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Table 4 Quality assurance program for the Improving Care of ALI Patients (ICAP) study

From: Study protocol: The Improving Care of Acute Lung Injury Patients (ICAP) study

1. Quality assurance at data collection

   a. Initial training of new study coordinators

i. Written Operations Manual as a reference source for standardized in-patient and out-patient data collection (more than 200 pages)

ii. Comprehensive group training sessions, including review of the Operations Manual, and demonstration and supervised completion of relevant assessment techniques

iii. Individual training sessions for data abstraction methods for paper-based and electronic-based ICU charting systems, and for out-patient interviews and assessments

   b. Certification of study coordinators for independent data collection

i. Use of standardized quality assurance data collection instruments to re-abstract pertinent data for the first three study participants of each in-patient study coordinator. Accuracy of at least 95% is required for a study coordinator to be certified for ongoing independent data collection

ii. Supervision of completion of patient surveys and assessments for new out-patient study staff. Demonstration of adherence to study protocol is required before independent data collection

   c. Ongoing quality assurance

i. Monthly, in-person meetings of all in-patient study and out-patient study coordinators to review data collection questions and quality assurance concerns

ii. Regular e-mail reminders clarifying any data collection guidelines

iii. Ongoing, random quality assurance reviews as described in (b) above

2. Quality assurance at data entry

   a. Manual review of all data collection forms for missing and potentially inaccurate data by data entry staff with follow-up of questionable data items by lead study coordinator

   b. Automated data entry validity checks by database software using predefined parameters for each specific data item

   c. Independent duplicate data entry with reconciliation of any differences

3. Quality assurance after data entry

   a. Ongoing and regular review of a customized set of descriptive statistics for all data in the database to identify potentially missing, outlier and illogical data items. All identified items are individual checked by study coordinators and any systematic problems are relayed to study coordinators for corrective measures

  1. ALI, acute lung injury; ICU, intensive care unit.