垂体手术研究的核心结局集：一项国际德尔菲共识研究。

A core outcome set for pituitary surgery research: an international delphi consensus study.

作者信息

Valetopoulou Alexandra, Newall Nicola, Khan Danyal Z, Borg Anouk, Bouloux Pierre M G, Bremner Fion, Buchfelder Michael, Cudlip Simon, Dorward Neil, Drake William M, Fernandez-Miranda Juan C, Fleseriu Maria, Geltzeiler Mathew, Ginn Joy, Gurnell Mark, Harris Steve, Jaunmuktane Zane, Korbonits Márta, Kosmin Michael, Koulouri Olympia, Horsfall Hugo Layard, Mamelak Adam N, Mannion Richard, McBride Pat, McCormack Ann I, Melmed Shlomo, Miszkiel Katherine A, Raverot Gerald, Santarius Thomas, Schwartz Theodore H, Serrano Inma, Zada Gabriel, Baldeweg Stephanie E, Marcus Hani J, Kolias Angelos G

机构信息

National Hospital for Neurology and Neurosurgery, London, UK.

Hawkes Institute, Department of Computer Science, University College London, London, UK.

出版信息

Pituitary. 2025 Jul 23;28(4):88. doi: 10.1007/s11102-025-01553-w.

DOI:10.1007/s11102-025-01553-w

PMID:40702372

Abstract

PURPOSE

This study aimed to develop a core outcome set (COS) for pituitary surgery to enhance the quality, efficiency and effectiveness of future pituitary adenoma surgery research.

METHODS

Thirty-three outcomes were identified through a systematic review of pituitary adenoma surgery outcomes and a study on patient-reported measures. These were presented in an online survey to healthcare professionals (HCPs), patients and caregivers. In the first round, participants scored each outcome's importance on a 5-point scale (1-strongly disagree; 5-strongly agree) and could also suggest additional outcomes, which were reviewed and, if appropriate, added to existing domains. In the second round, participants re-scored the updated the list, considering group median and interquartile range scores from the previous round. Outcomes with a median score of 5 were included in the COS. A final live online consensus meeting discussed and voted on borderline outcomes (median scores 3-4).

RESULTS

The first round received 95 responses (52% HCPs, 48% patients/caregivers). Of the 33 outcomes, 16 received a median score of 5 (strongly agree), three received 4.5 and 14 received 4 (agree). Round two received 87 responses (52% HCPs, 48% patients and caregivers). Of the 33 outcomes, 14 received a median ranking of 5, two received 4.5, 15 received 4 and two received 3 (neutral). The live meeting (attended by 12 participants: 5 HCPs, 6 patients, 1 caregiver), reached consensus on the final COS, which includes 7 domains: short-term surgical outcomes; nasal outcomes; ophthalmic outcomes; endocrine outcomes; quality of life and psychological outcomes; other short-term outcomes; and disease control outcomes.

CONCLUSION

We advocate for use of the COS in future pituitary surgery research.

摘要

目的

本研究旨在制定垂体手术的核心结局集（COS），以提高未来垂体腺瘤手术研究的质量、效率和效果。

方法

通过对垂体腺瘤手术结局的系统评价和患者报告指标的研究，确定了33项结局。这些结局在一项在线调查中呈现给医疗保健专业人员（HCPs）、患者和护理人员。在第一轮中，参与者以5分制（1 - 强烈不同意；5 - 强烈同意）对每个结局的重要性进行评分，还可以提出其他结局，这些结局经过审查后，酌情添加到现有领域。在第二轮中，参与者根据上一轮的组中位数和四分位间距分数对更新后的列表重新评分。中位数评分为5的结局被纳入核心结局集。最后一次在线共识会议对临界结局（中位数评分为3 - 4）进行了讨论和投票。

结果

第一轮收到95份回复（52%为HCPs，48%为患者/护理人员）。在33项结局中，16项的中位数评分为5（强烈同意），3项为4.5，14项为4（同意）。第二轮收到87份回复（52%为HCPs，48%为患者和护理人员）。在33项结局中，14项的中位数排名为5，2项为4.5，15项为4，2项为3（中立）。现场会议（12名参与者参加：5名HCPs，6名患者，1名护理人员）就最终的核心结局集达成了共识，该核心结局集包括7个领域：短期手术结局；鼻部结局；眼科结局；内分泌结局；生活质量和心理结局；其他短期结局；以及疾病控制结局。