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Universal Screening for HIV and False Positives
Submit responseWhile we agree in principle with the guidelines set forth regarding HIV screening (1) and have generally adopted similar practices in our clinics, we are concerned that some consequences of universal screening were not addressed in this paper. Specifically, assuming the sensitivity and specificity profiles set forth in the article of greater than 99% and greater than 99.99%, respectively, for the sequential screening test (initial enzyme immunoassay followed by either confirmatory Western blot or immunofluorescent assay), and United States population estimates for people greater than 13 years old of 244,926,386 people (2), then applying sequential universal screening to this population would result in 24,393 false positive HIV tests in individuals who do not actually have the disease. This represents an extremely unfortunate consequence of universal screening, and no mention is made of the cost to these individuals of misdiagnosis, which could involve unnecessary medical intervention and squandering limited health care resources (3).
Additionally, the falsely diagnosed may suffer severe psychosocial distress (4), inability to obtain health insurance, and these cases may result in significant financial cost to the health-care system with respect to litigation (5). Furthermore, this does not even address the many thousands of individuals who would test positive on the initial enzyme immunoassay before testing negative with a confirmatory test which would result in further psychosocial stress. As a result, while broader screening approaches are undoubtedly warranted, we feel that educating medical practitioners who initiate HIV screening to the potential of false positive tests should be ensured before future guideline statements are constructed for universal HIV screening.
References
1. Qaseem, A., et al., Screening for HIV in Health Care Settings: A Guidance Statement From the American College of Physicians and HIV Medicine Association. Ann Intern Med, 2008.
2. Population Division, U.S.C.B., Annual Estimates of the Population by Sex and Selected Age Groups for the United States: April 1, 2000 to July 1, 2007, (NC-EST2007-02), Editor. May 1, 2008.
3. Grimes, D.A. and K.F. Schulz, Uses and abuses of screening tests. Lancet, 2002. 359(9309): p. 881-4.
4. Bhattacharya, R., S. Barton, and J. Catalan, When good news is bad news: psychological impact of false positive diagnosis of HIV. AIDS Care, 2008. 20(5): p. 560-4.
5. Testing. $350,000 damages affirmed in false HIV-positive case. AIDS Policy Law, 2008. 23(11): p. 7.
Conflict of Interest:
None declared
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American College of Physicians' HIV Screening Guidance: Cost-effectiveness Considerations
Submit responseThe American College of Physicians (ACP) recently published Clinical Practice Guidelines on HIV screening in health care settings (1). One of the authors of the Guidelines (Owens) and two of the acknowledged commentators (Walensky and Paltiel) have published cost-effectiveness analyses of routine HIV testing, but this is not the universe of researchers (such as myself) who have published on this topic. In the Guidelines, only the economic evaluation work of the authors and commentors is said to be of good quality while the literature that they did not generate is inaccurately characterized. For instance, the Guidelines dismiss my peer-reviewed cost-effectiveness analysis of a variety of counseling and testing strategies because it is said that in the targeted counseling and testing scenario an assumption is made that high risk clients can be identified at no additional cost (2). This assumption was made in the base case analysis because targeting does not need to isolate individual clients for testing but can use existing surveillance information and other data to identify venue types and geographic areas with a higher background HIV seroprevalence. Still, I published a sensitivity analysis exploring this specific assumption and found that even if one-third of the available budget were spent on expenses related to targeting (and other highly conservative assumptions were simultaneously employed), a targeted testing strategy continues to yield more HIV diagnoses and linkages to care than would CDC’s opt-out approach (3).
The cost-effectiveness papers stated to be of good quality in the Guidelines (citations 24-28) are themselves subject to limitations; first, those papers do not fully estimate the costs and consequences of a national implementation of CDC’s opt-out testing recommendations but the Guidelines generalize from them to national policy. Second, those papers compare screening to the absence of screening or to the status quo; failure to compare screening to a variety of other counseling and testing strategies or even to other types of HIV prevention interventions means that these papers do not inform policy questions such as how to optimize the health benefits from limited HIV prevention resources (4) or how to quickly maximize the number of people learning that they are living with HIV and thereby accessing treatment.
When developing practice guidelines, ACP should have the literature reviewed either by a completely independent group of researchers (ala the Institute of Medicine), or include all persons publishing in the field so as to avoid mischaracterizations.
References
1. Qaseem A, Snow V, Shekelle P, Hopkins Jr. R, Owens DK for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Ann Intern Med 2009:150 (published ePub ahead of print, December 1, 2008)
2. Holtgrave D. Costs and consequences of the US Centers for Disease Control and Prevention’s recommendations for opt-out HIV testing. PLoS Medicine 2007;1011-1018.
3. Holtgrave D. Holtgrave responds to Branson and Janssen. PLoS Medicine. November 26, 2007. Available online at http://medicine.plosjournals.org/perlserv/?request=read-response&doi=10.1371/journal.pmed.0040194&ct=1. Accessed December 13, 2008.
4. Holtgrave D. When “heightened” means “lessened”: the case of HIV prevention resources in the United States. J Urban Health 2007;84:648-652.
Conflict of Interest:
None declared
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The importance of screening children of African HIV positive immigrants
Submit responseThe guidance for screening for HIV in Health Care settings issued by the Clinical Efficacy Assessment Subcommittee of the American College of Physicians is meant to address the issue of HIV testing of all persons at risk of HIV infection (1). A very important risk factor for HIV infection in children not included in the guidance or the documents issued by the Centre for Disease Control and Prevention is history of birth to an HIV infected mother in Africa. A recent investigation into HIV status of children of HIV positive immigrant mothers in the United Kingdom revealed that despite appropriate counselling of mothers 73% of their children had not been screened for HIV infection more than a year after maternal diagnosis (2). The children had been born before the introduction of measures to prevent maternal to child transmission and of those tested 22% were HIV positive. The main reasons for not having their children tested for HIV appeared to be fear of disclosure of the diagnosis and the perception that a well child could not be HIV infected. Children with vertically transmitted HIV infection may remain asymptomatic until adolescence if they are long term slow progressors and then eventually suffer severe opportunistic infections or transmit infections sexually to partners. Physicians looking after adults with HIV infection in Genitourinary Medicine clinics need to ensure all children of infected mothers not screened as part of prevention of mother to child transmission are referred for HIV testing.
References:
1. Qaseem A, Snow V, Shekelle P, Hopkins R, Owens DK and for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Ann Intern Med 2008; 60520-300.
2. Eisenhut M, Sharma V, Kawsar M, Balachandran T. Knowledge of their children's HIV status in HIV-positive mothers attending a genitourinary medicine clinic in the UK. HIV Med. 2008;9:257-9
Conflict of Interest:
None declared