Levels of Evidence for Cancer Genetics Studies (PDQ®): Genetics - Health Professional Information [NCI]-Use of Levels of Evidence The PDQ editorial boards use a ranking system of levels of evidence to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. For any given therapy, results of prevention and treatment studies can be ranked on each of the following two scales:

1. Strength of the study design.
2. Strength of the endpoints.

Together, the two rankings provide a measure of the overall level of evidence. Screening studies are ranked on strength of study design alone. Depending on perspective, different expert panels, professional organizations, or individual physicians may use different cut-off points related to overall strength of evidence in formulating therapeutic guidelines or in taking action; however, a formal description of the level of evidence provides a uniform framework for the data, leading to specific recommendations.

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There are varying levels of evidence related to screening, prevention, and treatment that support a given summary. The summaries are subject to modification as new evidence becomes available. The strongest evidence would be that obtained from a well-designed and well-conducted randomized controlled trial. It is not always practical, however to conduct such a trial to address every question in the fields of cancer screening, prevention, and treatment.

Evidence Related to Screening

The PDQ Cancer Genetics Editorial Board has adopted the following definitions related to screening:

• Screening is a means of accomplishing early detection of disease in people without symptoms of the disease being sought.
• Examinations, tests, or procedures used in cancer screening are often not definitive but sort out persons suspected of harboring a clinically occult cancer from those in whom a cancer is not likely to be present.
• Diagnosis of disease is made after a workup, biopsy, or other tests are completed in pursuing symptoms or following positive detection procedures.

The five requirements that should be met before it is considered appropriate to screen for a particular medical condition as part of routine medical practice are as follows:[1,2]

1. The medical condition being sought must cause a substantial burden of suffering, measured both as mortality and as the frequency and severity of morbidity and loss of function.
2. A screening test or procedure exists that will detect cancers earlier in their natural history than when diagnosis is prompted by symptoms, and this test must be acceptable to patients and society in terms of convenience, comfort, risk, and cost.
3. Strong evidence exists that early detection and treatment improve disease outcomes, particularly disease-specific survival.
4. The harms of screening must be known and acceptable.
5. Screening must be judged to do more good than harm, considering all benefits and harms it induces in addition to the cost and cost-effectiveness of the screening program.

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