Changes to Data Collection

Throughout the course of the study, the data collection schedule changed to accommodate substudies and improve collection of study endpoints.

Changes to baseline data collection included:

  • Expansion of data collection related to past medical history (June 2013)
  • Expansion of data collection related to past history of cancer (June 2013)

Changes to longitudinal data collection included:

  • Introduction of the Participant Medical History Update form with associated expansion of data collection related to clinical events (June 2013)
  • Introduction of annual administration of CES-D 10 questionnaire (1 Jan 2015)
  • Introduction of six-monthly administration of the modified list of Katz ADL questions (Feb 2013)

Details of these changes are discussed in the following sections.

Participant Past Medical History Collection

With the introduction of the Participant Medical History - Baseline (PMHB) form, the capture of past medical history changed from three structured medical condition fields to 17 structured medical condition fields. A free-text option to collect ‘other medication history’ remained available throughout the period of participant enrolment.

Table 1. Collection of participant past medical history pre and post June 2013.

Participant past medical history pre June 2013 (excluding cancer)
Question Other data
History of bowel polyp Number of polyps
History of diabetes
History of kidney disease Requirement for dialysis, history of kidney transplant
History of other medical condition (free-text)
Participant past medical history post June 2013 (excluding cancer)
Question Other data
History of asthma -
History of benign prostatic hyperplasia -
History of bowel polyp Number of polyps
History of deep vein thrombosis -
History of depression -
History of diabetes -
History of gastro-oesophageal reflux disease -
History of gout -
History of high blood pressure -
History of high cholesterol -
History of kidney disease Requirement for dialysis, history of kidney transplant
History of macular degeneration -
History of minor bleeding -
History of osteoarthritis -
History of Parkinson’s disease -
History of pneumonia -
History of ringing in the ears -
History of other medical condition (free-text) -

Following introduction of the PMHB, free-text responses under ‘other medical condition’ collected prior to June 2013 were reviewed and where appropriate converted into the new medical conditions. Medical history reports that did not fit into one of the 17 new medical condition categories remained as ‘other medical condition’.

Introduction of Detailed Cancer Data Collection

ASPREE Cancer Endpoint Study (ACES), was funded by the National Cancer Institute and operationalised in June 2013. New questions regarding family cancer history, participant cancer history and participant cancer screening tests were added to data collection at Baseline.

Family Cancer History

Family history questions introduced in June 2013 added to existing data regarding family cancer history. 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. The differences in family cancer history data collection are shown below in Figure 1.

Existing free-text responses recorded under ‘other cancer’ were reviewed and where appropriate converted to the new detailed cancer types. Cancer reports that did not fit into a detailed cancer type remained as ‘other’. 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.

Family cancer history collection prior to June 2013 and post June 2013.

Participant Cancer History

Similarly, prior to ACES, participant cancer history was collected under the categories of ‘colorectal cancer’ or ‘other cancer’. The ACES substudy allowed for more detailed collection of the type of pre-existing cancer. The differences in participant cancer history data collection are shown below in Figure 2.

Existing free-text responses under ‘other cancer’ were reviewed and where appropriate converted into the new detailed cancer types. Cancer reports that did not fit into a detailed cancer type remained as ‘other’. 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.

Participant cancer history collection prior to June 2013 and post June 2013.

Cancer Screening

New data was collected regarding cancer screening tests. No conversion was required for these items as there was no pre-existing data.

Introduction of Participant Medical History Update

When the ACES substudy was introduced in June 2013, the system for recording clinical endpoints was updated. To ensure that staff collected sufficient information to allow for endpoint coding and supporting document collection, the Participant Medical History Update (PMHU) form was developed. This form includes structured questions about each endpoint and associated operational data.

From June 2013 to June 2017, the PMHU was administered at six-month phone calls and annual visits for the purpose of event collection.

Relevant data from the PMHU has been included in Section F2 and F3 of the ASPREE Longitudinal data set.

NOTE: Unverified operational fields have not been included in the data set.

Introduction of Annual CES-D 10 Questionnaire

In June 2015 the ASPREE-D (ASPREE - Depression) substudy was funded. To support this substudy, the CES-D 10 questionnaire was introduced at all even year annual visits. Prior to this time, the CES-D 10 was only administered at odd year annual visits where the cognitive tests were also administered.

CES-D 10 variables linked with even year visits conducted prior to June 2015 have been annotated with a commentary code of 2 to indicate that they were not active at the time of data collection.

Introduction of Katz ADL Questionnaires at All Six-Month Phone Calls

Initially the modified list of Katz ADL questions were also administered at six-month phone calls if a physical disability trigger (i.e. a report of ‘a lot of difficulty’ or ‘unable to do’ or needing assistance for one of the six Katz ADLs) was recorded at the preceding annual visit. However, in order to improve detection of physical disability triggers, in February 2013 the Katz ADL questions were added to six-month phone call data collection.

Katz ADL variables linked with six-month phone calls conducted prior to February 2013 have been annotated with a commentary code of 2 to indicate that they were not active at the time of data collection.

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