False-negative results in screening programs - Medical, psychological, andother implications

Objectives: Assessment of the appropriateness of screening programs involve s consideration of the harms as well as the benefits. These harms include t he risk of false-negative results, the consequences of which have remained underinvestigated. This paper reports the results of a systematic literatur e review that aimed to assess the medical psychological, economic, and lega l consequences of false-negative results in national screening programs. Methods: The review included a comprehensive literature search and contact with experts to identify relevant literature. Most studies that were identi fied presented only anecdotal evidence. However, thirteen studies presented quantitative information on medical consequences of false negatives, eight studies presented information on psychological consequences, and two studi es presented information on economic consequences. Results: The strength of evidence from most of the primary studies was low. There is some evidence, however, that false-negative results may have a la rge legal impact. There is also a consensus in the literature that false ne gatives may have a negative impact on public confidence on screening; evide nce is however limited. Conclusions: False negatives are evident even in high-quality screening pro grams. They may have the potential to delay the detection of breast and cer vical cancer, but there is little evidence to help in assessing their psych ological consequences. They also may lead to legal action being taken by th ose affected and may reduce public confidence in screening. Their impact ma y be reduced by provision of full information to participants about the ben efits and limitations of screening programs and by increasing public educat ion on these issues.