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Background and Purpose: Patient-reported outcomes have become important endpoints in comparative effectiveness research and in patient-centered health care. Valid patient-reported outcome measures detect and respond to clinically relevant changes. The purpose of this study was to evaluate responsiveness of the thyroid-related quality of life (QoL) instrument ThyPRO in patients undergoing relevant clinical treatments for benign thyroid diseases and to compare it with responsiveness of the generic SF-36 Health Survey., Methods: A sample of 435 patients undergoing treatment completed the ThyPRO and SF-36 Health Survey (Version 2) at baseline and 6 months after treatment initiation. Responsiveness was evaluated in three thyroid patient groups: patients with hyperthyroidism (n = 66) and hypothyroidism (n = 84) rendered euthyroid after medical therapy, and patients with a clinically detectable nontoxic goiter treated with surgery or radioactive iodine and remaining euthyroid (n = 62). Changes in QoL were evaluated in terms of effect size and compared to the changes predicted by clinical experts. The responsiveness of equivalent scales from ThyPRO and SF-36 Health Survey were compared with the relative validity index., Results: The ThyPRO demonstrated good responsiveness across the whole range of QoL aspects in patients with hyper- and hypothyroidism. Responsiveness to treatment of nontoxic goiter was also demonstrated for physical and mental symptoms and overall QoL, but not for impact on social life or cosmetic complaints, in contrast to clinicians' predictions. For all comparable scales except one, the ThyPRO was more responsive to treatment than the SF-36 Health Survey., Conclusions: The ThyPRO was responsive to treatment across the range of benign thyroid diseases. We suggest implementing this measurement instrument as a patient-reported outcome in clinical studies and in clinical management.

Introduction: The effect of (131)I therapy amplification by recombinant human (rh) TSH prestimulation in very large goiters has not been evaluated in a double-blinded, placebo-controlled study., Methods: Twenty-nine patients (22 females; age range 37-87 yr) with a large multinodular goiter (median 160 ml, range 99-440 ml) were randomized to receive placebo (n = 15) or 0.3 mg rhTSH (n = 14) 24 h before (131)I administration. Goiter volume was monitored by magnetic resonance imaging., Results: On average, the goiter volume was unchanged 1 wk after therapy in both groups, but the largest deviations from baseline were observed in the rhTSH group. After 12 months the median goiter volume was reduced from 170 to 121 ml in the placebo group and from 151 to 72 ml in the rhTSH group, respectively (within group: P = 0.001; between group: P = 0.019). This corresponds to reductions of 34.1 +/- 3.2 and 53.3 +/- 3.3%, respectively (between group: P < 0.001). In the placebo group, the goiter reduction correlated positively with the retained thyroid (131)I dose, whereas such a relationship was absent in the rhTSH group. Adverse effects, mainly related to thyroid pain and cervical compression, were more frequent in the rhTSH group. At 12 months, goiter-related complaints were significantly reduced in both groups without any between-group difference. One and three patients in the placebo and the rhTSH group, respectively, developed hypothyroidism., Conclusion: rhTSH-stimulated (131)I therapy improves the reduction of very large goiters by more than 50%, compared with (131)I therapy alone, but at the expense of more adverse effects after therapy. Our data suggest that rhTSH stimulation may work through mechanisms that go beyond the increase in thyroid (131)I uptake.

Context: Hashimoto's thyroiditis is an autoimmune disease that can produce marked clinical symptoms when patients have large diffuse goiters., Design: This retrospective cohort study was designed to evaluate whether radioactive iodine (RAI) is effective for Hashimoto's thyroiditis with a large goiter. Starting in November 1999, 13 Hashimoto's patients with large goiters, whose thyroiditis was refractory to TSH suppression therapy with thyroid hormone administration [two men and 11 women with a mean age of 61.2 +/- 8.9 yr (50-79 yr)], were recruited for the present study. The duration of symptomatic goiter before undergoing RAI was 12.0 +/- 7.9 yr (4-33 yr). Thirteen millicuries of 131I was administered two to six times, at an interval of 1-6 months on an outpatient basis. Thyroid weight was measured ultrasonographically, or by computed tomography if ultrasound was not possible due to the large size of the goiter., Results: RAI was administered an average of 4.7 +/- 1.4 times (two to six times), with a total dose of 59.8 +/- 17.3 mCi (25.0-78.0 mCi). The observation period was 47.9 +/- 13.4 months (26-66 months) after the first RAI. The average weight of the thyroid gland was 125.3 +/- 57.7 g (42.9-269.4 g) before the first RAI, decreasing significantly to 49.7 +/- 25.8 g (18.3-93.3 g) after the last RAI (P < 0.001, paired Student's t test). The percent reduction from baseline was 58.7 +/- 14.2% (35.7-84.0%). None of the patients showed an increase in goiter size or complained of a pressure sensation after any of the RAI treatments., Conclusion: RAI is effective in Hashimoto's thyroiditis with a large goiter.

Some patients with very large goiters (>150 mL) are not candidates for surgery. We evaluated the feasibility of high dose 131I in such patients. Twenty-three patients (2 men and 21 women; median age, 67 yr; range, 42-86 yr) with very large goiter (8 toxic) were treated with calculated high dose 131I [median, 2281 megabecquerels (61.6 mCi); range, 988-4620 megabecquerels (26.7-124.9 mCi)]. During the 12-month observation period, goiter reduction and tracheal anatomy were monitored by magnetic resonance imaging, and the respiratory capacity was monitored by pulmonary function tests. Five patients (22%) developed hypothyroidism. Thyroid volumes were at baseline, after 1 week, and after 1 yr [mean +/- SEM, 311 +/- 28, 314 +/- 26 (P = NS), and 215 +/- 26 (P < 0.01) mL]. The relative changes 1 week after therapy ranged from -14.1% to 15.3%. After 1 yr the mean size was reduced by 33.9% (range, 13.5-61.4%). Only the initial goiter size showed a significant negative correlation to the percent reduction. The smallest cross-sectional area of the trachea decreased 9.2% within 1 week after treatment, but eventually emerged with a 17.9% larger area [mean +/- SEM, 84.3 +/- 4.8, 75.5 +/- 5.1 (P < 0.01), and 98.2 +/- 6.0 (P < 0.01) mm2]. The inspiratory parameter, FIF50%, improved after an initial insignificant decline [baseline therapy, after 1 week, after 3 months, and after 1 yr (mean +/- SEM), 2.37 +/- 0.24, 2.20 +/- 0.21 (P = NS), 2.51 +/- 0.23 (P = NS), and 2.76 +/- 0.25 (P = 0.01) L/s]. FIF50% correlated significantly with the smallest cross-sectional tracheal area (baseline, 1 week, and 1 yr: r = 0.74; P < 0.001, r = 0.63; P < 0.005, and r = 0.46; P < 0.05). Changes in tracheal anatomy did not correlate with changes in either lung dynamics or goiter size. In conclusion, very large goiters can be reduced by a third, on the average, with high dose 131I therapy without any initial clinically significant tracheal compression. Tracheal cross-sectional area as well as pulmonary inspiratory capacity improve. No serious adverse effects are seen.

Effectiveness of radioiodine for Graves' hyperthyroidism depends also on its intrathyroidal persistence. The latter is enhanced by lithium by blocking iodine release from the thyroid. One hundred ten patients with Graves' hyperthyroidism were randomly assigned to treatment with radioiodine or radioiodine plus lithium, stratified according to goiter size (< or =40 or >40 mL) and evaluated for changes in thyroid function and goiter size, at monthly intervals, for 12 months. Cure of hyperthyroidism occurred in 33 of 46 patients (72%) treated with radioiodine and in 45 of 54 patients (83%) treated with radioiodine plus lithium. The probability of curing hyperthyroidism was higher and its control prompter (P = 0.02) in the radioiodine-plus-lithium group. Patients with < or =40-mL goiters had similar persistence of hyperthyroidism (13%), but lithium-treated patients had hyperthyroidism controlled earlier (P = 0.04). Among patients with >40-mL goiters, hyperthyroidism was cured in 6 of 15 patients (40%) treated with radioiodine alone and in 12 of 16 patients (75%) treated with radioiodine plus lithium (P = 0.07), and cure occurred earlier in the latter (P = 0.05). Goiters shrank in both groups (P < 0.0001), more effectively and promptly (P < 0.0005) in the radioiodine-plus-lithium group. Serum free T4 and T3 levels increased shortly after therapy only in the radioiodine group (P < 0.01). Lithium carbonate enhances the effectiveness of radioiodine therapy, in terms of prompter control of hyperthyroidism, in patients with small or large goiters. In the latter group, lithium also increases the rate of permanent control of hyperthyroidism.

The use of 131I treatment in patients with benign nontoxic goiter is increasing, and the described side-effects are few. In this paper we describe appearance of TSH receptor antibodies (TRAb) and concomitant development of hyperthyroidism as a side-effect of 131I treatment in patients with nontoxic goiter. In this retrospective study, 191 consecutive patients with 131I-treated nontoxic goiter are described. Nine patients (5%) developed hyperthyroidism 3 months after 131I treatment, and 5 patients (3%) developed radiation thyroiditis within the first month. Frozen sera were analyzed for thyroid peroxidase antibodies (anti-TPO) in 130 patients before 131I treatment. In 21% of these, serum levels of anti-TPO were over 200 U/mL. The complication frequency of Graves'-like hyperthyroidism and hypothyroidism was 51% in patients with elevated anti-TPO (n = 27) and 15% in patients with normal serum anti-TPO levels (P < 0.00005). TRAb, anti-TPO, and thyroglobulin were followed in patients developing hyperthyroidism or radiation thyroiditis and in 10 control patients remaining euthyroid. At the time of 131I treatment, all patients had serum TRAb values within the normal range. Three months after administration of 131I, the patients developing hyperthyroidism had a transient extensive rise in serum TRAb and anti-TPO levels parallel to a rise in the serum free T4 index. In patients developing radiation thyroiditis, serum TRAb values were normal. In control patients, serum TRAb and anti-TPO values were both within the normal range throughout the observation period. In conclusion, hyperthyroidism can be triggered by 131I in patients with nontoxic goiter, not only related to radiation thyroiditis but also as a Graves'-like hyperthyroidism induced by TRAb. Elevated anti-TPO pretreatment is a marker of an increased risk of side-effects to 131I treatment in nontoxic goiter.