Objective To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.Design Randomised non-inferiority trial.Setting Thirty-seven Dutch university and general hospitals.Population Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities.Methods Women were allocated to RBC transfusion or non-intervention.Main outcome measures Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum.Results In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable.Conclusions Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.
PurposeTo describe the health-related quality of life (HRQoL) of an unselected population of patients with chronic lymphocytic leukaemia (CLL) including untreated patients.MethodsHRQoL was measured by the EORTC QLQ-C30 including the CLL16 module, EQ-5D, and VAS in an observational study over multiple years. All HRQoL measurements per patient were connected and analysed using area under the curve analysis over the entire study duration. The total patient group was compared with the general population, and three groups of CLL patients were described separately, i.e. patients without any active treatment (“watch and wait”), chlorambucil treatment only, and patients with other treatment(s).ResultsHRQoL in the total group of CLL patients was compromised when compared with age- and gender-matched norm scores of the general population. CLL patients scored statistically worse on the VAS and utility score of the EQ-5D, all functioning scales of the EORTC QLQ-C30, and the symptoms of fatigue, dyspnoea, sleeping disturbance, appetite loss, and financial difficulties. In untreated patients, the HRQoL was slightly reduced. In all treatment stages, HRQoL was compromised considerably. Patients treated with chlorambucil only scored worse on the EORTC QLQ-C30 than patients who were treated with other treatments with regard to emotional functioning, cognitive functioning, bruises, uncomfortable stomach, and apathy.ConclusionsCLL patients differ most from the general population on role functioning, fatigue, concerns about future health, and having not enough energy. Once treatment is indicated, HRQoL becomes considerably compromised. This applies to all treatments, including chlorambucil, which is considered to be a mild treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s11136-015-1039-y) contains supplementary material, which is available to authorized users.
In this double-blind placebo-controlled randomized clinical trial, we investigated the influence of filgrastim administration on the quality of life (QOL) of refractory chronic sinusitis patients who did not respond to regular treatments. QOL was considered to be an important outcome measurement because apart from classic sinusitis parameters, it measures the overall burden of the symptomatology of chronic sinusitis patients caused by general malaise, tiredness, and social impediments. The QOL of 56 patients was assessed five times during the 24-week trial with the EuroQol, the Short Form (SF)-36, and the McGill pain questionnaire (MPQ). The QOL scores were all well below population norm scores and scores in a group of patients with chronic sinusitis who had sinus surgery. QOL scores of the filgrastim group suggested a better QOL than the placebo group, although none of the differences were statistically significant. There were indications that it might be possible to determine a subpopulation in which the results are better. Although the QOL measurements were not able to show a significant treatment effect of filgrastim in this group of patients with refractory chronic sinusitis, these measurements are important in studying chronic sinusitis because they enable the comparison of the burden of illness of patients with chronic sinusitis with other patient groups.
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