Health-Related Quality of Life in Patients With a Stable or Growing Vestibular Schwannoma Managed by Wait and Scan or Stereotactic Radiosurgery.

OBJECTIVE: To assess the effect of wait and scan (W&S) and stereotactic radiosurgery (SRS) on health-related quality of life (HRQoL) over time in patients with a stable vestibular schwannoma (VS) and growing VS. STUDY DESIGN: Longitudinal, multicenter, observational study. SETTING: Tertiary expert center for VS (Radboudumc Nijmegen) and Gamma-Knife center ETZ Hospital Tilburg. METHODS: Changes in HRQoL, measured with the Penn Acoustic Neuroma Quality-of-Life (PANQOL), and the physical and mental component summary scores (PCS and MCS, respectively) derived from the 36-Item Short Form Health Survey (SF-36), were compared among patients managed by W&S and SRS between 2017 and 2022. Second, HRQoL over time in patients with a growing VS was compared between W&S and SRS. RESULTS: Differences in PANQOL total and subdomain scores, PCS and MCS scores over time in the W&S (n = 73) and SRS (n = 170) groups were nonsignificant and on average did not exceed the minimal clinically important differences (mean difference of -2.56 [PANQOL total], 1.22 [PCS], and -1.76 [MCS]; all P > .05). In growing VS, comparison of W&S (n = 29) and SRS (n = 154) also revealed no significant difference (mean difference of 1.19 (PANQOL total), 1.83 (PCS) and -0.12 (MCS); all P > .05). CONCLUSION: Differences in HRQoL in patients with VS are minor and not significantly different or clinically relevant between patients managed with W&S or SRS. Similarly, patients with a growing VS managed with W&S or SRS exhibit no significant or clinical relevant difference in HRQoL during follow-up. This can aid clinicians in the counseling of patients regarding HRQoL when deciding on a management strategy after diagnosis or documented growth.

A Prediction Model for Successful Increase of Adalimumab Dose Intervals in Patients with Crohn's Disease: Secondary Analysis of the Pragmatic Open-Label Randomised Controlled Non-inferiority LADI Trial.

BACKGROUND: In the pragmatic open-label randomised controlled non-inferiority LADI trial we showed that increasing adalimumab (ADA) dose intervals was non-inferior to conventional dosing for persistent flares in patients with Crohn's disease (CD) in clinical and biochemical remission. AIMS: To develop a prediction model to identify patients who can successfully increase their ADA dose interval based on secondary analysis of trial data. METHODS: Patients in the intervention group of the LADI trial increased ADA intervals to 3 and then to 4 weeks. The dose interval increase was defined as successful when patients had no persistent flare (> 8 weeks), no intervention-related severe adverse events, no rescue medication use during the study, and were on an increased dose interval while in clinical and biochemical remission at week 48. Prediction models were based on logistic regression with relaxed LASSO. Models were internally validated using bootstrap optimism correction. RESULTS: We included 109 patients, of which 60.6% successfully increased their dose interval. Patients that were active smokers (odds ratio [OR] 0.90), had previous CD-related intra-abdominal surgeries (OR 0.85), proximal small bowel disease (OR 0.92), an increased Harvey-Bradshaw Index (OR 0.99) or increased faecal calprotectin (OR 0.997) were less likely to successfully increase their dose interval. The model had fair discriminative ability (AUC = 0.63) and net benefit analysis showed that the model could be used to select patients who could increase their dose interval. CONCLUSION: The final prediction model seems promising to select patients who could successfully increase their ADA dose interval. The model should be validated externally before it may be applied in clinical practice. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT03172377.

Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial.

BACKGROUND & AIMS: Gastrointestinal angiodysplasias are vascular anomalies that may result in transfusion-dependent anemia despite endoscopic therapy. An individual patient data meta-analysis of cohort studies suggests that octreotide decreases rebleeding rates, but component studies possessed a high risk of bias. We investigated the efficacy of octreotide in reducing the transfusion requirements of patients with angiodysplasia-related anemia in a clinical trial setting. METHODS: The study was designed as a multicenter, open-label, randomized controlled trial. Patients with angiodysplasia bleeding were required to have had at least 4 red blood cell (RBC) units or parental iron infusions, or both, in the year preceding randomization. Patients were allocated (1:1) to 40-mg octreotide long-acting release intramuscular every 28 days or standard of care, including endoscopic therapy. The treatment duration was 1 year. The primary outcome was the mean difference in the number of transfusion units (RBC + parental iron) between the octreotide and standard of care groups. Patients who received at least 1 octreotide injection or followed standard of care for at least 1 month were included in the intention-to-treat analyses. Analyses of covariance were used to adjust for baseline transfusion requirements and incomplete follow-up. RESULTS: We enrolled 62 patients (mean age, 72 years; 32 men) from 17 Dutch hospitals in the octreotide (n = 31) and standard of care (n = 31) groups. Patients required a mean number of 20.3 (standard deviation, 15.6) transfusion units and 2.4 (standard deviation, 2.0) endoscopic procedures in the year before enrollment. The total number of transfusions was lower with octreotide (11.0; 95% confidence interval [CI], 5.5-16.5) compared with standard of care (21.2; 95% CI, 15.7-26.7). Octreotide reduced the mean number of transfusion units by 10.2 (95% CI, 2.4-18.1; P = .012). Octreotide reduced the annual volume of endoscopic procedures by 0.9 (95% CI, 0.3-1.5). CONCLUSIONS: Octreotide effectively reduces transfusion requirements and the need for endoscopic therapy in patients with angiodysplasia-related anemia. CLINICALTRIALS: gov, NCT02384122.