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Research article
First published online October 23, 2012

Evaluating the evidence: direct-to-consumer screening tests advertised online

Abstract

Objectives

Unsupervised online direct-to-consumer (DTC) access to medical services has rapidly expanded to medical screening tests, which have not been critically evaluated for their evidence basis. The objective of this study is to identify the scope of online-advertised DTC screening tests, outline the evidence for use of available DTC testing and suggest regulatory reform to address the relevant issues.

Methods

An observational study of website advertisements, testing services and counselling/follow-up services for DTC testing was conducted. Data were collected from websites between 4 April and 1 June 2011. Each website was assessed for tests offered, advertised indications and availability of counselling/follow-up services. Advertised testing indications were compared with US Preventive Services Task Force recommendations and/or specialty guidelines and categorized as Supported, Against, Insufficient Evidence or No Guidance.

Results

Of 20 companies identified as offering DTC screening tests, 95% (19/20) do not clearly offer pretest counselling, post-test counselling and/or test follow-up. One hundred and twenty-seven different tests were identified. Only 19/127 (15%) could be Supported for screening in a target group selected for testing; 38/127 (30%) were given recommendations to avoid use in specific target group(s) selected for testing (‘Against recommendations’); 29/127 (23%) had Insufficient Evidence of value, and for 64/127 (50%) No Guidance could be given. Only 4/127 (3%) tests were Supported for general screening use.

Conclusions

Virtually all identified medical tests advertised and offered DTC are not recommended for use in screening by evidence-based guidelines. Limited oversight may lead to inaccurate self-diagnosis, treatment and wasted health resources.

INTRODUCTION

Direct-to-consumer (DTC) availability of medical products is expanding rapidly. DTC marketing has broadened beyond traditional television, print and radio media onto the Internet. Consequently, DTC advertising potentially reaches millions of consumers searching online for health-care resources.1 Whereas pharmaceutical advertising has traditionally dominated the DTC medical marketplace, online DTC advertising has now expanded to include medical tests of questionable efficacy, safety and utility for disease screening and diagnosis. Previous studies have highlighted the controversial marketing and sale of genetic susceptibility testing,2 but little attention has been paid to the plethora of non-genetic medical tests available DTC that are being offered for ‘screening’ purposes.
The medical community defines disease screening as ‘the systematic application of a test or inquiry, to identify individuals at sufficient risk of a specific disorder to benefit from further investigation or direct preventive action, among persons who have not sought medical attention on account of symptoms of that disorder’.3 This definition necessitates a pretest evaluation with screened individuals to ensure the absence of symptoms as well as a quantification of each individual's risk of disease.
There are generally nine factors that contribute to the usefulness of a specific screening test: (1) the disease being screened for is well defined; (2) the incidence/prevalence of the disease being screened for is known; (3) the disease being screened for will lead to morbidity and/or mortality; (4) early management of asymptomatic individuals is more effective than management at clinical presentation of disease; (5) the screening test is simple and safe; (6) the test performs well with acceptable rates of false-positive and false-negatives; (7) the health benefit of screening justifies test costs; (8) there is access to resources for further diagnosis and treatment; (9) follow-up management after diagnosis is agreed upon and acceptable to both medical professionals and patients.4 To ensure safety, meeting these criteria requires screening outcomes evaluation and evidence-based support for screening test use before making testing widely available for screening purposes.
Companies advertising online and offering DTC medical tests for screening purposes are creating unique safety risks for any person, nationally and globally, with access to the Internet. While aiming to empower consumers by providing private medical testing without professional consultation, these companies may be marketing unproven or harmful medical testing, resulting in poor health outcomes. By definition, where a pretest evaluation with consumers is absent, these DTC medical tests cannot be properly identified as ‘screening’ tests despite their advertised purpose and consumers are at risk for making ill informed decisions regarding medical care.5 Furthermore, similar to online DTC drug advertising, medical test risk and benefit information given to consumers may be misleading, inaccurate or incomplete. Several studies examining DTC medical tests for cardiovascular disease, genetic testing and imaging services have highlighted the potential risks involved in offering medical testing DTC without medical professional oversight.68
The DTC medical testing industry is fueling medical consumerism growth, unnecessary medical interventions and downstream resource waste. For example, a recent study reported 22 clinical cases of patients arriving self-referred or physician-referred to geneticists due to results of DTC genetic testing.9 The costs of initial genetic testing for each of these 22 patients was as high as US$3120, while the cost of subsequent follow-up care (including visit to genetic counselor, referrals to specialists and referrals for additional diagnostic testing) ranged from $40 to $20,604 per patient.9 Not surprisingly, with the exception of BRCA 1/2 testing for breast cancer susceptibility, 64% of DTC genetic tests performed in these case reports were considered not clinically useful by genetic health-care professionals seeing these patients in follow-up.9
In response to powerful concerns related to DTC availability of genetic testing, the Food and Drug Administration (FDA) issued warning letters to companies offering DTC genetic testing.8,10 Further, recent recommendations for DTC genetic and cardiac testing have appropriately included requiring that testing be FDA approved before use/marketing, outcomes research be conducted before public availability, that testing be offered through health-care professionals and that counselling be offered pre-test and post-test to guide consumers toward appropriate care and follow-up.6,11 Despite these efforts, concerns remain regarding the ability of the FDA to regulate the DTC industry, given its limited mandate, inadequate funding and staff, and reluctance of US legislatures to infringe on commercial rights of free speech.12
It is important for global health, health-care cost containment and public safety that DTC medical testing be critically evaluated, the scope of the problem outlined and further policy pursued to regulate a currently unfettered industry that may be exploiting unproven medical testing at the expense of patient and consumer safety. In this study, we identify medical tests advertised online and available DTC, outline the evidence-base for use of available DTC testing, evaluate the availability of counselling and follow-up offered by DTC testing companies related to DTC testing services, and suggest regulatory reform and coordination among various stakeholders to address the relevant issues.

METHODS

Google searches were performed to identify medical tests advertised online via DTC medical testing company websites. ‘DTC Medical Testing Company’ was defined as a company offering medical testing direct-to-consumer without prior physician consultation/prescription. ‘Medical tests’ were defined as any imaging test or any tests advertised as measuring any serum, saliva or urine analyte. The company websites were evaluated for information including: whether the companies offer pre-/post-test counselling or follow-up for abnormal results. Where the companies did not explicitly address these issues on their websites, they were coded ‘unclear from website’.
Google searches were run using US Department of Health and Human Services-focused health categories beyond ‘general health’,13 i.e. heart health, diabetes, prostate health, reproductive health, colorectal health, eye and ear health, breast health, and oral health. Terms were searched with the term ‘screening’ added (for example, ‘heart health screening’). To provide a general sense of the scope of offered DTC medical testing while limiting the number of identified medical tests to a manageable data-set, organic and sponsored search results of pages 1 and 2 were evaluated to identify DTC Medical Testing Companies, medical tests offered, availability of pre-/post-test counselling and follow-up care provisions. ‘Organic search results’ are listings on search engine results pages that appear because of their relevance to the search terms, as opposed to appearing as advertisements. In contrast, ‘sponsored search results’ are paid-for listings that appear on the results page for a fee to the search engine company. Indeed, consumers may be confused regarding the difference in these search results, with studies indicating that only 38% of US users could make a distinction between organic and sponsored results.14 Searches were completed between 4 April and 1 June 2011.
After identifying medical tests, we evaluated the evidence-base for medical test use via US Preventive Services Task Force (‘USPSTF’) guidelines or relevant specialty society guidelines where USPSTF guidance was unavailable. We chose this method primarily because all identified DTC medical tests were advertised specifically for ‘screening’ purposes. We chose to evaluate the usefulness of each identified medical test according to the evidence-base relating to the advertised testing purpose. Medical tests were stratified according to whether evidence-based guidelines support screening (Supported); advise against screening (Against), do not offer definitive recommendations because of conflicting, poor, or incomplete data (Insufficient Evidence), or do not address the medical test for screening purposes (No Guidance). The ‘Insufficient Evidence’ category is based on USPSTF ‘I Statements’, which signify ‘current evidence is insufficient, … of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.’15 Because screening guidelines generally provide recommendations for specific populations, any given medical test may have ≥1 recommendation, coded ‘multiple recommendations.’

RESULTS

Twenty DTC Medical Testing Companies were identified (Table 1); 19 (95%) websites either do not offer or do not indicate whether they offer pre-/post-test counselling, or follow-up (Table 1).
Table 1 Identified direct-to-consumer testing companies and parameters of offered services
Company NameURL (Archived URL)Pre-test counselling availablePost-test counselling availableFollow-up with physician for abnormal tests available
Advanced Body Scan of Newporthttp://www.newportbodyscan.com/PricingandIncentivePrograms.htm (Archived at http://www.webcitation.org/618OEAbZh)Unclear from websiteUnclear from websiteUnclear from website
Affordable Wellnesshttp://www.labscreening.com/ (Archived at http://www.webcitation.org/618OLthVw)NoNoNo
Ann Arbor Thermographyhttp://aathermography.com/FAQ/FAQ.html (Archived at http://www.webcitation.org/618OTqGTz)NoNoNo
Bone Health Montanahttp://www.bonehealthmontana.com/CompanyInformation/BoneDensityTestingFAQ.html (Archived at http://www.webcitation.org/618OmAcb7)NoYes (non-physician)Unclear from website
Carlsbad Imaging Centerhttp://www.carlsbadimaging.com/cash_pricelist.html (Archived at http://www.webcitation.org/618P02dm9)Unclear from websiteNoNo
Dr Mercola's Natural Health Centerhttp://naturalhealthcenter.mercola.com/services/thermography.aspx (Archived at http://www.webcitation.org/618P6zZgk)Unclear from websiteNoNo
Health Check USAhttp://www.healthcheckusa.com/Find-a-Test/46823/. (Archived at http://www.webcitation.org/618PNlc9J)NoUnclear from websiteUnclear from website
Health Testing Centershttp://www.healthtestingcenters.com/blood-test-list.aspx (Archived at http://www.webcitation.org/618PUm85r)NoNoNo
Health Watchhttp://www.healthwatch.cc/testing_services.html. (Archived at http://www.webcitation.org/618PdwItc)NoUnclear from websiteNo
Heart Health Screeninghttp://www.dean-wellness.com/fe/13007-hhscreen. (Archived at http://www.webcitation.org/618QR4z5v)Available at extra costAvailable at extra costAvailable at extra cost
Home Health Screeninghttp://www.homehealthscreening.com. (Archived at http://www.webcitation.org/618QdqSFo)NoNoNo
Home Health Testinghttp://www.homehealthtesting.com. (Archived at http://www.webcitation.org/618QjM5TD)NoNoNo
Lifeline Screeninghttp://www.lifelinescreening.com/health-screening-services/default.aspx (Archived at http://www.webcitation.org/618QtDtxk)NoNoNo
Optimum Health Centerhttp://www.optimumhealthclinic.info/och_ebook/events.html (Archived at http://www.webcitation.org/618R7jeGV)Yes (with non-physician)Yes (with non-physician)Unclear from website
Safe Heart Health Screenshttp://www.safehearthealthscreens.com/html/faq.html (Archived at http://www.webcitation.org/618RDI0jx)NoNoNo
Superior Body Scanwww.superiorbodyscan.com (Archived at http://www.webcitation.org/618RI9KQN)YesAvailable at extra costUnclear from website
Testcountry.comhttp://www.testcountry.com (Archived at http://www.webcitation.org/618RNB6Wb)NoNoNo
Testmyhormones.comhttp://www.testmyhormones.com/test_information.htm (Archived at http://www.webcitation.org/618RSReYg)NoNoNo
US Wellnesshttp://www.uswellness.com/dt/pl/uw/screening.asp (Archived at http://www.webcitation.org/618Rbl46s)Unclear from websiteUnclear from websiteUnclear from website
9Health Fairhttp://www.9healthfair.org/find/screenings.aspx (Archived at http://www.webcitation.org/618Rh5Utm)Unclear from websiteVariableVariable
A total of 127 DTC medical tests were identified (Table 2). In several cases, medical test components were not decipherable from website descriptions and therefore listed by panel name (e.g. ‘antioxidants’, ‘female hormones’, ‘male hormones’ and ‘heavy metals’). Medical tests include a host of body fluid and imaging studies. Importantly, our searches did not reveal many types of DTC genetic testing that have been highly publicized in recent years.
Table 2 Identified direct-to-consumer medical tests
 Test identifiedMode identifiedSupportAgainstInsufficient evidenceNo guidance
1Abdominal aortic aneurysmUltrasoundXX  
2ABO/RH blood typesBlood   X
3Alcohol useBlood   X
4Alcohol useUrine   X
5Alcohol useHome testing kit   X
6Alkaline phosphataseBlood   X
7Allergy IgE testingBlood X  
8AlphafetoproteinBlood   X
9ALTBlood   X
10AmylaseBlood   X
11ANABlood   X
12Anti-SM antibodiesBlood   X
13AntioxidantsBlood   X
14ASTBlood   X
15Atrial fibrillationElectrocardiogram   X
16Atrial fibrillationEchocardiogram   X
17BacteruriaUrineXX  
18BacteruriaHome testing kit   X
19Beta caroteneBlood   X
20Beta naturetic peptideBlood X  
21BRCABlood X  
22Breast cancerSelf breast exam pads X  
23Breast cancerDigital mammogram  X 
24Breast cancerMRI  X 
25Breast cancerThermography   X
26Breast cancerMammogramX   
27CA 27-29 tumour markerBlood X  
28CA-125 tumour markerBlood X  
29CA-19-9 tumour markerBlood X  
30Cardiac diseaseElectrocardiogram XX 
31Cardiac diseaseNon-contrast CT XX 
32Cardiac diseaseElectron beam CT XX 
33Cardiac diseaseEchocardiogramXX  
34Cardiac diseaseNon-contrast MRI X  
35Cardiac diseaseCT angiography X  
36Carotid artery stenosisUltrasound X  
37Carotid intima media thicknessUltrasound  X 
38Complete blood countBloodX X 
39CEA tumour markerBlood X  
40Celiac diseaseBloodXX  
41Chlamydia/GCBloodXXX 
42Co-Q10Blood   X
43Cocaine useBlood   X
44Cocaine useUrine   X
45Cocaine useHome testing kit   X
46Colon cancerFecesXX  
47Colon cancerVirtual colonoscopy  X 
48Colon cancerHome testing kit   X
49CortisolBlood   X
50Dental diseaseNon-contrast CT   X
51Diabetes mellitusFasting glucose, bloodX X 
52Diabetes mellitusRandom glucose, bloodX X 
53Diabetes mellitusHg A1c, bloodX X 
54Diabetes mellitusFasting glucose, finger stick (FS)   X
55Diabetes mellitusRandom glucose, FS   X
56Diabetes mellitusHg A1C, FS   X
57Diabetes mellitusHome testing kit   X
58Diabetes mellitusUrine   X
59Ecstasy useBlood   X
60Ecstasy useUrine   X
61Ecstasy useHome testing kit   X
62ElectrolytesBlood   X
63Female hormonesSaliva   X
64Female hormonesBlood   X
65FolateBlood   X
66Full body imagingNon-contrast CT X  
67Full body imagingNon-contrast MRI X  
68Full body imagingElectron beam CT X  
69Heavy metalsBlood   X
70Helicobacter pyloriBlood  X 
71Hepatitis BBloodXX  
72Hepatitis CBlood XX 
73Heroin useBlood   X
74Heroin useUrine   X
75Heroin useHome testing kit   X
76HIVBloodXX  
77HomocysteineBlood  X 
78HS-CRPBlood  X 
79IronBlood   X
80LeadBlood XX 
81LipaseBlood   X
82LipidsBloodXXX 
83LipidsBlood, FS   X
84Lung diseaseNon-contrast CT  X 
85Lung diseaseElectron beam CT  X 
86Lung diseaseX-ray  X 
87Lyme diseaseBlood X  
88MagnesiumBlood   X
89Male hormonesSaliva   X
90Male hormonesBlood   X
91Marijuana useHome testing kit   X
92Marijuana useBlood   X
93Marijuana useUrine   X
94MelatoninBlood   X
95Nicotine useBlood   X
96Nicotine useUrine   X
97Nicotine useHair   X
98Nicotine useHome testing kit   X
99Nuclear magnetic resonance (NMR) lipoprofileBlood X  
100Orthopaedic imaging3D CT X  
101OsteoporosisHeel UltrasoundX X 
102OsteoporosisDXAX X 
103OsteoporosisQuantitative CTX   
104Parathyroid functionBlood   X
105Peripheral arterial diseaseUltrasound X  
106Prostate specific antigenBlood XX 
107Pulmonary function testsSpirometry X  
108Rheumatoid factorBlood   X
109SeleniumBlood   X
110Skin cancerDermoscopy  X 
111Spinal diseaseNon-contrast MRI X  
112SyphillisBloodX   
113Thyroid functionTSH, blood  X 
114Thyroid functionT4, blood  X 
115Thyroid functionT3, blood  X 
116Thyroid functionT7, blood  X 
117Vertical autoprofile (VAP) lipoprofileBlood X  
118Viral herpesBlood X  
119Virtual arteriography3D CT   X
120Virtual bronchoscopy3D CT   X
121Vitamin ABlood   X
122Vitamin B6Blood   X
123Vitamin B12Blood X  
124Vitamin CBlood   X
125Vitamin DBloodX   
126Vitamin EBlood   X
127Vitamin KBlood   X
Totals19382964  
CT, computed tomography; ALT, alanine transaminase; ANA, antinuclear antibody; AST, aspartate transaminase; BRCA, breast cancer; MRI, magnetic resonance imaging; HS-CRP, high sensitivity C-reactive protien; DXA, dual-energy X-ray absorptiometry; CA, Cancer Antigen; CEA, Carcinoembryonic Antigen
Of 127 medical tests, 63 (50%) have USPSTF or relevant specialty society screening guidance, 19/127 (15%) have ≥1 Supported recommendation for screening use; double this number (38/127, 30%) were given recommendations to avoid use in specific target group(s) selected for testing (‘Against recommendations’); and 27/127 (21%) carry ≥1 statement of Insufficient Evidence of value.
A detailed review revealed that only 4/127 (3%) are Supported without any Against or Insufficient Evidence recommendations (Table 2). The remainder (N = 123, 97%) had only recommendations Against (N = 23, 18%), statements of Insufficient Evidence (N = 15, 12%), multiple recommendations (N = 21, 17%), or No Guidance (N = 64, 50%). Virtually all DTC medical tests are not clearly supported for screening in the general population.
Tests are further categorized in Tables 35 by published guidance. Table 3 lists the 19 DTC medical tests carrying any Support recommendation. Most (15/19, 79%) of these also carry recommendations Against use and/or statements of Insufficient Evidence. For example, USPSTF recommends colon cancer screening in individuals aged 50–75 but recommends against screening for individuals over age 76. Moreover, even for the 4 Supported tests without Against or Insufficient Evidence recommendations, guidelines clearly limit Support recommendations to specific target populations. For example, breast cancer screening is USPSTF Supported, but only for average risk women over 49 and younger high-risk women. Therefore, we count these tests as Supported, but the guideline clearly excludes many other target populations (e.g. low-risk women aged 35).
Table 3 Direct-to-consumer medical tests with guideline support for use in screening
Identified screening testIdentified testing modalityGuidelines recommendation
Bone health
Osteoporosis
Heel ultrasound
Dual-energy X-ray absorptiometry (DXA)
Quantitative computed tomography (qCT) of spine
ImagingUSPSTF supports for women >64 yo and younger women with significant risk factors with heel ultrasound and DXA16
American College of Radiology supports Heel ultrasound, DXA, and qCT of the spine17
Breast health
Breast cancer
Mammography
ImagingUSPSTF supports for average risk women >50 yo and younger high-risk women16
Colorectal health
Colon cancer
Faecal occult blood testing
FaecesUSPSTF supports for adults 50–75 yo16
Diabetes health
Diabetes
Fasting glucose
Random glucose
Haemoglobin A1C
BloodUSPSTF supports for adults with hypertension16
General health
Anaemia screening (complete blood count)BloodUSPSTF supports for anaemia screening in pregnant women16
BacteruriaUrinalysisUSPSTF supports for pregnant women only16
Celiac diseaseBloodAmerican Gastroenterological Association18 and American Dietetic Association19 recommend screening for individuals with positive diagnosis in first-degree relative
Sexually transmitted diseases
Chlamydia/GC
Hepatitis B
HIV
Syphillis
Blood
Urine
USPSTF supports for syphilis screening in high risk and pregnant women, HIV screening for high-risk adults, Hepatitis B screening in pregnant women, Chlamydia/GC screening in high-risk women16
Vitamin D deficiencyBloodNational Guidelines Clearinghouse lists one recommendation supporting screening in distinct high-risk groups of patients. There are otherwise no official guidelines on this screening test20
Heart and lung health
Abdominal aortic aneurysmUltrasoundUSPSTF supports for men 65–75 yo who ever smoked16
Cardiac diseaseEchocardiogramAmerican College of Cardiologists and American Heart Association suggest that the benefits might slightly outweigh the risks for patients with known hypertension21
LipidsBloodUSPSTF supports for high-risk men 20–35 yo, average risk men >34 yo, high-risk women >20 yo16
USPSTF, US Preventive Services Task Force; yo, years old; GC, Gonnococcal
Table 4 Direct-to-consumer medical tests with guidelines against use in screening
Identified screening testsTesting modalityGuidelines recommendation
Breast health
Breast cancer
Self breast examination (SBE) pads
Physical examUSPSTF recommends against SBE16
Colorectal health
Faecal occult blood testing
FaecesUSPSTF recommends against colon cancer screening for adults >76 yo16
General health
Allergy screening
IgE levels for various foods and allergens
BloodAmerican Academy of Allergy, Asthma, and Immunology recommends against the use of random or indiscriminate screening for allergies using serum testing, especially without correlation to history and physical examination22
BacteruriaUrinalysisUSPSTF recommends against bacteruria screening in non-pregnant women and men16
BRCA screening for breast/ovarian cancerBloodUSPSTF recommends against BRCA screening in low-risk patients16
CA-125 screening for ovarian cancerBloodUSPSTF recommends against ovarian cancer screening with CA-12516
GI cancer
CEA
CA-19-9
CA-27-29
BloodUSPSTF recommends against pancreatic cancer screening with the use of serological markers: CEA, CA-19-9, CA-27-2916
Celiac diseaseBloodAmerican Gastroenterological Association18 and American Dietetic Association19 recommend against population screening in asymptomatic and low risk patients
Full body imaging
Non-contrast computed tomography (CT)
Non-contrast magnetic resonance imaging (MRI)
Electron beam CT (EBT)
ImagingUSPSTF recommends against pancreatic cancer screening, ovarian cancer screening, heart scan in low-risk patients16
American College of Radiology (ACR) recommends against use of CT/MRI/EBT for screening purposes17
Joint disease with orthopaedic imaging
3D CT arthrography
ImagingACR recommends against use of CT arthrography for screening or first-line diagnosis of most types of suspected joint pathology17
Lead screeningBloodUSPSTF recommends against lead screening in low-risk children and pregnant women16
Lyme disease screeningBloodCenters for Disease Control and Infectious Diseases Society of America recommends against lyme disease screening for the general population23
Sexually transmitted diseases
Chlamydia/GC
Hepatitis B
Hepatitis C
HIV
Viral herpes
Blood
Urine
USPSTF recommends against syphilis screening in patients at low risk for infection, HIV screening in low-risk patients, hepatitis B screening in low-risk patients, hepatitis C screening in low-risk patients, viral herpes screening for any patients, chlamydia/GC screening in low-risk women16
Spinal disease
Non-contrast MRI
ImagingACR recommends against use of this modality of spinal imaging in the absence of neurological signs or symptoms17
Vitamin B12 deficiency screeningBloodCenters for Disease Control recommends against B12 deficiency screening in the general population23
Heart and lung health
Abdominal aortic aneurysmUltrasoundUSPSTF recommends against screening in men 65–75 who never smoked and all women16
Beta naturietic peptide (BNP)BloodACC/AHA recommend against the use of BNP to evaluate asymptomatic adults for heart disease21
Cardiac disease
Non-contrast CT
Electron beam CT
Echocardiogram
Electrocardiogram
Non-contrast MRI
CT angiography
ImagingUSPSTF recommends against screening in low-risk patients for EKG, non-contrast CT and electron beam CT16
American College of Cardiology (ACC) and American Heart Association (AHA) recommend against use of CT or MRI for screening purposes and recommend against use of echocardiogram to screen in patients without known hypertension21
Carotid artery stenosisUltrasoundUSPSTF recommends against16
LipidsBloodUSPSTF recommends against screening in low-risk men <35 yo and all low-risk women16
Nuclear magnetic resonance (NMR) lipoprofileBloodACC/AHA recommend against the use of any lipoprofile beyond standard lipid screening for screening of cardiovascular disease21
Peripheral arterial diseaseAnkle Brachial IndexUSPSTF recommends against16
Pulmonary function testsSpirometryUSPSTF recommends against16
Vertical auto profile (VAP) lipoprofileBloodACC/AHA recommend against the use of any lipoprofile beyond standard lipid screening for screening of cardiovascular disease21
Prostate health
Prostate cancer (PSA)BloodUSPSTF recommends against screening in men >74 yo16
USPSTF, US Preventive Services Task Force; BRCA, breast cancer; CEA, Carcinoembryonic antigen
Table 5 Direct-to-consumer medical tests with insufficient evidence for use in screening
Identified screening testsTesting modalityGuidelines recommendation
Bone health
Osteoporosis
Heel ultrasound
Dual-energy X-ray sbsorptiometry (DXA)
ImagingUSPSTF makes I Statement for all men16
Breast health
Breast cancer
Digital mammography
Magnetic resonance imaging
ImagingUSPSTF makes I Statement for both digital mammography and magnetic resonance imaging16
Colorectal health
Colon cancer
Virtual colonoscopy with non-contrast computed tomography
ImagingUSPSTF makes I Statement16
Diabetes health
Diabetes
Fasting glucose
Random glucose
Haemoglobin A1C
BloodUSPSTF makes I Statement for adults without hypertension16
General health
Anaemia screening (complete blood count)BloodUSPSTF makes I Statement for children16
Drugs of abuse (nicotine, heroin, cocaine, marijuana, ecstasy, alcohol)Blood
Urine
Hair
Saliva
USPSTF makes I Statement about screening with questionnaires. However, there is no guidance to direct the use of body fluid screening in patients16
Helicobacter pylori screeningBloodAmerican Gastroenterological Association makes the statement that there is not enough data to support or advise against use24
Lead screeningBloodUSPSTF makes I Statement for lead screening in high-risk children16
Lung disease
Non-contrast computed tomography (CT)
Electron beam CT
X-ray
ImagingUSPSTF makes I Statement for high-risk patients16
Sexually transmitted diseases
Chlamydia/GC
Hepatitis C
Blood
Urine
USPSTF makes I Statement for hepatitis C screening in high-risk individuals and chlamydia/GC screening in high-risk men and low-risk pregnant women16
Skin cancer screeningDermoscopyUSPSTF makes I Statement for skin cancer screening by patient or by primary care physicians16
Thyroid screening
TSH
T3
T4
T7
BloodUSPSTF makes I Statement16
Heart health
Cardiac disease
Non-contrast computed tomography (CT)
Electron beam CT
Electrocardiogram
ImagingUSPSTF makes I Statement for high-risk patients16
Carotid intima media thicknessUltrasoundUSPSTF makes I Statement for high-risk patients16
Coronary calcium score
Non-contrast computed tomography (CT)
Electron Beam CT
ImagingUSPSTF makes I Statement for high-risk patients16
LipidsBloodUSPSTF makes I Statement for patients <20 yo with high risk for cardiovascular disease16
Non-traditional cardiac risk factors
HS-CRP
homocysteine
BloodUSPSTF makes I Statement for both HS-CRP and homocysteine16
Prostate health
Prostate cancer (PSA)BloodUSPSTF makes I Statement for men <75 yo16
US Preventive Services Task Force; TSH, thyroid-stimulating hormone; HS-CRP, high-sensitivity C-reactive protien
Table 4 lists the 38 medical tests with ≥1 recommendation Against use in screening; 19/38 tests (32%) carry specific recommendations Against use in all target population groups, while another 10/38 tests (37%) are advised Against for all low-risk patients. For example, guidelines recommend Against carotid artery stenosis screening for all persons, while AAA screening is Supported for men age >65 who have smoked but recommended Against for all women. Within this group of tests, most (N = 29, 69%) are recommended Against for either all individuals or all low-risk individuals.
Of the 127 medical tests, 29 (23%) medical tests carry ≥1 recommendation of Insufficient Evidence to inform use in screening (Table 5). Some may have arguable clinical utility but evidence-based guidance suggests that the available data are insufficient to determine whether screening benefits outweigh risks (e.g. osteoporosis screening in men, hyperlipidaemia screening in young persons and diabetes screening in persons without hypertension).
Finally, 64 (50%) identified DTC medical tests have no published guidance from USPSTF or specialty societies (Table 6). These also involve body fluid testing and imaging studies, spanning the scope from melatonin levels and antioxidant screening through virtual bronchoscopy and thermography.
Table 6 Direct-to-consumer medical tests with no guidance for use in screening
Screening test identifiedTesting modalityGuidelines searched
Atrial fibrillation
Electrocardiogram
Echocardiogram
ImagingUSPSTF
National Guideline Clearinghouse
American College of Cardiology
American Heart Association
Breast cancer screening
Thermography
ImagingUSPSTF
National Guidelines Clearinghouse
American College of Radiology
American Cancer Society (ACS)
ACS states on their website that thermography should not be used as a substitute for mammography25
Co-Q10BloodUSPSTF
American College of Cardiology
American Heart Association
Dental screening
Non-contrast computed tomography
ImagingUSPSTF
National Guideline Clearinghouse
American Dental Association
Diabetes screening
Glucose
UrineUSPSTF
National Guidelines Clearinghouse
American Endocrinologic Association
American Diabetes Association
None of the guidelines making recommendations on screening for diabetes consider urine testing for screening purposes
Female hormonesSalivaUSPSTF
National Guidelines Clearinghouse
American College of Obstetrics and Gynecology
Finger stick testing Various including lipids, Hg A1c, random glucose, fasting glucose, HS-CRPBloodFinger stick blood testing has not been discussed in any guidelines as an effective modality of screening patients for disease
Home testing kits Various including bacteruria, diabetes, drugs of abuse, colon cancer, male hormones, female hormones, sexually transmitted diseasesVaryingHome testing kits have not been discussed in any guidelines as an effective modality of screening patients for disease
Drugs of abuse
Body fluid testing for: alcohol, cocaine, ecstasy, heroin, nicotine
VaryingUSPSTF National Guidelines Clearinghouse
USPSTF does give recommendations for screening for drugs of abuse with questionnaires but does not discuss body fluid testing as a screening modality for drugs of abuse.
Male hormonesSalivaUSPSTF National Guidelines Clearinghouse
Virtual arteriography
3D computed tomography
ImagingUSPSTF
National Guidelines Clearinghouse
American College of Cardiology
American Heart Association
American College of Radiology
Virtual bronchoscopy
3D computed tomography
ImagingUSPSTF
National Guidelines Clearinghouse
American College of Chest Physicians
American College of Radiology
Various blood testing includes ABO/Rh blood type, Alpha fetoprotein, alkaline phosphatase, ALT, amylase, ANA, anti-SM antibodies, antioxidants, AST, beta carotene, cortisol, electrolytes, female hormones, folate, heavy metals, iron, lipase, magnesium, male hormones, parathyroid hormone, RF, selenium, vitamin A, vitamin B6, vitamin C, vitamin E, vitamin KBloodUSPSTF
National Guidelines Clearinghouse
USPSTF, US Preventive Services Task Force; ALT, alanine transaminase; ANA, antinuclear antibody; AST, aspartate transaminase; SM, Smooth muscle; HS-CRP, high-sensitivity C-reactive protein

DISCUSSION

Though recent commentary has focused on the implications of DTC cardiac and genetic tests, the patient safety threat posed by the breadth of available DTC medical tests has not been adequately addressed. Furthermore, probably due to recent FDA warnings targeting DTC genetic testing companies, access to DTC genetic tests has become much less appreciable. In fact, most companies we identified did not specifically advertise or offer the range of DTC genetic susceptibility tests previously reported in the literature. However, we have identified a large scope of non-genetic DTC medical testing and, as such, regulatory oversight in combination with non-governmental and professional society intervention is critical in future efforts.

Principal results and implications

Of the 127 identified DTC medical tests advertised online, virtually all (97%) have clear guidance advising against use, insufficient or conflicting evidence to inform use, or no guidance at all regarding use for screening purposes.
The relative lack of evidence-based support is alarming, but in addition the 3% of tests with unopposed recommendations of Support were all limited to very specific target populations. In fact, where tests are Supported, they are supported for a narrow range of individuals, and where tests are advised Against, they are advised against for target populations. This means that not a single identified DTC screening test has evidence-based guidance to support general population screening. Ultimately, traditional medical care uses evidence-based guidelines based on outcome data to restrict screening test recommendations to narrow target populations in order to improve the risk/benefit ratio of testing. However, DTC medical testing companies do not limit their testing according to evidence-based guidelines, and are therefore exposing the general population to tests that likely pose more risk than benefit to many of these consumers. In general, no screening tests are recommended for broad use in the general population, yet these tests are offered to the public without any mechanism to filter consumers who may benefit and those who may not. Indeed, medical testing offered to the general public without adequate pretest evaluation cannot even be properly identified as a ‘screening’ test. Consumers searching online are therefore confronted with a quagmire of medical tests that are generally not evidence-based and in all probability not applicable to their specific circumstance.
Online advertisements for DTC medical tests generally fail to offer evidence-based screening information, informed consent and potential risks of testing. This information is necessary for informed acceptance or refusal of test risks and benefits. Informed consent provides a mode of evidence-based patient selection and accountability for advising use of various medical tests for screening purposes and direct questioning with a qualified health professional allows determination of whether a consumer is truly seeking screening for asymptomatic disease or if he/she has symptoms requiring diagnostic testing and follow-up.
In addition to a lack of informed consent and pretest counselling, consumers are generally not offered post-test counselling or follow-up. On the basis of misused testing and/or misinterpreted results, patients may choose to self-diagnose and self-treat, including purchasing pharmaceuticals online.26 Inappropriate self-interpretation may prompt patients to seek unnecessary care, or worse, erroneously preclude them from seeking needed care because they believe a single test has precluded a positive result. Pre- and post-test counselling, even if offered, has its own limitations, and may not promote patient safety without adequate referral services to a medical professional. The vast majority of identified sites offered no pre- post-test counselling and consequently also did not offer any referral services following a test result. This lack of adequate patient follow-up and continuity of care could have significant adverse impact.
In general, abnormal results from DTC medical testing lead to further care for repeat testing, treatment or further investigation. Consequently, medical testing that is promoted in a fashion inconsistent with evidence-based medicine is highly likely to lead to unnecessary resource waste, iatrogenic harm from downstream treatments or management, premature labelling of patients and excessive anxiety over testing results, while not improving health outcomes.
Legally, given that nearly all identified medical tests lack evidence to support use in the general population, online DTC advertising and/or sale of this testing as ‘screening’ or otherwise may be construed as false or misleading where it does not adequately reflect the risk versus benefit of use. This may represent violation of FDA regulations regarding advertisement and sale of DTC medical products.27 Moreover, advertisements for DTC medical tests that include potentially fraudulent or misleading statements regarding efficacy and/or utility6 also implicate US state and federal consumer protection laws.28,29

Recommendations for reform

Collectively, the limited scientific support, lack of patient/consumer safety protections and legal concerns necessitate multistakeholder actions to address this burgeoning industry. Like illicit online pharmacies, unregulated online advertisement, sale and administration of DTC medical testing poses a threat to public health and inappropriately fuels health expenditures.1,68 Yet medical screening tests, if evidence-based and used appropriately with patient safety safeguards, can promote and inform health and education. Hence, efforts to collect outcomes data, create public awareness, highlight best practices for the DTC medical testing industry and implement a robust regulatory regimen to promote responsible access to DTC medical screening tests should be explored.
Collecting outcomes data are an essential first step in addressing the DTC medical testing industry. As seen via evidence-based guidelines based on outcome data, unnecessary screening with many of these medical tests will lead to downstream harms within traditional medical practice. In addition to known harms from false-positive/negative results and iatrogenic harms from widespread testing, it is probably that there are additional harms related to a lack of informed consent and follow-up in the DTC medical testing industry. While there are few case reports detailing severe anxiety and hopelessness of consumers after being given results of DTC genetic screening tests,30 larger outcome based studies evaluating DTC testing harms, downstream intervention harms and costs are needed.
Secondly, DTC medical testing companies should be limited to offering medical screening as a public health service, in an organized manner, according to a specified protocol, requiring medical professional oversight, appropriate pre-test evaluation, post-test counselling for people with positive testing results, availability of diagnostic services and diagnostic support and treatment, and service monitoring.4 Indeed, where medical testing is being advertised and offered DTC without appropriate medical professional oversight, it should be prosecuted by US state Attorney Generals and organized medical associations as the unauthorized practice of medicine. DTC medical testing companies should be limited to offering only outcomes proven medical screening tests endorsed by professional screening bodies. In addition, where online advertisements could be construed as fraudulent, misleading or lacking appropriate evidence-based risk/benefit information, companies should be sanctioned.
Because of the national scope of this DTC medical testing industry, the FDA should be a primary driver for regulation and oversight in the US FDA involvement here is consistent with draft guidance indicating oversight of tests that: ‘might use measured or observed values of multiple variables, such as a patient's age, weight, metabolite level, and gene expression levels.’31 FDA oversight could include guidance and surveillance of websites advertising and selling DTC screening tests,12 including requiring DTC testing companies be FDA-registered under a programme verifying federal certification for engagement in medical testing sale and administration.
The combination of these safeguards would ensure companies selling DTC screening tests in the US are legitimate, tests are evidence-based, patients are informed, counselling is available, and that marketing is responsible, monitored by regulators, and appropriately reflects screening test risks and benefits. Importantly as well, providing accessible consultation by a medical professional would alleviate the burden on patients in interpreting confusing (especially abnormal) results, and would allow patients to make more informed decisions regarding health care and screening test purchase and follow-up care. DTC medical testing in combination with the unprecedented increase in Internet access and illicit pharmaceutical activity has now moved the health-care arena into uniquely troubling waters. Society now faces unfettered diagnosis and treatment completely peripheral to professional guidance, creating the potential for a medical delivery system promoting patient self-diagnosis and self-treatment that may be inaccurate, ineffective, potentially harmful and resource wasteful. This safety risk is growing as DTC sale and online advertisement of medical resources expands and regulation lags.

Study limitations

There are several limitations to this study. First, our study methodology did not capture various previously identified DTC tests such as genetic testing and fetal ultrasound imaging.7,32 This implies, however, that there are probably more suspect DTC tests available than those identified here. In addition, our methodology did not address actual utilization of online DTC screening test services, making it difficult to quantify the public health and patient safety impact; however, the continued existence of these companies offering such a spectrum of medical tests implies that there is a lucrative market keeping companies financially viable and tests available. Finally, the Internet is a rapidly changing, dynamic environment, and our assessment was limited to data from the specific time periods when we performed searches.

CONCLUSION

Online advertising and access to DTC medical products has made screening tests readily available to consumers without the need of a prescription or medical consultation and without adequate clinical follow-up. The scope of DTC medical testing advertised online is broad and most available medical tests have limited evidentiary support. Companies offering DTC medical tests fail to provide for informed consent, pre-/post-test counselling or follow-up care, creating substantial risks to patient safety and legal concerns. Reform is needed to address this growing public health risk.

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Article first published online: October 23, 2012
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PubMed: 23093732

Authors

Affiliations

Kimberly M Lovett
Kaiser Permanente; Department of Family and Preventive Medicine, University of California, San Diego School of Medicine; Institute of Health Law Studies, California Western School of Law; San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, CA, USA
Timothy K Mackey
Institute of Health Law Studies, California Western School of Law; Joint Doctoral Program in Global Health, University of California, San Diego-San Diego State University; San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, CA, USA
Bryan A Liang
Institute of Health Law Studies, California Western School of Law; Department of Anesthesiology, University of California, San Diego School of Medicine; San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, CA, USA

Notes

Correspondence to: Kimberly Lovett, 1630 East Main Street, El Cajon, CA 92021, USA; [email protected]

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