To compare pre-agreed health-related quality of life (HRQOL) domains in patients with esophageal or junctional cancer who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery or surgery alone. Secondary aims were to examine the effect of nCRT on HRQOL before surgery and the effect of surgery on HRQOL. Patients and MethodsPatients were randomly assigned to nCRT (carboplatin plus paclitaxel with concurrent 41.4-Gy radiotherapy) followed by surgery or surgery alone. HRQOL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and -Oesophageal Cancer Module (QLQ-OES24) questionnaires pretreatment and at 3, 6, 9, and 12 months postoperatively. The nCRT group also received preoperative questionnaires. Physical functioning (PF; QLQ-C30) and eating problems (EA; QLQ-OES24) were chosen as predefined primary end points. Predefined secondary end points were global QOL (GQOL; QLQ-C30), fatigue (FA; QLQ-C30), and emotional problems (EM; QLQ-OES24). ResultsA total of 363 patients were analyzed. No statistically significant differences in postoperative HRQOL were found between treatment groups. In the nCRT group, PF, EA, GQOL, FA, and EM scores deteriorated 1 week after nCRT (Cohen's d: 20.93, P , .001; 0.47, P , .001; 20.84, P , .001; 1.45, P , .001; and 0.32, P = .001, respectively). In both treatment groups, all end points declined 3 months postoperatively compared with baseline (Cohen's d: 21.00, 0.33, 20.47, 20.34, and 0.33, respectively; all P , .001), followed by a continuous gradual improvement. EA, GQOL, and EM were restored to baseline levels during follow-up, whereas PF and FA remained impaired 1 year postoperatively (Cohen's d: 0.52 and 20.53, respectively; both P , .001). ConclusionAlthough HRQOL declined during nCRT, no effect of nCRT was apparent on postoperative HRQOL compared with surgery alone. In addition to the improvement in survival, these findings support the view that nCRT according to the Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study-regimen can be regarded as a standard of care.

Netherlands Trial Register NTR487.

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PurposeThe structural equation modeling (SEM) approach for detection of response shift (Oort in Qual Life Res 14:587–598, 2005. doi:10.1007/s11136-004-0830-y) is especially suited for continuous data, e.g., questionnaire scales. The present objective is to explain how the SEM approach can be applied to discrete data and to illustrate response shift detection in items measuring health-related quality of life (HRQL) of cancer patients.MethodsThe SEM approach for discrete data includes two stages: (1) establishing a model of underlying continuous variables that represent the observed discrete variables, (2) using these underlying continuous variables to establish a common factor model for the detection of response shift and to assess true change. The proposed SEM approach was illustrated with data of 485 cancer patients whose HRQL was measured with the SF-36, before and after start of antineoplastic treatment.ResultsResponse shift effects were detected in items of the subscales mental health, physical functioning, role limitations due to physical health, and bodily pain. Recalibration response shifts indicated that patients experienced relatively fewer limitations with “bathing or dressing yourself” (effect size d = 0.51) and less “nervousness” (d = 0.30), but more “pain” (d = −0.23) and less “happiness” (d = −0.16) after antineoplastic treatment as compared to the other symptoms of the same subscale. Overall, patients’ mental health improved, while their physical health, vitality, and social functioning deteriorated. No change was found for the other subscales of the SF-36.ConclusionThe proposed SEM approach to discrete data enables response shift detection at the item level. This will lead to a better understanding of the response shift phenomena at the item level and therefore enhances interpretation of change in the area of HRQL.Electronic supplementary materialThe online version of this article (doi:10.1007/s11136-015-1195-0) contains supplementary material, which is available to authorized users.

Early deficits in receptive and expressive vocabulary are associated with later reading. Early vocabulary growth of FR-dyslexic children is characterized by a delay but not deviance of growth. Vocabulary can be considered an additional risk factor for dyslexia.

Objective Unmet health care needs require additional care resources to achieve optimal patient well‐being. In this nationwide study we examined associations between a number of risk factors and unmet needs after treatment among women with breast cancer, while taking into account their health care practices. We expected that more care use would be associated with lower levels of unmet needs. Methods A multicenter, prospective, observational design was employed. Women with primary breast cancer completed questionnaires 6 and 15 months post‐diagnosis. Medical data were retrieved from medical records. Direct and indirect associations between sociodemographic and clinical risk factors, distress, care use, and unmet needs were investigated with structural equation modeling. Results Seven hundred forty‐six participants completed both questionnaires (response rate 73.7%). The care services received were not negatively associated with the reported levels of unmet needs after treatment. Comorbidity was associated with higher physical and daily living needs. Higher age was associated with higher health system‐related and informational needs. Having had chemotherapy and a mastectomy were associated with higher sexuality needs and breast cancer‐specific issues, respectively. A higher level of distress was associated with higher levels of unmet need in all domains. Conclusions Clinicians may use these results to timely identify which women are at risk of developing specific unmet needs after treatment. Evidence‐based, cost‐effective (online) interventions that target distress, the most influential risk factor, should be further implemented and disseminated among patients and clinicians.

The guidelines-checklist has the potential to stimulate rigorous and replicable research using existing data sets and to assist investigators in assessing the appropriateness and potential of a data set and model-based methods for response shift research.