Standard and reference‐based conditional mean imputation

Wolbers, Marcel; Noci, Alessandro; Delmar, Paul; Gower-Page, Craig; Yiu, Sean; Bartlett, Jonathan

doi:10.1002/pst.2234

Cited by 16 publications

(5 citation statements)

References 26 publications

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“…Statistical data were analyzed with SPSS 25.0 (IBM Corporation). All outcome analyses were conducted according to the intention-to-treat principle, and the missing data were dealt with using conditional mean imputation [ 37 ]. Repeated-measures ANOVA was used for continuous data to compare efficacy differences within/between groups.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and Cost-Effectiveness Analysis of Internet-Based Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: Randomized Controlled Trial

Wu¹,

Li²,

Zhou³

et al. 2023

J Med Internet Res

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Background Obsessive-compulsive disorder (OCD) is a common and chronic mental illness with a high rate of disability. Internet-based cognitive behavioral therapy (ICBT) makes online treatment available to patients and has been shown to be effective. However, 3-arm trials on ICBT, face-to-face cognitive behavioral group therapy (CBGT), and only medication are still lacking. Objective This study is a randomized, controlled, assessor-blinded trial of 3 groups for OCD: ICBT combined with medication, CBGT combined with medication, and conventional medical treatment (ie, treatment as usual [TAU]). The study aims to investigate the efficacy and cost-effectiveness of ICBT related to CBGT and TAU for adults with OCD in China. Methods In total, 99 patients with OCD were selected and randomly assigned to the ICBT, CBGT, and TAU groups for treatment for 6 weeks. The primary outcomes were the Yale-Brown Obsessive-Compulsive Scale (YBOCS) and the self-rating Florida Obsessive-Compulsive Inventory (FOCI), compared at baseline, during treatment (3 weeks), and after treatment (6 weeks), to analyze efficacy. The secondary outcome was the EuroQol Visual Analogue Scale (EQ-VAS) scores of the EuroQol 5D Questionnaire (EQ-5D). The cost questionnaires were recorded to analyze cost-effectiveness. Results Repeated-measures ANOVA was used for data analysis, and the final effective sample size was 93 (ICBT: n=32, 34.4%; CBGT: n=28, 30.1%; TAU: n=33, 35.5%). After 6-week treatment, the YBOCS scores of the 3 groups significantly decreased (P<.001), and there were no significant differences among groups. The FOCI score of the ICBT (P=.001) and CBGT (P=.035) groups was significantly lower than that of the TAU group after treatment. The total cost of the CBGT group (renminbi [RMB] 6678.45, 95% CI 4460.88-8896.01 [US $1010.36, 95% CI 678.87-1345.84]) was significantly higher than that of the ICBT group (RMB 3308.81, 95% CI 2476.89-4140.73[US $500.58, 95% CI 374.72-626.43], P<.001) and the TAU group (RMB 2259.61, 95% CI 2074.16-2445.05 [US $341.85, 95% CI 313.79-369.90], P<.001) after treatment. The ICBT group spent RMB 303.19 (US $45.97) less than the CBGT group and RMB 11.57 (US $1.75) less than the TAU group for each unit reduction in the YBOCS score. Conclusions Therapist-guided ICBT combined with medication is as effective as face-to-face CBGT combined with medication for OCD. ICBT combined with medication is more cost-effective than CBGT combined with medication and conventional medical treatment. It is expected to become an efficacious and economic alternative for adults with OCD when face-to-face CBGT is not available. Trial Registration Chinese Clinical Trial Registry ChiCTR1900023840; https://www.chictr.org.cn/showproj.html?proj=39294

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Section: Methodsmentioning

confidence: 99%

Efficacy and Cost-Effectiveness Analysis of Internet-Based Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: Randomized Controlled Trial

Wu¹,

Li²,

Zhou³

et al. 2023

J Med Internet Res

View full text Add to dashboard Cite

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“…The primary analysis will be based on the intention-to-treat principle, i.e. data for all randomized participants will be analysed, with conservative imputation of missing outcomes [ 86 ]. In a sensitivity analysis, multiple imputation procedures will be used to include dropout status and secondary outcomes in the imputation model.…”

Section: Methodsmentioning

confidence: 99%

Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)

Arendt,

Gondan,

Juul

et al. 2024

Trials

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Background About one third of patients with depression are in a condition that can be termed as “difficult-to-treat”. Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently uncertain. The aim of this trial is to investigate the beneficial and harmful effects of 30 sessions of individual schema therapy versus treatment as usual for difficult-to-treat depression in the Danish secondary, public mental health sector. Methods In this randomized, multi-centre, parallel-group, superiority clinical trial, 129 outpatients with difficult-to-treat depression will be randomized (1:1) to 30 sessions of individual schema therapy or treatment as usual; in this context mainly group-based, short-term cognitive behaviour or psychodynamic therapy. The primary outcome is the change from baseline in depressive symptoms 12 months after randomization, measured on the observer-rated 6-item Hamilton Rating Scale for Depression. The secondary outcomes are health-related quality of life assessed with the European Quality of Life 5 Dimensions 5 Level Version, functional impairment assessed with the Work and Social Adjustment Scale, psychological wellbeing assessed with the WHO-5 Well-being Index, and negative effects of treatment assessed with the Negative Effects Questionnaire. Exploratory outcomes are improvement on patient self-defined outcomes, personal recovery, anxiety symptoms, anger reactions, metacognitive beliefs about anger, and perseverative negative thinking. Outcomes will be assessed at 6, 12, and 24 months after randomization; the 12-month time-point being the primary time-point of interest. Outcome assessors performing the depression-rating, data managers, statisticians, the data safety and monitoring committee, and conclusion makers for the outcome article will be blinded to treatment allocation and results. To assess cost-effectiveness of the intervention, a health economic analysis will be performed. Discussion This trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group. Trial registration ClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023).

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“…Technical details on both J2R and CR methods are deferred to the appendix and can also be found in literature. 17,18 Besides the Bayesian random multiple imputation and Rubin's rules proposed by Carpenter et al, 16,17 Wolbers et al 19 discussed the conditional mean imputation combined with the jackknife or bootstrap as an alternative approach to carry out J2R and CR. In general, the J2R approach yields more conservative results than the CR approach if the experimental treatment has better treatment effect than the control treatment.…”

Section: Jump To Reference and Copy Reference Methodsmentioning

confidence: 99%

Statistical methods for handling missing data to align with treatment policy strategy

Wang

Kim

et al. 2023

Pharmaceutical Statistics

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The International Council for Harmonization (ICH) E9(R1) addendum recommends choosing an appropriate estimand based on the study objectives in advance of trial design. One defining attribute of an estimand is the intercurrent event, specifically what is considered an intercurrent event and how it should be handled. The primary objective of a clinical study is usually to assess a product's effectiveness and safety based on the planned treatment regimen instead of the actual treatment received. The estimand using the treatment policy strategy, which collects and analyzes data regardless of the occurrence of intercurrent events, is usually utilized. In this article, we explain how missing data can be handled using the treatment policy strategy from the authors' viewpoint in connection with antihyperglycemic product development programs. The article discusses five statistical methods to impute missing data occurring after intercurrent events. All five methods are applied within the framework of the treatment policy strategy. The article compares the five methods via Markov Chain Monte Carlo simulations and showcases how three of these five methods have been applied to estimate the treatment effects published in the labels for three antihyperglycemic agents currently on the market.intercurrent events, missing data, retrieved dropouts, return-to-baseline, treatment policy strategy, washout method | INTRODUCTIONAn estimand is what treatment effect is to be estimated in a clinical trial. The International Council for Harmonization (ICH) E9(R1) addendum on "Estimands and Sensitivity Analysis in Clinical Trials" 1 defines an estimand as a precise description of the treatment effect aligning with a given clinical trial objective. As further explained in the addendum, an estimand features the following five attributes: treatment, target population, variable of interest (endpoint), intercurrent events, and population-level summary. An intercurrent event is defined as an event occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question ofThe contribution was made while Dr. Susie Sinks worked at the FDA.

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Standard and reference‐based conditional mean imputation

Cited by 16 publications

References 26 publications

Efficacy and Cost-Effectiveness Analysis of Internet-Based Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: Randomized Controlled Trial

Efficacy and Cost-Effectiveness Analysis of Internet-Based Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: Randomized Controlled Trial

Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)

Statistical methods for handling missing data to align with treatment policy strategy

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