Shared Decision Making: Understanding HPV Information Needs

As common as HPV is, most people have never heard of it, and those who have it usually don’t know it.^19,27 In a September 2004 nationwide poll of women on topics related to health, only 3 percent of respondents said they knew HPV caused cervical cancer.²⁸ Although the vast majority (85 percent) said their health care provider had never spoken to them about HPV testing, more than half (66 percent) said they would want to be tested after being told about HPV tests by the pollster. Clearly, women and their health care providers want—and need—more information about HPV to be able to share the process of making decisions about being tested for HPV and managing test results, especially as choices increase.

“The general population does not know what HPV is,” says Diane M. Harper, MD, MPH, MS, associate professor and director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School. “There have not been enough appropriate public health education programs, enough soap operas, enough ‘Saturday Night Live’ shows, enough sitcoms, enough MTV spots that discuss the infection to make a dent in public education.”

The news media also could do a better job. In a recent content analysis of more than 100 news stories about HPV from the ten most circulated newspapers and from three major television networks, researchers found that most stories focused on HPV as a sexually transmitted infection (79 percent); only about half reported that HPV is very common. In addition, few (26 percent) made the point that most women with HPV will not develop cervical carcinoma. Providing information about low-risk and high-risk types of HPV and their differing links to cervical cancer; describing HPV prevention, transmission, and symptoms; explaining the benefits and consequences of HPV testing; and outlining the latest screening guidelines in every story would better fulfill women’s educational needs, the study’s authors concluded.²⁹

Along with her regular caseload, Harper sees 15–20 patients a week who have been misguided by other physicians about what it is they have. Often patients have been told that HPV is like herpes and that they will have it forever, Harper said. Most clinicians fail to tell patients that the vast majority of HPV infections will clear on their own.

“Women who are infected with HPV want to understand and be able to make their own decisions about management options,” she said. “It is incredibly rewarding for me to be able to help them, but let’s get our own colleagues talking on the same page.”

Experts agree that the clinical community plays a critical role in creating the kind of environment in which decisions about screening can be shared and results can be discussed without anxiety and psychological distress.³⁰

HPV: What’s the Risk?

HPV is not an easy virus to explain, Harper concedes. What is known is that sexual behavior is the primary risk factor for infection. Risk increases with increasing numbers of lifetime sex partners: women with larger numbers of sexual partners have a higher risk of contracting the virus than women with only one or few partners, as do women whose partners have had many partners. HPV travels from person to person from the skin, most commonly during sexual activity, particularly during vaginal and anal sex. Scientists believe it may be possible that some HPV transmission occurs during oral sex. In very rare cases, HPV may be transmitted non-sexually, possibly through contact with infected urogenital secretions from sharing towels or bathwater.^32–33

There is no direct antiviral or effective systemic therapy for genital HPV. After transmission, the virus is most commonly cleared by the immune system (or suppressed below the limits of detection), or it causes persistent (lasting) infection. The period between exposure and identification of being HPV positive or development of a lesion is highly variable, making it virtually impossible for most individuals to determine exactly when and from whom HPV exposure occurred. HPV can be present for years with no symptoms.

Men or women who engage in anal sex are susceptible to HPV infections and may be at risk for anal cancer. This is a concern for homosexual men in particular, but also for heterosexual women who have anal-receptive intercourse. Anal cancer is still uncommon, but incidence has increased for both women and men in the United States. In fact, the high proportion of tumors with detectable HPV suggests that infection with HPV may be a prerequisite for anal cancer.³⁴

“There is so little understanding of HPV, of the sexual transmission involved with cervical cancer, often women feel stigmatized, and clinicians are not comfortable or able to discuss HPV with their patients,” Saslow said. (See page 10 for information on counseling patients with HPV. The American Cancer Society has a new booklet about these issues and a second booklet in development. See Resources for Web site information.)

As Dartmouth’s Harper wrote in a recent article, a strategy of informed, shared decision making can help overcome these problems: “Patients are more comfortable and less anxious about their diagnosis and management if they understand the disease and their choices for management; if they understand their own values and preferences for the choices of care; and if they are able to participate in the decisions about their management.”³⁶

Other Risk Factors for Cervical Cancer

HPV may be necessary for the development of cervical cancer, but it is not sufficient to cause cancer on its own. Only about one out of 1,000 women with HPV develops invasive cervical cancer, because most women with HPV do not develop highest-risk cell abnormality (CIN 3), and when they do, detection by cervical screening and subsequent treatment areas successful in preventing most cervical cancers.³⁷ Studies suggest that whether a person will develop cancer depends on a variety of factors that act together with HPV. These include smoking, decreased resistance to infection, and infection with other sexually transmitted infections, such as human immunodeficiency virus (HIV), chlamydia, and genital herpes.^38–39

Genetic susceptibility to HPV infection also appears to be important. In one study, investigators found that women whose biological mother or sister had cervical cancer were almost twice as likely to develop cervical cancer as women who did not have a family history of the disease.^40-41

HPV DNA Testing

It is known that certain HPV types are the primary cause of cervical cancer. If individuals carrying this virus could be identified, women at risk could be monitored more closely and treated earlier for abnormal cell changes that might otherwise develop into cervical cancer.

This is the challenge of the first FDA-approved DNA test for HPV, The Hybrid Capture^®, which detects the 13 high-risk HPV types.

In routine cervical cancer screening of women age 30 years and older, the FDA has approved the use of the HPV test at the same time the Pap test is done (DNA with Pap™). In women younger than 30, an HPV test typically is done after the Pap test is read, if the results are inconclusive.

When the HPV DNA test is used in conjunction with the Pap test, it can help determine which women are at virtually no risk of having precancer or cancer either now or in the next three years (women with a normal Pap and a negative HPV test) and which women are at some increased risk and require more frequent screening (HPV positive). In most instances, women with a Pap reading more abnormal than ASC-US need colposcopy, no matter what the HPV result is, as recommended by the American Society for Colposcopy and Cervical Pathology (ASCCP).⁴³

Studies show that the overall sensitivity of the Pap test for identifying women with cervical cancer or its precursor conditions ranges from 51 to 85 percent. A recent study in a leading medical journal found the sensitivity of the Pap test used in conjunction with the HPV DNA test to be almost 100 percent.⁴⁴

“Cervical cancer is one of the few cancers we know how to prevent,” says Walter Kinney, MD, a gynecological oncologist for Kaiser Permanente. “This enhanced testing enables us to more accurately predict which women are at risk of cervical cancer and which women can be spared unnecessary invasive procedures when they have an abnormal Pap test result.”

HPV DNA testing is an assessment of risk and an objective measure on which to plan the frequency of follow-up testing. These changes have prompted new recommendations for the screening and management of cervical lesions.

Guidelines issued by the American College of Obstetricians and Gynecologists (ACOG) and the American Cancer Society (ACS) now recommend HPV testing in conjunction with a Pap test as an option for routine cervical cancer screening for women age 30 and older—the group most likely to have persistent HPV infections. In addition, the National Cancer Institute and the ASCCP recently joined with the ACS to issue “interim guidance” on the management of women screened with both the Pap and HPV tests, according to their test results. (See Resources for these organizations’ Web sites, where guidelines may be viewed in full.

Cost-Effectiveness of HPV DNA Testing

It costs more initially, but research shows that for women over 30, receiving a Pap test in conjunction with HPV screening every two to three years makes good economic sense, both in screening for cervical cancer and in managing an Pap test result of ASC-US.

In one recent study, researchers used a mathematical model to compare the costs of a Pap test plus an HPV test, a Pap test alone, and an HPV test alone. The combination of an HPV test plus a Pap test provided “maximal savings in life years” when offered without an upper age limit. In addition, the study showed that adding HPV testing to lifetime biennial Pap screening can help prevent 225 cases of invasive cervical cancer per 100,000 women and can decrease cervical cancer mortality by an additional 59 percent over the use of a Pap test alone.⁴⁵

Another study concluded that for women age 30 and over, a strategy of screening every two or three years that uses either (1) HPV DNA testing in combination with cytology for primary screening or (2) cytology with reflex HPV DNA testing for equivocal results will provide a greater reduction in cancer incidence and be less costly than annual conventional cytology.⁴⁶

Most recently, data presented for the first time at the October 2004 meeting of the European Research Organization on Genital Infection and Neoplasia (EUROGIN) show that testing women with the combined Pap/HPV test in accordance with published screening guidelines is as or more cost effective than doing a Pap test alone to screen for cervical cancer. The research, which looked at six studies on the cost-effectiveness of different strategies for cervical cancer screening, is the most comprehensive analysis to date of the economic impact of HPV testing.

“Our analysis showed that HPV testing is highly cost-effective,” said Jeremy Holmes, lead researcher and director of PMSI Healthcare, a London-based health economics and policy consultancy. “The results showed that the costeffectiveness of HPV testing is comparable to or greater than cytology alone when done no more often than every two years and only for women age 30 and over.”

HPV DNA screening shows great promise, experts agree, but it is too early to gauge its overall impact. And there are other factors to consider. Chief among these is the potential for overuse.

“These tests should NOT be used every year, but women seem to WANT to be tested every year anyway,” Saslow said. “And doctors oblige or want to test them as well.”

The idea of a routine annual test for cervical cancer is commonly held, both by patients and their clinicians who may not understand screening guidelines (The Challenge to Improve Screening). Unnecessary testing leads to wasted resources— time and money—and may increase stress.