Abstract
AimThis study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy.MethodsParticipants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman’s correlation and the level of agreement was explored using Bland–Altman plots.ResultsData from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores.ConclusionThe QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L.Trial registration: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011.
Highlights
Esophageal cancer is the 8th most common cancer in the world with a global incidence of 6.7 per 100,000 and a generally poor prognosis [1, 2]
Demographics 164 of the original cohort of 276 patients completed both quality of life questionnaires before and after surgery and were included in the analysis presented in this study. 112 patients were excluded as they only had one set of quality of life data
The findings from this study suggest that the newer QLUC10D is comparable to the more widely applied generic EuroQol 5 dimensions (EQ-5D)-3L
Summary
Esophageal cancer is the 8th most common cancer in the world with a global incidence of 6.7 per 100,000 and a generally poor prognosis [1, 2]. There are two major subtypes, squamous cell carcinoma (ESCC) and adenocarcinoma (EAC). Overall 5-year survival rates for populations developing these cancers are reported to be 17–20% [3]. Treatment for EAC depends on TNM staging (T = tumour growth through tissue, N = nodal involvement and M = metastatic involvement). Uni-modality treatment involves surgery or endoscopic resection, dual modality involves chemotherapy and radiation while tri-modality involves surgery, chemotherapy and radiation. Uni-modality treatment is preferred for the earliest stages of cancer. Surgery for EAC or esophagectomy is an invasive operation involving access to thorax and abdomen. Treatment for esophageal cancer is expensive, resource intensive, and carries a high morbidity and quality of life detriments [5, 6]. It is important to understand the QoL experienced by patients undergoing treatment to guide tailoring of interventions and patient information and to inform health funding decisions
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