(171) Characterization and prediction of placebo responders in peripheral neuropathic patients in a 4-week analgesic clinical trial

Pereira, Amanda Rocha Firmino; Dualé, Christian; Clermont, Frantz; Gramme, Pierre; Branders, Samuel; Gossuin, C.; Demolle, Dominique

doi:10.1016/j.jpain.2016.01.074

Cited by 5 publications

(8 citation statements)

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“…Psychological traits related to the placebo response were assessed at baseline using the self-reported Multidimensional Psychological Questionnaire (MPsQ e Tools4Patient, Belgium). These traits, along with baseline disease intensity measures, were used to compute the Placebell©™ Covariate, representing each patient's expected placebo responsiveness 23,24 . Post hoc analysis outcomes included 20% and 50% improvement rates in pain VAS, FIHOA, patient's global assessment and the responder criteria developed by the Outcome Measures in Rheumatology Arthritis Clinical Trials Osteoarthritis Research Society International (OMERACT-OARSI) 25 .…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study

Liu¹,

Robbins²,

Eyles³

et al. 2021

Osteoarthritis and Cartilage

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study

Liu¹,

Robbins²,

Eyles³

et al. 2021

Osteoarthritis and Cartilage

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“…Individual patient placebo response: baseline Multidimensional Psychological Questionnaire (MPsQ) modules will be used to assess the placebo response,37 38 which is a self-reported questionnaire using a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) contributing to the evaluation of individual patient response to placebo by assessing participants’ basic personality traits, expectation traits and perception.…”

Section: Methods and Analysismentioning

confidence: 99%

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial)

et al. 2021

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IntroductionKnee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months.Methods and analysisThe Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat.Ethics and disseminationThis protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications.Trial registration numbersAustralian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.

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“…The composite covariate approach was motivated by the recent advances in placebo effect characterization [9][10][11] . In chronic pain, the magnitude and the variability of the placebo response can obscure the superiority of active compounds compared to placebo [25][26][27][28] .…”

Section: Introductionmentioning

confidence: 99%

Leveraging historical data to optimize the number of covariates and their explained variance in the analysis of randomized clinical trials.

Branders¹,

Pereira²,

Ernst

et al. 2021

Stat Methods Med Res

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The amount of data collected from patients involved in clinical trials is continuously growing. All baseline patient characteristics are potential covariates that could be used to improve clinical trial analysis and power. However, the limited number of patients in phases I and II studies restricts the possible number of covariates included in the analyses. In this paper, we investigate the cost/benefit ratio of including covariates in the analysis of clinical trials with a continuous outcome. Within this context, we address the long-running question “What is the optimum number of covariates to include in a clinical trial?” To further improve the benefit/cost ratio of covariates, historical data can be leveraged to pre-specify the covariate weights, which can be viewed as the definition of a new composite covariate. Here we analyze the use of a composite covariate to improve the estimated treatment effect in small clinical trials. A composite covariate limits the loss of degrees of freedom and the risk of overfitting.

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(171) Characterization and prediction of placebo responders in peripheral neuropathic patients in a 4-week analgesic clinical trial

Cited by 5 publications

References 0 publications

Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study

Efficacy and safety of a supplement combination on hand pain among people with symptomatic hand osteoarthritis an internet-based, randomised clinical trial the RADIANT study

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial)

Leveraging historical data to optimize the number of covariates and their explained variance in the analysis of randomized clinical trials.

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