Tellum T, Naftalin J, Hirsch M, Saridogan E, Jurkovic D
Facts Views Vis Obgyn. 2021 Sep;13(3):203-208. doi: 10.52054/FVVO.13.3.034.
Adenomyosis is a common benign gynaecological condition that has been associated with heavy and/or painful periods, subfertility and poor obstetric outcomes including miscarriage and preterm delivery. Studies evaluating treatments for adenomyosis have reported a wide range of outcomes and outcome measures. This variation in outcomes and outcome measures prevents effective data synthesis, thereby hampering the ability of meta-analyses to draw useful conclusions and inform clinical practice.
Our aim is to develop a minimum set of outcomes to be reported in all future studies that investigate any uterus-sparing intervention for treating uterine adenomyosis. Wide adoption of 'core outcomes' into research on adenomyosis would reduce the heterogeneity of studies and make data synthesis easier. This will ultimately lead to comparable, prioritised, and patient-centred conclusions from meta-analyses and guidelines.
Outcomes identified from a systematic review of the literature will form a long list, agreed by an international steering group representing key stakeholders, including healthcare professionals, researchers, and public research partners. Through a modified Delphi process, key stakeholders will score outcomes from the agreed long list on a nine-point Likert scale that ranges from 1 (not important) to 9 (critical). Following the Delphi process, the refined outcome set will be finalised by the steering group. Finally, the steering group will develop recommendations for high-quality measures for each outcome. The study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number 1649.
The implementation of the core outcome set for adenomyosis in future trials will enhance the availability of comparable data to facilitate more patient-centred evidence-based care.
WHAT IS NEW?: The core outcome set will facilitate the generation of clinically important and patient centred outcomes for studies evaluating treatments for adenomyosis.
子宫腺肌病是一种常见的妇科良性疾病，与月经过多和/或痛经、生育力低下以及包括流产和早产在内的不良产科结局有关。评估子宫腺肌病治疗方法的研究报告了广泛的结局和结局指标。结局和结局指标的这种差异阻碍了有效的数据综合，从而妨碍了荟萃分析得出有用结论并为临床实践提供信息的能力。
我们的目标是制定一套最小化的结局指标，以便在未来所有研究子宫腺肌病保留子宫干预措施的研究中进行报告。在子宫腺肌病研究中广泛采用“核心结局”将减少研究的异质性，使数据综合更容易。这最终将导致荟萃分析和指南得出可比、优先且以患者为中心的结论。
通过对文献的系统综述确定的结局将形成一个长列表，由代表关键利益相关者的国际指导小组商定，这些利益相关者包括医疗保健专业人员、研究人员和公共研究伙伴。通过改良的德尔菲法，关键利益相关者将对商定的长列表中的结局按照从1（不重要）到9（关键）的九点李克特量表进行评分。在德尔菲法之后，指导小组将最终确定精炼后的结局集。最后，指导小组将为每个结局制定高质量测量的建议。该研究已在有效性试验倡议核心结局测量中进行了前瞻性注册；编号为1649。
在未来试验中实施子宫腺肌病核心结局集将提高可比数据的可用性，以促进更以患者为中心的循证护理。
新内容是什么？：核心结局集将有助于为评估子宫腺肌病治疗方法的研究生成具有临床重要性且以患者为中心的结局。
