Introduction
Dysphagia is one of the most common side effects before, during and/or after treatment for head and neck cancer (HNC) [
1]. It is a major cause of malnutrition, dehydration, weight loss, chronic aspiration and aspiration pneumonia [
2,
3]. In addition, due to the social function of eating and drinking, dysphagia causes psychosocial complications such as depression, social isolation or reduced quality of life (QoL) [
4‐
6]. Late-onset dysphagia, even in a mild form, is one of the most important factors negatively affecting QoL in HNC patients [
5].
The high prevalence rates of up to 95% of the HNC patients and the detrimental effects of dysphagia highlight the importance of comprehensive research to determine the impact of dysphagia in HNC [
7]. To adequately capture the functional impact of dysphagia, it is appropriate to use the International Classification of Functioning, Disability and Health (ICF) model. This model provides a common language to describe people’s health and functioning [
8,
9]. The ICF-model includes not only the patient’s physical functions and impairments, but the patient is viewed in a broader perspective that includes participation (ability to do housework, to have a salaried occupation,…), activities (sitting, cleaning, grocery shopping,…), personal (age, gender, education) and environmental factors (EF) (social and work environment, friends). Recent research by Moloney et al. demonstrated by mapping the most commonly used patient- reported outcome measures for dysphagia to the ICF- model that both tools (SWAL-QOL and EAT-10) did not survey the impact of EF on dysphagia. They conclude that the development of a suitable and appropriate patient-reported assessment tool covering all aspects of the ICF model dysphagia patients is warranted [
10].
Research often shows a discrepancy between purely clinical assessments and patient-reported outcomes [
11]. This shows that clinician-rated instruments and Patient Reported Outcome Measures (PROMs) measure different health-related domains. However, PROMs appear to be equally valid for measuring disease status and predicting long-term outcomes [
12]. Therefore, it is important to include the patient’s experience when assessing dysphagia.
A review of the literature shows that several PROMs have been developed to examine the psychosocial impact of dysphagia. However, most instruments focus largely on the physiological aspects of swallowing (functions and anatomical features) [
13]. The activity and participation components receive limited attention in the questionnaires, and the influence of EF is often not explored [
8,
13]. However, several studies have shown that patients with HNC consider the support of family, friends and carers to be crucial during treatment and rehabilitation, highlighting the importance and influence of these EF [
14]. The lack of questionnaires that adequately assess the influence of EF may incompletely capture the impact of dysphagia in this target population.
To address this shortcoming, the Head and Neck Cancer Survivors’ Assessment of Mealtimes (HNSAM) was developed [
14]. The questionnaire, constructed according to the ICF framework, consists of 31 items. These are divided into three components: Functions and anatomical features, Activities and Participation (A&P), and EF. The HNSAM was designed to assess the impact of meal-related problems and has a unique subscale related to EF. The HNSAM was originally developed in English by the Chan et al. research group, and then translated and validated in Chinese [
14]. Until now research involving the HNSAM is limited to the research about the development of the tool and the translation into English.
Since the HNSAM questions multiple aspects of the ICF-model, including activities, participation and EF, it is a valuable PROM with a potential asset for clinical practice. To date, the instrument is only available in two languages and is therefore not very accessible. The aim of this study is to translate the English version of the HNSAM into Dutch and to validate this version (D-HNSAM).
Methods
The method consists of two phases: first, the translation and cross-cultural adaptation of the HNSAM, and second, the clinical trial with data collection. The study was approved by the medical ethics committee: Ethics Committee University Hospital Antwerp (UZA) and University Hospital Ghent (UZ Ghent) with reference number B3002021000111.
Phase 1: Translation and Cross-cultural Adaptation
The translation of the English version of the Head and Neck Cancer Survivors’ Assessment of Mealtimes (HNSAM) was done according to the Guidelines for Cross-Cultural Adaptation of Health-Related Quality of Life Measurement Instruments [
15]. Cross-cultural adaptation of a questionnaire refers to the process of internal changes in questions of the original instrument to be able to function in a different culture. The standardized procedure of translation & back-translation was followed [
15].
1.
The original questionnaire was translated from English by two independent native speakers of Dutch. Through consultation between the researchers’ discrepancies were eliminated and an interim version was obtained.
2.
Back-translation: two independent native English speakers translated the translated Dutch version back into English.
3.
The original English questionnaire and the back-translated version were compared. Discrepancies or ambiguities were clarified.
The original tool uses yes/no options for the background preliminary information section and Likert scales for all other sections. For the background section, the translated version includes the standard options ‘yes’ and ‘no’ with in addition to the standard options ‘yes’ and ‘no’, a ‘not applicable (NA)’ option for the background section. This option was added to document the applicability of the items in the specific context of the individual patient. An additional question was added at the end of the questionnaire to inquire about the overall impact of dysphagia on the patient’s daily life. This question, “How much do the changes in eating and swallowing affect your daily life?” required the patient to answer on a visual analogue scale (VAS) ranging from 0 (no impact) to 10 (severe impact). The score on the VAS scale is not included in the total score of the D-HNSAM.
In addition, the original scoring system of the EF subscale of the Chinese version of the HNSAM as described by Chan et al. was adopted. The researchers opted for a scoring format with a score range of − 4 to + 4. A score of − 4 to − 1 corresponded to choosing the option hindrance. In that way − 4 was a more severe hindrance than − 1. A positive score corresponded to choosing help, with 4 being a major help and a score 1 being a mild help.
The obtained questionnaire was then completed by 10 HNC patients (6 men, 4 women) in a pilot study with the minimal adjustments mentioned above. The subjects were selected based on the same inclusion criteria as for the clinical trial and were approached by a speech and language pathologist in the University Hospital of Antwerp. Additionally, the linguistic formulation of the test items was also examined. All subjects who met the inclusion criteria described below indicated whether the wording was “OK” or “not OK”. In a semi-structured interview formatted and conducted by the involved researchers, participants were asked to explain the difficulties with the wording and to make suggestions for improvement. Answers were noted by the researchers.
Phase 2: Clinical Study
Study Participants
50 Dutch-speaking patients with HNC who had completed treatment with surgery, radiotherapy and/or chemoradiotherapy at least 6 months previously were included in this study. All patients signed an informed consent form, and their data were pseudonymized. Participants were included in the same manner as for the pilot study.
Study Design
In order to examine the psychometric properties of the D-HNSAM, the subjects were asked to complete, in addition to the D-HNSAM, the Dutch Dysphagia Handicap Index (DHI) [
16] and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) [
17]. These questionnaires were completed under the supervision of the speech therapist-researcher.
Following an interview, the investigator completed the Dutch Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) [
18] and the Functional Oral Intake Scale (FOIS) [
19].
One week after completing the questionnaires, patients were asked to complete the D-HNSAM a second time. Patients were given the choice of completing the questionnaire digitally or on paper.
Assessment
Dutch Version of the Head and Neck Cancer Survivors Assessment of Mealtime (D-HNSAM)
The D-HNSAM is a PROM and assesses several aspects of the ICF model. It consists of 31 items. This is broken down into three components: Functions and Anatomical Features, A&P, and EF.
As described by Chan et al. all three components [Physical Functions and Structures (PF&S), A&P and EF] are scored on an ordinal scale from 0 to 4, with a higher score reflecting a higher degree of impairment.
Total scores refer to the sum of all scores on all subscales of the instrument. Core scores were created by summing the subscale scores of the PF&S subscale and the A&P subscale, as described by Chan et al. The higher the score, the higher the impact of the dysphagia on the patient’s life.
Dysphagia Handicap Index (DHI)
The DHI is a PROM that assesses the impact of disorders on quality of life [
16]. The PROM has been translated and validated in Dutch by Guns et al [
20]. The questionnaire consists of 25 items divided into three subscales: a Functional subscale (F, 9 items), an Emotional subscale (E, 7 items) and a Physical subscale (P, 9 items). The items are scored using a three-point scale. The subscale scores are summed to give a total DHI score.
The PSS-HN is a validated Dutch instrument used by researchers to assess the discomfort experienced by people with HNC [
18,
21]. The D-PSS-HN cannot be classified as a PROM. It is an instrument completed by the researcher based on open questions to the patient. The questionnaire consists of three subscales that measure the ability to follow a normal diet, to eat in public, and to produce completely intelligible speech. The three subscales are scored on a scale from 0 to 100. For each subscale, a score of 50 or less is considered moderate to severe discomfort. The higher the score, the less negative impact the patient experiences in terms of intelligibility, eating public and dietary restrictions.
Functional Oral Intake Scale (FOIS)
Using this instrument, the researcher quantifies the patient’s functional oral intake at the activity level [
19]. The FOIS consists of a seven-point scale, with three items (1,2,3) referring to non-oral or tube feeding, and four items (4,5,6,7) relating to oral feeding. The scale is scored based on a semi-structured interview with the patient.
Utrecht Scale for Evaluation and Rehabilitation—Participation (USER-P)
The Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) is a validated and reliable Dutch instrument used to assess the impact of general outpatient rehabilitation. The questionnaire assesses functioning in daily life and consists of four items: (1) how much time is spent on work, study and housework, (2) how often certain activities are performed, (3) whether limitations are experienced in daily life, and (4) how satisfied the patient is with his/her daily life. The USER-P has 31 items under three scales: frequency, limitations and satisfaction. The higher the score the less the presence of dysphagia hinders the patient’s functioning [
17].
Statistical Analysis
Statistical analysis was performed using IBM SPSS v27 (IBM, Armonk, New York).
Similar to Chan’s (2014) article, several scores were calculated and used in the statistical analysis.
First, a subscore was calculated for each subscale of the D-HNSAM, with the exception of the Background Information (BI) subscale given the non-numeric nature of this subscale.
A core score was then calculated by summing the subscale scores of the Physical Functions and Structures (PF&S) subscale and the Activities and Participation (A&P) subscale. The subscale score of the EF subscale was excluded from the core score.
Finally, a total score was also calculated for the D-HNSAM by summing all questions from the PF&S, A&P and EF subscales [
11].
Cronbach’s alpha (
α) reliability coefficient was used to assess the internal consistency of the D-HNSAM subscales using baseline measurement data. Cronbach’s
α greater than 0.70 is considered acceptable, and a value greater than 0.80 is considered good internal consistency. Test–retest reliability between baseline and one week was calculated using interclass correlation coefficients (ICC). An ICC greater than 0.70 was considered acceptable [
14].
Convergent validity expresses the extent to which the new instrument corresponds to an existing questionnaire. Therefore, in this case, high correlation coefficients (> 0.70) [
22] were expected between the D-HNSAM sum scores and the DHI, and between the D-HNSAM and the subscales normalcy of diet and eating in public of the PSS-HN. Divergent validity was assessed to determine whether the new instrument differed from known instruments measuring an unrelated construct. Low correlations were expected between the D-HNSAM, the FOIS and the USER-P (< 0.30) [
22].
Finally, clinical interpretability was checked by inspection of the score distribution using a graphical representation of the core score of the D-HNSAM and the VAS at the end of the questionnaire, which gauged the impact of the change in eating and swallowing on daily life. A scatter plot was generated to see if the D-HNSAM was able to discriminate between different severity groups of dysphagia impact.
Discussion
The Head-and-Neck Cancer Survivors’ Assessment of Mealtimes (HNSAM) is a unique PROM that thoroughly assesses participation and EF in addition to function and activity in head and neck cancer patients with dysphagia. The aim of this study was to culturally adapt, translate and validate the HNSAM into Dutch.
Cross Cultural Adaptation
The first step in this study was cross-cultural adaptation [
15]. Cultural differences can explain why a questionnaire in the original language is valid but the translated version is not [
23]. As such, it is important to systematically summarize and assess the process of cultural adaptation in order to maintain the content validity of questionnaires [
24]. However, there is no uniform standard for implementing cultural adaptation [
24]. In contrast to the study by Chan et al., the content validity of the D-HNSAM was not checked in this study [
14]. The original researchers justified the content and relevance of the questions of the HNSAM to the HNC population, in both the clinical setting and everyday life. Since cultural adaptation was considered in the current study when translating the HNSAM, similar content validity as in the original instrument can be assumed for the D-HNSAM.
Reliability and Validity
Similar to the validation of the Chinese HNSAM by Chan et al. (2019) [
25], good internal consistency was found for the Physical Functions and Structures (PF&S) and Activities and Participation (A&P) subscales. In contrast to the validation of the Chinese HNSAM, weak internal consistency was found for the EF subscale. This finding may be explained by the observed difficulties encountered in completing the EF subscale, especially the section asking the patient to estimate the degree of help or limitation. Nevertheless, this study showed good overall test–retest reliability for the D-HNSAM.
In terms of convergent validity, the D-HNSAM measures what it aims to measure, as this questionnaire correlates well with the DHI. The moderate correlation between the Physical subscale of the DHI and the D-HNSAM can be explained by the fact that the D-HNSAM assesses the patient’s functioning at both disorder and activity & participation levels, whereas the Physical subscale of the DHI focuses only on disorder level [
14,
20]. In line with the hypotheses, moderate to strong correlations were also found between the PSS-HN subscales normalcy of diet and eating in public and each subscale and the total score of the D-HNSAM, except for the EF subscale. No correlation was found between the two PSS-HN subscales and the EF subscale of the D-HNSAM. This can be explained by the fact that the PSS-HN does not assess the influence of EF.
The results of the current study do not fully support the hypothesis of divergent validity. No correlation was expected between the D-HNSAM and scores on the FOIS. However, a moderate correlation was found between the FOIS and the subscales LF&S, A&P, the core score and the total score of the D-HNSAM. This suggests that the dietary restrictions applied are related to the social impairment experienced by the patient. The less dietary changes or compensatory measures are used, the less the social life of HNC patients is restricted [
25]. Only for the EF subscale, no correlation was found with the results of the FOIS. A possible explanation is that the FOIS does not capture the influence of EF. This emphasizes the unique properties of the D-HNSAM. In addition, no or low correlations were expected between the subscales of the USER-P and the D-HNSAM. For most correlation values, our hypothesis was correct. However, some weak to moderate correlations were observed, suggesting some relatedness between the constructs of the two scales. An explanation for the somewhat stronger correlation between the two scales may be that the participation part of the USER-P covers a larger part of the D-HNSAM than we previously assumed. In general, good divergent validity was obtained.
The low correlations between the EF subscale and the other questionnaires used in this study strengthen the finding of Chan et al. [
14] that there is a lack of questionnaires based on the international ICF-model, that capture the influence of EF. Threats (2007) [
8] emphasizes the importance of the influence of EF and their interaction with the disorder and impairment experienced by the patient. A study of Tatiane Correia Rios et al. (2021) [
26] in elderly cancer patients showed that poorer nutritional status was significantly associated with worsened physical, social, emotional and functional well-being QoL domains. As such, poorer nutritional status is an independent risk factor for worsened QoL. Another study investigated the impact of social support in cancer patients and concluded that good social support can buffer the impact of negative treatment side—effects. This study thereby emphasizes the importance of social support for cancer patients [
27]. The D-HNSAM provides an opportunity to evaluate—in a standardized way—whether dietary modifications and social and professional support meet the patient’s psychosocial needs. However, it should be noted that only the global score (help or limitation) of the EF section of the D-HNSAM is internally consistent. Further scoring should be avoided in the Dutch version. Information extracted from the EF scale can only be used as qualitative information for the specific patient. However, we should not negate the added value of standardized questioning of EF factors.
Limitations
The data collection required for this study took place during the global Covid-19 epidemic. In addition, the sample consisted of a heterogeneous group of patients with different tumor locations in the head and neck region, which probably means that the results cannot be generalized to the entire HNC population. Furthermore, it should be borne in mind that the translation and validation of the D-HNSAM was based on the English-language version of the HNSAM, which has not yet been validated. Finally, this study included a relatively small number of participants [
28]. Most validation studies include more than 50 participants [
20,
22,
23,
29]. However, a sample size calculation was carried out at the start of this study, resulting in a sample size of 50.
As the validation of a questionnaire cannot be fully assessed by a single study, further research on the D-HNSAM is appropriate to deepen its psychometric properties. This study has succeeded in validating the Dutch version of the HNSAM. At least partially, as the content validity has not been verified. Overall, the D-HNSAM seems to be a valid instrument. Only the EF scale was not robust. The items of the EF subscale of the D-HNSAM are relevant, but the scoring system seems to be too complex for patients, which affects the reliability and validity of the assessment tool. Future research could focus on reconstructing the EF subscale of the D-HNSAM or constructing another instrument based on the international ICF model that captures the influence of EF.
Future Directions
Future research could focus on expanding the items within the EF subscale. To date, the D-HNSAM contains only a few questions that capture EF. A more comprehensive survey of possible EF would be more appropriate. In addition, the D-HNSAM currently lacks a section on personal factors such as social background, education and occupation, experiences, character and lifestyle. Including the PF domain in the PROM would make the PROM even more complete and valuable.
Conclusion
In conclusion, the D-HNSAM is a reliable and clinically valuable instrument. Promising results have already been found regarding the concept validity of the D-HNSAM. However, in the context of a positive assessment of validity, further modifications and additional research are indicated. Despite the psychometric limitations, the D-HNSAM is currently the only instrument that measures all facets of the ICF model. As there is much evidence that dysphagia has a major impact on all components of the ICF, it is very important to measure it. The D-HNSAM can be used as an additional questionnaire, in addition to the measures taken by the speech therapist, to assess the impact of dysphagia on daily life from the perspective of the person with dysphagia. This questionnaire allows the questioning of problems related to eating with a unique subscale on the impact of EF. In other words, this aspect provides an opportunity to assess whether dietary changes and social and professional support are meeting the patient’s needs. As such, the D-HNSAM enables a holistic approach to the patient, where the patient and their quality of life become the focus of care.
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