SIED-GISCOR recommendations for colonoscopy in screening programs: Part I - Diagnostic.

The implementation of FIT programs reduces incidence and mortality from CRC in the screened subjects. The ultimate efficacy for CRC morbidity and mortality prevention in a FIT program depends on the colonoscopy in FIT+ subjects that has the task of detecting and removing these advanced lesions. Recently, there has been growing evidence on factors that influence the quality of colonoscopy specifically withing organized FIT programs, prompting to dedicated interventions in order to maximize the benefit/harm ratio of post-FIT colonoscopy.

Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy.

Objective: To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer-CRC-or advanced adenoma).

Design: Prospective cohort of subjects aged 50-69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy.

Methods: All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces).

Guidance for faecal occult blood testing: quantitative immunochemical method (FIT-HB) in colorectal cancer screening programmes.

Background: in Italy, colorectal cancer screening is included as part of the Italian National Health Service - SSN (Servizio Sanitario Nazionale) Essential Levels of Care - LEA (Livelli Essenziali Assistenziali) and the European Guidelines, which specify quantitative FIT-Hb testing as the best strategy for organised screening programmes. To ensure consistent operating standards in Member States, European regulations require the implementation of certification and accreditation requirements for diagnostic and care-related processes. The requirement, based on ISO 17021 accreditation standards, includes ISO 9001 certification for systems and ISO 15189:2012 accreditation for laboratories.

Effects of fecal sampling on preanalytical and analytical phases in quantitative fecal immunochemical tests for hemoglobin.

Background: Information on preanalytical variability is mandatory to bring laboratories up to ISO 15189 requirements. Fecal sampling is greatly affected by lack of harmonization in laboratory medicine. The aims of this study were to obtain information on the devices used for fecal sampling and to explore the effect of different amounts of feces on the results from the fecal immunochemical test for hemoglobin (FIT-Hb).

A comparative effectiveness trial of two faecal immunochemical tests for haemoglobin (FIT). Assessment of test performance and adherence in a single round of a population-based screening programme for colorectal cancer.

Aim: To compare acceptability and diagnostic accuracy of a recently available faecal immunochemical test (FIT) system (HM-JACKarc) with the FIT routinely used in an established screening programme (OC-Sensor).

Design: Randomised controlled trial (ISRCTN20086618) within a population-based colorectal cancer (CRC) screening programme. Subjects eligible for invitation in the Umbria Region (Italy) programme were randomised (ratio 1:1) to be screened using one of the FIT systems.

Impact of a new sampling buffer on faecal haemoglobin stability in a colorectal cancer screening programme by the faecal immunochemical test.

Haemoglobin (Hb) stability in faecal samples is an important issue in colorectal cancer screening by the faecal immunochemical test (FIT) for Hb. This study evaluated the performance of the FIT-Hb (OC-Sensor Eiken) used in the Florence screening programme by comparing two different formulations of the buffer, both in an analytical and in a clinical setting. In the laboratory simulation, six faecal pools (three in each buffer type) were stored at different temperatures and analysed eight times in 10 replicates over 21 days.

Impact of preanalytical factors on fecal immunochemical tests: need for new strategies in comparison of methods.

Background: Harmonization of fecal immunochemical tests for hemoglobin (FIT-Hb) is crucial to compare clinical outcomes in screening programs. The lack of reference materials and standard procedures does not allow the use of usual protocols to compare methods. We propose 2 protocols, based on artificial biological samples (ABS), to discriminate preanalytical and analytical variation and investigate clinical performances.

How to improve the performances of Fecal Immunological Tests (FIT): Need for standardization of the sampling and pre-analytical phases and revision of the procedures for comparison of methods.

Lack of reference materials and standard procedures, on faecal tests leads to major problems in harmonisation of methods and do not allow the comparison of outcome data. In particular the absence of standardisation of pre-analytical characteristic was noted for faecal test methods for haemoglobin since different manufacturers have developed different sampling procedures and report units. Moreover the physical characteristics of the faecal specimen and the designs of specimen collection devices do not allow analysis of samples on different systems in consequence, faecal tests cannot be compared using standard evaluation protocols.

Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening.

Background: Faecal immunochemical tests (FIT) are becoming widely used in colorectal cancer (CRC) screening. Availability of data on faecal haemoglobin concentrations (f-Hb) in three countries prompted an observational study on sex and age and the transferability of data across geography.

Methods: Single estimates of f-Hb in large groups were made in Scotland, Taiwan and Italy using quantitative automated immunoturbidimetry on the Eiken OC-Sensor.

The impact of immunochemical faecal occult blood testing on colorectal cancer incidence.

Background: The efficacy of colorectal cancer screening based on faecal immunochemical test, in terms of reduction of colorectal cancer incidence, is under debate. In the district of Florence, an organized screening programme based on faecal immunochemical test has been running since the early 1990s. The aim of this study was to compare the risk of developing colorectal cancer for subjects undergoing faecal immunochemical test with those who did not undergo the test in the same period.

Overall evaluation of an immunological latex agglutination system for fecal occult blood testing in the colorectal cancer screening program of Florence.

Several immunological fecal occult blood tests (FOBT) are currently available for colorectal cancer (CRC) screening. We compared the HM Jack (Jack) (Kiowa, Japan), with the OC-Hemodia (OC) (Eiken, Japan) in use in the Florence screening program. Aims of the study were: (i) to investigate the diagnostic performance and the best cutoff value for Jack; (ii) to evaluate the handiness of sampling tubes; (iii) to compare costs.

Direct mailing of faecal occult blood tests for colorectal cancer screening: a randomized population study from Central Italy.

Background: Sending faecal occult blood tests (FOBT) by mail has been proposed both as a method to increase participation and a way to reduce staff costs in colorectal cancer screening.

Methods: Two multicentre randomized controlled trials (ISRCTN10351276) were performed: one randomly assigned 3196 individuals who had previously participated in colorectal screening to receive a FOBT kit at home or a standard invitation; in the second, 4219 people aged 50-69 years who did not respond to a screening invitation were either sent a FOBT or a standard recall letter. The cost per returned kit was calculated in each arm.

Influence of seasonal variations in ambient temperatures on performance of immunochemical faecal occult blood test for colorectal cancer screening: observational study from the Florence district.

Background: Faecal occult blood testing (FOBT) in population screening has proved to be effective in reducing mortality from colorectal cancer. In Italy a latex agglutination FOBT has been adopted for a single-sample screening programme. The aim of this study was to examine the performance of FOBTs in the Florence screening programme over several seasons to evaluate the impact of variations in ambient temperature on the performance of the screening test.

Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening.

Background & Aims: We conducted a study to estimate population coverage and detection rate (DR) achievable through different strategies of colorectal cancer (CRC) screening.

Methods: A population-based multicenter randomized trial comparing 3 strategies was used: (1) biennial immunologic fecal occult blood test (FIT), (2) "once only" sigmoidoscopy (FS), and (3) "once only" colonoscopy (TC). A random sample of men and women, aged 55 to 64 years, was drawn from general practitioners' (GP) rosters.

Analysis of morphologic patterns of fine-needle aspiration of the breast to reduce false-negative results in breast cytology.

Background: The identification of specific morphologic diagnostic criteria is of paramount importance to optimize the accuracy of fine-needle aspiration cytology (FNAC) and to reduce the rate of false-negative results. In the current study, the authors reviewed a consecutive series of false-negative findings observed in the study center to define the presence and degree of cytologic abnormalities. False-negative cases were randomly mixed with true-negative cases and were reviewed by a panel of expert readers in a blinded fashion.

Free to total PSA ratio is not a reliable predictor of prostate biopsy outcome.

Aims And Background: The aim of this study was to assess the validity of predictors of prostate biopsy outcome in order to improve their positive predictive value.

Material And Methods: The study material consisted of a consecutive series of 410 prostate biopsies performed during 2003. The variables tested as possible predictors were age, findings at palpation (DRE) and ultrasonography (TRUS), total prostate-specific antigen (PSA), and free-to-total prostate-specific antigen (F/T) ratio.

A feasibility study of the use of the AutoPap screening system as a primary screening and location-guided rescreening device.

Background: The AutoPap 300 QC system (Tripath Imaging, Inc., Burlington, NC) is an automated device that was designed to screen conventionally prepared cervical smears and, more recently, thin-layer slide preparations. The system has been tested in large clinical trials.