Impact of different follow-up regimens on health-related quality of life and costs in endometrial cancer patients: Results from the TOTEM randomized trial.

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.

Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial.

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.

The transferability and validity of a population-level simulation model for the economic evaluation of interventions in diabetes: the MICADO model.

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.

Frequency and risk factors for thrombosis in acute myeloid leukemia and high-risk myelodysplastic syndromes treated with intensive chemotherapy: a two centers observational study.

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.

Quality of life among germ-cell testicular cancer survivors: The effect of time since cancer diagnosis.

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.

Response shift in health-related quality of life measures in the presence of formative indicators.

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.

Prediction of mortality and major cardiovascular complications in type 2 diabetes: External validation of UK Prospective Diabetes Study outcomes model version 2 in two European observational cohorts.

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).

Missing data in longitudinal studies: Comparison of multiple imputation methods in a real clinical setting.

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.

Tailoring chemotherapy supply according to patients' preferences: a quantitative method in colorectal cancer care.

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. Focus groups were used to identify the attributes and levels for the discrete choice experiment.

Baseline selection on a collider: a ubiquitous mechanism occurring in both representative and selected cohort studies.

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.

Different quality of treatment in retroperitoneal sarcomas (RPS) according to hospital-case volume and surgeon-case volume: a retrospective regional analysis in Italy.

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.

Compliance with clinical practice guidelines for breast cancer treatment: a population-based study of quality-of-care indicators in Italy.

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).

Economic burden of injuries in children: cohort study based on administrative data in a northwestern Italian region.

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.

Impact of initial pattern of care on hospital costs in a cohort of incident lung cancer cases.

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.

Factors affecting pattern of care and survival in a population-based cohort of non-small-cell lung cancer incident cases.

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).

A high positive predictive value algorithm using hospital administrative data identified incident cancer cases.

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.

[Use of discharge records to define the oncological diagnoses for outpatient radiotherapy patients].

Objective: Outpatient activity recording system has a potential role in clinical practice evaluation. Nevertheless, up to now, its utilisation has been limited by the paucity of its clinical data. This study describes a procedure for identifying the oncological diagnosis in patients receiving radiotherapy at an ambulatory service in the Piedmont Region.

Accessibility as a major determinant of radiotherapy underutilization: a population based study.

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.