|Year : 2013 | Volume
| Issue : 2 | Page : 72-77
Patient concerns in treated hypothyroidism: A cross-sectional evaluation
Sukriti Bhutani1, Jaikrit Bhutani2, Yatan Pal Singh Balhara3, Sanjay Kalra4
1 MBBS Students, MAIMRE, Agroha, India
2 PGIMS, Rohtak, India
3 National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India
4 Consultant, Endocrinology, BRIDE, Karnal, India
|Date of Web Publication||16-Apr-2013|
Yatan Pal Singh Balhara
National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi- 110 029
Source of Support: None, Conflict of Interest: None
Background: Advances and improvements in the diagnosis of hypothyroidism have ensured the detection of a larger number of patients. The question that arises is that should we treat patients according to their Thyroid Stimulating Hormone level, which represents their "biochemical health" or according to their symptoms, which represent the health of the whole body? Aim: The current study aimed at exploring the concerns of patients diagnosed with hypothyroidism. Materials and Methods: The research was planned as a single center cross-sectional study at an endocrine center in a district headquarter (Karnal) in Haryana, India. One hundred consecutive hypothyroid patients attending the endocrine clinic were administered a pre-tested, structured questionnaire designed to capture personal, anthropometric, biochemical, and clinical data. Pearson's correlation coefficient was calculated to find out the correlations between continuous variables. Independent Student's t-test was used for in-between group comparisons. Results: The average duration of hypothyroidism in 100 subjects was 5.12 ± 6.87 years. All patients were on L-Thyroxine supplementation. The commonest dose used was 100 mcg/day (n = 35), followed by 125 mcg/day (n = 20). The most important patient rated concern was fatigue (3.39 ± 1.053), followed by neuropathic pain (3.00 ± 1.363) and permanence of medication (2.77 ± 1.377). Other important concerns from the patient perspective were lack of weight loss, lack of well-being and feeling of being sick. Conclusions: The results will help sensitize physicians and endocrinologists towards eliciting a patient sensitive history, while focusing on clinical and social aspects of relevance of the patient's age and clinical picture.
Keywords: Hypothyroidism, patient concern, thyroid
|How to cite this article:|
Bhutani S, Bhutani J, Balhara YP, Kalra S. Patient concerns in treated hypothyroidism: A cross-sectional evaluation. Thyroid Res Pract 2013;10:72-7
|How to cite this URL:|
Bhutani S, Bhutani J, Balhara YP, Kalra S. Patient concerns in treated hypothyroidism: A cross-sectional evaluation. Thyroid Res Pract [serial online] 2013 [cited 2020 Apr 1];10:72-7. Available from: http://www.thetrp.net/text.asp?2013/10/2/72/110590
| Introduction|| |
Thyroid diseases are amongst the commonest endocrine disorders worldwide. India too, is no exception. It has been shown earlier that about 42 million people in India suffer from thyroid diseases, out of which hypothyroidism forms a formidable part. 
Advances and improvements in the diagnosis of hypothyroidism have ensured the detection of a larger number of patients.  The relatively easy diagnosis ensures treatment in a greater number of subjects. The treatment is supposedly simple, easy and cost-effective in many patients, as it involves only the replacement of thyroxine. This is in contrast to clinical challenges that endocrinologists of the previous generations faced, when they had to titrate desiccated thyroid extract or tri-iodo-thyroxine doses based on clinical symptoms or on unreliable laboratory assays. ,
Some patients after being diagnosed hypothyroidism and having received thyroxine replacement for the same continue to experience various hypothyroid symptoms. These are emotionally stressful and probably decrease work efficiency and quality of life.  The replacement of thyroxine in a biochemically appropriate dose, does not necessarily relieve the patient of these symptoms. Some patients complain of persistent psychological symptoms while some tend to experience physical symptoms as well. Others state that they just do not feel normal in spite of ongoing therapy.  This may be related to the underlying disease itself, adverse effect of drugs, financial and social issues, or other common causes like anemia, hyponatremia, Vitamin D deficiency, menopause, hypocalcemia, other endocrine disorders, celiac disease, physical unfitness, obstructive sleep apnea, etc. ,,,,, The role and importance of these symptoms in the treatment plans of hypothyroid subjects has not been researched extensively earlier, which creates a need for this study.
The question that arises is that should we treat patients according to their Thyroid Stimulating Hormone (TSH) level, which represents their "biochemical health" or according to their symptoms, which represent the health of the whole body?
Therefore, we suggest a patient oriented method of treating hypothyroidism, which could probably be the most promising method as it ensures a high-level of patient satisfaction and compliance. The current study aimed at exploring the concerns of patients diagnosed with hypothyroidism.
| Materials and Methods|| |
The research was planned as a single center cross-sectional study at an endocrine center in a district headquarter (Karnal) in Haryana, India to assess concerns of patients being treated for hypothyroidism. It was performed as part of a larger project designed to study the clinical profile of patients with hypothyroidism.
After taking an informed consent, 100 consecutive hypothyroid patients attending the endocrine clinic in January 2012 were administered a pre-tested, structured questionnaire designed to capture personal, anthropometric, biochemical, and clinical data.
Further, twenty patient concerns were identified from focused history taking and interviewing conducted as a part of routine clinical care. These concerns were grouped into the following domains:
General Health related concerns
Following identification of the common concerns, patients were asked to prioritize their main concerns and rate their importance on a 5 point Likert Scale.
- Lack of well-being
- Lack of weight loss
- Feeling of being sick
- Swelling of feet
- Neuropathic pain
- Neck related symptoms and signs
- Frequency of infections
- Frequency of - Upper Respiratory Catarrah
- Difficulty in breathing
- Difficulty in swallowing
- Neck swallowing
- Gynecology related symptoms and signs
- Menstrual disturbance
- Recurrent pregnancy loss
- Vertical transmission
- Drug related concerns
- Permanence of medication
- Side effects of medication
- Interaction with other medications
- Social concerns
- Anxiety about marital prospects
- Financial constraints
Each study participant was examined for height, weight, waist circumference (WC), and hip circumference (HC) without shoes or other footwear and with minimal clothing as per cardiovascular survey methods,  body mass index (BMI) was calculated by formula of weight in kg/height m 2 . Waist to Hip Ratio was calculated by WC/HC in centimeters. Value of BMI greater than or equal to 23 kg/m 2 was used to define overweight and greater than or equal to 25 kg/m 2 was used to define obese. Value of WC >90 cm in men and >80 cm in women was defined as abnormal. 
Values of fasting plasma glucose (FPG), Glycated Hemoglobin and lipid profile were recorded for each patient enrolled. Blood pressure was measured in respective out-patient departments (OPDs) using a standard mercury sphygmomanometer under standard conditions as mentioned in cardiovascular survey methods. 
Diabetes mellitus (DM) was labeled if a subject was a known diabetic or on treatment with any oral glucose lowering drug or if FPG ≥126 mg/dL.  Dyslipidemia was defined according to National Cholesterol Education Program - Adult Treatment Panel III guidelines.  Hypertension was labeled if blood pressure ≥140 mmHg systolic blood pressure and ≥90 mmHg diastolic blood pressure or known to be hypertensive on treatment with any blood pressure. 
Analysis was carried out using the Statistical Package for the Social Sciences Version 19.0. Pearson's correlation coefficient was calculated to find out the correlations between continuous variables. Independent Student's t-test was used for in-between group comparisons. For all the tests performed, results were considered statistically significant for P < 0.05.
| Results|| |
The study cohort comprised of 100 hypothyroid patients, out of which 88 (88%) were females. The mean age was 42.14 ± 13.14 years.
Ninety nine participants, out of 100 under study were married and the average duration of hypothyroidism in 100 subjects was 5.12 ± 6.87 years. Thirty two had a current (within the past 1 month) euthyroid TSH Value (0.35-5.00 mIU/l), while 11 reported TSH <0.35 and 57 reported TSH ≥5.00. None of them had undergone thyroid surgery or iodine ablation.
The anthropometric and metabolic characteristics for the study cohort are given in [Table 1].
There was a wide spectrum of patients in terms of age, height, BMI, thyroid control, blood glucose, and lipid profiles. Twenty five men and women were diabetic, 52 had dyslipidemia.
All patients were on L-Thyroxine supplementation. The commonest dose used was 100 mcg/day (n = 35), followed by 125 mcg/day (n = 20). The mean total daily dose (TDD) was 101.17 ± 24.91 mcg/day. The mean dose per kg body weight (DBW)- was 1.452 ± 0.38 mcg/kg. No difference was noted in DBW in men and women (male: 1.29 ± 0.46, female: 1.47 ± 0.37). No difference was noted in the dose prescribed to well- controlled (1.44 mcg/kg/day) and poorly controlled (1.46 mcg/kg/day) patients. Frequency of administration was once daily in 95 patients, with five patients taking divided doses twice a day. When timing was assessed, the results were as follows, 91 patients took L-Thyroxine once daily, at least 30 min before breakfast. Two patients took their dose "2 h after breakfast and 2 h before lunch," while another two followed a bed time regime. Five patients preferred to take L-Thyroxine in doses divided between early morning and at bed time. Patients had requested change in early morning administration of L-Thyroxine because of uneasiness (n = 3/7), palpitation (n = 2/7) and increased hunger (n = 1/7) after ingesting the tablet. One patient could not remember the reason why she had shifted to a twice daily regime. In all cases, the symptoms subsided 1 time or frequency of intake was changed. The 7 patients (1 male, 6 females) those with atypical administration of L-Thyroxine, did not differ from the rest of the cohort with respect to age, gender, duration of hypothyroidism, co morbid condition or concomitant medication. These results have been reported earlier. 
The structured questionnaire listed 20 potential patient concerns, which were to be assessed by the patient on a 5 point Likert Scale. A higher score would mean a relatively greater degree of concern related to that particular symptom, sign or medico-social issue [Table 2].
The most important patient rated concern was fatigue (3.39 ± 1.053), followed by neuropathic pain (3.00 ± 1.363) and permanence of medication (2.77 ± 1.377). Other important concerns from the patient perspective were lack of weight loss, lack of well-being, and feeling of being sick. A domain based analysis of the patient concerns highlighted that the most important patient concern was general well-being. The drug concerns, neck related symptoms and signs, social concerns and gynecology related symptoms and signs were secondary to it.
A bivariate analysis of the data revealed that the duration of hypothyroidism affected the patient concerns of permanent medicine, difficulty in swallowing and swelling of feet, i.e., as the duration of hypothyroidism increased the frequency of these concerns increased [Table 3]. For the rest of the patient concerns the analysis was not statistically significant.
When analysis was done separately for well controlled (TSH ≤5 mIU/mL; n = 43) and poorly controlled (TSH >5 mIU/mL; n = 57) patients, a different picture occurred. Fatigue, feeling of being sick and lack of well-being were rated higher by the poorly controlled group. Need for permanent medication and lack of weight loss were sources of relatively greater concern for the well-controlled group [Table 4]. The rest of the patient concerns did not relate significantly to the Last TSH Value.
|Table 4: Patient concerns in poorly and well controlled subjects (n = 100)|
Click here to view
| Discussion|| |
A patient-centered approach to management of disease, especially chronic disease, has long been advocated. The strongest call for this approach of treatment is in the field of DM, where Diabetes Self-Management and Education is an integral part of therapy.  Similar calls have also been made for shared decision making as well as for empowerment of patients with hypothyroidism. ,
The first step towards patient satisfaction and empowerment in hypothyroidism is an assessment of patient concern. Endocrinologists are aware of the fact that their hypothyroid patients are unhappy with the treatment being provided to them. Various clinical and biochemical explanations have been preferred for this.  However, no work has been performed in India, to the best of our knowledge, to assess and classify specific hypothyroid patient concerns or to facilitate appropriate history taking by physicians when dealing with hypothyroidism. This study provides a cross-sectional analysis of hypothyroid patients attending an endocrine clinic in North India, while trying to focus on their concerns.
The prevalence of DM and dyslipidemia in this cohort was 25% and 52% respectively. This is much more than the earlier reports in which prevalence of hypothyroidism in patients with hypercholesterolemia was 4.3% and diabetes was 5.7%. , This difference could exist due to a selection bias, as the current study reveals values from an endocrine clinic, while the older ones may present data from an internal medicine outpatient department.
The main patient concerns were fatigue, followed by neuropathic pain and permanence of medication. In uncontrolled patients, fatigue, feeling of being sick and lack of well-being were ranked higher, while controlled patients tended to rate need for permanent medication and lack of weight loss, higher. Duration of hypothyroidism did have an effect on patient concerns. As the duration of hypothyroidism increased the patient concern of permanent medicine, difficulty in swallowing and swelling of feet increased.
On a domain based analysis, neck related and gynecological signs and symptoms were concerns of less importance, contrary to the expectation of the authors.
Further, the classification of patient concerns into various domains represents a simple tool for health-care providers to take a detailed, complete history in hypothyroid patients. It helps patients verbalize their concerns and symptoms in an easily understandable manner and also the clinicians by making history taking easier and precise. This contributes to the process of patient empowerment, equipoise, and shared decision making. Hopefully, effective use of this strategy will improve patient satisfaction and therapeutic outcomes in patients with hypothyroidism.
This clinical paradox of symptoms with persistent patient concerns, in spite of "optimal" thyroxine dosage, can be explained on the basis of the concept of tissue hypothyroidism or hypothyroidism at cellular level.  Another explanation could be that diurnal variation in TSH secretion may cause false overestimation of thyroid status. This can happen if TSH levels are measured during early afternoon, when they are at their lowest.  Unsatisfactory weight loss, or unwanted weight gain during course of therapy may cause psychological symptoms.  Other causes of such symptoms include Vitamin D deficiency, celiac disease, menopause, anemia, obstructive sleep apnea, hyponatremia, hypocalcemia, other endocrine disorders, physical unfitness etc. ,,,,,
| Conclusions|| |
While thyroxine cannot be replaced in the management of hypothyroidism, the definition of "optimal thyroxine replacement" is yet not clear. Some authors use the clinical profiling of patients to regulate the thyroxine dosage,  while others advise a combination of TSH measurement and clinical evaluation for the same. 
This study has tried to analyze patient concerns and marks a step forward in trying to promote patient centered management in hypothyroidism. The results will help sensitize physicians and endocrinologists towards eliciting a patient sensitive history, while focusing on clinical and social aspects of relevance of the patient's age and clinical picture.
This cross-sectional study was initially designed as a clinical audit, to assess patient concerns, and management trends in hypothyroid patients. The small sample size, uni-centric design and lack of controls are limiting factors of the study. No gender based analysis was performed due to less number of male patients. Detailed investigations for surrogate markers of hypothyroidism were not carried out. However, we feel that the results are applicable to the vast majority of hypothyroid patients and reflect the clinical picture seen in endocrine clinics across the world.
| Acknowledgments|| |
We acknowledge the contribution of Dr. J. K. Bhutani in providing patients for data collection for this study.
| References|| |
|1.||Available from: http://www.iisc.ernet.in/currsci/oct252000/n%20kochupillai.PDF. [Last accessed on 2012 July 3]. |
|2.||Unnikrishnan AG, Menon UV. Thyroid disorders in India: An epidemiological perspective. Indian J Endocrinol Metab 2011;15:S78-81. |
|3.||Macgregor AG. Why does anybody use thyroid B.P? Lancet 1961;1:329-32. |
|4.||O′Reilly DS. Thyroid function tests-time for a reassessment. BMJ 2000;320:1332-4. |
|5.||Kaplan MM, Sarne DH, Schneider AB. In search of the impossible dream? Thyroid hormone replacement therapy that treats all symptoms in all hypothyroid patients. J Clin Endocrinol Metab 2003;88:4540-2. |
|6.||Robert ND. Psychological problems in thyroid disease. Br Thyroid Found Newsl 1996;18:3. |
|7.||Kalra S, Kalra B, Khandelwal SK. Vitamin D status in well controlled hypothyroid patients in Haryana, India. Thyroid Res Pract 2011;8:12-6. |
|8.||Collins D, Wilcox R, Nathan M, Zubarik R. Celiac disease and hypothyroidism. Am J Med 2012;125:278-82. |
|9.||Mehmet E, Aybike K, Ganidagli S, Mustafa K. Characteristics of anemia in subclinical and overt hypothyroid patients. Endocr J 2012;59:213-20. |
|10.||Hernández Valencia M, Córdova Pérez N, Zárate A, Basurto L, Manuel Apolinar L, Ruiz M, et al. Hypothyroidism associated to menopause symptoms worsening change with thyroid substitution therapy. Ginecol Obstet Mex 2008;76:571-5. |
|11.||Bahammam SA, Sharif MM, Jammah AA, Bahammam AS. Prevalence of thyroid disease in patients with obstructive sleep apnea. Respir Med 2011;105:1755-60. |
|12.||Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in patients on ′adequate′ doses of l-thyroxine: Results of a large, controlled community-based questionnaire study. Clin Endocrinol (Oxf) 2002;57:577-85. |
|13.||Luepker RV, Evans A, McKeigue P, Reddy S. Cardiovascular Survey Methods. 3 rd ed. Geneva: World Health Organization; 2004. p. 114. |
|14.||WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004;363:157-63. |
|15.||American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2011;34:S62-9. |
|16.||Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP). Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285:2486-97. |
|17.||Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 report. JAMA 2003;289:2560-72. |
|18.||Bhutani S, Bhutani J, Balhara YP, Kalra S. Atypical thyroxine replacement in hypothyroidism: A clinical audit. Thyroid Res Pract 2012;9:81-3 |
|19.||Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes: A patient-centered approach: Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364-79. |
|20.||Kalra S, Unnikrishnan AG, Skovlund SE. Patient empowerment in endocrinology. Indian J Endocrinol Metab 2012;16:1-3. |
|21.||Kalra S, Kalra B. Improving compliance in hypothyroidism: What can we do?. Thyroid Res Pract 2012;9:78-80 |
|22.||Tagami T, Kimura H, Ohtani S, Tanaka T, Tanaka T, Hata S, et al. Multi-center study on the prevalence of hypothyroidism in patients with hypercholesterolemia. Endocr J 2011;58:449-57. |
|23.||Tamez-Pérez HE, Martínez E, Quintanilla-Flores DL, Tamez-Peña AL, Gutiérrez-Hermosillo H, Díaz de León-González E. The rate of primary hypothyroidism in diabetic patients is greater than in the non-diabetic population. An observational study. Med Clin (Barc) 2012;138:475-7. |
|24.||Staub JJ, Althaus BU, Engler H, Ryff AS, Trabucco P, Marquardt K, et al. Spectrum of subclinical and overt hypothyroidism: Effect on thyrotropin, prolactin, and thyroid reserve, and metabolic impact on peripheral target tissues. Am J Med 1992;92:631-42. |
|25.||Sturgess I, Thomas SH, Pennell DJ, Mitchell D, Croft DN. Diurnal variation in TSH and free thyroid hormones in patients on thyroxine replacement. Acta Endocrinol (Copenh) 1989;121:674-6. |
|26.||Dale J, Daykin J, Holder R, Sheppard MC, Franklyn JA. Weight gain following treatment of hyperthyroidism. Clin Endocrinol (Oxf) 2001;55:233-9. |
|27.||Skinner GR, Thomas R, Taylor M, Sellarajah M, Bolt S, Krett S, et al. Thyroxine should be tried in clinically hypothyroid but biochemically euthyroid patients. BMJ 1997;314:1764. |
|28.||Almandoz JP, Gharib H. Hypothyroidism: Etiology, diagnosis, and management. Med Clin North Am 2012;96:203-21. |
[Table 1], [Table 2], [Table 3], [Table 4]