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This section includes an overview of the procedures for carrying out specific WHI tasks that generated data items. The frequency of data collection table outlines the contacts at which these procedures were conducted, specified by WHI study component.
Clinical Center staff involved in data collection were trained, certified, and re-certified annually to carry out specific data collection procedures. Clinical Center staff training, certification, and annual recertification, staff performance of clinical measurements Observations of staff collecting data were conducted regularly by Clinical Center lead staff and during quality assurance visits by specially trained field representatives from the Clinical Coordinating Center.
Self-administered forms were pretested with representative groups of age-eligible women. Data collection procedures, such as administration options (e.g., by interview) and review for missing items, incorporated some flexibility depending on (1) study priorities for the data being collected, (2) when the form was due, and (3) specific participant situations. Most self-administered forms were available as mark-sense forms, and all self-administered forms were translated into Spanish. Some data items asked participants to write-in specifics of their situation, but this text information was not always entered in the database. If participants had a question about a specific item on a self-administered form, Clinical Center staff were trained not to define or elaborate on items on the item, but to repeat the exact text and ask the participant for her best response.
Data on the participant’s past hormone use at baseline, current medications, and current supplements were collected by in-person interviews. In addition, management and safety data for Hormone Therapy (HT) and Calcium and Vitamin D (CaD) participants were collected by interview at annual visits and often by phone interview for semi-annual contacts. Clinical Center staff were trained to read scripted interview items exactly as written and to be careful when probing to avoid defining or elaborating on items.
Detailed procedures for collecting clinical measurement data were documented in study manuals.