64 research outputs found

    Dutch juvenile idiopathic arthritis patients, carers and clinicians create a research agenda together following the James Lind Alliance method: A study protocol

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    Background: Research on Juvenile Idiopathic Arthritis (JIA) should support patients, caregivers/parents (carers) and clinicians to make important decisions in the consulting room and eventually to improve the lives of patients with JIA. Thus far these end-users of JIA-research have rarely been involved in the prioritisation of future research. Main body: Dutch organisations of patients, carers and clinicians will collaboratively develop a research agenda for JIA, following the James Lind Alliance (JLA) methodology. In a 'Priority Setting Partnership' (PSP), they will gradually establish a top 10 list of the most important unanswered research questions for JIA. In this process the input from clinicians, patients and their carers will be equally valued. Additionally, focus groups will be organised to involve young people with JIA. The involvement of all contributors will be monitored and evaluated. In this manner, the project will contribute to the growing body of literature on how to involve young people in agenda setting in a meaningful way. Conclusion: A JIA research agenda established through the JLA method and thus co-created by patients, carers and clinicians will inform researchers and research funders about the most important research questions for JIA. This will lead to research that really matters

    Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia

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    Introduction  Despite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates.  Methods  Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses.  Results  ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient's experienced psychopathology, nor their self-rating of functional impairment.  Conclusions  Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient's decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment

    Leading the vigilant organization

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    Factors associated with placebo response in depression trials:A systematic review of published meta-analyses (1990–2017)

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    Background: Placebo response is common in patients with major depressive disorder (MDD) and decreases the likelihood of demonstrating drug superiority over placebo in a randomized, controlled trial (RCT). This paper aims to review the collective evidence for particular patient characteristics and trial features being associated with placebo response in MDD. Methods: MEDLINE/PubMed publication database and Cochrane Library were searched for meta-analyses of placebo response in MDD, published in English from January 1990 to December 2017. The evidence for factors predicting a low or high placebo response was tabulated and weighted on the basis of methods, results, and quality of supporting studies. Results: We identified 58 papers, examining the possible association of 40 different factors with placebo response in MDD. Research methods varied considerably across articles so that our reporting remained descriptive. The evidence for any factor being associated with placebo response in MDD appeared very weak to weak. Limitations: Since none of the pooled analyses that we included could be regarded as a meta-analysis in its strict sense, and analytical approaches varied considerably, the current work is descriptive only, and without formal statistical analysis. Conclusions: Despite 25 years of pooling data from RCTs in MDD, there is no single factor for which strong evidence exists that it influences placebo response

    Decision sciences : an integrative perspective

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    ix, 470 p. ; 23 cm
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