Cancer screening programmes in Italy during the COVID-19 pandemic: an update of a nationwide survey on activity volumes and delayed diagnoses.

INTRODUCTION: In Italy, regional governments are in charge of implementing cervical, breast and colorectal cancer screening programmes. The 2020 Coronavirus pandemic led to a national lockdown and the temporary suspension of several non-urgent healthcare activities, including cancer screening. This paper aims to describe the results of a national survey carried out by the National Centre for Screening Monitoring (ONS) on cervical, breast and colorectal cancer screening activities in 2020. MATERIALS AND METHODS: A national survey was conducted by ONS in 2020 to assess: the number of screening invitations by Region; the volumes of screening tests and the attitude to attend the screening programme compared to 2019; the number of delayed diagnoses of malignant or pre-malignant lesions caused by the slowing down of screening programmes, based on the average Region-specific screening detection rate for cervical, breast and colorectal cancers. RESULTS: Screening tests for breast, colorectal and cervical cancer decreased by 37.6%, 45.5% and 43.4% in 2020 compared with 2019. In 2020 the estimated numbers of undiagnosed lesions are: 3,324 breast cancers, 1,299 colorectal cancers, 7,474 colorectal advanced adenomas and 2,782 CIN2 or more severe cervical lesions. Participation in cancer screening programmes decreased by 15%, 15% and 20%, for cervical, breast and CRC screening, respectively. DISCUSSION AND CONCLUSIONS: An urgent call to action is needed to prevent further delays and to limit the impact of the pandemic on cancer diagnosis and prevention.

[Oncological organized screening programmes in the COVID-19 era: an Italian survey on accrued delays, reboot velocity, and diagnostic delay estimates]. / Ritardi maturati dai programmi di screening oncologici ai tempi del COVID-19 in Italia, velocità della ripartenza e stima dei possibili ritardi diagnostici.

OBJECTIVES: to describe the course of Italian organized cancer screening programmes during the COVID-19 emergency; to provide estimates of the diagnosis of malignant or pre-malignant lesions that will face a diagnostic delay due to the slowing down of screening activities. DESIGN: quantitative survey of aggregated data for each Region and overall for Italy relating to screening tests carried out in the period January-May 2020 compared to those of the same period of 2019; estimate of diagnostic delays starting from the calculation of the average detection rate of the last 3 years available (specific by Region). SETTING AND PARTICIPANTS: Italian mass screening programmes. Data on the tests carried out in the target population of the breast (women 50-69 years old), cervix (women 25-64 years old), and colorectal (women and men 50-69 years old) cancer screening. MAIN OUTCOME MEASURES: the cumulative delay (in absolute numbers and as a percentage) in the period January-May 2020 compared to the same period of 2019, by Region; the difference of screening tests (in absolute number and in percentage) performed in May 2020 compared to May 2019; the estimate of the fewer lesions diagnosed in 2020 compared with 2019 with relative 95% confidence intervals (95%CI); the 'standard months' of delay (proportion of fewer tests carried out from January to May 2020 for the corresponding number of months). RESULTS: 20 Regions out of 21 participated. In the period January-May 2020, the fewer screening tests performed in comparison with the same period of 2019 were: 472,389 (equal to 53.8%) with an average delay of standard months of 2.7 for mammography screening; 585,287 (equal to 54.9%) with an average delay of standard months of 2.7 for colorectal screening; 371,273 (equal to 55.3%) with an average delay of 2.8 standard months for cervical screening. The estimated number of undiagnosed lesions is 2,201 (95%CI 2,173-2,220) breast cancers; 645 (95%CI 632-661) colorectal carcinomas; 3,890 (95%CI 3,855-3,924) advanced colorectal adenomas and 1,497 (95%CI 1,413-1,586) CIN2 or more serious lesions. CONCLUSIONS: mass screenings need to be restarted as quickly as possible. In order to make up for the delay that is accumulating, it is necessary to provide for wider delivery times, greater resources, and new organizational approaches. It will also be essential to develop communication strategies suitable for promoting participation during this emergency.

[Introduction of a centralised system (Service) for collecting clinical data in cancer screening programmes in Piedmont (Northern Italy): a pre-post assessment of a hub&spoke model]. / L'introduzione di un sistema centralizzato (Service) per la raccolta dei dati clinici negli screening oncologici in Piemonte: valutazione pre-post di un modello hub&spoke.

OBJECTIVES: evaluation of a centralised collection of clinical data (Service) within cancer screening programmes in Piedmont based on a hub&spoke model and its impact on process indicators. DESIGN: assessment of an organisational intervention, through a non-controlled pre-post design. SETTING AND PARTICIPANTS: organised screening programmes within the Piedmont Region, divided into 9 departments. MAIN OUTCOME MEASURES: clinical data (extracted from medical charts for mammography screening and from excision histology reports for cervical screening) obtained through the Service were quantified and their completeness was assessed. The Service impact on the detection rate (DR) was evaluated, comparing the DR pre- (2005-2008) and post-Service (2009- 2012) within breast screening; the DR was computed through histological diagnosis made during colposcopy (pre-Service method) or through the worst diagnosis between the latter and that reported from excision histology (post-Service method) within cervical screening (data available for department 1, year 2013). Some hints on human resources employed in pre- and post-Service periods were reported. RESULTS: within mammography screening, the Service obtained 53.1% of extra-department medical charts and 45.8% of extra-region ones; the percentage of missing diagnoses changed from 5.5% (pre- Service) to 3.7% (post-Service). The age standardised DR for malignant tumours in the post-Service period is 1.3 times the DR of the pre-Service period per 1,000 screening tests. Within cervical screening, 51.7% of histological reports was recorded. Crude DR for high-grade lesions changed from 3.9 (pre-Service) to 4.7 (post-Service) per 1,000 screened women. The system centralisation did not imply an increase in the dedicated personnel. CONCLUSION: the Service is an operational core which coordinates the collection of clinical data, impacting on process indicators without an increase in human resources at departmental level.

A first survey of HPV-based screening in routine cervical cancer screening in Italy.

Pilot HPV-based cervical screening programmes have recently started in Italy, partly on the strength of a large randomized trial. The Ministry of Health recommended that regions shift toward HPV-based screening in early 2013 and provided guidelines for its application (stand-alone HPV testing by validated methods, cytological triage of HPV positives, beginning at age 30-35, 5-year intervals). A first survey on the 2012 activity was conducted in 2013. In 2012, 19 Italian organized cervical screening programmes from 10 regional programmes invited 311,856 women (8.0%of all women invited for cervical screening in 2012 in Italy) for HPV-based screening; 41.5% complied, with a decreasing North-South trend. Among screened women, 7.9% (range 4.3%-13.9%) were HPV positive, decreasing to 6.6% (range 4.0%-12.4%) when considering women aged 35-64 years. Among HPV positive women, 34.8%(with high variability between programmes: range 11.1%-59.3%) were judged to have ASC-US or more severe cytology (5.3%ASC-US, 26.6%L-SIL, 5.2% H-SIL). Out of all screened women, those referred to colposcopy based on HPV and cytology results were 2.9% (range 0.6%-4.8%), whereas they were 2.0% when considering only women aged 35-64 years.

Extension of organized cervical cancer screening programmes in Italy and their process indicators, 2011-2012 activity.

Italian national guidelines recommend regional implementation of organized screening programmes for cervical cancer. As we have been doing since 1998, we collected aggregated tables of data from Italian organized cervical screening programmes in order to centrally compute process indicators. Data on women invited during 2011 and 2012 and screened up to April of the subsequent year were considered. In 2012, the target population of Italian organized screening programmes included 14,497,207 women, corresponding to 87.3% of Italian women aged 25-64 years. Compliance to invitation was 41.2%in 2011 and 40.8%in 2012, with a strong decreasing North-South trend. However, it should be considered that many women are screened outside any organized programmes. In 2012, of the women screened, 3.5% were referred for repeat cytology and 71.1% of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.3%among women referred because of ASC-US or more severe cytology and 90.4% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASC-US or more severe cytology for CIN2 or more severe histology was 16.9%. The unadjusted detection rate of CIN2 or more severe histology was 3.4 per 1,000 screened women (3.6 standardized on the Italian population, truncated 25-64). CIN2 or more severe histology was detected in 64.6% of colposcopies classified as grade 2 or higher. Of all colposcopies during which a CIN2 or more severe histology was obtained, 33.6% were classified as grade 2 or higher. Follow-up only was recommended to 81.7% of women with CIN1. Excision by radio-frequency device was the most common treatment for women with CIN2 (52.8%) and CIN3 (57.0%). However 0.4% of all CIN2 and 2.3% of all CIN3 had hysterectomy.

[Extension of organised cervical cancer screening programmes in Italy and their process indicators, 2010 activity]. / Estensione dei programmi organizzati di screening del cancro cervicale in Italia e loro indicatori di processo, attività 2010.

Italian national guidelines recommend to regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998 we collected aggregated tables of data from Italian organised cervical screening programmes in order to centrally compute process indicators. Data on women invited during 2010 and screened up to April 2011 were considered. In 2010, the target population of Italian organised screening programmes included 13,538,080 women, corresponding to 80.1% of Italian women aged 25-64 years. Compliance to invitation was 39.8%, with a strong North-South decreasing trend. However, it should be considered that many women are screened outside organised programmes. Among screened women, 4.7% were referred for repeat cytology and 62.7% of them complied; 2.5% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.9% among women referred because of ASC-US or more severe cytology and 88.7% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASC-US or more severe cytology for CIN2 or more severe histology was 16.0%. The unadjusted detection rate of CIN2 or more severe histology was 3.2 per 1,000 screened women (3.5 standardised on the Italian population, truncated 25-64).

[Cervical cancer screening in Italy: quality of colposcopy and treatment. 2010 activity]. / Lo screening per il cervicocarcinoma in Italia: qualità della colposcopia e del trattamento. Attività 2010.

Data were collected from organised Italian cervical screening programmes on: a) the correlation between colposcopic findings (according to the 1990 international classification) and histology, and (b) the treatment/management of screen-detected histologically-confirmed cervical intraepithelial neoplasia (CIN). Data routinely registered by organised programmes were obtained as aggregated tables. Of the 26,320 reported colposcopies, 39.6% were classified as normal and 11.2% as unsatisfactory. CIN2 or more severe histology was detected in 65.3% of colposcopies classified as grade 2 or higher. Of all colposcopies, the outcome of which was CIN2 or more severe histology, 42.7% were classified as grade 2 or higher. Of the 5,695 women with CIN1, 78.9% were recommended to have follow-up only. However, 1.4% of them had cold-knife conisation and 4.5% were treated by diathermocoagulation. Of the 3,841 women with CIN2 or CIN3, 6.4% had not yet been treated when data were collected, and no data rewere available for a further 12.7%. Excision by radio-frequency device was the most common treatment among these women (64.1% of those with known treatment). However, 0.7% of all CIN2 and 1.7% of all CIN3 had hysterectomy. Among the 151 women with invasive carcinoma, 10.6% plausibly with microinvasive disease, only one treatment LLETZ is reported.

Extension of organised cervical cancer screening programmes in Italy and their process indicators, 2009 activity.

Italian national guidelines recommend to regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998, we collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. Data on women invited during 2009 and screened up to April 2010 were considered. In 2009, the target population of Italian organised screening programmes included 13,120,269 women, corresponding to 78.0%of Italian women aged 25-64 years. Compliance to invitation was 39.3%, with a strong North-South decreasing trend. However, it should be considered that many women are screened outside the organised programmes. Of the women screened, 4.7%were referred for repeat cytology and 60.8% of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.1% among women referred because of ASC-US or more severe cytology and 89.3% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASC-US or more severe cytology for CIN2 or more severe histology was 16.2%. The unadjusted detection rate of CIN2 or more severe histology was 3.2 per 1,000 screened women (3.2 standardised on the Italian population, truncated 25-64).

Cervical cancer screening in Italy: quality of colposcopy and treatment. 2009 activity.

We collected data from organised Italian cervical screening programmes on: a) the correlation between colposcopic findings (according to the 1990 international classification) and histology, and (b) the treatment/management of screen-detected histologically-confirmed cervical intraepithelial neoplasia (CIN). Data routinely registered by organised programmes were obtained as aggregated tables. Of the 30,049 reported colposcopies, 40.3% were classified as normal and 19.9% as unsatisfactory. CIN2 or more severe histology was detected in 66.4% of colposcopies classified as grade 2 or higher. Of all colposcopies, the outcome of which was CIN2 or more severe histology, 41.8% were classified as grade 2 or higher. Of the 5,734 women with CIN1, 73%were recommended to have follow-up only. However, 0.8%of them had cold-knife conisation and 3.8%were treated by diathermocoagulation. Of the 3,713 women with CIN2 or CIN3, 5.1%had not yet been treated when data were collected, and no data were available for a further 15.1%. Excision by radio-frequency device was the most common treatment among these women (68.6% of those with known treatment). However 0.4% of all CIN2 and 3.6% of all CIN3 had hysterectomy. Among the 199 women with invasive carcinoma, 12% plausibly with microinvasive disease had only excisional treatment reported.

Quality of colposcopy and treatment: data from the national survey of Italian organised cervical screening programmes. 2008 activity.

We collected data from organised Italian cervical screening programmes on (a) the correlation between colposcopic findings (according to the 1990 international classification) and histology, and (b) the treatment/management of screen-detected histologically confirmed cervical intraepithelial neoplasia (CIN). Data routinely registered by organised programmes were obtained as aggregated tables. Of the 25,932 reported colposcopies 38.1% were classified as normal and 20.2% as unsatisfactory. CIN2 or more severe histology was detected in 64.0% of colposcopies classified as grade 2 or higher. Of all colposcopies, the outcome of which was CIN2 or more severe histology, 41.7% were classified as grade 2 or higher. Of the 4,923 women with CIN1, 78.1% had follow-up only. However 0.8% of them had cold-knife conisation, 4.7% were treated by diathermocoagulation and 0.1% had a hysterectomy. Of the 3,788 women with CIN2 or CIN3, 3.9% had not yet been treated when data were collected and no data were available for a further 9.9%. Excision by radio-frequency device was the most common treatment among these women (66.7% of those with known treatment). However 0.7% of all CIN2 and 4.0% of all CIN3 had a hysterectomy. Among the 163 women with invasive carcinoma, 17.2% plausibly with microinvasive disease had only excisional treatment reported.

Extension of organised cervical cancer screening programmes in Italy and their process indicators: 2008 activity.

Italian national guidelines recommend to Regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998, we collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. Data on women invited during 2008 and screened up to April 2009 were considered. In 2008, the target population of Italian organised screening programmes included 13,094,025 women, corresponding to 78.4% of Italian women aged 25-64 years. Compliance to invitation was 39.7%, with a strong North-South decreasing trend. However, it should be considered that many women are screened outside the organised programmes. Of the women screened, 5.2%were referred for repeat cytology and 63.0% of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.1%among women referred because of ASCUS or more severe cytology and 89.3%among those referred because of HSIL or more severe cytology.The positive predictive value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 16.0%. The unadjusted detection rate of CIN2 or more severe histology was 3.1 per 1,000 screened women (3.0 standardised on the Italian population, truncated 25-64).

The reproducibility of CIN diagnoses among different pathologists: data from histology reviews from a multicenter randomized study.

The reproducibility of cervical histology diagnoses is critical for efficient screening and to evaluate the effectiveness of new technologies. The vast majority of cervical intraepithelial neoplasia (CIN) diagnoses reported in the New Technologies for Cervical Cancer study were blindly reviewed by 2 independent pathologists. Only H&E-stained slides were used for the review. The reviewers were asked to reclassify cases using the following categories: normal CIN 1, CIN 2, CIN 3, and squamous and glandular invasive cancer. We reviewed 1,003 cases. The interobserver agreement was 0.36 (95% confidence interval [CI], 0.32-0.40) with an unweighted kappa and 0.54 with a weighted kappa (95% CI, 0.50-0.58). The kappa values from dichotomous classifications with the threshold at CIN 2 were 0.69 (95% CI, 0.64-0.73) and 0.57 (95% CI, 0.51-0.63) with the threshold at CIN 3. The CIN 2 diagnosis had the lowest class-specific agreement, with fewer than 50% of cases confirmed by the panel members, which supports the fact that CIN 2 is not a well-defined stage in the pathogenesis of cervical neoplasia.

Extension of organised cervical cancer screening programmes in Italy and their process indicators: 2007 activity.

Italian national guidelines recommend to Regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998, we collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. Data on women invited during 2007 and screened up to April 2008 were considered. In 2007, the target population of Italian organised screening programmes included 11,872,810 women, corresponding to 71.8% of Italian women aged 25-64 years. Uptake of invitation was 39.8%, with a clear North-South decreasing trend. It should, however, be considered that many women are screened outside the organised programmes. Of the women screened, 5.0% were referred for repeat cytology and 60.4 % of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 82.3% among women referred because of ASCUS or more severe cytology and 89.5% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 16.0%. The unadjusted detection rate of CIN2 or more severe histology was 2.9 per 1,000 screened women (3.1 standardised on the Italian population, truncated 25-64).

Quality of colposcopy and treatment--data from the national survey of Italian organised cervical screening programmes: 2006 activity.

We collected from Italian organised cervical screening programmes data on the correlation between colposcopic findings (according to the 1990 international classification) and histology and on the treatment/management of screen-detected histologically confirmed cervical intraepithelial neoplasia (CIN). Data routinely registered by organised programmes were provided as aggregated tables. We obtained data on colpo-histological correlation from 72 programmes. Of the 18,340 reported colposcopies 37.9% were classified as normal and 20.9% as unsatisfactory. CIN2 or more severe histology was detected in 71.6% of colposcopies classified as grade 2 or higher. Of all colposcopies the outcome of which was CIN2 or more severe histology, 40.6% had a colposcopy classified as grade 2 or higher. We obtained data on treatment from 83 programmes. Of the 3,405 women with CIN1 69.3% had follow-up only. However 0.8% of them had cold-knife conisation, 7.5% were treated by diathermocoagulation and 0.1% had hysterectomy. Of the 2,597 women with CIN2 or CIN3 4.1% had not yet been treated when data were collected and no data were available for a further 8.1%. Excision by radio-frequency device was the most common treatment among these women (60.9% of those with known treatment). However 0.7% of all CIN2 and 3.4% of all CIN3 had hysterectomy. Among the 100 women with invasive carcinoma, 17% (plausibly with microinvasive disease) had only excisional treatment reported.

Process performance of cervical screening programmes in Europe.

Standardised tables of aggregated data were collected from 15 European national or regional cervical screening programmes and key performance indicators computed as reported in European Union (EU) Guidelines, 2nd edition. Cytological results varied widely between countries both for the total proportion of abnormal tests (from 1.2% in Germany (Mecklenburg-Vorpommern) to 11.7% in Ireland-Midwest Region) and for their distribution by grade. Referral rates for repeat cytology (ranging from 2.9% of screened women in the Netherlands to 16.6% in Slovenia) or for colposcopy (ranging from 0.8% in Finland to 4.4% in Romania-Cluj) and the Positive Predictive Value (PPV) of colposcopic attendance (ranging from 8% in Romania-Cluj to 52% in Lithuania) were strongly influenced by management protocols, in particular for atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) cytology. However, cytology-specific PPV also showed remarkable variability. The detection rate of CIN2+ histology ranged from <0.1% of screened women in Poland to >1% in England and Denmark. Low attendance for colposcopy after referral was observed in some east-European countries. These comparisons may be useful for improving the performance of cervical screening in general and more so if new screening technologies and vaccination for Human Papillomavirus are introduced. Overall, quality was better in countries that have operated organised programmes for a longer time, plausibly as a result of long-lasting monitoring and quality assurance activities. Therefore, the availability of these data, the first comparing European countries, and the increased number of countries that can provide such data (only five in 2004) represent progress. Nevertheless, there is a clear need to standardise the cytological and histological classifications used in screening, as well as data registration systems across Europe.

Extension of organised cervical cancer screening programmes in Italy and their process indicators.

Since 1996, Italian national guidelines recommend that Regions implement organised screening programmes for cervical cancer. As in previous years since 1998, we have collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. In 2006, the target population of Italian organised screening programmes included 11,362,580 women, corresponding to 69% of Italian women aged 25-64 years. However, taking into account the proportion of women invited, the actual extension was 52.9%. Compliance to invitation was 38.5%, with a clear North-South decreasing trend. It should, however, be considered that many women are screened outside the organised programmes. The remaining process indicators deal with women invited during 2005 and screened up to April 2006 Of these, 6.1% were recommended to repeat cytology and 57% of them complied; 2.3% of screened women were referred to colposcopy. Compliance to colposcopy was 84.7% among women referred because of ASCUS or more severe cytology and 90% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 16.8%. There was a relevant variability of both referral rate and PPV that were inversely related. The unadjusted detection rate of histologically confirmed CIN2 or more severe was 2.7 per 1,000 screened women (2.6 standardised on the Italian population, truncated 25-64).

Quality of colposcopy and treatment: data from the national survey of Italian organised cervical screening programmes.

We collected from Italian organised cervical screening programmes data (a) on the correlation between colposcopic findings (according to the 1990 international classification) and histology, and (b) on the treatment/management of screen-detected histologically confirmed cervical intraepithelial neoplasia (CIN). Data routinely registered by organised programmes was provided as aggregated tables. We obtained data on colpo-histological correlation from 63 programmes. Of the 14,745 reported colposcopies 38.9% were classified as normal and 19.6% as unsatisfactory. CIN1 or more severe histology was detected in 2,664/4,877 (54.6%) colposcopies classified as grade 1. CIN2 or more severe histology was detected in 865/1,239 (69.8%) colposcopies classified as grade 2 or higher. Of all colposcopies during which a CIN2 or more severe histology was detected, 40.3% had a colposcopy classified as grade 2 or higher. We obtained data on treatment from 82 programmes. Of the 2,903 women with CIN1, 69.8% had follow-up only. However 25 (0.9%) of them had cold-knife conisation, 212 (7.3%) were treated by diathermocoagulation and 17 (0.6%) had hysterectomy. Of the 2,568 women with CIN2 or CIN3, 4.9% had not yet been treated when data was collected and no data was available for a further 7.5%. Excision by radio-frequency device was the most common treatment among these women (60. 6% of those with known treatment). However, 1.5 % of all CIN2 and 5.5 % of all CIN3 had hysterectomy. Among the 140 women with invasive carcinoma 17.8%, plausibly with microinvasive disease, had excisional treatment only reported.

The risk of false-positive histology according to the reason for colposcopy referral in cervical cancer screening: a blind revision of all histologic lesions found in the NTCC trial.

All cervical intraepithelial neoplasia (CIN) diagnoses identified during the New Technologies for Cervical Cancer trial (ISRCTN81678807) were blindly reviewed by 2 pathologists. Original diagnoses based on colposcopy-guided biopsies were compared with those made by the reviewers who had access to all clinical histologic samples (including postsurgical). Cases downgraded from CIN 2+ by the reviewers were considered indicative of unnecessary treatments. The analyses are presented according to the molecular (high-risk human papillomavirus [HPV]) and/or cytologic diagnosis used to refer the women for colposcopy. We reviewed 812 CIN 1 and 364 CIN 2 + diagnoses. The specificity of colposcopy-guided biopsy was 98% and the sensitivity, 84%. The probability of unnecessary treatment was 27% for women with atypical squamous cells of undetermined significance cytologic findings and 8% for women with low-grade squamous intraepithelial lesion or worse, 10% for HPV+ and positive cytologic findings, and 16% for HPV+ alone. The positive predictive value of the first-level screening test was inversely associated with probability of a histologic false-positive result (P = .015). In screening, a low positive predictive value of the colposcopy-referring test may result in unnecessary treatments.

Extension of organised cervical cancer screening programmes in Italy and their process indicators.

Since 1996, Italian national guidelines have recommended to regions the implementation of organised screening programmes for cervical cancer. As in the previous years, starting from 1998, we collected aggregated tables of data from Italian organised cervical screening programmes in order to centrally compute process indicators. In 2005, the target population of Italian organised screening programmes included 10,969,571 women, corresponding to 66.7% of Italian women aged 25-64 years. However, these programmes invited only 24.8% of their target population in 2005, vs. 33.3% expected in order to invite the entire target population in the 3-year recommended interval. Compliance to invitation was 36.7%, with a clear North-South decreasing trend. It must however be considered that many women are screened outside the organised programmes. The remaining process indicators deal with women invited during 2004 and screened up to April 2005. Unsatisfactory smears were 3.1%. It was recommended to 6.1% of women to repeat cytology, and 61% of them complied. Some (2.5%) of screened women were referred to colposcopy. Compliance to colposcopy was 84.7% among women referred because of ASCUS or more severe cytology and 88.2% among those referred because of HSIL or more severe cytology. The Positive Predictive Value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 15.5%. There was a relevant variability of both referral rate and PPV, that were inversely related, and 10 % ofprogrammes referred > 5% of women, suggesting too broad criteria of interpretation of cytology. The unadjusted detection rate ofhistologically confirmed CIN2 or more severe was 2.7 per 1000 screened women (3.0 per 1000, standardised on the Italian population, truncated 25-64).

Quality of colposcopy and treatment: data from the national survey of Italian organised cervical screening programmes.

We collected from Italian organised cervical screening programmes data (a) on the correlation between colposcopic findings (according to the 1990 international classification) and histology and (b) on the treatment/management of screen-detected histologically confirmed cervical intraepithelial neoplasia (CIN). Data routinely recorded by organised programmes was provided as aggregated tables. We obtained data on colpo-histological correlation from 41 programmes. Of the 16,292 reported colposcopies, 43% were classified as normal and 23 % as unsatisfactory. CINI or more severe histology was detected in 2278/4449 (51%) of colposcopies classified as grade 1. CIN2 or more severe histology was detected in 651/1033 (63%) ofcolposcopies classified as grade 2 or higher. Ofall colposcopies that found CIN2 or more severe histology, 41% had a colposcopy classified as grade 2 or higher. We obtained data on treatment from 71 programmes. Of the 2,895 women with CINI, 73.4% had follow-up only, 14 (0.5%) of them had cold-knife conisation, 170 (5.9%) were treated by diathermocoagulation and 4 (0.1%) had hysterectomy. Of the 1972 women with CIN2 or CIN3, 4.8% had not yet been treated when data were collected and no data was available for a further 12.9%. Excision by radio-frequency device was the most common treatment among these women (58.7% of those with known treatment). However, 0.8% of women with CIN2 and 4.2% of women with CIN3 had hysterectomy. Of the 76 women with invasive carcinoma, 19.8%, plausibly with microinvasive disease, had excisional treatment only reported.