<p>The European Council recommends adopting risk-based screening when relevant. In triaging HPV-positive women, it can be an effective strategy to reduce overtreatment and referral to colposcopy. HPV genotyping and p16/ki67 expression may allow a better risk stratification than cytology. In Italy, recommendations on their use (alone or combined) in screening were developed by a multi-professional (nine scientific societies) and multidisciplinary working group (including patients and decision makers). Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Data from large clinical trials on screening populations with long follow-up instructed the biomarkers’ evaluation. The working group defined the CIN3+ risk thresholds (a surrogate marker of cancer risk) to guide decisions on management: immediate colposcopy, referral to 1-year and 3-year retesting. The risk-based approach allowed to reduce the number of possible strategies to be compared to five specific healthcare questions framed as PICOs. The prioritised outcomes were risk of cancer and of CIN3+ in HPV+/triage-negative women, number of colposcopies, number of samples to be taken, and number of unneeded treatments. The combination of morphological markers (cytology or p16/ki67) and extended HPV genotyping was the only strategy with a conditional recommendation in favour when compared with cytology.</p>

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Italian guidelines for cervical cancer screening. Multisocietal recommendations on the use of biomarkers in HPV screening with risk-based approach and GRADE methodology

  • Silvia Gori,
  • Francesco Venturelli,
  • Francesca Carozzi,
  • Paolo Giorgi Rossi,
  • Annarosa Del Mistro,
  • Tiziano Maggino,
  • Roberta Giornelli,
  • Paolo Cristoforoni,
  • Giovanni Negri,
  • Antonella Pellegrini,
  • Maggiorino Barbero,
  • Filippo Murina,
  • Emanuele Torri,
  • Franco Maria Buonaguro,
  • Paola Mantellini,
  • Anna Iossa,
  • Paola Garutti,
  • Anna Gillio Tos,
  • Elena Allia,
  • Barbara Aguiari,
  • Karin Louise Andersson,
  • Paola Armaroli,
  • Maria Benevolo,
  • Simonetta Bisanzi,
  • Annalisa Brozzetti,
  • Simonetta Bulletti,
  • Elena Burroni,
  • Filippo Cellai,
  • Elena Cesarini,
  • Lucia Ciccocioppo,
  • Clementina Cocuzza,
  • Laura De Marco,
  • Prassede Foxi,
  • Helena Frayle,
  • Concetta Fumia,
  • Daniela Gustinucci,
  • Vincenzo Maccallini,
  • Luigia Macrì,
  • Marianna Martinelli,
  • Serena Matarese,
  • Valeria Nofrini,
  • Basilio Passamonti,
  • Tiziana Rotondo,
  • Cristina Sani,
  • Priscilla Sassoli de Bianchi,
  • Maria Lina Tornesello,
  • Ezio Venturino,
  • Carmen Beatriz Visioli,
  • Iacopo Baussano,
  • Marco Zappa,
  • Anna Daniela Iacobone,
  • Eleonora Petra Preti

摘要

The European Council recommends adopting risk-based screening when relevant. In triaging HPV-positive women, it can be an effective strategy to reduce overtreatment and referral to colposcopy. HPV genotyping and p16/ki67 expression may allow a better risk stratification than cytology. In Italy, recommendations on their use (alone or combined) in screening were developed by a multi-professional (nine scientific societies) and multidisciplinary working group (including patients and decision makers). Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Data from large clinical trials on screening populations with long follow-up instructed the biomarkers’ evaluation. The working group defined the CIN3+ risk thresholds (a surrogate marker of cancer risk) to guide decisions on management: immediate colposcopy, referral to 1-year and 3-year retesting. The risk-based approach allowed to reduce the number of possible strategies to be compared to five specific healthcare questions framed as PICOs. The prioritised outcomes were risk of cancer and of CIN3+ in HPV+/triage-negative women, number of colposcopies, number of samples to be taken, and number of unneeded treatments. The combination of morphological markers (cytology or p16/ki67) and extended HPV genotyping was the only strategy with a conditional recommendation in favour when compared with cytology.