Translation procedure
The questionnaire to be translated was the Phase 3 version of QLQ-LC29 which has 29 items aggregated into five multi-item scales (coughing, shortness of breath, side-effects, existential issues related to tumor progression, and surgery-related symptoms). It also has five single items which include coughing up blood, pain in the chest, arm/shoulder and other parts of the body, and weight loss. All items refer to a specific time (i.e., “during the past week”), and are to be scored on a 4-point Likert scale with the response options labeled “not at all”; “a little”; “quite a bit”, and “very much”.
For the translation of the QLQ-LC29, approval was obtained from the EORTC QoL Department. The translation followed the standard EORTC procedure, including forward translation, reconciliation, back translation, proofreading and pilot testing in a small sample of the target population, whereby 15 patients are considered sufficient [15]. Figure 1 shows the flowchart of the translation procedure of EORTC QLQ-LC29 into the Nepalese version.
Pilot testing of the Nepalese version of the QLQ-LC-29
Procedure
After the Nepalese translation was approved by the EORTC Translationa Unit (TU), it was pilot-tested in a 15 Nepalese patients diagnosed with lung cancer (LC) at an oncology-based hospital situated in Province No 3 in Nepal. The treatment available in this hospital are chemotherapy, radiotherapy, surgery, targeted therapy, and immunotherapy. More than 3000 patients visit this hospital for the treatment of cancer annually.
Before the data collection for the pilot study, formal permission was obtained from each participant and the respondents were informed about the purpose and objectives of the study. Privacy and confidentiality were maintained by not disclosing the name of the participants and ensuring them, that collected information was used only for the research purpose. Patients were handed with the Nepalese version of the QLQ-LC29 along with a self-administered questionnaire (i.e demographic questionnaire such as age, gender, ethnicity, educational qualifications and occupation) by a researcher. Patients filled out both questionnaires themselves. After completion, they were interviewed by the researcher if they had any comments regarding the questionnaire to determine whether translated questionnaire items were either difficult to answer or confusing or difficult to understand or upsetting/offensive. Patients were also asked whether they would have worded the question differently.
Patient inclusion and exclusion criteria
Inclusion criteria for this study were histologically confirmed cases of LC diagnosed patients, active cancer treatment, mentally fit to complete a questionnaire, able to understand the Nepalese language and informed consent. We have excluded those patients who were not mentally fit to complete a questionnaire and unable to understand the Nepalese language. There were no restrictions regarding gender, age, or level of education.
Statistical analysis
Descriptive statistics included counts, percentages, means and standard deviations and were reported for age, gender, ethnicity, education, and occupation. Qualitative data stemming from patient interviews were listed in tabular form. The IBM Statistical Package for the Social Sciences (SPSS) Version 21.0 was used (IBM SPSS Statistics for Windows, IBM Corp Armonk, NY, USA, 2017).
Ethics approval
The ethics approval was obtained from the Institutional Review Committee (IRC) of Nobel College, Affiliated to Pokhara University, Kathmandu, Province No. 3, Nepal (Reference number EPY IRC 216/2018). Permission to conduct the study at the oncology-based hospital was also obtained from the respective Department of Medical Oncology.