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Comparing the sensitivities of two screening tests in nonblinded randomized paired screen-positive trials with differential screening uptake.

ABSTRACT: Before a new screening test can be used in routine screening, its performance needs to be compared to the standard screening test. This comparison is generally done in population screening trials with a screen-positive design where participants undergo one or both screening tests after which disease verification takes place for those positive on at least one screening test. We consider the randomized paired screen-positive design of Alonzo and Kittelson where participants are randomized to receive one of the two screening tests and only participants with a positive screening test subsequently receive the other screening test followed by disease verification. The tests are usually offered in an unblinded fashion in which case the screening uptake may differ between arms, in particular when one test is more burdensome than the other. When uptake is associated with disease, the estimator for the relative sensitivity derived by Alonzo and Kittelson may be biased and the type I error of the associated statistical test is no longer guaranteed to be controlled. We present methods for comparing sensitivities of screening tests in randomized paired screen-positive trials that are robust to differential screening uptake. In a simulation study, we show that our methods adequately control the type I error when screening uptake is associated with disease. We apply the developed methods to data from the IMPROVE trial, a nonblinded cervical cancer screening trial comparing the accuracy of HPV testing on self-collected versus provider-collected samples. In this trial, screening uptake was higher among participants randomized to self-collection.

SUBMITTER: van de Ven PM

PROVIDER: S-EPMC9293348 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and study aims Bowel cancer is a National Health Service (NHS) priority as 1 in 20 people will develop the disease and half of those will die, equating to 17,000 each year in the UK. Bowel cancer is largely preventable via the timely detection and removal of precancerous growths in the bowel (called adenomas) and chances of survival are improved greatly if bowel cancer is detected early, before the disease causes symptoms. As a result, screening tests for adenomas and bowel cancer in people who do not currently have symptoms are an important method for reducing the number of deaths from bowel cancer. However, the success of any screening test depends on people being willing to be tested so it is essential that tests are as acceptable as possible to invitees in order to maximise uptake. There are several tests that could be used to screen for bowel cancer, each with their own advantages and disadvantages, and there is no clearly superior option. For example, some tests are more accurate than others but screening invitees might consider these to be less convenient than alternatives. It is currently unclear which test people would be most likely to have. It is also uncertain what the specific reasons are that underpin these preferences. This study aims to answer these questions. Who can participate? We are recruiting members of the public who are representative of individuals who have not had bowel cancer screening before but are approaching the age at which it is offered. We are sending out questionnaires to men and women aged 45-54 years via their General Practitioner. We are also using several other criteria to ensure that people in our study are similar to those who would be offered screening. For example, individuals will only be invited to take part if they have not previously had a diagnosis of bowel cancer or already have regular bowel tests for reasons unrelated to screening. What does the study involve? People who are eligible to take part in the study will be posted a questionnaire and written information about one of the four tests that we are investigating. The test that they will receive information about will be randomly determined. Individuals will be asked to read the information and complete the questionnaire, which asks questions on whether they believe they would be willing to have the test and their impressions of the different aspects of the procedure (for example, how convenient or inconvenient it might be for them). Participants will then send the questionnaire back to the main study centre, where we will compare peoples responses across the different tests once they have all been collected.

Project description:BackgroundClinical trials frequently spend considerable effort to collect data on patients who were assessed for eligibility but not enrolled. The Consolidated Standards of Reporting Trials (CONSORT) guidelines' recommended flow diagram for randomized clinical trials reinforces the belief that the collection of screening data is a necessary and worthwhile endeavor. The rationale for collecting screening data includes scientific, trial management, and ethno-socio-cultural reasons.PurposeWe posit that the cost of collecting screening data is not justified, in part due to inability to centrally monitor and verify the screening data in the same manner as other clinical trial data.MethodsTo illustrate the effort and site-to-site variability, we analyzed the screening data from a multicenter, randomized clinical trial of patients with transient ischemic attack or minor ischemic stroke (Platelet-Oriented Inhibition in New Transient Ischemic Attack and Minor Ischemic Stroke (POINT)).ResultsData were collected on over 27,000 patients screened across 172 enrolling sites, 95% of whom were not enrolled. Although the rate of return of screen failure logs was high overall (95%), there were a considerable number of logs that were returned with 'no data to report' (23%), often due to administrative reasons rather than no patients screened.ConclusionIn spite of attempts to standardize the collection of screening data, due to differences in site processes, multicenter clinical trials face challenges in collecting those data completely and uniformly. The efforts required to centrally collect high-quality data on an extensive number of screened patients may outweigh the scientific value of the data. Moreover, the lack of a standardized definition of 'screened' and the challenges of collecting meaningful characteristics for patients who have not signed consent limits the ability to compare across studies and to assess generalizability and selection bias as intended.

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Comparing the sensitivities of two screening tests in nonblinded randomized paired screen-positive trials with differential screening uptake.

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