Clinical relevance of partial HPV16/18 genotyping in stratifying HPV-positive women attending routine cervical cancer screening: a population-based cohort study.

OBJECTIVE: To evaluate partial HPV16/18 genotyping as a possible biomarker to select women attending HPV-based cervical cancer screening at higher risk to be referred to colposcopy. DESIGN: Population-based cohort study. SETTING: Organised cervical cancer screening programmes (Italy). POPULATION: Women with high-risk HPV infection (period: 2015-2019). METHODS: We analysed the association between partial HPV16/18 genotyping, cytology triage and histologically confirmed diagnosis of high-grade cervical intraepithelial neoplasia (CIN3+ ) lesions. MAIN OUTCOME MEASURES: Detection rate (DR) and positive predictive value (PPV) for histologically confirmed CIN3+ (any episode in the 2 years after baseline); sensitivity for CIN3+ and number of colposcopies needed for lesion detection. RESULTS: The study included 145 437 women screened with HPV testing by the clinically validated COBAS 4800 HPV assay (Roche). Overall, 9601 (6.6%) women were HPV+ at baseline; HPV16 and HPV18 were present in 1865 and 594 samples, respectively. The cumulative (baseline plus 1-year repeat) cytology positivity was 42.8% and high-grade cytology was significantly higher (P < 0.0001) among women with HPV16 infection at baseline (15.2%). The cumulative CIN3+ DR for women with HPV16, HPV18 and other HPV-type infections was 9.8%, 3.4% and 1.8%, respectively. CONCLUSIONS: Partial HPV16 genotyping may play a role in triage, whereas HPV18 seems to behave much more similarly to the other HPV types and does not provide additional stratification. HPV16 genotyping combined with high-grade cytology can be envisaged as a triage biomarker in cervical screening to maximise CIN3+ detection while minimising colposcopy at baseline or 1-year repeat. TWEETABLE ABSTRACT: HPV16 genotyping combined with high-grade cytology can be used as triage biomarker for CIN3+ in HPV-positive women.

Expression of p16 in abnormal pap-tests as an indicator of CIN2+ lesions: a possible role in the low grade ASC/US and L/SIL (Ig) cytologic lesions for screening prevention of uterine cervical tumours.

The aim of this study was to assess the validity of protein p16 expression as an indicator of progression in lesions as ASC-US and L-SIL. For this purpose, we examined 246 cytological samples (91 ASC-US, 60 L-SIL, 36 ASC-H, 59 H-SIL) of which 151 were conventional Pap-tests (CC) and 95 in liquid based cytology (LBC) with colposcopic and histology follow-up. The results showed that in the positive p16 Pap-tests a 59% PPV vs CIN2+ in all cytologic diagnoses compared to 43% in cytologic reading alone. 96% of HG cytologic lesions were positive for p16, and the data showed good correlation between positivity for p16 in the cytologic preparations and the presence of CIN2+ lesions in the histologic test (chi-square for trend p < 0.0001). The sensitivity, specificity and NPV were 93%, 52% and 91%, respectively, in all cytologic diagnostic categories. P16 was positive in 46% of ASC-US and 53% of L-SIL. The PPV vs expressed CIN2+ was higher than that observed in cytologic reading (48% vs 26%, and 31% vs 20%, respectively). The sensitivity was 83%, the specificity 67% and 54%, respectively, and the VNP was 92% and 93%. It is possible to design algorithms for colposcopic follow-up that can reduce the need to obtain a follow-up. The future application of this test may allow the creation of a bio-molecular automated pap test.

Cancer patients as 'experts' in defining quality of life domains. A multicentre survey by the Italian Group for the Evaluation of Outcomes in Oncology (IGEO).

Although the subjective nature of quality of life is generally accepted, less attention has been paid to the procedure of selecting domains to be explored with questionnaires. To explore what contributes to cancer patients' quality of life, a survey was conducted with the aim of identifying contents of quality of life using cancer patients as 'experts'. A questionnaire with open-ended items aimed at exploring the meaning of quality of life and at determining the contents of health and not health related quality of life, was submitted to a sample of cancer patients stratified by residence, cancer site and stage of disease. The 248 questionnaires received were transcribed and broken down into phrases to allow coding. A content analysis was performed, using as a conceptual framework, the domains identified by the Italian Society of Psycho-Oncology. Overall, 43 domains and a list of symptoms were identified. The two most frequently reported symptoms were pain (21.4% patients) and fatigue (14.1% patients). Social relationships and psychological domains were heavily represented. Twenty sub-domains related to the domain 'psychological well-being'. This study suggests that information on the content of quality of life questionnaires to be submitted to people affected by a specific disease, should be derived by studying people suffering the specific disease. These results reinforce the criticism that available quality of life instruments are more likely to reflect the perspective of health professionals than patients.

[Evaluation of quality of life in oncology. Rationale and objectives of the first phase of the Quality of Life in Oncology project]. / La valutazione della qualità di vita in oncologia. Razionale ed obiettivi della prima fase del progetto QvOnc.

Although the subjective nature of quality of life perception is generally accepted, less attention has been paid to the procedure of selecting domains to be explored with questionnaires. In most cases domains are selected by panel of experts. It is not known whether these domains are relevant for the patients. Moreover, questionnaires developed in 'foreign' countries may not be culturally sound or relevant for patients living in different cultural background. In order to explore what really contributes to quality of life of Italian patients, a survey was conducted with the aim of identifying any dimension of quality of life, positively or negatively impacted on from the illness and therapies. A sample of two hundred and eighty eight cancer patients with previously specified characteristics (primary tumor, stage of disease and place of residence) were identified. After consenting to partecipate to the study, a staff member (a physician, a nurse or a psychologist) asked the patient to complete an open-ended questionnaire in the out-patient clinic or at home. This questionnaire, partially derived from a study by Padilla et al. made up of 5 questions: 'What does the term quality of life mean to you?', 'What contributes to a good quality of life?', 'What contributes to a poor or bad quality of life?', 'Which either physical or psychological symptom interferes with your quality of life?', 'State any positive or negative change in your quality of life, due to illness or treatments'. The first question was asked to explore the meaning of quality of life for the patient; the second and third question were asked to determine the contents of quality of life not health related; the fourth question and the diary provided information about quality of life contents related to his own experience of disease. Two hundred and forty eight questionnaires (86.1%) were obtained from 7 Cancer Centres participating to the study (Genova, Milano, Roma, Perugia, Napoli, Cagliari, Palermo). All the questionnaires were transcribed and subsequently broken down in phrases on a form that allowed coding. Three raters (a research nurse, an oncologist and a clinical psychologist) made the content analysis using as conceptual framework the list of domains identified by the Italian Society of Psycho-Oncology. The present study shows the possibility to define the content domain of quality of life attributes for cancer patients, using patients as experts.

[In vitro study of the antifungal activity of two chlorine derivatives to be used in antisepsis]. / Studio "in vitro" dell'attivita' antifungina di due cloroderivati per l'impiego nell'antisepsi.

The activity of two chlorine derivates, sodium hypochlorite in water solution with NaCl (product A) and electrolytic chloroxidant (product B) has been tested in vitro against potentially human pathogenic fungi (Aspergillus niger, Aspergillus fumigatus, Microsporum gypseum, Candida albicans, Cryptococcus neoformans, Trichophyton mentagrophytes, Microsporum canis, Epidermophyton floccosum, Trichophyton rubrum, Sporotrix schenkii). For A. niger, the relation of the two compounds has also been considered between mycelial and sporidial forms. Dilutions used ranged from 0.15 to 10% (corresponding to 17.2-1150 ppm of active principle for product A, and to 18.3-1220 ppm of active principle for product B). These were applied for different times in order to assess the minimal inhibitory concentration (M.I.C.) and to evaluate the survival time of the microorganisms tested, which were strains from the collection of the Institute of Mycology, (Faculty of Agrarian Science, Perugia) and recently isolated ones from animal and vegetable tissues, cultivated on Sabouraud medium. The cell suspension to be tested was obtained on nutrient broth in shaken flasks (120 rpm) at 28 degrees C for 48 h, and was separated by centrifugation and 10000 rpm at 5 degrees C for 20 min, repeatedly washed with sterile physiologic saline and resuspended in sterile water where it was submitted to delicate pressure in order to fragment the mycelium. Activity tests were carried out on Sabouraud broth and Sabouraud agar with controls for every case without the active principle. Aliquots of the suspensions (microrganism++ + disinfectant) were transferred at regular intervals (1, 3, 5 and 10 minutes) to the two substrates in liquid and solid state, and the growth of microorganisms was followed at 28 degrees C for 48-72 h in the case of yeasts, and for up to 21 days in the case of sower growing fungi. The cell content of the different suspensions was found to range from 10(4) to 10(9) UFC/ml. The active chlorine contents of the two compounds was evaluated by iodometry simultaneously with the pH of the different solutions. Useful data were obtained from the comparison of the two systems of activity assessment of the fluid and agarized substrate. It was thus found that the two compounds were equally active against the species tested. Some of these (A. fumigatus, M. gypseum, A. niger, C. albicans, C. neoformans) were less sensitive to the compounds examined (doses for cell inactivation 0.62-2.5% for product A, and O.15-1.25% for product B) where at any rate product B was more active.(ABSTRACT TRUNCATED AT 400 WORDS)