Study to Evaluate How Patients Regard the Benefits and Risks of Low-dose Aspirin for the Prevention of Heart and Blood Vessels Disease and for the Prevention of Cancer of the Colon and Rectum

Completed

Brief Summary: Research shows that low-dose Aspirin prevents diseases of heart and blood vessels as well as cancer of the colon and rectum and it is also associated with risk of bleeding. In this study, they want to learn how patients regard the benefits and risks of low-dose Aspirin for the prevention of these diseases. The researchers also want to learn how patients balance these risks and benefits.

Recruitment & Eligibility

Inclusion Criteria

Age and CVD characteristics
- Primary prevention:
  - 50-70 years of age
  - Self-report clinical characteristics that result to 20% or higher, 10-year risk of CVD based on the Progetto Cuore scores
- Secondary prevention:
  - 18 years or older
  - Having a self-reported history of CV event (e.g., myocardial infarction (MI), ischaemic stroke or Transient Ischaemic stroke, , and angina)
Able to read and understand Italian
No participation in an investigational program with interventions outside of routine clinical practice
For qualitative interviews:
- Willing and able to provide (electronic) informed consent to participate in the study
- Willing and able to participate in a telephone interview, and to be audio-recorded
For pilot/cognitive interviews :
- Willing and able to complete an online survey
- Willing and able to provide (electronic) informed consent to participate in the study
- Willing and able to participate in an in-person interview, and to be audio-recorded
For quantitative main survey:
- Willing and able to complete an online survey
- Willing and able to provide (electronic) informed consent to participate in the study

Exclusion Criteria

Have glucose-6-phosphate dehydrogenase (G6PD) deficiency (which commonly causes haemolytic anaemia, which is often triggered from eating fava beans, a condition called Favism)
Have the following conditions (which are contraindications to low-dose aspirin)
- Known hypersensitivity to salicylates
- Known to have had asthma induced by salicylates
- Having been diagnosed with acute gastroduodenal ulcers
- Haemorrhagic diathesis
- Renal failure
- Hepatic failure
Concomitant treatment with methotrexate
Cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, or insufficient knowledge of Italian that-in the opinion of the investigator/interviewer-could interfere with a patient's ability to provide written consent and complete an interview or survey
To be currently pregnant
Are pharmaceutical company employees or employed in a position where they have a direct role in treating patients with CVD

Physician Eligibility Criteria:

A medically trained physician
Able to read, speak, and understand Italian sufficiently to complete an interview
Able to provide informed consent electronically
Have at least five year experience prescribing low-dose aspirin for primary and secondary prevention of CVD
Willing to be audio-recorded, including adherence to the interview instructions

Arm && Interventions

Group	Intervention	Description
Primary prevention	Acetylsalicylic acid (Aspirin, BAYE4465)	Patients in Italy who are eligible to use low-dose aspirin for primary prevention of CVD and CRC. Subgroups: * Patients eligible for and using low-dose aspirin who are at 20% ten-year CVD risk for primary prevention of CVD * Patients eligible for and not using low-dose aspirin who are at 20% ten-year CVD risk for primary prevention of CVD
Secondary prevention	Acetylsalicylic acid (Aspirin, BAYE4465)	Patients in Italy who are eligible to use low-dose aspirin for secondary prevention of CVD and CRC. Subgroups: * Patients eligible for and using low-dose aspirin for secondary prevention of CVD * Patients eligible for and not using low-dose aspirin for secondary prevention of CVD

Primary Outcome Measures

Name	Time	Method
Perceive of low dose aspirin	Up to 1 hour	Using qualitative interviews to assess how patients and physicians perceive the benefits and risks of low-dose aspirin for the prevention of cardiovascular disease (CVD) and colorectal cancer (CRC)
Patients' benefit/risk trade-offs	Up to 1 hour	Using quantitative surveys to elicit patients' benefit/risk trade-offs on key efficacy and safety outcomes of low-dose aspirin in CVD and CRC prevention

Secondary Outcome Measures

Name	Time	Method
Change in likelihood of AEs	Up to 1 hour	Quantify the change in likelihood of adverse events (AEs) that patients are willing to accept in order to experience the benefits of low-dose aspirin for CRC and CVD prevention compared to CVD prevention alone
Preferences of aspirin using in different subgroups	Up to 1 hour	Assess how different subgroups of patients, such as those using low-dose aspirin and those eligible for but not using low-dose aspirin, differ in their preferences