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Biomedical subjects

N Segnan

Publications and source records attributed to N Segnan.

At least 19 recordsLinked to original sources

Impact of the introduction of organised screening for cervical cancer in Turin, Italy: cancer incidence by screening history 1992-98.

After an organised cervical screening programme was introduced in Turin in 1992, the age-adjusted cervical cancer incidence ratio in 1992-98 was 0.81 (95% confidence interval (CI) 0.59-1.09) for invited vs not invited women and 0.25 (95% CI 0.13-0.50) for attenders vs non attenders. An organised screening programme can further reduce cervical cancer incidence in an area where substantial spontaneous activity was previously present.

Female↗

Predictive value of rectal bleeding for distal colonic neoplastic lesions in a screened population.

The aim of this study was to determine the diagnostic value of rectal bleeding for distal colorectal cancer (CRC), or large (> or =10 mm) adenomas among an average-risk population. A cross-sectional survey was conducted among individuals aged 55-64 years, who attended sigmoidoscopy (FS) screening in the context of a multicentre randomised trial of FS screening for CRC. Sensitivity, specificity and positive predictive value (PPV) of rectal bleeding for large distal adenomas or CRC were calculated. Rectal bleeding was reported by 8.8% of 8507 patients examined (15% of those with large adenomas and 29% of those with CRC). The risk of CRC was increased when bleeding was associated with an altered bowel habit: odds ratio (OR)=10.42; 95% Confidence Interval (CI): 4.08-26.59; the corresponding OR for isolated bleeding was 5.29 (95% CI: 2.28-12.30). Rectal bleeding carries an increased risk of distal neoplastic lesions. However, most lesions are detected among asymptomatic subjects. This finding suggests that screening represents the optimal strategy to detect CRC or large adenomas in the distal colon in the targeted age range.

Colonic Neoplasms↗

Monitoring surgical treatment of screen-detected breast lesions in Italy.

The object of this study was to assess quality of care and adherence to treatment guidelines of screen-detected lesions in Italy using a new audit system. Data on screen-detected cases surgically treated in 1997 were collected using a system (QT 2.3) developed within the Italian Group for Planning and Evaluating Mammographic Screening Programmes (GISMa) and the European Breast Cancer Screening Network. Results of 18 performance parameters were considered compared with the reference standards. In 1997, 515 lesions (335 invasive, 60 in situ and 120 benign) in 496 patients were collected from 14 departments in the Central and Northern area of Italy. The 18 indicators were analysed and grouped according to six quality objectives. Some results were good and others were excellent, such as intraoperative identification, breast conservation surgery, adequate axillary procedures and completeness of pathology reports, but most of them failed: waiting times, preoperative diagnosis, employment of frozen section on small lesions and avoiding axillary procedures in ductal carcinoma-in-situ. This work is a first attempt in Italy to evaluate and uniform the criteria adopted for quality control of breast cancer treatment, using a standardised system. Some results are good or excellent, the overall level of compliance with quality indicators is not satisfactory and corrective actions should be undertaken for a number of issues. A continuous monitoring should be performed and appropriate action taken in order to verify the effectiveness of the corrective actions and to provide screen-detected patients with the best quality of care.

Breast Neoplasms↗

The impact of organised screening programmes on the stage-specific incidence of breast cancer in some Italian areas.

The aim of this study was to examine the effects of mammographic screening programmes on stage-specific incidence of breast cancer. The study compared prescreening and screening periods in seven areas in Italy, primarily evaluating the first screening round. All 17617 breast cancers (16554 invasive, 1063 in situ) registered in women aged 40-79 years between 1988 and 1999 were analysed through age-standardised rates and Poisson regression models. For all areas, independent of the baseline rates, the introduction of screening increased incidence for invasive cancers overall and, more markedly, for early cancers (screening/prescreening ratio: range 1.07-1.47 and 1.23-1.82, respectively), modifying the pattern of age-specific rates. The multiple regression analysis showed that the percentage of cases diagnosed at screening explained most of the increase; a residual effect of diagnosis period (screening versus prescreening) suggested a role for 'spontaneous' early detection in ages outside of the screening programme. Advanced cases did not show consistent variations across the registries for those aged 40-79 years (range: 0.91-1.21), whereas a more coherent picture was observed for those aged 50-69 years. In one area, a moderate reduction in the number of 'advanced' cases in the second screening period was observed. For all stages, the age-specific incidence rates of cases diagnosed outside of the screening programme for the age groups 50-69 years were lower than the corresponding rates in the prescreening period, suggesting a shift from the usual clinical services to the screening programme. Our results confirmed the increase in early-stage cancers occurring at the start of screening, and substantially explained the rise in breast cancer incidence. In addition, our study confirms the importance of cancer registries in monitoring the effect of breast cancer screening and the validity, for this purpose, of the linkage between cancer registries and screening programme databases.

Adult↗

Effect of circulation and discussion of cervical smears on agreement between laboratories.

The study objective was assessing whether circulation of smears and discussion of those with differing interpretation can increase reproducibility between laboratories. The study included: the blind interpretation of a first set of 194 smears among seven laboratories, the discussion of smears with discrepant diagnoses during the previous phase and the blind interpretation of a second set of smears of same size and characteristics. After discussions, the overall weighted kappa increased in five laboratories (substantially in three : +50%, +27% and +20%). However, no change was observed in one laboratory and a slight decrease (-4%) in another. The latter interpreted the second set of smears at a longer time interval from discussions. Agreement improved for all diagnostic classes except low grade intraepithelial neoplasia (LSIL). Overall, the intervention increased diagnostic agreement, but its effect varied with laboratory and by diagnostic class and could be transient. Continued programmes of smear exchange and discussion appear to be advisable.

Cytodiagnosis↗

Cervical cancer screening in Italy.

Until recently cervical cancer screening in Italy has been mainly spontaneous, with only a few organised programmes. This resulted in low coverage and high frequency of tests in screened women (mostly every year). The situation is, however, rapidly changing. In 1996 nationwide organised programmes, on a regional basis, were recommended. National guidelines recommend personal invitation of women aged 25-64 years for a Pap-test every third year. At the end of 1999 34% of the Italian population 25-64 years old was included in organised programmes. Most organised programmes have fail-safe systems for women referred for colposcopy, protocols for diagnostic work-up and treatment and reference centres for such phases, according to the recommendations of national and European guidelines. However the size of laboratories is frequently smaller than recommended. Most organised programmes implement quality assurance processes for cytology interpretation, that have been intensive in some centre, but there is no nationwide standardisation. In recent years data for monitoring screening activity have been collected in a standardised way by most organised programmes, in the framework of GISCi (Italian Group for Cervical Cancer Screening) allowing internal and external comparisons. In some cases strong improvements of coverage after the introduction of an organised activity have been documented. Data, however, suggest a relevant heterogeneity of criteria for cytology interpretation, requiring actions to increase consistency. The impact of these transformations on incidence of cervical cancer will be observed in the future: preliminary results suggest a reduction in older programmes.

Adult↗

Prediction of high-grade cervical intraepithelial neoplasia in cytologically normal women by human papillomavirus testing.

Human papillomavirus (HPV) testing has been suggested for primary screening of cervical cancer. Prediction of future high-grade cervical lesions is crucial for effectiveness and cost. We performed a case control study in a retrospective cohort of women with at least two cervical smears, all but the last one being negative, from the organized cervical screening programme in Florence, Italy. We searched for high-risk HPV in all previous, archival, smears from cases (new histologically confirmed cervical intraepithelial neoplasia (CIN) grade II or worse) and in one previous smear from each control (last smear cytologically normal, matched by age and interval (latency) from last smear). We applied polymerase chain reaction (PCR), and the b-globin gene was used as a DNA preservation marker. High-risk HPV was identified in 71/92 (77.17%) previous smears from 79 cases and 17/332 controls (5.12%). The odds ratio (OR) was 63.76 (95% CI 30.57-132.96). Among cases the proportion of HPV-positive smears declined slightly with increasing latency. Among cases, HPV was found in 81.24% (95% CI 69.93-88.96%) of smears with latency < 4 years and in 67.80% (95% CI 47.72-82.93%) of those taken at longer intervals, up to 6 years. These findings suggest that testing for high-risk HPV allows predicting 80% of CINII/III 3 years before the cytological diagnosis and two thirds 6 years before. They also suggest that testing women negative for high-risk HPV at longer interval and strictly following-up women who are HPV positive could be an effective strategy for cervical cancer screening.

Adult↗

Comparing participants and nonparticipants in a smoking cessation trial: selection factors associated with general practitioner recruitment activity.

We studied the relationship between smokers' sociodemographic characteristics, their smoking habit, health status, and the probability of their having been approached for recruitment in the smoking cessation trial performed in Turin, Italy, with the aim of gathering information on the role of selection criteria adopted by general practitioners (GPs) in offering anti-smoking counseling. The 965 smokers who were offered participation in the trial were matched to a sample of eligible smokers (n = 277), selected from the rosters of the 42 GPs collaborating in the trial, who had not been invited to participate. The probability of being offered enrollment, estimated through a multiple conditional logistic regression model, assuming the GP as the matching variable, was significantly increased for intermediate (10-19 cigarettes per day: odds ratio [OR] = 4.13; 95% confidence interval [CI]: 2.63-6.47) and heavy (20 cigarettes per day or more: OR = 10.12; 95% CI: 6.51-15.75) smokers, for smokers diagnosed with chronic cardiovascular (OR = 2.06; 95% CI: 1.19-3.58), or respiratory (OR = 2.50; 95% CI: 1.40-4.48) diseases, and for smokers mentioning an intermediate number (2-4) of past quit attempts (OR = 3.70; 95% CI: 2.18-6.28). General Practitioners focused their recruitment activity on higer-risk smokers or smokers who had tried to quit, to offer more clues for intervention. Assessing the potential public health benefit of preventive interventions requires a more systematic evaluation of the generalizability of the reported findings.

Adult↗

Adjusting for non-compliance and contamination in randomized clinical trials.

A method of analysis is presented for estimating the magnitude of a treatment effect among compliers in a clinical trial which is asymptotically unbiased and respects the randomization. The approach is valid even when compliers have a different baseline risk than non-compliers. Adjustments for contamination (use of the treatment by individuals in the control arm) are also developed. When the baseline failure rates in non-compliers and contaminators are the same as those who accept their allocated treatment, the method produces larger treatment effects than an 'intent-to-treat' analysis, but the confidence limits are also wider, and (even without this assumption) asymptotically the efficiencies are the same. In addition to providing a better estimate of the true effect of a treatment in compliers, the method also provides a more realistic confidence interval, which can be especially important for trials aimed at showing the equivalence of two treatments. In this case the intent-to-treat analysis can give unrealistically narrow confidence intervals if substantial numbers of patients elect to have the treatment they were not randomized to receive.

Adult↗

Interaction of spontaneous and organised screening for cervical cancer in Turin, Italy.

In a screening programme for cervical cancer, coverage of the target population is a major determinant of effectiveness and cost-effectiveness and is one of the parameters for programme monitoring recommended by the "European Guidelines for Quality Assurance". An organised screening programme was started in Turin, Italy, in 1992. Spontaneous screening was already largely present, but coverage (proportion of women who had at least a test within 3 years) was low (< 50%) and distribution of smears uneven. No comprehensive registration of spontaneous smears was available. All women were invited for the first round, independently of their previous test history. Coverage was estimated by integrating routine data from the organised programme with data on spontaneous screening obtained by interviews of a random sample of 268 non-compliers to invitation and 167 compliers. Overall (spontaneous + organised) coverage was estimated to be 74% (95% CI, 71-78%). The proportion of the target population covered as an effect of invitation was estimated to be 17% (95% CI, 15-20%). Invitations were successful in increasing coverage in previously poorly screened groups. Although 20-25% of compliers was estimated to have had further tests before the end of the round, we estimated that switching to a 3-year interval saved approximately 0.26 tests per complier. This suggests that invitations to an organised programme even to previously covered women, can be a cost-effective policy. Our method of estimating overall coverage can be useful in many other European areas where a comprehensive registration of smears is not available.

Adult↗

Socioeconomic status and cancer screening.

The only widely applied cancer screening programmes are those for cancers of the cervix and female breast. Participation in breast cancer screening has been shown to depend on income and education, health insurance and type of health service. Women in low social classes tend to have lower screening participation rates than those in higher classes. Socioeconomic differences in screening practices tend to decrease when participation is promoted, cultural and economic barriers are removed, and social support is offered. In both developed and developing countries, women of low socioeconomic status have a higher than average risk of cervical cancer, and a lower than average participation in Pap smear screening.

Adult↗

Estimating the sensitivity of cervical cytology: errors of interpretation and test limitations.

The objective of this study was to estimate: (i) the sensitivity of cytologists in recognizing abnormal smears; (ii) the sensitivity of cervical cytology as a method of detecting abnormal smears among those obtained in the presence of cervical intraepithelial neoplasia (CIN). Study subjects were 61 women with a histologically confirmed CIN identified through colpohistological and cytologic screening. For objective (i) new smears were taken from study subjects just before treatment, mixed with routine preparations, interpreted by unaware cytologists and then blindly reviewed by a group of three expert supervisors, who reached a consensus diagnosis. Cytologists classified as positive for squamous intraepithelial lesion (SIL) 30 of the 34 smears judged as positive by supervisors (100% of smears classified as high-grade and 67% of smears classified as low-grade SIL by the supervisors). Our approach, based on creating a set of smears with a high a priori probability of being positive, proved to be an efficient way of estimating errors of interpretation. For objective (ii), smears taken at the moment of diagnosis, just before biopsy, were also reviewed by the same supervisors. These CIN cases were identified among asymptomatic women independently of cytological findings and results are therefore not subject to verification bias. Among the 33 histological CINII/III, four (12%) smears had no atypical cells (three negatives and one unsatisfactory) at review. The same proportion was 26% (four negatives and one unsatisfactory) among the 19 histological CINI. No significant differences in smear content were found between the seven 'false negatives' and a sample of 'true positive' and 'true negatives' for a number of formal adequacy criteria (including presence of endocervical cells). Strong differences were found between positive smears taken just before biopsy and those taken just before treatment (in 11 women the first smear only was positive, while the opposite was never observed), suggesting an effect of punch biopsy in removing lesions.

Diagnostic Errors↗

Screening for colorectal cancer by once only sigmoidoscopy: a feasibility study in Turin, Italy.

OBJECTIVES: To assess the impact on compliance of three invitation methods, as well as the acceptability and efficacy of two bowel preparation regimens, for endoscopic screening in the general population. METHODS: 1170 subjects (men and women aged 55 to 59, in the rosters of a sample of general practitioners (GPs) in Turin), were randomly allocated to one of three invitation groups (A: personal letter, signed by GP, with a pre-fixed appointment; B: same as for A + letter supporting the study by a well known scientist; C: letter signed by the study coordinator, NS) and two preparation regimens (i: one enema, self administered at home two hours before the test; ii: two enemas, administered the night before and two hours before the test). A postal reminder was mailed to non-attenders. A sample of non-responders was contacted for a telephone interview by a trained nurse. Written consent was obtained from all subjects undergoing the test. RESULTS: A total of 278 subjects attended for sigmoidoscopic screening. An invitation from the GP alone produced the highest response rate (compliance: A = 29.3%; B = 24.9%; C = 26.8%). A single enema was as effective as two enemas in achieving satisfactory preparation for the test: the proportion of subjects invited to repeat the test was 8.1% in the single enema group, and 9.6% in the group receiving two enemas. CONCLUSIONS: Compliance with this screening procedure tends to be low. One enema, self administered two hours before sigmoidoscopy, can ensure a satisfactory bowel preparation.

Colorectal Neoplasms↗

Accuracy of the umbilical arteries Doppler flow velocity waveforms in detecting adverse perinatal outcomes in a high-risk population.

OBJECTIVE: To define the accuracy of the umbilical artery Doppler flow velocity waveforms, according to different cut-off values, in predicting adverse perinatal outcomes among fetuses at high risk of hypoxic complications. SUBJECTS: Two hundred and sixty-five pregnant women with diagnosis of small for gestational age fetus and/or pregnancy induced hypertension studied in four Italian ultrasound units. METHODS: Prospective study. Serial Doppler ultrasound measurements of the umbilical artery were performed. Results were not available for clinical management. Cut-off curves, corresponding to different age-specific centiles of the pulsatility index distribution among pregnancies resulting in healthy newborns, regardless of birthweight, were computed by regression methods. Sensitivity, specificity, positive predictive value and negative predictive value of such cut-off curves, and of absent/reverse end-diastolic flow, in predicting different adverse outcomes were estimated. The adverse outcomes were: perinatal or neonatal death (OUTCOME 1). Death or Apgar<7 at 5' or need for admission to intensive care unit or other hypoxic related abnormalities (OUTCOME 2). Either OUTCOME 2 or birthweight<l0th centile (OUTCOME 3). Both OUTCOME 2 and birthweight<10th centile (OUTCOME 4). RESULTS: The best accuracy was in predicting OUTCOMES 1 and 4. Positive predictive value increased strongly with higher cut-off curves while negative predictive value only decreased slightly. For absent/reverse end-diastolic flow, negative predictive value and positive predictive value were respectively 94% and 39% for death, and 81% and 72% respectively for OUTCOME 2. For the 95th centile curve the corresponding figures were 96%, 33% and 84%, 67%. The 60th centile curve had a 85% and 74% sensitivity value for death and OUTCOME 2 respectively, but the corresponding positive predictive values were 18% and 40% only. CONCLUSIONS: The findings of an absent end diastolic flow or of pulsatility index values above the 95th centile curve strongly suggest it is time to deliver the fetus. The 60th centile curve is the most suitable to recognize fetuses at risk for abnormal outcome, but early delivery should be avoided because of its low positive predictive value.

Apgar Score↗

[Evaluation of the effectiveness of screening for tumors of the digestive system].

Some features of digestive cancers encourage screening programs, even though no such program has been shown so far effective in reducing mortality rates. The visual inspection of the oral cavity and pharynx, with the addition of flexible endoscopy and, possibly, blue-toluidine staining, can be easily performed by specialists and dentists. The strong association with smoking habits and alcohol consumption favours the organization of screening programs but primary prevention maintains the highest priority. For cancer of the colon-rectum two different screening approaches are under close scrutiny: fecal occult blood testing, on an yearly basis, and once-in-a-life sigmoidoscopy at 55-60 years of age. Only one of five ongoing randomized prospective studies on occult blood testing has reported, so far, a significant reduction, around 33%, of mortality from colorectal cancer, with, however, a large burden of sigmoidoscopies.

Colorectal Neoplasms↗