RLS Rating scale
Vital signs
after 5min sitting
integer
after 5 minutes sitting
integer
after 5 minutes sitting
integer
Medical procedures
Concomitant Medication
Adverse reaction
Patient rated scale
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
text
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
text
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
text
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
text
Healthcare resource utilisation - visits/contacts with physician
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
boolean
Healthcare resource utilisation - visits/contacts with physician
date of visit physician
date
Type of physician
integer
Visit location
integer
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).
integer
tests or procedures during visit
text
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
text
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
date of visit paramedical practitioner
date
Type of paramedical practitioner
integer
Visit location
integer
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).
integer
Healthcare resource utilisation - Hospitalisation
Healthcare resource utilisation - hospitalisation
date of admission
date
date of discharge
date
Hospitalisation cause
text
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.
text
type of ward
integer
in days
durationDatetime
Healthcare resource utilisation - accident & emergency / emergency room visits
Healthcare resource utilisation - accident & emergency / emergency room visits
Date of visit in A&E
date
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.
text
Clinical global impression
Instructions for the investigator
Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense Weeks 13 - 24 study medication. Complete the Study Medication and Compliance Section at the back of the next module. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return in 84 days (plus or minus 3 days) for the Week 24 clinic visit. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.
text
Clinical Global impression
Dose change between scheduled visits
Study medication and compliance record
Specify 1 - 8
integer
First Dose Date
date
Date last dose
date
Number of tablets dispensed
integer
Number of tablets returned
integer
Dose changes
Study Medication Week number
integer
Specify 1 - 8
integer
First Dose Date
date
Date last dose
date
Number of tablets dispensed
integer
Number of tablets returned
integer
Medical procedures
If 'Yes', please record details below using standard medical terminology
integer
Medical procedures
Procedure
text
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
text
Procedure Start Date
date
End Date Procedure
date
Concomitant medication
Concomitant medication
Drug name
text
eg. 500 mg
text
Any new medical illness/diagnosis (or symptoms in the absence of a diagnosis) should be recorded in the Adverse Experiences and/or SAE sections as appropriate using the same terminology.
text
start date of medication
date
End Date of medication
date
If a medication was marked ‘Continuing’ at a previous visit, but has since had a dosage change or has been stopped, it must be recorded as a change below with the new start and end date.
boolean
Adverse experience (non-serious)
Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column. If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the Serious Adverse Experience (SAE) section (See opposite for definitions of an SAE).
boolean
Adverse experience (non-serious)
Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column.
text
Adverse Event Start Date Time
datetime
(If ongoing please leave blank)
datetime
If patient died, STOP: go to SAE section and follow instructions given there
integer
adverse event course
integer
only answer if previous answer was 'intermittent'
integer
Intensity concerning the maximum
integer
Action Taken with Respect to Investigational Drug
integer
Relationship to Investigational Drug
integer
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
integer
Was patient withdrawn due to this specific AE?
boolean
Pregnancy information
Patient continuation/ withdrawal
If ’No’, please mark the primary cause of withdrawal.
boolean
Cause of withdrawal from study
integer
Other cause of withdrawal from study
text
Investigator signature
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
text
Investigator signature date
date