Periodic Screening for Breast Cancer: The Health Insurance Plan Project and Its Sequelae, 1963-1986

The status of breast cancer screening: A quarter of a century of research

“…The objectives, methodology, and results of the randomized controlled trial in HIP has been extensively reported in the literature [1,2]. Briefly, the project was initiated in December, 1963 to determine whether periodic breast cancer screening with mammography and clinical examination of the breast holds substantial promise for lowering mortality in the female population from breast cancer.…”

Design of Cancer Screening Trials/Randomized Trials for Evaluation of Cancer Screening

“…As in most countries, screening is performed as a public health activity, based on the general population, most screening trials have incorporated subjects drawn from an identifiable population by some means or other. The first screening trial was set in a contributory health plan, the Health Insurance Plan of Greater New York (HIP) 4. That made it possible to select potential trial participants from the records of the plan and invite those allocated to be screened; a comparable group was not invited but was studied as the controls.…”

“…However, those in the control group who would have declined to participate if they had been given the opportunity to do so cannot be identified, so the effect of screening in the group allocated to screening is diluted by the noncompliers with screening. In the HIP trial 35% declined screening,4 and in a few trials with this design the proportion of noncompliers was even higher,14 although in one of the Swedish breast screening trials more than 90% agreed to be screened 15. The other issue relates to informed consent.…”

“…In RSTs over the years, performance of the randomization has varied; the early RSTs combined manual methods, often using lists, whereas now it would be exceptional not to have an entirely computer‐based system, sometimes based on the Internet. The first RST randomized by matched pairs 4. This approach was criticized22 but was probably valid.…”

“…The first randomized screening trial employed mammography and breast physical examination to screen for breast cancer 4. This trial was largely responsible for the widespread introduction of mammography screening, especially when its early reports of benefit among women 50 to 69 years of age were followed by confirmatory reports from Sweden 5.…”