Validation of the Arabic Version of ThyroidEx and its Reliability among Arabic-Speaking Patients Enduring Thyroid Surgery

Validation of the Arabic Version of ThyroidEx and its Reliability among Arabic-Speaking Patients Enduring Thyroid Surgery | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 9 January 2025 V1 Latest version Share on Validation of the Arabic Version of ThyroidEx and its Reliability among Arabic-Speaking Patients Enduring Thyroid Surgery Authors : Rafeef Alhajress , Hemail Alsubaie 0000-0002-3127-9644 [email protected] , Mayar Alsaqr , Ahmed Alhussien 0000-0003-4754-0293 , Alhanouf Alhedaithy 0000-0001-5475-7496 , Ehab S. Alameer , Faisal R. Alzahrani , Saleh Al-Dhahri , Khalid Al-Qahtani , and Mohammed Alessa Authors Info & Affiliations https://doi.org/10.22541/au.173641408.84857096/v1 270 views 99 downloads Contents Abstract Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: ThyroidEx is a 19-item self-reported outcome measure designed to evaluate the expectations related to thyroid surgery. This study intended to validate the Arabic version of the ThyroidEx and measure its reliability and applicability among Arabic-speaking patients undergoing total thyroidectomy. Methods: A prospective cohort study was conducted where the ThyroidEx questionnaire was translated into Arabic and culturally adapted. In contrast to the original study, we included only patients who underwent total thyroidectomy as it suits most of the questions within the measure, such as thyroid medications and hypocalcemia concerns, while those set to undergo hemithyroidectomy or completion thyroidectomy were excluded. Participants were asked to complete the Arabic ThyroidEx questionnaire before surgery and again after surgery. The internal consistency of the questionnaire was analyzed using Cronbach’s alpha. Results: Our study revealed that patient expectations regarding mood changes due to medication adjustments significantly increased after surgery, with a P-value of 0.012. While expectations about pain and fatigue remained consistent before and after surgery, there was a slight increase in the anticipation of fatigue postoperatively. Concerns about long-term medication use, side effects of thyroid medication, and cancer recurrence also heightened after surgery, reflecting growing patient anxiety in these areas. Conclusion: The findings underscore the importance of addressing mood changes, medication side effects, and long-term management in preoperative discussions. The significant shift in mood-related expectations and the stable reliability of the Arabic ThyroidEx questionnaire highlights its effectiveness in capturing patient concerns, which can guide better patient support and improve postoperative outcomes. Validation of the Arabic Version of ThyroidEx and its Reliability among Arabic-Speaking Patients Enduring Thyroid Surgery Abstract: Background: ThyroidEx is a 19-item self-reported outcome measure designed to evaluate the expectations related to thyroid surgery. This study intended to validate the Arabic version of the ThyroidEx and measure its reliability and applicability among Arabic-speaking patients undergoing total thyroidectomy. Methods: A prospective cohort study was conducted where the ThyroidEx questionnaire was translated into Arabic and culturally adapted. In contrast to the original study, we included only patients who underwent total thyroidectomy as it suits most of the questions within the measure, such as thyroid medications and hypocalcemia concerns, while those set to undergo hemithyroidectomy or completion thyroidectomy were excluded. Participants were asked to complete the Arabic ThyroidEx questionnaire before surgery and again after surgery. The internal consistency of the questionnaire was analyzed using Cronbach’s alpha. Results: Our study revealed that patient expectations regarding mood changes due to medication adjustments significantly increased after surgery, with a P-value of 0.012. While expectations about pain and fatigue remained consistent before and after surgery, there was a slight increase in the anticipation of fatigue postoperatively. Concerns about long-term medication use, side effects of thyroid medication, and cancer recurrence also heightened after surgery, reflecting growing patient anxiety in these areas. Conclusion: The findings underscore the importance of addressing mood changes, medication side effects, and long-term management in preoperative discussions. The significant shift in mood-related expectations and the stable reliability of the Arabic ThyroidEx questionnaire highlights its effectiveness in capturing patient concerns, which can guide better patient support and improve postoperative outcomes. Key Points: 1. Validation of ThyroidEx in Arabic: This study validated the Arabic version of the ThyroidEx, ensuring its cultural and linguistic suitability for Arabic-speaking patients undergoing thyroid surgery. 2. Reliable Outcome Measure: The Arabic ThyroidEx demonstrated strong internal consistency (Cronbach’s alpha), confirming its reliability as a patient-reported outcome measure. 3. Preoperative and Postoperative Expectations: Significant changes in patient expectations regarding mood and medication side effects were observed postoperatively, underscoring areas requiring better preoperative counseling. 4. Target Population: The study focused on total thyroidectomy patients, highlighting concerns specific to this group, including long-term medication use and cancer recurrence. 5. Clinical Implications: The Arabic ThyroidEx is an effective tool for addressing patient concerns and enhancing communication, paving the way for improved preoperative and postoperative care strategies. Introduction: The incidence of thyroid cancer is increasing worldwide among many countries as it reaches 3.1 for every 100,000 males and 10.1 for every 100,000 females; however, the mortality rates are considered to be the same, which can be attributed to earlier diagnosis and proper management [1]. Thyroid surgeries are usually the first line of management in treating thyroid cancers [2]. However, thyroid surgeries can be associated with different complications like neck scar, hematoma, hypoparathyroidism that can lead to hypocalcemia, and vocal cord paralysis due to recurrent laryngeal nerve injury [3]. Although postoperative thyroidectomy complications are considered to be rare [4], the fear of these complications can affect postoperative patient satisfaction and their health-related quality of life outcomes (HRQoL) [5–7]. This is supported by the decreased HRQoL of survivors of thyroid cancer patients compared to other types of malignancies despite the excellent prognosis of thyroid cancer [8,9]. This might be explained by the lack of information provided to patients before thyroid surgery, which does not meet their expectations [10,11]. The types of thyroid surgeries, techniques, and scar sites vary; patients’ satisfaction and reported outcomes are used to clarify their subjective experience [12,13]. However, as described earlier, patients’ expectations can influence their satisfaction with a specific type of surgery and hence their HRQoL. The literature is abundant with questionnaires assessing patients’ reported outcomes and HRQoL, but it lacks questionnaires assessing patients’ expectations and satisfaction [14–16]. The ThyroidEx is the first questionnaire designed to measure pre-operative expectations in thyroid cancer patients undergoing thyroid surgeries. It is used to measure the patients’ expectations regarding thyroid cancer surgery. The instrument comprises three parts; beliefs, expectations, and concerns, with a total of 19 items. (Appendix 2) The first part – beliefs – is formed of only one item, the second part – expectations – is formed of nine items, and the third part – concerns – is formed of nine items. The questionnaire was validated in English in the United States. [5] The main goal of this study was to translate the ThyroidEx into Arabic, adapt it cross-culturally, and validate it. Methods: The Institutional Review Board of [Blinded for review] approved the study. Permission was obtained through direct contact with the original ThyroidEx authors [5] to validate the Arabic version of the questionnaire. Written consent was obtained from all patients who participated in the study. All steps in the study were performed in accordance with the Declaration of Helsinki. Subjects: This study was conducted at [Blinded for review] outpatient department of otolaryngology, head and neck surgery. Data were prospectively collected from January 2022 to December 2023. Patients ≥ 18 years old and were scheduled to undergo total thyroidectomy for thyroid tumors were included in the study. Patients with planned neck dissection, hemithyroidectomy, or completion thyroidectomy were excluded. The principal investigators gave Eligible patients the electronic questionnaire link after taking the written consent. It was distributed to patients pre-operativly and then on the first post-op clinic visit. A total of 46 patients participated in this study, including 5 patients who were piloted. The study conducted after being approved by the Ethical Committee and Institutinal Review Board (IRB) at [Blinded for review], with project number E-22-6605. Also, the participation is completely voulantry, and patients are included after signing a written consent retrieved by the principal investigator of the study. Forward and backward translation The initial translation of the original English version of the ThyroidEx (Appendix 2) was done independently by bilingual translators; two of them had head and neck backgrounds, and a freelance translator did have a Bachelor’s in English. Three copies were collected and revised by the investigators. Discrepancies between the three copies were discussed and resolved in one chosen copy. The selected version was translated back to English by another translator with a bilingual medical background blinded to the original ThyroidEx to ensure translation accuracy. It was then sent to the primary investigator and revised by an expert committee, including head and neck surgery consultants, to ensure it was comprehensive and acceptable. All discrepancies were discussed and resolved to ensure that the translated and original versions were conceptually equivalent. They tested the questionnaire’s content validity, ensured that the questions were straightforward, and measured all the thyroid surgery concerns. Pilot test: Semantic equivalence was assessed through a pilot test. It was conducted through structured interviews to ensure that the target population’s respondents understood the questionnaire’s elements as they were in the original language. A pre-final version of Arabic ThyroidEx (A-ThyroidEx) was distributed to 5 patients planned for total thyroidectomy. Feedback was implemented, and additional explanatory words were added to some questions for which the participants had difficulties clearly understanding. Statistical analysis Data was analyzed using desktop software SPSS version 19.0. Descriptive statistics were performed, and data was presented as mean +- standard deviation (SD) for continuous variables and frequency (percentage) for dichotomous variables. Internal consistency was assessed using Cronbach’s α values for both expectations and concerns. Results: Forty-six patients were included in this study. They filled out the questionnaire once before and once after surgery. The mean age of the patients was 43, with a standard deviation of 10.09 and ranging from 24 to 66 years old, as shown in (Table.1) Table 1: Demographic characteristics of the included patients Number of participants 46 Age, y (mean ± SD) 43 ± 10.09 Age range (years) 24-66 Gender (number [%]) - Male 12 [26.1%] - Female 34 [73.9%] The instrument is formed of three main concepts; a) The patient’s belief about the cure for thyroid cancer, b) The patient’s expectation towards the thyroid surgery, and c) The patient’s concerns about the thyroid surgery. We have removed the first item from the original questionnaire, which stated, “Thyroid cancer is one of the most curable cancers,” to be more culturally acceptable as patients may infer that they may have malignancy. Main study: Figures 1 and 2 present descriptive statistics for patients’ expectations and concerns before and after total thyroidectomy surgery. A significant difference was observed for expectation item E8: “I expect that I will experience some changes to my mood while I am adjusting to the dosage of the medication,” with a P-value of 0.012. This finding indicates a notable shift in patient expectations regarding mood changes related to medication adjustments post-surgery. For other expectation items, no significant differences were found. For example, the expectation of temporary dysfunction of the parathyroid glands (E1) had a P-value of 0.191, suggesting no significant change in this perception. Similarly, expectations concerning self-consciousness about scarring (E2), voice changes (E3), numbness (E4), pain (E5), fatigue (E6), and metabolic adjustments (E7) remained stable, with P-values ranging from 0.083 to 0.882. Regarding concerns, no significant changes were observed between pre- and post-surgery. Concerns about the length of hospital stay (C1), severity of pain (C2), bleeding (C3), and scarring (C4) showed P-values between 0.427 and 0.757, indicating stable concerns across these areas. Likewise, concerns related to being judged by others (C5), medication side effects (C6), post-surgery well-being (C7), cancer recurrence (C8), and long-term medication use (C9) did not exhibit significant differences, with P-values ranging from 0.204 to 0.701. Internal consistency was assessed using Cronbach’s Alpha values, which were 0.804 for expectations and 0.839 for concerns after surgery, based on a sample of 46 participants. These values demonstrate strong internal consistency and reliability for the scales in the postoperative context. For comparison, the original questionnaire, administered to 67 participants, showed Cronbach’s Alpha values of 0.81 for expectations and 0.89 for concerns. The minimal decrease in these values post-surgery indicates that the scales continue to perform well. Similarly, Cronbach’s Alpha values for the pre-surgery scales were 0.804 for expectations and 0.841 for concerns, reflecting consistent internal reliability before the surgery. Overall, the Cronbach’s Alpha values for both pre- and postoperative assessments are within acceptable ranges, highlighting the robustness and reliability of the questionnaire across different stages of the surgical experience. Finally, while most expectations and concerns remained stable, the significant shift in mood-related expectations emphasizes the importance of addressing this aspect in patient care. The solid internal consistency of the questionnaire confirms its effectiveness in reliably capturing patient perceptions throughout the surgical process, as shown in (Table.2) Figure 1: Expectations before and after thyroid surgery. Figure 2: Concerns before and after thyroid surgery. Table.2: The internal consistency of the questionnaire’s expectations and concerns E1 .637 .766 E2 .469 .789 E3 .278 .812 E4 .402 .798 E5 .475 .788 E6 .575 .777 E7 .495 .785 E8 .705 .757 E9 .476 .788 Total 1.000 .804 C1 .419 .835 C2 .504 .827 C3 .450 .832 C4 .623 .814 C5 .407 .836 C6 .644 .811 C7 .647 .813 C8 .598 .817 C9 .646 .811 Total 1.000 .839 E1-E9 represent the Expectations questions, and C1-C9 represent the Concerns questions Discussion: We validated an Arabic version of the ThyroidEx questionnaire after applying it to 46 thyroid patients who underwent total thyroidectomy. We found that Cronbach’s α values for expectations and concerns were 0.804 and 0.839, respectively, which indicated an accepted level of internal validity of the questionnaire similar to the original study where the values were 0.81 and 0.89, respectively [5]. The Cronbach’s α values were considered significant as they ranged between 0.7 and 0.95, and values higher than 0.9 are not recommended as they indicate too many questions with the same purpose. Also, it is important not to rely on a single Cronbach’s α value to ensure the validity of the questionnaire. This is why we have calculated them, and these results confirm the validity and reliability of this questionnaire in assessing patients’ satisfaction pre-operatively and HRQoL outcomes postoperatively. However, to confirm our findings, it is important to test it multiple times initially[17,18]. Although we found that nearly all concerns and expectations were improved postoperatively, this improvement was only statically significant in the eighth concern about mood changes after taking medications (P = 0.012). This supported our hypothesis about the importance of pre-operative satisfaction measures and knowing their concerns could influence the patient-reported outcomes after surgeries. This was also supported by Pitt 2019 et al., who assessed the patients’ needs pre-operatively in papillary thyroid cancer patients and found that providing information, emotional support, and respect for the patient as a person prepared the patient for the treatment successfully increased the feeling of reassurance, and hence could increase the HRQoL outcomes [19]. This also highlighted the importance of providing strategies to improve surgeons’ communication, advocation, and proficiency skills when dealing with thyroid patients [20,21]. Many believe pre-operative expectations or concerns reflect the patient-reported outcomes after surgeries [22]. A systematic review investigated the association between patients’ expectations and related outcomes and found that fulfilling their expectations has improved their satisfaction in about 18 studies out of 36 of the included studies [22]. Also, in lumbar surgeries, patients who had expectations of experiencing pain, taking a long recovery time, and returning late to work were associated with decreased levels of satisfaction after surgeries [23]. Therefore, objectively measuring expectations is crucial to increase patients’ related outcomes and study their level of satisfaction. Studying these items in each disease will help physicians focus on proper pre-operative assessment and engage in patients’ education, as Patel 2021 et al. found in the original study that validated the ThyroidEx questionnaire. They found that patients’ concerns were significantly different and higher than the surgeons’ expectations regarding pos-operative pain (P = 0.002), getting adjusted to the normal metabolism (P = 0.001), experiencing bleeding (P = 0.01), and developing post-operative scar (P = 0.005) [5]. Despite the fact that they are considered possible complications after thyroid surgeries, their incidence is not that common compared to the elevated level of concern of patients about them [4]. This can explain the decreased HRQoL outcomes of thyroid cancer survivor patients in comparison to other types of malignancies [8,9]. Also, Patients’ belief in curability for thyroid cancer could increase their fear of the disease. It could change their thoughts about the diagnosis and prognosis of the usually low-risk thyroid cancer they had. That was the sole reason our experts had removed the first question of the questionnaire. Interestingly, patients’ overestimated concerns are sometimes obtained from incorrect external sources like family members, the internet, or friends [5]. Strengths and limitations: Our study is considered the first to validate the ThyroidEx questionnaire in Arabic to suit the Arabic culture. This study is regarded as the second time this questionnaire is being utilized. Moreover, publishing it now will help validate this questionnaire, increase the chances of applying it, and improve the ability to test other modalities of treatment options other than just surgeries like radioactive iodine and thyroid medications for the same group of patients. As an attempt to reduce the heterogeneity in this study, our cohort included only patients who underwent total thyroidectomy. However, more future studies are required to investigate their role in different types and techniques of thyroid surgeries. Another limitation is the absence of a control group to confirm the importance of providing a pre-operative assessment of expectations in improving the HRQoL outcomes despite being difficult to establish while validating a study. In addition, our sample size is considered small. Therefore, applying the questionnaire to a larger sample is important to confirm our findings. Finally, further research needs to test the factors associated with satisfaction levels, like age, gender, psychiatric background, and other demographic characteristics. Conclusion: Our prospective cohort successfully validated the Arabic version of the ThyroidEx questionnaire, proving its applicability and reliability within the Arabic-speaking population. The results indicate that the questionnaire effectively captures and addresses patient expectations and concerns related to thyroid surgery, with a significant improvement in mood changes following medication adjustments. This emphasizes the critical role of thorough pre-operative assessment and counseling in enhancing patients’ post-operative outcomes and overall quality of life (HRQoL). However, further research with larger sample sizes is essential to confirm these findings. Future studies should also explore the impact of pre-operative assessments by comparing patients who undergo such evaluations with those who do not to better understand their role in improving HRQoL outcomes. Acknowledgment: We would like to thank [Blinded for review] for giving us permission to translate and validate the original ThyroidEx questionnaire. Data Availability Statement: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. Authors Contribution: Blinded for review. Authors’ Disclosure Statement : The authors have no relevant financial or non-financial interests to disclose. 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DOI: 10.1097/00005650-199902000-00006 Information & Authors Information Version history V1 Version 1 09 January 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Authors Affiliations Rafeef Alhajress King Saud University Medical City View all articles by this author Hemail Alsubaie 0000-0002-3127-9644 [email protected] King Saud University Medical City View all articles by this author Mayar Alsaqr King Saud University Medical City View all articles by this author Ahmed Alhussien 0000-0003-4754-0293 King Saud University Medical City View all articles by this author Alhanouf Alhedaithy 0000-0001-5475-7496 King Fahd Military Medical Complex View all articles by this author Ehab S. Alameer Jazan University College of Medicine View all articles by this author Faisal R. Alzahrani King Saud University Medical City View all articles by this author Saleh Al-Dhahri King Saud University Medical City View all articles by this author Khalid Al-Qahtani King Saud University Medical City View all articles by this author Mohammed Alessa King Saud University Medical City View all articles by this author Metrics & Citations Metrics Article Usage 270 views 99 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Rafeef Alhajress, Hemail Alsubaie, Mayar Alsaqr, et al. Validation of the Arabic Version of ThyroidEx and its Reliability among Arabic-Speaking Patients Enduring Thyroid Surgery. Authorea . 09 January 2025. DOI: https://doi.org/10.22541/au.173641408.84857096/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. 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