Unnecessary Testing in Obstetrics, Gynecology, and General Medicine: Causes and Consequences of the Unwarranted Use of Costly and Unscientific (Yet Profitable) Screening Modalities

Martin Donohoe, MD, FACP

Disclosures

April 30, 2007

Overview

Unnecessary testing is becoming increasing common in medical practice and consumer demand for certain types of tests have escalated. Such testing is expensive, diverts patient and provider time and attention from addressing evidence-based screening, can provide unwarranted reassurance or cause unnecessary anxiety, and can lead to further interventions that may carry risks of physical harm and even death. This column will provide an overview of unnecessary testing, using examples from obstetrics, gynecology, and general medicine.

There is a large body of evidence-based literature describing the extent, reasons for, and consequences of inappropriate use of laboratory tests, especially in the hospital setting. However, this column will focus primarily on more expensive screening tests, such as full-body scans, which are often marketed directly to unwitting consumers.

Space limitation precludes a thorough discussion of an evidence-based approach to screening tests, but this section provides a brief overview of criteria for appropriate screening. Tests to screen for disease in the pre-symptomatic stages should meet certain criteria before being recommended. These criteria include [1,2]:

  • The disease being screened for must be reasonably common and have a significant effect on either duration or quality of life;

  • Acceptable, effective treatment must exist, and the condition must have an asymptomatic period during which detection and treatment can improve outcome;

  • Treatment during the asymptomatic period must be superior to treatment once symptoms occur; and

  • The screening test must be safe, affordable, and have adequate sensitivity (ie, the test is usually positive in those with disease) and specificity (the test is usually negative in those without disease).

Examples of gynecologic- or obstetrically-related screening tests meeting these criteria include Pap smears, mammography, oral glucose tolerance testing during pregnancy, and universal testing of newborns for certain congenital disorders.[3,4] Other general tests of proven value include blood pressure monitoring for those older than 21 years of age, cholesterol tests for those 35 to 65 years of age, and abdominal ultrasounds for persons (especially men) with coronary risk factors and/or positive family history to screen for abdominal aortic aneurysms.

Regrettably, many well-established screening tests are underused, especially among nonwhites, those of lower socioeconomic status (SES), and those with inadequate or no health insurance.[5] Such underuse has been clearly linked with increased risk for adverse outcome. For example, SES differences in access to and use of screening mammography have been associated with advanced stage at time of breast cancer diagnosis and lower survival rates, especially among African-Americans.[6] SES differences in the use of prenatal testing for trisomy 21 have also been associated with disparities in the live-birth prevalence of Down syndrome. Because incidence of this disease does not vary according to SES, it has been demonstrated that early prenatal diagnosis leads to a higher rate of elective termination of pregnancy by individuals of higher SES.[7]

Certain once-broadly accepted monitoring tests that were used routinely have not been supported by outcome data. Examples from obstetric practice include electronic fetal heart rate monitoring and fetal pulse oximetry. Routine electronic fetal heart rate monitoring has not been demonstrated to decrease the rate of cerebral palsy, but has been linked to increases in the overall rate of cesarean delivery.[8,9] It has also been determined that routine use of fetal pulse oximetry is not associated with either reduced rates of cesarean delivery or improvement in the condition of newborns.[10] Although these tests are not recommended for routine assessment, they remain in use in many hospitals in the United States.

Other monitoring tests may be misused. One example of this is fetal ultrasonography. Although it is helpful in estimating gestational age, identifying twin pregnancies, and detecting genetic anomalies, the American College of Obstetrics and Gynecology (ACOG) position is that routine ultrasonographic screening during pregnancy is not mandatory. They deem routine use reasonable when requested by a patient.[11] Most women in the United States undergo at least 1 or 2 ultrasounds during pregnancy; this level of exposure has never been associated with significant risk and use may provide significant benefits. However, some expectant couples have followed the lead of actors Tom Cruise and Katie Holmes and purchased (for costs ranging between $15,000 and $200,000) their own ultrasound machines, which they use daily.[12]

There are some data (mostly from other vertebrates) suggesting that prolonged and frequent use of fetal ultrasound can cause abnormalities in fetal brain development, behavior, and body weight.[13] Even though such findings have not been substantiated in humans,[13] the US Food and Drug Administration (FDA) considers promotion, selling or leasing of ultrasound equipment for the purpose of making "keepsake fetal videos" an unapproved use of a medical device.[14] Such use may also violate state laws and regulations.

Full Body Screening. Unnecessary testing has been promoted by both well-intentioned medical practitioners and outright quacks for centuries. Due to lack of health literacy and/or a powerful need for reassurance, many individuals are willing to pay -- sometime exorbitant amounts -- for screening tests that lack scientific merit. Regrettably, numerous companies have recently been created to meet this demand. For example, Biophysical 250 charges $3400 'to screen for hundreds of diseases and conditions...including cancer, cardiovascular disease, metabolic disorders, autoimmune disease, viral and bacterial disease and hormonal imbalance.'[15]

Full-body screening, via computed tomography (CT) scanning, became increasingly popular after television talk show host Oprah Winfrey underwent testing in 2001.[16] The number of self-referral body imaging centers, where such scans are often performed, totaled 161 in 2003, up from 88 in 2001.[17] One company, Ultra Life, offers 'real time color ultrasound' of various organs, or for those inclined, a $500 'full body scan.'[18]

Companies offering 'metabolic screens' and whole body scans tend to market in areas of higher SES. They prey on fear of heart disease and cancer, and on an individual's natural desire to detect health problems early in hopes of achieving a cure, or at least avoiding potentially disfiguring or toxic therapies.

Some companies also market testing devices such as body composition analyzers and bone densitometers directly to healthcare providers. Having such equipment available no doubt increases use and, when such testing is reimbursable, contributes to practice income. Education programs may be offered to assist clinicians in 'optimizing the clinic visit.' Under certain circumstances, this could be interpreted as 'optimizing receipts through the use of procedures of questionable utility performed under dubious circumstances.'

A 2004 survey of 500 Americans found that 85% would choose a full-body CT scan over $1000 cash.[19] It is certainly problematic that these scans can deliver a radiation dose nearly 100 times that of a typical mammogram.[20] A single scan exposes the person being scanned to a level of radiation linked to increased cancer mortality in low-dose atomic bomb survivors from Hiroshima and Nagasaki.[20] Undergoing such scans annually would substantially increase one's lifetime risk of malignancy. Of course, this is not meant to imply that one should avoid medically indicated diagnostic CT scans of particular organs.

Naturopathic Testing. Many 'naturopathic' approaches to diagnostic testing exist, including iridology; pulse and tongue diagnosis; electrodiagnosis; hair, urine and stool analyses; applied kinesiology; and some forms of acupuncture.[21,22] Often, such testing leads to recommendations for treatment with unproven and/or dangerous supplements. Avoidance of standard prescription drugs and surgical treatments in favor of alternative treatment such as colonic irrigation, cranioelectrical stimulation, detoxification diets, and chelation therapy may occur.[21,22]

Most alternative practitioners do not encourage patients to forego standard medical treatment, but instead offer naturopathic treatment as an adjunct. However, the risk that a patient may choose an unproven alternative remedy over a proven effective traditional therapy could lead to unnecessary harm, as could possible harmful interactions between traditional and non-traditional therapies.[23]

Before considering a full-body scan or other non-proven screening test, individuals should be made aware of the potential risks. False-positive test results are extremely common among individuals with no signs or symptoms of disease; multiple tests increase the likelihood of false-positive results. Such alarming, yet incorrect test results, can lead to further unnecessary investigations, additional patient costs, heightened anxiety, and risk to future insurability. Conversely, true positive results can lead to the overdiagnosis of conditions that would not have become clinically significant, thus leading to further risky interventions.[1]

Examples of potentially harmful screening methods and possible outcomes include:

  • Pelvic ultrasounds on asymptomatic women to search for ovarian cancer could lead to unnecessary laparoscopies and biopsies, with attendant complications; and

  • Screening all current and former smokers in the United States for lung cancer with a CT scan would identify more than 180 million lung nodules, the vast majority of which would be benign. Millions of patients with nodules could needlessly undergo invasive needle lung biopsies and/or removal of parts of their lungs, resulting in many cases of impaired breathing, pneumothorax, hemorrhage, infection, and even death.

Even commonly recommended tests carry a sometimes large risk of a false-positive result. For example, among women in their early 40s with abnormal mammograms, it was shown that approximately 57 women without cancer underwent further diagnostic workup for every 1 woman found to have a malignancy.[24]

One area where over-testing is rife is luxury primary care, also known as concierge care, boutique medicine, retainer practice, executive healthcare, or premium practice.[25,26,27] Luxury care contributes to the erosion of the scientific practice of medicine by offering 'clients' screening tests that are often not indicated and can cause more harm than good.

There is no evidence documenting a higher quality of care in concierge practices, and little data support the clinical or cost-effectiveness of many of the tests typically offered by such practices to their asymptomatic clients. Examples include percent body fat measurements, chest radiographs in smokers and nonsmokers aged 35 years and older to screen for lung cancer, electron-beam CT scans and stress echocardiograms to look for evidence of coronary artery disease, and abdominal-pelvic ultrasounds to screen for ovarian or liver cancer.[24,25,28,29] Other examples, such as mammography starting at age 35 and genetic testing, are also controversial.

Although clients pay for these tests, technicians and equipment time are diverted to produce immediate results. Because patients jump the queue in the radiology and phlebotomy suites, tests for other patients with more appropriate/urgent needs may be delayed. Regrettably, such luxury practices are often associated with, and actively promoted by, academic medical centers. Such association sullies these institutions' images as arbiters of evidence-based medicine and facilitates an erosion of professional ethics by perpetuating a two-tiered system of care within institutions that have been the traditional healthcare providers to the indigent and where clinicians in training learn professional ethics.

The use of clinically unjustifiable tests also erodes the scientific underpinnings of medical practice and sends a mixed message to trainees and patients about when and why to use diagnostic studies.[30] Such use also runs counter to physicians' ethical obligations 'to contribute to the responsible stewardship of health care resources.'[31] Some might argue that if patients are willing to pay for scientifically unsupported testing, they should be allowed to do so. However, such a 'buffet' approach to diagnosis over-medicalizes healthcare and makes a mockery of evidence-based medicine.

Pseudoscience and anti-science.< > Without adequate science and health education and knowledge, individuals may lack the skepticism necessary to refuse unwarranted testing. Public education, including science and health education, has suffered from decaying infrastructure, funding cuts, sponsored 'educational' curricula produced by corporations, and high student-teacher ratios.[32,33,34,35,36] At least some of the increase in unnecessary testing is due to the general erosion of science under the current federal administration, as manifested through:

  • Appointments to key scientific bodies based on corporate connections and political or religious ideology, rather than scientific expertise;

  • Excessive corporate influence over legislation; and

  • The rewriting and even suppression of scientific policy statements.[31,32,33,34,35,36]

Health scams are ubiquitous on the Internet and even in traditional media. Warning signs of bogus science include[37,38]:

  • Claims pitched directly to the media, rather than via publication in peer-reviewed journals;

  • The discoverer says that a powerful establishment is trying to suppress his or her work;

  • Appeals to false authorities, emotion, or magical thinking;

  • The scientific effect involved is at the very limit of detection;

  • Evidence for the test or treatment is anecdotal and relies on subjective validation;

  • The promoter states a belief is credible because it has endured for centuries; and

  • The need to propose new laws of nature to explain an observation.

Patients should be encouraged to query their healthcare providers about sources of reliable information and to consult providers before obtaining screening and/or diagnostic tests or undergoing alternative treatments (including the use of 'supplements' and 'nutraceuticals'). The US Food and Drug Administration has warned consumers against purchasing medical devices from the Internet, including laboratory diagnostic kits to detect serious illnesses.[39]

Unnecessary testing is common among both traditional and alternative medical providers. Improved science and health education, more nuanced and responsible communication of medical information by the media, enhanced scientific integrity of governmental bodies, eliminating -- or at least limiting the expansion of -- luxury care, and better communication between patients and healthcare providers would all help contribute to increased use of appropriate, less harmful screening practices and to enhanced health outcomes.

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