Overcoming challenges to data quality in the ASPREE clinical trial

Table 3 ASPREE longitudinal data quality

Data category	TOTAL potential values^ab	Number of variables collected	Entered within range or found to be correct on querying	Unresolved queries	Protocol deviations	Values where data collection not possible^c
Data category	TOTAL potential values^ab	Number of variables collected	number (% of total)	number	number	Values where data collection not possible^c
Participant demographics	824,947	80	795,984 (96.5%)	0	0	704,173
Clinical information^e	2,413,294	227	2,358,542 (97.7%)	0	14	1,925,584
Pathology	959,347	88	842,136 (87.8%)	0	5	722,685
Medications	939,684	31^d	937,256 (99.7%)	0	0	72,444
Family history	293,929	37	286,982 (97.6%)	0	0	413,289
Cognitive measures	2,737,448	590	2,689,837 (98.3%)	0	0	8,539,812
Physical function	509,858	73	488,648 (95.8%)	0	0	885,464
Mood, function and quality of life	6,317,845	749	6,070,867 (96.1%)	0	0	7,998,541
Endpoints	146,243	46	146,243 (100%)	0	0	733,001
Study medication	97,004	8	97,004 (100%)	0	0	55,908
Visit conduct	469,259	61	456,539 (97.3%)	0	0	696,695
TOTAL	15,708,858	1990	15,170,038 (96.6%)	0	19	23,399,596

^aIncludes all data values scheduled for collection between randomisation, death, withdrawal of consent, or study closure. Excludes fields that were not active at the time of data collection, and fields that were not applicable due to a response to a hierarchical question
^bAll values queried for missing and out-of-range data
^cIncludes all data values scheduled for collection after death, withdrawal on consent or study closure. Also includes fields that were not active at the time of data collection, and fields that were not applicable due to a response to a hierarchical question
^dPlus concomitant medication. The number of medications reported varied for each participant
^eIncludes past medical history, past cancer screening, and physical examination measures such as blood pressure, heart rate, height, weight and abdominal circumference

ISSN: 1745-6215