HPV test: Doctors are still not following testing guidelines

by Brian Jackson, MD and Brian Shirts, MD, PhD

We’ve heard a lot of talk lately about personalized medicine (i.e., using advanced diagnostics to guide customized therapy).

A great deal of research is going into creating new molecular and genetic tests. But whether the health care system is prepared to actually generate value from these advanced diagnostics remains an open question. Our group’s research, presented in a new study published in the Journal of Pathology Informatics, finds that one relatively new test is widely misused in ways that drive up costs without benefiting patients.

Cervical cancer screening with annual Pap smears has been a bedrock component of women’s health care for decades. It’s so engrained in the medical culture that many women continue to receive annual Paps even after total hysterectomy (see JAMA article). The personalized medicine philosophy would suggest that screening frequency (and, potentially, modality) should be customized to a patient’s individual risk of cancer rather than following a cookbook formula. And the most important component of that risk turns out to be persistent infection with certain HPV genotypes.

The American Society for Colposcopy and Cervical Pathology (ASCCP) has developed a detailed set of recommendations for personalized cervical cancer screening using HPV testing together with Pap smears. Our study, which analyzed more than 450,000 HPV tests performed at ARUP Laboratories between 2003 and 2009, was designed to assess whether doctors are following those recommendations.

Briefly, the ASCCP recommendations state:

  • HPV testing is contraindicated in women under 21.
  • In women 21 to 29, HPV testing should not be used as a first-line test but may be used for stratifying patients with certain Pap smear findings (e.g., patients with atypical squamous cells of undetermined significance).
  • For women 30 and older, HPV testing may be used either for primary screening or for stratifying patients with those Pap smear findings.
  • In evaluation of HPV-positive, colonoscopy-negative cervical lesions, repeat HPV testing is recommended after one year; shorter intervals are not indicated given the natural history of HPV infections.
  • In women older than 30, negative-screening HPV and cytology allow the follow-up interval to be safely extended to three years, and annual screening is not necessary.

Although we did find HPV-ordering patterns are starting to trend toward the testing guidelines, overall, we found that nearly a quarter of all HPV tests ordered were unnecessary. Here are our key findings in the study:

  • The proportion of HPV tests performed on women under 21 declined over the six-year study period from 20 to 5 percent. Teenage girls and young women under 21 generally do not benefit from HPV testing. In some cases, testing these patients may lead to unnecessary follow-up care, including colposcopy and cervical biopsy.
  • One-third of tests on women between ages 21 and 29 arrived at our laboratory five or fewer days after collection, suggesting that these tests were ordered before the Pap smear result was known.
  • For women 30 and older who were HPV positive, the test was often repeated three to six months later, which is too short a time interval to provide useful information. According to the guidelines, decisions about follow-up actions, such as colposcopy, do not require a repeat HPV test. Thus, a more rational interval before a subsequent HPV test (in conjunction with a Pap test) would be 12 months.
  • For women older than 30 with a negative HPV test result, the most common time interval before the next test was 12 months, suggesting that annual screening is predominant in this group. For low-risk women with negative Pap and HPV results, however, screening every three years is safe and appropriate. Only 6 percent of follow-up tests after a negative HPV results had an interval of three years or more.

These findings aren’t too surprising given the large body of previous research showing that medical practice often doesn’t follow published recommendations. But regardless, the findings show that our health care system has not sufficiently figured out how to optimize and customize treatment based on test results. To achieve the promise of personalized medicine, we need more than new high-tech tests. We need to fundamentally change how we deliver care.

Brian Jackson is Medical Director of Informatics at ARUP Laboratories and Brian Shirts is a Molecular Genetic Pathology Fellow at the University of Utah School of Medicine and Assistant Medical Director of Informatics at ARUP Laboratories.

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  • stargirl65

    I agree that we need to change how we deliver care to the patients but patients also need to change what they expect. My patients EXPECT a pap smear every year from about age 18 until they die. They even expect them after hysterectomies for noncancerous reasons. If you tell them that they don’t need a pap smear every year (as their HPV test and pap smear were normal and they are low risk) then they equate this with there be no reason to return in one year for a yearly evaluation. They think they don’t have to return for 3 years. This is despite the fact that many need other screenings such as breast exams. Also they think that since they don’t need a pap smear that they don’t need a pelvic exam. The two are the same thing in their minds. (Some of you please don’t yell at me if you understand. Some patients get this concept but most do not. I am speaking of them.)

    • MC

      The USPSTF recommends against ovarian screening which is basically a pelvic exam. It’s a grade D. It doesn’t need to be done. Patients need to be educated about these things. Giving in to patient’s expectations (which are usually incorrect and lead to unnecessary tests) just wastes money. I constantly go over guidelines with patients on the spot and then they are totally OK with it, they just want an explanation.

  • Marghosa

    Stargirl65,
    There is something inauthentic about your comment. First, you accuse women of wanting annual pap smears or annual testing, yet in the same breath you admit that if you don’t tell patients to come back yearly, they won’t come in for other exams you deem necessary.

    You feed into the yearly visit which is often unnecessary unless the patient has a valid medical condition requiring regular attendance.

    Can you provide valid scientific research stating that yearly bi-manual pelvic exams and breast exams actually bring down the death rate considerably? How about a true and factual account of the number of false positives associated with over-examining and over-screening your patients? False positives HARM patients with increased anxiety and worry unnecessarily. I HIGHLY DOUBT you can find any evidenced-based research supporting your practice.

    These yearly exams just clear your fear of liability and provide FALSE reassurance to your patients– while you make $$ from unnecessary exams. It also exposes patients to risks associated with screening which doctors RARELY discuss with their patients. Doctors really don’t care if their patients demand more of their services, despite clear evidenced-based research to the contrary.

    Where are the ethics? Patients do NOT need to be cleared from cancer yearly. No other society in history or currently engages in such aggressive practices.

    Dr. Gilbert Welch, addresses this topic in his book being released next week titled, OVERDIAGNOSED, Making People Sick in Pursuit of Health.

  • Eliz52

    I have to say American doctors terrify me.
    As an Australian woman, I haven’t been brainwashed into believing I need to climb into stirrups every year for a degrading ordeal that is not only completely unnecessary, but risks my health.
    I feel so sorry for American women who are routinely coerced into these exams, even if they’ve been smart enough to smell a rat and do their own research and know these exams are about power and $$$$ and more likely to harm them – I call them, sick-woman exams. I couldn’t believe doctors could routinely deny women the Pill or HRT or other unrelated meds UNTIL they submit to unnecessary invasive exams and force a cancer screening test that is unrelated to the safe use of the Pill and for which, legally and ethically, the patients informed consent is required – what is going on in the States? Are women third class citizens?
    The systematic scare campaigns and misinformation that is fed to women is insidious and damages their health and well-being – and for what – the highest number of hysterectomies in the world – 1 in 3 will have one by age 60 and 95% of women will be referred for a colposcopy and usually some sort of biopsy to cover a lifetime risk of cervical cancer of 0.65%….you log into US health forums and there is young woman after young woman having a piece of cervix removed for pre-cancer or ANOTHER biopsy or another LEEP or considering a hysterectomy for dysplasia. In the UK, Finland and the Netherlands these women would be protected from your doctors. This is harmful stuff…
    Being a woman in America means accepting you’re disease prone and showing up yearly for an array of very invasive and unnecessary exams that risk your health – they so often lead to more unnecessary investigations and even surgery.
    It sometimes starts with well-girl exams – shudder! ACOG are now calling for girls of 13 to have annual exams – of course, they don’t provide any clinical need for these exams – they are simply looking to make up lost income with some women now choosing not to see them annually after the guidelines for pap tests were finally reduced…
    Those exams are very likely to cause lasting psychological damage to your children. (and possibly physical)

    I’m afraid your health system has gone mad and is the greatest risk to your health. As an Australian woman, these exams are not recommended for symptom-free women at any stage of life and pap tests are an optional cancer screening test – we can get the Pill with a simple blood pressure test and after providing our medical history. We don’t get honest information about cancer screening and our doctors are paid undisclosed target payments by the Govt for pap tests, but if a woman chooses not to have pap tests and is firm, she can find a Dr who’ll respect her decision.
    I made an informed decision more than 25 years ago, as a low risk woman, not to have pap tests and recently rejected mammograms. So, we have our problems too, but nothing like the American system.
    I can tell you if one of our doctors suggested I get into stirrups for these invasive exams for the Pill or HRT – I’d be speaking to the Police and the Medical Board.
    The Dr who puts his patients through invasive exams every year that are not only unnecessary, but risk the health of his patients, needs a refresher in medical ethics. It is his/her job to educate patients, not profit from excessive and unnecessary exams and tests that harm – also, most women have been brainwashed and terrified over decades by doctors – perhaps, you should lead the way and start treating your female patients with respect and guide them to make the best decisions for their health.
    I hope the situation improves for American women and you reclaim your dignity, bodily autonomy and protect your health.
    More American women are rejecting these exams and refusing to be coerced – they’re seeking their health care overseas or using online pharmacies for their needs.
    It shouldn’t be necessary – why isn’t every ethical and decent person in the profession, community leaders, women’s groups and govt officials up in arms over this situation?