Development and psychometric evaluation of the Thirst Distress Scale for patients with heart failure

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1 728624CNU / European Journal of Cardiovascular Nursing 0(0)Waldréus et al. research-article2017 Original Article Development and psychometric evaluation of the Thirst Distress Scale for patients with heart failure European Journal of Cardiovascular Nursing 2018, Vol. 17(3) The European Society of Cardiology 2017 Reprints and permissions: sagepub.co.uk/journalspermissions.nav DOI: journals.sagepub.com/home/cnu Nana Waldréus 1, Tiny Jaarsma 2,3, Martje HL van der Wal 2,4 and Naoko P Kato 2,5 Abstract Background: Patients with heart failure can experience thirst distress. However, there is no instrument to measure this in patients with heart failure. The aim of the present study was to develop the Thirst Distress Scale for patients with Heart Failure (TDS-HF) and to evaluate psychometric properties of the scale. Methods and results: The TDS-HF was developed to measure thirst distress in patients with heart failure. Face and content validity was confirmed using expert panels including patients and healthcare professionals. Data on the TDS-HF was collected from patients with heart failure at outpatient heart failure clinics and hospitals in Sweden, the Netherlands and Japan. Psychometric properties were evaluated using data from 256 heart failure patients (age 72±11 years). Concurrent validity of the scale was assessed using a thirst intensity visual analogue scale. Patients did not have any difficulties answering the questions, and time taken to answer the questions was about five minutes. Factor analysis of the scale showed one factor. After psychometric testing, one item was deleted. For the eight item TDS-HF, a single factor explained 61% of the variance and Cronbach s alpha was The eight item TDS-HF was significantly associated with the thirst intensity score (r=0.55, p<0.001). Regarding test-retest reliability, the intraclass correlation coefficient was 0.88, and the weighted kappa values ranged from Conclusion: The eight-item TDS-HF is valid and reliable for measuring thirst distress in patients with heart failure. Keywords Thirst distress, heart failure, scale Date received: 2 June 2017; accepted: 2 August 2017 Introduction Thirst is a sensation associated with dryness in the mouth and a desire or craving for water to drink. 1,2 Thirst can be increased in patients with heart failure (HF), and is described as a problem that may cause distress. 3 6 Thirst distress is one of the dimensions that has been used to describe thirst in patients with HF and is defined as the degree to which a person is bothered by thirst (p.145). 4 The other dimensions of thirst as a symptom are thirst intensity (the severity of thirst), thirst quality (how thirst is described in the patients own words), and thirst time dimension (e.g. frequency). 4 Moderate to severe thirst distress has been reported in 46% of patients with HF. 6 Other studies have shown that one in five patients with stable HF 1 Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Sweden 2 Department of Social and Welfare Studies, Linköping University, Sweden 3 Mary McKillop Institute for Health Research, Catholic University of Australia, Australia 4 Department of Cardiology, University of Groningen, Groningen, The Netherlands 5 Department of Therapeutic Strategy for Heart Failure, The University of Tokyo Graduate School of Medicine, Japan Corresponding author: Nana Waldréus, Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Alfred Nobels Alle 23, Huddinge, S , Sweden. nana.waldreus@ki.se

2 Waldréus et al. 227 are troubled by persistent thirst. 7 Thirst is associated with fluid restriction in HF, independent of HF medical treatment and HF severity. 5,8 It is important to measure thirst distress in patients with HF, considering that thirst is one of the factors that decreases quality of life in these patients. 4,6,9 Thirst distress can have emotional consequences, described by HF patients as suffering from thirst. 10,11 There is an increasing trend in health care to measure patient-reported outcomes, but for some outcomes there is only a limited number of instruments available. 12,13 Only one scale measuring thirst distress has been found for patients with chronic disease. 14 Welch (2002) developed the Thirst Distress Scale (TDS) for patients with renal failure who experience troublesome thirst due to haemodialysis treatment. 14 Yet, there is no scale to measure thirst distress in patients with HF. Patients with HF may have disease-specific difficulties related to thirst, especially when they are prescribed fluid restriction. This leads to them thinking about thirst all day, which can cause thirst distress. 4,5,8 11 In order to understand the sensation of thirst distress in patients with HF, a valid and reliable scale is needed. The aim of this study was to develop a scale for patients with HF that measures thirst distress and to evaluate psychometric properties of the scale. Methods Design and procedure In 2011, we first developed the TDS for patients with HF (TDS-HF) in Swedish and English from the original TDS for patients with renal failure, with the permission of Janet L Welch. Subsequently, the Japanese and Dutch versions of the TDS-HF were made, and psychometric properties of the scale were evaluated in an international study in Sweden, the Netherlands and Japan. The original TDS for patients with renal failure was developed to measure thirst distress due to haemodialysis treatment. 14 The items of the scale were developed through a literature review, interviews with patients with renal failure, and the conceptual definition of thirst distress. Content validity of the TDS was confirmed by an expert panel of nine individuals within the areas of symptom management and instrument development, and nursing in nephrology. 14 Reliability and validity of the TDS were tested in 247 outpatients on haemodialysis treatment. During this process, 25 out of 31 items were deleted due to low or high inter-item correlations. 14 As a result, a total of six items remained in the TDS scale for patients with renal failure: My thirst causes me discomfort, My thirst bothers me a lot, I am very uncomfortable when I am thirsty, My mouth feels like cotton when I am thirsty, My saliva is very thick when I am thirsty and When I drink less, my thirst gets worse. 14 Patients answered the six items on a five-point Likert scale. Total scores range from 6 30, with higher scores indicating higher thirst distress. The final scale was demonstrated to be unidimensional. The internal consistency of the TDS was satisfactory (Cronbach s alpha 0.78). 14 Development of the TDS-HF After having been granted permission from the author of the TDS for renal failure patients, the scale was translated from English into Swedish by two bilingual researchers (Swedish and English). 15 The translated Swedish version was then back-translated into English (US) by a professional translator at the Swedish Association of Professional Translators. 15,16 The back-translated scale was considered acceptable by the original TDS author. To determine content and face validity of the TDS-HF, an expert panel in the HF field consisting of four HF nurses (two with a PhD degree), a cardiologist and a dietician evaluated the relevance and clarity of the items. 15 The following changes were made: (a) the original item My thirst causes me discomfort was excluded, as it was almost identical to the other original item I am very uncomfortable when I am thirsty ; (b) the word cotton was replaced by sandpaper in the item My mouth feels like cotton when I am thirsty which describes the feeling in Swedish better; and (c) four new items were added to the scale as items for HF-specific thirst distress: My thirst bothers me daily, My mouth feels dry when I am thirsty, I am so thirsty I could drink water uncontrollably, and My thirst feels difficult to overcome. After this, the TDS-HF consisted of nine items. Ten Swedish patients confirmed the relevance and clarity of these nine items. Subsequently, the Swedish TDS-HF was translated into English by a native English (US) professional translator, with English (US) being the target language and Swedish the source language. The translator was specialised in translations in medicine, natural sciences and educational material. In order to develop the nine-item TDS-HF into Japanese and Dutch versions, forward and back-translations from the English version were performed in each country according to the standard translation process of the scale. 15 Expert panels in each country, including HF nurses, cardiologists and HF nursing scientists discussed the nine items. With regard to the item My mouth feels like sandpaper when I am thirsty, the word sandpaper, which was used in the Swedish and Dutch scales, was translated to rough in the Japanese version: My mouth feels rough when I am thirsty. No items were excluded or included in the Dutch or Japanese versions of the TDS-HF. The nine items of the TDS-HF are rated on a five-point Likert scale, ranging from strongly disagree (score of one) to strongly agree (score of five), and takes about five minutes to complete. The total score ranges from 9 45, where a higher score indicates more thirst distress.

3 228 European Journal of Cardiovascular Nursing 17(3) In the present study, usability was evaluated by asking patients (5 10 patients per country) if the TDS-HF was clear, easy to use and if the questions were relevant. With construct validity, by using factor analysis, we evaluated if the TDS-HF measures what it is set out to measure, namely thirst distress. With concurrent validity the TDS-HF was compared with the patients thirst intensity. Reliability (internal consistency and stability) were evaluated by Cronbachs alpha and test-retest. Sample and setting Patients with HF from all three countries were enrolled from university hospitals, and also from a middle-sized hospital in Stockholm, Sweden. Patients who were admitted to the hospital due to HF deterioration and outpatients who had an appointment at the outpatient HF clinic were included in this study. Inclusion criteria were: patients diagnosed with HF, older than 20 years at the time of enrolment, and free from psychiatric disorder diagnosis. In Sweden, only HF patients with reduced ejection fraction were included. The study complies with the Declaration of Helsinki. Ethical approval for the studies were obtained from ethical committees in each country (in Sweden, the Ethics Committee in Stockholm, 2011/232-31/1, 2012/42-32; in the Netherlands, the Medical Ethical Committee, University Medical Center Groningen, 2015/366; in Japan, the Institutional Review Board at the University of Tokyo Hospital, 10422). Informed and written consent was obtained from each patient prior to study participation. Data collection The study was performed between in Sweden, in the Netherlands, and between in Japan. Patients were asked to fill in the TDS-HF after the visit at the outpatient HF clinic or during hospital admission. To evaluate the test-retest reliability of the TDS-HF, patients from Sweden and Japan filled in the questionnaire again after two weeks. Measurements In addition to collecting data on thirst distress by the TDS-HF, patients thirst intensity was assessed by a visual analogue scale (VAS). 17 Patients were asked to rate how thirsty they were at that moment on a line (100 mm), with the left side of the line indicating no thirst (0 mm), and the right side indicating worst possible thirst (100 mm). 3,17 Data was collected from medical records regarding background demographics and clinical characteristics of the study sample, such as age, left ventricular ejection fraction (LVEF; %), New York Heart Association functional (NYHA) class, and medication (loop-diuretics, angiotensin-converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), mineralocorticoid receptor antagonist (MRA), and beta-blockers). Data analyses First, the distribution of responses for each item of the TDS-HF was examined. To assess construct validity, we performed an exploratory factor analysis (maximum likelihood extraction). 18 Prior to the analysis, the Kaiser-Meyer- Olkin (KMO) measure of sampling adequacy and Bartlett s test of sphericity were used to test the appropriateness of factor analysis. To determine the number of factors, we used the criterion that an eigenvalue is greater than one in the scree plot. 18 To evaluate concurrent validity, Spearman s rank correlation was calculated between thirst intensity (VAS) and the total score of the TDS-HF. 19 With regard to reliability, Cronbach s alpha was calculated to assess the internal consistency of the TDS-HF. 18,20 We also calculated the item-total correlations and the inter-item correlations using Spearman correlation analysis. The stability of the item response of the TDS-HF over time was evaluated using the intra-class correlation coefficient (ICC). For the individual items, weighted kappa was used. 21 For examination of validity and reliability, we used data from patients who answered all items of the TDS-HF. Data is presented as mean values (standard deviation (SD)), medians (interquartile range (IQR)) and numbers (%). The level of statistical significance was set to <0.05. All analyses were performed using SPSS (version 22, SPSS Inc., Chicago, Illinois, USA). Results Participants A total of 99 Swedish, 101 Dutch, and 72 Japanese patients with HF participated in the study (n=272) (Table 1). The median age of the 272 patients with HF from the three countries was 75 years (67 81), 182 (67%) were men and 101 (37%) were in NYHA class III IV. The majority of the patients (86%, n=235) were enrolled from outpatient HF clinics. As there were no significant differences in the total score of the TDS-HF between the three countries (p=0.25) (Table 1), we combined all data and analysed it to examine the validity and reliability of the scale. Data quality A total of 16 patients (6%) had missing answers in the TDS-HF. The percentage of missing answers in the items ranged from 1% (items 1 3, 5, 8), to 3% (item 6) (Table 2). All response options were used in all the nine items. With regard to ceiling and floor effects, some of the items (item

4 Waldréus et al. 229 Table 1. Characteristics of study samples. All (n=272) Sweden (n=99) The Netherlands (n=101) Japan (n=72) Age 75 (67 81) 76 (69 82) 74 (67 79) 73 (54 80) Gender, male, n (%) 182 (67%) 73 (74%) 56 (55%) 54 (75%) Married or cohabiting, n (%) 55 (56%) 63 (88%) Setting Outpatient clinic, n (%) 235 (86%) 69 (70%) 101 (100%) 65 (90%) Hospital, n (%) 37 (14%) 30 (30%) 0 (0%) 7 (10%) NYHA III IV, n (%) 101 (37%) 62 (63%) 27 (27%) 9 (13%) LVEF, mean±sd 38 ± ± ± 9 48 ± 19 Fluid restriction, n (%) 162 (60%) 42 (42%) 97 (96%) 23 (32%) Medication Loop-diuretic, n (%) 157 (58%) 78 (79%) 39 (39%) 40 (56%) MRA, n (%) 11 (11%) 28 (39%) ARB, n (%) 13 (13%) 29 (40%) ACE, n (%) 63 (64%) 27 (38%) Beta-blocker, n (%) 89 (90%) 51 (71%) TDS-HF (scores) 9-item TDS-HF (9 45) 18.3 ± ± ± ± item TDS-HF (8 40) 16.4 ± ± ± ± 8.0 ACE: angiotensin-converting enzyme inhibitor; ARB: angiotensin receptor blocker; LVEF: left ventricular ejection fraction; MRA: mineralocorticoid receptor antagonist; NYHA: New York Heart Association; TDS-HF: Thirst Distress Scale for patients with Heart Failure. 1, 2, 8 and 9) had a negatively skewed distribution as many patients responded score of one or two (Table 2). For item 5, My mouth feels dry when I am thirsty, more patients also responded with scores of three to five. The patients did not have any difficulty answering or interpreting the questions. Construct validity As for factor validity, the sampling adequacy was good, evaluated with the KMO measure of sampling adequacy (0.90) and the Bartlett s test of sphericity (p<0.001). The scree plot detected a one-dimensionality of the scale. The exploratory factor analysis showed that the single factor explained 62% of the variance of the TDS-HF. The contribution of each item to the factor showing by factor loadings was between (Table 3). Concurrent validity The median thirst intensity score (VAS, mm) was 16 mm (IQR 4 44). A total of 139 patients (53%) had a score lower than 20 (median 5 mm (IQR 0 9)), and 122 patients (47%) had a score higher than 20 (median 45 mm (IQR 29 56)). The TDS-HF was significantly associated with the thirst intensity score (r=0.56, p<0.001). Internal consistency The internal consistency of the TDS-HF analysed with Cronbach s alpha was 0.92 (Table 3). Homogeneity of the items was evaluated by item-total correlations (acceptable level set to r 0.4) and inter-item correlations. 18 The itemtotal correlations varied between (Table 4). The strongest item-total correlation occurred in item 2 (My thirst bothers me daily) (r=0.81), and the weakest correlation was found in item 4 (My mouth feels like sandpaper when I am thirsty) (r=0.63). The inter-item correlations varied between The strongest correlation was found between item 1 (My thirst bothers me a lot) and item 2 (My thirst bothers me daily) (r=0.85), and the weakest correlation was found between item 5 (My mouth feels dry when I am thirsty) and item 9 (My thirst feels difficult to overcome) (r=0.36) (Table 4). Reduction of one item In the nine-item TDS-HF, Cronbach s alpha was 0.92, which is higher than the recommended maximum alpha value of This suggests redundancies and also that it might be possible to remove some of the items from the scale. 20 We observed a high correlation between item 1 (My thirst bothers me a lot) and item 2 (My thirst bothers me daily) (r=0.85). We also discussed the possibility that item 2 might reflect the thirst-time dimension, e.g. how often thirst is bothersome, rather than thirst distress. Another restriction with item 2 is that it does not allow the scale to be used more than once a day. Based on this, we decided to delete item 2 from the nine-item scale and use an eight-item TDS-HF instead. The total mean score for the eight-item TDS-HF was 16.4±7.8 (Table 1). There were no significant differences

5 230 European Journal of Cardiovascular Nursing 17(3) Table 2. Scores of the items, item distribution, and missing items (n=272). Item Mean±SD Agreement for each item, n (%) Missing n (%) Strongly disagree Strongly agree My thirst bothers me a lot 1.9 ± (52%) 48 (18%) 52 (19%) 21 (8%) 9 (3%) 3 (1%) 2. My thirst bothers me daily 1.9 ± (55%) 51 (19%) 33 (12%) 21 (8%) 17 (6%) 3 (1%) 3. I am very uncomfortable when I am thirsty 2.0 ± (47%) 51 (19%) 49 (18%) 29 (11%) 12 (5%) 3 (1%) 4. My mouth feels like sandpaper when I am thirsty 2.1 ± (51%) 44 (16%) 34 (13%) 29 (11%) 24 (9%) 5 (2%) 5. My mouth feels dry when I am thirsty 2.7 ± (32%) 41 (15%) 55 (20%) 42 (16%) 46 (17%) 3 (1%) 6. My saliva is very thick when I am thirsty 2.0 ± (53%) 47 (18%) 36 (14%) 24 (9%) 17 (6%) 7 (3%) 7. When I drink less water, my thirst gets worse 2.2 ± (48%) 36 (13%) 36 (14%) 42 (16%) 25 (9%) 4 (2%) 8. I am so thirsty I could drink water uncontrollably 1.8 ± (61%) 31 (12%) 41 (15%) 17 (6%) 17 (6%) 2 (1%) 9. My thirst feels difficult to overcome 1.6 ± (66%) 37 (13%) 26 (10%) 15 (6%) 12 (5%) 5 (2%) SD: standard deviation. in the mean (SD) score among the three countries (p=0.32): Sweden 17.3±7.6, the Netherlands 16.3±8.0, and Japan 15.4±8.0. Validity and reliability of the eight-item TDS-HF The factor analysis of the eight-item (total score ranging from 8 40) showed that a single factor explained 61% of the variance. With regard to concurrent validity, the eightitem TDS-HF was significantly associated with the value of thirst intensity (r=0.55, p<0.001). Cronbach s alpha for the reliability of the eight-item TDS-HF was 0.90, which was a little lower than in the nine-item scale (0.92) (Table 3). Item-total correlations varied between (Table 4). Test-retest reliability For an evaluation of the test-retest reliability of the eightitem TDS-HF, data from 25 patients from Sweden and 52 patients from Japan who completed the questionnaire twice was used. The ICC of the eight item scale was 0.88 (p<0.001) (Table 5). The inter-rater agreement values measured with weighted kappa of the eight items ranged between (Table 5). For four items, the weighted kappa was >0.40, and for four items this was Discussion In the present study we developed an eight-item instrument to measure thirst distress in patients with HF in English, Swedish, Dutch and Japanese, and evaluated psychometric properties of the scale using three language versions. The result shows that the TDS-HF is the first valid and reliable instrument to measure thirst distress in patients with HF. We would like to emphasise that the TDS-HF was developed in English, Swedish, Dutch and Japanese, and evaluated psychometric properties in both European and Asian countries. We assumed that cultural and physical differences between the European and Asian countries might influence items on the scale and the psychometric properties. We translated the TDS-HF according to an established procedure for translation of scales. 15,16 Only one word was translated slightly different in the Japanese version; the word sandpaper in the Swedish and Dutch versions was translated into rough in the Japanese version, while in the original English TDS it was described with the word cotton. As this feeling in the mouth was described differently in some countries and languages, the TDS-HF was therefore culturally adapted for the different countries. On the other hand, there were no significant differences in the total and item scores of the scale, and we therefore combined all data from the three countries and analysed it together. Validity and reliability of the TDS-HF were confirmed in the international samples.

6 Waldréus et al. 231 Table 3. Factor loadings of nine items and eight items on one factor and reliability of the scales if item is deleted (n=256). Item Factor loading a Cronbach s alpha if item deleted 9-Item 8-Item 9-Item 8-Item 1. My thirst bothers me a lot My thirst bothers me daily I am very uncomfortable when I am thirsty My mouth feels like sandpaper when I am thirsty My mouth feels dry when I am thirsty My saliva is very thick when I am thirsty When I drink less water, my thirst gets worse I am so thirsty I could drink water uncontrollably My thirst feels difficult to overcome Cronbach s alpha TDS-HF 9-item 0.92 KMO: Kaiser-Meyer-Olkin; TDS-HF: Thirst Distress Scale for patients with Heart Failure. For 9-item TDS-HF, KMO (<0.001); 8-item TDS-HF, KMO (<0.001). a Maximum likelihood analysis used as extraction method. 8-item 0.90 Table 4. The item-total and inter-item correlations of the eight-item and nine-item Thirst Distress Scale for patients with Heart Failure (TDS-HF) (n=256). Item Item-total correlations Inter-item correlations 8-Item scale 9-Item scale My thirst bothers me a lot My thirst bothers me daily I am very uncomfortable when I am thirsty My mouth feels like sandpaper when I am thirsty My mouth feels dry when I am thirsty My saliva is very thick when I am thirsty When I drink less water, my thirst gets worse I am so thirsty I could drink water uncontrollably My thirst feels difficult to overcome Thirst distress is the degree to which a person is bothered by thirst, 4,14 and the TDS-HF is the first instrument to measure thirst distress in patients with HF. Looking at the items of the eight-item TDS-HF, three items deal with thirst and the feeling in the patient s mouth, while the other five items include more general claims about thirst distress. We discussed the scale with an expert group that included cardiologists, nurses with extensive knowledge on HF and dieticians. The study patients did not have difficulty answering or interpreting the questions, and the time taken to answer the questions was appropriate. The percentage of missing items was low. From these findings, we consider that face validity, content validity and usability of the TDS-HF have been confirmed. A scree plot and factor analysis showed a one-dimensionality of the scale. After we deleted one item, 61% of the variance was explained by the one factor. Factor loading of all eight items was higher than the recommended minimum value of On the basis of these results, we considered that the TDS-HF measures a single factor. There was a statistically significant relationship between the total score of the TDS-HF and the value of thirst intensity, suggesting an adequately concurrent validity. However, the correlation was, as expected, moderate, as one instrument measures the intensity of thirst and the other the distress of thirst, which confirms that these are different concepts and that there is a need for different scales measuring thirst intensity and thirst distress. As the value of Cronbach s alpha in the nine-item TDS-HF was higher than the recommended ( ), 20 we deleted one item. Subsequently, the alpha value was 0.90, which suggests that internal consistency is high. As the results of psychometric properties might be influenced by the study population, a future study is necessary to

7 232 European Journal of Cardiovascular Nursing 17(3) Table 5. Stability of the eight-item Thirst Distress Scale for patients with Heart Failure (TDS-HF) over time (n=77). Item Weighted kappa 1. My thirst bothers me a lot I am very uncomfortable when I am 0.33 thirsty 3. My mouth feels like sandpaper when I 0.41 am thirsty 4. My mouth feels dry when I am thirsty My saliva is very thick when I am thirsty When I drink less water, my thirst gets 0.32 worse 7. I am so thirsty I could drink water 0.45 uncontrollably 8. My thirst feels difficult to overcome 0.60 Intra-class correlation coefficient (95% Cl) 0.88 ( ) a Cl: confidence interval. a p-value< examine whether there would be a possibility to exclude more items from the TDS-HF in a larger varied sample that includes more HF patients experiencing intensive thirst, or patients who have severe HF. As for stability of the TDS-HF, the ICC for the total score was This value was satisfactory when judged against the recommended value of 0.70 or higher. 21 The weighted kappa value was greater than 0.40 for four items, confirming the reliability of these items. The other four items with low weighted kappa values might include experiences with thirst that can be easier for the patient to correct with different actions, and can therefore affect the stability of the items. For example, the items My mouth feels dry when I am thirsty, My saliva is very thick when I am thirsty and When I drink less water, my thirst gets worse might more easily be changed by, for example, drinking water and therefore be less stable over time. The items might also be influenced by patients who did not have severe thirst. Thirst distress has been measured with the original TDS with six items in patients with renal failure on haemodialysis in America and Turkey, and in these studies the internal consistency was also good (Cronbach s alpha 0.78 and 0.81, respectively). 14,22 For the American study, a scree plot showed support for a one-factor solution, but in the Turkish study it did not clearly indicate if one or two factors existed. The correlation between TDS and thirst intensity was slightly lower in both studies (r=0.31 and r=0.41, respectively) compared to the TDS-HF with eight items (r=0.55). The TDS has also been used for patients with HF, however no psychometric evaluation was presented. 6 Although there have not been many studies on thirst distress among patients with other diseases or illnesses, some patients who have diabetes, cancer, older patients with multimorbidity or patients in an intensive care unit, may also suffer from thirst distress Our study population was mostly representative of stable patients with HF visiting a HF clinic. However, the thirst intensity score in some patients was rather low (i.e. less than 20 mm), which suggests that they did not feel a strong thirst intensity. If a patient is not so thirsty, the TDS-HF might not be able to measure thirst distress sufficiently, which may lead to reduced sensitivity of the scale. Indeed, in the present study, some items were biased to a score of one or two, possibly because some patients did not feel severe thirst. For this reason, future studies should be designed to investigate how the TDS-HF can be used in patients with high thirst intensity, and how the concepts of thirst intensity and thirst distress are related. Furthermore, thirst distress might be influenced by climate and weather, depending on the residence of the patient. It could therefore also be important to examine thirst distress among patients who live in hot countries. Our findings demonstrate that the TDS-HF is a valid and reliable scale. The scale has now been translated into English, Swedish, Dutch and Japanese (can be obtained from the authors). Currently, a German version of the scale is also being developed and we encourage further use of the scale in other countries. The recently developed scale could be useful to assess patients thirst distress in daily care, as well as to evaluate treatment and care provided by health-care professionals in research settings. In addition, patients receiving palliative care or patients hospitalised in intensive care units might experience strong thirst distress. 22,23 This new scale would be helpful in order to assess their thirst distress and carry out appropriate interventions. 27 The eight-item scale was developed to capture the level of thirst distress in patients with HF, but it remains to be elucidated whether, and how, this scale is specific to HF patients. In future studies it would be interesting to examine thirst distress in other populations that experience troublesome thirst Limitations Although we recruited study patients without any strict exclusion criteria, some of the participants did not experience severe thirst intensity. We also included patients from specific countries (Sweden, Japan and the Netherlands), which should be taken into consideration when interpreting our results. There were demographical differences, such that patients from Sweden were slightly older, had lower LVEF and more patients had higher NYHA class, compared to the other two countries. The Netherlands had only outpatients included and a majority were prescribed fluid restriction. Regarding possible geographical differences and thirst between the countries, data was collected throughout the year. Although the temperature varies greatly during the different seasons in all three countries, there were no differences in the TDS-HF among the countries.

8 Waldréus et al. 233 Conclusion We developed the Swedish, Dutch and Japanese versions of the TDS-HF. Our findings demonstrate that the eightitem TDS-HF is a valid and reliable scale for measuring thirst distress in patients with HF. Implications for practice The eight-item Thirst Distress Scale for patients with heart failure is a new and one-dimensional scale that has been developed to assess thirst distress in patients with heart failure. The eight-item Thirst Distress Scale for patients with heart failure has good reliability and validity in assessing thirst distress in patients with heart failure, which is a cornerstone for identifying those patients with thirst distress. Thirst distress can be experienced as troublesome in patients with heart failure, lead to preoccupation with thirst and have an impact on patient s quality of life. The Thirst Distress Scale for patients with heart failure can be helpful in order to assess heart failure patients thirst distress in daily care and carry out appropriate interventions. Acknowledgements The authors wish to express their sincere gratitude to all participating patients in all three countries, the expert groups for the development of the scale, and a special thanks to HF nurses and cardiologists for helping with the recruitment of study participants and data collection; Pia Jonsson, Södertälje sjukhus; Patrik Lyngå, Södersjukhuset; Ewa Hägglund, Karolinska Universitetssjukhuset Huddinge (Sweden); Edske Mensinga and Rieanne Aardema at the HF clinic in Wilhelmina Ziekenhuis Assen (the Netherlands); Koichiro Kinugawa, Toyama University; Ikuko Okada and Naoko Takayama, University of Tokyo (Japan). Declaration of conflicting interest The authors declare that there is no conflict of interest. Funding This work was supported in Sweden by Riksförbundet-HjärtLung (grant number E100/13), Stockholms läns landsting (Pick-Up project), and Svensk Sjuksköterskeförening, Estrid Rodhe funding to NW; in Japan by a Grant-in-Aid for Research Activity Start-up to NPK from the Japan Society for the Promotion Science KAKENHI (JP ). References 1. Porth CM and Erickson M. Physiology of thirst and drinking: Implication for nursing practice. Heart Lung 1992; 21: Greenleaf JE. Problem: Thirst, drinking behavior, and involuntary dehydration. Med Sci Sports Exerc 1992; 24: Waldréus N, Sjöstrand F and Hahn RG. Thirst in the elderly with and without heart failure. Arch Gerontol Geriatr 2011; 53: Waldréus N, Hahn R and Jaarsma T. Thirst in heart failure: A systematic literature review. Eur J Heart Fail 2013; 15: Waldréus N, Hahn RG, Lyngå P, et al. Changes in thirst intensity during optimization of heart failure medical therapy by nurses at the outpatient clinic. J Cardiovasc Nurs 2016; 31: E17 E Reilly CM, Meadows K and Dunbar S. Thirst and QOL in persons with heart failure. Heart Lung 2010; 39: Waldréus N, van der Wal M, Hahn RG, et al. Thirst trajectory and factors associated with persistent thirst in patients with heart failure. J Cardiac Fail 2014; 20: Johansson P, van der Wal MH, Strömberg A, et al. Fluid restriction in patients with heart failure: How should we think? Eur J Cardiovasc Nurs 2016; 15: Reilly CM, Higgins M, Smith A, et al. Isolating the benefits of fluid restriction in patients with heart failure: A pilot study. Eur J Cardiovasc Nurs 2015; 14: Brännström M, Ekman I, Norberg A, et al. Living with severe chronic heart failure in palliative advanced home care. Eur J Cardiovasc Nurs 2006; 5: van der Wal MHL, Jaarsma T, Moser DK, et al. Qualitative examination of compliance in heart failure patients in the Netherlands. Heart Lung 2010; 39: Norekvål TM, Fålun N and Fridlund B. Patient-Reported Outcomes in Cardiology (PROCARD) research group. Patient-reported outcomes on the agenda in cardiovascular clinical practice. Eur J Cardiovasc Nurs 2016; 15: Pani L, Pecorelli S, Rosano G, et al. Steps forward in regulatory pathways for acute and chronic heart failure. Eur J Heart Fail 2015; 17: Welch JL. Development of the thirst distress scale. Nephrol Nurs J 2002; 29: Polit DF and Beck CT. Nursing research: Generating and assessing evidence for nursing practice. Ninth ed. Philadelphia, PA: Lippincott Williams and Wilkins, Streiner DL, Norman GR and Cairney J. Health measurement scales. A practical guide to their development and use. Fifth ed. New York: Oxford University Press, Holst M, Stromberg A, Lindholm M, et al. Fluid restriction in heart failure patients: Is it useful? The design of a prospective, randomised study. Eur J Cardiovasc Nurs 2003; 2: Field AP. Discovering statistics using IBM SPSS statistics. Fourth ed. London: SAGE, Fayers PM and Machin D. Quality of life: The assessment, analysis and interpretation of patient reported outcomes. Second ed. West Sussex: John Wiley & Sons, Streiner DL. Starting at the beginning: An introduction to coefficient alpha and internal consistency. J Personality Assessment 2003; 80:

9 234 European Journal of Cardiovascular Nursing 17(3) 21. McHugh ML. Interrater reliability: The kappa statistic. Biochemia Medica 2012; 22: Kara B. Validity and reliability of the Turkish version of the Thirst Distress Scale in patients on hemodialysis. Asian Nurs Res 2013; 7: Morita T, Tei Y, Tsunoda J, et al. Determinants of the sensation of thirst in terminally ill cancer patients. Supp Care Cancer 2001; 9: Stotts NA, Arai SR, Cooper BA, et al. Predictors of thirst in intensive care unit patients. J Pain Symptom Manage 2015; 49: Warren R, Deary IJ and Frier BM. The symptoms of hyperglycaemia in people with insulin-treated diabetes: Classification using principal component analysis. Diabetes Metab Res Rev 2003; 19: Eckerblad J, Theander K, Ekdahl A, et al. Symptom trajectory and symptom burden in older people with multimorbidity, secondary outcome from the RCT Age-FIT study. J Adv Nurs 2016; 72: Ponikowski P, Voors AA, Anker SD, et al ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2016; 18:

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