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
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.
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