RLS Rating Scale
Item
Patient has a total score ≥ 15 on the RLS Rating Scale at baseline.
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
secondary RLS or pregnancy
Item
Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia) or pregnancy at baseline.
boolean
C1536279 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0680251 (UMLS CUI [3])
augmentation and/or end of dose rebound
Item
Patient suffers from augmentation and/or end of dose rebound at baseline.
boolean
C0473305 (UMLS CUI [1])
C0454417 (UMLS CUI [2])
C0680251 (UMLS CUI [3])
clinically significant abnormal laboratory, ECG or physical examination findings
Item
Patient has clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the time of the baseline examinations.
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0747585 (UMLS CUI [3])
C0680251 (UMLS CUI [4])
medication known to induce drowsiness, affect RLS or sleep
Item
Patient is taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period).
boolean
C0013227 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
blood pressure
Item
Patient has a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg OR systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at baseline.
boolean
C0005823 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
participated in any clinical drug or device trial
Item
Patient has participated in any clinical drug or device trial in the 3 months prior to the baseline visit.
boolean
C2348568 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
hormone replacement therapy
Item
Patient has withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, (HRT)) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through to the follow-up visit at end of study.
boolean
C0282402 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Baseline RLS Score
Item
RLS Rating Scales: Mark the patient’s total score for all 10 items
integer
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0282121 (UMLS CUI [1,3])
Sitting blood pressure systolic
Item
Sitting blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting blood pressure diastolic
Item
Sitting blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting heart rate
Item
Sitting heart rate
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item
Which of the following categories best describes the patient at this time?
integer
C0242271 (UMLS CUI [1])
Code List
Which of the following categories best describes the patient at this time?
CL Item
Full time employment (1)
CL Item
Part-time employment (2)
CL Item
Volunteer/Unpaid work (3)
CL Item
Unemployed due to RLS (4)
CL Item
Unemployed due to other (non-RLS) disability (5)
CL Item
Unempoyed for other reason (6)
Part-time employment
Item
If part-time employed, please list approximate hours per week
float
C0682294 (UMLS CUI [1,1])
C2584953 (UMLS CUI [1,2])
Volunteer/Unpaid work
Item
If volunteer/unpaid work, please list approximate hours per week
float
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
Date of retirement
Item
If retired, please specify date of retirement
date
C0035345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work, please mark the one option below which best describes the category of the patient´s occupation:
integer
C0421456 (UMLS CUI [1])
Code List
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work, please mark the one option below which best describes the category of the patient´s occupation:
CL Item
Legislator, senior official or manager (e.g specialist managers, directors and chief executives) (1)
CL Item
Professional (e.g. teaching, legal, science and health professionals) (2)
CL Item
Technician or associate professional (computer associates, nurses/midwifes, ship & aircraft controllers, police inspectors, finance & sales) (3)
CL Item
Clerk (secretaries, cashiers and other office clerks) (4)
CL Item
Service worker or shop and market sales worker (e.g housekeeping and restaurant services, shop salesperson & demonstrators, and models) (5)
CL Item
Skilled agricultural or fishery worker (e.g animal/crop producers, market gardeners, fishery workers, hunters and trappers) (6)
CL Item
Craft and related trade workers (e.g miners, builders, blacksmiths, potters, glass-makers, textile workers) (7)
CL Item
Plant and machine operator or assembler (e.g. metal processing plant operator, food and related products machine operators) (8)
Visits with physicians
Item
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
boolean
C0583555 (UMLS CUI [1])
date of visit physician
Item
Date of Visit
date
C1320303 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item
Type of physician
integer
C0031831 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of physician
CL Item
Diabetologist (2)
CL Item
Dermatologist (3)
CL Item
Endocrinologist (4)
CL Item
ENT (Ear Nose & Throat) (5)
CL Item
Gastroenterologist (6)
CL Item
General/Internal Medical (7)
CL Item
General Practitioner/Family Practitioner (8)
CL Item
Gynaecologist (10)
CL Item
Infectious Disease (11)
CL Item
Nephrologist (12)
CL Item
Psychiatrist (14)
CL Item
Ophthalmologist (17)
CL Item
Respiratory/Chest Physician (18)
CL Item
Rheumatologist (19)
CL Item
Sleep Disorder Specialist (21)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the Visit RLS Related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Code List
Was the Visit RLS Related?
Item
Were any tests or procedures prescribed or conducted at this visit?
integer
C0430022 (UMLS CUI [1])
C0033080 (UMLS CUI [2])
Code List
Were any tests or procedures prescribed or conducted at this visit?
patient visit with paramedical practitioners
Item
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
boolean
C0545082 (UMLS CUI [1,1])
C0030450 (UMLS CUI [1,2])
date of visit paramedical practitioner
Item
Date of visit
date
C0030450 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Item
Type of paramedical practitioner
integer
C0030450 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of paramedical practitioner
CL Item
Acupuncturist (1)
CL Item
Chiropodist/ Footcare Practitioner (2)
CL Item
Homeopath/Herbalist (6)
CL Item
Physiotherapist (9)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the visit RLS related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Code List
Was the visit RLS related?
Hospitalisation
Item
In the past 4 weeks...was the patient hospitalised?
boolean
C0019993 (UMLS CUI [1])
date of admission
Item
Date of admission
date
C1302393 (UMLS CUI [1])
date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1])
Hospitalisation cause
Item
Main reason for stay
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Was the Visit RLS Related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Code List
Was the Visit RLS Related?
Item
Type of ward
integer
C1305702 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
Cardiovascular (1)
CL Item
Dermatological (2)
CL Item
Endocrinological (3)
CL Item
ENT (Ear, Nose & Throat) (4)
CL Item
Gastroenterological (5)
CL Item
General Medical (6)
CL Item
Gynaecological (8)
CL Item
Infectious Disease (9)
CL Item
Nephrological (10)
CL Item
Intensive Care (11)
CL Item
Neurological (12)
CL Item
Ophthalmological (16)
CL Item
Respiratory/Chest (17)
CL Item
Rheumatological (18)
length of stay on ward
Item
Length of stay on ward
integer
C1305702 (UMLS CUI [1,1])
C0023303 (UMLS CUI [1,2])
A&E visits
Item
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
boolean
C0562508 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Date of visit in A&E
Item
Date of visit
date
C0562508 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Item
Was the visit RLS related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Code List
Was the visit RLS related?