Do guidelines really need to get even more complex?
Consider the myriad management decisions that confront us in the field of cervical cancer screening, and the potential result of each choice. Even when cervical screening involves cytology alone, there are five major categories for abnormal results, each associated with a different level of risk requiring a unique level of management:
- atypical squamous cells – undetermined significance (ASC-US)
- atypical squamous cells – cannot rule out a high-grade lesion (ASC-H)
- atypical glandular cells (AGC)
- low-grade squamous intraepithelial lesion (LSIL)
- high-grade squamous intraepithelial lesion (HSIL).
Add in HPV testing with cervical cytology for women 30 years and older, and there is one more abnormal category—normal Pap/ HPV-positive. And these categories just cover initial management. Also needed are guidelines for appropriate follow-up of women who undergo colposcopy for each abnormal cytologic result when no CIN 2, CIN 3, or AIS is found that requires treatment, as well as guidelines for managing women following treatment when high-grade histology is found.
As our understanding of the natural history of HPV and cervical oncogenesis has increased, it has become clearer that we must further adjust management decisions on the basis of age, essentially creating many parallel sets of guidelines for women aged 21 to 24, 25 to 29, and 30 years and older.
Yes, cervical screening and management are complex. We are fortunate that the Internet and new “apps” for smartphones give us easy access to guidelines for most of the potential combinations of clinical findings and results. The guideline algorithms are available at www.asccp.org, and full explanatory articles are available at www.jlgtd.com and www.greenjournal.org (comprehensive apps are available for download for almost every smartphone device).
Remember, it is impossible to create guidelines for every possible clinical situation, so clinical judgment must always be paramount when applying guidelines to individual patients.1
What are the major changes of the latest set of guidelines and its update?
Massad LS, Einstein MH, Huh WK, et al. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Obstet Gynecol. 2013;121(4):829–846. [Also published in J Low Genit Tract Dis. 2013;17(5 Suppl 1):S1–S27.]
Let’s start by focusing on how the experts crafted the 2012 guidelines. New evidence to guide decisions about the management of abnormal screening tests, CIN, and AIS emerged in 2012 from a review of the world literature and from analyses of a large 7-year clinical database (1.4 million women) at the Kaiser Permanente Northern California Medical Care Plan, conducted in collaboration with scientists from the National Cancer Institute.1
Most of the 2006 guidelines remain valid, but new evidence has modified some of the guidelines and created others where gaps existed. Guideline developers recognized that cervical cancer prevention is a process that entails both benefits and potential harms, and that the potential risks cannot be reduced to zero with the strategies currently available. Attempts to achieve zero risk could result in unbalanced harms, including overtreatment.
Potential harms from cervical cancer screening
- Anxiety from an abnormal test that the patient might fear to be a sign of cancer
- Stigma from diagnosis of a ubiquitous sexually transmitted infection (HPV)
- Time and patient expense related to screening and management
- Pain and injury from the procedures and treatment
- Increased risk of premature delivery and pregnancy loss.
Defining acceptable risk levels
Applying the concept of “similar management for similar risks,” guideline developers benchmarked risks to the risks associated with accepted screening and management strategies. Because the 5-year risk for CIN 3+ for a woman with an LSIL Pap finding is about 5.2%, and the recommendation for LSIL is colposcopy, 5.2% was set as the lower limit of the level of risk that provides enough benefit (detection of CIN 3+) to balance the potential harms of colposcopy.1 (See the box on harms above.)
When women return to prolonged screening as follow-up to abnormal cytology or a positive HPV test, acceptable risk was considered to be that approximating the risk for CIN3+ three years after negative cytology or 5 years after negative cotesting—as these risks were considered acceptable to guide recent primary cervical screening guidelines.2-4
To be as precise as possible, experts stratified the guidelines by risk, according to the woman’s age, cytologic diagnosis, and HPV status, including HPV genotyping for types 16 and 18, when tested. Of course, guidelines for management apply only to women who are found to have abnormalities during routine screening.1 Women who experience postcoital or unexplained abnormal vaginal bleeding, pelvic pain, abnormal discharge, or a visible lesion need individualized evaluations.1
Only changes or additions to the guidelines are listed here, so be sure to read the published guidelines and supplemental articles and/or visit the Web sites listed earlier for a review of all the guidelines.