While health-related QoL is an important consideration in the management of patients with H&N cancers, the lack of suitable tools in Urdu precludes the assessment of QoL amongst patients in Pakistan. To this effect, we translated the EORTC QLQ-H&N35 into the Urdu language, and validated it in a sample of 250 patients with H&N cancer. The Cronbach alpha multi-item domains of the Urdu version of the QLQ-H&N35 ranged from 0.5 to 0.98, indicating variable internal consistency across domains. Moreover, high agreement was observed for both the expert-reported and patient-reported relevance (CVI: 0.88 and 0.92, respectively) and clarity (CVI: 0.84 and 0.93).
In our sample, the internal consistency of 6/7 multi-item symptom domains of QLQ-H&N35 ranged from acceptable to good (Cronbach’s alpha range: 0.75–0.98; p < 0.001), while the internal consistency of “Senses Problems” was subpar at 0.499. The low internal consistency of the “Senses Problems” multi-item scale was also seen in the validation of the Mexican , Hindi and Marathi , Cantonese , and Greek  versions of the QLQ-H&N35, as well when the QLQ-H&N35 was used in Norway, Sweden, the Netherlands , Arkansas , and Italy . It has also been suggested that the items comprising “Senses Problems” be considered as individual items, rather than part of a multi-item scale . Nevertheless, other translations, such as the Moroccan Arabic version (0.94)  and the Polish version (0.82) , demonstrate excellent internal consistency for “Senses Problems”.
Inter-scale correlations for the Urdu version of the EORTC QLQ-H&N35 revealed weak-to-strong positive correlation between 13 symptom domain of QLQ-H&N35 (Pain; Swallowing; Senses; Speech; Trouble Social eating; Trouble Social Contact; Less Sexuality; Teeth; Opening Mouth; Dry Mouth; Sticky Saliva; and Coughing). This pattern was also evident in the validation study by Sherman et al. conducted in Arkansas . In addition, the Urdu version of the EORTC QLQ-H&N35 also demonstrated suitable discriminatory validity, evidenced by the distribution of floor and ceiling percentages.
The EORTC QLQ-H&N35 demonstrated good discriminant validity, with 13 symptom domains showing a weak negative correlation with resilience. Though conceptually it may be expected that resilience and QoL have a strong relationship, our results do little to affirm this hypothesis. Further work is required to explore the correlation of QoL and resilience amongst patients with H&N cancer. The EORTC QLQ-H&N35 also demonstrated a significant weak-to-moderate positive correlation between 13 symptom domains and depression and with anxiety. A similar study by Singer et al. also found only a weak-to-moderate correlation between the German translations of the EORTC QLQ-H&N35 and HADS . The study by Sherman et al. demonstrated similar moderate correlation between the EORTC QLQ-H&N35 and depression and anxiety as measured by tools other than the HADS . Thus, although our results show good discriminant validity of the EORTC QLQ-H&N35 with RS-14 and HADS, this may be due to mono-method bias. Mono-method bias arises when measurement of a construct is based of only a single tool for each construct (i.e., RS-14 for resilience and HADS for anxiety and depression), and it can pose a threat to discriminant validity by misrepresenting the true degree of association between constructs. Future studies may negate mono-method bias by measuring resilience, anxiety, and depression using multiple tools.
When assessing correlations between EORTC QLQ-30 and QLQ-H&N35, we observed a significant weak-to-moderate negative correlation of the 14 symptoms domains of QLQ-H&N35 with global QoL measured by the QLQ-30 and a significant weak-to-strong negative correlations with the functional domains of QLQ-30. These results are similar to those seen in the validation study by Sherman et al. , but unlike that of the Mexican translation  where excellent correlations were reported between EORTC QLQ-30 and QLQ-H&N35. Nevertheless, the weak correlations between the EORTC QLQ-30 and QLQ-H&N35 in our study indicate that although both measured QoL, they each assessed unique aspects of the construct. While the QLQ-30 focuses on overall QoL and functioning (physical, role, emotional, cognitive & social) with few generalized symptoms (fatigue, pain, nausea, and vomiting), the QLQ-H&N35 bases its QoL measurement predominantly off locoregional symptomatology (e.g., swallowing, speech problems, trouble with social eating, opening mouth, dry mouth, sticky saliva, coughing etc.). However, given the questionable convergent validity, it is important for clinicians and researchers to interpret QoL findings measured by the QLQ-H&N35 in the context of the QoL results provided by the more highly validated QLQ-C30.
The Urdu translation of the QLQ-H&N35 bears considerable importance for the management of H&N cancers in Pakistan. Considering social and cultural differences in Pakistan, and that most patients with H&N cancers belong to less educated backgrounds, it is crucial to have valid tools to assess QoL in a Pakistani setting. As Urdu is the national and official language of the country, it is understood and spoken throughout Pakistan. With the Urdu adaption of the QLQ-H&N35, the assessment of QoL may be incorporated as a routine feature in the management, prognostication, goal-setting, and monitoring of patients with H&N cancers in Pakistan. Moreover, it also provides a valid and reliable tool for clinical studies seeking to incorporate QoL measurement as part of their outcome assessment. Thus, this translation is a vital landmark for many stakeholders, including clinicians, patients, and cancer researchers.
For the most part, the translation and validation of the EORTC QLQ-H&N35 presented few challenges. The Urdu version was able to convey the intended English equivalents accurately, and was easily understandable to all the patients. This, coupled with the excellent internal consistency, and patient-reported clarity and relevance, confirm the Urdu version of the EORTC QLQ-H&N35 as a valid tool for the measurement of QoL amongst patients with H&N cancer in Pakistan. Moreover, our results also affirm the suitability of administration of the Urdu version of the EORTC QLQ-H&N35 via in-person interviews, which may be a necessity when the tool is used in populations with lower literacy rates. The setting of this study also adds to the generalizability and utility of the Urdu version of the EORTC QLQ-H&N35 across patient populations in Pakistan. The study took place in Karachi, the largest metropolitan city in Pakistan, and home to all major ethnicities in the country. Moreover, AKU, being one of the largest quaternary care hospitals in the surrounding regions, caters to diverse socioeconomic groups, as evidenced by the distribution of monthly family incomes.
However, our study has a few limitations. We did not perform test–retest analysis to investigate stability. Moreover, due to the cross-sectional nature of the study, we were unable to capture the temporal relationship between QoL, resilience, depression, and anxiety. Additionally, since our sample was recruited from a single center, our validation results may have limited generalizability to other centers in Pakistan. Lastly, our administration of the tool via patient interviews, as opposed to the recommended self-administered method, may have introduced interviewer or response biases. Future studies should aim to explore the interactions between QoL, resilience, and mental health longitudinally across extended periods of time, to better understand nuances in their relationship. Additionally, more sophisticated validation analyses of the Urdu versions of the EORTC QLQ-H&N35 must be performed to further judge its applicability in Pakistan.