Vice-Chair, Associate Clinical Professor, Department of Obstetrics and Gynecology

Ilana Cass, MD

The Papanicolaou (Pap) smear test came into widespread use in the 1950s and is considered to be the most successful screening test in modern medicine.

 For more than 5 decades, cervical cytology was the only way to detect precancer or early invasive cancer. 

The discovery of the causative role of human papillomavirus (HPV) in the 1970s has laid the foundation for new ways to screen for, and potentially eradicate, this largely preventable disease.

Over the past decade, data have strongly suggested that primary HPV nucleic acid screening will eventually supplant cytology-based technology.

 This evolution toward primary HPV testing for optimal cervical cancer screening will require considerable provider support, patient education, and updated laboratory technology and procedures before existing cytology-based screening options (cytology alone and cotesting) can be phased out.

The prevention of cervical cancer can be primary or secondary. Cytology and HPV screening provide secondary prevention as they detect asymptomatic precancer and early cancers. Primary prevention focuses on the avoidance of genital HPV infection and its consequences by the use of HPV vaccination and behavioral steps such as condom use and smoking cessation. 

We should do everything we can to support primary prevention efforts, particularly through HPV vaccination as recommended by current guidelines.

At least half of the approximately 14,000 cervical cancers diagnosed annually in the United States will be in unscreened or underscreened (not screened in the previous 5 years) women.

Cervical cancer disproportionally affects racial minority, rural, and uninsured populations.

 It is essential to expand access to all available, effective cervical cancer screening options for the most vulnerable populations. The targeted use of any particular screening modality in higher-risk populations is not supported by evidence-based guidelines; any effective screening is the priority.

 Cervical cytology can be collected as a conventional slide (“smear”); cells are taken directly from the cervix using a broom device or spatula (with or without an endocervical brush) and spread on a glass slide with immediate spraying with or immersion in a fixative. 

Liquid-based cytology calls for the similarly collected cells to be transferred directly into a liquid fixation and transport medium, a Pap “test.” Conventional slide and liquid-based cytology have equivalent performance in the detection of cervical cancer and its significant precursors.

Liquid-based cytology now accounts for nearly all cervical cytology testing in the United States, as automated slide preparation and preliminary review are possible, and the remaining transport medium can be used for HPV and other testing.

HPV testing: By convention, HPV testing refers to clinical testing only for either 13 or 14 high-risk HPV types. Cells are collected from the cervix using the same collection devices, technique, and transport media as those recommended for cytology sampling. 

These HPV types account for nearly all cervical cancers.

Some HPV tests provide “genotyping.” This refers to testing that specifically identifies HPVs 16 and 18, whereas the other high-risk HPVs are detected within a pooled group. HPVs 16 and 18 are considerably more oncogenic than the others and their detection may influence management.

At this time, 5 clinical HPV tests are available in the United States that are US Food and Drug Administration approved. Only 2 of these are currently approved for primary HPV testing in individuals aged 25 years and older (cobas 4800 HPV Test, Roche Diagnostics; and BD Onclarity HPV Assay, Becton, Dickinson and Company).

It is widely accepted that testing for low-risk HPV types (types 6 and 11) has no role in clinical practice and it is strongly discouraged; the presence of these types does not increase the risk of developing anogenital cancers. 

Also, HPV testing should not be used to screen for sexually transmitted infections, as it detects only a specific group of genital HPV types at levels indicative of an elevated risk of cervical intraepithelial neoplasia 3 or cancer (CIN 3+). Therefore, a negative test does not mean that HPV is not present.

Three effective screening options are supported by clinical guidelines: cytology, cotesting, and primary HPV testing (

 They can be selected based on patient and provider preference (shared decision-making optimal), financial considerations (patient and/or health care system resources), and familiarity with the triage of results.

 Few labs are set up for primary HPV screening, but this option is expected to become more widely available in the near future.

Cervical cytology screening can be ordered as cytology alone but is most commonly ordered with reflex HPV testing. Reflex HPV testing is arranged in advance with the clinical laboratory with established parameters for when an HPV test should be performed once the cytol

ve been obtained. Its main use is to stratify the risk of CIN 3+ of an atypical squamous cell of undetermined significance cytology, which is the most common and lowest-risk Pap abnormality. 

Cytology, usually with reflex HPV testing, remains a mainstay of cervical cancer prevention and is highly cost-effective.

 It is repeated at shorter intervals (3 years) than cotesting or primary HPV testing to compensate for its lower sensitivity and less durable reassurance that CIN 3+ will not develop.

Cotesting is cytology with a concurrent HPV test. The HPV test is carried out regardless of the Pap result, even if that was negative. Concurrent HPV negativity offers stronger reassurance that CIN 3+ is not present and will not develop over the next several years than cytology alone; this reassurance allows for screening intervals to be extended safely to 5 years.

Cotesting was deemed the preferred screening modality (over cytology) in 2012 by 2 of 3 major gynecologic institutions

; however, this is not the case for the latest guidelines.

Disadvantages of cotesting include complex results to manage appropriately and more expense (doubles the number of tests), and it is less specific than cytology alone. Cotesting also results in more colposcopy referrals, which can lead to more treatment of transient HPV infections and lesions that may have regressed over time without intervention.

Primary HPV testing reverses the traditional cytology-based screening paradigm by obtaining the results of the HPV test first and calling for a reflex cytology result only if the specimen is HPV positive. 

The rationale for this strategy is that the presence of high-risk HPV infection is necessary to develop CIN 3+ and therefore there is no need for a cytology test if the HPV test is negative. The HPV positivity rate in the general population varies between studies. 

The results of 1 large US study using the cobas test found HPV positivity rates were higher (10.5%) than the baseline abnormal cytology rates (6.4%).

 For now, the collection of cells is the same as for cytology or cotesting. 

Contact with the cervix, particularly the squamocolumnar junction, is not as critical for HPV testing as for cytology, and therefore self-collection by vaginal swab may become an option in the foreseeable future to determine who needs further evaluation.

Current guidelines call for the triage of positive primary HPV results by reflex cytology testing; the paired results inform management decisions.

Reflex testing with more precise technology for predicting the presence of CIN 3+ risk may replace cytology triage using candidates such as p16/Ki67 dual staining.

Findings from numerous large, randomized, controlled trials have established that HPV-based testing improves screening sensitivity compared with cytology, increasing the detection of CIN 3+ in the first round of screening by a factor of 2 to 3.

The absence of high-risk HPV is associated with lower risks of developing CIN 3+ over longer intervals than is negative cytology screening.

A large, randomized US trial compared the 3 current screening strategies in women 25 years and older. The sensitivities for the detection of CIN 3+ were cytology, 48%; cytology changing to cotesting at age 30, 62%; and primary HPV testing, 76%.

This increased sensitivity of HPV-based testing comes at the cost of decreased specificity and increased referrals for colposcopy. Also, over-referral can lead to treatment of mild and moderate severity lesions that may regress spontaneously. It is important to manage abnormal results according to risk-based management guidelines that seek to avoid overtreatment.

Another argument in support of HPV-based testing is the relative and absolute increase in cervical adenocarcinoma incidence in the United States and elsewhere over recent decades, despite cervical cancer screening.

 Adenocarcinomas now make up 20% to 30% of cervical cancers.

This implies that cytology screening identifies squamous lesions vs glandular ones with greater sensitivity and perhaps that identification of squamous precursors is more effective in cancer prevention than the identification of adenocarcinomas in situ. It is hoped that HPV-based screening will be more sensitive than cytology for identifying cervical adenocarcinoma in situ and adenocarcinomas.

Although evidence shows that HPV-based testing offers advantages over cytology-based screening, there is debate as to whether cotesting is preferable to primary HPV testing; the basis of debate is over sensitivity.

The concept of cervical cancer screening without cytology can be unfamiliar and unsettling to patients and providers alike. 

However, the incidence of HPV-negative but cytology-abnormal tests preceding cervical precancer and cancer is a relatively rare event; it is estimated the cytology component of cotesting would prevent 5 cervical cancers per 1 million women per year.

This small gain comes at a considerable cost, doubling the number of tests performed and adding considerable expense and resource utilization, not to mention leading to the diagnosis and overtreatment of lesser lesions. 

No screening program is expected to diagnose or prevent every case of the target disease, and attempting do so, particularly in the case of cervical cancer, would be cost-prohibitive
and misguided.

It should be remembered that HPV vaccination will continue to decrease the prevalence of vaccine-type oncogenic HPVs in the general population over time. As precursor lesions and cervical cancers become rarer, false-positive cytologic abnormalities will become more common and cytology screening will become even less efficient.

The most recent cervical cancer screening guidelines come from the United States Preventive Services Task Force (USPSTF)

 The American College of Obstetricians and Gynecologists, on behalf of other stakeholder organizations, has issued a statement endorsing the USPSTF guidelines (

Both major guidelines endorse all 3 screening options (cytology, cotesting, and primary HPV testing) for individuals 30 years and older. There are 2 major differences between them, however. 

First, the USPSTF continues to recommend that screening start at age 21, whereas the ACS now recommends delaying the initiation of screening to age 25, beacuase of the rarity of cervical cancer below this age and the potential for overtreatment of lesions destined to spontaneously regress.

Table 2. Current Guideline Recommendations

Second, the USPSTF recommends that individuals aged 21 to 29 years be screened with cytology every 3 years because of the higher rate of HPV positivity in this age group; thereafter, any of the 3 screening modalities can be used, with shared decision-making encouraged. 

The ACS recommends primary HPV testing every 5 years as the preferred screening modality from age 25 on; if primary HPV testing is not yet clinically available, screening with cotesting every 5 years or cytology every 3 years is acceptable. 

Current guidelines recognize 3 highly effective ways to screen for cervical cancer: cytology, cotesting, and primary human papillomavirwus (HPV) testing.

Clinical HPV testing detects the presence of high-risk HPVs that account for nearly all cervical cancers.

HPV-based screening is more sensitive than cytology and allows for longer intervals between screenings.

Cotesting offers little advantage over primary HPV testing and comes at greater cost.

Disparities in cervical cancer incidence can be countered by screening using any guideline-supported modality with evidence-based management of abnormal results.

The ACS recommends phasing out cytology and cotesting as soon as primary HPV testing can be implemented. The rationale for primary HPV testing supplanting cytology is its greater sensitivity for detecting current CIN 3+ and superior reassurance that CIN 3+ will not develop over the next 5 years compared with a negative cytology. 

The ACS acknowledges that very few settings are ready for this transition in terms of laboratory infrastructure.

Preventing cervical cancer is a process. Primary prevention with HPV vaccination and secondary prevention with effective screening remain the priorities. As vaccine uptake increases, cytology screening is expected to become less efficient. Cervical cancer screening will continue to evolve along with our understanding of HPV biology and technological advances. 

Ultimately, a highly accurate and cost-effective test with streamlined triage and management of abnormal results will translate into the best outcomes for most individuals. Clinical guidelines are shifting from cytology to HPV-based testing, with primary HPV testing presenting the most advantageous balance between sensitivity, specificity, and cost. 

During this time of transition, it should be remembered that the best strategy is to screen as many women as possible using any of the 3 strategies approved by current clinical guidelines. 

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Articles

It is essential to expand access to all available, effective cervical cancer screening options for the most vulnerable populations. The targeted use of any particular screening modality in higher-risk populations is not supported by evidence-based guidelines; any effective screening is the priority.

Current choices in cervical cancer screening

The Fetal Life Protection Act was part of a $13.5 billion budget bill in New Hampshire. Gov. Chris Sununu signed "the most regressive anti-reproductive health care budget in New Hampshire history, ignoring public opinion and opposition from more than 

200 of the state’s leading medical experts

The law is slated to take effect in January 2022. Get Cass' take on what this means for providers. 

We spoke with Editorial Board member Ilana Cass, MD, about her opinion of her state's latest abortion restrictions. 

New Hampshire's abortion restrictions

Videos

Introducing Editorial Advisory Board member Ilana Cass, MD. 

Meet the Board: Ilana Cass, MD

As ob/gyns, we care for patients with a variety of gynecologic and reproductive health issues that can be emotionally charged and intensely private. Although gynecologic health issues are medical issues as are headaches or sprained ankles, the extent to which individuals want to talk openly about them varies. In our offices, patients share their fears, their pains, and their hopes, and discuss their sexuality, their gender identity, and their sexual behaviors. We talk with preteens about puberty, with teens about their periods, with women who are excited to be pregnant, and with those who are not. We talk to women who have never told anyone about a past sexual assault. We talk with women who are facing infertility or the need for a hysterectomy. Our patients know we will listen to and treat them with dignity and provide accurate health education that enables them to be a partner in their health care decisions.

Three recent pieces of legislation highlight a threat to the physician-patient relationship. The proposal of laws that interfere with this complex and intimate relationship is a step too far. These pieces of legislation illustrate this overreach by the state: dictating medical care for transgender adolescents (Arkansas and 18 other states),

 mandating medically inaccurate information about abortion (18 states),

 and requiring resuscitation for newborns with fatal diagnoses (New Hampshire).

As Frank Bruni pointed out in his recent 

 op-ed column, politicians are currently demonizing trans people in a new culture war, similar to the way in which they vilified gays and lesbians, charging that gay marriages would somehow undermine straight marriages.

 Politicians, including former President Donald Trump, assert that trans equality would “destroy women’s sports.”

 This is a political strategy that ignores the realities of the patients in our offices. It ignores the transgender individual who has found puberty blockers to be immensely helpful or the trans persons who had previously been suicidal when attempting to fit in to a gender-binary world. It ignores the parents who have wrestled with their child’s affirmed gender identity, done extensive research and reading about the issue, and who love their child and support therapy and potentially medication to help alleviate their child’s gender dysphoria. It ignores our medical judgment and recommendations after we have listened to the patient and their parents. It ignores the expertise of our colleagues in endocrinology, psychology, adolescent medicine, adolescent gynecology, urology, and social work who work with transgender youth. As Bruni describes, these lawmakers are stunningly arrogant, and are “getting between physicians and patients.”

As many state legislatures across the U.S. introduce or have in process bills that could directly impact the physician-patient relationship and how treatments are administered, several professional organizations issued position statements. 

In its statement, the North American Society of Adolescent and Pediatric Gynecology stated that it has nearly 470 members consisting of physicians, advanced practice providers, nurses, and professional health care trainees. “Our mission is to provide multidisciplinary leadership in education, research and gynecologic care to improve the reproductive health of all youth, inclusive of children and adolescents who are gender diverse. 

We advocate for the provision of unrestricted, unbiased and evidence-based practice of pediatric and adolescent gynecology. We stand with national medical organizations supporting comprehensive care of adolescents and the confidential relationship between patients and their physicians.

 We support the positions that `physicians must be able to practice medicine that is informed by their years of medical education, training, experience, and the available evidence, freely and without threat of punishment. Patients, their families and caretakers in partnership with their physicians, not policymakers, should be the ones to make decisions about what care is best for them.’”

The other organizations included the American College of Obstetricians and Gynecologists; the American Academy of Family Physicians; the American Academy of Pediatrics; the American Psychiatric Association; and the American Osteopathic Association.

Frontline physicians oppose legislation that interferes in or penalizes patient care. American Academy of Pediatrics. April 2, 2021. Accessed April 26, 2021.

https://services.aap.org/en/news-room/news-releases/aap/2021/frontline-physicians-oppose-legislation-that-interferes-in-or-penalizes-patient-care/

It is not controversial to agree that our obligation as physicians is to care for our patients in a way that best meets their needs. We should also agree that legislatures do not have a role in dictating specifics of medical care. The Coalition to Protect the Patient-Provider Relationship is comprised of nonpartisan, nonprofit organizations united in the “opposition to inappropriate interference in the relationship between a patient and health care provider.”6 Member organizations include the American College of Obstetricians and Gynecologists (ACOG), American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Medical Association, American Medical Student Association, American Medical Women’s Association, American Nurses Association, American Osteopathic Association, American Public Health Association. The coalition states that “patients deserve accurate information, high-quality care, and the treatment options that best meet their needs. Physicians and other health care providers should be able to follow the best medical science and training based on available evidence, and adhere to their ethical obligations.”

It’s not just in areas of women’s health that we must protect that relationship. Other health and safety issues for which politicians are passing laws that stand between us and our patients include gun safety and environmental hazards. Resources for clinicians include a report, “Politics in the Exam Room: A Growing Threat,” by the National Partnership for Women & Families, National Physicians Alliance, Natural Resources Defense Council, and Giffords Law Center to Prevent Gun Violence.

According to ACOG’s policy statement on legislative interference with patient care, medical decisions, and the patient-physician relationship, “laws should not interfere with the ability of physicians to determine appropriate treatment options and have open, honest, and confidential communications with their patients. Nor should laws interfere with the patient’s right to be counseled by a physician according to the best currently available medical evidence and the physician’s professional medical judgment. ACOG strongly opposes any governmental interference that threatens communications between patients and their physicians or causes a physician to compromise his or her medical judgment about what information or treatment is in the best interest of the patient.”

When state legislators try to come between our patients and us, we must speak out strongly. We must not let politics trump science or interfere with our hallowed patient relationships. Our patients must be able to rely upon us to provide appropriate and confidential care, based on science and our medical judgment. 

Legislative tracker: anti-transgender medical care bans

. Freedom for All Americans. Accessed April 13, 2021. 

https://freedomforallamericans.org/legislative-tracker/medical-care-bans/

2.Cox C. As Arkansas bans treatments for transgender youth, 15 other states consider similar bills. 

. April 8, 2021. Accessed April 13, 2021. https://www.usatoday.com/story/news/politics/2021/04/08/states-consider-bills-medical-treatments-transgender-youth/7129101002/

3.An overview of abortion laws. Guttmacher Institute. Updated April 1, 2021. Accessed April 11, 2021. https://www.guttmacher.org/state-policy/explore/overview-abortion-laws

4.Bruni F. Republicans find a cruel new culture war. 

. April 10, 2021. Accessed April 11, 2021. https://www.nytimes.com/2021/04/10/opinion/sunday/transgender-rights-republicans-arkansas.html

5.Ennis D. What Donald Trump’s transphobia really means for women’s sports. 

. February 28, 2021. Accessed April 13, 2021. https://www.forbes.com/sites/dawnstaceyennis/2021/02/28/what-donald-trumps-transphobia-really-means-for-womens-sports/?sh=3fac76545e66

6.About the coalition. Coalition to Protect the Patient-Provider Relationship. Accessed April 13, 2021. 

7.Politics in the exam room: a growing threat. National Partnership for Women & Families. October 2015. Accessed April 13, 2021. https://www.nationalpartnership.org/our-work/resources/repro/politics-in-the-exam-room-a-growing-threat.pdf

8.Legislative interference with patient care, medical decisions, and the patient-physician relationship. ACOG. Updated July 2019. Accessed April 13, 2021. 

https://www.acog.org/clinical-information/policy-and-position-statements/statements-of-policy/2019

Three recent pieces of legislation highlight a threat to the physician-patient relationship.


Keeping Politicians Out of the Exam Room

Slideshows

These ten images can help ob/gyns recognize the additional information GBCA administration provides in MRIs.

The value of GBCA in MRI images

Gadolinium-based intravenous contrast agents (GBCA) provide additional information based on signal intensity changes after GBCA administration. 