Evaluating the evidence: direct-to-consumer screening tests advertised online
Abstract
Objectives
Methods
Results
Conclusions
INTRODUCTION
METHODS
RESULTS
Test identified | Mode identified | Support | Against | Insufficient evidence | No guidance | |
---|---|---|---|---|---|---|
1 | Abdominal aortic aneurysm | Ultrasound | X | X | ||
2 | ABO/RH blood types | Blood | X | |||
3 | Alcohol use | Blood | X | |||
4 | Alcohol use | Urine | X | |||
5 | Alcohol use | Home testing kit | X | |||
6 | Alkaline phosphatase | Blood | X | |||
7 | Allergy IgE testing | Blood | X | |||
8 | Alphafetoprotein | Blood | X | |||
9 | ALT | Blood | X | |||
10 | Amylase | Blood | X | |||
11 | ANA | Blood | X | |||
12 | Anti-SM antibodies | Blood | X | |||
13 | Antioxidants | Blood | X | |||
14 | AST | Blood | X | |||
15 | Atrial fibrillation | Electrocardiogram | X | |||
16 | Atrial fibrillation | Echocardiogram | X | |||
17 | Bacteruria | Urine | X | X | ||
18 | Bacteruria | Home testing kit | X | |||
19 | Beta carotene | Blood | X | |||
20 | Beta naturetic peptide | Blood | X | |||
21 | BRCA | Blood | X | |||
22 | Breast cancer | Self breast exam pads | X | |||
23 | Breast cancer | Digital mammogram | X | |||
24 | Breast cancer | MRI | X | |||
25 | Breast cancer | Thermography | X | |||
26 | Breast cancer | Mammogram | X | |||
27 | CA 27-29 tumour marker | Blood | X | |||
28 | CA-125 tumour marker | Blood | X | |||
29 | CA-19-9 tumour marker | Blood | X | |||
30 | Cardiac disease | Electrocardiogram | X | X | ||
31 | Cardiac disease | Non-contrast CT | X | X | ||
32 | Cardiac disease | Electron beam CT | X | X | ||
33 | Cardiac disease | Echocardiogram | X | X | ||
34 | Cardiac disease | Non-contrast MRI | X | |||
35 | Cardiac disease | CT angiography | X | |||
36 | Carotid artery stenosis | Ultrasound | X | |||
37 | Carotid intima media thickness | Ultrasound | X | |||
38 | Complete blood count | Blood | X | X | ||
39 | CEA tumour marker | Blood | X | |||
40 | Celiac disease | Blood | X | X | ||
41 | Chlamydia/GC | Blood | X | X | X | |
42 | Co-Q10 | Blood | X | |||
43 | Cocaine use | Blood | X | |||
44 | Cocaine use | Urine | X | |||
45 | Cocaine use | Home testing kit | X | |||
46 | Colon cancer | Feces | X | X | ||
47 | Colon cancer | Virtual colonoscopy | X | |||
48 | Colon cancer | Home testing kit | X | |||
49 | Cortisol | Blood | X | |||
50 | Dental disease | Non-contrast CT | X | |||
51 | Diabetes mellitus | Fasting glucose, blood | X | X | ||
52 | Diabetes mellitus | Random glucose, blood | X | X | ||
53 | Diabetes mellitus | Hg A1c, blood | X | X | ||
54 | Diabetes mellitus | Fasting glucose, finger stick (FS) | X | |||
55 | Diabetes mellitus | Random glucose, FS | X | |||
56 | Diabetes mellitus | Hg A1C, FS | X | |||
57 | Diabetes mellitus | Home testing kit | X | |||
58 | Diabetes mellitus | Urine | X | |||
59 | Ecstasy use | Blood | X | |||
60 | Ecstasy use | Urine | X | |||
61 | Ecstasy use | Home testing kit | X | |||
62 | Electrolytes | Blood | X | |||
63 | Female hormones | Saliva | X | |||
64 | Female hormones | Blood | X | |||
65 | Folate | Blood | X | |||
66 | Full body imaging | Non-contrast CT | X | |||
67 | Full body imaging | Non-contrast MRI | X | |||
68 | Full body imaging | Electron beam CT | X | |||
69 | Heavy metals | Blood | X | |||
70 | Helicobacter pylori | Blood | X | |||
71 | Hepatitis B | Blood | X | X | ||
72 | Hepatitis C | Blood | X | X | ||
73 | Heroin use | Blood | X | |||
74 | Heroin use | Urine | X | |||
75 | Heroin use | Home testing kit | X | |||
76 | HIV | Blood | X | X | ||
77 | Homocysteine | Blood | X | |||
78 | HS-CRP | Blood | X | |||
79 | Iron | Blood | X | |||
80 | Lead | Blood | X | X | ||
81 | Lipase | Blood | X | |||
82 | Lipids | Blood | X | X | X | |
83 | Lipids | Blood, FS | X | |||
84 | Lung disease | Non-contrast CT | X | |||
85 | Lung disease | Electron beam CT | X | |||
86 | Lung disease | X-ray | X | |||
87 | Lyme disease | Blood | X | |||
88 | Magnesium | Blood | X | |||
89 | Male hormones | Saliva | X | |||
90 | Male hormones | Blood | X | |||
91 | Marijuana use | Home testing kit | X | |||
92 | Marijuana use | Blood | X | |||
93 | Marijuana use | Urine | X | |||
94 | Melatonin | Blood | X | |||
95 | Nicotine use | Blood | X | |||
96 | Nicotine use | Urine | X | |||
97 | Nicotine use | Hair | X | |||
98 | Nicotine use | Home testing kit | X | |||
99 | Nuclear magnetic resonance (NMR) lipoprofile | Blood | X | |||
100 | Orthopaedic imaging | 3D CT | X | |||
101 | Osteoporosis | Heel Ultrasound | X | X | ||
102 | Osteoporosis | DXA | X | X | ||
103 | Osteoporosis | Quantitative CT | X | |||
104 | Parathyroid function | Blood | X | |||
105 | Peripheral arterial disease | Ultrasound | X | |||
106 | Prostate specific antigen | Blood | X | X | ||
107 | Pulmonary function tests | Spirometry | X | |||
108 | Rheumatoid factor | Blood | X | |||
109 | Selenium | Blood | X | |||
110 | Skin cancer | Dermoscopy | X | |||
111 | Spinal disease | Non-contrast MRI | X | |||
112 | Syphillis | Blood | X | |||
113 | Thyroid function | TSH, blood | X | |||
114 | Thyroid function | T4, blood | X | |||
115 | Thyroid function | T3, blood | X | |||
116 | Thyroid function | T7, blood | X | |||
117 | Vertical autoprofile (VAP) lipoprofile | Blood | X | |||
118 | Viral herpes | Blood | X | |||
119 | Virtual arteriography | 3D CT | X | |||
120 | Virtual bronchoscopy | 3D CT | X | |||
121 | Vitamin A | Blood | X | |||
122 | Vitamin B6 | Blood | X | |||
123 | Vitamin B12 | Blood | X | |||
124 | Vitamin C | Blood | X | |||
125 | Vitamin D | Blood | X | |||
126 | Vitamin E | Blood | X | |||
127 | Vitamin K | Blood | X | |||
Totals | 19 | 38 | 29 | 64 |
Identified screening test | Identified testing modality | Guidelines recommendation |
---|---|---|
Bone health | ||
Osteoporosis • Heel ultrasound • Dual-energy X-ray absorptiometry (DXA) • Quantitative computed tomography (qCT) of spine | Imaging | USPSTF 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 | Imaging | USPSTF supports for average risk women >50 yo and younger high-risk women16 |
Colorectal health | ||
Colon cancer • Faecal occult blood testing | Faeces | USPSTF supports for adults 50–75 yo16 |
Diabetes health | ||
Diabetes • Fasting glucose • Random glucose • Haemoglobin A1C | Blood | USPSTF supports for adults with hypertension16 |
General health | ||
Anaemia screening (complete blood count) | Blood | USPSTF supports for anaemia screening in pregnant women16 |
Bacteruria | Urinalysis | USPSTF supports for pregnant women only16 |
Celiac disease | Blood | American 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 deficiency | Blood | National 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 aneurysm | Ultrasound | USPSTF supports for men 65–75 yo who ever smoked16 |
Cardiac disease | Echocardiogram | American College of Cardiologists and American Heart Association suggest that the benefits might slightly outweigh the risks for patients with known hypertension21 |
Lipids | Blood | USPSTF supports for high-risk men 20–35 yo, average risk men >34 yo, high-risk women >20 yo16 |
Identified screening tests | Testing modality | Guidelines recommendation |
---|---|---|
Breast health | ||
Breast cancer • Self breast examination (SBE) pads | Physical exam | USPSTF recommends against SBE16 |
Colorectal health | ||
• Faecal occult blood testing | Faeces | USPSTF recommends against colon cancer screening for adults >76 yo16 |
General health | ||
Allergy screening • IgE levels for various foods and allergens | Blood | American 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 |
Bacteruria | Urinalysis | USPSTF recommends against bacteruria screening in non-pregnant women and men16 |
BRCA screening for breast/ovarian cancer | Blood | USPSTF recommends against BRCA screening in low-risk patients16 |
CA-125 screening for ovarian cancer | Blood | USPSTF recommends against ovarian cancer screening with CA-12516 |
GI cancer • CEA • CA-19-9 • CA-27-29 | Blood | USPSTF recommends against pancreatic cancer screening with the use of serological markers: CEA, CA-19-9, CA-27-2916 |
Celiac disease | Blood | American 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) | Imaging | USPSTF 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 | Imaging | ACR recommends against use of CT arthrography for screening or first-line diagnosis of most types of suspected joint pathology17 |
Lead screening | Blood | USPSTF recommends against lead screening in low-risk children and pregnant women16 |
Lyme disease screening | Blood | Centers 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 | Imaging | ACR recommends against use of this modality of spinal imaging in the absence of neurological signs or symptoms17 |
Vitamin B12 deficiency screening | Blood | Centers for Disease Control recommends against B12 deficiency screening in the general population23 |
Heart and lung health | ||
Abdominal aortic aneurysm | Ultrasound | USPSTF recommends against screening in men 65–75 who never smoked and all women16 |
Beta naturietic peptide (BNP) | Blood | ACC/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 | Imaging | USPSTF 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 stenosis | Ultrasound | USPSTF recommends against16 |
Lipids | Blood | USPSTF recommends against screening in low-risk men <35 yo and all low-risk women16 |
Nuclear magnetic resonance (NMR) lipoprofile | Blood | ACC/AHA recommend against the use of any lipoprofile beyond standard lipid screening for screening of cardiovascular disease21 |
Peripheral arterial disease | Ankle Brachial Index | USPSTF recommends against16 |
Pulmonary function tests | Spirometry | USPSTF recommends against16 |
Vertical auto profile (VAP) lipoprofile | Blood | ACC/AHA recommend against the use of any lipoprofile beyond standard lipid screening for screening of cardiovascular disease21 |
Prostate health | ||
Prostate cancer (PSA) | Blood | USPSTF recommends against screening in men >74 yo16 |
Identified screening tests | Testing modality | Guidelines recommendation |
---|---|---|
Bone health | ||
Osteoporosis • Heel ultrasound • Dual-energy X-ray sbsorptiometry (DXA) | Imaging | USPSTF makes I Statement for all men16 |
Breast health | ||
Breast cancer • Digital mammography • Magnetic resonance imaging | Imaging | USPSTF makes I Statement for both digital mammography and magnetic resonance imaging16 |
Colorectal health | ||
Colon cancer • Virtual colonoscopy with non-contrast computed tomography | Imaging | USPSTF makes I Statement16 |
Diabetes health | ||
Diabetes • Fasting glucose • Random glucose • Haemoglobin A1C | Blood | USPSTF makes I Statement for adults without hypertension16 |
General health | ||
Anaemia screening (complete blood count) | Blood | USPSTF 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 screening | Blood | American Gastroenterological Association makes the statement that there is not enough data to support or advise against use24 |
Lead screening | Blood | USPSTF makes I Statement for lead screening in high-risk children16 |
Lung disease • Non-contrast computed tomography (CT) • Electron beam CT • X-ray | Imaging | USPSTF 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 screening | Dermoscopy | USPSTF makes I Statement for skin cancer screening by patient or by primary care physicians16 |
Thyroid screening • TSH • T3 • T4 • T7 | Blood | USPSTF makes I Statement16 |
Heart health | ||
Cardiac disease • Non-contrast computed tomography (CT) • Electron beam CT • Electrocardiogram | Imaging | USPSTF makes I Statement for high-risk patients16 |
Carotid intima media thickness | Ultrasound | USPSTF makes I Statement for high-risk patients16 |
Coronary calcium score • Non-contrast computed tomography (CT) • Electron Beam CT | Imaging | USPSTF makes I Statement for high-risk patients16 |
Lipids | Blood | USPSTF makes I Statement for patients <20 yo with high risk for cardiovascular disease16 |
Non-traditional cardiac risk factors • HS-CRP • homocysteine | Blood | USPSTF makes I Statement for both HS-CRP and homocysteine16 |
Prostate health | ||
Prostate cancer (PSA) | Blood | USPSTF makes I Statement for men <75 yo16 |
Screening test identified | Testing modality | Guidelines searched |
---|---|---|
Atrial fibrillation • Electrocardiogram • Echocardiogram | Imaging | USPSTF National Guideline Clearinghouse American College of Cardiology American Heart Association |
Breast cancer screening • Thermography | Imaging | USPSTF 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-Q10 | Blood | USPSTF American College of Cardiology American Heart Association |
Dental screening • Non-contrast computed tomography | Imaging | USPSTF National Guideline Clearinghouse American Dental Association |
Diabetes screening • Glucose | Urine | USPSTF 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 hormones | Saliva | USPSTF National Guidelines Clearinghouse American College of Obstetrics and Gynecology |
Finger stick testing Various including lipids, Hg A1c, random glucose, fasting glucose, HS-CRP | Blood | Finger 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 diseases | Varying | Home 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 | Varying | USPSTF 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 hormones | Saliva | USPSTF National Guidelines Clearinghouse |
Virtual arteriography • 3D computed tomography | Imaging | USPSTF National Guidelines Clearinghouse American College of Cardiology American Heart Association American College of Radiology |
Virtual bronchoscopy • 3D computed tomography | Imaging | USPSTF 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 K | Blood | USPSTF National Guidelines Clearinghouse |
DISCUSSION
Principal results and implications
Recommendations for reform
Study limitations
CONCLUSION
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This article was published in Journal of Medical Screening.
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