Trial Documentation

These documents are for use by collaborators involved in the PREDNOS 2 trial. They are the property of the University of Birmingham and Central Manchester University Hospitals NHS Foundation Trust and do not constitute any form of advice to participants.

As of the 22nd February 2013 the PREDNOS 2 trial is open to recruitment. Please see links below in order to download PREDNOS 2 documentation. 

PREDNOS 2 Protocol

PREDNOS 2 Protocol v1.2 (25th September 2013)

PREDNOS 2 PIS/GP Letters/Consent Forms

PREDNOS 2 Parent Information Sheet V1.2 (1st February 2013)

PREDNOS 2 Patient Information Sheet 16-18yrs v1.2 (1st February 2013)

PREDNOS 2 Older Child Information Sheet v1.2 (1st February 2013)

PREDNOS 2 Younger Child Information Sheet v1.2 (1st February 2013)

PREDNOS 2 Parent Consent Form v1.2 (1st February 2013)

PREDNOS 2 Participant Consent Form 16-18yrs v1.2 (1st February 2013)

PREDNOS 2 Letter to accompany Parent/Participant Information Sheets v1.0 (1st October 2012)

PREDNOS 2 Assent Form v1.0 (1st October 2012)

PREDNOS 2 Letter to GP v1.0 (1st October 2012)

PREDNOS 2 Other documentation

PREDNOS 2 Letter to accompany medication v1.0 (1st October 2012) 

PREDNOS 2 Advice Letter to Parent if participant receiving alternate day prednisolone v1.1 (22nd November 2012)

PREDNOS 2 Advice Letter to Parent if participant not receiving alternate day prednisolone v1.1 (22nd November 2012)

PREDNOS 2 Advice Letter to Participant if receiving alternate day prednisolone v1.1 (22nd November 2012)

PREDNOS 2 Advice Letter to Participant if not receiving alternate day prednisolone v1.1 (22nd November 2012)

PREDNOS 2 Patient Diary v1.0 (1st October 2012) 

PREDNOS 2 Reminder cards/magnets v1.0 (1st October 2012)

PREDNOS 2 Thank you cards v1.0 (1st October 2012)

PREDNOS 2 Advertising text for NEST and KKR websites v1.0 (1st October 2012)

PREDNOS 2 Flyer for Social Media v1.0 (22nd May 2014)

PREDNOS 2 Advertising Text for Social Media and Websites v1.0 (22nd May 2014)

PREDNOS 2 CRFs

Please use the links below for copies of the following forms:

Randomisation Form v1.2 (5th March 2014)

Baseline Form v2.2 (5th March 2014)

Follow Up Form v1.2 (5th March 2014)

Follow Up Form Continuation Sheet v1.2 (5th March 2014)

Serious Adverse Event Form v1.1 (5th March 2014)

Please contact us for copies of the following forms (we cannot add these questionnaires to the website for download as they are copyright protected):

Achenbach Childhood Behaviour Checklist for Ages 1.5-5

Achenbach Childhood Behaviour Checklist for Ages 6-18

Child Health Utility (CHU) 9D

Paediatric Quality of Life Inventory (Parent Report for Children ages 2-4) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Children ages 5-7) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Children ages 8-12) Peds QL

Paediatric Quality of Life Inventory (Parent Report for Children ages 13-18) PedsQL

EQ-5D parent reported

Please ensure you use the correct form for the age of the patient (see protocol Appendix 3).