Management of Hypothyroidism in Internal Medicine: Patient Profile and Effects of an Educational Programme in the Cluster-Randomized FADOI TIAMO Study

Abstract

Background and aims: There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).

Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization. Four EBGs and 39 CPRs provided the basis on which 22 treatment management indicators were identified (7 referring to the time of hospital admission, 15 to post-admission).

Results: The 21 participating centres recruited 587 hospitalized patients with hypothyroidism, 421 of which were females (71.7%, mean age 74.1 + 14.4 yrs): 318 in phase 1 and 269 in phase 3. The cause of hypothyroidism was unknown in 282 patients (48%). Evaluation at the time of admission identified satisfactory adherence to CPRs (>50%) for 63.6% of the indicators. In the phase 3, TG centres showed significant improvement vs CG in 4 of the 15 post-admission indicators, while 1 out of 15 was significantly worse.

Conclusions: The EP based on outreach visits significantly improved some indicators in the management of patients with hypothyroidism, with specific reference to appropriateness of TSH dosage and levothyroxine (LT4) treatment modality.

Clinical trial registration: ClinicalTrials.gov, identifier NCT05314790.

Keywords: educational program; guidelines; hypothyroidism; internal medicine; levo-thyroxine therapy.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Brancato, Biondi, Attardo, Fierro, Nizzoli, Vettor, Monaco, Romano, Ariete, Usai, Zagarrì and Campanini.

Figures

Figure 1

(A) TSH values (within and outside ATA target range) in relation to age, in subjects treated with L-T4 during the phase 1. The green rectangle shows the ATA TSH target range (17), respectively for non-elderly (to the left of the yellow vertical line) and elderly subjects (to the right of the yellow vertical line). Each blue dot represents the TSH value of a single subject treated with L-T4. Overall, 23.8% subjects where within ATA TSH target range; only few elderly subjects were within the target. (B) TSH values (within and outside ATA target range) in relation to age, in subjects treated with L-T4 during the phase 3. The green rectangle shows the ATA TSH target range (17), respectively for non-elderly (to the left of the yellow vertical line) and elderly subjects (to the right of the yellow vertical line). Each blue dot represents the TSH value of a single subject treated with L-T4. Overall, 26.0% subjects where within ATA TSH target range; only few elderly subjects were within the target. (C) TSH values (within and outside AME target range) in relation to age, in subjects treated with L-T4 during the phase 1. The green rectangle shows the AME TSH target range (23), respectively for non-elderly (to the left of the yellow vertical line) and elderly subjects (to the right of the yellow vertical line). Each blue dot represents the TSH value of a single subject treated with L-T4. Overall, 18.2% subjects where within AME TSH target range; only few elderly subjects were within the target. (D) TSH values (within and outside AME target range) in relation to age, in subjects treated with L-T4 during the phase 3. The green rectangle shows the AME TSH target range (23), respectively for non-elderly (to the left of the yellow vertical line) and elderly subjects (to the right of the yellow vertical line). Each blue dot represents the TSH value of a single subject treated with L-T4. Overall, 14.7% subjects where within AME TSH target range; only few elderly subjects were within the target.

Figure 2

(A) Patients under and overtreated in relation to the ATA TSH target, in phase 1 and 3 of the study: elderly and non-elderly. The yellow columns and the red columns represent, respectively, the % of overtreated and undertreated subjects. Both in the phase 1 and phase 3 of the study elderly subjects were mostly overtreated, while non-elderly subjects were mostly undertreated. (B) Patients under and overtreated in relation to the AME TSH target, in phase 1 and 3 of the study: elderly and non-elderly. The yellow columns and the red columns represent, respectively, the % of overtreated and undertreated subjects. Both in the phase 1 and phase 3 of the study elderly subjects were mostly overtreated, while non-elderly subjects were mostly undertreated.