Multiple choice questions (MCQs) offer high reliability and easy machine-marking, but allow for cueing and stimulate recognition-based learning. Very short answer questions (VSAQs), which are open... Show moreMultiple choice questions (MCQs) offer high reliability and easy machine-marking, but allow for cueing and stimulate recognition-based learning. Very short answer questions (VSAQs), which are open-ended questions requiring a very short answer, may circumvent these limitations. Although VSAQ use in medical assessment increases, almost all research on reliability and validity of VSAQs in medical education has been performed by a single research group with extensive experience in the development of VSAQs. Therefore, we aimed to validate previous findings about VSAQ reliability, discrimination, and acceptability in undergraduate medical students and teachers with limited experience in VSAQs development. To validate the results presented in previous studies, we partially replicated a previous study and extended results on student experiences. Dutch undergraduate medical students (n = 375) were randomized to VSAQs first and MCQs second or vice versa in a formative exam in two courses, to determine reliability, discrimination, and cueing. Acceptability for teachers (i.e., VSAQ review time) was determined in the summative exam. Reliability (Cronbach's & alpha;) was 0.74 for VSAQs and 0.57 for MCQs in one course. In the other course, Cronbach's & alpha; was 0.87 for VSAQs and 0.83 for MCQs. Discrimination (average R-ir) was 0.27 vs. 0.17 and 0.43 vs. 0.39 for VSAQs vs. MCQs, respectively. Reviewing time of one VSAQ for the entire student cohort was & PLUSMN;2 minutes on average. Positive cueing occurred more in MCQs than in VSAQs (20% vs. 4% and 20.8% vs. 8.3% of questions per person in both courses). This study validates the positive results regarding VSAQs reliability, discrimination, and acceptability in undergraduate medical students. Furthermore, we demonstrate that VSAQ use is reliable among teachers with limited experience in writing and marking VSAQs. The short learning curve for teachers, favourable marking time and applicability regardless of the topic suggest that VSAQs might also be valuable beyond medical assessment. Show less
Melisse, B.; Blankers, M.; Berg, E. van den; Jonge, M. de; Lommerse, N.; Furth, E. van; ... ; Beurs, E. de 2023
IntroductionThe aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self-help cognitive behavioral therapy-enhanced (CBT-E) for binge-eating disorder ... Show moreIntroductionThe aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self-help cognitive behavioral therapy-enhanced (CBT-E) for binge-eating disorder (BED) to a waiting list control condition. MethodsBED patients (N = 212) were randomly assigned to guided self-help CBT-E or the 3-month waiting list. Measurements took place at baseline and the end-of-treatment. The cost-effectiveness analysis was performed using the number of binge-eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost-utility analysis was performed using the EuroQol-5D. ResultsThe difference in societal costs over the 3 months of the intervention between both conditions was euro679 (confidence interval [CI] 50-1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self-help condition was approximately euro18 (CI 1-41). From a societal perspective there was a 96% likelihood that guided self-help CBT-E led to a greater number of binge-eating episodes prevented, but at higher costs. Each additional quality-adjusted life year (QALY) gained was associated with incremental costs of euro34,000 (CI 2494-154,530). With a 95% likelihood guided self-help CBT-E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness-to-pay threshold of euro35,000 per QALY, guided self-help CBT-E can be considered cost-effective with a likelihood of 95% from a societal perspective. DiscussionGuided self-help CBT-E is likely a cost-effective treatment for BED in the short-term (3-month course of treatment). Comparison to treatment-as-usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. Public SignificanceOffering treatment remotely has several benefits for patients suffering from binge-eating disorders. Guided self-help CBT-E is an efficacious and likely cost-effective treatment, reducing binge eating and improving quality-of-life, albeit at higher societal costs. Show less
Melisse, B.; Blankers, M.; Berg, E. van den; Jonge, M. de; Lommerse, N.; Furth, E. van; ... ; Beurs, E. de 2023
Background: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to... Show moreBackground: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.Objective: The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.Methods: A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.Results: During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.Conclusions: This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Show less
Melisse, B.; Dekker, J.; Berg, E. van den; Jonge, M. de; Furth, E.F. van; Peen, J.; Beurs, E. de 2023
Introduction: Cognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among... Show moreIntroduction: Cognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among transdiagnostic samples and remains unknown for binge eating disorder. The aim of present study was to assess several treatment outcome predictors and to compare effectiveness of CBT-E among adult outpatients with bulimia nervosa (N=370), binge eating disorder (N=113), and those with a restrictive food pattern diagnosed with other specified feeding and eating disorder (N=139).Method: Effectiveness of CBT-E was assessed in routine clinical practice in a specialised eating disorders centre. Eating disorder pathology was measured with the EDE-Q pre- and post-treatment, and at 20 weeks follow-up. Linear mixed model analyses with fixed effect were performed to compare treatment outcome among the eating disorder groups. Several predictors of treatment completion and outcome were examined with a regression analysis.Results: No predictors for drop-out were found, except the diagnosis of bulimia nervosa. Eating disorder pathology decreased among all groups with effect sizes between 1.43-1.70 on the EDE-Q total score. There were no differences in remission rates between the three groups at end of treatment or at follow-up. Eating disorder severity at baseline affected treatment response.Discussion: The results can be generalised to other specialised treatment centres. No subgroup of patients differentially benefited from CBT-E supporting the transdiagnostic perspective for the treatment of eating disorders. Longer-term follow-up data are necessary to measure persistence of treatment benefits. Show less
Background: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to... Show moreBackground: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy–enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.Objective: The aim of this study is to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.Methods: A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90) or the delayed-treatment control condition (n=90) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination–Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.Results: During the last 4 weeks of treatment, objective binges reduced from an average of 19 (16) to 3 (5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between groups. Of the 180 participants, 142 (78.9%) completed treatment. Overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.Conclusions: This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study’s findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Show less
Melisse, B.; Dekker, J.; Berg, E. van den; Jonge, M. de; Furth, E.F. van; Peen, J.; Beurs, E. de 2022
Cognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among... Show moreCognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among transdiagnostic samples and remains unknown for binge eating disorder. The aim of the present study was to assess several treatment outcome predictors and to compare effectiveness of CBT-E among adult out-patients with bulimia nervosa (n=370), binge eating disorder (n=113), and those with a restrictive food pattern diagnosed with other specified feeding and eating disorders (n=139). Effectiveness of CBT-E was assessed in routine clinical practice in a specialised eating disorders centre. Eating disorder pathology was measured with the EDEQ pre- and post-treatment, and at 20 weeks follow-up. Linear mixed model analyses with fixed effect were performed to compare treatment outcome among the eating disorder groups. Several predictors of treatment completion and outcome were examined with a regression analysis. No predictors for drop-out were found, except the diagnosis of bulimia nervosa. Eating disorder pathology decreased among all groups with effect sizes between 1.43 and 1.70 on the EDE-Q total score. There were no differences in remission rates between the three groups at end of treatment or at follow-up. Eating disorder severity at baseline affected treatment response. The results can be generalised to other specialised treatment centres. No subgroup of patients differentially benefited from CBT-E supporting the transdiagnostic perspective for the treatment of eating disorders. Longer-term follow-up data are necessary to measure persistence of treatment benefits. Show less
BACKGROUNDAmong patients with non-small-cell lung cancer (NSCLC),METexon 14 skipping mutations occur in 3 to 4% andMETamplifications occur in 1 to 6%. Capmatinib, a selective inhibitor of the MET... Show moreBACKGROUNDAmong patients with non-small-cell lung cancer (NSCLC),METexon 14 skipping mutations occur in 3 to 4% andMETamplifications occur in 1 to 6%. Capmatinib, a selective inhibitor of the MET receptor, has shown activity in cancer models with various types of MET activation.METHODSWe conducted a multiple-cohort, phase 2 study evaluating capmatinib in patients withMET-dysregulated advanced NSCLC. Patients were assigned to cohorts on the basis of previous lines of therapy andMETstatus (METexon 14 skipping mutation orMETamplification according to gene copy number in tumor tissue). Patients received capmatinib (400-mg tablet) twice daily. The primary end point was overall response (complete or partial response), and the key secondary end point was response duration; both end points were assessed by an independent review committee whose members were unaware of the cohort assignments.RESULTSA total of 364 patients were assigned to the cohorts. Among patients with NSCLC with aMETexon 14 skipping mutation, overall response was observed in 41% (95% confidence interval [CI], 29 to 53) of 69 patients who had received one or two lines of therapy previously and in 68% (95% CI, 48 to 84) of 28 patients who had not received treatment previously; the median duration of response was 9.7 months (95% CI, 5.6 to 13.0) and 12.6 months (95% CI, 5.6 to could not be estimated), respectively. Limited efficacy was observed in previously treated patients withMETamplification who had a gene copy number of less than 10 (overall response in 7 to 12% of patients). Among patients withMETamplification and a gene copy number of 10 or higher, overall response was observed in 29% (95% CI, 19 to 41) of previously treated patients and in 40% (95% CI, 16 to 68) of those who had not received treatment previously. The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%); these events were mostly of grade 1 or 2.CONCLUSIONSCapmatinib showed substantial antitumor activity in patients with advanced NSCLC with aMETexon 14 skipping mutation, particularly in those not treated previously. The efficacy inMET-amplified advanced NSCLC was higher in tumors with a high gene copy number than in those with a low gene copy number. Low-grade peripheral edema and nausea were the main toxic effects. Show less
Berg, E. van den; Melisse, B.; Koenders, J.; Jonge, M. de; Blankers, M.; Beurs, E. de; Dekker, J. 2020
Background: Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral... Show moreBackground: Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition.Methods: The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed.Discussion: This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial. Show less
Jonge, M. de; Auguste, A.; Schouten, P.; Kroon, C. de; Meijers, M.; Haar, N. ter; ... ; Bosse, T. 2017
