Yoder Whitney Rose, Karyotaki Eirini, Cristea Ioana-Alina, van Duin Daniëlle, Cuijpers Pim
Department of Clinical, Neuro and Developmental Psychology Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.
BMJ Open. 2019 Feb 19;9(2):e024622. doi: 10.1136/bmjopen-2018-024622.
INTRODUCTION: One potential source of bias in randomised clinical trials of psychological interventions is researcher allegiance (RA). The operationalisation of RA differs strongly across studies, and there is not a generally accepted method of operationalising or measuring it. Furthermore, it remains unclear as to how RA affects the outcomes of trials and if it results in better outcomes for a preferred intervention. The aim of this project is to develop and validate a scale that accurately identifies RA, contribute to the understanding of the impact that RA has in a research setting and to make recommendations for addressing RA in practice. METHODS AND ANALYSIS: A scale will first be developed and validated to measure RA in psychotherapy trials. The scale will be validated by surveying authors of psychotherapy trials to assess their opinions, beliefs and preferences of psychotherapy interventions. Furthermore, the scale will be validated for use outside the field of psychotherapy. The validated checklist will then be used to examine two potential mechanisms of how RA may affect outcomes of interventions: publication bias (by assessing grants) and risk of bias (RoB). Finally, recommendations will be developed, and a feasibility study will be conducted at a national mental health agency in The Netherlands. Main analyses comprise inter-rater reliability of checklist items, correlations to examine the relationship between checklist items and author survey (convergent validity) as well as checklist items and trial outcomes and multivariate meta-regression techniques to assess potential mechanisms of how allegiance affects trial outcomes (publication bias and RoB). ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Scientific and Ethical Review Board (VCWE) at the Vrije Universiteit Amsterdam. Study result and advancements will also be published on the Open Science Framework. Furthermore, main findings will be disseminated through articles in international peer-reviewed open access journals. Results and recommendations will be communicated to the Cochrane Collaboration, the Campbell Collaboration and other funding agencies.
引言:心理干预随机临床试验中一个潜在的偏倚来源是研究者的偏好(RA)。不同研究中RA的操作化差异很大,且尚无普遍接受的操作化或测量方法。此外,RA如何影响试验结果以及它是否会使首选干预措施产生更好的结果仍不清楚。本项目的目的是开发并验证一个能够准确识别RA的量表,促进对RA在研究环境中所产生影响的理解,并为在实践中应对RA提出建议。 方法与分析:首先将开发并验证一个量表,用于测量心理治疗试验中的RA。该量表将通过对心理治疗试验的作者进行调查来验证,以评估他们对心理治疗干预的看法、信念和偏好。此外,该量表将在心理治疗领域之外进行验证。然后,经过验证的清单将用于研究RA可能影响干预结果的两种潜在机制:发表偏倚(通过评估资助情况)和偏倚风险(RoB)。最后,将提出建议,并在荷兰的一家国家心理健康机构进行可行性研究。主要分析包括清单项目的评分者间信度、用于检验清单项目与作者调查之间关系的相关性(收敛效度)以及清单项目与试验结果之间的相关性,以及用于评估偏好如何影响试验结果的潜在机制(发表偏倚和RoB)的多变量元回归技术。 伦理与传播:本研究已由阿姆斯特丹自由大学的科学与伦理审查委员会(VCWE)审查并批准。研究结果和进展也将在开放科学框架上发表。此外,主要研究结果将通过国际同行评审的开放获取期刊上的文章进行传播。结果和建议将传达给Cochrane协作网、坎贝尔协作网和其他资助机构。
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