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Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol

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机构: [1]Sleep Research Institute of Chinese Medicine, The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China. [2]Evidence-based Medicine Center, The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China. [3]Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China. [4]The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China. [5]Guangzhou University of Chinese Medicine, Guangzhou, China.
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Patient-reported outcomes (PROs) are health reports that come directly from the patients themselves and represented the experience and insights of the patient's perspective on the impact of the intervention. PROs were increasingly emphasised in acupuncture randomised controlled trials (RCTs). However, the reporting quality of PROs in acupuncture RCTs has not been investigated to date. Therefore, we constructed this study to reveal the basic characteristics and reporting quality of PROs in acupuncture RCTs, and explore the relationship between concealment, blinding and RROs. We hope our findings can provide guidance for the reporting standards and future development of PROs in acupuncture RCTs in reverse.RCTs using acupuncture treatment as the intervention and PROs as primary outcomes or secondary outcomes will be systematically searched through seven databases MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP between 1 January 2012 and 15 October 2022. The basic characteristics, concealment, blinding design and the characteristics of PROs in included RCTs will be summarised. The reporting quality of PROs will be assessed based on the CONSORT PRO extension. Logistic analysis will be performed to identify the association between concealment, blinding and RROs.Ethical approval is not required for this study. This protocol has been registered in Open Science Framework (OSF) Registries. The findings of this study will be submitted to a peer-reviewed academic journal.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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出版当年[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
第一作者:
第一作者机构: [1]Sleep Research Institute of Chinese Medicine, The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China. [2]Evidence-based Medicine Center, The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China.
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