Data management for prospective research studies using SAS software.
BACKGROUND
Maintaining data quality and integrity is important for research studies involving prospective data collection. Data must be entered, erroneous or missing data must be identified and corrected if possible, and an audit trail created.


METHODS
Using as an example a large prospective study, the Missouri Lower Respiratory Infection (LRI) Project, we present an approach to data management predominantly using SAS software. The Missouri LRI Project was a prospective cohort study of nursing home residents who developed an LRI. Subjects were enrolled, data collected, and follow-ups occurred for over three years. Data were collected on twenty different forms. Forms were inspected visually and sent off-site for data entry. SAS software was used to read the entered data files, check for potential errors, apply corrections to data sets, and combine batches into analytic data sets. The data management procedures are described.


RESULTS
Study data collection resulted in over 20,000 completed forms. Data management was successful, resulting in clean, internally consistent data sets for analysis. The amount of time required for data management was substantially underestimated.


CONCLUSIONS
Data management for prospective studies should be planned well in advance of data collection. An ongoing process with data entered and checked as they become available allows timely recovery of errors and missing data.
Kruse
Robin L
RL
Department of Family and Community Medicine, University of Missouri School of Medicine, Columbia, MO 65212, USA. kruser@health.missouri.edu
Mehr
David R
DR
D003625:Data Collection / Q000592:standards*; D003627:Data Interpretation, Statistical; D006302:Health Services Research / Q000379:methods* / Q000458:organization & administration; D006801:Humans; D008923:Missouri; D015999:Multivariate Analysis; D009735:Nursing Homes; D010865:Pilot Projects; D011446:Prospective Studies; D015203:Reproducibility of Results; D012141:Respiratory Tract Infections / Q000401:mortality / Q000503:physiopathology; D012984:Software; D016896:Treatment Outcome
Ann Acad Med Singap. 2000 Sep;29(5):576-81
11126691
Control Clin Trials. 1995 Apr;16(2 Suppl):66S-103S
7789144
Paediatr Perinat Epidemiol. 1998 Oct;12 Suppl 2:142-55
9805727
Environ Health Perspect. 2003 Apr;111(4):414-20
12676592
Pediatr Nephrol. 1991 May;5(3):348-51
1867992
Control Clin Trials. 1981 May;2(1):15-29
7261636
Stat Med. 1988 Nov;7(11):1165-70
3201042
Control Clin Trials. 1995 Apr;16(2 Suppl):104S-136S
7789140
Ann Fam Med. 2008 Mar-Apr;6(2):154-60
18332408
Control Clin Trials. 2001 Dec;22(6 Suppl):168S-80S
11728622
Control Clin Trials. 1986 Jun;7(2):89-117
3755669
J Stud Alcohol. 2003 May;64(3):358-66
12817824
JAMA. 2001 Nov 21;286(19):2427-36
11712938
Am J Emerg Med. 1985 Jul;3(4):360-3
4005011
J Manipulative Physiol Ther. 2002 Jan;25(1):49-57
11898018
Neth J Med. 1996 Jan;48(1):38-44
8775751
J Fam Pract. 2001 Nov;50(11):931-7
11711008
Control Clin Trials. 1995 Apr;16(2 Suppl):30S-65S
7789142
Control Clin Trials. 1986 Sep;7(3 Suppl):34S-45S
3802845
Stat Med. 2001 May 15-30;20(9-10):1323-30
11343353