RLS Rating scale
Vital signs
weight in kg
boolean
Weight in lbs
boolean
Weight
float
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
Laboratory evaluation
Please take a blood sample for routine analysis.
date
Laboratory label
text
If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.
boolean
Urine dipstick
Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.
integer
Pregnancy dipstick
If ’Yes’, please perform a pregnancy dipstick test and record result below.
boolean
Only answer if the patient is a female of child bearing potential. If ’Positive’, please record details on the Pregnancy Notification Form
integer
Clinical global impression
Pregnancy information
Study conclusion
If 'No' please mark the primary cause of withdrawal.
boolean
Reason for not completing the study
integer
Only answer, if you chose 'other' reason for not completing the 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