Go Search!



Facts of Life

Facts of Life:
Issue Briefings for Health Reporters
Vol. 11, No. 9
September 2006
By Becky Ham, Science Writer

Self-Test: Are Patients Ready?

The Issue

The Facts

Infertility on the Internet

Expert Sources


References

The Issue:

Medical self-testing is an option that has been around for a long time. For people with conditions such as diabetes, self-testing is a daily and lifesaving occurrence strongly encouraged by health professionals. For others, self-testing fills an occasional need. Millions of women have used home pregnancy tests since 1977, a phenomenon that historian Sarah Leavitt calls “a private little revolution” in public health. 1

Using Testing Technologies
Self-testing options have increased as more complex chemistry is packaged in handheld devices or telltale strips of paper. However, concerns remain about whether people will use the tests properly. For instance, Dr. Subir Roy of the University of Southern California and colleagues tested whether women would be able to understand information distributed with an over-the-counter vaginal pH test. 2 Most women understood the information and used it to decide whether to seek a doctor’s care. “If people are spending money to get a test that is going to help them, they are apt to pay more attention to the process,” Roy says.

Handling the Results
If the technology is getting easier, interpreting the results may be getting more complicated. Home-testers for potentially life-threatening diseases may be left with more confusion and little support as to what to do next, according to several studies. 3,4 DNA screening kits sold online -- the latest frontier of self-testing -- may be fraudulent or at the very least unregulated and lacking in appropriate follow-up counseling. 5

The Facts:

  • In a 2005 survey of anticoagulation specialists across the United States, 60 percent said their clinic policies prohibited patient self-testing as part of managing their therapy. 6
  • Patients using anti-blood clotting therapies are more likely to stay within the therapeutic ranges recommended for the drugs if they regularly monitor their blood coagulation times at home, according to a 2003 review. 7
  • People with diabetes who were given home test kits by their health plan to monitor blood glucose levels were reluctant to use them, mostly because they did not want to duplicate their physicians’ tests, according to a 2001 study. 8
  • Free home blood-glucose monitors can help African-American diabetes patients improve self-management of the disease, but the effect may wane after a year, according to a 2006 study. 9
  • Asthma patients with no prior computer use were able to test their lung function at home with a breathing device and Internet-based monitoring system, with results comparable to those collected by a medical professional, according to a small pilot study. 10
  • Data from home blood-pressure monitoring may not be sensitive enough to determine whether a person has “white coat hypertension”-- blood pressure that is elevated at a clinic but normal outside a medical setting. 11
  • British researchers have developed an at-home sperm test that measures the amount of active sperm (an indication of potential fertility) in a semen sample within an hour. 12
  • Adolescent girls who underwent a variety of at-home and in-clinic tests were more likely to prefer at-home urine tests to at-home vaginal swabs and clinic pelvic exams as a way to detect sexually transmitted infections. 13
  • A review of Internet sites for home test kits for illegal drugs, aimed at parents testing their children, found that only half of the sites recommended contacting a professional if the drug test was positive. 14
  • The most common reasons for not using a home HIV test kit included concerns about accuracy and cost, according to a 2002 survey of people at high risk for HIV infection. 15
  • Although at-home genetic tests for many conditions can be purchased online, the Food and Drug Administration has reviewed and approved only a dozen genetic tests for clinical use. 5
  • In 42 percent of emergency room visits related to injuries from medical devices, the injury occurred in the home -- more frequently than any other location, including health care facilities. 16

No Do-It-Yourself for Anticoagulation Patients

  People who take anticoagulation medicines -- drugs that prevent abnormal blood clotting -- for heart valve replacements, irregular heartbeat and dangerous blood vessel clots in the legs and lungs share a goal: keeping their blood coagulation times within a “therapeutic” range.

Like people with diabetes who measure blood sugar levels faithfully, people on anticoagulants must keep a close watch on their international normalized ratio or INR -- the number that represents how fast their blood clots and how well their medication is working. But unlike people with diabetes, most anticoagulant patients in the United States are not keeping tabs on their INR at home.

The technology to take INR measurements at home is widely available in Europe, where research shows that people are more likely to stay within their therapeutic range if they regularly test themselves (7, 17, 18). But a recent survey of U.S. anticoagulation clinics found that fewer than 1 percent of people treated by the clinics used INR self-testing. (6)

Ann Wittkowsky, the director of anticoagulation services at the University of Washington Medical Center, who led the survey team, says money was the number-one concern of the clinics and their patients. “The main barrier seems to be the economics behind the whole process. Devices are relatively expensive and generally not paid for by health insurance companies.”

Nearly 60 percent of the clinics surveyed had policies that prohibited INR self-testing, although the majority said they would reconsider the policy if patients could be reimbursed for the devices and replacement test cartridges.

Wittkowsky has patients who do test their INR at home, but they must phone in their results to the clinic, which can cause other money woes. “When patients are involved in anticoagulation clinics, there is no [insurance] reimbursement for telephone counseling,” she says. “As a clinic director, my concerns are partially financial. I have to think about to what extent we’re providing free care.”

Clinics surveyed were less fearful that self-testing might lead to poor health outcomes, although 35 percent said it was a concern. As with many types of self-testing, health providers are less worried about their patients’ grasp on the testing technology and more worried that their patients will self-treat (or not treat) in harmful ways.

“The major obstacle that we continue to face with self-testing is the reliability of results. When they are out of range, we don’t know why,” Wittkowsky says, adding that “on any given day, 40 percent of all our patients are out of range.” Many factors including diet changes and new medications can nudge INR numbers out of the therapeutic range, making it important that patients -- even those few who do self-test -- consult with their health providers.

In Europe, national health care systems provide “an organized approach to training patients to self-manage, not just self-test,” Wittkowsky says. But in the United States, “many people are leery of moving to self-management.”

Expert Sources:

Ann Wittkowsky, PharmD
University of Washington
(206) 598-5626
akwitt@u.washington.edu

Subir Roy, M.D.
University of Southern California
(323) 226-2502
subirro@usc.edu

Chris Gardiner
University College London
+44 20 7387 9300 x8527
chris.gardiner@uchevaluation.co.uk

Gail Javitt, J.D., M.P.H.
Genetics and Public Policy Center
(202) 663-5971
gjavitt1@jhu.edu

References

1. S. Leavitt (2006) “A private little revolution:” the home pregnancy test in American culture. Bulletin of the History of Medicine, 80, 317-345.

2. S. Roy et al. (2005) The role of an over-the-counter vaginal pH self-test device package insert: Can subjects learn what the device is for and how to use it? American Journal of Obstetrics and Gynecology, 192, 1963-1967.

3. S.I. Hou et al. (2005) Experience of colorectal cancer screening using a home-administered kit for fecal occult blood tests among a Chinese worksite population in Taiwan. Psychological Reports, 96, 178-180.

4. K. Howard and G. Salkeld (2003) Home bowel cancer tests and informed choice -- is current information sufficient? Australian and New Zealand Journal of Public Health, 27, 513-516.

5. Government Accounting Office. Nutrigenetic testing: tests purchased from four Web sites mislead customers, Testimony before the Special Committee on Aging, U.S. Senate, July 27, 2006. Last accessed 08-22-06 at http://www.gao.gov/docsearch/abstract.php?rptno=GAO-06-977T.

6. A.K. Wittkowsky et al. (2005) Barriers to patient self-testing of prothrombin time: national survey of anticoagulation practitioners. Pharmacotherapy, 25, 265-269.

7. J. Hambleton (2003) Home monitoring of anticoagulation. Journal of Thrombosis and Thrombolysis, 16, 39-42.

8. T.S. Rector et al. (2001) Use of home hemoglobin A1c test kits to monitor the effectiveness of diabetes care. The Joint Commission Journal on Quality Improvement, 27, 265-277.

9. C.A. Mah et al. (2006) Racial differences in impact of coverage on diabetes self-monitoring in a health maintenance organization. Medical Care, 44, 392-397.

10. J. Finkelstein et al. (2000) Internet-based home asthma telemonitoring: can patients handle the technology? Chest, 117, 148-155.

11. J. Bayo et al. (2006) Home blood pressure self-monitoring: diagnostic performance in white-coat hypertension. Blood Pressure Monitoring, 11, 47-52.

12. L. Bjorndahl et al. (2006) Development of a novel home sperm test. Human Reproduction, 21, 145-149.

13. K.P. Tebb et al. (2004) Home STI testing: the adolescent female's opinion. Journal of Adolescent Health, 35, 462-467.

14. S. Levy et al. (2004) A review of Internet-based home drug-testing products for parents. Pediatrics, 113, 720-726.

15. G.N. Colfax et al. (2002) What happened to home HIV test collection kits? Intent to use kits, actual use, and barriers to use among persons at risk for HIV infection. AIDS Care, 14, 675-682.

16. B.J. Hefflin et al. (2004) Estimates of medical device—associated adverse events from emergency departments. American Journal of Preventive Medicine, 27, 246-253.

17. C. Heneghan et al. (2006) Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. The Lancet, 367, 404-411.

18. C. Gardiner et al. (2006) A randomised control trial of patient self-management of oral anticoagulation compared with patient self-testing. British Journal of Haematology, 132, 598-603.

The Center for the Advancement of Health identifies and disseminates state-of-the-science evidence about the influence of behavioral, social and economic factors on disease and well-being. Its purpose is to support health decision-making by the public and strengthen relationships among researchers and policymakers. The Center receives funding from a number of foundations, principally The Annenberg Foundation, the John D. and Catherine T. MacArthur Foundation and the W.K. Kellogg Foundation.

For Information Contact:
Lisa Esposito
Editor, Health Behavior News Service
Center for the Advancement of Health
2000 Florida Ave., NW, Suite 210
Washington, DC 20009
p. 202.387.2829 / f. 202.387-2857
press@cfah.org
http://www.cfah.org

© Copyright 2006, Center for the Advancement of Health