Formic software trainingfor the SCOOP study

Mikey Desai, Training Consultant, Formic LtdLiz Lenaghan, SCOOP Study Manager, UEA

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

Overview of data scanning using Formic for the SCOOP study

SCOOP trial proceduresIdentification 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)

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

How will study data be processed?

2 main methods of data entry:-

• Manual data entry

• Import data in pre-defined format (.csv)

Manual data entry

Examples:-

• Consent form (basic patient details)• Decline form (decline reasons)• Background information form • Logging dates of questionnaire receipt etc• DEXA results

Funded by:

Local Study Centre University Logo

I f you wish to take part in the SSCCOOOOPP study, please place your initials in each of the boxes below, sign and date this form, and complete the questions overleaf. Please return these forms in the pre-paid envelope provided. I f you (or a relative or friend) would like to ask more questions about this study before deciding whether to take part, please do not hesitate to contact [local researcher], the local study co-ordinator on [phone number].

1. I confirm that I have read and understand the information sheet version [no.]

dated [date] for the above study and have had the opportunity to ask questions by phoning the contact number provided. I agree to take part in the SSCCOOOOPP study.

2. I don’t think I am currently taking any of the following medicines for the

prevention or treatment of osteoporosis: - Alendronic acid, Fosamax®, Fosavance®, Didronel®, Actonel®, Evista®, Protelos®, Forsteo®, Bonviva® or Aclasta®.

3. I understand that my participation is voluntary and that I am free to withdraw

at any time without giving any reason, and without my medical care or legal rights being affected.

4. I understand that sections of my health care records may be looked at by

researchers from the University of [location], and that information held by the General Register Office may be used to keep in touch with me and follow up my health status for the duration of the study. I give permission for these individuals to have access to my records.

……………………………………..……… …..…/…...../ ..…… ……………………..….…………………………………… Name of patient Date Signature Your telephone number: ……………………………………………………………….……… (Your phone number will be kept confidential and won’t be released to anyone outside the research team) Other research studies Researchers from the SCOOP team would like to contact women who agree to take part in the main SCOOP study to see if they would be interested in helping with other related studies – these are entirely optional. I f you would not like to be sent information about related studies, please tick this box

<Patient name> < Admin code> <Address1> <NHS number> <Address2> <Address3> <Postcode> <Date of birth> <GP code> <GP practice code>

PARTI CI PANT CONSENT FORM

Funded by:

Local Study Centre University Logo

We would find it really helpful to have a wide range of women joining this study – you do not have to be concerned about the health of your bones to take part. As long as you are between 70 and 85 years of age and are not already on treatment for the prevention or treatment of osteoporosis, you are suitable for this study.

However, we quite understand if you do not wish to take part. I f this is the case, we would be grateful if you could tell us the reason(s) why by placing a tick in as many boxes as apply to you from the list below: - I am currently taking one of the following medicines prescribed by my GP or hospital doctor for the prevention or treatment of osteoporosis: - Alendronic acid, Fosamax®, Fosavance®, Didronel®, Actonel®, Evista®, Protelos®, Forsteo®, Bonviva® or Aclasta®.

I am not interested in taking part in this study

I would not want to have a DXA (bone density) scan

I f treatment was recommended, I would not want to take any medicines

I feel too unwell to take part in this study

I do not have the time to take part in this study

Other reason Please give more details here if you would like to: -

…………………………………………………………………………………………………………………………………………………………….

……………………………………………………………………………………………………………………………………..…………………….

I t would be very helpful if you would be willing to give us some brief details about yourself. We will not be able to identify you from this form, and we will not contact you again. We will use the anonymous information that you provide to help us see if there are any differences between those who agree to take part and those who decline. I f you wish, please complete the background information questions overleaf, and return these forms in the pre-paid envelope provided. Thank you very much.

Admin code

Admin code

DECLI NE FORM

Funded by:

Local Study Centre University Logo

Admin code

Please answer the following questions:-

1. What is your date of birth? _ _ _ _ / _ _ _ _ / _ _ _ _ _ _ (dd mm yyyy)

2. How tall are you?

_ _ _ _ feet and _ _ _ _ inches OR _ _ _ _ _ cm

3. How much do you weigh? _ _ _ _ stones and _ _ _ _ lbs OR _ _ _ _ kg 4.

Have you ever broken a bone after the age of 50 years that resulted from a low level of injury (e.g. a simple fall from standing height?)

Yes

No

Don’t know

5. Have either of your parents ever broken a hip following a low level of injury e.g. a fall from standing height?

Yes No Don’t know

6. Are you a smoker?

Yes No Don’t know

7. On average, do you drink 3 or more units each day? (1½ pints of beer or 3 glasses of wine or 3 short measures of spirits)

Yes

No

Don’t know

8. Please describe your previous main employment: -

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Please be as specific as possible)

9. Please describe your husband’s previous main employment: -

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Please be as specific as possible)

10. Did your education continue after the minimum school leaving age?

Yes No

11. Do you have a degree or equivalent professional qualification?

Yes No

12. To which of these ethnic groups do you consider you belong? (Please tick one box)

White Asian or Asian British Black or Black British

Other ethnic group Please describe _ ________________

Thank you for taking the time to complete these questions Please return these forms in the pre-paid envelope provided

BACKGROUND I NFORMATI ON

Import data in pre-defined format

Examples

• Anonymised dataset from each participating GP practice

• ?medication data from GP practices• Standardised questionnaire data

FORMIC

Standardised questionnaire dataBaseline 6 mth 12 mth 24 mth 36 mth 48 mth 60 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

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

SCOOP study procedures prior to scanning questionnaires

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)

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?

Responsevalid?

Responsevalid?

END

YES

NO

YES

YES

YES

YES

NO

NO

NONO

NOLog PL2 response

= ‘Decline’

YES

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

Data verification rules (1) Sample 1st 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

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.

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

‘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

Importing scanned questionnaire data into the SCOOP study database

• 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

Any questions?