Patient-Reported Satisfaction with Thyroid Hormone Replacement Therapy for Subclinical Hypothyroidism in Older Adults: A Pooled Analysis of Individual Participant Data from Two Randomized Controlled Trials.

Levothyroxine and placebo groups did not differ significantly in global treatment satisfaction among older adults with subclinical hypothyroidism.

• Mean difference in global satisfaction score was -1.1 (CI: -4.5 to 2.1), p = 0.48
• No significant differences were found in any other domain of treatment satisfaction (perceived effectiveness, side effects, convenience)
• 536 participants were included in the pooled analysis
• Results were assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) at the final study visit

The study population consisted of community-dwelling older adults with persistent subclinical hypothyroidism.

• Participants were aged ≥65 years with median (IQR) age of 74.9 (69.7–81.4) years
• 292 (55%) were women
• SCH was defined as persistent thyrotropin levels 4.60–19.99 mIU/L for >3 months with normal free T4
• Median (IQR) TSH at baseline was 5.80 (5.10–7.00) mIU/L in both groups

Levothyroxine treatment successfully normalized TSH levels compared to placebo by the final visit.

• At final visit, median (IQR) TSH was 4.97 (3.90–6.35) mIU/L in the placebo group
• At final visit, median (IQR) TSH was 3.24 (2.49–4.41) mIU/L in the levothyroxine group
• Intervention dose was titrated until TSH levels normalized, with mock dose adjustment for placebo

There was no significant difference between groups in participants' desire to continue study medication after the trial.

• 35% of levothyroxine participants vs. 27% of placebo participants wished to continue medication (p = 0.14)
• 27% of levothyroxine participants vs. 30% of placebo participants did not wish to continue
• 37% of levothyroxine participants vs. 42% of placebo participants did not know whether they wished to continue

In a subpopulation with high hypothyroid symptom burden at baseline, levothyroxine-treated participants more often desired to continue medication after the trial than placebo-treated participants.

• Mean difference in desire to continue was -21.1% (CI: -35.6% to -6.5%) favoring levothyroxine
• This was identified as a subgroup analysis in participants with high symptom burden from hypothyroid symptoms at baseline
• This finding was an exception to the otherwise null results across the full study population

The absence of treatment satisfaction differences held true regardless of baseline TSH levels or symptom burden in the overall sample.

• Sensitivity analyses were conducted stratifying by baseline thyrotropin levels
• Analyses were also stratified by baseline symptom burden
• No significant differences in treatment satisfaction were found in any subgroup except those with high hypothyroid symptom burden for the desire-to-continue outcome

The study design was a pooled individual participant data analysis from two randomized, double-blind, placebo-controlled trials.

• Both trials investigated effects of levothyroxine treatment in older adults with SCH
• Participants were community-dwelling and aged ≥65 years
• Total pooled sample size was 536 participants
• Treatment satisfaction was assessed using the TSQM, which encompasses perceived effectiveness, side effects, convenience, and global satisfaction