Validation of the Danish version of the disease specific instrument EORTC QLQ-CR38 to assess Health-related quality of life in patients with colorectal cancer

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) quality of life colorectal questionnaire module (QLQ-CR38) was developed in 1999, and an update, the QLQ CR29 was published recently. To date the Danish version of the questionnaire has not been validated. The aim of this study was to examine the psychometric properties of the Danish version of EORTC QLQ-CR38. METHODS: EORTC QLQ-CR38 was administered to 190 patients with colorectal cancer in two Danish hospitals, one month after their operation. A psychometric evaluation of the questionnaire’s structure, reliability, convergent, divergent and known-groups validity was performed. RESULTS: Data from 164 (86.3%) patients were available for analysis. The Danish version of EORTC QLQ-CR38 showed satisfactory psychometric properties for the scales: body image, sexual functioning, male sexual problems and defecations problems. Suboptimal psychometric performances were found for the scales: micturition problems, symptoms of the gastrointestinal tract and weight loss. Evaluation of the psychometric properties of the scale chemotherapy side effects was limited by the low number of patients receiving chemotherapy. It was not possible to assess the psychometric properties of the scale female sexual problems and the single item sexual enjoyment due to a high number of missing values. The homogeneity of the study population made the evaluation of known-group validity difficult. CONCLUSIONS: The results of this study suggest that the validity of the Danish version of EORTC QLQ-CR38 is acceptable. Furthermore, the results support the appropriateness of the updated version, the EORTC QLQ-CR29

Incisional hernia and its impact on health-related quality of life after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a national prospective cohort study

Abstract Background To evaluate the incidence of incisional hernia (IH) after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) and its impact on health-related quality of life (HRQoL). Method From June 2006 until June 2016, 152 patients were followed after CRS + HIPEC at Aarhus University Hospital, a single national center. Patients were seen postoperatively in an outpatient clinic at 3, 6, 12, 18, 24, 36 48, and 60 months. Clinical examinations at these follow-up visits were used to evaluate IH events prospectively. The incidence of IH was estimated using competing risk analysis and is presented as the cumulative incidence proportion (CIP). We expected the incidence to be 15% at 12 months. HRQoL was assessed at 12 months by the Short Form (SF-36) questionnaire, which we used to compare patients with an IH to patients without an IH. Results The median follow-up time was 16.6 months [range 0.9–62.0]. During this period, 14/152 (9.2%) patients developed an IH. The 1-year CIP was 5.9% [95% CI 2.9; 10.4] (n = 8), and the 2-year CIP was 9.2% [95% CI 5.3; 14.5] (n = 14). Patients with an IH were significantly older (67 years [range 48–72]) compared to patients without IH (60 years [range 24–75], p ≤ 0.01). The rate of postoperative complications between patients with and without IH was comparable, except that a greater proportion of patients with IH had a fascial dehiscence (21.4%) compared to patients without an IH (3.6%). Reponses to the SF-36 show that patients with an IH report lower HRQoL with regard to Role-physical (mean difference − 32.9 [95% CI − 60.6; − 5.3]) and Role-emotional (mean difference − 20.2 [95% CI − 43.4; 3.1]), meaning a reduction in work and daily activities due to their physical and psychological health. We found no general decrease in HRQoL. Conclusion CRS + HIPEC do not increase the risk of IH as measured within 12 months postoperatively, contrary to expectations. However, patients with an IH report a limitation in daily activities, which can best be explained by changes in physical and psychological health. A larger cohort from multiple centres is necessary to verify our findings

Initial validation of the Danish version of the Fear of Cancer Recurrence Inventory (FCRI) in colorectal cancer patients

PURPOSE :The Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional measure for fear of cancer recurrence (FCR). The aim of this study was to assess the psychometric properties of the translated Danish version of the FCRI in a population of colorectal cancer patients. METHODS: The English version of the FCRI was forward-backward translated into Danish and pilot tested in a gynaecological cancer population. The psychometric properties of the FCRI were assessed in terms of responsiveness, test-retest reliability and discriminative and convergent validity in a population of colorectal cancer patients by asking them to complete questionnaires at three time points during follow-up. Clinical FCR was defined as ≥ 16 at the FCRI short form. RESULTS: The participation rate was 57%. A low association was found between higher scores on the FCRI and younger age (r = - 0.29, p = 0.02). A moderate correlation was found between the FCRI score and a measure for worry traits (r = 0.49, p < 0.001). Mean difference in total FCRI score was statistically significant between 'pre-scan' and 'postscan' (p < 0.001), thus indicating that the FCRI was responsive to change. The FCRI score showed good test-retest reliability (intraclass correlation = 0.84). CONCLUSION: The Danish version of the FCRI is a reliable and responsive measure for FCR in colorectal cancer patients and shows acceptable discriminative and convergent validity. IMPLICATIONS FOR CANCER SURVIVORS: A valid measure for FCR is crucial in order to identify patients with a need for special attention or interventions for high levels of FCR and to improve future research into FCR among cancer survivors

The effects of respiratory rate and tidal volume on pulse pressure variation in healthy lungs-a generalized additive model approach may help overcome limitations

Pulse pressure variation (PPV) is a well-established method for predicting fluid responsiveness in mechanically ventilated patients. The predictive accuracy is, however, disputed for ventilation with low tidal volume (VT) or low heart-rate-to-respiratory-rate ratio (HR/RR). We investigated the effects of VT and RR on PPV and on PPV's ability to predict fluid responsiveness. We included patients scheduled for open abdominal surgery. Prior to a 250 ml fluid bolus, we ventilated patients with combinations of VT from 4 to 10 ml kg-1 and RR from 10 to 31 min-1. For each of 10 RR-VT combinations, PPV was derived using both a classic approach and a generalized additive model (GAM) approach. The stroke volume (SV) response to fluid was evaluated using uncalibrated pulse contour analysis. An SV increase &gt; 10% defined fluid responsiveness. Fifty of 52 included patients received a fluid bolus. Ten were fluid responders. For all ventilator settings, fluid responsiveness prediction with PPV was inconclusive with point estimates for the area under the receiver operating characteristics curve between 0.62 and 0.82. Both PPV measures were nearly proportional to VT. Higher RR was associated with lower PPV. Classically derived PPV was affected more by RR than GAM-derived PPV. Correcting PPV for VT could improve PPV's predictive utility. Low HR/RR has limited effect on GAM-derived PPV, indicating that the low HR/RR limitation is related to how PPV is calculated. We did not demonstrate any benefit of GAM-derived PPV in predicting fluid responsiveness.Trial registration: ClinicalTrials.gov, reg. March 6, 2020, NCT04298931.</p