Section B

Section B of the longitudinal data set contains both baseline and longitudinal data. Baseline data includes information relating to past medical and cancer history prior to the trial. Baseline and longitudinal data include cancer screening information, pathology measures, concomitant medication use and longitudinal family medical history. This section also contains a one-off collection of non-prescription medications.

B.1 Baseline Participant Medical History

Description

This section contains key participant medical and cancer history details at the time of study enrolment. Aspects of this data collection were introduced in June 2013 when the capture of participant past medical history was expanded. Data collection was expanded from the initial capture of three structured medical conditions to include 17 conditions in total. Where appropriate, any medical conditions collected in free-text prior to June 2013 were converted into the new categories. Data was primarily collected in person. Baseline participant cancer history data was collected from medical records for a small number of participants.

Timing of Data Collection

Data presented in this section were collected at Visit 1 which occurred prior to randomisation during the screening process. Baseline participant cancer history data were collected retrospectively for all participants who underwent their Visit 1 prior to June 2013.

Summary of Data Dictionary

This section primarily contains nominal data. Ordinal data regarding aspirin usage is also presented. Non-cancer related variables linked with visits conducted prior to June 2013 are annotated with a commentary code of 2 to indicate that they were not active at the time of data collection.

B.2 Baseline and Longitudinal Physical Examination

Description

This section contains all physical participant data, including physical function testing, collected at baseline and during the follow-up period. Measures taken include blood pressure and heart rate, height, weight and abdominal circumference. Participants also underwent two physical function tests (gait speed and hand grip strength).

Timing of Data Collection

Blood pressure and heart rate were collected at Visit 1 while height, weight and abdominal circumference were collected at Visit 2. Both visits occurred prior to randomisation during the screening process. Blood pressure, heart rate, weight and abdominal circumference were then collected annually thereafter. Height was collected again at annual visits in year 5 and at the Milestone Visit. Physical function testing data were collected at Visit 2, at even year annual visits and at the Milestone Visit.

Summary of Data Dictionary

This section primarily contains discrete data. Nominal data regarding the presence of an irregular heart rate is also presented. Data for BMI at each collection time point have been derived from participant height and weight collected at that time point. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection.

B.3 Longitudinal Cancer Screening

Description

This section contains baseline and longitudinal participant cancer screening data. Data collection for cancer screening tests were introduced to baseline data collection in June 2013 when new funding became available. Information on the following screening tests were collected:

  • Breast cancer: Mammogram, breast ultrasound, breast MRI, physical breast examination, breast biopsy or other breast cancer screening measures.
  • Cervical cancer: Pap smear, cervical HPV test, cervical biopsy or other cervical cancer screening measures.
  • Colorectal cancer: Sigmoidoscopy, colonoscopy, CT colonoscopy, stool based test (fecal occult blood test, fecal immunochemical test, DNA test or other), barium enema, colorectal biopsy or other colorectal cancer screening measures.
  • Prostate cancer: PSA or digital rectal exam, prostate biopsy or other prostate screening measures.
  • Lung cancer: Chest x-ray, chest CT scan, biopsy or other lung cancer screening measures.
  • Skin cancer: Photographic mole check, physical exam by healthcare provider, biopsy or other skin cancer screening measures.

These questions were presented as part of the baseline participant medical history questionnaire and were therefore collected in person.

Timing of Data Collection

Data on participant cancer screening tests was collected at Visit 1, which occurred prior to randomisation during the screening process, and annually thereafter.

Summary of Data Dictionary

This section contains discrete data only. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection. Variables for participants who completed their Visit 1 prior to June 2013 are annotated with a commentary code of 2 to indicate that they were not active at the time of data collection.

B.4 Longitudinal Pathology

Description

This section contains all baseline and longitudinal participant pathology data. Measures collected including haemoglobin, fasting lipids (total cholesterol, HDL, LDL, triglyceride), fasting glucose, serum creatinine and urine albumin:creatinine ratio. In general, ASPREE did not conduct pathology measures directly (point-of-care haemoglobin measures were available at some US sites). Rather, participants were provided with pathology slips and asked to attend a local pathology centre for blood and urine collection and analysis. ASPREE details were included in the pathology slip to enable feedback of results. For ease of use, results have been provided in multiple relevant units. For example, in mmol/L and mg/DL. Values for estimated glomerular filtration rate have also been provided using the Modification of Diet in Renal Disease (MDRD) formula and the Chronic Kidney Disease (CKD) Epidemiology Collaboration formula.

Timing of Data Collection

In Australia, all pathology measures were collected at Visit 1, which occurred prior to randomisation and during the screening process, and annually thereafter. In the US, haemoglobin was collected each year and other measures were only collected at certain time points.

Summary of Data Dictionary

This section primarily contains continuous data. Ordinal data have been presented for the urine albumin: creatinine ratio. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection. Where pathology results were requested from a third party pathology provider but never provided, a commentary code of 6 has been applied.

B.5 Longitudinal Concomitant Medication Use

Description

This section contains baseline and longitudinal participant concomitant (ConMed) data. ConMed data collected include medication name, ATC code and whether or not the medication was taken during each calendar year of follow-up. Prescription medications were entered into AWARD-Data by selecting an option from a dropdown list. If the medication was not listed, the name was recorded in free-text and later converted to ATC codes. Data collection occurred in person or was collected from medical records.

Timing of Data Collection

Data on participant ConMed use was collected at Visit 2, which occurred prior to randomisation during the screening process, and annually thereafter.

Summary of Data Dictionary

This section contains nominal and string data. Refer to the ATC coding system for interpretation of ATC codes. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection. A commentary code of 19 (insufficient data to derive) has been applied where an indeterminate start year for a medication was recorded in the database and hence calculation of medication use by year is not possible.

B.6 Longitudinal Family Medical History

Description

This section contains key baseline and longitudinal family medical and cancer history details. Data has been collected for the following family members: mother, father, siblings and children. General medical history details collected include the diagnosis of heart attack, stroke, dementia, kidney disease, dialysis treatment and kidney transplant.

In June 2013 the capture of family cancer history was expanded. Prior to June 2013 family cancer history was collected as “colorectal cancer” or “other cancer”. Post June 2013 a number of other cancer types were collected:

  • Bladder
  • Blood
  • Brain
  • Breast
  • Cervical
  • Colon/rectum
  • Gallbladder/bile ducts
  • Kidney
  • Liver
  • Lung
  • Melanoma
  • Ovarian/endometrium
  • Pancreas
  • Stomach/oesophageal
  • Thyroid
  • Unknown
  • Other (free-text)

Where appropriate, any “other” cancers collected in free-text prior to June 2013 were converted into the new cancer categories. Existing data for age of onset in years was converted into ACES age brackets (< 50 years or 50+ years) for cancer onset rather than age in years. All data collection occurred in person.

Timing of Data Collection

Data on family cancer history were collected at Visit 1, which occurred prior to randomisation during the screening process, and annually thereafter.

Summary of Data Dictionary

This section contains nominal data only, with all possible responses as follows: none reported, reported at age <50 years, reported at age 50+ years, reported age is unknown or reported two ages. Two ages may have been reported for the same cancer type at separate annual visits. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection. For participants who completed their Visit 1 prior to June 2013, relevant family cancer history variables are annotated with a commentary code of 2 to indicate that they were not active at the time of data collection.

B.7 Non-Prescription Medication Use (Milestone Visit Only)

Description

This section contains participant use of non-prescription medications. Data was collected on the number of non-prescription/over the counter pills that will be taken that day and the number of different types of non-prescription/over the counter pills that will be taken that day. Data was also collected regarding the use of the following: fish oil, glucosamine, coenzyme Q10, zinc and calcium, multivitamins, Chinese or other herbal medicines, vitamin B (including thiamine), vitamin C, vitamin D, vitamin E, Ginko Biloba, Ginseng or other supplements, herbal or complementary medicines. Data collection occurred in person.

Timing of Data Collection

Data collection occurred at the Milestone Visit only.

Summary of Data Dictionary

This section contains ordinal and nominal data. A commentary code of 26 has been applied where the Milestone Visit could not occur or did not occur prior to participant ceassation of study medication in June 2017.

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