EUGOGO INITIAL ASSESSMENT
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1 EUGOGO INITIAL ASSESSMENT Please complete non-italicised boxes except where indicated, plus relevant italicised ones. 1. Date of inclusion Year of birth Sex male female dd mm yyyy Race Caucasian Black Asian Randomization code Other (specify) Local Hospital number 2. Thyroid history Graves hyperthyroidism Primary hypothyroidism Hashitoxicosis thyroid disease (Ophthalmic Graves'): if you have ticked this box go straight to section 3 Onset of thyroid symptoms (dd mm ( or season) /yyyy) Time since diagnosis, (months) Has your patient relapsed after treatment? After a course of anti-thyroid drugs After radioiodine After partial thyroidectomy 2.1 Previous thyroid treatments a) Anti-thyroid drugs Number of courses b) Radio-iodine Total dose given (MBq) (MBq=37xmCi) Date of last treatment (dd mm yyyy) c) Thyroidectomy Operation date (dd mm yyyy) CRF-INITIAL-GJK 1
2 3. Patient co-morbidity (non ocular) Disease Date of Diagnosis Surgical treatment (Y/N) Ongoing? (Y/N) Menopause If no: a. Date of last menses dd mm yyyy b. Pregnancy test Positive Negative 4. Current thyroid status 4.1 Visible goitre 4.2 Thyroid dermopathy 4.3 Current thyroid medication Time since starting (months) carbimazole mg /day methimazole mg/day PTU mg/day T4 T3 medication µg/day µg/day CRF-INITIAL-GJK 2
3 4.4 Thyroid tests Please send all reference ranges to co-ordinator prior to each study ft4, pmol/l /, ng/dl ft3, pmol/l /, pg/ml / OR T3, nmol/l TSH, mu/l TSH-R-ab, specify units and assay 5. Laboratory tests Total white blood cell count (cells/nl) Neutrophils % Lymphocytes % Monocytes % Eosinophils % Basophils % AST ALT γgt ALP 6. Concurrent medications (please list all medications) Drug Dose Times per day Smoking history Never smoked if you have ticked this box go straight to section 6 Ex-smoker Current smoker total consumption packyears (years x packs per day) If ex-smoker, when stopped total consumption packyears (years x packs per day) current daily intake (dd mm yyyy) Passive smoker CRF-INITIAL-GJK 3
4 8. GO history Date of eye symptom onset (dd mm yyyy) 9. Graves orbitopathy: current status SYMPTOMS - during last four weeks 9.1. Painful oppressive feeling in or behind globe 9.2. Gaze evoked pain 9.3. Excessive watering 9.4. Photophobia 9.5. Grittiness 9.6. Double vision 9.7. Gorman score (NB: if wearing prism daily then score as constant ): no diplopia intermittent inconstant (gaze evoked) constant in 1º or reading 9.8. Blurred vision 10. Physical examination Height (m), Body Weight (kg), Pulse rate (/min) Blood pressure (mmhg) CRF-INITIAL-GJK 4
5 11. Ophthalmic examination Right / OD Best visual acuity (decimalised),, Left / OS RAPD Colour vision / / rmal / Abnormal / not tested rmal / Abnormal / not tested SOFT TISSUE SIGNS (all according to atlas) Eyelid swelling (equivocal= no ) / Mild / Moderate / Severe / Mild / Moderate / Severe Eyelid erythema / / Conjunctival redness / Mild / / Mild / Chemosis (mild= no ) / / Caruncle OR plical swelling SHORT CAS OD/OS / / / 7 / 7 EYELID POSITIONS (examine with distance fixation) Palpebral aperture* mm mm ( *insert asterisk after measurement if it is not possible to measure PA in primary fixation) (+ / - ) (+ / - ) Upper lid retraction mm mm (relative to limbus) Lower lid retraction mm mm (relative to limbus) Lagophthalmos / / PROPTOSIS (mm) Intercanthal distance Exophthalmometer CORNEA no / keratopathy / ulcer no / keratopathy / ulcer Clear/cataract LENS OPTIC NEUROPATHY ASSESSMENT (in addition to VA, colour + pupil assessments) Clear/cataract Disc normal / atrophic / swollen normal / atrophic / swollen Choroidal folds / / Is there evidence of optic neuropathy? / / Equivocal / / Equivocal please specify any addition evidence for this e.g. visual fields, VEP, contrast sensitivity CRF-INITIAL-GJK 5
6 INTRAOCULAR PRESSURE In primary gaze. mm Hg. mm Hg In upgaze MOTILITY a) Abnormal head posture present b) Orthotropic. mm Hg. mm Hg / / If no" what is manifest deviation with preferred distance fixation and without head posture exotropia esotropia hypotropia hypertropia c) Binocular single vision possible without prism / d) Monocular ductions ( ) Right / OD Left / OS adduction abduction elevation depression 12. CONCLUSION NOSPECS OD OS Please complete all numbered boxes with 0,a,b or c (0 = absent, a = minor, b = moderate, c = severe) For class 3 (proptosis): 0 = < 20, a = 20-22, b = 23-25, c = > or = 26 (in mm) For class 4 (diplopia): 0 = absent, a = intermittent, ab = inconstant, b = constant, c = fixed eyes TOTAL EYE SCORE The total Eye Score is calculated as the sum of each NOSPECS class present times the grade in that class (for that purpose 1, 2 and 3, respectively, are substituted for grades a,b and c) OD/OS CRF-INITIAL-GJK 6
7 13. GO QUALITY OF LIFE questionnaire To be filled at 0, 12 and 24 weeks, seriously limited, a little limited, not limited at all 1) Bicycling (never learned to ride a bike ) 2) Driving (no driver s licence ) 3) Moving around the house 4) Walking outdoors 5) Reading 6) Watching TV 7) Hobby or pastime, i.e. 8) During the past, week, did you feel hindered from something that you wanted to do because fo your thyroid eye disease? 9) Do you feel that your appearance has changed because of you thyroid eye disease?, very much so, a little, not at all 10) Do you feel that you are stared at in the streets because of your thyroid eye disease? 11) Do you feel that people react unpleasantly because of your thyroid eye disease? 12) Do you feel that your thyroid eye disease has an influence on your self-confidence? 13) Do you feel socially isolated because of your thyroid eye disease? 14) Do you feel that your thyroid eye disease has an influence on making friends? 15) Do you feel that you appear less often on photos than before you had thyroid eye disease? 16) Do you try to mask changes in appearance caused by your thyroid eye disease? I have reviewed and found all data pertaining to this subject to be complete and accurate: Date and Investigator s signature CRF-INITIAL-GJK 7
EUGOGO FOLLOW-UP assessment
EUGOGO FOLLOW-UP assessment Please complete non-italicized boxes except where indicated, plus relevant italicized ones. F1. Date follow-up (dd mm yyyy) Visit # Year of birth ( yyyy ) Randomization code
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