Content validation of the EORTC QLQ-BN20+2 with patients and health care professionals to assess quality of life in brain metastases

Abstract

Objective The validated EORTC quality of life (QOL) questionnaire QLQ-BN20 is a cancer subtype-specific supplement to the QLQ-C30 general QOL questionnaire for patients with primary brain neoplasms. The QLQ-C15-PAL core palliative questionnaire is an abbreviated version of the QLQ-C30 designed to decrease patient burden. We conducted content validation of the QLQ-BN20+2 for patients with brain metastases. Methods and materials Patients undergoing treatment for brain metastases, along with health care professionals (HCPs) completed the QLQ-C15-PAL and QLQ-BN20+2 questionnaires. A structured interview followed to assess for any difficulties with the QLQ-BN20+2, irrelevant items, and whether additional pertinent items should be included. Results Seventy-four patients and 71 HCPs participated. The majority of patients (84 %) were treated with whole-brain radiotherapy only. Over 50 % of patients felt that seizures, hair loss and trouble controlling bladder were not related to brain metastases. Questions regarding uncertainty about the future were the most difficult, although still a small proportion (12-16 %). All items were endorsed by over 50 % of HCPs as 'quite' or 'very' relevant to brain metastases patients, with two exceptions: 15 and 12 % of HCPs rated pruritis and future uncertainty as irrelevant, respectively. Conclusion We report the first content validation of the QLQ-BN20+2 and QLQ-C15-PAL QOL questionnaires for patients undergoing treatment for brain metastases, demonstrating feasibility and relevance. These questionnaires should be used together as universal QOL assessment tools in this setting.

Validation of the Brain Symptom and Impact Questionnaire (BASIQ) to assess symptom and quality of life in brain metastases

“…In this content validation study, feedback from patients and HCPs were based on methods previously used in a number of studies to examine content validity of QOL instruments [15][16][17]. The patient feedback indicated that the questionnaire was overall well received in this patient population.…”

Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases

“…Of note, future uncertainty is a complex metric, arguably nonspecific for patients with brain metastases, highly situationally dependent (influenced by financial uncertainty and personal concerns even unrelated to the cancer diagnosis), and thus difficult to validate as a BN20 metric. 29 Thus, services aimed at financial toxicity or psychosocial concerns during cancer treatment could improve patient concerns noted by this QoL metric. 28 To minimize further adjustment of the FDR because of multiplicity of testing, we focused our analysis on the 9 main scales previously analyzed in other central nervous system tumor and brain metastases studies.…”

“…28 To minimize further adjustment of the FDR because of multiplicity of testing, we focused our analysis on the 9 main scales previously analyzed in other central nervous system tumor and brain metastases studies. [23][24][25][26][27][28][29][30] Notably, the EORTC phase III trial of WBRT versus observation reported significant changes in global health, physical function, and fatigue, with no clinically significant changes in the remaining QoL metrics. 30 A prospective study of the DEGRO QoL working group evaluated patients receiving SRS versus WBRT, and found that future uncertainty was the most prominent baseline metric among both arms (similarly reported by Caissie et al 23 ), which improved after SRS.…”

“…27 Given the prominence of future uncertainty in two of the above studies, we included emotional and social functioning which may be interrelated with future uncertainty. 25,29 Other metrics in the above studies included improvement in insomnia after brain radiotherapy (WBRT or SRS) 23 , and worsening communication deficit after WBRT. 28 Questionnaire compliance and survival were poor following WBRT, thus we could not confidently evaluate QoL metrics after WBRT.…”

“…18 Nine scales were selected for analysis (C30 metrics of global health status, physical functioning, social functioning, emotional functioning, fatigue, insomnia; and BN20 metrics of motor dysfunction, communication deficit, future uncertainty), based on prior studies in primary central nervous system tumors and brain metastases. [23][24][25][26][27][28][29][30] We did not run exploratory analyses on the remaining metrics given largely negative findings from the studies cited and to avoid diluting study power, as additional analyses would require further adjustment of the false discovery rate (FDR) given multiplicity of testing.…”