Quality of life and decision regret in patients with late-hypothyroidism after radioiodine treatment for Graves' disease.

OBJECTIVE: Patients with Graves' disease often engage in shared decision-making to select an individualised treatment regimen from multiple options. Radioactive iodine (RAI) is one of the treatment choices for their condition, aims to improve quality of life and well-being. Likewise, dissatisfaction with treatment outcomes can result in decision regret. We employed validated questionnaires to assess the prospective quality of life, decision regret and relative factors involved in decision-making of patients with late hypothyroidism after RAI therapy. METHODS: A questionnaire survey was conducted among patients in hypothyroidism status for more than 1 year after RAI therapy. Disease-specific and generic QoL were assessed using the short form of thyroid-related patient-reported outcome (ThyPRO-39) questionnaire. Patient satisfaction regarding their decision to undergo RAI was assessed using the Decision Regret Scale (DRS) and patients were asked about the importance of relative factors in decision-making. RESULTS: Of 254 patients who responded to the survey, the mean age of patients was 45.3 years (range: 18-78 years) and the median time from RAI therapy to survey was 4 years (range: 1-30 years). Patients' median and mean DRS score were 34.4 and 38.8 (range: 0-100), respectively. A total of 100 (39.4%) patients express absent-to-mild regret (score: 0-25), 154 (60.6%) patients express moderate-to-severe regret (score: >25). The mean score of the absent-to-mild regret group were significantly higher than those of the moderate-to-severe regret group on most ThyPRO-39 scales. A statistically significant positive correlation was observed between DRS score and most ThyPRO-39 scale score. There was a significant positive association between higher DRS score and longer time intervals after RAI treatment, a brief duration of hyperthyroidism, and the significance of long-time outpatient follow-up. More decision regret was negatively associated Iodine-free diet, ineffectiveness of ATD, fear of surgery. CONCLUSION: Impairment of quality of life was positively correlated with decision regret in patients with late-hypothyroidism after radioiodine therapy. Patients with insufficient information support before decision-making are more likely to have higher decision regret after treatment. Our findings suggest that health providers should fully communicate with patients and provide information support in multiple dimensions during the shared-decision-making process.

The Impact of Subclinical Hypothyroidism on the Quality of Life During Pregnancy: Mapping 5-Level Version of EQ-5D and ThyPRO-39.

OBJECTIVES: To describe how subclinical hypothyroidism (SubHypo) influences the quality of life (QoL) during pregnancy. METHODS: In primary data collection (NCT04167423), thyroid stimulating hormone (TSH), free thyroxine (FT4), thyroid peroxidase antibodies, generic quality of life (QoL; 5-level version of EQ-5D [EQ-5D-5L]), and disease-specific QoL (ThyPRO-39) were measured among pregnant women. SubHypo during each trimester was defined according to the 2014 European Thyroid Association guidelines (TSH > 2.5, 3.0, and 3.5 IU/L, respectively; with normal FT4). Path analysis described relationships and tested mediation. Linear ordinary least squares, beta, tobit, and two-part regressions were used to map ThyPRO-39 and EQ-5D-5L. Alternative SubHypo definition was tested in sensitivity analysis. RESULTS: A total of 253 women at 14 sites (31 ± 5 years old, 15 ± 6 weeks pregnant) completed the questionnaires. Sixty-one (26%) had SubHypo and differed from 174 (74%) euthyroid women in smoking history (61% vs 41%), primiparity (62% vs 43%) and TSH level (4.1 ± 1.4 vs 1.5 ± 0.7 mIU/L, P < .001). EQ-5D-5L utility in SubHypo (0.89 ± 0.12) was lower than that in euthyroid (0.92 ± 0.11; P = .028) even after adjustment (difference -0.04, P = .033), whereas ocular (P = .001, ThyPRO-39), cognitive symptoms (P = .043), anxiety (P < .0001), and the composite score were higher. The impact of SubHypo on utility was mediated by anxiety. Results were confirmed by sensitivity analysis. Final mapping equation (ordinary least squares) includes goiter symptoms, anxiety, upset stomach, composite score (ThyPRO-39), FT4 levels, and week of pregnancy (determination coefficient 0.36). CONCLUSION: This is the first QoL mapping of SubHypo during pregnancy and the first evidence that SubHypo is associated with a negative impact on QoL. The effect is mediated by anxiety. EQ-5D-5L utilities can be generated based on ThyPRO-39 scores collected in pregnant euthyroid and patients with SubHypo.

Psychometric properties of EQ-5D-5L for use in patients with Graves' disease.

BACKGROUND: The EQ-5D-5 L is a commonly used generic measure of health. This study aimed to evaluate the psychometric properties of the EQ-5D-5 L in patients with Graves' disease (GD). METHODS: A prospective cohort of patients with GD recruited at three public hospitals in Hong Kong completed the EQ-5D-5 L and ThyPRO-39 questionnaires at baseline, 1-month, and 6-month follow-ups. Convergent validity was tested by examining the Spearman correlation between EQ-5D-5 L and ThyPRO-39 scores at baseline. 1-month test-retest reliability was assessed by Intraclass Correlation Coefficient (ICC), Gwet's Agreement Coefficient 2 (AC2), and percentage agreement. Responsiveness of EQ-5D-5 L index and EQ-VAS scores was assessed using effect size statistics (standardized effect size [SES] and standardized response mean [SRM]). RESULTS: Of 125 recruited patients, 101 (80.8%) and 100 (80.0%) patients were followed up at 1- and 6-month, respectively. For convergent validity, there was a moderate negative correlation between EQ-5D-5 L index or EQ-VAS score and ThyPRO-39 overall QoL-impact score (-0.350, -0.451), between EQ-VAS score and composite score (-0.483), and strong negative correlation between EQ-5D-5 L index score and composite score (-0.567). The Gwet's AC2 and percentage agreement were the highest in self-care (0.964 and 0.967), followed by mobility (0.952 and 0.962), usual activities (0.934 and 0.948), pain/discomfort (0.801 and 0.887), and anxiety/depression (0.788 and 0.882). The ICC for the EQ-5D-5 L index and the EQ-VAS was 0.707 and 0.700. For patients who reported having 'worsened' health at 6-month follow-up, the SES and SRM were - 0.66 and - 0.42 for EQ-5D-5 L index and - 1.15 and - 1.00 for EQ-VAS, respectively. CONCLUSIONS: The EQ-5D-5 L demonstrated convergent validity, test-retest reliability, and responsiveness to worsened health status among patients with GD.

Changes in quality of life after thyroidectomy in subjects with thyroid cancer in relation to the dose of levothyroxine.

PURPOSE: Previous studies demonstrated decreased quality of life (QoL) in differentiated thyroid cancer (DTC) survivors and suggested QoL variability related to time from thyroidectomy and levothyroxine dosage. The aims of this study were to evaluate QoL in thyroidectomized subjects in different levothyroxine states and to evaluate the association between TSH and thyroid hormones and QoL. METHODS: Prospective 5-year study enrolling 208 patients thyroidectomized for DTC, studied in one to four times according to levothyroxine dosage: withdrawal (WITHD), complete (C-SUPP) and mild TSH-suppression (M-SUPP), replacement (REPL). Each patient was allowed to participate into the study more than one time. A total of 300 evaluations were collected, consisting of detailed thyroid hormone profile and QoL assessment through the ThyPRO questionnaire. RESULTS: Comparing the four groups, significant differences were found for anxiety, impaired social and daily life and item 12 (overall impact of thyroid disease) domains (p < 0.05). Interestingly, C-SUPP subjects reported the best scores in almost all ThyPRO scales. Significant correlations were found between QoL and pituitary-thyroid axis function, as well as between QoL and gender, being females more affected. At multiple regression analyses fT3 demonstrated to be the best explanatory factor for overall impact of thyroid disease on the patient's life, followed by gender. CONCLUSIONS: TSH-suppressive doses of levothyroxine are more effective in improving QoL in DTC patients after thyroidectomy. These results confirm the urgent need of further studies aimed to define the best treatment of hypothyroidism, effective on well-being and harmless for patients.

Impact of thyroidectomy on quality of life in benign goitres: results from a prospective cohort study.

PURPOSE: Benign thyroid diseases encompass a large spectrum of conditions that are chronic and subtle in nature. A majority of patients choose non-surgical management and continue living their daily lives with subconscious impairment of optimal functioning. We studied the effect of thyroidectomy on the quality of life (QoL) in patients with benign goitres. METHODS: A prospective study was conducted on 50 patients between January 2017 and August 2018 using the ThyPRO 39 questionnaire. This is a disease-specific health-related questionnaire administered the day before surgery and 6 months following surgery. Data analysis was performed using EpiData Manager and EpiData Entry Client (v 3.1). RESULTS: The mean age of the cohort was 43.30 years ± 11.61, with a female preponderance (34:16). The most common indications for surgery were suspicion of malignancy and compressive symptoms in 34% and 30%, respectively. The most common histopathology reported was nodular/adenomatous hyperplasia (56%). Prior to surgery, the most common domains affected were emotional susceptibility and tiredness. Following surgery, a significant improvement in all domains of the ThyPRO 39 questionnaire were seen except for psychological well-being (p=0.126). In addition, the composite scores significantly improved (p<0.001). Younger age, female gender, and longer duration of goitre were the factors that significantly affected the outcomes in various domains. CONCLUSION: Patients with benign goitres have subtle impairment of QoL which showed significant improvement following thyroidectomy.

Treatment choice, satisfaction and quality of life in patients with Graves' disease.

BACKGROUND: Thyrotoxicosis, most often caused by Graves' disease (GD), when treated inadequately may result in premature mortality. There is little consensus as to which of the 3 treatment options available - antithyroid drugs (ATD), radioactive iodine (RAI) and surgery, is better. AIMS: (i) To assess factors involved in treatment choice and treatment satisfaction in patients treated for Graves' disease; (ii) To assess quality of life (QoL) following treatment of Graves' disease. METHOD: Participants were selected from a prospective study cohort assessing thyrotoxicosis incidence and severity. Of the 172 eligible patients with Graves' disease, 123 treated patients participated (64% had received ATD only, 11% RAI and 25% total thyroidectomy, the latter 2 usually after a period of ATD), along with 18 untreated patients with newly diagnosed Graves' disease (overall participation rate, 73%). Consented patients completed a questionnaire detailing factors involved in treatment choice, QoL and satisfaction with treatment. RESULTS: Participants reported that the most important factors in choosing a treatment were the following: the effects on activities of daily living, concern about use of radioiodine, possibility of depression or anxiety, and doctor's recommendations. Satisfaction levels were high across all 3 treatment types. QoL 1-year following treatment was higher than in untreated patients, and comparable with other international studies. CONCLUSIONS: Patient satisfaction with therapy and QoL does not differ by treatment type. Therefore, clinical and social factors, in combination with patient choice and resource availability, should determine which treatment modality patients with Graves' disease should receive.

Measurement properties of ThyPRO short-form (ThyPRO-39) for use in Chinese patients with benign thyroid diseases.

PURPOSE: To evaluate the validity and reliability of a newly-translated Thyroid-specific Patient-Reported Outcome short-form (ThyPRO-39) instrument for ethnic-Chinese patients suffering from benign thyroid diseases. METHODS: The translation and cross-cultural adaptation of the English ThyPRO-39 were performed using the double forward translation, reconciliation, single backward translation, and cognitive debriefing, followed by a panel review. Cross-sectional data of 308 patients with benign thyroid diseases were utilized for this psychometric evaluation of ThyPRO-39 instrument. Convergent validity between similar construct in the ThyPRO-39, SF-6D, and SF-12v2 was assessed using Spearman correlations. The internal construct validity was assessed by corrected item-total correlations. Sensitivity of the ThyPRO-39 domain scores was determined by performing known group comparisons by independent t test. The internal consistency reliability was assessed by Cronbach's alpha coefficient. RESULTS: Significant floor effects were observed in 9 out of 13 domains of the ThyPRO-39. The hypothesized correlations between similar constructs in the ThyPRO-39 and the SF-12v2 and SF-6D were generally observed, supporting convergent validity. The internal construct validity was supported in most items, except eight items in six scales. Scale score of hyperthyroid symptoms of the ThyPRO-39 was significantly higher in the group with Graves' disease or hyperthyroid disease than the group without Graves' disease nor hyperthyroid disease. Scale scores of eye symptoms and impaired daily life were significantly higher in the incidental group than the non-incidental group. For six domains (hyperthyroid symptoms, hypothyroid symptoms, eye symptoms, tiredness, depressivity, and emotional susceptibility), Cronbach's alpha did not reach the recommended standard of 0.7. CONCLUSIONS: This was the first psychometric study to translate and adapt the ThyPRO-39 instrument for non-Caucasian patients, and report its validity and reliability for use in Chinese patients with benign thyroid diseases. Given the low item-total correlations in eight items and low internal consistency reliability in respective scales of the ThyPRO-39, we suggest that the improvement of those eight items should produce a more valid and reliable ThyPRO-39 instrument.

Improved quality of life in hyperthyroidism patients after surgery.

BACKGROUND: The most common causes of hyperthyroidism are Graves disease (GD) and toxic nodular goiter (TNG). GD and TNG might influence patients' quality of life (QoL). The aim of our study was to analyze and compare the QoL of patients with GD with that of TNG patients and to evaluate the influence of surgical treatment on their QoL. MATERIALS AND METHODS: A prospective case-control study was conducted at the Center for Endocrine surgery in Belgrade, Serbia. The ThyPRO questionnaire was used in the QoL assessment of the GD and TNG patients (31 and 28, respectively) pre- and post-operatively. RESULTS: All patients were receiving antithyroid drugs, and none of the patients were overtly hyperthyroid at the time of completing the preoperative questionnaire. The QoL of the GD patients was worse than that of the TNG patients, with significant differences in eye symptoms, anxiety, and sex life domains (P < 0.001, P = 0.005, and P = 0.004, respectively), preoperatively, and in eye symptoms, anxiety, emotional susceptibility, and overall QoL (P = 0.001, P = 0.027, P = 0.005 and P = 0.013, respectively), postoperatively. The improvement in QoL in the GD patients was significant after surgical treatment in all ThyPRO domains. In the TNG patients, the improvement was significant in all but one ThyPRO domain, sex life (P = 0.066). CONCLUSIONS: The QoL of GD patients is worse than those of TNG patients. Surgery may improve QoL in patients with GD and TNG even if they have achieved satisfying thyroid status with medication treatment, preoperatively.

Quality of Life Following Robotic Transaxillary Versus Conventional Hemithyroidectomy: A Comparative Analysis.

Background: Robotic technology has proven safe and effective for thyroidectomy procedures. Few studies have addressed the quality-of-life outcomes of robotic thyroidectomy compared with conventional thyroidectomy. Materials and Methods: The database of a tertiary medical center was retrospectively reviewed for all patients with thyroid disease who had undergone robotic hemithyroidectomy in 2012-2020. All patients treated by transaxillary robotic surgery and a similar number of randomly selected patients treated by conventional cervical surgery completed a standardized self-administered thyroid disease-specific quality-of-life (QOL) questionnaire (ThyPRO). Clinical data were derived from the medical files. The results were compared using mean comparison tests and multivariate logistic regression models. Results: The cohort consisted of 131 patients: 63 after robotic thyroidectomy and 68 after conventional thyroidectomy. The mean age was 38.87 ± 14.11 and 58.85 ± 14.1 years, respectively (P < .0001). The robotic hemithyroidectomy group reported better QOL outcomes in physical and mental health parameters, including decreased anxiety, depression, lower sex life impairment, and cognitive impairment scores (P < .0001). Furthermore, after adjusting for age, gender, malignancy status, and surgical approach, we found that patients undergoing robotic hemithyroidectomy had a lower probability of experiencing depressive symptoms than the conventional hemithyroidectomy group (odds ratio = 0.31; 95% confidence interval, 0.11-0.88). Of interest, no significant difference in cosmetic outcomes was found. Conclusions: Patients who underwent robotic thyroidectomy report better postoperative QOL after surgery than patients operated by the conventional approach in terms of anxiety, depression, cognitive and sex-life scores.

Adaptation and validation of the Hungarian version of Thyroid-Related Patient-Reported Outcome-39 (ThyPro-39) questionnaire: testing factor structure, known-group validity with the comparison of quality of life in Hashimoto's thyroiditis and Graves' disease.

BACKGROUND: Living with autoimmune thyroid disease is a longstanding challenge and can seriously affect the quality of life. We aimed to adapt and validate the Hungarian version of the Thyroid-Related Patient-Reported Outcome-39 (ThyPro-39) questionnaire, test its factor structure, and compare two frequent autoimmune thyroid diseases, Hashimoto's thyroiditis, and Graves' disease. We tested the factor structure of ThyPro-39 with a series of confirmatory factor analyses (CFAs). To examine the validity of ThyPro-39 and to compare the quality of life of the two groups - Hashimoto's thyroiditis (N = 240), Graves' disease (N = 51) - CFA with covariates were used. RESULTS: Our results supported a bifactor model with psychosocial and somatic symptoms as general factors, and 12 symptom-specific factors. Based on the analysis of omega hierarchical indices ranging between 0.22 and 0.66, the specific scales also carry information besides the composite scores and should be used when a more detailed analysis is required. In the multivariate analysis, perceived stress was significantly associated with the general psychosocial factor (ß = 0.80), symptom factors (ß = 0.34), anxiety (ß = 0.43), depressivity (ß = 0.37), and emotional susceptibility (ß = 0.38) specific factors. Graves' patients reported more eye symptoms (d = 0.45) and cosmetic complaints (d = 0.40), while Hashimoto patients had more cognitive problems (d = 0.36) and more severe hypothyroid symptoms (d = 0.35). These group differences confirm the known-group validity of the questionnaire. CONCLUSIONS: The validity of the Hungarian version of ThyPRO-39 is supported. We recommend using two composite scores of psychosocial and somatic symptoms and the specific symptoms scores to measure the quality of life in clinical practice and research.

The Effect of Laser Thermal Ablation on Quality of Life: Improvements in Patients with Solid-Cystic Thyroid Nodules.

Background: Evidence of the efficacy of laser thermal ablation (LTA) in benign thyroid nodules is abundant. However, little is known about the effect on quality of life (QoL) of this treatment. Methods: Prospective cohort study investigating the effect of LTA before, three, and six months after LTA on QoL using the thyroid-specific patient-reported outcome (ThyPRO) measure. Patients receiving LTA (laser group [LG]) was compared with a well-characterized control group (CG) from the Danish civil registry. Results: The LG comprised 54 patients, with no age or sex differences compared with the CG (n = 739). Sixty-nine percent of the patients had a recurrent cystic thyroid nodule, 6% had a solid nodule, while the remaining 25% were of mixed character. The median nodule volume was 6.8 mL (interquartile range [IQR]: 4.0-11.1) before LTA, and 1.8 mL (IQR: 0.6-4.1) at 6 months post-LTA (p < 0.001), corresponding to a median reduction of 78%. All cystic fluid (median: 6 mL; IQR: 2.0-9.0) was aspirated before LTA. Median treatment time was 400 seconds (IQR: 300-600), applying a median energy of 823 J (IQR: 600-1200). At baseline and according to the ThyPRO scales, the LG differed significantly from the CG by having more goiter symptoms, hyperthyroid symptoms, tiredness, and cognitive complaints (p < 0.05 for all variables), but only the difference in the goiter symptom scale was of a clinically important magnitude. At three months, the LG experienced a large improvement in goiter symptoms (effect size [ES] = 1.05), a moderate improvement in cosmetic complaints (ES = 0.50), and a moderate improvement in the overall QoL (ES = 0.64). Only the improvements in the goiter symptom and the cosmetic complaint scales were clinically important. Six months after LTA, the anxiety scale showed further improvement of moderate size (ES = 0.52). At 6 months, the results above were maintained, and 79% of patients experienced a large and clinically important improvement in the goiter symptom scale and no clinically important differences were found between the LG and the CG. Conclusions: In this unblinded, prospective observational study, measures of disease-specific QoL were significantly improved compared with preprocedure levels, in patients with solid-cystic nodules.

Psychometric properties of the thyroid-specific quality of life questionnaire ThyPRO in Singaporean patients with Graves' disease.

BACKGROUND: Graves' disease is the most common cause of hyperthyroidism. It results in accelerated tissue metabolism with multi-organ involvement ranging from cardiovascular to neuropsychological function. This results in a negative impact on the quality of life (QOL) of the individual patient. We aim to evaluate the psychometric properties of ThyPRO, a Thyroid-related Patient Reported Outcome questionnaire, and validate its use in our multi-ethnic Asian patients with Graves' hyperthyroidism. METHODS: Forty-seven consecutive Graves' hyperthyroidism patients answered the ThyPRO questionnaire at baseline and at 4 months after treatment initiation. Data were recorded for thyroid related symptoms and signs, thyroid function tests and thyroid volume. We analyzed the internal consistency using Cronbach's alpha, construct validity by evaluating relationship between clinical variables and ThyPRO scales, ceiling and floor effects, and responsiveness of ThyPRO to treatment based on Cohen's effect size. RESULTS: Correlations between individual scale scores and free thyroxine concentrations were moderate and statistically significant: 0.21-0.64 (p <  0.05). There was high internal consistency between the items in this instrument, Cronbach's alpha > 0.7 for all scales. ThyPRO was responsive to the changes in QOL after treatment (Effect Size: 0.20-0.77) in 9 of the 14 scales including the hyperthyroid symptoms and psychosocial scales (Tiredness, Cognitive complaints, Anxiety, Emotional susceptibility, Impact on Social, Daily and Sex life). CONCLUSION: This study provides evidence that ThyPRO has satisfactory measurement properties in hyperthyroid Graves' disease patients in Singapore population with the potential to complement clinical care.

A comparative cross-sectional study on sleep quality in patients with a history of differentiated thyroid carcinoma and its correlation with quality of life.

PURPOSE: To evaluate sleep quality in differentiated thyroid carcinoma (DTC) patients and correlate sleep disturbances with quality of life (QoL). METHODS: 119 DTC patients were enrolled (DTC group). The Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI) inventories were administered. The Thyroid-specific Patient-Reported Outcome (ThyPRO) questionnaire, the Billewicz scale (BS) and an ad-hoc visual analogic scale (VAS) were used to measure QoL and subjective therapy-related complaints. The same examinations were conducted in 53 subjects (control group) who had undergone surgery for benign thyroid pathology. RESULTS: L-T4 dosages and TSH levels differed between the groups. BS and VAS scores were comparable. PSQI documented a similar percentage of poor sleepers in the DTC (74%) and control (62%) groups. ISI showed no difference in subjects without clinically significant insomnia: DTC (43%) and controls (48%). ThyPRO showed significantly worse scores in DTC than control subjects. In DTC patients, PSQI (P = 0.002) and ISI (P = 0.04) correlated significantly with age. In control subjects, TSH displayed a significant positive association with PSQI (P = 0.02) and ISI (P < 0.05). The ThyPRO general score correlated significantly with PSQI in DTC patients. In both groups, ISI correlated significantly with several ThyPRO scales and the ThyPRO general score. "Anxiety" and "emotional susceptibility" were the scales most significantly related with PSQI and ISI. CONCLUSION: In disease-free DTC patients and subjects who undergo thyroid surgery for benign pathology, abnormal sleep components and insomnia are similar. The ThyPRO questionnaire closely reflects sleep disturbances in all subjects. Recognising and treating sleep disturbances might improve QoL.

Determining minimal important change for the thyroid-related quality of life questionnaire ThyPRO.

OBJECTIVE: ThyPRO is the standard thyroid patient-reported outcome (PRO). The change in scores that patients perceive as important remains to be ascertained. The purpose of this study was to determine values for minimal important change (MIC) for ThyPRO. METHODS: A total of 435 patients treated for benign thyroid diseases completed ThyPRO at baseline and 6 weeks following treatment initiation. At 6 weeks follow-up, patients also completed Global Rating of Change items. For each 0-100 scale, two MIC values were identified: An MIC for groups, using the receiver operating characteristic (ROC) curve method and an MIC for individual patients, using the Reliable Change Index. RESULTS: ROC analyses provided group-MIC estimates of 6.3-14.3 (score range 0-100). Evaluation of area under the curve (AUC) supported the robustness for 9 of 14 scales (AUC > 0.7). Reliable Change Index estimates of individual-MIC were 8.0-21.1. For all scales but two, the individual-MIC values were larger than the group-MIC values. CONCLUSIONS: Interpretability of ThyPRO was improved by the establishment of MIC values, which was 6.3-14.3 for groups and 8.0-21.1 for individuals. Thus, estimates of which changes are clinically relevant, are now available for future studies. We recommend using MIC values found by ROC analyses to evaluate changes in groups of patients, whereas MIC values identified by a dual criterion, including the reliability of changes, should be used for individual patients, for example, to identify individual responders in clinical studies or practice.

The Influence of Prophylactic Calcium and Magnesium Supplementation on Postoperative Quality of Life and Hypocalcemia After Total Thyroidectomy: Study Protocol for a Randomized Controlled Trial.

Background: We want to investigate if a routine preoperative dietary supplementation of calcium and magnesium prior to thyroidectomy for nodular goiter and graves' disease can influence patients' outcome with regards to hypocalcemia associated symptoms and quality of life in order to reduce the risk of post-thyroidectomy hypocalcemia and to improve patient's quality of life. Methods: The study will be conducted as a two-armed randomized controlled trial including patients scheduled for total thyroidectomy. Patients assigned to the intervention group will receive calcium carbonate and magnesium oxide starting 2 weeks preoperatively. Primary outcome is the postoperative quality of life measured by the ThyPRO-39 and EQ-5D questionnaires. Secondary outcome is the assessment of postoperative biochemical (calcium and PTH levels) and clinical hypocalcemia (symptoms as reported by the patient). Discussion: A prophylactic dietary supplementation with calcium and magnesium, which could easily be implemented in the preoperative setting, could potentially help to avoid or reduce hypocalcemia-associated symptoms and improve quality of life. In the event of a positive outcome, this preoperative procedure can be an inexpensive way to prepare patients scheduled for thyroidectomy and can possibly reduce disease-specific costs by reducing the postoperative complication rate. Clinical Trial Registration: DRKS00017195 in the German clinical trials register (Deutsches Register Klinischer Studien, DRKS) on the 22.05.2019.

Validity and reliability of the German version of the shortened thyroid-specific quality of life questionnaire (ThyPRO-39de).

OBJECTIVES: Validation of a German version of the ThyPRO-39 questionnaire for quality of life (QoL) in patients with benign thyroid diseases. DESIGN: Internal consistency, retest reliability, and validity were to be assessed in a test-retest study. METHODS: The ThyPRO-39 was translated based on standard methodology. A sample of 98 patients with benign thyroid diseases was tested with the ThyPRO-39de and the generic EuroQol 5D-5L. Forty-four patients with stable symptoms after 2 weeks formed the repeated measures sample. Cronbach's alpha was calculated for the ThyPRO-39de composite score and for each disease-specific scale. Intraclass correlations between the original and the repeated measures sample were calculated for each scale as well as Pearson correlations between various ThyPRO scales and the EuroQol. T-tests were used to test for differences in the goiter and hyperthyroid symptom scales between relevant patient groups and other patients. RESULTS: Internal consistency was between satisfactory and good, except for two scales (tiredness and cosmetic complaints/appearance). The test-retest correlation was between 0.62 and 0.8 for most scales, but below 0.5 for two scales (tiredness and impaired social life). There were significant correlations between the EuroQol index score and most aspects of the ThyPRO-39de. Only the hyperthyroid symptoms scale was specific for the relevant patient group (Graves' disease). CONCLUSION: The ThyPRO-39de may be recommended for use in clinical and research settings, especially with regards to the composite score. However, the underlying thyroid disease should always be kept in mind when interpreting the test results. A larger sample would be needed to implement further improvements.

Evaluation of Quality of Life in Patients with Differentiated Thyroid Cancer by Means of the Thyroid-Specific Patient-Reported Outcome Questionnaire: A 5-Year Longitudinal Study.

BACKGROUND: Patients with malignancy suffer impairment of their quality of life (QoL). QoL has been evaluated in thyroid cancer patients. Since 2010, a new inventory, the thyroid-specific patient-reported outcome (ThyPRO) measure for benign thyroid disorders, has been available. AIM: This study evaluated QoL longitudinally in patients with a history of differentiated thyroid cancer (DTC) by means of the ThyPRO questionnaire. Methods : From 2012 to 2016, QoL was evaluated yearly in 123 adult DTC patients by means of ThyPRO. The ThyPRO questionnaire consists of 13 scales on which higher scores represent greater impact on QoL in areas affected by thyroid pathology. Disease-specific morbidity due to possible inadequate L-T4 treatment was evaluated by means of the Billewicz scale (BS). The same examinations were conducted in 192 control subjects who had undergone surgery for benign thyroid pathology. RESULTS: DTC and control subjects had similar scores on all but one scale; scores on the hyperthyroid symptoms scale were significantly higher in DTC patients than in controls. Over the 5 years, scores did not change significantly in the DTC group. Overall, QoL and BS scores showed a slight, but not significant, improvement during the study period in DTC patients. BMI impacted on several ThyPRO scales. No significant differences between genders were noted in DTC. CONCLUSIONS: The ThyPRO questionnaire indicates that illness perception is similar after thyroidectomy for malign and benign pathology. Only a marginal improvement in QoL was noted in DTC subjects over the 5-year study period. In both groups, females showed a greater perception of illness than males.

How does thyroidectomy for benign thyroid disease impact upon quality of life? A prospective study.

BACKGROUND: Choosing which patients to recommend surgery for benign thyroid conditions can be difficult due to the subjective nature of compressive thyroid and hormonal symptoms. The aim of this prospective study was to analyse changes in quality of life (QOL) following thyroid surgery using a validated disease-specific assessment tool, the thyroid-related patient-reported outcome (ThyPRO) questionnaire. METHODS: Participants undergoing elective thyroid surgery for benign conditions were recruited. Patient demographics and clinical data were collected. ThyPRO consists of 85 questions grouped into 13 physical, mental and social symptom domains. Patients completed a ThyPRO questionnaire pre-operatively and at 6 weeks and 6 months post-operatively. ThyPRO items were scored according to protocol to produce 13 subscales. Repeated measures linear models with no random effects were performed using data for each outcome. RESULTS: Results were available for a total of 72 patients. The sample was predominately female (n = 63, 88%) with average age 49.8 years. The majority of patients underwent surgery for multi-nodular goitre. At 6 weeks post-operatively, significant improvement was demonstrated in the goitre, hypothyroid, hyperthyroid and anxiety symptom domains. At 6 months post-operatively, significant improvement was demonstrated in all but four domains. No domains demonstrated significant increase in impairment post-operatively. CONCLUSION: Patients had significant improvement in nine of 13 symptom domains following surgery. Patients did not experience a negative impact on QOL following surgery. Further studies with larger patient cohorts may be able to identify potential pre-operative predictive factors for a post-operative improvement in QOL for benign thyroid disease.

Using Thypro 39 Scale For Predicting The Quality Of Life In Hypothyroid Patients At Lady Reading Hospital.

BACKGROUND: Thyroid disorders are the second most common of the endocrine diseases. With regards to Hypothyroidism, it has a slow indolent course over the years, before its diagnosis. Most of the patient, on adequate treatment with biochemical euthyroid status, have generalised symptoms that affect their quality of life. Several tools to assess quality of life in thyroid disorders have been validated and recommended for use for those patients in clinical follow ups. ThyPRO 39 is one of a recently developed thyroid-specific quality of life (QoL) questionnaires applicable to patients with benign thyroid disorders (BTD). The purpose of this study was to predict the thyroid-related quality of life (QoL) instrument ThyPRO 39 in patients with Hypothyroidism, who were rendered euthyroid with thyroid replacement therapy prior to the administration of study tool and to assess the internal reliability of this scale in our population. METHODS: A sample of 52 patients undergoing maintenance treatment for Hypothyroidism who visited the outpatient Endocrinology clinics at Lady Reading Hospital was studied. They were interviewed for their baseline demographic details and details on ThyPRO 39 questionnaire were recorded after a written informed consent. The data was entered and analysed using SPSS 25. The Internal reliability of the ThyPRO 39 scale was assessed for multi-item scales using Cronbach's alpha coefficient. RESULTS: The ThyPRO 39 scale demonstrated good response across the whole range of QoL aspects in patients with hypothyroidism. Internal reliability for ThyPRO 39 scale was satisfactory. Cronbach's Alpha in our study was 0.928, which was comparable to the results of other studies. CONCLUSIONS: We suggest implementing this measurement tool as a patient-reported outcome in clinical studies in our indigenous population and further more to utilise it as a screening tool for QoL in clinical management of Hypothyroidism in our routine medical consultations.

Ecological momentary assessments (EMAs) did not improve responsiveness of patient-reported outcomes on quality of life.

OBJECTIVES: Clinical practice guidelines recommend questionnaires with short recall. We compare responsiveness of ecological momentary assessments (EMAs) and retrospective assessments of thyroid-related quality of life. STUDY DESIGN AND SETTING: Patients with newly diagnosed thyrotoxicosis completed retrospective Thyroid-related Patient-Reported Outcome measures (ThyPROs) with 4-week and 1-week recall, respectively, and three daily EMAs for 4 weeks at time of inclusion and again after treatment (N = 115). Magnitude of change and statistical power (F-test statistics) were compared. Two designs were applied to the same data: Design 1 mimicked the practical realities of clinical trials by comparing 4-week recall ThyPRO administered at time of inclusion with EMA initiated at time of inclusion and collected prospectively for 1 week, thus not covering the same time frame or duration. Design 2 compared assessments covering the same 4 weeks after inclusion. RESULTS: Design 1: the estimated change and statistical power were significantly larger for 4-week ThyPRO compared with EMAs. Design 2: retrospective assessments and EMAs had comparable change and power. Repeated 1-week ThyPRO administrations increased the statistical power. CONCLUSION: Selecting the optimal time frame for evaluation proved crucial for responsiveness. EMAs did not provide higher responsiveness than retrospective measures in either design. Repeated 1-week ThyPRO administrations increased statistical power.