哪些临床研究问题最重要？澳大利亚和新西兰肌肉骨骼（ANZMUSC）临床试验网络研究问题重要性工具（ANZMUSC-RQIT）的制定和初步验证。

Which clinical research questions are the most important? Development and preliminary validation of the Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network Research Question Importance Tool (ANZMUSC-RQIT).

机构信息

University of Otago, Wellington, New Zealand.

Hutt Valley District Health Board, Lower Hutt, New Zealand.

出版信息

PLoS One. 2023 Mar 17;18(3):e0281308. doi: 10.1371/journal.pone.0281308. eCollection 2023.

DOI:10.1371/journal.pone.0281308

PMID:36930668

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10022765/

Abstract

BACKGROUND AND AIMS

High quality clinical research that addresses important questions requires significant resources. In resource-constrained environments, projects will therefore need to be prioritized. The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network aimed to develop a stakeholder-based, transparent, easily implementable tool that provides a score for the 'importance' of a research question which could be used to rank research projects in order of importance.

METHODS

Using a mixed-methods, multi-stage approach that included a Delphi survey, consensus workshop, inter-rater reliability testing, validity testing and calibration using a discrete-choice methodology, the Research Question Importance Tool (ANZMUSC-RQIT) was developed. The tool incorporated broad stakeholder opinion, including consumers, at each stage and is designed for scoring by committee consensus.

RESULTS

The ANZMUSC-RQIT tool consists of 5 dimensions (compared to 6 dimensions for an earlier version of RQIT): (1) extent of stakeholder consensus, (2) social burden of health condition, (3) patient burden of health condition, (4) anticipated effectiveness of proposed intervention, and (5) extent to which health equity is addressed by the research. Each dimension is assessed by defining ordered levels of a relevant attribute and by assigning a score to each level. The scores for the dimensions are then summed to obtain an overall ANZMUSC-RQIT score, which represents the importance of the research question. The result is a score on an interval scale with an arbitrary unit, ranging from 0 (minimal importance) to 1000. The ANZMUSC-RQIT dimensions can be reliably ordered by committee consensus (ICC 0.73-0.93) and the overall score is positively associated with citation count (standardised regression coefficient 0.33, p<0.001) and journal impact factor group (OR 6.78, 95% CI 3.17 to 14.50 for 3rd tertile compared to 1st tertile of ANZMUSC-RQIT scores) for 200 published musculoskeletal clinical trials.

CONCLUSION

We propose that the ANZMUSC-RQIT is a useful tool for prioritising the importance of a research question.

摘要

背景和目的

高质量的临床研究需要解决重要问题，需要大量资源。因此，在资源有限的环境中，项目需要优先排序。澳大利亚和新西兰肌肉骨骼（ANZMUSC）临床试验网络旨在开发一种基于利益相关者的、透明的、易于实施的工具，该工具为研究问题的“重要性”提供一个分数，可用于按重要性对研究项目进行排序。

方法

使用混合方法、多阶段方法，包括德尔菲调查、共识研讨会、内部评分者间可靠性测试、有效性测试和使用离散选择方法进行校准，开发了研究问题重要性工具（ANZMUSC-RQIT）。该工具纳入了广泛的利益相关者意见，包括消费者，在每个阶段，并设计用于委员会共识评分。

结果

ANZMUSC-RQIT 工具由 5 个维度组成（而早期版本的 RQIT 有 6 个维度）：（1）利益相关者共识程度，（2）健康状况的社会负担，（3）健康状况的患者负担，（4）拟议干预措施的预期效果，以及（5）研究解决健康公平问题的程度。每个维度通过定义相关属性的有序水平并为每个水平分配一个分数来评估。然后将各维度的分数相加，得出 ANZMUSC-RQIT 的总分，代表研究问题的重要性。结果是一个区间尺度上的分数，单位任意，范围从 0（最小重要性）到 1000。ANZMUSC-RQIT 的维度可以通过委员会共识进行可靠排序（ICC 0.73-0.93），总分与引用次数呈正相关（标准化回归系数 0.33，p<0.001），与期刊影响因子组呈正相关（OR 6.78，95%CI 3.17 至 14.50，第 3 三分位与 ANZMUSC-RQIT 分数第 1 三分位相比）对于 200 篇已发表的肌肉骨骼临床试验。