ID

44222

Beschreibung

This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim

Stichworte

Versionen (4)
  1. 08.03.16 08.03.16 -
  2. 08.03.16 08.03.16 -
  3. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  4. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Visit 1 - Baseline Form Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis

Englisch

Visit 1 - Baseline Form

1 Formulare  
Header module
Beschreibung

Header module

Visit number
Beschreibung

Visit Number

Datentyp

integer

Alias
UMLS CUI [1]
C1549755
Patient Name
Beschreibung

Patient Name

Datentyp

integer

Alias
UMLS CUI [1]
C1299487
Center #
Beschreibung

Center #

Datentyp

integer

Alias
UMLS CUI [1]
C0009469
Date
Beschreibung

Date

Datentyp

integer

Alias
UMLS CUI [1]
C0011008
Patient demographics
Beschreibung

Patient demographics

Date of birth
Beschreibung

Date of birth

Datentyp

integer

Alias
UMLS CUI [1]
C0421451
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperatur
Beschreibung

Temperatur

Datentyp

integer

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Blood pressure
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • 1/sec
Alias
UMLS CUI [1]
C0018810
1/sec
Gender
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnic Group

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Medical history of serious illness, accidents, surgeries
Beschreibung

Medical history of serious illness, accidents, surgeries

Datentyp

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2]
C0000924
UMLS CUI [3]
C0543467
Does the patient suffer from allergies?
Beschreibung

Does the patient suffer from allergies?

Datentyp

integer

Alias
UMLS CUI [1]
C0489531
Chronic sinusitis
Beschreibung

Patient has suffered from chronic sinusitis since:

Datentyp

integer

Alias
UMLS CUI [1]
C0149516
Inclusion criteria
Beschreibung

Inclusion criteria

Initial examination including Ear, Nose and Throat Examination
Beschreibung

Initial examination including Ear, Nose and Throat Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C2729337
UMLS CUI [2]
C0278350
Patient age between 18-65
Beschreibung

Patient age

Datentyp

boolean

Patient with chronic sinusitis
Beschreibung

Patient with chronic sinusitis for more than 8 weeks or with more than 4 periods during at least 10 days/year (nasal obstruction and unspecific headache, rhinorrhea, post-nasal-drip, facial pain, facial pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0149516
Sinusitis symptom score
Beschreibung

Sinusitis Symptom Score total >= 5 and nasal obstruction score total >=2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3533163
UMLS CUI [1,2]
C0037199
UMLS CUI [2,1]
C1299570
UMLS CUI [2,2]
C0037199
Sinusitis diagnostics through coronary CT
Beschreibung

Sinusitis diagnostics via coronary CT not older than 6 month. Sinusitis diagnosis and scale: osteo-meatal complex score= 2 on at least one side, total score < 10

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037199
UMLS CUI [1,2]
C1634617
Patient in good general condition
Beschreibung

Patient in good general condition without clinically significant disease which could affect study goal or study methods or which might impair patient´s safety.

Datentyp

boolean

Alias
UMLS CUI [1]
C1142435
Patient with stable intermittent asthma
Beschreibung

Patient with stable intermittent asthma: No medication at all or no medication with Beta-2 adrenergic receptor antagonists and without systemic, intranasal or inhaled corticosteroids medication.

Datentyp

boolean

Alias
UMLS CUI [1]
C1740754
Patient on prior medication
Beschreibung

Patient on prior medication: Observe wash out times prior to begin of study

Datentyp

boolean

Alias
UMLS CUI [1]
C2826257
Written informed consent
Beschreibung

Written informed consent based on patient information by physician

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Footer module
Beschreibung

Footer module

no participation
Beschreibung

In case one of the above mentioned questions is answered “NO” the patient may not be included into the study.

Datentyp

boolean

Alias
UMLS CUI [1]
C0680252
Date and signature
Beschreibung

Date and signature by physician

Datentyp

integer

Alias
UMLS CUI [1]
C0807937
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Patient who do not fulfill all inclusion criteria
Beschreibung

Patient who do not fulfill all inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C2827031
Patient without contraception, pregnant/ breast-feeding
Beschreibung

Patient without contraception, pregnant/ breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0549206
UMLS CUI [3]
C0006147
Patient has undergone nasal operation within the last 6 months
Beschreibung

Patient has undergone nasal operation within the last 6 months

Datentyp

boolean

Alias
UMLS CUI [1]
C0188970
Patient with significant ECG changes
Beschreibung

Patient with significant ECG changes

Datentyp

boolean

Alias
UMLS CUI [1]
C0855329
Patient with clinically relevant changes of vital bodily function
Beschreibung

Patient with clinically relevant changes of vital bodily function

Datentyp

boolean

Alias
UMLS CUI [1]
C0277803
Patient with Wegener's granulomatosis and/ or several other diseases
Beschreibung

Patient with Wegener's granulomatosis, Cystic fibrosis, Nasal polyp, Young syndrome, Primary ciliary dyskinesia, Glaucoma, cardiovascular, pulmonary, renal, hepatic, metabolic, hematological or neurological disease, that may impair with the therapy, patient on immunosuppressive agents or with Churg–Strauss syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C3495801
UMLS CUI [2,1]
C0010674
UMLS CUI [2,2]
C0027430
UMLS CUI [3]
C0340037
UMLS CUI [4]
C0008780
UMLS CUI [5]
C0017601
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0024115
UMLS CUI [8]
C0022658
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0025517
UMLS CUI [9,3]
C0018939
UMLS CUI [9,4]
C0027765
UMLS CUI [10]
C0021081
UMLS CUI [11]
C0008728
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Beschreibung

Patient on systemic steroid therapy < 4 weeks prior to begin of study

Datentyp

boolean

Alias
UMLS CUI [1]
C4039704
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Beschreibung

Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study

Datentyp

boolean

Alias
UMLS CUI [1]
C3539185
Drug intolerance
Beschreibung

Drug intolerance to pharmaceutical ingredients of study medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0277585
Acute exacerbation of sinusitis
Beschreibung

Acute exacerbation of sinusitis or acute nasal infection < 2 weeks prior to begin of examination that required antibiotic therapy.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235874
UMLS CUI [1,2]
C0037199
UMLS CUI [1,3]
C0338237
Body Temperature
Beschreibung

Body Temperature > 38.5 °C at start of trial

Datentyp

boolean

Alias
UMLS CUI [1]
C0005903
White blood cell count
Beschreibung

White blood cell count exceeding > 150 % of upper limit

Datentyp

integer

Alias
UMLS CUI [1]
C0580531
Acute Upper Respiratory Infection
Beschreibung

Acute Upper Respiratory Infection within last two weeks

Datentyp

boolean

Alias
UMLS CUI [1]
C0264222
Patient on antibiotic therapy
Beschreibung

Patient on antibiotic therapy after increase of symptoms during medication phase.

Datentyp

boolean

Alias
UMLS CUI [1]
C0338237
Person participating in trial
Beschreibung

Person participating in trial or their relatives

Datentyp

boolean

Alias
UMLS CUI [1]
C0008976
Exclusion Criteria
Beschreibung

In case one of the above mentioned questions is answered “YES” the patient may not be included into the study.

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Physical Examination
Beschreibung

Physical Examination

Physical Examination
Beschreibung

Physical Examination

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
Examination of nose
Beschreibung

Examination of nose

Datentyp

integer

Alias
UMLS CUI [1]
C0558826
Anatomic, Congenital , Surgery-induced changes
Beschreibung

Anatomic, Congenital , Surgery-induced changes

Datentyp

boolean

Alias
UMLS CUI [1]
C0302142
UMLS CUI [2]
C0000768
Nasal Polyps
Beschreibung

Nasal Polyps

Datentyp

boolean

Alias
UMLS CUI [1]
C0027430
Endoscopy
Beschreibung

Endoscopy

Datentyp

integer

Alias
UMLS CUI [1]
C0014245
Endoscopy findings
Beschreibung

Endoscopy findings: Assessment scale: 0=no finding; 1=minor; 2=major

Datentyp

integer

Alias
UMLS CUI [1]
C0438280
Lund-MacKay (LM) CT scoring scale
Beschreibung

Lund-MacKay (LM) CT scoring scale

Datentyp

integer

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0036449
Medication
Beschreibung

Medication

Concomitant medications
Beschreibung

Please list all drugs that the patient is taking at the start of this trial or that he will be taking during this trial. Please also note change of dosage. Please observe excluded drugs under the exclusion criteria section of this form.

Datentyp

integer

Alias
UMLS CUI [1]
C2347852
PRN Medicines
Beschreibung

Please liste all "As Needed" medication

Datentyp

integer

Alias
UMLS CUI [1]
C3176065
Non-drug therapy
Beschreibung

Pleae list all non-drug therapies the patient has sofar undergone or will undergo during this trial.

Datentyp

integer

Alias
UMLS CUI [1]
C0677097
Signature
Beschreibung

Signature

Datentyp

integer

Alias
UMLS CUI [1]
C1519316
Laboratory
Beschreibung

Laboratory

Blood test
Beschreibung

Blood test

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Rhinosinusitis Disability Index (RSBI)
Beschreibung

Rhinosinusitis Disability Index (RSBI)

Rhinosinusitis Disability Index (RSBI)
Beschreibung

The Rhinosinusitis Disability Index (RSDI) is a measure of sinus-related disability. It is a standardized, statistically validated, disease-specific tool and used to investigate the disability suffered patients with rhinologic diagnosis.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0948780
UMLS CUI [1,2]
C3826998
Impairment due to chronic sinusitis
Beschreibung

The following questions refer to the effects of chronic sinusitis on your ability to work and your daily activities. Please check the following boxes: 1. Are you currently employed? If no, please continue with question No. 6. The next questions refer to the last 7 days, today excluded: 2. How many hours of work did you miss in the last 7 days due to problems or discomfort resulting from your chronic sinusitis? 3. How many hours of work did you miss in the last 7 days due to other reasons such as holidays or because of participating at this trial? 4. How many hours did you work in the last 7 days in total? If you insert 0 hours, please skip the next question and continue with question 6. 5. How did the chronic sinusitis affect your performance at work in the last 7 days? Please take into consideration those days when the amount and type of work you could accomplish was reduced. Also consider those days when you accomplished less than you had planned to and you did not work as diligently as usual. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment: 6. How did the chronic sinusitis affect your regular daily activities that are not work related in the last 7 days? Regular activities refer to house and garden work, shopping, education, sport etc.. Please consider the type and amount of your daily activities you could not do. Also consider those days when you accomplished less than you had planned to. If the chronic sinusitis had only a minor effect on your work please mark a low number. Mark a high number if you experienced a more severe impairment:

Datentyp

integer

Alias
UMLS CUI [1]
C0681116
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Ähnliche Modelle

Visit 1 - Baseline Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header module
Visit Number
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Patient Name
Item
Patient Name
integer
C1299487 (UMLS CUI [1])
Center #
Item
Center #
integer
C0009469 (UMLS CUI [1])
Date
Item
Date
integer
C0011008 (UMLS CUI [1])
Item Group
Patient demographics
Date of birth
Item
Date of birth
integer
C0421451 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Temperatur
Item
Temperatur
integer
C0039476 (UMLS CUI [1])
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
Blood pressure
Code List
Blood pressure
CL Item
Systolic (1)
C0871470 (UMLS CUI-1)
CL Item
Diastolic (2)
C0428883 (UMLS CUI-1)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
C1706180 (UMLS CUI-1)
CL Item
female (2)
C0086287 (UMLS CUI-1)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnic Group
Code List
Ethnicity
CL Item
Caucasian (1)
CL Item
Black (2)
CL Item
Oriental/Asian (3)
CL Item
Other (4)
Medical history of serious illness, accidents, surgeries
Item
Medical history of serious illness, accidents, surgeries
boolean
C0010340 (UMLS CUI [1])
C0000924 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Item
Does the patient suffer from allergies?
integer
C0489531 (UMLS CUI [1])
Does the patient suffer from allergies?
Code List
Does the patient suffer from allergies?
CL Item
Yes (1)
CL Item
No (2)
CL Item
If yes, please specify (3)
Item
Chronic sinusitis
integer
C0149516 (UMLS CUI [1])
Chronic sinusitis
Code List
Chronic sinusitis
CL Item
Symptoms persit for more than 8 weeks (1)
CL Item
Patient has had at east 4 episodes with more than 10 symptom days/ year (2)
CL Item
What kind of pretreatment has been applied? (3)
Item Group
Inclusion criteria
Initial examination including Ear, Nose and Throat Examination
Item
Initial examination including Ear, Nose and Throat Examination
boolean
C2729337 (UMLS CUI [1])
C0278350 (UMLS CUI [2])
Patient age between 18-65
Item
Patient age between 18-65
boolean
Patient with chronic sinusitis
Item
Patient with chronic sinusitis
boolean
C0149516 (UMLS CUI [1])
Sinusitis symptom score
Item
Sinusitis symptom score
boolean
C3533163 (UMLS CUI [1,1])
C0037199 (UMLS CUI [1,2])
C1299570 (UMLS CUI [2,1])
C0037199 (UMLS CUI [2,2])
Sinusitis diagnostics through coronary CT
Item
Sinusitis diagnostics through coronary CT
boolean
C0037199 (UMLS CUI [1,1])
C1634617 (UMLS CUI [1,2])
Patient in good general condition
Item
Patient in good general condition
boolean
C1142435 (UMLS CUI [1])
Patient with stable intermittent asthma
Item
Patient with stable intermittent asthma
boolean
C1740754 (UMLS CUI [1])
Patient on prior medication
Item
Patient on prior medication
boolean
C2826257 (UMLS CUI [1])
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Footer module
no participation
Item
no participation
boolean
C0680252 (UMLS CUI [1])
Date and signature
Item
Date and signature
integer
C0807937 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Patient who do not fulfill all inclusion criteria
Item
Patient who do not fulfill all inclusion criteria
boolean
C2827031 (UMLS CUI [1])
Patient without contraception, pregnant/ breast-feeding
Item
Patient without contraception, pregnant/ breast-feeding
boolean
C0700589 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Patient has undergone nasal operation within the last 6 months
Item
Patient has undergone nasal operation within the last 6 months
boolean
C0188970 (UMLS CUI [1])
Patient with significant ECG changes
Item
Patient with significant ECG changes
boolean
C0855329 (UMLS CUI [1])
Patient with clinically relevant changes of vital bodily function
Item
Patient with clinically relevant changes of vital bodily function
boolean
C0277803 (UMLS CUI [1])
Patient with Wegener's granulomatosis
Item
Patient with Wegener's granulomatosis and/ or several other diseases
boolean
C3495801 (UMLS CUI [1])
C0010674 (UMLS CUI [2,1])
C0027430 (UMLS CUI [2,2])
C0340037 (UMLS CUI [3])
C0008780 (UMLS CUI [4])
C0017601 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9,1])
C0025517 (UMLS CUI [9,2])
C0018939 (UMLS CUI [9,3])
C0027765 (UMLS CUI [9,4])
C0021081 (UMLS CUI [10])
C0008728 (UMLS CUI [11])
Patient on systemic steroid therapy < 4 weeks prior to begin of study
Item
Patient on systemic steroid therapy < 4 weeks prior to begin of study
boolean
C4039704 (UMLS CUI [1])
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
Item
Patient on inhalable or intranasal steroid therapy < 2 weeks prior to begin of study
boolean
C3539185 (UMLS CUI [1])
Drug intolerance
Item
Drug intolerance
boolean
C0277585 (UMLS CUI [1])
Acute exacerbation of sinusitis
Item
Acute exacerbation of sinusitis
boolean
C0235874 (UMLS CUI [1,1])
C0037199 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Body Temperature
Item
Body Temperature
boolean
C0005903 (UMLS CUI [1])
White blood cell count
Item
White blood cell count
integer
C0580531 (UMLS CUI [1])
Acute Upper Respiratory Infection
Item
Acute Upper Respiratory Infection
boolean
C0264222 (UMLS CUI [1])
Patient on antibiotic therapy
Item
Patient on antibiotic therapy
boolean
C0338237 (UMLS CUI [1])
Person participating in trial
Item
Person participating in trial
boolean
C0008976 (UMLS CUI [1])
Exclusion Criteria
Item
Exclusion Criteria
boolean
C0680251 (UMLS CUI [1])
Item Group
Physical Examination
Item
Physical Examination
integer
C0031809 (UMLS CUI [1])
Physical Examination
Code List
Physical Examination
CL Item
Done (1)
CL Item
Not done (2)
CL Item
Findings (3)
C0243095 (UMLS CUI-1)
Item
Examination of nose
integer
C0558826 (UMLS CUI [1])
Examination of nose
Code List
Examination of nose
CL Item
Done (1)
CL Item
Note done (2)
CL Item
Findings (3)
Anatomic, Congenital , Surgery-induced changes
Item
Anatomic, Congenital , Surgery-induced changes
boolean
C0302142 (UMLS CUI [1])
C0000768 (UMLS CUI [2])
Nasal Polyps
Item
Nasal Polyps
boolean
C0027430 (UMLS CUI [1])
Item
Endoscopy
integer
C0014245 (UMLS CUI [1])
Endoscopy
Code List
Endoscopy
CL Item
Done (1)
CL Item
Note done (2)
CL Item
Findings (3)
Item
Endoscopy findings
integer
C0438280 (UMLS CUI [1])
Endoscopy findings
Code List
Endoscopy findings
CL Item
Edema (1)
C0013604 (UMLS CUI-1)
CL Item
Post-nasal drip (2)
C0032781 (UMLS CUI-1)
CL Item
Irritation (3)
C0441723 (UMLS CUI-1)
CL Item
Ulceration (4)
C3887532 (UMLS CUI-1)
Item
Lund-MacKay (LM) CT scoring scale
integer
C0040405 (UMLS CUI [1,1])
C0036449 (UMLS CUI [1,2])
Lund-MacKay (LM) CT scoring scale
Code List
Lund-MacKay (LM) CT scoring scale
CL Item
Maxillary Sinus (1)
C0024957 (UMLS CUI-1)
CL Item
Frontal Sinus  (2)
C0016734 (UMLS CUI-1)
CL Item
Sphenoidal sinus  (3)
C0037885 (UMLS CUI-1)
CL Item
Ethmoidal sinus  (4)
C0015028 (UMLS CUI-1)
CL Item
osteo-meatal complex (5)
Item Group
Medication
Item
Concomitant medications
integer
C2347852 (UMLS CUI [1])
Concomitant medications
Code List
Concomitant medications
CL Item
Drug, please put generic name (1)
C0592502 (UMLS CUI-1)
CL Item
Dosage (2)
C0178602 (UMLS CUI-1)
CL Item
Start of medication (3)
C0451613 (UMLS CUI-1)
CL Item
End of medication (4)
C2826744 (UMLS CUI-1)
CL Item
Indication (5)
C3146298 (UMLS CUI-1)
Item
PRN Medicines
integer
C3176065 (UMLS CUI [1])
PRN Medicines
Code List
PRN Medicines
CL Item
Drug (1)
C0013227 (UMLS CUI-1)
CL Item
Dosage (2)
C0178602 (UMLS CUI-1)
CL Item
Date (3)
C0011008 (UMLS CUI-1)
CL Item
Indication (4)
C3146298 (UMLS CUI-1)
Item
Non-drug therapy
integer
C0677097 (UMLS CUI [1])
Non-drug therapy
Code List
Non-drug therapy
CL Item
Typ of treatment (1)
CL Item
Start (2)
C0808070 (UMLS CUI-1)
CL Item
End (3)
C0806020 (UMLS CUI-1)
CL Item
Indication (4)
C3146298 (UMLS CUI-1)
Signature
Item
Signature
integer
C1519316 (UMLS CUI [1])
Item Group
Laboratory
Item
Blood test
integer
C0018941 (UMLS CUI [1])
Blood test
Code List
Blood test
CL Item
Sodium (1)
C0337443 (UMLS CUI-1)
CL Item
Potassium (2)
C0202194 (UMLS CUI-1)
CL Item
Glucose  (3)
C0202042 (UMLS CUI-1)
CL Item
Alanine transaminase (4)
C1557189 (UMLS CUI-1)
CL Item
Aspartate transaminase  (5)
C0004002 (UMLS CUI-1)
CL Item
Bilirubin (6)
C1278039 (UMLS CUI-1)
CL Item
Creatinine (7)
C0201976 (UMLS CUI-1)
CL Item
Phosphate (HPO42−) (8)
C0523826 (UMLS CUI-1)
CL Item
CRP (9)
C0201657 (UMLS CUI-1)
CL Item
Chorionic Gonadotropin (bHCG) (10)
C0106132 (UMLS CUI-1)
CL Item
Erythrocyte sedimentation rate (11)
C0492504 (UMLS CUI-1)
CL Item
Urea (12)
C0041942 (UMLS CUI-1)
Item Group
Rhinosinusitis Disability Index (RSBI)
Item
Rhinosinusitis Disability Index (RSBI)
integer
C0948780 (UMLS CUI [1,1])
C3826998 (UMLS CUI [1,2])
Rhinosinusitis Disability Index (RSBI)
Code List
Rhinosinusitis Disability Index (RSBI)
CL Item
Physical (11 items) (1)
CL Item
1. The pain or pressure in my face makes it difficult for me to concentrate (2)
CL Item
2. The pain in my eyes makes it difficult for me to read (3)
CL Item
3. I have difficulty stooping over to lift objects because of face pressure (4)
CL Item
4. Because of my problem I have difficulty with strenuous yard work and housework (5)
CL Item
5. Straining increases or worsens my problem (6)
CL Item
6. I am inconvenienced by my chronic runny nose (7)
CL Item
7. Food does not taste good because of my change in smell (8)
CL Item
8. My frequent sniffing is irritating to my friends and family (9)
CL Item
9. Because of my problem I don’t sleep well (10)
CL Item
10. I have difficulty with exertion due to my nasal obstruction (11)
CL Item
11. My sexual activity is affected by my problem (12)
CL Item
Functional (9 items) (13)
CL Item
1. Because of my problem I feel handicapped (14)
CL Item
2. Because of my problem I feel restricted in performance of my routine daily activities (15)
CL Item
3. Because of my problem I restrict my recreational activities (16)
CL Item
4. Because of my problem I feel frustrated (17)
CL Item
5. Because of my problem I feel fatigued (18)
CL Item
6. Because of my problem I avoid traveling (19)
CL Item
7. Because of my problem I miss work or social activities (20)
CL Item
8. My outlook on the world is affected by my problem (21)
CL Item
9. Because of my problem I find it difficult to focus my attention away from my problem and on other things (22)
CL Item
Emotional (10 items) (23)
CL Item
1. Because of my problem I feel stressed in relationships with friends and family (24)
CL Item
2. Because of my problem I feel confused (25)
CL Item
3. Because of my problem I have difficulty paying attention (26)
CL Item
4. Because of my problem I avoid being around people (27)
CL Item
5. Because of my problem I am frequently angry (28)
CL Item
6. Because of my problem I do not like to socialize (29)
CL Item
7. Because of my problem I frequently feel tense (30)
CL Item
8. Because of my problem I frequently feel irritable (31)
CL Item
9. Because of my problem I am depressed (32)
CL Item
10. My problem places stress on my relationships with members of my family or friends (33)
Impairment due to chronic sinusitis
Item
Impairment due to chronic sinusitis
integer
C0681116 (UMLS CUI [1])
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