Introduction and Program Purpose
The People.Health Low-Dose Chest CT Screening Program is a screening program designed to detect problems in people who are at risk for certain medical conditions. Through this program, People.Health will use a low-dose computed tomography (CT) scanner to scan individuals who have had COVID-19 to try to identify if they have any COVID-related lung damage and to try to see if these individuals may need a follow-up appointment with a healthcare specialist.
If you would like to participate in People.Health’s program, please read and sign this consent form.
How It Is Done
A low-dose CT scan is a test that uses x-rays to make detailed images of structures inside of the body. The test will take about 10-15 minutes.
You may need to take off any jewelry or clothes that have metal. You may be given a gown to use during the test.
During the test, you will lie on a table that is attached to the CT scanner, which is a doughnut-shaped machine. People.Health will use a low-dose CT scanner called the BodyTom 32 slice CT Scanner, which is approved in the USA for these types of images. The CT scanner sends X-rays through the body area being studied. In this case, the area being studied will be your chest. Each rotation of the scanner will provide a picture of a thin slice of the organ or area. People.Health will save the pictures on a computer.
A radiologist will review the pictures taken by the scanner to determine if there are any problems with your lungs. If a finding that may have clinical significance (i.e., the finding provides information about a disease or condition that can significantly impact your health in the near future and we have proven ways to treat or reduce that health risk) is seen by the radiologist, we will tell you about it. You may need to follow up with your physician and you may have additional testing done by your physician in connection with these findings. There may also be costs associated with further evaluation and treatment which you understand will be your responsibility, not that of People.Health.
Risks
The test will not cause pain, but some people may feel nervous inside the CT scanner.
During the test you will be briefly exposed to ionizing radiation. Because the scanner People.Health will use is low-dose CT scanner, it emits approximately four to five times less radiation than a typical diagnostic CT scan. The chance of a CT scan causing a problem is small. There is a risk of damage to cells or tissue from being exposed to radiation, including the small amounts used in CT scans, X-rays, and other medical tests. Over time, exposure to radiation may cause cancer and other health problems. But in most cases, the risk of getting cancer from being exposed to small amounts of radiation is low. It is not a reason to avoid these tests for most people. Also, People.Health abides by the principles of ALARA (“as low as reasonably achievable”) to maintain your safety. Receiving a low-dose CT scan during pregnancy may present risk to the baby.
Although the primary focus of this test is on the lungs, it is possible that the pictures taken by the scanner may reveal information about your health that is unrelated to the purpose of this program and that was previously unknown. These are known as “incidental findings” because they are findings that are not necessarily relevant to this program (i.e., the radiologist did not set out to learn this information) but may be relevant to you and your medical care. If an incidental finding that may have clinical significance (i.e., the finding provides information about a disease or condition that can significantly impact your health in the near future and we have proven ways to treat or reduce that health risk) is seen by the radiologist, we may tell you about it. You may need to follow up with your physician and you may have additional testing done by your physician in connection with these incidental findings. There may also be costs associated with further evaluation and treatment which you understand will be your responsibility, not that of People.Health.
By signing this consent form and agreeing to take part in the program, you are allowing the People.Health team to use and disclose health information about you for purposes of conducting the program and for future scientific research that may or may not be related to this program. This may include information about you that already exists as well as any new information generated as part of this program. There is the potential for loss of confidentiality by participating in this program, however, appropriate efforts will be made to protect the confidentiality and privacy about you and your health information.
Statement of Consent
I am aware, as with all radiology exams, I will be exposed to a small amount of ionizing radiation.
● If I am female, I understand that receiving a low-dose CT scan during pregnancy, particularly those of the pelvis may present risk to the baby and I certify that, to the best of my knowledge, I am NOT pregnant.
● I am aware that the findings of the program may require that I have additional testing done by my physician and that I will be responsible for the costs associated with these further evaluations and treatments.
● I am aware that there may be incidental findings noted by the radiologist that may require that I have additional testing done by my physician and that I will be responsible for the costs associated with these further evaluations and treatments.
● I understand and agree to allow my health information to be used for the program and for future scientific research.
I certify that I have read and fully understand the above statements and I voluntarily consent to its contents and to the performance of the low-dose CT chest screening.