Danish translation and linguistic validation of the Melanoma Concerns Questionnaire

Rising awareness of health-related quality of life (HRQoL) has led to the development of numerous quality-of-life measures, also termed patient-reported outcome measures (PROMs). Some are generic, suitable regardless of diagnosis, whereas others are disease-specific PROMs. Before selecting a PROM, users should consider the objective and scope of the examination, as well as the quality of the PROM [1, 2].

In Denmark, most melanoma patients enter a national stage-specific, risk-stratified follow-up programme based on recurrence risk, including clinical examinations and PET/CT according to risk category. Clinical follow-up visits focus on a thorough examination of the skin and lymph node regions, leaving little time to address the patient’s concerns.

PROMs are effective tools for incorporating the patient’s perspective during follow-up visits with limited time [3, 4]. Patients complete the PROM before the consultation, allowing the clinician to ask targeted questions based on their responses. Furthermore, PROMs are a fast, cost-effective way to collect subjective data on treatment satisfaction, sequelae, fear of recurrence and HRQoL for research or quality assessment [5]. It is advisable to use PROMs that are already in use and ideally psychometrically validated [6] because this enables cross-study comparisons and requires fewer resources than developing new PROMs.

We identified the Melanoma Concerns Questionnaire (MCQ-28) and Functional Assessment of Cancer Therapy – Melanoma (FACT-M) as the most promising PROMs in melanoma; both have undergone psychometric validation in English [7]. The MCQ-28 is a PROM developed to measure “the patient experience following diagnosis and treatment of melanoma” and was published in 2019 by Winstanley et al. (Supplementary material) [8]. It was originally developed as a supplementary module to the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30). The original measure followed guidelines for PROM development outlined by the EORTC Quality of Life Group [9]. The MCQ-28 is developed as a standalone measure but can also be combined with the QLQ-C30 [8, 10]. To compare the usability of the MCQ-28 with that of the FACT-M, which has already been translated, the MCQ-28 also needs to be translated into Danish.

When translating PROMs, it is important to consider cultural relevance. A linguistic validation consists of a translation process and a cultural adaptation to ensure both the understandability and the conceptual equivalence between the original and the translated measure. Ideally, this occurs in close collaboration with the measure’s developers.

This study is a linguistic validation of the MCQ-28 from English to Danish. The process was based on the guidelines for translation and cultural adaptation of PROMs developed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) [11]. The MCQ-28 is ideal for this process, as it has already been tested for content validity and psychometrically validated in a cohort of 132 patients, and because it has been found to be a valid instrument [12].

Methods

The translation of MCQ-28 from English to Danish followed the ISPOR guidelines, which describe the stepwise process involved [11]. All ten steps of the process are outlined in Figure 1.

Step 7 – cognitive debriefing – consisted of 21 semi-structured interviews with patients at different melanoma stages. Patients were randomly invited and interviewed during scheduled follow-up visits at the Department for Plastic Surgery at Herlev Hospital; however, to secure representation, seven patients from each of the three risk groups were included. Debriefing was conducted as a content validity study, focusing on comprehensibility, comprehensiveness and relevance, and following COSMIN standards [13-15]. The interview guide was developed by two authors (JRB and LRH), pilot-tested on nine patients and revised before use in all interviews. Interviews were conducted by JRB and AVM, and covered item- and questionnaire-level comprehensibility and relevance, as well as clarity of instructions, recall period, response options and overall length. All interviews were recorded, transcribed and qualitatively analysed by both interviewers.

Trial registration: not relevant.

Results

The results are presented according to the ISPOR guideline steps [11]:

Step 1 Preparation: Seven items were considered ambiguously phrased and needed clarification from the developers before forward translation. They are outlined in Table 1.

Step 2 Forward translation: At every point of uncertainty, the translators aimed for a conceptual rather than a literal approach, as per the ISPOR guideline [11]; however, this was not always straightforward. The term ”melanoma” is not widely used in Danish. Therefore, “melanoma” was changed to “modermærkekræft” (Danish for mole cancer) to ensure understandability for all patients. This is consistent with most other patient-facing materials on melanoma in Denmark.

Step 3 Reconciliation: The translators proposed two different sets of response options and eventually settled on the version used in similar PROMs (the Q-Portfolio) [16].

Step 4 Back translation: The back translator had no notes on the process.

Steps 5 + 6 Back-translation review and harmonisation: The original MCQ-28 was thoroughly compared with the back-translated version by JRB. A total of 25 items, the introduction and all the instructions were deemed to be “identical” or having only “insignificant” discrepancies. After this initial review, comments were made by two Danish translators (LRH and JRB) to explain the remaining three items, which had discrepancies marked as “significant”. The back-translated version and the translators’ comments were sent to one of the developers for review. Some additional items had discrepancies that were deemed “insignificant” by the translator but “significant” by the developer. This was solved by further explanations. All discrepancies were eventually accepted by both the developers and the translators. See Table 2 for all “significant” discrepancies and comments.

Steps 7 + 8 Cognitive debriefing and review: The focus was to ensure that the content was true to the original concept and to make only minor adjustments to ensure the questionnaire’s fit with the Danish population. We interviewed 21 patients (57% female, 42% over 70 years old), seven patients in each follow-up category (low, intermediate og high risk). We applied an analytical approach consisting of thematisation based on verbatim transcriptions of the audio-recorded interviews to ensure comprehensiveness. See Table 3 for all patient demographics.

Overall, patients found the MCQ-28 relevant and welcomed the idea of it being an integrated part of their melanoma follow-up.

A recurring theme was that low- and intermediate-risk melanoma patients and patients at later stages in their follow-up programme experienced next to none of the symptoms and concerns described in the questionnaire and thus encountered mild difficulties in answering the questions. This prompted some patients to mark certain items as irrelevant. If asked again, they would say that they still appreciated being asked and could imagine it being relevant to other melanoma patients. Additionally, most patients completed the first section of the PROM (items 1-5 should only be completed if a patient has had surgery for their melanoma within 12 months), even if more than a year had passed since their melanoma surgery.

In the SUP (items 19-24) and CARE (items 25, 27, 28) scales, patients are asked to address any distress or dissatisfaction regarding encounters with the healthcare system. As these questions are posed within a four-week timeframe, many of the participants struggled to answer because most follow-ups are scheduled at three- to six-month intervals. A negative reply (“not at all”) to item 19, for example, (“How much has your melanoma doctor supported you?”) could either be interpreted as “I did not receive any support from my melanoma doctor” or, as was most often the case, within this timeframe and especially for low-risk patients with fewer sequelae, “I did not require any support from my melanoma doctor”. Equally, item 22, “How much has your primary care doctor supported you?” was deemed problematic as the primary care doctor/general practitioner in Denmark is responsible only for referring the patient to further specialist diagnostic assessment. Thereafter, follow-up is performed by a plastic surgeon or oncologist at the facility undertaking the patient’s treatment and/or follow-up.

Finally, items 25 and 27 caused confusion for some of the patients. Both items concern treatment options. Several patients reported not having had different options and were instead just informed of the treatment plan.

Step 9 Proofreading: The finalised draft of the translated questionnaire, approved by the developers and a sample of melanoma patients, was proofread by a linguistic expert.

Discussion

To our knowledge, this is the first Danish linguistic validation of the MCQ-28 following the ISPOR guidelines [7]. Contributions from both a professional translator and a medical translator, supported by clinical experts, ensured a balance between conceptual accuracy and fidelity to the original. Patients considered the MCQ-28 relevant and expressed support for its integration into routine melanoma follow-up care.

Even though unambiguity was intended, patient interviews revealed considerable variation in how items were interpreted. This variation appeared to reflect individual perspectives, i.e. the influence of comorbidities, which made it difficult for patients to distinguish melanoma-related concerns from other health conditions. A trained interviewer could potentially mitigate these issues by clarifying item meaning and ensuring that patients focus on melanoma-specific experiences. Additionally, many patients overlooked instructions such as completing items 1-5 only if surgery had occurred within the past 12 months, further highlighting the potential value of guidance. However, providing personal support is neither feasible nor cost-effective in large-scale clinical settings, ultimately undermining practicality, consistency and efficiency, and motivation for PROM use. Possible solutions to this issue include highlighting important information or creating hard stops in an electronic version of the PROM.

As noted in the Results section, the general practitioner plays little or no role in the primary treatment of melanoma in Denmark. This, along with the four-week recall period, makes it difficult for Danish patients to answer the items in the SUP and CARE scales consistently. Individual misinterpretations can be clarified during follow-up, and clinicians might choose to include only the relevant subscales for the patient. For research on larger cohorts or databases, researchers might consider omitting certain subscales and refraining from reporting total scores. In that case, researchers will need to be aware of potential changes to the scoring system's integrity.

Depending on each patient’s personal disease experience, their interpretation of the PROM contents can vary considerably. Similarly, personal experience and severity of symptoms might translate very differently into PROM scores. This is why most PROMs have great potential to measure changes in perceived well-being at the patient level. When conducting research, however, it is important that the PROM, in this case the MCQ-28, is thoroughly validated and that all psychometric properties are accurately characterised in an appropriate sample group before large-scale implementation [13, 14].

One major limitation of the MCQ-28 is that it contains no items on sentinel lymph node biopsy (SLNB) or complete lymph node dissection (CLND). SLNB is currently performed in about 40% of the Danish melanoma population [17]. Fortunately, the number of patients undergoing CLND in case of positive sentinel node has decreased dramatically since 2018, when the results of two randomised clinical trials found no effect on survival [18, 19]. Sequelae after lymph node surgery can have a considerable impact on function and HRQoL [20]. The interviewers noted that patients who had undergone lymph node surgery, especially those experiencing sequelae, sometimes mistakenly assumed that this was what some of the questions about “swelling” in the first block referred to. Our study group suggested to the developers that they either add items asking about lymphoedema to the first section for patients who have undergone surgery within the past 12 months, or develop a stand-alone lymph-node surgery module.

Strengths and limitations

A strength of this study is that the linguistic validation of the MCQ-28 was conducted in strict accordance with the ISPOR guidelines for translation and cultural adaptation of PROMs. Additionally, the results were strengthened by expanding the patient cohort to 21 interviewees in total rather than the recommended ten to compensate for the heterogeneity of the group [11].

As this is a single-site study, the representativeness of our participants is limited. Additionally, the patients were only presented with the Danish MCQ-28 immediately before the interview. Had they been allowed a few days to read, consider and evaluate the questionnaire before the interview, they might have been able to provide further insight and opinions. However, we aimed to amend this by using a pre-tested interview guide.

Conclusions

Following the ISPOR guidelines, a culturally relevant, linguistically validated Danish version of the MCQ-28 was developed. The MCQ-28 is an interesting candidate for future implementation in Danish and other settings that care for melanoma patients and will potentially enable cross-clinic and international collaborations on studies of melanoma-related HRQoL. Before the measure is put to clinical use, however, it will need to undergo further psychometric validation in the Danish context.