Analysis of workload generated in the two years following first consultation by each new cancer patient: studying the past to plan the future of cancer care.

INTRODUCTION: Prevalence of cancer patients is dramatically increasing. We aimed at quantifying the oncology workload generated by each new cancer patient in the two years following first consultation. METHODS: In this record-based retrospective study, we retrieved data of all newly diagnosed patients treated at the Oncology Department of Udine Academic Hospital between 01.01.2012 and 31.12.2017. We calculated mean number and standard deviation of the activity type generated by each new cancer patient during the following 2 years. RESULTS: Seven thousand four hundred fifty-two cancer patients generated a total of 85,338 clinical episodes. The two-years mean number of oncology episodes generated was 11.31 (i.e., for every 1,000 new cancer patients, 11,310 oncology activities are generated overall in the following two-year lapse). Patients with advanced disease generated the highest workload (24.3; SD 18.8) with a statistically significant difference compared to adjuvant and follow-up patients (p < 0.001). The workload generated in the period 0-6 and 0-12 months was significantly higher than in the following months (p < 0.001) and it was also higher for patients initially designated to treatment (p < 0.001). CONCLUSION: This is the first study reporting on the mean oncology workload generated during the 2 years following first consultation. Workload is the highest for patient with advanced disease, especially in the first months and in patients in active treatment. A detailed analysis of workloads in oncology is feasible and could be crucial for planning a sustainable framework for cancer care in the next future.

Economic evaluation of Zepatier for the management of HCV in the Italian scenario.

BACKGROUND: Hepatitis C virus (HCV) is a major health issue worldwide. New generation of direct-active antiviral medications is an epoch-making turning point in the management of HCV infections. OBJECTIVE: Conducing a cost-effectiveness analysis comparing the combination of elbasvir/grazoprevir and sofosbuvir + pegylated interferon/ribavirin for the management of all HCV patients (even those in the initial stages of fibrosis). METHODS: A Markov model was built on the natural history of the disease to assess the efficacy of the alternatives. The outcomes are expressed in terms of quality adjusted life-years (QALYs) and result in terms of incremental cost-effectiveness ratio). RESULTS: Elbasvir/grazoprevir implies an expenditure of €21,104,253.74 with a gain of 19,287.90 QALYs and sofosbuvir + pegylated interferon/ribavirin implies an expenditure of €31,904,410.11 with a gain of 18,855.96 QALYs. Elbasvir/grazoprevir is thus a dominant strategy. CONCLUSION: Consideration should be given to the opportunity cost of not treating patients with a lower degree of fibrosis (F0-F2).

Sustainability of Endovenous Iron Deficiency Anaemia Treatment: Hospital-Based Health Technology Assessment in IBD Patients.

Iron deficiency anaemia (IDA) is the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD). The Health Technology Assessment approach was applied to evaluate the sustainability of intravenous (IV) iron formulations in the Italian hospital setting, with particular focus on ferric carboxymaltose. Data on the epidemiology of IBD and associated IDA, in addition to the efficacy and safety of IV iron formulations currently used in Italy, were retrieved from scientific literature. A hospital-based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed. IDA prevalence in IBD patients varies markedly from 9 to 73%. IV iron preparations were proven to have good efficacy and safety profiles, and ferric carboxymaltose provided a fast correction of haemoglobin and serum ferritin levels in iron-deficient patients. Despite a higher price, ferric carboxymaltose would confer a beneficial effect to the hospital, in terms of reduced cost related to individual patient management and additionally to the patient by reducing the number of infusions and admissions to healthcare facilities. Ethically, the evaluation is appropriate due to its efficacy and compliance. This assessment supports the introduction of ferric carboxymaltose in the Italian outpatient setting.

Health technology assessment on reprocessing single-use catheters for cardiac electrophysiology: results of a three-years study.

The study aims to define the technical, ethical, juridical and economic issues involved in the assessment of a reprocessing policy for single-use interventional cardiac devices (SUDs). The feasibility of reprocessing was evaluated for cardiac electrophysiology catheters by comparing the chemical, physical and functional properties of new and reprocessed devices. The issue of hygiene was addressed by developing microbiological tests for the quantification of bioburden, sterility and pyrogenic load. The results of more than 1500 tests, conducted on 531 catheters, suggested a precautionary number of regenerations of five cycles. The ethical aspects were reviewed and the European juridical framework was assessed, revealing a need for harmonization. Applying a specific economic model, potential savings were calculated for a representative cardiology department and estimated at national and European level. Potential savings of 41.2% and 32.9% were calculated for diagnostic and ablation catheters, respectively. Safe and effective reprocessing of SUDs could be pursued if quality control processes and certified procedures are met. A reprocessing policy in EP laboratory could lead to savings of about 27,250 euros per 100,000 population, but the economic benefits are strongly dependent on the maximum number of regenerations and the regeneration rate.

An evaluation of the use of and user satisfaction with a teleconsultation system in oncology practice.

A three-year oncology teleconsulting project was concluded in November 2000. During a six-month study period, 38 clinical physicians and 47 nurses used the system. A total of 617 electronic patient records were created in the oncology department, 297 in dermatology and 24 in gynaecology. There were 45 synchronous teleconsultations involving various participants, lasting a total of 708 min. We conducted surveys of the attitudes of users to the teleconsulting system both before and after its implementation. There were no significant differences between the two surveys and the results showed that users had a positive reaction to the system and high expectations of its future utilization.

Mammography, routine ultrasonography in pregnancy, and PSA screenings in Italy.

OBJECTIVE: To present current scientific statements and practice on mammography, ultrasonography in pregnancy, and PSA within the Italian National Health Service (NHS). METHODS: Information on the three screenings was found in several position papers prepared by working groups at national and regional levels. RESULTS: For mammography the adjusted mortality rate for breast cancer increased in the last four decades and decreased in the last few years. Only 4.9% of women aged 50-70 years are covered by screening. In 1996 a consensus paper stated that biennial examination for women aged 50-69 years should be offered to reduce breast cancer mortality. A national program for breast cancer screening was launched under the responsibility of regional governments, but data about its implementation are not yet available. Regarding PSA screening, the results show that prostate cancer is the fourth most frequent neoplasm in males. A formal evaluation of prostate cancer screening was done in 1995 by the National Research Council and the Italian Association for Cancer Research; they did not recommend the NHS implement this service. In the National Health Plan 1998-2000, prostate cancer screening is not mentioned. So far, an organized and standardized screening program, based on routine PSA testing, does not exist in Italy. Nevertheless, a lot of PSA tests are performed at the clinical level to detect early prostate cancers. The results with regard to routine ultrasonography in pregnancy show that in 1996 the birth rate was 9.30 per 1,000 inhabitants, with 536,740 live births. In the period from 1992-94, the percentage of babies with a birth weight less than 2,500 gm and less than 1,500 gm were 5.85% and 0.91%, respectively. A formal screening program for detecting fetal growth retardation, based on the routine ultrasonography in the third trimester of the normal pregnancy, doesn't exist in Italy, but this test is widely performed. It is paid for under NHS coverage. CONCLUSION: In 1998 the National Health Plan 1998-2000 stated that the NHS should offer only evidence-based preventive and diagnostic interventions and stressed the importance of appropriate use of health technology.

Will elderly patients stand aside for younger patients in the queue for cardiac services?

BACKGROUND: Fair management of queues for hospital-based services requires consideration of clinical need, but there is no information on public attitudes towards non-clinical factors such as age or work status as determinants of priority. METHODS: We asked elderly residents of Padova, Italy, whether, if they were awaiting cardiac surgery or an outpatient cardiology consultant, they would give up their place in line for a younger or self-employed individual. We also elicited responses from a convenience sample of younger health workers asked to imagine themselves as elderly persons facing the same choices. FINDINGS: The eligible response rate was 72% (443/616). About half deemed it right to give up their place in line for cardiac surgery to a 45-year-old (51%, 95% CI 46-56) or self-employed person (47%, 95% CI 42-51) Proportions were significantly higher for an outpatient consultation (68%, 95% CI 63-72). In multivariate analyses, married respondents, those closer to age 65, university graduates, and those who were formerly self-employed were significantly less likely to respond affirmatively. In significant contrast for all four scenarios (p<0.0001), the overwhelming majority of non-elderly respondents refused to give up their places in line. INTERPRETATION: The majority of elderly citizens were hypothetically willing to cede priority in accessing cardiac care to younger or self-employed persons, but this willingness was attenuated among the "young" elderly and more privileged respondents. Non-elderly respondents were much less self-sacrificing, suggesting that ageing baby-boomers may be more assertive about their continuing rights to health care.

Utilization of percutaneous transluminal coronary angioplasty for quality assurance in health care from 1983 to 1996.

OBJECTIVES: To examine the distribution of interventional cardiac catheterization laboratories, their case load, the time trends, and the regional variation of percutaneous transluminal cutaneous angioplasty (PTCA) utilization in Italy. METHODS: Analysis of data was provided by the annual reports of the Italian Group of Studies and Interventional Cardiology over the period from 1983 to 1996. RESULTS: The number of PTCA facilities and their use steadily increased, mainly in the North. In 1996 the utilization rate was 34 per 100,000 population, but only 60% of labs performed 200 or more procedures. CONCLUSIONS: Dramatic time trends and regional variations often took place without an epidemiology and technology assessment-based planning process.

[Coronary angiography in two defined populations: Padua and Citadella]. / La coronarografia in due popolazioni definite: a Padova ed a Cittadella.

BACKGROUND: Coronary angiography is an invasive procedure that is relatively expensive and that requires an appropriate indication. METHODS: Utilization rate and the appropriateness of the use of the coronary angiography have been compared in two defined populations, namely residents from the city of Padua (group A), and subjects from the local health unit of Cittadella (group B), who underwent coronary angiography between June 1, 1992 and May 31, 1993. Appropriateness was evaluated both by comparison with the AHA/ACC guidelines and by observation of the outcome following diagnosis one year after the coronary angiogram was performed. RESULTS: One hundred and seventy-one patients in group A and 100 patients in group B underwent coronary angiography: both groups had similar age and sex distribution. Utilization rate was 8 per 10,000 inhabitants in group A, and 10 per 10,000 inhabitants in group B. Appropriate coronary angiography, evaluated by comparison with the AHA/ACC guidelines, was 69.9% in group A and 68% in group B. Coronary angiogram showed at least one stenosis > or = 50% in 133 patients from group A and in 66 patients from group B. These patients were followed up for at least 12 months. Of 13 deaths, 12 occurred as fatal cardiac events, while of the 147 surviving patients who had complete follow-up data, 114 (77%) improved. The outcome was measured through symptoms and stress test. In addition, subjective improvement was measured in group A using the "Nottingham Health Profile". CONCLUSIONS: Criteria of appropriateness for an invasive diagnostic procedure such as coronary angiography, which is a determinant "entry point" for revascularization procedures, is based on common clinical knowledge that may be evolving with time. Based on these data, it seems that the current guidelines could be modified, especially for indications within the setting of myocardial infarction.

Time trends in the utilization of cardiac catheterization procedures in Italy, 1983-93.

The use of cardiac catheterization procedures and the number of hemodynamic laboratories in Italy increased steadily from 1983 through 1993, sometimes with no planning or modern technology assessment. It is recommended that in the future funds be assigned to improve underused laboratories rather than to build new facilities.

[The distribution and activities of hemodynamic laboratories in Italy: the implications for the quality of services]. / La distribuzione e l'attività dei laboratori di emodinamica in Italia: implicazioni per la qualità dei servizi.

BACKGROUND: The diffusion of cardiac catheterization laboratories in Italy has been increasing in the last decade, often without a rational planning process evaluating costs, safety, concentration and case loads. METHODS: Data have been provided by the 1990 annual report of the Italian Group of Hemodynamic Studies and Interventional Cardiology which includes, following the best estimates, about 90% of public and private labs. These data include all cardiac catheterization visits. In analysis, PTCA's have been separately considered. RESULTS: In 1990, 85 laboratories with 101 rooms were active. The distribution of the labs was 58% in the north, 14% in the middle and 28% in the south of the country. The number of labs per million inhabitants was 1.9, 1.1 and 1.2 respectively, with a national average of 1.5. The percentage of labs performing fewer than 300 visits per year was 33% in the country. Within the areas, such percentages were 33%, 17% and 42% respectively. A total of 48,518 exams were performed (61%, 18% and 21% in the three areas) with a rate per 100,000 of 115, 82 and 51 (national rate 86). 5,145 PTCA's were carried out in the same year, about 80% of which were in the north area. CONCLUSIONS: Even if data could be underestimated, a great difference in geographical distribution of labs was confirmed. This might be explained by morbidity, population age and mobility of patients across the country. The percentage of labs performing fewer than 300 studies is relevant, in particular in the south and in the Isles. Planning for future requirements should include the amelioration of utilization rates (in a perspective of cost containment and patient safety), a thorough evaluation of demographic and morbidity trends, and an estimate of the proportion of inappropriate procedures.

[Coronary angiography in a defined population: a pilot study of the residents of Padua]. / La coronarografia in una popolazione definita: studio pilota nei residenti a Padova.

In recent years there has been a steady increase in number of coronary angiography procedures and coronary angioplasty. Since these interventions are relatively expensive, we tried to evaluate the appropriateness of coronary angiography indications. A retrospective pilot study was undertaken on all residents in Padua who had had a coronary angiography performed in 1988. In order to take into account patients who, although resident in Padua, had a coronary angiography performed outside Padua or even abroad, all Italian Hemodynamic Centers and the Office for Foreign Cures Authorization of ULSS 21 were contacted. Follow-up was stopped on April, 1991. Patients were first checked if living by consulting the Register's Office of the Community of Padua; they were then interviewed by letter on state of health. One hundred twenty-four patients underwent 138 coronary angiography. Utilization rate is 5.6 per 10,000 people (CI 4.6-6.6). This figure is lower than the present USA utilization rate, and is similar to the rate of late 70's. From patient records, 3 out 8 groups emerged as predominant indication for coronary angiography: unstable angina (37%), valvular heart disease (20%) and recent myocardial infarction (20%). According the ACC/AHA guidelines, indication was considered "appropriate" in 69%, "inappropriate" in 7%, "doubtful" in 20% and impossible to evaluate in 5% of cases. Although this classification may have been built up with incomplete information, it is note-worthy that the percentage of inappropriate indication is comparable to that of other reports. A further observation is that not in every case the treatment assigned at the time of diagnostic angiography was really carried out on the patients.(ABSTRACT TRUNCATED AT 250 WORDS)

The appropriateness of human albumin use in the hospital of Padova, Italy.

The authors present the findings of a study in three stages (1989-1991) on the appropriateness of human albumin use at the hospital of Padova, Italy. In the first stage, guidelines for appropriate use were defined and a monitoring system was set up. In the second stage, compliance of the hospital departments with the new guidelines was assessed in a sample of human albumin prescription charts and related medical records. This revealed a reduction in consumption of 25%. Sixty-eight per cent of all albumin was given for indications that are only occasionally appropriate. The information given in the prescription chart agreed with the diagnosis contained in the medical records in 78% of cases. At the end of this stage new regulating mechanisms were introduced. The third stage consisted of a medium-term assessment and produced basically the same results as the previous stage. Crucial steps in the implementation of effective actions in quality improvement processes have been discussed.

The quality improvement system in the hospitals of Padua (Italy).

A quality improvement system has been established in 1989 in the hospital network of Padua and its organization is described. Three selected experiences are reported. (1) Appropriateness of the use of human albumin. After the assessment of the clinical policy, new guidelines were experimentally introduced and an evaluation after 3 months has shown a decrease of the total number of prescriptions (25%) and of inappropriate indications (9% vs 40.1%). (2) Urinary Tract Infections (UTI) and indwelling catheterization. The study showed 49% of conditions related to UTI and some corrigible inadequacies in the process of care: 37.2% of indications were probably not justified; 40% of patients who did not undergo urineculture had indications and 13% who underwent urineculture had no indications to the test. Guidelines for appropriate indications and a continuing education programme have been introduced. (3) Falls by hospitalized patients. The patient fall rate was 0.3/1000. As the reporting system showed inaccuracies (for example, the severity of injury was not collected in 34% of cases), a new notification form was introduced in 1991.

Chloracne following environmental contamination by TCDD in Seveso, Italy.

Data are presented on the occurrence of chloracne, clinical symptoms and biochemical changes in 164 children following environmental contamination by TCDD from an industrial accident in Seveso, Italy. An overall positive association was found between the territorial distribution of chloracne cases and the different levels of soil contamination in the affected area. Individual risk factors such as condition and length of exposure, intake via contaminated foods, etc. were evaluated; no single factor appeared to be associated with chloracne. Disturbances of the gastrointestinal tract were more frequently observed in children affected with chloracne in those from the same areas having no skin lesions. However, no clinically definable systemic disease has been diagnosed.

Experiences from the accident of Seveso.

Provisional data on selected sanitary events which took place at Seveso after July 10 1976 are reported. 187 cases of chloracne, mostly in children, were detected, 50 just after the accident, the others within a year. Most polluted area (zone A) provided almost all "early" and most severe cases, but the territorial distribution of chloracne prevalence rates showed some inconsistencies with the soil TCDD pollution map; interpretations for such findings are discussed. Thirty-eight birth defects were detected in 1977 (none in zones A and B), more than in previous years, but still less than expected in a well controlled "normal" population: no clustering around a given type was observed. Spontaneous abortions, evaluated both as abortion rates and as pregnancy loss rates, showed scattered and statistically non-significant variations, inconsistent with the pollution map. No differences in birth and death rates compared to surrounding areas were observed. Data on ad hoc cytogenetic, neurological and immunological surveys are commented. Limitations of the presently available data are discussed and further research lines are anticipated.