骨盆带疼痛女性研究与临床实践的核心结局集：PGP-COS
A core outcome set for research and clinical practice in women with pelvic girdle pain: PGP-COS.
作者信息
Remus Alexandria, Smith Valerie, Gutke Annelie, Mena Juan Jose Saldaña, Mørkved Siv, Wikmar Lena Nilsson, Öberg Birgitta, Olsson Christina, Robinson Hilde Stendal, Stuge Britt, Wuytack Francesca
机构信息
School of Nursing & Midwifery, Trinity College Dublin, Dublin, Ireland.
Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, University of Gothenburg, Göteborg, Sweden.
出版信息
PLoS One. 2021 Feb 25;16(2):e0247466. doi: 10.1371/journal.pone.0247466. eCollection 2021.
BACKGROUND
Inconsistent reporting of outcomes in clinical trials of women with Pelvic Girdle Pain (PGP) hinders comparison of findings and the reliability of evidence synthesis. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials on the condition. The aim of this study was to develop a consensus-based COS for evaluating the effectiveness of interventions in PGP during pregnancy and postpartum for use in research and clinical practice.
METHODS
A systematic review of previous studies on PGP and semi-structured interviews with women were undertaken to identify all outcomes that were reported in prior studies and that are relevant to those experiencing the condition. Key stakeholders (clinicians, researchers, service providers/policy makers and individuals with PGP) then rated the importance of these outcomes for including in a preliminary PGP-COS using a 3-round Delphi study. The final COS was agreed at a face-to-face consensus meeting.
RESULTS
Consensus was achieved on five outcomes for inclusion in the final PGP-COS. All outcomes are grouped under the "life impact" domain and include: pain frequency, pain intensity/severity, function/disability/activity limitation, health-related quality of life and fear avoidance.
CONCLUSION
This study identified a COS for evaluating the effectiveness of interventions in pregnancy-related and postpartum-related PGP in research and clinical settings. It is advocated that all trials, other non-randomised studies and clinicians in this area use this COS by reporting these outcomes as a minimum. This will ensure the reporting of meaningful outcomes and will enable the findings of future studies to be compared and combined. Future work will determine how to measure the outcomes of the PGP-COS.
CORE OUTCOME SET REGISTRATION
This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).
背景
骨盆带疼痛（PGP）女性临床试验中结局报告不一致，阻碍了研究结果的比较及证据综合的可靠性。核心结局集（COS）可解决这一问题，因为它定义了针对该病症的所有临床试验均应报告的最小结局集。本研究的目的是制定一个基于共识的COS，用于评估孕期和产后PGP干预措施的有效性，以用于研究和临床实践。
方法
对先前关于PGP的研究进行系统综述，并对女性进行半结构化访谈，以确定先前研究中报告的以及与该病症患者相关的所有结局。然后，关键利益相关者（临床医生、研究人员、服务提供者/政策制定者以及PGP患者）通过三轮德尔菲研究对这些结局纳入初步PGP-COS的重要性进行评分。最终的COS在一次面对面的共识会议上达成一致。
结果
就纳入最终PGP-COS的五个结局达成了共识。所有结局都归类于“生活影响”领域，包括：疼痛频率、疼痛强度/严重程度、功能/残疾/活动受限、健康相关生活质量以及恐惧回避。
结论
本研究确定了一个用于评估研究和临床环境中与妊娠相关和产后相关PGP干预措施有效性的COS。提倡该领域的所有试验、其他非随机研究以及临床医生至少报告这些结局，以此使用该COS。这将确保有意义的结局得到报告，并使未来研究的结果能够进行比较和整合。未来的工作将确定如何测量PGP-COS的结局。
核心结局集注册
该PGP-COS于2017年1月在COMET（有效性试验核心结局测量）注册（http://www.comet-initiative.org/studies/details/958）。
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