Endokrynologia Polska 4/2015-ThyPROpl – The Polish version of the thyroid-specific quality of life questionnaire ThyPRO

SZKOLENIE PODYPLOMOWE/POSTGRADUATE EDUCATION

ThyPROpl – The Polish version of the thyroid-specific quality of life questionnaire ThyPRO

ThyPROpl – polska wersja kwestionariusza oceny jakości życia u pacjentów z chorobami tarczycy

Nadia Sawicka-Gutaj1, Torquil Watt 2 , Jerzy Sowiński 1 , Paweł Gutaj3, Joanna Waligórska-Stachura 1 , Marek Ruchała 1

1Department of Endocrinology, Metabolism, and Internal Medicine, Poznan University of Medical Sciences, Poznan, Poland

2Copenhagen University Hospital Rigshospitalet, Denmark

3Department of Obstetrics and Women’s Diseases, Poznan University of Medical Sciences, Poznan, Poland

Nadia Sawicka-Gutaj M.D., Department of Endocrinology, Metabolism, and Internal Medicine, Przybyszewski St. 49, 60-355 Poznań, Poland, phone: +48 61 869 13 30; fax: +48 61 869 16 82, e-mail: nyha@tlen.pl

Abstract

Introduction: Thyroid disorders have a significant impact on patients’ quality of life. ThyPRO is a thyroid-specific quality of life (QoL) questionnaire applicable to patients with benign thyroid disorders. There is substantial evidence for its clinical validity and reliability in patients with benign thyroid disorders.
Our aim was to develop a validated Polish version of this questionnaire (ThyPROpl).

Material and methods: ThyPROpl was translated and validated according to standard methodology for translation of patient-reported outcomes (PRO). Firstly two independent translations from English to Polish were performed by two translators native in Polish, and a consensus version was reached in collaboration with an in-country consultant. A third translator prepared a back-translation from Polish to English, which likewise was reviewed by the in-country consultant. The backwards translation was reviewed by a PRO translation expert native in English (Health Research Associates HRA) and by the developer of ThyPRO, who provided additional revisions. Finally, ThyPROpl was tested among five patients with thyroid disorders with cognitive interview techniques, and new changes and clarifications needed for its full understanding were made.

Results: ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire.

Conclusions: We recommend ThyPROpl for the evaluation of QoL among Polish patients with benign thyroid disorders. ThyPRO has now been translated into 13 languages.

(Endokrynol Pol 2015; 66 (4): 367-380)

 

Key words: quality of life; hypothyroidism; Hashimoto disease; hyperthyroidism; Graves disease; thyroid eye disease; goitre

 

Streszczenie

Wstęp: Choroby tarczycy mają znaczący wpływ na jakość życia pacjentów. ThyPRO jest kwestionariuszem oceny jakości życia przeznaczonym dla pacjentów z łagodnymi chorobami tarczycy. Kwestionariusz poddano walidacji i standaryzacji.
Celem pracy było stworzenie polskiej wersji kwestionariusza ThyPRO.

Materiał i metody: Kwestionariusz ThyPROpl przetłumaczono zgodnie ze standardową metodologią tłumaczenia kwestionariuszy samooceny jakości życia dokonywanej przez pacjentów. Początkowo dwóch niezależnych badaczy przetłumaczyło wersję angielską kwestionariusza na język polski. Wstępną, polską wersję kwestionariusza opracowano na bazie konsensusu pomiędzy tłumaczami oraz konsultantem. Trzeci tłumacz, który nie znał wersji oryginalnej kwestionariusza, na podstawie polskiej wersji przygotował wersję angielską, która również była oceniona przez konsultanta. Następnie tłumaczenie to poddano analizie przez zewnętrznego eksperta, którego językiem ojczystym jest język angielski oraz przez twórcę ThyPRO, którzy wprowadzili dodatkowe poprawki. Ostatecznie, pięcioro pacjentów zostało poproszonych o odpowiedź na pytania zawarte w ThyPROpl i zgodnie z ich sugestiami kolejne poprawki były wprowadzone celem udoskonalenia tłumaczenia.

Wyniki: ThyPROpl jest polską wersją ThyPRO poddaną językowej walidacji.

Wnioski: Autorzy rekomendują ThyPROpl do oceny jakości życia u polskich pacjentów z łagodnymi chorobami tarczycy. ThyPRO aktualnie występuje w 13 wersjach językowych.

(Endokrynol Pol 2015; 66 (4): 367-380)

 

Słowa kluczowe: jakość życia; niedoczynność tarczycy; choroba Hashimoto; nadczynność tarczycy; choroba Cravesa-Basedowa; orbitopatia tarczycowa; wole

Funding : Danish Counsel for Strategic Research (09-066886).

Introduction

Quality of life in patients with benign thyroid disorders

Thyroid disorders have a significant impact on patients’ quality of life (QoL). Since benign thyroid diseases are very common and the outcome of therapy cannot be exclusively based on laboratory findings, we need a comprehensive instrument to assess tire health-related QoL [1 ]. Nowadays, tire impairment of thyroid dysfunction or thyroid eye disease on QoL is well established [2-7]. However, the negative influence of other thyroid disorders such as benign goitre or chronic autoimmune thyroiditis on patients’ QoL has been suggested in recent studies [8-11].

ThyPRO – a thyroid-specific patient-reported outcome questionnaire

ThyPRO is a thyroid-specific QoL questionnaire applicable to patients with benign thyroid disorders. We chose to translate this questionnaire because there is substantial evidence for its clinical validity and reliability in patients with benign thyroid disorders [12]. ThyPRO consists of 85 questions summarised in 13 scales measuring aspects of QoL relevant to thyroid patients. The patient needs approximately 14 minutes to answer all of the questions. The 13 multi-item scales are listed in Table I.

Table I. The list of 13 multi-item scales ofThyPROpl
Tabela I.  Lista 13 uńelopozycyjnych skal, z których składa się ThyPROpl

  Goitre Symptoms   Tiredness   Impaired Social Life
1a Sense of fullness in neck 2a Been tired 8a Difficult being with other people
1b Visible swelling in front of neck 2b Been exhausted 8b A burden to other people
1c Pressure in throat 2c Difficulty getting motivated 8c Conflicts with other people
1d Pain in front of neck 2d Felt worn out 8d People lack understanding
1e Throat pain felt in ears 3a Full of life   Impaired Daily Life
1f Lump in throat 3b Energetic 9a Difficulty managing daily life
1g Clear throat often 3c Able to cope with life 9b Limit leisure activities
1h Discomfort swallowing   Cognitive Complaints 9c Difficulty participating in life
1i Difficulty swallowing 4a Problems remembering 9d Difficulty getting around
1j Sense of suffocating 4b Slow or unclear thinking 9e Everything takes longer
1k Hoarseness 4c Difficulty finding words 9f Difficulty managing job
  Hyperthyroid Symptoms 4d Been confused   Impaired Sex Life
1l Trembling hands 4e Difficulty learning 10a Negative influence on sex life
1m Increased sweating 4f Difficulty concentrating 10b Decreased sexual desire
1n Palpitations   Anxiety   Cosmetic Complaints
1o Shortness of breath 5a Nervous 11a Disease affect appearance
1p Sensitive to heat 5b Afraid or anxious 11b Unsatisfied with appearance
1r Increased appetite 5c Felt tension 11c Camouflage or mask visible signs
1s Loose stools 5d Concerned being seriously ill lid Bothered by other people looking
1t Upset stomach 5e Uneasy lie Influence on clothes worn
  Hypothyroid Symptoms 5f Restless Ilf Felt too fat
1q Sensitive to cold   Depressivity   Overall Quality of Life
1cc Swollen hands or feet 6a Sad 12 Has your thyroid disease had a negative effect on your quality of life?
1 dd Dry skin 6b Depressed    
1ee Itching skin 6c Discouraged    
  Eye Symptoms 6d Crying easily    
1u Watery eyes 6e Unhappy    
1v Bags under the eyes 6f Happy    
1w Grittiness in eyes 6g Self-confident    
1x Reduced sight   Emotional Susceptibility    
1y Pressure in eyes 7a Difficulty coping    
1z Double vision 7b Not like yourself    
1aa Pain in eyes 7c Easily stressed    
1 bb Sensitive to light 7d Mood swings    
    7e Irritable    
    7f Frustrated    
    7g Angry    
    7h Felt in control    
    7i Felt in balance    

Patients are asked to rate their responses for each item on a five-point Likert scale: 0 – not at all; 1 – a little; 2 – some; 3 – quite a bit; 4 – very much. The reference period is four weeks. If more than half of the items in a scale receive a valid response, then the scale scores are derived by taking the average item scores of each domain and transforming them linearly into a 0-100 scale (item mean *25). Thus, if all four items in the Hypothyroid Symptoms scale have received an answer „not at all”, then the scale score is 0. If all items within a scale receive an answer of „Very much”, then the scale score is 100 (4*25). If for example two of the four hypothyroid items are answered with „a little”, one „some”, and one „quite a bit”, then the scale score would be (1 + 1 + 2 + 3)/4 *25 = 44.

Material and methods

Our aim was to develop a validated Polish version of this questionnaire (ThyPROpl). The developer of the questionnaire gave consent for translation. ThyPROpl was translated and validated according to standard methodology for translation of patient-reported outcomes (PRO). Firstly, two independent translations from English to Polish were performed by two translators native in Polish, and a consensus version was reached in collaboration with an in-country consultant. A third translator prepared a back-translation from Polish to English, which likewise was reviewed by the in-country consultant. The backwards translation was compared to the original English version by a PRO translation expert native in English (Health Research Associates HRA). If some discrepancies were found, the translation steps were repeated for those portions. The back-translated version was also reviewed by the developer of ThyPRO, who provided additional revisions. Finally, ThyPROpl was tested among five patients with thyroid disorders with cognitive interview techniques, and new changes and clarifications needed for its full understanding were made. There was one major disagreement between the two translators during the forward translation step. During HRA evaluation 36 revisions were made by the in-country consultant and 8 comments were provided by the developer. Based on patients’ comments, five revisions were performed and subsequently tested by the in-country consultant. After proof-reading by an external consultant recruited by HRA and formatting, ThyPROpl was finally approved.

Results

ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire.

Conclusions

We recommend tire ThyPROpl for tire evaluation of QoL among Polish patients with benign thyroid disorders. ThyPRO has now been translated into 13 languages.

References

  1. Sowiński J, Czupryniak L, Milewicz A, Hubalewska-Dydejczyk A, Szelachowska M, et al. Recommendations of the Polish Society of Endocrinology and Polish Diabetes Association for the management of thyroid dysfunction in type 1 and type 2 diabetes. Endokrynol Pol 2013; 64: 73-77
  2. Jaeschke F, Cook D, Harper S et al. Spectrum of quality hypothyroidism of life impairment in hypothyroidism. Qual Life Res 1994; 3: 323-327.
  3. Estcourt S, Quinn AG, Vaidya B. Quality of life in thyroid eye disease: impact of quality of care. Eur J Endocrinol 2011; 164: 649-655.
  4. Wiersinga WM. Quality of life in Graves’ ophthalmopathy. Best Practice & Research Clinical Endocrinology & Metabolism 2012; 26: 359-370.
  5. Watt T, Groenvold M, Rasmussen AK et al. Quality of life in patients with benign thyroid disorders. A review. Eur J Endocrinol 2006; 154: 501-510.
  6. Sawicka-Gutaj N, Gutaj P, Sowiński J et al. Influence of cigarette smoking on thyroid gland – an update. Endokrynol Pol 2014; 65: 54-62.
  7. Jabrocka-Hybel A, Bednarczuk T, Bartalena L et al. Amiodarone and the thyroid. Endokrynol Pol 2015; 66: 176-196.
  8. Mishra A, Sabaretnam M, Chand G et al. Quality of life (QoL) in patients with benign thyroid goiters (pre- and post-thyroidectomy): a prospective study. World J Surg 2013; 37: 2322-2329.
  9. Ott J, Promberger R, Kober F et al. Hashimoto’s thyroiditis affects symptom load and quality of life unrelated to hypothyroidism: a prospective case-control study in women undergoing thyroidectomy for benign goiter. Thyroid 2011; 21: 161-167.
  10. Promberger R, Hermann M, Pallikunnel SJ et al. Quality of life after thyroid surgery in women with benign euthyroid goiter: influencing factors including Hashimoto’s thyroiditis. American Journal of Surgery 2013; 207: 974-979.
  11. Watt T, Hegediis L, Bjorner JB et al. Is thyroid autoimmunity per se a determinant of quality of life in patients with autoimmune hypothyroidism? Eur Thyroid J 2012; 1: 186-192.
  12. Watt T, Hegediis L, Groenvold M et al. Validity and reliability of the novel thyroid-specific quality of life questionnaire, Thy PRO. Eur J Endocrinol 2010; 62: 161-167.

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