAART, after adjusting for sex and age through direct standardization. An anonymous record linkage between Italian AIDS Registry (21,951 cases) and Cancer Registries (17.3 million, 30% of Italian population) was performed. In PWHA, crude IR, sex- and age-standardized IR and age-specific IR were estimated. The standardized IR for Kaposi sarcoma and non-Hodgkin lymphoma greatly declined in the HAART period. Although the crude IR for all non-AIDS-defining cancers increased in the HAART period, standardized IR did not significantly differ in the 2 periods (352 and 379/100,000, respectively). Increases were seen only for cancer of the liver (IR ratio = 4.6, 95% CI: 1.3-17.0) and lung (IR ratio = 1.8, 95% CI: 1.0-3.2). Age-specific IRs for liver and lung cancers, however, largely overlapped in the 2 periods pointing to the strong influence of the shift in the age distribution of PWHA on the observed upward trends. In conclusion, standardized IRs for non-AIDS-defining cancers have not risen in the HAART period, even if crude IRs of these cancers increased. This scenario calls, however, for the intensification of cancer-prevention strategies, notably smoking cessation and screening programs, in middle-aged HIV-patients.

Spironolactone and gastrointestinal bleeding: a population based study.

BACKGROUND: Several medical reports showed an increased risk of stomach and duodenum bleeding associated with the use of spironolactone. The objective of this work is to examine the association between upper gastrointestinal (UGI) bleeding and exposure to spironolactone, using a population-based cohort design. METHODS: Using the pharmaceutical prescriptions from 2000 to 2006, a cohort was identified of residents in Milan (Italy) with chronic exposure to spironolactone or other diuretic drugs. The main outcome was defined as the hospital admission for UGI bleeding or ulcers. To control for potential bias related to spironolactone use, the propensity score was estimated. Then, each patient treated with spironolactone was randomly matched with one treated with other diuretics and having the same propensity score using the caliper matching method. Proportional hazard models were fitted by computing hazard ratios (HR) and the corresponding 95% confidence intervals (95%CI). RESULTS: A total of 53 550 unexposed and 10 564 exposed to spironolactone were identified. Overall in the study period, 174 patients (3.2%) developed UGI bleeding in the unexposed and 51 (4.8%) in the exposed group. HR for UGI bleeding for the spironolactone exposed group was 1.94 (95%CI 1.42-2.65). The sensitivity analysis based on the matched design using the propensity score showed a statistically significant twofold increase of gastrointestinal bleeding only among subjects exposed to high spironolactone dose (HR 2.50; 95%CI 1.08-5.79). CONCLUSIONS: Results from a large population based study confirm that spironolactone increases the risk of UGI bleeding.

Metabolic syndrome and cancer risk.

OBJECTIVE: The purpose of this population-based study is to explore for the first time the link between metabolic syndrome and cancer risk using information from the health information system of the Cancer Registry. METHODS: Referring to all pharmaceutical prescriptions between 1 January 1999 and 31 December 2005, coded with the Anatomical Therapeutic Chemical classification, all subjects aged 40 and over resident in Milan, which were simultaneously prescribed with antihypertensive, hypolypemic and hypoglycaemic drugs, were considered affected by metabolic syndrome. New cancer cases among cohort subjects were identified trough the local Cancer Registry and standardised incidence ratios (and corresponding 95% exact confidence intervals) were computed. RESULTS: Overall 16,677 subjects were identified corresponding to 45,828 person-years; among them 823 incidents cancers occurred. Significantly increased risks for pancreatic cancer in males--SIR 178 (114-266)--and colorectal cancer in females--SIR 133 (101-170)--were observed. Non-significantly increased risks were also observed in women for liver, gallbladder and biliary tract, breast and endometrial cancers. CONCLUSIONS: Our study suggests that the risk for several cancers increases in subjects affected by metabolic syndrome. The pharmacological control of the syndrome seems to be inadequate for reducing cancer risk, even though both a high competitive mortality effect and short duration of follow up have to be considered.