Introduction

Spinal cord injury (SCI) is associated with a transient or permanent reduction in mobility, sensibility loss, disturbed urination or defecation, and sexual dysfunction [1]. In addition, patients may suffer from secondary complications, such as respiratory and cardiovascular problems, pressure ulcers, urinary tract infections, and neuropathic pain [2]. Besides physical problems, patients with SCI may have to deal with psychological issues, such as depression and anxiety, as well as having altered social roles [3]. This injury type and its complications have a major impact on patient lives, well-being, and health-related quality of life (HRQOL). The definition of HRQOL includes subjective physical, psychological, and social aspects of health influenced by patient experiences, beliefs, expectations, and perceptions, which have been clearly shown to affect physical and mental health [4, 5]. Most studies of patients with SCI assess neurological (e.g., International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [6]) and functional (e.g., Spinal Cord Independence Measure (SCIM) [7]) recovery to evaluate the impact of therapy; however, the secondary complications that influence the HRQOL are yet to be fully elucidated. Although some general QOL questionnaires have been validated in the SCI population (e.g., the 36-Item Short Form Survey (SF-36) [8] and the Sickness Impact Profile (SIP68) [9]), these existing questionnaires contain questions that are often irrelevant for patients with SCI, such as questions about running and climbing stairs [10, 11]. Lorio et al. used the SF-6d for patients with traumatic SCI, concluding that the level of injury and neurological status did not impact the long-term QOL [12]. Post et al. used the SIP68 and the Life Satisfaction Questionnaire with these patients and also concluded that neither the level nor the completeness of the injury affects life satisfaction [13]. The authors of both studies suggested that these results may not correspond with reality however, due to the presence of irrelevant questions for patients with SCI, which caused measurement error, lack of validity, and floor and ceiling effects. They therefore recommended the use of a disease-specific questionnaire.

Tulsky et al. developed the Spinal Cord Injury-Quality of Life (SCI-QOL) measurement system to specifically measure HRQOL in patients with SCI, based on the Patient-Reported Outcomes Measurement Information System (PROMIS) [11]. The SCI-QOL is an American-English questionnaire. To use the SCI-QOL questionnaire in the Netherlands and Flanders, the Dutch-speaking part of Belgium, it must be translated and cross-culturally adapted. This paper describes the linguistic translation and cultural adaptation of the short forms from the English version of the SCI-QOL into Dutch-Flemish.

Method

The SCI-QOL consists of 19 item banks, including one bank (wheelchair mobility) that contains two subdomains and 3 fixed-length scales, in total 715 items. The development of the SCI-QOL was previously reported by Tulsky et al. in 2015 [11] and is therefore not repeated in this paper. We translated the 20 short forms of the items banks plus the 3 fixed scales, in total 207 items (see Table 1). The short forms consist of 6 to 11 items each, with five response options on a Likert scale. Forty-six items from nine short forms (Anxiety, Depression, Pain Behavior, Pain Interference, Satisfaction with Social Roles and Activities, Basic Mobility, Ambulation, Fine Motor, and Selfcare) were previously translated by the Dutch-Flemish PROMIS group [14]. The remaining 161 items were translated in this study.

Table 1 The SCI-QOL item banks, the number of items per short form and item bank, the availability of Dutch-Flemish item translations, and the reference item bank from which most items originate
Full size table

Translation steps

The translation was performed according to the FACIT translation methodology. This methodology was developed to establish equivalence of meaning and measurement between the different versions of the questionnaire targeted to different languages [27, 28]. Steps 1–7 from this methodology were performed in this study to achieve linguistic, content, and conceptual equivalence.

Step 1. Forward translation. Three forward translations of the source items were performed, one by an independent translation agency (Radboud in’to Languages), one by a native Dutch speaker with a medical background (EB, first author), and one by a native English speaker who speaks Dutch fluently but does not have a medical background or knowledge about the objective of the questionnaire (LH). Translators were instructed to translate the source items into simple and logical Dutch sentences.

Step 2 Reconciliation. The three forward translations were reconciled by a representative of the Dwarslaesie Organisatie Nederland (DON) (IH), the Dutch Spinal Cord Organization; a rehabilitation physician (HvdM); a representative of the Dutch-Flemish PROMIS National Center (CT); and the first author (EB), in order to achieve equivalence [29]. To strive for a universal Dutch-Flemish SCI-QOL translation, as was done for the PROMIS translations, the translated Dutch item banks were also checked by a native Flemish speaker (HD) for any differences between the two languages.

Step 3 Back translation. The reconciled Dutch-Flemish version of the SCI-QOL was then translated back into English by another native English speaker from Radboud in’to Languages. A second backward translation was performed by a native Dutch speaker living in England, who speaks fluent English (TH). Both persons were blind to the source items and had no medical background.

Step 4 Compare back translations to source. The two backward-translated versions were compared to the source items of the SCI-QOL questionnaire by the main author (EB) to identify discrepancies. In case of evident differences between the source item and the backward translation, the forward translations were reviewed, and if necessary, the translated items were adapted to match the source item.

Step 5 Expert review. An expert committee, consisting of the same participants as in the reconciliation step, reviewed the translation process. Existing ambiguity in the translations was discussed and items were adapted if necessary.

Step 6 Harmonization, quality control, and proofreading. A proofreader, who was not involved in the earlier translation process, was asked to assess the translation process and take a critical look at the spelling and sentence structure (JB). The first author implemented the improvement suggestions and finalized the short forms for cognitive debriefing. The representative of the Dutch-Flemish PROMIS National Center assessed the translation process and checked the pre-final translation.

Step 7 Cognitive debriefing. A stratified group of five Dutch and five Flemish patients with SCI and five Dutch and five Flemish people from the general population were asked to participate in a cognitive debriefing to assess the comprehensibility of the translated items. In addition to their different countries of origin, the interviewed participants had different ages, educational levels, and levels of SCI to achieve a wide spectrum of respondents. The interviews were performed by the main author, who was trained to conduct interviews. All interviews were audio-recorded. The audio recordings were analyzed, and comments about whether the adaptation of an item was necessary were reviewed.

Results

An acceptable translation of the SCI-QOL was obtained by completing the seven steps of the FACIT translation method. Table 3 in Appendix shows an example of the translation process of a single item. The translations of 20 out of 23 short forms were suitable for both Dutch and Flemish speakers, while three short forms required separate Dutch and Flemish versions. For instance, in the short form Ambulation, the word ‘ambulation’ was translated into Dutch as ‘lopen’; however, ‘lopen’ means ‘running’ in Flemish, so ‘ambulation’ was translated as ‘stappen’ in Flemish. ‘Stappen’ cannot be used in the Dutch translation as it means ‘going out’ in this language. In another example, the item Mwc30 in the short form Manual Wheelchair needed separate translations because the word ‘traffic light’ needed to be translated as ‘stoplicht’ in Dutch and as ‘verkeerslicht’ in Flemish. The item SQNQSTG04 in the short form Stigma needed separate translations of ‘I felt left out of things’ because this phrase was translated as ‘buitengesloten voelen’ in Dutch, while Flemish translators preferred ‘uitgesloten voelen.’

A general comment from the participants of the cognitive debriefing was that uniformity within the questionnaires was lacking. Within one short form, questions and statements were combined, e.g., in the item bank Fine Motor, the question ‘Are you able to make and receive calls on a cell phone?’ was followed by the statement ‘I can turn the knob on a door….’. The reason for these differences is that the SCI-QOL items originated from several existing item banks (Neuro-QOL and PROMIS). To achieve uniformity within the short forms, sentences were changed to only questions or only statements without violating the response options (see Table 2).

Table 2 Overview of the Dutch-Flemish SCI-QOL items that were adapted during the translation process and cognitive debriefing
Full size table

Another general comment from the participants of the cognitive debriefing was that different response options within the same short form were considered confusing. For example, in the short form Basic Mobility, the response options ‘Without any difficulty,’ ‘With a little difficulty,’ ‘With some difficulty,’ ‘With much difficulty,’ ‘Unable to do’ were followed by the response options ‘No difficulty,’ ‘A little difficulty,’ ‘Some difficulty,’ ‘A lot of difficulty,’ ‘Can’t do.’ The meaning of both sets of response options is equal; therefore, we tried to achieve uniformity in response options where possible.

Linguistic adaptations

In the short form Bladder Management Difficulties, the word ‘bladder accidents’ (‘blaasongelukken’) is uncommon in Dutch and therefore it was translated as ‘urineverlies’ (‘urine loss’). In the same short form, ‘bladder management’ was discussed. A layman would be unfamiliar with the term ‘bladder management’ and a proper Dutch translation is lacking; therefore, ‘bladder management’ was initially literally translated as ‘blaasmanagement.’ The same translation problem was encountered in the short form Bowel Management Difficulties. After cognitive debriefing, ‘bladder management’ was translated as ‘katheteriseren’ (‘catheterization’) because this comprises the most important part of bladder management. ‘Bowel management’ was translated as ‘ontlasting op gang krijgen’ (‘passing stools’).

Although the English word ‘socialize’ is frequently used by Dutch young adults, in the short form Satisfaction with Social Roles and Activities, ‘socialize’ was translated as ‘omgaan’ (‘hang out’), which is more commonly used in the general population. ‘Socialize’ in the short form Ability to Participate in Social Roles and Activities was translated as ‘leuke dingen doen’ (‘do enjoyable things’). The term ‘upsetting thoughts’ in the short form Psychological Trauma would literally be translated as ‘verontrustende gedachten’; however, this was translated as ‘piekeren’ (‘worrying’), which is more common in Dutch.

Adaptation of the content

Some items needed an adaptation of the content to clarify the meaning of the item, such as when the literal translation was considered incorrect. For example, the item Resilience_25 in the short form Resilience was ‘I was confident that I could overcome my limitations.’ Participants of the cognitive debriefing who suffer from a SCI explained that it is not possible to overcome your limitations; it is only possible to learn to deal with your limitations. The content of Resilience_25 was therefore changed to ‘I was confident that I could learn to deal with my limitations.’ The short form Selfcare consists of Csc39: ‘I can scratch my face’; however, participants of the cognitive debriefing questioned the reason behind scratching the face and stated that scratching could also be interpreted as being harmful. We therefore adapted the sentence in Dutch to ‘I can scratch my face when it is itching.’

Conceptual adaptations

Some sentences needed conceptual adaptation because a word had multiple meanings or because they involved an item that is not frequently used in the Dutch language. For example, in the short form Basic Mobility, patients are asked if they are able to pull up their sheets and blankets when lying in bed; however, in the Netherlands and Flanders most people sleep under a ‘duvet’ (translated as ‘dekbed’) instead of ‘sheets and blankets.’ In the short form Fine Motor, the item ‘I can turn the knob on a door…’ was translated as ‘ik kan de klink van een deur naar beneden doen’ (‘I can push down the latch’) because most doors in the Netherlands and Flanders have a latch instead of a knob.

Discussion

This study presents the translation process and cross-cultural adaptation of 23 English SCI-QOL short forms into Dutch-Flemish using the FACIT translation method. Due to a high-quality translation process and comprehensive cognitive debriefing with patients and non-patients, we provide acceptable translated short forms of the SCI-QOL. These Dutch-Flemish SCI-QOL shorts forms can be used to measure the HRQOL of people with SCI in the Netherlands and Flanders, Belgium.

The nature of the source instrument, with its simple language, made it generally easy to translate the items into proper Dutch-Flemish, and translation difficulties could easily be resolved during the reconciliation and cognitive debriefing. Although the translated short forms are not yet validated, this translation provides evidence for the content validity of the measures in the new language.

The SCI-QOL consists of a combination of SCI-specific item banks (e.g., Bladder Management) and generic item banks derived from PROMIS (e.g., Pain Interference) [11] or Neuro-QOL (e.g., Positive Affect & Well-being). The SCI-QOL can be used in clinical settings to evaluate the impact of SCI on patients’ HRQOL, to evaluate the effect of therapy, or to support rehabilitation goals. In addition, the SCI-QOL questionnaires can be used in clinical research to evaluate rehabilitation programs. In the future, large datasets may contribute to changes in policy [11]. Depending on the research question, all 23 short forms or a selection of short forms can be administered. Because these measures are relatively new, no clinical studies using the SCI-QOL have yet been performed. Future studies should focus on determining relevant cut points, minimal important differences, and indices of reliable changes [11].

By following the steps of the FACIT translation process, we developed a translation that is understandable by both Dutch and Flemish persons instead of creating two separate translations for both countries. Despite the large Dutch-Flemish similarity, some words required separate translations in Dutch and Flemish to achieve an understandable translation. This resulted in three linguistically separate short forms along with 20 common Dutch-Flemish short forms.

In this study, we translated short forms instead of the full item banks. A short form is a selection of the most informative items extracted from a large item bank, which is used to precisely estimate a patient’s HRQOL score [30]. Short forms are therefore more efficient than large item banks and result in less of an administration burden for respondents. A disadvantage is that Computer Adaptive Testing (CAT) is not possible with short forms, as the full item bank is required. In order to enable CAT application and to further increase measurement precision, we recommend the translation of the remaining SCI-QOL items in the future.

This study comprised a process of establishing linguistic, content, and conceptual equivalence through translations and cognitive debriefing; however, cultural differences between the USA and Netherlands and Flanders might affect the reliability and validity of SCI-QOL [29]. In this study we did not assess concurrent validity. Psychometric properties, such as cross-cultural validity (Differential Item Functioning or DIF analyses), construct validity, and floor and ceiling effects, should therefore be evaluated in a follow-up study.

The Dutch-Flemish SCI-QOL short forms will be preserved and distributed by the Dutch-Flemish PROMIS National Center (www.dutchflemishpromis.nl).

Conclusion

After a comprehensive translation of the SCI-QOL short forms following the FACIT translation methodology, a linguistically equivalent Dutch-Flemish version of the SCI-QOL is now available for clinical and research purposes in the Netherlands and Flanders, Belgium.