Data collection and management
Information is collected at every stage of recruitment,
treatment allocation, and throughout treatment, so that
the patient flow can be reported according to the CONSORT
guidelines [93]. Specifically, we collect recruitment
source, total number of responses per recruitment
source, potential participants’ resolution (e.g. ineligible,
do not wish to participate, allocated), the number allocated
to each treatment group, participant compliance
to treatment protocol, the number lost to follow-up,
and the number of participants completing the trial.
Participant self-report questionnaires are collected on
paper forms. The only identifier on a given data collection
form is a unique participant ID; no other personal
identifiers are recorded on these forms. Study coordinators
have oversight for all paper data collection forms,
log each completed form into a form tracking interface
of the web system and submit data forms for key-entry
weekly. Paper data collection forms are stored in locked
filing cabinets. The paper forms are double key-entered
by trained data entry clerks in an MS Windows program
using range and validation checks to improve accuracy.
The project’s web system is password-protected and
uses a Microsoft SQL Server database platform to store
all data. Study personnel have unique user IDs and passwords
restricting access from a Main Menu. All data
collected by study personnel are recorded in userfriendly
data-entry interfaces. Study coordinators assure
that clinicians and biomechanical examiners complete
paper data collection and web data-entry for the chiropractic
research measures. The data manager creates the
data dictionaries and datasets for analysis.
Quality control procedures are utilized to ensure that
recruitment is on schedule, treatment allocation is
occurring as planned, data collection protocols are being
used accurately, data collected through the CATI and
other web interfaces are being stored correctly in the
SQL databases, sensorimotor outcome variables are
extracted from the biomechanical measurements within
2 weeks of data collection and that the data are being
transferred and retrieved properly.
Data collection and managementInformation is collected at every stage of recruitment,treatment allocation, and throughout treatment, so thatthe patient flow can be reported according to the CONSORTguidelines [93]. Specifically, we collect recruitmentsource, total number of responses per recruitmentsource, potential participants’ resolution (e.g. ineligible,do not wish to participate, allocated), the number allocatedto each treatment group, participant complianceto treatment protocol, the number lost to follow-up,and the number of participants completing the trial.Participant self-report questionnaires are collected onpaper forms. The only identifier on a given data collectionform is a unique participant ID; no other personalidentifiers are recorded on these forms. Study coordinatorshave oversight for all paper data collection forms,log each completed form into a form tracking interfaceof the web system and submit data forms for key-entryweekly. Paper data collection forms are stored in lockedfiling cabinets. The paper forms are double key-enteredby trained data entry clerks in an MS Windows programusing range and validation checks to improve accuracy.The project’s web system is password-protected anduses a Microsoft SQL Server database platform to storeall data. Study personnel have unique user IDs and passwordsrestricting access from a Main Menu. All datacollected by study personnel are recorded in userfriendlydata-entry interfaces. Study coordinators assurethat clinicians and biomechanical examiners completepaper data collection and web data-entry for the chiropracticresearch measures. The data manager creates thedata dictionaries and datasets for analysis.Quality control procedures are utilized to ensure thatrecruitment is on schedule, treatment allocation isoccurring as planned, data collection protocols are beingused accurately, data collected through the CATI andother web interfaces are being stored correctly in theSQL databases, sensorimotor outcome variables areextracted from the biomechanical measurements within2 weeks of data collection and that the data are beingtransferred and retrieved properly.
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