|Year : 2021 | Volume
| Issue : 2 | Page : 74-81
Development of a symptoms-based thyroid risk questionnaire to screen for hypothyroidism in India
KM Prasanna Kumar1, Bipin Kumar Sethi2, Sanjay P Khare3, Mahesh Padsalge4, Anadya Prakash Tripathi5, Milind Bhole5, Dyotona Sen Roy6
1 Center for Diabetes and Endocrine Care, Bengaluru, Karnataka, India
2 Care Outpatient Centre, Care Hospitals, Jayabheri Pine Valley, Hitec City, Hyderabad, Telangana, India
3 Dr. Khare's Clinic, Navi Mumbai, Maharashtra, India
4 Diabecare, Diabetes and Endocrine Clinic, Navi Mumbai, Maharashtra, India
5 Established Pharmaceuticals Division, Abbott Healthcare Pvt. Ltd, Mumbai, Maharashtra, India
6 Established Pharmaceuticals Division, Abbott India Ltd., Mumbai, Maharashtra, India
|Date of Submission||03-Mar-2022|
|Date of Acceptance||28-Jun-2022|
|Date of Web Publication||22-Jul-2022|
Dr. K M Prasanna Kumar
Center for Diabetes and Endocrine Care, PAMS - 1st Stage, 3rd Block, Near BDA Complex, HBR Layout, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
Context: In India, many cases of hypothyroidism go undetected due to lack of timely screening.
Aims: The aim of the study is to develop a symptom-based thyroid risk index (STRI) questionnaire.
Subjects and Methods: Questionnaire development involved the following steps: (1) hypothyroidism symptom selection and questionnaire construction based on the literature survey, (2) expert (2 endocrinologists and 2 consultant physicians) review, (3) face validation (Phase 1, cross-sectional survey followed by review by a psychometrician, an endocrinologist, and a layperson), and (4) pilot survey (Phase 2). The face validation was conducted in subjects from general population naïve to their thyroid status (Arm 1 [at 2 nonclinical settings], n = 16) and in subjects with hypothyroidism who were treatment-naïve (Arm 2 [at 2 clinical centers], n = 19). Results were summarized descriptively.
Results: Hypothyroid symptoms were incorporated into the questionnaire in the form of 18 questions under four sections and were assigned a score from 1 to 4 based on the strength of literature evidence. The questionnaire underwent face validation followed by incorporation of expert review and recommendations. In Arm 1, 12 subjects (75%) had thyroid-stimulating hormone levels >4.5 mIU/L indicating hypothyroidism. The total mean (standard deviation) STRI score was 25.4 (10.7) in the Arm 1 (29.8 [8.2] in the 12 hypothyroid-positive subjects) and was 18.6 (10.8) in the Arm 2.
Conclusions: The STRI questionnaire was successfully face validated for its applicability in clinical and nonclinical settings. The questionnaire, finalized after expert committee review and recommendations, will be validated for its sensitivity and specificity to detect symptoms of hypothyroidism in a pan-India pilot study.
Keywords: Face validation, hypothyroidism, screening questionnaire, thyroid risk index
|How to cite this article:|
Prasanna Kumar K M, Sethi BK, Khare SP, Padsalge M, Tripathi AP, Bhole M, Roy DS. Development of a symptoms-based thyroid risk questionnaire to screen for hypothyroidism in India. Thyroid Res Pract 2021;18:74-81
|How to cite this URL:|
Prasanna Kumar K M, Sethi BK, Khare SP, Padsalge M, Tripathi AP, Bhole M, Roy DS. Development of a symptoms-based thyroid risk questionnaire to screen for hypothyroidism in India. Thyroid Res Pract [serial online] 2021 [cited 2022 Sep 28];18:74-81. Available from: https://www.thetrp.net/text.asp?2021/18/2/74/351645
| Introduction|| |
Primary hypothyroidism is a pathological condition arising from failure of the thyroid gland, leading to thyroid hormone deficiency., It is the predominant type of hypothyroidism observed in over 99% of cases., Hypothyroidism is one of the most common diseases globally. It is reported to be prevalent in up to 5% of the general population in Europe, with another 5% being undiagnosed., India has a higher prevalence of hypothyroidism of around 11%., The prevalence rate is higher in women and in the elderly.,,
The most common symptoms of hypothyroidism in adults are fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin, which often overlap with other common diseases., Factors such as age, sex, and time between onset and diagnosis lead to variations in clinical presentation of the condition. Hypothyroidism, if untreated, can lead to serious adverse effects such as infertility, cardiovascular disease, neurological conditions, and musculoskeletal symptoms.
The condition is often underdiagnosed due to the large variation in clinical presentation and the absence of symptom specificity. In India, especially, majority of cases of hypothyroid go undetected as physician assessment and timely testing are not widespread practices. In the epidemiological study conducted by Unnikrishnan et al., it was observed that 3.47% of the population studied was undiagnosed.
Hence, to control hypothyroidism in India, it is important to spread awareness in the population and to do targeted screening and early management of the disease. While there are no guidelines for screening for thyroid dysfunction in nonpregnant asymptomatic adults in India, in the United States, the American Thyroid Association has recommended routine screening at the age of 35 for both sexes and every 5 years thereafter, considering the asymptomatic nature of subclinical hypothyroidism. To avoid hypothyroidism-related long-term morbidity and mortality from fractures, cancer, or cardiovascular disease, the United States Preventive Services Task Force recommends early detection and treatment of asymptomatic persons with abnormal serum thyroid-stimulating hormone (TSH) levels, even though existing evidence is insufficient.
Thyroid function tests are routinely used for screening for hypothyroidism, but financial and resource constraints may prevent widespread use of the tests in India. Hence, availability of a tool such as a questionnaire that can help screen for potential hypothyroidism in the general population will ensure timely treatment of the condition and reduce risk of comorbidities. In addition, the use of the screening tool would help reduce the financial and resource burden of unnecessary testing, which is especially beneficial for a populous country like India.
Objectives of the study
We aimed to develop a valid symptom-based thyroid risk index (STRI) questionnaire with robust sensitivity and specificity to detect signs and symptoms of hypothyroidism. Here, we report developmental steps up to face validation of the questionnaire.
| Subjects and Methods|| |
The development of the questionnaire involved the following steps: (1) symptom selection of hypothyroidism and questionnaire construction, (2) expert review of the survey questionnaire for its relevance, integrity, and accuracy, (3) face validation of survey questionnaire (Phase 1), and (4) pilot survey (Phase 2). [Figure 1] depicts the steps in the questionnaire development. The study is registered at www.ClinicalTrials.gov as NCT04784208.
|Figure 1: Workflow of STRI questionnaire development, STRI: Symptom-based thyroid risk index|
Click here to view
Step 1 Symptom selection of hypothyroidism and questionnaire construction
A literature search was carried out up to 2019 to collect theoretical strength of evidence for symptoms of hypothyroidism to be included in the questionnaire. The search was carried out using the PubMed database with the help of the following keywords and Medical Subject Headings (MeSH) strings for different hypothyroid-associated symptoms: (1) Fatigue: “hypothyroidism” (Title) AND “fatigue” OR “ tiredness;” (2) Neurocognitive dysfunction: “hypothyroidism” AND “neurology/pathology” OR “cognition;” (3) Depression: (hypothyroidism [Title]) AND “depression” OR “mood disorder” OR “psychiatric pathology” OR “psychiatric symptoms” OR “pediatric depression” OR “bipolar disorder” OR “quality of life;” (4) Weight gain: (hypothyroidism [Title]) AND “obesity” OR “weight gain” OR “weight gain in subclinical hypothyroidism” OR “body weight;” (5) Dermatological changes: (hypothyroidism [Title]) AND “hair fall” OR “hair loss” OR “dermatological changes” OR “dry skin” OR “skin” OR “alopecia” OR “cutaneous manifestations” OR “myxedema” OR “xerosis cutis” OR “ xerosis;” (5) Cold intolerance: (hypothyroidism [Title]) AND “cold intolerance” OR “cold intolerance in hypothyroidism (generalized search)” OR “energy expenditure in hypothyroidism” OR “cold sensitivity in hypothyroidism;” (6) Constipation: (hypothyroidism [Title]) AND “constipation” OR “constipation/analysis”[MeSH] OR “constipation/epidemiology”[MeSH] OR “constipation/statistics and numerical data”[MeSH] OR “hypothyroidism/epidemiology”[MeSH] OR “hypothyroidism/statistics and numerical data”[MeSH]; (7) Menstrual dysfunction: (hypothyroidism [Title]) AND “menstruation” OR “oligomenorrhea” OR “infertility;” (8) Hoarseness: (hypothyroidism [Title]) AND “hoarseness (generalized search)” OR “vocal cords” OR “laryngeal irritation” OR “dry cough;” (9) Reduced appetite: (hypothyroidism [Title]) AND “appetite” OR “reduced appetite” OR “decreased appetite” OR “appetite loss” OR “anorexia” OR “loss of appetite” OR “hypophagia;” (10) Muscle aches and cramps: (hypothyroidism [Title]) AND “myalgia” OR “muscle weakness” OR “muscle twitching” OR “decreased movement” OR “myopathy” OR “neuromuscular dysfunction” OR “muscle stiffness;” (11) Goiter: (hypothyroidism [Title]) AND “goiter ((prevalence) AND goiter)” OR (“hypothyroidism/analysis”[MeSH] OR “hypothyroidism/statistics and numerical data”[MeSH]) AND (“goiter, nodular/analysis”[MeSH] OR “goiter nodular/statistics and numerical data”[MeSH]); (“hypothyroidism”[MeSH]) AND “thyroiditis autoimmune”[MeSH]); (hypothyroidism [Title]) AND goiter; (12) Edema: (hypothyroidism [Title]) AND “edema” OR “swelling” OR “hormonal causes of edema;” (13) Macroglossia: “hypothyroidism” and “tongue diseases” OR “ macroglossia;” (14) Drug-induced hypothyroidism: (“hypothyroidism/chemically induced”[MeSH]) AND “perchlorate/adverse effects”[MeSH] OR “interferon-alpha/adverse effects”[MeSH] OR “amiodarone/adverse effects”[MeSH] OR “nitroprusside” OR “iodine/adverse effects”[MeSH] OR “thalidomide/adverse effects”[MeSH] OR “lithium”[MeSH].
A total of 5505 articles were retrieved of which 216 were found to be relevant and related to hypothyroidism symptoms. Based on the literature evidence available for each of the symptoms, a weightage or score was assigned for each of the symptoms using the criteria as described in [Table 1].
|Table 1: Weightage for hypothyroid symptoms based on literature evidence|
Click here to view
The symptoms were then incorporated into the STRI questionnaire, in the form of questions, avoiding the use of complex medical terminology, and with trichotomous answer choices: Yes, No, or Maybe/Sometimes/Not sure/Do not know. In addition to questions related to symptoms of hypothyroidism, the questionnaire also contained questions related to contributory factors from patient history such as comorbidities and family history of hypothyroidism. The questionnaire was divided into four sections, and questions within a section were grouped based on the strength of evidence available for each symptom. Questions in Section 1 were related to symptoms that had the strongest literature-based evidence and received the highest weightage, whereas those in Section 4 were related to symptoms that had the weakest literature-based evidence and received the lowest weightage. Thus, a Yes response for any question in Section 1 corresponded to 4 points; in Section 2, 3 points; in Section 3, 2 points; and in Section 4, 1 point. A “No or Maybe/Sometimes/Not sure/Do not know” response for any of the questions in the questionnaire corresponded to 0 point.
Step 2: Expert review of the survey questionnaire
An advisory board was formed consisting of two endocrinologists and two consultant physicians. The criteria for selection of the advisory board were a doctorate in medicine or fellowship in endocrinology or internal medicine from a recognized institute, a valid Indian license for medical practice, at least 5 years of relevant clinical experience, and an ability to be an effective part of a team of peers with similar qualifications. In addition, experience with research activities in the thyroid gland and familiarity with statistical analysis methods were preferred.
The questionnaire and weightage scale for each question were reviewed by the advisory board, and the STRI questionnaire was finalized based on the advisory board recommendations. The finalized STRI questionnaire containing 18 questions was used for the face validation step [Table 2].
Step 3: Face validation of symptom-based thyroid risk index questionnaire (Phase 1)
The validity of the STRI questionnaire was assessed in this step by comparing the outcomes of the responses between subjects chosen from the general population who were naïve to their thyroid status (n = 16, Arm 1) and subjects with hypothyroidism who were treatment-naïve (n = 19, Arm 2). The face validation committee consisted of a psychometrician who evaluated the validity, reliability, and fairness of the questionnaire keeping in mind the end user, an endocrinologist who was expected to provide inputs from a clinical perspective, and a layperson (representative of the general population) who had been informed about the survey and its objectives and who assessed the questionnaire for its lucidity and ease of understanding. Face validation by the review committee was intended to ensure that the questions appropriately elucidated the symptoms, for which they had been designed and to ensure easy readability and understanding of the questions by the layperson. The questionnaire will be modified according to the inputs from the review committee, and the modified and finalized questionnaire will be used for Phase 2 pilot study.
The face validation was conducted between January 18, 2021, and February 18, 2021. The thyroid status-naïve subjects were chosen from two nonclinical settings (a housing colony and an educational institution) in Hyderabad, India. Treatment-naïve hypothyroid subjects were chosen from two clinical centers, one in Nellore, India, and the other in Bengaluru, India.
All enrolled subjects were sent the STRI questionnaire as a web-based link. Completed questionnaires from hypothyroid status-naïve subjects were collected by survey coordinators, who, in addition, scheduled laboratory technician appointments for blood sample collection for TSH test from these subjects. The treatment-naïve hypothyroid subjects responded to the questionnaire through the digital link, and the survey coordinators collected a copy of the TSH report used for hypothyroid diagnosis from the subjects.
The study was conducted in accordance with the International Council for Harmonization Harmonized Tripartite Guidelines for Good Clinical Practice, the ethical principles laid down in the Declaration of Helsinki, applicable local regulations, as well as in compliance with the “The New Drugs and Clinical Trial Rules-2019,” of the Ministry of Health, Government of India. The protocol including amendments and other relevant study documents were reviewed and approved by an independent ethics committee before initiation of the study. All subjects provided written informed consent.
Subjects between the age of 18 and 65 years were included. In addition, treatment-naïve hypothyroid subjects should have had TSH level >4.5 mIU/L, been diagnosed by a physician with hypothyroidism within 2 weeks before the date of survey, been treatment-naïve, and be willing to provide the TSH report used to diagnose hypothyroidism.
Study data were summarized using descriptive statistics. The parameters for analysis included qualitative variables: sex, age category (≥18–≤30 years, >30–≤40 years, >40–≤50 years, and >50 years), number and percentage of thyroid status-naïve subjects with positive hypothyroid status, number and percentage of “Yes” and “No” responses to questions in the STRI questionnaire; as well as quantitative variables: age, mean TSH levels, and mean STRI questionnaire score - total, section-wise, and for individual questions. For the face validation part of the study, no formal sample size calculation was performed. However, for the Phase 2 pilot study, a subject-to-item ratio of 11:1 will be maintained with a sample size of 200, in line with the evidence from previous patient-reported outcomes studies. Analysis was performed using SPSS Statistics 23.0, IBM, United States.
| Results|| |
The demographic and baseline characteristics of the subjects are summarized in [Table 3]. The mean (standard deviation [SD]) age of thyroid status-naïve subjects was 38.2 (11.9) years and of treatment-naïve hypothyroid subjects was 39.2 (12.5) years. There were more males among thyroid status-naïve subjects (12/16; 75.0%) and more females among treatment-naïve hypothyroid subjects (12/19; 63.2%). The mean (SD) TSH level was 13.0 (9.9) mIU/L in the thyroid status-naïve subjects and (9.9) mIU/L in the treatment-naïve hypothyroid subjects.
In thyroid status-naïve subjects, testing of TSH levels in the collected blood samples revealed 12 subjects to be positive for hypothyroidism (TSH levels >4.5 mIU/L). In these 12 subjects, the mean TSH level was 16.0 (9.8) mIU/L. In the remaining four subjects, the mean TSH level was 4.0 (0.0) mIU/L.
Symptom-based thyroid risk index questionnaire responses
Among thyroid status-naïve subjects, 100% of subjects acknowledged having hair fall, 93.8% felt uncomfortable in cold, 87.5% had dry and itchy skin, and 75% had swelling of the neck [Table 4]. Of the 12 thyroid status-naïve subjects who tested hypothyroid positive, all mentioned that they felt uncomfortable during cold weather, and 91.7% responded that they felt tired. Of 4 subjects who were hypothyroid negative, 75% mentioned that they felt uncomfortable during cold weather, while none responded that felt tired [Table 4]. All treatment-naïve hypothyroid subjects acknowledged having thyroid surgery/past treatment of thyrotoxicosis/radiation of the neck and 63.2% of subjects each responded having hair fall and feeling uncomfortable in cold [Table 4].
Mean symptom-based thyroid risk index questionnaire scores
The STRI questionnaire has a total possible score of 51. The total mean (SD) STRI score was 25.4 (10.7) for thyroid status-naïve subjects and 18.6 (10.8) for treatment-naïve hypothyroid subjects. The section-wise mean (SD) scores were 14.3 (5.8), 6.2 (2.8), 4.3 (3.0), and 0.8 (0.4) for Sections 1, 2, 3, and 4, respectively, for thyroid status-naïve subjects and 10.5 (6.4), 4.7 (3.8), 3.3 (2.7), and 0.1 (0.3) for Sections 1, 2, 3, and 4, respectively, for treatment-naïve hypothyroid subjects [Table 5].
| Discussion|| |
Screening is an important part of preventive medicine, and the use of screening tools enables early identification of diseases to provide treatment and avoid or reduce symptoms, thereby improving health outcomes of the population., However, screening represents an immediate economic burden, especially for healthcare systems with financial and resource constraints.
In recent years, there has been an increased focus on making healthcare more patient-centric. Self-reported questionnaires capture patients' perceptions on their health, quality of life, or functional status associated with healthcare or treatment tools and enable them to directly report or rate their symptoms without interpretation of the patient responses by clinicians, other healthcare professionals, caregivers, or guardians. There are validated screening questionnaires available for several disease conditions, such as chronic obstructive pulmonary disease, psoriatic arthritis, inflammatory arthritis, Parkinson's disease,, and neurological disorders.
For hypothyroidism, there are questionnaires for diagnosis, assessing quality of life, and treatment satisfaction,, but not for screening in general population. This could be related to the lack of sensitivity and specificity of hypothyroid symptoms, leading to TSH levels being the primary screening test for thyroid dysfunction. However, screening questionnaires can be a useful tool in the long run, even if not completely foolproof, especially in India with its existing health infrastructure. Hence, the STRI questionnaire was developed to preliminarily identify subjects with an underlying hypothyroid condition who can then be screened for hypothyroidism by measuring TSH levels. The intention of developing the STRI questionnaire is to make screening easier and more cost-effective and reduce the unnecessary burden of laboratory testing. The face validation step confirmed the choice of words and their intended meaning for all the questions and that the questions were consistent in their measurement. Of the 16 thyroid status-naïve subjects, 12 (75%) were diagnosed with hypothyroidism based on TSH levels. The mean questionnaire scores for these 12 subjects were higher than the scores for those who did not have hypothyroidism based on the TSH levels.
As a next step, a review committee consisting of a psychometrician, an endocrinologist, and a layperson will evaluate the responses to the questionnaire received during face validation survey. The experts will ensure that the questions appropriately elucidate the symptoms, for which they have been designed, and the layperson will ensure the easy readability and understanding of the questions, considering that the questionnaire is intended as a patient-reported tool. Committee members will suggest changes in questions and/or the design of the STRI questionnaire in consultation with the members of the advisory board formed before face validation. The questionnaire finalized based on the committee recommendations will then be used for Step 4, which is the Phase 2 or pilot study.
| Conclusions|| |
The STRI questionnaire was successfully tested for its applicability in clinical and nonclinical setting. The committee designed for face validation agreed that the questions were clear, comprehensible, and consistent in their measurement. Suggestions from the committee members have been incorporated, and the questionnaire has been modified for the pilot study, which is to be conducted in a larger group of subjects naïve to their thyroid status and in treatment-naïve subjects with hypothyroidism. Further, the pilot study is expected to establish the validity of the STRI questionnaire as a screening tool and to establish the sensitivity and specificity of the questionnaire to detect signs and symptoms of hypothyroidism.
Rupanwita Ghosh, Abbott India Limited, provided medical input and reviewed all versions of the manuscript. Lakshmi Venkatraman, PhD, provided medical writing support, which was funded by Abbott India Limited.
Financial support and sponsorship
The study was funded by Abbott India Limited.
Conflicts of interest
K. M. Prasanna Kumar has received speaker fees from Abbott and is in a fiduciary role with RSSDI, ESI, ITS, and Karnataka ESI. Bipin Sethi received honoraria for symposia and webinars and lecture fees from Sanofi, Abbott, Boehringer Ingelheim, Intas, and Novo Nordisk. Sanjay Khare and Mahesh Padsalge have no conflicts of interest to disclose. Anadya Prakash Tripathi, Milind Bhole, and Dyotona Sen Roy are employees of Abbott.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]