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Abstract Background It has been documented that variations exist in breast cancer treatment despite wide dissemination of clinical practice guidelines. The aim of this population-based study was to evaluate the impact of regional guidelines (Piedmont guidelines, PGL) for breast cancer diagnosis and treatment on quality-of-care indicators in the Northwestern Italian region of Piedmont. Methods We included two samples of women aged 50–69 years with incident breast cancer treated in Piedmont before and after the introduction of PGL: 600 in 2002 (pre-PGL) and 621 in 2004 (post-PGL). Patients were randomly selected among all incident breast cancer cases identified through the hospital discharge records database. We extracted clinical data on breast cancer cases from medical charts and ascertained vital status through linkage with town offices. We assessed compliance with 14 quality-of-care indicators from PGL recommendations, before and after their introduction in clinical practice. Results Among patients with invasive lesions, 77.1% (N = 368) and 77.5% (N = 383) in the pre-PGL and post-PGL groups, respectively, received breast conservative surgery (BCS) as a first-line treatment. Following BCS, 87.7% received radiotherapy in 2002, compared to 87.9% in 2004. Of all patients at medium-to-high risk of distant metastasis, 65.5% (N = 268) and 63.6% (N = 252) received chemotherapy in 2002 and in 2004, respectively. Among the 117 patients with invasive lesions and negative estrogen receptor status in 2002, hormonal therapy was prescribed in 23 of them (19.6%). The incorrect prescription of hormonal therapy decreased to 10.8% (N = 10) among the 92 estrogen receptor-negative patients in 2004 (p < 0.01). Compliance with PGL recommendations was already high in the pre-PGL group, although some quality-of-care indicators did not reach the standard. In the pre/post analysis, 8 out of 14 quality-of-care indicators showed an improvement from 2002 to 2004, but only 4 out of 14 reached statistical significance. We did not find any change in the risk of mortality in the post-PGL versus the pre-PGL group (adjusted hazard ratio 0.94, 95%CI 0.56–1.56). Conclusions These results highlight the need to continue to improve breast cancer care and to measure adherence to PGL.

Purpose: To investigate whether intensive follow-up (INT) after surgery for endometrial cancer impact health-related quality of life (HRQoL) and healthcare costs compared to minimalist follow-up (MIN), in the absence of evidence supporting any benefit on 5-year overall survival., Methods: In the TOTEM trial, HRQoL was assessed using the SF-12 and the Psychological General Well-Being (PGWB) questionnaires at baseline, after 6 and 12 months and then annually up to 5 years of follow-up. Costs were analyzed after 4 years of follow-up from a National Health Service perspective, stratified by risk level. The probability of missing data was analyzed for both endpoints., Results: 1847 patients were included in the analyses. The probability of missing data was not influenced by the study arms (MIN vs INT OR: 0.97 95%CI: 0.87-1.08). Longitudinal changes in HRQoL scores did not differ between the two follow-up regimens (MIN vs INT SF-12 PCS: -0.573, CI95%: -1.31; 0.16; SF-12 MCS: -0.243, CI95%: -1.08; 0.59; PGWB: -0.057, CI95%: -0,88; 0,77). The mean cost difference between the intensive and minimalist arm was €531 for low-risk patients and €683 for high-risk patients., Conclusion: In the follow-up of endometrial cancer after surgery, a minimalist treatment regimen did not affect quality of life and was cost-saving in both low-risk and high-risk recurrence patients. As previous results showed no survival benefit, a minimalist approach is justified. The relevant proportion of missing data on secondary outcomes of interest could be a critical point that deserves special attention., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: In the absence of clear evidence from randomized trials, the intensity of follow-up regimens after surgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, we conducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimen improves overall survival (OS) in patients undergoing operation for endometrial cancer., Methods: The TOTEM study was a large, pragmatic randomized trial, conducted in 42 hospitals (in Italy and France) including patients surgically treated for endometrial cancer, in complete clinical remission, International Federation of Gynecology and Obstetrics stage I-IV. After stratification by center and risk of relapse (low or high), patients were randomly assigned (1:1) to INT or MIN hospital-based follow-up regimens. The study was powered to demonstrate an absolute improvement of 5% of the 5-year OS with the INT regimen., Results: In total, 1,871 patients were randomly assigned between November 2008 and July 2018, and 1,847 patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the 5-year OS was 90.6% in the INT and 91.9% in the MIN arms (hazard ratio, 1.13, 95% CI, 0.86 to 1.50, P = .380). No differences in OS were found in subgroup analyses considering age, cancer treatment, risk of relapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapse was slightly higher in the INT arm (hazard ratio, 1.17; 95% CI, 0.92 to 1.48; P = .194)., Conclusion: An INT follow-up in endometrial cancer-treated patients does not improve OS, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the MIN regimens used in this trial.

Aims: Valid health economic models are essential to inform the adoption and reimbursement of therapies for diabetes mellitus. Often existing health economic models are applied in other countries and settings than those where they were developed. This practice requires assessing the transferability of a model developed from one setting to another. We evaluate the transferability of the MICADO model, developed for the Dutch 2007 setting, in two different settings using a range of adjustment steps. MICADO predicts micro- and macrovascular events at the population level., Methods: MICADO simulation results were compared to observed events in an Italian 2000-2015 cohort (Casale Monferrato Survey [CMS]) and in a Dutch 2008-2019 (Hoorn Diabetes Care Center [DCS]) cohort after adjusting the demographic characteristics. Additional adjustments were performed to: (1) risk factors prevalence at baseline, (2) prevalence of complications, and (3) all-cause mortality risks by age and sex. Model validity was assessed by mean average percentage error (MAPE) of cumulative incidences over 10 years of follow-up, where lower values mean better accuracy., Results: For mortality, MAPE was lower for CMS compared to DCS (0.38 vs. 0.70 following demographic adjustment) and adjustment step 3 improved it to 0.20 in CMS, whereas step 2 showed best results in DCS (0.65). MAPE for heart failure and stroke in DCS were 0.11 and 0.22, respectively, while for CMS was 0.42 and 0.41., Conclusions: The transferability of the MICADO model varied by event and per cohort. Additional adjustments improved prediction of events for MICADO. To ensure a valid model in a new setting it is imperative to assess the impact of adjustments in terms of model accuracy, even when this involves the same country, but a new time period., (© 2022. The Author(s).)

The frequency of thrombosis in AML has been evaluated only in a few studies and no validated predictive model is currently available. Recently, DIC score was shown to identify patients at higher thrombotic risk. We aimed to evaluate the frequency of thromboembolism in AML patients treated with intensive chemotherapy and to assess the ability of genetic and clinical factors to predict the thrombotic risk. We performed a retrospective observational study including 222 newly diagnosed adult AML (210) and high-risk MDS (12), treated with intensive chemotherapy between January 2013 and February 2020. With a median follow-up of 44 months, we observed 50 thrombotic events (90% were venous, VTE). The prevalence of thrombosis was 22.1% and the 6-months cumulative incidence of thrombosis was 10%. The median time to thrombosis was 84 days and 52% of the events occurred within 100 days from AML diagnosis. Khorana and DIC score failed to stratify patients according to their thrombotic risk. Only history of a thrombotic event (p = 0.043), particularly VTE (p = 0.0053), platelet count above 100 × 10 9 /L at diagnosis (p = 0.036) and active smoking (p = 0.025) significantly and independently increased the risk of thrombosis, the latter particularly of arterial events. AML genetic profile did not affect thrombosis occurrence. Results were confirmed considering only thromboses occurring within day 100 from diagnosis. DIC score at diagnosis, but not thrombosis, was independently associated with reduced survival (p = 0.004). Previous VTE, platelet count above 100 × 10 9 /L and active smoking were the only factors associate with increased thrombotic risk in AML patients treated intensively, but further studies are needed to validate these results., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Testicular cancer is one of the most treatable cancers, with a 10-year survival of more than 95%. Many patients will be long-term survivors and this disease strikes men in an important phase of their lives, therefore the quality of life (QoL) among these patients is an area of particular interest. We aimed to study whether QoL in testicular cancer survivors depends on the time since cancer diagnosis., Methods: Data were collected from the EPSAM (Esposizioni postnatali e salute maschile) study, a case-control study on patients with testicular cancer, diagnosed between 1997 and 2008 in the province of Turin, Northern Italy, and interviewed between 2008 and 2010 (response rate among cases 57%). Patients were contacted through their oncologist at the San Giovanni Batista Hospital in Turin or through their general practitioner (GP) in the rest of the Province of Turin. QoL was assessed cross-sectionally using the short form 12 (SF-12) questionnaire, a generic short-form health survey that produces two summary scores, PCS (physical component score) and MCS (mental component score), to evaluate physical and mental health, respectively., Results: Out of 234 study patients, 125 cases were seminomas and 109 cases were nonseminomas. The mean age at diagnosis was 34.5 years. After adjusting for age, time since diagnosis was not associated with PCS and MCS scores. Among nonseminomas, the median PCS slightly increased (adjusted OR (odds ratio) for 5+ vs < 2 years since cancer diagnosis: 1.78 (1.17-2.73), p = 0.008) and MCS slightly decreased (adjusted OR per 1-year increase since cancer diagnosis: 0.92, 95% CI: 0.82-1.05, p = 0.23) with time. Similar findings of no association between time since diagnosis and PCS and MCS were found when the analyses were restricted to the subgroup of cancer patients contacted through their oncologist, whose response proportion was 82%., Conclusion: In a study of testicular cancer patients interviewed cross-sectionally at 1 to more than 10 years since diagnosis, time since cancer diagnosis was not associated with QoL when we considered all germ-cell testicular cancer patients together. When stratified by histology type, we found certain evidence that nonseminoma cases report higher PCS over time since cancer diagnosis., Competing Interests: The authors have declared that no competing interests exist.

Aim: To externally validate the UK Prospective Diabetes Study Outcomes Model version 2 (UKPDS-OM2) by comparing the predicted and observed outcomes in two European population-based cohorts of people with type 2 diabetes., Materials and Methods: We used data from the Casale Monferrato Survey (CMS; n = 1931) and a subgroup of the Hoorn Diabetes Care System (DCS) cohort (n = 5188). The following outcomes were analysed: all-cause mortality, myocardial infarction (MI), ischaemic heart disease (IHD), stroke, and congestive heart failure (CHF). Model performance was assessed by comparing predictions with observed cumulative incidences in each cohort during follow-up., Results: All-cause mortality was overestimated by the UKPDS-OM2 in both the cohorts, with a bias of 0.05 in the CMS and 0.12 in the DCS at 10 years of follow-up. For MI, predictions were consistently higher than observed incidence over the entire follow-up in both cohorts (10 years bias 0.07 for CMS and 0.10 for DCS). The model performed well for stroke and IHD outcomes in both cohorts. CHF incidence was predicted well for the DCS (5 years bias -0.001), but underestimated for the CMS cohort., Conclusions: The UKPDS-OM2 consistently overpredicted the risk of mortality and MI in both cohorts during follow-up. Period effects may partially explain the differences. Results indicate that transferability is not satisfactory for all outcomes, and new or adjusted risk equations may be needed before applying the model to the Italian or Dutch settings., (© 2020 John Wiley & Sons Ltd.)

Rationale, Aims, and Objectives: Missing data represent a challenge in longitudinal studies. The aim of the study is to compare the performance of the multivariate normal imputation and the fully conditional specification methods, using real data set with missing data partially completed 2 years later., Method: The data used came from an ongoing randomized controlled trial with 5-year follow-up. At a certain time, we observed a number of patients with missing data and a number of patients whose data were unobserved because they were not yet eligible for a given follow-up. Both unobserved and missing data were imputed. The imputed unobserved data were compared with the corresponding real information obtained 2 years later., Results: Both imputation methods showed similar performance on the accuracy measures and produced minimally biased estimates., Conclusion: Despite the large number of repeated measures with intermittent missing data and the non-normal multivariate distribution of data, both methods performed well and was not possible to determine which was better., (© 2020 John Wiley & Sons, Ltd.)

Background: Response shift (RS) has been defined as a change in the meaning of an individual's self-evaluation that needs to be accounted for when assessing longitudinal changes in health-related quality of life (HRQoL). RS detection through structural equation modeling is accomplished by adopting Oort's procedure based on a measurement model in which the observed variables are defined as reflective indicators of the HRQoL latent variable; that is, the latent variable causes the variation in the reflective indicators. This study aims to propose a procedure that assesses RS when formative indicators are used in measuring HRQoL; in this last case, the latent variable is considered to be a function of some formative indicators. A secondary aim is to compare the new procedure with Oort's procedure to highlight similarities and differences., Methods: The data were retrieved from a consecutive series of 258 patients newly diagnosed with colorectal cancer and undergoing chemotherapy and/or surgery. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QOL-C30) was administered twice, once before and once six months after treatment. Structural equation modeling was used to evaluate RS and true change with the newly proposed method (in which fatigue and pain were defined as formative indicators) and with Oort's procedure (in which fatigue and pain were defined as reflective indicators)., Results: According to the new procedure, there was no measurement bias, and on average, patients' quality of life improved by 3.53 points (on a scale ranging from 0 to 100) at the 6-month follow-up. With Oort's procedure, the loading of the pain indicator was not invariant across the two time points, suggesting the presence of reprioritization, whereas the estimation of true change was very similar to the previous one: 3.87., Conclusions: RS and true change in HRQoL can be evaluated in the presence of formative indicators. Defining a measurement model by formative or reflective indicators can lead to different results.

Objectives: The aim of this study was to conduct a discrete choice experiment with patients affected by colorectal cancer to understand their preferences for different attributes of the chemotherapy supply. Our overall goal is to provide evidence on the relative importance of each attribute in order to tailor chemotherapy supply according to patients' priorities in the design or reorganization processes of cancer services. Methods: Focus groups were used to identify the attributes and levels for the discrete choice experiment. The attributes were: continuity of care, understanding, information, treatment choice, and time for therapy. Respondents were asked to choose between two mutually exclusive hypothetical alternatives of chemotherapy supply. Patients completed the discrete choice experiment along with the health-related quality of life and patients' satisfaction questions. Conditional and mixed logistic models were used to analyses the data. Results: Patients with colorectal cancer treated with chemotherapy ( n  = 76) completed the survey. The most important aspects of chemotherapy supply were: "Providing detailed and complete information" and "High ability in understanding" patients. Preferences were also influenced by the availability of a trusted doctor. Except for one attribute (waiting time for therapy), all other characteristics significantly influenced respondents' preferences. Conclusions: Results should support a policy of strengthening medical doctors' capabilities to communicate with patients, providing them complete information and involving them in the clinical decisions. Specifically, the findings should be used to improve the current provision of cancer care by identifying areas of preferred intervention from the perspectives of patients in order to tailor the service supply accordingly.

There is debate as to whether cohort studies are valid when they are based on a source population that is non-representative of a given general population. This baseline selection may introduce collider bias if the exposure of interest and some other outcome risk factors affect the probability of being in the source population, thus altering the associations between the exposure and those risk factors. We argue that this mechanism is not specific to 'selected cohorts' and also occurs in 'representative cohorts' due to the selection processes that occur in any population. These selection processes are for example linked to the life status, immigration and emigration, which, in turn, may be affected by environmental and social determinants, lifestyles and genetics. We provide real-world examples of this phenomenon using data on the population of the Piedmont region, Italy. In addition to well-recognised mechanisms, such as shared common causes, the associations between the exposure of interest and the risk factors for the outcome of interest in any source population are potentially shaped by collider bias due to the underlying selection processes. We conclude that, when conducting a cohort study, different source populations, whether 'selected' or 'representative', may lead to different exposure-outcome risk factor associations, and thus different degrees of lack of exchangeability, but that one approach is not inherently more or less biased than the other. The key issue is whether the relevant risk factors can be identified and controlled., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Retroperitoneal sarcomas (RPS) should be surgically managed in specialized sarcoma centers. However, it is not clearly demonstrated if clinical outcome is more influenced by Center Case Volume (CCV) or by Surgeon Case Volume (SCV). The aim of this study is to retrospectively explore the relationship between CCV and SCV and the quality of surgery in a wide region of Northern Italy., Methods: We retrospectively collected data about patients M0 surgically treated for RPSs in 22 different hospitals from 2006 to 2011, dividing them in two hospital groups according to sarcoma clinical activity volume (HCV, high case volume or LCV, low case volume hospitals). The HCV group (> 100 sarcomas observed per year) included a Comprehensive Cancer Center (HVCCC) with a high sarcoma SCV (> 20 cases/year), and a Tertiary Academic Hospital (HVTCA) with multiple surgeon teams and a low sarcoma SCV (≤ 5 cases/year for each involved surgeon). All other hospitals were included in the LCV group (< 100 sarcomas observed per year)., Results: Data regarding 138 patients were collected. Patients coming from LCV hospitals (66) were excluded from the analysis as prognostic data were frequently not available. Among the 72 remaining cases of HCV hospitals 60% of cases had R0/R1 margins, with a more favorable distribution of R0/R1 versus R2 in HVCCC compared to HVTCA., Conclusions: In HCV hospitals, sarcoma SCV may significantly influence RPS treatment quality. In low-volume centers surgical reports can often miss important prognostic issues and surgical quality is generally poor.

Rationale, Aims and Objectives: Lung cancer is a disease with high consumption of health care resources. The aim of this study was to describe hospital costs due to lung cancer care from diagnosis until death or end of the study follow-up, in a cohort of incident cases, by using administrative data., Methods: Particular attention was given to the determinants of total costs and the impact of the initial treatment approach on the process of costs accumulation. Incident cases were identified by the local Cancer Registry (January 2000-December 2003) among the residents of Turin (Italy). Per patient hospital care has been determined from administrative databases (outpatient radiotherapy records and hospital discharge records). Costs determinants were identified via a multivariable generalized linear model (GLM), with a Gamma cost distribution and a logarithmic link function. To assess the time effect over the cost accumulation process for non-small-cell lung cancer cases, the same GLM Gamma model was repeated at different follow-up periods. Analyses were stratified by cancer histotype., Results: Results evidenced the relevant role of initial patterns of care on the cost accumulation process, with increased midterm costs associated with curative patterns of care., Conclusion: The use of administrative data enabled hospital lung cancer care to be described, and related costs to be estimated., (© 2010 Blackwell Publishing Ltd.)

Background: The aims of the present study were to identify which types of injuries are responsible for the major component of the health burden and to estimate the relative costs in a cohort of Italian children., Methods: All children (0-14 years) residing in the Piedmont region, who were hospitalized for an injury (ICD-9-CM codes 800-995, excluding late effects from injury and allergies) between 1 January 2003 and 31 December 2003, were considered. The cohort was linked by a unique identifier to: all the hospitalizations, all the day-hospital care, and all the prescribed medicines. Outcome was defined as the difference in health service use in the 12 months following the injury, and was compared to the year preceding the injury occurrence. Total number of hospital admissions for each individual, cumulative length of stay, day-hospital care, and prescribed medicines were calculated for the two periods. The cost of additional inpatient days and of additional outpatient care was calculated., Results: The three most common injury categories were: intracranial injury (27.6%), fracture of upper limb (18.7%); and fracture of lower limb (9.07%); they were responsible for the major part of the additional inpatient days (55%) and outpatient care (70%). The additional expense for the National Health System during the year following an injury is approximately 1700 € for children aged 0-14., Conclusions: This is the first Italian study to attempt to quantify the injury economic burden in a cohort of children: the costs imposed on society by injuries, suggest how important it is to commit resources to injury prevention., (© 2011 The Authors. Pediatrics International © 2011 Japan Pediatric Society.)

Objective: To analyze the role of sociodemographic factors as determinants of the initial pattern of care and survival in incident NSCLC cases., Methods: We linked 2298 incident NSCLC cases, identified by the Piedmont Cancer Registry of Turin (PCRT) with administrative health records to identify the initial pattern of care. Because stage of disease strongly influences pattern of care and prognosis of NSCLC, all the analyses were stratified according to stage (early and advanced). The association between the set of patient's characteristics and the probability of accessing a specific pattern of care was analysed with a multivariable multinomial logistic regression model. Survival was analysed with the Cox proportional hazard model., Results: In the early stage group, presence of comorbidities, older age and low educational level were all associated with a lower probability of receiving surgery. These same factors, as well as being unmarried, were associated with higher probability of receiving other non-curative care only. The effects of comorbidities and low educational level as barriers to receiving more effective patterns of care were not relevant in the advanced stage group. When controlling for initial patterns of care, in the early stage group, an age older than 75 years and being unmarried were negative prognostic factors, while survival was completely independent from educational level. Among patients with an advanced stage of disease, only comorbidities had a negative impact on survival., Conclusion: Appropriate lung cancer care is affected by sociodemographic factors. Greater attention to social and health programs is recommended to improve the timeliness of diagnosis, the staging of potentially resectable patients, and to implement more comprehensive multidisciplinary evaluations of those who may benefit from curative treatments.

Objective: We have developed and validated an algorithm based on Piedmont hospital discharge abstracts for ascertainment of incident cases of breast, colorectal, and lung cancer., Study Design and Setting: The algorithm training and validation sets were based on data from 2000 and 2001, respectively. The validation was carried out at an individual level by linkage of cases identified by the algorithm with cases in the Piedmont Cancer Registry diagnosed in 2001., Results: The sensitivity of the algorithm was higher for lung cancer (80.8%) than for breast (76.7%) and colorectal (72.4%) cancers. The positive predictive values were 78.7%, 87.9%, and 92.6% for lung, colorectal, and breast cancer, respectively. The high values for colorectal and breast cancers were due to the model's ability to distinguish prevalent from incident cases and to the accuracy of surgery claims for case identification., Conclusions: Given its moderate sensitivity, this algorithm is not intended to replace cancer registration, but it is a valuable tool to investigate other aspects of cancer surveillance. This method provides a valid study base for timely monitoring cancer practice and related outcomes, geographic and temporal variations, and costs.

Background and Purpose: A survey was conducted of radiotherapy (RT) resources and utilization in a northwestern Italian Region in order to assess geographical variations in radiotherapy utilization rates, and the effects of infrastructure supply on accessibility., Materials and Methods: The survey was conducted by analysing standardized utilization rates based on administrative records. The data were analysed at both Regional and Local Health Unit (LHU) level., Results: Wide variation was found among LHUs RT utilization rates--the sex- and age-standardized rates varied from 1.8/1000 inhabitants to more than 3/1000 inhabitants. Patients resident in LHUs with no RT service showed a lower probability of accessing RT (standardized rate ratio (SRR), 0.82; 95%IC, 0.80-0.85). The utilization rate decreased in relation to the distance between a patient's residence and the nearest RT service; the reduction was greater for patients > or =70 years of age., Conclusion: The wide geographic variation implies lack of equity in access to services. Utilization levels decreased significantly with increasing distance from the nearest RT service, distance being a barrier to access particularly for older persons. The heterogeneous distribution of services on the Regional territory seems a relevant explanation of differences in utilization rates.