Antonio Federici

The immunochemical faecal occult blood test leads to higher compliance than the guaiac for colorectal cancer screening programmes: a cluster randomized controlled trial.

Introduction: We conducted a cluster-randomized trial aimed at assessing the effect of the type of faecal occult blood, guaiac or immunochemical test on screening compliance. Methods: We sampled 130 general practitioners (GPs) who consented to participate in the trial. We randomly allocated half of them to the guaiac (Hemo-Fec) and half to the immunochemical test (OC-Hemodia). We sampled 2/10 of the GPs 50–75-year-old patients (n=7332) and randomly divided this population into half. One half was invited to be screened at the GPs office and the other to the nearest gastroenterology ward. The principal outcome was the percentage of returned tests. Results: The immunochemical test had a compliance of 35.8% and the guaiac of 30.4% (relative risk [RR] 1.20; 95% confidence interval [CI] 1.02–1.44). The difference was mostly due to a higher probability of returning the sample: 93.8% and 88.6% for immunochemical and guaiac, respectively (RR 1.06; 95% CI 1.02–1.10). The guaiac test had a higher prevalence of positives (10.3% versus 6.3%, RR 0.603; 95% CI 0.433–0.837). There was a higher variability in the results obtained with the guaiac test compared with the immunochemical (F[1, 12] = 16.25; P=0.0017). Conclusions: Compliance is more likely with the immunochemical than the guaiac test, independent of the provider. Guaiac tests show a higher variability of the results among centres. The successful implementation of a screening programme requires a period of standardization of the test reading in order to avoid unexpected work overload for colonscopy services.

Laser-Evoked Potentials Habituation in Fibromyalgia

UNLABELLEDnAbnormalities of central pain processing play an important role in the pathophysiology of fibromyalgia (FM). The aims of the present study were to: 1) evaluate habituation of laser-evoked potentials (LEP) to repeated painful stimulation of 1 tender and 2 nontender points; and 2) determine correlations between LEP abnormalities and major clinical features of FM. Fourteen consecutive FM outpatients and 13 normal controls were included. LEP were recorded from scalp designations Fz, Cz, Pz, T3, and T4. The dorsum of the right hand, the right supra-orbital zone, and the right knee (a tender point in all patients) were subjected to repeated CO2 laser stimuli. For each stimulation site, recordings were obtained for 3 consecutive series of 20 stimuli. The 3 main findings in FM patients were: 1) an increased amplitude of vertex LEP and subjective laser pain; 2) decreased habituation of vertex LEP and subjective laser pain; and 3) a correlation between reduced N2 wave habituation and the severity of self-reported depressive symptoms. As with other chronic pain syndromes, the pathophysiology of FM may involve a generalized increase in the perception of painful stimuli and reduced habituation of the sensory cortex.nnnPERSPECTIVEnReduced habituation of cortical responses to laser stimuli in FM patients suggests alterations in the pattern of cortical excitability. This is facilitated by depressive symptoms and abnormalities in central neurotransmission. These findings provide further support for the use of medications with effects on the central nervous system in the management of FM.

The Role of GPs in Increasing Compliance to Colorectal Cancer Screening: A Randomised Controlled Trial (Italy)

Aims To assess the effect of the provider (GPs versus hospital) on the compliance in returning the faecal occult blood test. To analyse the characteristics of the GP associated with high compliance among his beneficiaries.Methods A questionnaire about screening attitudes was mailed to the 1192xa0GPs working in 13 districts of the Lazio region. We asked the GPs to participate in a randomised trial, we sampled 130xa0GPs and about 1/10 of the GPs’ 50–75xa0year old beneficiaries (n = 3657) were invited to be screened at the GP office and 1/10 (3675) at the nearest gastroenterology centre.Results 58.5% of the GPs completed the questionnaire and 22.7% agreed to participate in the trial. The compliance in the GP arm was 50%, in the hospital arm 16% (RR 3.4; 95% CI: 3.13–3.70). There was a high variability in the compliance obtained by the GPs. GPs with more than 25 patients visited/day and those incorrectly recommended screening of colorectal cancer obtained a lower compliance (OR 0.74, 95% CI: 0.57–0.95 and OR 0.76, 95% CI: 0.59–0.97, respectively).Conclusions The involvement of GPs in colorectal cancer screening can be very effective to enhance the compliance, but the effectiveness is dependent on their willingness to be involved.

Clinical features of headache patients with fibromyalgia comorbidity

Our previous study assessed the prevalence of fibromyalgia (FM) syndrome in migraine and tension-type headache. We aimed to update our previous results, considering a larger cohort of primary headache patients who came for the first time at our tertiary headache ambulatory. A consecutive sample of 1,123 patients was screened. Frequency of FM in the main groups and types of primary headaches; discriminating factor for FM comorbidity derived from headache frequency and duration, age, anxiety, depression, headache disability, allodynia, pericranial tenderness, fatigue, quality of life and sleep, and probability of FM membership in groups; and types of primary headaches were assessed. FM was present in 174 among a total of 889 included patients. It prevailed in the tension-type headache main group (35%, pxa0<xa00.0001) and chronic tension-type headache subtype (44.3%, pxa0<xa00.0001). Headache frequency, anxiety, pericranial tenderness, poor sleep quality, and physical disability were the best discriminating variables for FM comorbidity, with 81.2% sensitivity. Patients presenting with chronic migraine and chronic tension-type headache had a higher probability of sharing the FM profile (Bonferroni test, pxa0<xa00.01). A phenotypic profile where headache frequency concurs with anxiety, sleep disturbance, and pericranial tenderness should be individuated to detect the development of diffuse pain in headache patients.

Epidemiology and costs of cervical cancer screening and cervical dysplasia in Italy.

BackgroundWe estimated the number of women undergoing cervical cancer screening annually in Italy, the rates of cervical abnormalities detected, and the costs of screening and management of abnormalities.MethodsThe annual number of screened women was estimated from National Health Interview data. Data from the Italian Group for Cervical Cancer Screening were used to estimate the number of positive, negative and unsatisfactory Pap smears. The incidence of CIN (cervical intra-epithelial neoplasia) was estimated from the Emilia Romagna Cancer Registry. Patterns of follow-up and treatment costs were estimated using a typical disease management approach based on national guidelines and data from the Italian Group for Cervical Cancer Screening. Treatment unit costs were obtained from Italian National Health Service and Hospital Information System of the Lazio Region.ResultsAn estimated 6.4 million women aged 25–69 years undergo screening annually in Italy (1.2 million and 5.2 million through organized and opportunistic screening programs, respectively). Approximately 2.4% of tests have positive findings. There are approximately 21,000 cases of CIN1 and 7,000–17,000 cases of CIN2/3. Estimated costs to the healthcare service amount to €158.5 million for screening and €22.9 million for the management of cervical abnormalities.ConclusionAlthough some cervical abnormalities might have been underestimated, the total annual cost of cervical cancer prevention in Italy is approximately €181.5 million, of which 87% is attributable to screening.

Understanding non-compliance to colorectal cancer screening: a case control study, nested in a randomised trial [ISRCTN83029072].

BackgroundThe major limit to colorectal cancer screening effectiveness is often low compliance. We studied the reasons for non compliance and determinants of compliance to faecal occult blood tests in Lazio, Italy.MethodsThis is a case-control study nested within a trial that tested the effect of type of test and provider on colorectal cancer screening compliance. Non compliant trial subjects were classified as cases, and compliant subjects were classified as controls. We sampled 600 cases and 600 controls matched by their general practitioner, half were invited for screening at the hospital, and the other half directly at their general practitioners office. Cases and controls answered questions on: distance from test provider, logistical problems, perception of colorectal cancer risk, confidence in screening efficacy, fear of results, presence of colorectal cancer in the family, and gastrointestinal symptoms.ResultsAbout 31% of cases never received the letter offering free screening, and 17% of the sampled population had already been screened. The first reported reason for non-compliance was lack of time (30%); the major determinant of compliance was the distance from the test provider: odds ratio >30 minutes vs <15 minutes 0.3 (95%CI = 0.2–0.7). The odds ratio for lack of time was 0.16 (95% IC 0.1–0.26). The effect was stronger if the hospital (0.03 95%CI = 0.01–0.1) rather than the general practitioner (0.3 95%CI = 0.2–0.6) was the provider. Twenty-two percent of controls were accompanied by someone to the test.ConclusionTo increase compliance, screening programmes must involve test providers who are geographically close to the target population.

Incidence of invasive cervical cancer and direct costs associated with its management in Italy

Aim and background Cervical cancer is the second most common cancer in European women aged 15–44 years. The aim of this study was to estimate the direct cost of managing invasive cervical cancer in Italy. Methods Data from the Italian Network of Cancer Registries were used to estimate the annual number of new cervical cancer cases. To assess the management costs, a typical management pathway for each FIGO (Fédération Internationale de Gynécologie et dObstétrique) cervical cancer stage was derived from published guidelines. Data from the Modena Cancer Registry were used to estimate the proportion of patients by FIGO stage. This algorithm was combined with tariffs for outpatient and inpatient procedures to obtain a mean cost for each FIGO stage. Results An estimated 2,927 new cases of cervical cancer occurred in Italy in 2005 (crude incidence 9.7/100,000; world age-standardized incidence 6.0/100,000). The estimated numbers of new cases by FIGO stage were: FIGO I, 1,927; FIGO II, 556; FIGO III, 259; and FIGO IV, 185. Costs for the most frequent procedures were estimated as: € 6,041 for radical hysterectomy or other surgery; € 4,901 for radio-chemotherapy; € 1,588 for brachytherapy; and € 3,795 for palliative chemotherapy. Mean management costs for incident cases (including 10 years of follow-up) were estimated at: FIGO I, € 6,024; FIGO II, € 10,572; FIGO III, € 11,367; FIGO IV, € 8707; and € 5,854 for the terminal phase (1 month). The total direct management cost was estimated at € 28.3 million per year. Conclusions This is one of the first studies to estimate the direct cost of treating patients newly diagnosed with invasive cervical cancer in Italy. Although according to current management pathways real treatment costs are likely to be underestimated, this information is necessary to design evidence-based vaccination policies able to harmonize primary and secondary prevention of cervical cancer.

Estimation of Pap-test coverage in an area with an organised screening program: challenges for survey methods

BackgroundThe cytological screening programme of Viterbo has completed the second round of invitations to the entire target population (age 25–64). From a public health perspective, it is important to know the Pap-test coverage rate and the use of opportunistic screening. The most commonly used study design is the survey, but the validity of self-reports and the assumptions made about non respondents are often questioned.MethodsFrom the target population, 940 women were sampled, and responded to a telephone interview about Pap-test utilisation. The answers were compared with the screening program registry; comparing the dates of Pap-tests reported by both sources. Sensitivity analyses were performed for coverage over a 36-month period, according to various assumptions regarding non respondents.ResultsThe response rate was 68%. The coverage over 36 months was 86.4% if we assume that non respondents had the same coverage as respondents, 66% if we assume they were not covered at all, and 74.6% if we adjust for screening compliance in the non respondents. The sensitivity and specificity of the question, have you ever had a Pap test with the screening programme were 84.5% and 82.2% respectively. The test dates reported in the interview tended to be more recent than those reported in the registry, but 68% were within 12 months of each other.ConclusionSurveys are useful tools to understand the effectiveness of a screening programme and womens self-report was sufficiently reliable in our setting, but the coverage estimates were strongly influenced by the assumptions we made regarding non respondents.

Cervical cancer screening in women vaccinated against human papillomavirus infection: Recommendations from a consensus conference

In Italy, the cohorts of women who were offered Human papillomavirus (HPV) vaccination in 2007/08 will reach the age (25years) for cervical cancer (CC) screening from 2017. The simultaneous shift from cytology-based screening to HPV test-based screening gives the opportunity for unprecedented reorganisation of CC prevention. The ONS (National Screening Monitoring Centre) Directive and the GISCi (Italian Group for Cervical Screening) identified the consensus conference as the most suitable method for addressing this topic. A summary of consensus recommendations is reported here. The main objective was to define the best screening methods in girls vaccinated against HPV and the knowledge required for defining evidence-based screening strategies. A Jury made recommendations about questions and proposals formulated by a panel of experts representative of Italian scientific societies involved in CC prevention and based on systematic reviews of literature and evidence. The Jury considered changing the screening protocols for girls vaccinated in their twelfth year as appropriate. Tailored screening protocols based on vaccination status could be replaced by one size fits all protocols only when a herd immunity effect has been reached. Vaccinated women should start screening at age 30, instead of 25, with HPV test. Furthermore, there is a strong rationale for applying longer intervals for re-screening HPV negative women than the currently recommended 5years, but research is needed to determine the optimal screening time points. For non-vaccinated women and for women vaccinated in their fifteenth year or later, the current protocol should be kept.

The policy of public health genomics in Italy

Italy has a monitoring system for genetic testing, consisting in a periodic census of clinical and laboratory activities performed in the country. The experience is limited, however, concerning the translation of genomic testing for complex diseases into clinical practice. For the first time the Italian Ministry of Health has introduced a policy strategic plan on genomics and predictive medicine within the 2010-2012 National Prevention Plan. This achievement was supported by the Italian Network for Public Health Genomics (GENISAP) and will likely contribute to the integration of public health genomics into health care in the country. Our experience might be of interest not only in Italy, but in other high-income countries, struggling to keep a healthy economy and healthy citizens.