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Clinical guidelines

Guidelines for preventive activities in general practice 9th edition

15. Screening tests of unproven benefit

The following are not recommended as screening tests in low-risk or asymptomatic general practice populations. These tests may have a separate value as diagnostic tests or as tests to monitor disease progression.

Table 15.1. Screening tests not recommended in low-risk general practice populations
Screening testConditionReason not to use
Genomic sequencing Genetic risk Limited evidence on the balance of benefits and harms, ethical issues and uncertain utility in an asymptomatic adult 1-5
Genetic testing – methylenetetrahydrofolate reductase (MTHFR) Venous thrombo­embolism The MTHFR test has minimum clinical utility and is not recommended in the evaluation of thrombophilia, recurrent pregnancy loss, or assessment of risk of coronary artery disease or any other condition 6
Genetic testing – apolipoprotein E (ApoE) Alzheimer’s disease ApoE testing is not recommended to assess risk of Alzheimer’s disease due to its poor predictive value and the lack of preventive options 6
Vascular
Coronary computed tomography angiography* (CCTA) Coronary artery disease (CAD) No randomised controlled trial (RCT) evidence. RCTs of therapy show no effect on coronary artery progression 7–11

May be of benefit in those at moderate risk of CAD – but not in:
  • asymptomatic persons
  • subjects with known significant CAD
  • subjects with a high pre-test probability of CAD
Computed tomography (CT) calcium scoring† Coronary heart disease (CHD) Usually not appropriate in a low-risk asymptomatic population, but may be of possible value in risk reclassification in those at moderate risk 8, 9, 11–13
Serum homocysteine CHD Value as a risk factor for CHD is uncertain and published RCTs show no evidence of benefit by lowering levels 14-18
Exercise electrocardiogram (ECG) CHD Low yield and high false-positive rate given low prevalence in asymptomatic population 14, 19–22
High sensitivity C-reactive protein (hsCRP) Cardiovascular disease (CVD) Insufficient evidence to support the role of hsCRP in preventive screening of asymptomatic patients 14, 22–29
Ankle:brachial index (ABI) Peripheral vascular disease Current evidence is insufficient to assess benefits and costs of using ABI to screen for peripheral vascular disease 28, 30–37
Carotid artery ultrasound38–43 Asymptomatic carotid artery stenosis It is no longer justifiable to screen for the presence of asymptomatic carotid artery stenosis to select patients for carotid procedures. There is no current evidence of patient benefit. However, there is evidence of harms from screening, including significant procedural risk and cost

Carotid stenting cannot be recommended because it causes about twice as many strokes or deaths as carotid endarterectomy (CEA), a risk that is not offset by the CEA risk of myocardial infarction

Also, asymptomatic carotid artery stenosis patients with particularly high ipsilateral stroke risk who benefit from CEA, in addition to current optimal medical treatment alone, have not been identified. Evidence is insufficient to allow reliable risk stratification. For example, degree of stenosis within the 50–99% range, asymptomatic stenosis progression, plaque echolucency and transcranial Doppler embolus detection are not specific enough to identify patients likely to benefit from CEA

A research priority is to find out if screening to detect asymptomatic carotid artery stenosis improves medical treatment and patient outcomes over screening for, and optimal treatment of, other established vascular risk factors
Cancer
Magnetic resonance imaging (MRI)44–51 Breast cancer Ongoing surveillance strategies for women at high risk of breast cancer may include imaging with MRI. A Medicare rebate is available for MRI scans for asymptomatic women <50 years of age at high risk of breast cancer

There is no evidence for MRI as a stand-alone screening test for women at average risk of breast cancer
Thermography Breast cancer Thermography is associated with high false-positive and false-negative rates. There is insufficient evidence to support the use of thermography in breast cancer screening or as an adjunctive tool to mammography 52, 53
Single nucleotide polymorphism (SNP) testing46, 54–56 Breast cancer Use of a SNP‐based breast cancer risk assessment test should only be undertaken after an in‐depth discussion led by a clinical professional familiar with the implications of genetic risk assessment and testing, including the potential insurance implications

Genetic testing should be offered only with pre-test and post-test counselling to discuss the limitations, potential benefits, and possible consequences
Cancer antigen (CA)125/transvaginal ultrasound46, 57–61 Ovarian cancer There is no evidence to support the use of any test – including pelvic examination, CA125, or other biomarkers, ultrasound (including transvaginal ultrasound), or combination of tests – for routine population-based screening for ovarian cancer

CA125 is limited by poor sensitivity in early-stage disease and low specificity. The specificity of transvaginal ultrasound is low. The low prevalence of ovarian cancer means that even screening tests that have very high sensitivity and specificity have a low positive predictive value for disease detection

The recently reported UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) trial of transvaginal ultrasound +/– CA125 found no significant difference in mortality over 0–14 years

Secondary analyses suggest a possible benefit of screening using transvaginal ultrasound and CA125, but further follow-up is needed before firm conclusions can be reached on the long-term efficacy and cost-effectiveness of ovarian cancer screening
Optical colonoscopy or computed tomography (CT) colonography‡62–69 Colorectal cancer (CRC) These have good sensitivity for cancer and advanced polyps, and are more acceptable than colonoscopy, but there is no current evidence of the reduction of CRC mortality. There are several trials under way to assess effectiveness and cost effectiveness of this as a screening strategy

Neither optical colonoscopy nor CT colonography are recommended for primary screening because there is no current RCT evidence of effectiveness in relation to any harms
Whole-body CT or MRI Cancer Whole-body imaging has not been shown to improve quality of life and/or decrease mortality. It is associated with additional radiation exposure and a high number of false positive results. There are no RCTs of whole-body imaging to detect cancer or CVD 70–77
Lung disease
Spirometry78–83 Chronic obstructive pulmonary disease (COPD) Screening with spirometry in the absence of symptoms has no net benefit

Opportunistic case-finding should be considered in high-risk individuals. These include those aged >40 years, plus either:
  • symptoms (chronic cough, increased sputum production, wheezing or dyspnoea)
  • history of exposure to relevant environmental factors such as cigarette smoke
Several questionnaires§ are useful and if positive, should be followed by spirometry by a trained professional (consensus statement)
Endocrine
Thyroid function tests84–89 Thyroid dysfunction Despite the relatively high incidence of subclinical hypothyroidism in older women (up to 17%), there is a lack of convincing data from controlled trials that early treatment reduces lipid levels, symptoms or the risk for CVD in patients with mild thyroid dysfunction detected by screening

There is no evidence supporting an increased risk for stroke associated with subclinical thyroid dysfunction

More research is needed to determine the clinical benefits associated with thyroid screening
Chronic disease prevention
Vitamin D Vitamin D deficiency Current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults 90–97
Heel ultrasound Osteoporosis While there is some evidence that heel ultrasound in combination with femoral neck bone densitometry better predicts hip fracture, there are no RCTs showing any benefit of using heel ultrasound as the primary screening tool for osteoporosis, nor is its usefulness as a pre-screening tool in tandem with dual-energy X-ray absorptiometry (DXA) proven 98–103
Infection
Mid-stream urine (MSU) culture Asymptomatic bacteriuria (elderly) Identifying and treating non-pregnant adults with asymptomatic bacteriuria does not improve outcomes and may increase antibiotic resistance. The only two exceptions to this are pregnancy and a patient who is about to undergo a urological procedure 104, 105
Other tests
Enquiry about sleep106–109 Obstructive sleep apnoea (OSA) The prevalence of undiagnosed OSA is high and it is associated with considerable morbidity. While there are some screening tools that are available, there are no large-scale RCTs showing the benefit or cost-benefit of routine screening for OSA in primary care

Case-finding for OSA may be beneficial in commercial vehicle drivers and pilots, but it has not been mandated by any government authority
Bimanual pelvic exam During a routine Papanicolaou (Pap) test in an asymptomatic woman A bimanual examination performed as part of routine Pap smear examination is of no proven benefit, but studies are limited 110–113

It has been shown to be not an effective screening method for ovarian cancer detection
* CCTA involves the use of multi-slice CT and intravenously administered contrast material to obtain detailed images of the blood vessels of the heart. It has been used as an alternative to conventional invasive coronary angiography for evaluating CAD and coronary artery anomalies. CCTA requires high doses of ionizing radiation, with an average dose of 8.1 milliSieverts for patients weighing 75 kg. This dose is approximately two to three times higher than the average radiation dose administered to patients during conventional coronary angiography

† CT calcium scoring (also known as Coronary Calcium Scan and Coronary Artery Calcium Scoring). A good summary on CT calcium score [Accessed 26 May 2016]

‡ There are no current Medicare Benefits Schedule (MBS) rebates for performing cardiac CT in asymptomatic individuals.

§ Refer to the Lung Foundation

ABI, ankle:brachial index; ApoE, apolopoprotein E; CA, cancer antigen; CAD, coronary artery disease; CCTA, coronary computed tomography angiography; CEA, carotid endarterectomy; CHD, coronary heart disease; CT, computed tomography; CVD, cardiovascular disease; DXA, dual-energy X-ray absorptiometry; hsCRP, high sensitivity C-reactive protein; MBS, Medicare Benefits Schedule; MRI, magnetic resonance imaging; MSU, mid-stream urine; MTHFR, methylenetetrahydrofolate; OSA, obstructive sleep apnoea; Pap, Papanicolaou; RCT, randomised controlled trial; SNP, single nucleotide polymorphism; UKCTOCS, UK Collaborative Trial of Ovarian Cancer Screening
Table 15.2. Screening tests of indeterminate value
Screening testConditionReason not to use
Vitamin D92, 114–17 Pregnancy Pregnant women with one or more risk factors for low vitamin D levels should have their serum 25-hydroxy vitamin D levels measured at their first antenatal visit

Risk factors for low vitamin D levels are lack of skin exposure to sunlight, dark skin, southerly latitude, conditions affecting vitamin D metabolism and storage (including obesity) and, for infants, being born to a mother with low vitamin D levels and exclusive breastfeeding combined with at least one other risk factor.
Vascular
Ultrasound118–23 Abdominal aortic aneurysm (AAA) National screening of men aged 65 years has been successfully introduced in the UK and parts of Scandinavia for AAA. However, it is unclear what the impact of the lower-than-expected prevalence (<2%) of AAAs will be on the long-term benefit

The US Preventive Services Task Force (USPSTF) recommends screening of older male smokers. Limiting screening to this sub-group has raised some ethical issues and may influence cost-effectiveness

Unpublished recent data from the Western Australian trial of screening for AAA suggests that the magnitude of the benefit from screening men aged ≥65 years does not warrant the introduction of a national AAA screening program in Australia at this stage
B-type natriuretic peptide (BNP) Congestive cardiac failure The evidence for screening for heart failure using BNP is mixed despite its sensitivity and prognostic significance. It may be useful in excluding the condition in suspected heart failure. A recent, pragmatic, un-blinded randomised controlled trial (RCT) has shown some benefit for BNP screening in high-risk groups, but large scale trials are needed to confirm these findings and establish feasibility and cost effectiveness 25, 124–30
Cancer
Low-dose chest computed tomography131–38 Lung cancer A large trial in the US has shown that patients selected for high lung cancer risk have reduced lung cancer and total mortality within a carefully conducted LDCT screening program in the context of a structured program of selection, screening, evaluation, and management of the relatively high number of benign abnormalities

Performing CT scans in high-risk individuals outside well-designed and conducted research programs may lack any benefit and may be harmful. Low-risk persons should not have screening CT as the reasonably foreseeable benefits are lower and may be substantially outweighed by harms. More accurate data on the identification of the appropriate target group including the threshold for absolute lung cancer risk, are required before any recommendation on LDCT
Positron emission tomography – computed tomography (or PET CT scan) Lung cancer There is no current evidence of benefit for PET screening for lung cancer 135, 139, 140
Elderly
Visual acuity Visual impairment Current evidence is insufficient to assess the balance of benefits and harms of screening for impaired visual acuity in older adults 141–43
AAA, abdominal aortic aneurysm; BNP, B-type natriuretic peptide; LDCT, low-dose computed tomography; PET, positron emission tomography; RCT, randomised controlled trial ; USPSTF, US Preventive Services Task Force

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