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Abstract Randomized controlled trials (RCTs) are the gold standard to establish the benefit-risk ratio of novel drugs. However, the evaluation of mature results often takes many years. We hypothesized that the addition of Bayesian inference methods at interim analysis time points might accelerate and enforce the knowledge that such trials may generate. In order to test that hypothesis, we retrospectively applied a Bayesian approach to the HOVON 132 trial, in which 800 newly diagnosed AML patients aged 18 to 65 years were randomly assigned to a “7 + 3” induction with or without lenalidomide. Five years after the first patient was recruited, the trial was negative for its primary endpoint with no difference in event-free survival (EFS) between experimental and control groups (hazard ratio [HR] 0.99, p = 0.96) in the final conventional analysis. We retrospectively simulated interim analyses after the inclusion of 150, 300, 450, and 600 patients using a Bayesian methodology to detect early lack of efficacy signals. The HR for EFS comparing the lenalidomide arm with the control treatment arm was 1.21 (95% CI 0.81–1.69), 1.05 (95% CI 0.86–1.30), 1.00 (95% CI 0.84–1.19), and 1.02 (95% CI 0.87–1.19) at interim analysis 1, 2, 3 and 4, respectively. Complete remission rates were lower in the lenalidomide arm, and early deaths more frequent. A Bayesian approach identified that the probability of a clinically relevant benefit for EFS (HR

Abstract Background Although stimulating patients’ mobility is considered a component of fundamental nursing care, approximately 35% of hospitalized patients experience functional decline during or after hospital admission. The aim of this study is to assess mobility level and to identify factors affecting mobility status in hospitalized patients admitted in single-occupancy patient rooms (SPRs) on general wards. Methods Mobility level was quantified with the Johns Hopkins Highest Level of Mobility Scale (JH-HLM) and EQ-5D-3L. GENEActiv accelerometer data over 24 h were collected in a subset of patients. Data were analyzed using generalized ordinal logistic regression analysis. The STROBE reporting checklist was applied. Results Wearing pajamas during daytime, having pain, admission in an isolation room, and wearing three or more medical equipment were negatively associated with mobilization level. More than half of patients (58.9%) who were able to mobilize according to the EQ-5D-3L did not achieve the highest possible level of mobility according to the JH-HLM. The subset of patients that wore an accelerometer spent most of the day in sedentary behavior (median 88.1%, IQR 85.9–93.6). The median total daily step count was 1326 (range 22-5362). Conclusion We found that the majority of participating hospitalized patients staying in single-occupancy patient rooms were able to mobilize. It appeared, however, that most of the patients who are physically capable of walking, do not reach the highest possible level of mobility according to the JH-HLM scale. Nurses should take their responsibility to ensure that patients achieve the highest possible level of mobility.

ObjectiveApproximately 50% of adolescents who have undergone scoliosis surgery still experience severe pain one year postoperatively. We explored the postoperative pain trajectory and the potential value of preoperative Thermal Quantitative Sensory Testing (T-QST) as predictor of chronic postsurgical pain after scoliosis surgery.DesignSingle-center prospective cohort study in adolescents undergoing scoliosis surgery.OutcomesPrevalence of chronic postsurgical pain (CPSP) one year after scoliosis surgery and postsurgical pain course during this year. The need for rescue medication and the relationship between pre-operative T-QST, acute pain and CPSP.ResultsThirty-nine patients (mean age 13.9 years; SD 1.9 years) completed the study. One year postoperatively, ten patients (26%) self-reported pain [numeric rating scale (NRS) score ≥ 4]) when moving and two (5%) when in rest. Four of these patients (10.3%) experienced neuropathic pain. The pre-operative cold pain threshold was lower (p = 0.002) in patients with CPSP at 12 months. Preoperative cold and heat pain thresholds were correlated with the number of moderate or severe pain reports (NRS ≥ 4) in the first week postoperatively (r -.426; p = 0.009 and r.392; p = 0.016, respectively).ConclusionsOne year after scoliosis surgery, a significant part of patients (26%) still reported pain, some with neuropathic characteristics. Better diagnosis and treatment is needed; our study suggests that T-QST could be further explored to better understand and treat children with this negative outcome.