PURE Study Coordinator Group Discussions Lisbon, Portugal August 4 and 5, 2014
Agenda Original CRF completion errors Review of newly revised CRFs Participant Recruitment and Followup Schedule Q & A
PURE Study Coordinator Group Discussions PURE ORIGINAL CRF COMMON COMPLETION ERRORS
Original CRFs: Common Completion Errors Duplicate IDs Baseline IDs vs. Follow-up IDs (Mismatched IDs) Required fields missing Missing pages (i.e. follow-up and events) Event dates prior to recruitment or after death Responses not provided in English
Hints and Tips for clean data Provide responses to all questions Review query listings, and correct all errors as required. If you notice an error in any data provided, correct as soon as possible. You do NOT have to wait for a QC report to fix Review CRFs for completion PRIOR to faxing to PHRI (for missing fields, signatures and dates) Store Baseline forms (Family census, household adult Questionnaires) with Follow-up household and participant questionnaires
PURE Study Coordinator Group Discussions EXAMPLE OF MISMATCHED IDS
FAMILY CENSUS Questionnaire Household ID 95-501-360 Refer to Household Member # 3
ADULT Questionnaire Refer to ID and subject initials ID number is 95-501-360-02 According to FC, this individual should be 95-501-360-03
Example of Mismatched IDs 3 Year Follow-up visit CRF ID 95-501-360-1
Example of Mismatched IDs 4 Year Follow-up visit CRF ID 95-501-360-2
PURE Study Coordinator Group Discussions EXAMPLE OF DUPLICATE CRFS
Example 1 of Duplicate CRFs ID 11-001- 428-2, initials LSM, Visit # 3 Original CRF received
Example 1 of Duplicate CRFs Same ID, initials, visit: ID 11-001- 428-2, initials LSM, Visit # 3 Duplicate CRF received Different results Missing data
Example 2 of Duplicate CRFs ID 63-001- 005-1, initials JTL, Visit # 6 Original CRF received Visit date 2013-05-08
Example 2 of Duplicate CRFs (continued) ID 63-001- 005-1, initials JTL, Visit # 6 Duplicate CRF received Visit date 2012-04-13 NOTE that ID was originally provided to us as 63-004-005-1. It was changed to 63-001-005-1
Example 2 of Duplicate CRFs (continued) ID 63-001- 005-1, initials JTL, Visit # 6 Original values provided
Example 2 continued ID 63-001- 005-1, initials JTL, Visit # 6 Duplicate CRF received Values here do not match the values originally provided Which ones are correct?
PURE Study Coordinator Group Discussions PURE NEWLY REVISED CRFS
Visit Type and CRFs required Visits [1,2,4,5,7,8,10,11] Optional yearly visits Household Questionnaire CRF 101 and 102 are required Household Questionnaire CRFs 103-109 are optional depending on # of individuals # originally enumerated at baseline # of NEW individuals Participant Questionnaires CRF 301 and 302 are required
Visit Type and CRFs required Visits [3,6,9] Mandatory visits Household Questionnaire CRF 151 and 152 are required Household Questionnaire CRFs 153-159 are optional depending on # of individuals # originally enumerated at baseline # of NEW individuals Household Questionnaire CRFs 160-162 are required Participant Questionnaires CRF 351-361 are required Health Services Research CRFs 401-405 are required
PURE Study Coordinator Group Discussions PARTICIPANT QUESTIONNAIRE
R=Required Field PQ CRF 301 and 351 R R R R R To avoid mismatched ID queries, ensure that correct follow-up ID is always provided on all follow-up CRFs To avoid inconsistent queries, ensure that the SAME subject initials are used each time
PQ CRF 301 and 351 R=Required Field R R Last Follow-up Visit is either Baseline visit OR it s an annual visit [1-8]. If last visit was baseline, check box only. Do not provide baseline date. Otherwise, provide date of last visit and follow-visit number. Date provided must match date of corresponding visit number provided Current follow-up visit date must ALWAYS be after LAST follow-up visit date
PQ CRF 301 and 351 R=Required Field R R Refer to facing page for details about options 4a-d (Subject s follow-up status)
PQ CRF 301 and 351 If follow-up status is 4b,4c or 4d signature and date are required. CRFs 302 or 352-361 are no longer required If 4a, signature and date are required on CRF 302 (optional annual visits) or CRF 361 (mandatory 3,6,9 visits) only Date signed must NEVER be prior to current follow-up visit date
R=Required Field R PQ CRF 302 and 352 R If YES, at least ONE report # field is required. Report # provided MUST match the event CRF that was completed
Ensure that the correct report number, for the type of event that occurred, is provided. For example, Myocardial Infarction report numbers range from 100-119. Stroke report numbers range from 120-139. Do NOT indicate report number 001, 002 etc. PQ CRF 302 and 352 R
PQ CRF 302 and 352 If YES to 5h, 5j or 5k: supplemental CRFs are ONLY required if NEWLY diagnosed since last follow-up. If participant had history of HIV/AIDS, COPD, Chronic Bronchitis/Emph ysema OR Asthma at Baseline, these CRFs are NEVER required
Adult Questionnaire (AQ at Baseline) If YES to question 15, OR YES to questions 17i,17j or 17n on Adult questionnaire, the newly diagnosed CRFs (at follow-up) are never required If, during follow-up, an individual was hospitalized for any of these events, this information should be reported on the Hospitalization CRF
PQ CRF 352 only R=Required Field If YES to question 8,9a or 9b, time and date of diagnosis is ALWAYS required R R R If YES to question 9a or 9b, a response to question 10 (i.e. treated with medications) is ALWAYS required
PQ - CRF 353 - Hypertension
PQ CRF 353 - Diabetes
PQ CRF 354 - Cholesterol
CRF 354 Aspirin and Other heart medications
PQ CRF 354 - Medications List all medications OR check off Participant is NOT regularly taking any medications Do not leave both blank
PQ CRF 355 - Tobacco
PQ CRF 355 - Alcohol
PQ CRF 355 - Diet
PQ CRF 356 Diet (continued) New Split into two New
PQ CRF 356 Diet (continued) New New
PQ CRF 357 - Transportation
PQ CRF 357 Transportation (continued)
PQ CRF 358 Physical Activity Indicate days per week and usual time spent on one of those days OR indicate No activity or Don t know/not sure Do NOT leave both blank If providing usual time in minutes only, the time must be at least 10 minutes
PQ CRF 359 - Disability These same questions were asked at Baseline (Adult questionnaire)
PQ CRF 359 Disability (continued) New Questions
PQ CRF 360 - Spirometry Details discussions about spirometry will be in the other Study Coordinator Group Discussion
PQ CRF 360 Spirometry (continued)
PQ CRF 361 Physical Measurements
PQ CRF 361 Urine and Blood Blood collections are optional in this phase of follow-up; however, should you wish to obtain blood samples, please make all arrangements with your local laboratory facility. Record all lab results in question 55. Provide result or indicate Not done. Do not leave both blank.
PURE Study Coordinator Group Discussions HOUSEHOLD QUESTIONNAIRE
Original Family Census Questionnaire All members that were living in the household at the start of PURE, were listed on the original Family Census Questionnaire Each member was assigned a Household Member # This member # was to be used for ALL questionnaires at baseline (i.e. Adult Questionnaire) and at follow-up
Original Household Follow-up Questionnaire At subsequent follow-up visits, we asked for details about all members (enumerated at baseline) The original household member # was to be maintained Any NEW members were to be included
Newly Revised Household Follow-up Questionnaire If contact is not established (after numerous attempts), provide reasons why Continue to attempt to establish contact with household and all participating members at next round of follow-up
Newly Revised Household Follow-up Questionnaire If contact is established, proceed to question 2 and provide details of ALL individuals currently living in the household Details of each original enumerated participant and all NEW members are to be provided on 102 and 152
Newly Revised Household Follow-up Questionnaire All original enumerated individuals are to be listed FIRST, using the original member ID # All details are required (sex, age, participant type and live status) If individual has died, provide all details
Newly Revised Household Follow-up Questionnaire All NEW members are to listed after all original enumerated individuals All details are required (sex, age, participant type and live status) If individual has died, provide all details
Newly Revised Household Follow-up Questionnaire, CRF 160-162 Follow-up household possessions, to capture the changes overtime, are required at the 3,6 and 9 year follow-up visits
Newly Revised Household Follow-up Questionnaire, CRF 160-162 Follow-up housing environment and cooking and heating source information is also required (at 3,6 and 9 year)
Newly Revised Household Follow-up Questionnaire, CRF 160-162 Weekly, monthly and yearly expenditure details are NEW and are required at the 3,6 and 9 year follow-up visits Currency must be provided. All data must be provided using same currency
Newly Revised Household Follow-up Questionnaire, CRF 160-162
Newly Revised Household Follow-up Questionnaire, CRF 160-162
PURE Study Coordinator Group Discussions HEALTH SERVICES RESEARCH QUESTIONNAIRE
Health Services Research Questionnaire NEW CRF Required at the 3,6,9 year follow-up visit
Health Services Research Questionnaire Indicate any health care facility you ve visited in the last 12 months OR check NONE Do not leave both blank
Health Services Research Questionnaire If Q1 is NONE, you still need to provide a response to Q2 Q1 refers to facilities you ve visited in the last 12 months; Q2 is asking about your usual mode of transportation to these facilities. Choose one you visit most frequently
All CRFs at 3, 6 and 9 year followup visit The LAST follow visit information must be the SAME across all 3 CRFs, for the SAME visit
PURE Study Coordinator Group Discussions EVENT CRFS
Capturing Events at Follow-up If YES to any event/new diagnosis at follow-up visit, the corresponding event CRF is always required
Capturing Events at Follow-up On each event CRF, the follow-up visit number and date, when the event was reported, is REQUIRED The date provided must match the follow-up visit date on the corresponding visit CRF
Capturing Events at Follow-up Complete date of diagnosis (i.e. year and month) is always required The diagnosis date provided must be prior to the current follow-up visit date The date of diagnosis should always be after enrolment date, except in certain cases
Capturing Events at Death If YES to any event/new diagnosis since last follow-up visit, up to the date of death, the corresponding event CRF is always required
Capturing Events at Death For any event reported at time of death, check Reported at time of death on the corresponding event CRF Follow-up Date is not required
Capturing Events at Death Complete date of diagnosis (i.e. year and month) is always required The diagnosis date provided cannot be after death date
PURE Study Coordinator Group Discussions QUESTION AND ANSWERS