Using WHI Outcomes Data. Rebecca Hunt September 9, 2016

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Transcription:

Using WHI Outcomes Data Rebecca Hunt September 9, 2016

Focus on: What has been collected in WHI Which outcomes are adjudicated Changes between WHI and the extension studies (WHIX1 and WHIX2) What data is available on the WHI website Format How to use

Clinical Outcomes in the CT Defined as: primary or secondary Each study component (HT, DM, CaD) has 1 or 2 primary, and multiple secondary

Clinical Outcomes in the OS Same process for outcomes collection as in the CT No primary/secondary designation Fewer outcomes are adjudicated

Adjudication and Confirmation Most outcomes start as a self-report on Form 33 Form 33D used to collect more information Defined set of medical records obtained for selected outcomes Adjudication process confirms or denies the self-report (two levels: local and central)

Cardiovascular Outcomes, WHI Outcome HT DM CaD OS Form Cardiovascular: Coronary heart disease 1º - C 2º - L L L 121 Stroke 2º - C 2º - L L C 121/132 Congestive heart failure 2º - C 2º - L L L 121 Angina 2º - C 2º - L L L 121 Peripheral vascular disease 2º - C 2º - L L L 121 Carotid artery disease L L L L 121 Coronary revascularization 2º - C 2º - L L L 121 Total cardiovascular 2º 2º

Cancer Outcomes, WHI Outcome HT DM CaD OS Form Breast cancer 2º - C 1º - C 2º - C C 122/130 Endometrial cancer 2º - C 2º - C C C 122/130 Colorectal cancer C 1º - C 2º - C C 122/130 Ovarian cancer 2º - C 2º - C C C 122/130 Other cancer L L L L 122 Total cancer 2º 2º 2º

Fracture Outcomes, WHI Outcome HT DM CaD OS Form Hip fracture 2º - C C 1º - C C 123 Other fractures 2º - L L 2º - L L* 123 Total fractures 2º 2º * Only for participants at the 3 BMD clinical centers

Other Outcomes, WHI Outcome HT DM CaD OS Form Pulmonary embolism 2º - C 126 Deep vein thrombosis 2º - C 126 Diabetes mellitus requiring therapy S 2º - S S S 33 Death from any cause 2º - C 2º - C 2º-C L 124 1º - Primary outcome 2º - Secondary outcome C Centrally adjudicated L Locally adjudicated S Self-report

Self-reported Outcomes Source: Form 33 v. 5, question 8 Since the date given on the front of this form, has a doctor told you for the first time that you have any of the following specific conditions? Glaucoma, osteoporosis, osteoarthritis, rheumatoid arthritis, intestine or colon polyps or adenomas, gallbladder disease or gallstones, lupus, kidney or bladder stones, cataracts

Self-reported Outcomes (cont) Source: Form 33 v. 5, question 9 Since the date given on the front of this form, has a doctor prescribed for the first time any of the following pills or treatments? Pills for diabetes, insulin shots for diabetes, pills for high blood pressure

Other Sources of Outcomes Data ECG results (CT only) BMD results from DEXA (subset of CT & OS at 3 clinical centers) Form 33, question 3 (falls), question 10 (exams, tests, and procedures) OS follow-up questionnaires (Form 48, Forms 143-148) 19 conditions

Some Changes in outcome data (WHI vs WHIX1 vs WHIX2) There are no local adjudications in WHIX1/WHIX2, all adjudications are done centrally Angina and CHF were locally adjudicated in WHI, they are only self-reported in WHIX1/WHIX2 (though we now have UNC HF adjudicated for the MRC Supercohort throughout WHI/WHIX1/WHIX2) Deaths central (CT) and local (OS) adjudications during WHI; central only during WHIX1; central (MRC) and self-report (SRC) during WHIX2 National Death Index (NDI) deaths Fracture only hip fracture is adjudicated in WHIX1/WHIX2, all other fractures are self-report (fracture was adjudicated in the CT & OS BMD clinics in WHI) Some endpoints were only collected in WHI (e.g., ECG data) and a few endpoints were added during WHIX2 (atrial fibrillation, heart valve disease, aortic aneurysm/dissection)

Some Changes in outcome data (WHI vs WHIX1 vs WHIX2) (cont)

Some Changes in outcome data (WHI vs WHIX1 vs WHIX2) (cont)

Data on the WHI website Visit forms, clinical measures, and other study data (baseline and follow-up visits) Clinical outcomes and detail data files (Currently through Sep 2015 includes extension study data)

September 2015 Outcomes Data on the WHI website Clinical outcomes and detail data files: Adjudicated outcomes (CT+OS, CaD) Self-reported outcomes (CT+OS, CaD, MRC, SRC) F121 cardiovascular detail (CT+OS, CaD) F121/132 stroke/cad detail (CT+OS, CaD) F122/130 cancer detail (CT+OS, CaD) F122/130 breast cancer detail (CT+OS, CaD) F123 fracture detail (CT+OS, CaD) F124 death & all discovered death detail (CT+OS) F126 DVT/PE detail (HT) F131 Hysterectomy (HT) UNC heart failure detail (MRC Supercohort) Aging (Survival) (CT+OS) (Corresponding.dat,.sas, and.pdf files)

CaD Trial Outcomes 91% of CaD participants were randomized at year 1 of the CT 8% at year 2 of the CT 1 % at other visits Timing of events in CaD participants uses CaD randomization date as the starting point

Format of data for each outcome (adjudicated outcomes file, outc_ct_os_inv.dat) Three variables: Indicator that outcome occurred (yes/no) Days from randomization/enrollment to date of outcome Source of adjudication (local, central, cause of death, ECG) IMPORTANT: Outcomes are first occurrence only Outcome from best adjudication only

Format of detail data files One row per participant, per outcome (participants may have multiple rows) Variable indicating ascertainment source (central or local) Flags for each outcome included in the file (yes/no) Form level detail items

Actual Data ID ASCSOURCE ANGINA AANEUR ADISSECT AFIBR CABG CHF MI CREVASC HEARTVALVE PERIPH PTCA ECGPATTR CARDENZY 1 2....... 1.. 1 8 1 2 1....... 1.. 1 8 1 2 2...... 1.... 3 1 3 1..... 1..... 8 0 4 2... 1....... 8 1

Uses of Outcome Variables Get counts of outcomes (event flags include COD only events) Compare timing of events using days variables In time-to-event analyses (survival)

Example 1: select form 121 detail info for all clinical MI events and create time-to-event variable Read in pertinent datasets Form 121 data (outc_cardio_inv.dat) select rows where MI = 1. Variables to keep: ID, MI, MIDX, MIPROCTYP, etc. Adjudicated outcomes file (outc_ct_os_inv.dat). Variables to keep: ID, MI, MIDY, MISRC and ENDWHIDY, ENDEXT1DY or ENDFOLLOWDY. Merge the subsetted Form 121 file with the subsetted adjudicated outcomes file by participant id. Create time-to-event variable: => had event (MI = 1): misurvtm = MIDY => no event (MI = 0), censored (follow-up ends because of death or last contact): misurvtm = ENDFOLLOWDY

Example 2: using the breast cancer dataset

Example 2: using the breast cancer dataset

Example 2: using the breast cancer dataset The N s for invasive breast cancer in the adjudicated outcomes file and the breast cancer detail file do not match. The detail file only contains events that were adjudicated, it does not contain events only found through cause of death. Set up an analysis file for invasive breast cancer just as described for MI in Example 1. Descriptions for the ICD-O-2 codes and histology codes are contained in separate files and will also need to be merged with your dataset (merging on ICD-O-2 code and histology code, respectively).

Final thoughts Each time we release an updated set of outcome files, we remove the prior set from the website, so download all files at one time, including the corresponding data prep document Documentation is on the WHI website for outcome definitions and entire adjudication process Always study the forms associated with the data you are using to be sure you are grabbing the correct variables Other useful sources of information: Data Preparation and Use document, Outcomes chapter in the baseline monograph, several links on the Dataset Documentation web page

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