1. Formic software training for the SCOOP study Mikey Desai, Training Consultant, Formic Ltd Liz Lenaghan, SCOOP Study Manager, UEA

2. Aim:- To provide an overview of Formic and how it will be used to process standardised questionnaire response data in the SCOOP study Objectives:- Describe issues involved in questionnaire design in Formic Introduce SCOOP study approach to logging questionnaires and checking for incomplete data prior to scanning Demonstrate scanning & data verification processes Demonstrate how to prepare scanned data for import to the SCOOP study database

3. Overview of data scanning using Formic for the SCOOP study

4. SCOOP trial procedures Identification of eligible patients  PL1 invitation mailings (GP practices) PL1 response (consent / decline) & background info sent to study centre Consenters’ details registered on SCOOP study database Valid consenters sent PL2 baseline questionnaire mailing PL2 response (baseline questionnaire data) sent to study centre Valid PL2 responders randomised; if intervention  fracture risk calculated Intervention group procedures:- PL4 / GL4 mailings (DEXA result & final fracture risk) PL5 / GL5 mailings (if final fracture risk = ‘high’) Follow-up:- Questionnaire mailings PL6 to PL11 & response (6, 12, 24, 36, 48, 60 mths) Objective data collection on fracture incidence & osteoporosis medication px PL3 / GL3 mailings (randomisation group; if intervention above threshold  invite for DEXA)

5. SCOOP study database Repository for all trial participant data –eg. identifiable details, questionnaire data, randomisation group, fracture risk allocation, DEXA results etc ‘Housekeeping’ system to progress participants through relevant trial stages –eg. identify which participants are due for questionnaire mailings, computerised randomisation and fracture risk calculation, referral for DEXA etc

10. How will study data be processed? 2 main methods of data entry:- Manual data entry Import data in pre-defined format (.csv)

11. Manual data entry Examples:- Consent form (basic patient details) Decline form (decline reasons) Background information form Logging dates of questionnaire receipt etc DEXA results

15. Import data in pre-defined format Examples Anonymised dataset from each participating GP practice ?medication data from GP practices Standardised questionnaire data FORMIC

16. Standardised questionnaire data Baseline6 mth12 mth24 mth36 mth48 mth60 mth # risk questions √ SF-12 √√√√√√√ EQ-5d √√√√√√√ State-Trait √√√√√√√ Self-report adherence √√√√√√ Self-report # events √√√√√√ Each √ represents response data from approx 1650 study participants per study centre

17. Standardised questionnaire data Suitable for data scanning using Formic:- ‘Closed’ response format (cross in box) Only exception is fracture self-report (‘open’ responses expected from <10% of responders per time point – ie. where actual / suspected fracture incident is reported) Large volume of repetitive data Able to set rules for permitted responses

18. SCOOP study procedures prior to scanning questionnaires

19. SCOOP study questionnaires Centralised printing by UEA (printed Trial IDs).pdf files available to study centres for reminder mailings (hand written Trial IDs) Customised for study centres (logo, local hospital names on fracture self-report sections of follow-up questionnaires)

20. PL2 baseline mailing & response Send PL2 baseline questionnaire mailing to consenting pts RANDOMISE Log PL2 response = ‘Valid’ Scan in PL2 response data & import to study database PL2 reminder mailing Final reminder phonecall END Log PL2 response = ‘Invalid’ Contact respondent for missing data Scan in PL2 response data & import to study database END Response? Completed questionnaire returned? Response? Response valid? Response valid? END YES NO YES NO Log PL2 response = ‘Decline’ YES

21. Tasks prior to scanning Date stamp received questionnaire Log received date on study database Check response data and enter Response Status on study database (Valid / Invalid) Contact respondent for missing data if applicable Make manual corrections to hard copy of questionnaire if applicable Scan questionnaire

22. Data verification rules (1) Sample 1 st page of baseline questionnaire Response mandatory for every question Single response allowed per question (ie. ‘yes’ or ‘no’ or ‘don’t know’) (‘don’t know’ response will be treated as ‘no’ when fracture risk is calculated on randomisation) Contact respondent if:- –1 or more questions left blank (Example no. 6) –2 or more items ticked for any of the questions and the intention is not clear (Example no. 3) NB. Data verification high priority – Complete data required for randomisation

23. Data verification rules (2) Sample EQ-5d Response mandatory for every question Single response allowed per question (eg. ‘no problems’ or ‘some problems’ or ‘unable to…’) Contact respondent if:- –1 or more questions left blank –2 or more items ticked for any of the questions and the intention is not clear NB. Data verification lower priority – data not required for randomisation, but still aim for completeness where possible.

24. Data verification rules (3) Sample questions from follow-up questionnaire Response mandatory for Q1 If response to Q1 = ‘no’, remaining questions not applicable If response to Q1 = ‘yes’ or ‘don’t know’, expect responses to Q2 and ‘First incident’ section (though not mandatory) If response to Q1 = ‘yes’ or ‘don’t know’:- –multiple responses allowed to First Incident question i) –Description text allowed in First Incident question ii) Contact respondent if:- –Q1 left blank (Example no. 5) –Self-report of fracture not clear according to above rules

25. ‘Office use only’ box Enter a value if respondent contacted about missing / incomplete data ‘Office use only’ values:-  Left blank = Administered by post only  1 = Administered by phone only  2 = Administered by post & phone

26. Importing scanned questionnaire data into the SCOOP study database

27. Use “Import” bulk operation routines on SCOOP study database main menu Data can only be imported once per participant per time point (Error message displayed if attempt to overwrite data; manual edits allowed after import) If PL Response Status entered as ‘valid’, participant cannot proceed to subsequent trial stages until data imported Import procedure

32. Any questions?