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. 2019 Oct 30;322(20):1977–1986. doi: 10.1001/jama.2019.17274

Table 1. Baseline Characteristics of Participants in a Study of the Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.

Characteristic No. (%)
Levothyroxine (n = 112) Placebo (n = 139)
Age, mean (SD) [range], y 84.0 (3.3) [80.0-97.1] 85.0 (3.7) [80.1-96.7]
Sex
Men 60 (53.6) 73 (52.5)
Women 52 (46.4) 66 (47.5)
Self-identified racea
White 112 (100.0) 137 (98.6)
Asian 0 1 (0.7)
Black 0 0
Other 0 1 (0.7)
Living independently 106 (94.6) 129 (92.8)
Previous medical conditions or clinical descriptors
Hypertension 60 (53.6) 63 (45.7)
Ischemic heart disease 23 (20.5) 38 (27.3)
Atrial fibrillation 24 (21.6) 24 (17.3)
Osteoporosis 16 (14.5) 23 (16.5)
Diabetes mellitus 14 (12.5) 17 (12.3)
Current smoker 6 (5.4) 6 (4.3)
Concomitant medicines 106 (94.6) 134 (96.4)
No. of concomitant medications, median (IQR)b 5.0 (3.0-7.0) 4.0 (2.5-7.0)
Mini-Mental State Examination score, median (IQR)c 28.0 (27.0-29.5) 28.0 (27.0-29.0)
Weight <50 kg 1 (0.9) 1 (0.7)
Laboratory results
Thyrotropin level, mIU/Ld
Mean (SD) 6.4 (1.8) 6.3 (1.9)
Median (IQR) [range] 5.8 (5.1-7.2) [4.6-12.5] 5.7 (5.2-6.6) [4.6-17.6]
Free thyroxine, pmol/Le 13.8 (2.1) 13.8 (2.2)
Outcome measures
ThyPRO hypothyroid symptoms scoref
Mean (SD) 20.8 (19.1) 19.7 (19.3)
Median (IQR) 18.8 (6.2, 31.2) 12.5 (6.2, 31.2)
ThyPRO tiredness scoref
Mean (SD) 25.3 (21.0) 25.7 (19.6)
Median (IQR) 21.4 (9.8-35.7) 18.8 (10.7-35.7)
EuroQol-5D scoreg 0.774 (0.222) 0.808 (0.215)
EuroQol VAS scoreh 74.8 (14.8) 73.9 (14.4)
Handgrip strength, kgi 24.8 (9.0) 24.3 (9.9)
Letter-digit coding testj 21.6 (7.1) 21.3 (7.9)
Blood pressure, mean (SD), mm Hg
Systolic 144.2 (20.4) 145.4 (20.7)
Diastolic 70.8 (11.8) 72.0 (11.9)
Body mass index 27.8 (4.5) 27.4 (3.9)
Waist circumference, cm 99.2 (12.1) 98.0 (11.0)
Barthel index, median (IQR)k 20.0 (19.0-20.0) 20.0 (19.0-20.0)
Instrumental activities of daily living score, median (IQR)l 14.0 (13.0-14.0) 14.0 (13.0-14.0)

Abbreviations: IQR, interquartile range; ThyPRO, Thyroid-Related Quality of Life Patient-Reported Outcome; VAS, visual analog scale.

a

Participants selected their race from prespecified options reflecting the most common race groups in the study site countries.

b

The number of distinct ATC codes, excluding emollients and protectives, antiseptics and disinfectants, topical products for joint and muscular pain, nasal preparations, and local eye and ear medications.

c

Range, 0-30; 29-30 indicates no cognitive impairment; 25-28, mild cognitive impairment; 19-24, moderate cognitive impairment; less than 19, cognitive impairment.

d

Inclusion criteria range, 4.6-19.99 mIU/L.

e

Inclusion criteria ranges were laboratory and method specific (9-26 pmol/L); however, repeated within-participant measurements were solely performed using the same method for that individual to exclude any bias due to different assays.

f

Range 0-100; higher scores indicate more symptoms. The mean scores in the general population are 14 for hypothyroid symptoms and 35 for tiredness.

g

Range 0.50-1.00; higher scores indicate a better quality of life.

h

Range 0-100; higher scores indicate better health.

i

Higher scores indicate better muscle strength; median for women aged at least 80 years, 15.4 kg; median for men older than 80 years, 24.5 kg.

j

The number of digits coded within 90 seconds; higher scores indicate better executive cognitive function.

k

Range 0-20; 20 indicates fully independent in activities of daily living and mobility; 15-19, moderately to fully independent; 10-14, needing help but capable of own activities; 5-9, severely dependent; 0-4, totally dependent.

l

Range 0-14, higher scores indicate better performance in instrumental activities of daily living.