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宫颈癌保留生育功能手术研究中结局报告的变异性:一项系统评价。

Variation in outcome reporting in studies of fertility-sparing surgery for cervical cancer: A systematic review.

机构信息

Department of Obstetrics and Gynaecology, Royal Surrey NHS Foundation Trust, Guildford, UK.

Women's Health Division, Blizard Institute, Queen Mary University London, London, UK.

出版信息

BJOG. 2023 Jan;130(2):163-175. doi: 10.1111/1471-0528.17342.

Abstract

BACKGROUND

Cervical cancer affects 3197 women in the UK, and 604 000 women worldwide annually, with peak incidence seen in women between 30 and 34 years of age. For many, fertility-sparing surgery is an appealing option where possible. However, absence of large-scale data, along with a notable variation in reported outcomes in relevant studies, may undermine future efforts for consistent evidence synthesis.

OBJECTIVES

To systematically review the reported outcomes measured in studies that include women who underwent fertility-sparing surgery for cervical cancer and identify whether variation exists.

SEARCH STRATEGY

We searched MEDLINE, EMBASE and CENTRAL from inception to February 2019.

SELECTION CRITERIA

Randomised controlled trials, cohort and observational studies, and case studies of more than ten participants from January 1990 to date.

DATA COLLECTION AND ANALYSIS

Study characteristics and all reported treatment outcomes.

MAIN RESULTS

A total of 104 studies with a sum of 9535 participants were identified. Most studies reported on oncological outcomes (97/104), followed by fertility and pregnancy (86/104), postoperative complications (74/104), intra-operative complications (72/104) and quality of life (5/104). There was huge variation and heterogeneity in reported outcomes, with only 12% being good quality and 87% being of poor quality.

CONCLUSIONS

There is significant heterogeneity in the reported outcomes. An agreed Core Outcome Set is necessary for future studies to effectively harmonise reported outcomes that are measurable and relevant to patients, clinicians and researchers. This systematic review sets the groundwork for the development of a Core Outcome Set for fertility-sparing surgery in cervical cancer.

摘要

背景

宫颈癌每年在英国影响 3197 名女性,在全球影响 604000 名女性,发病高峰在 30 至 34 岁的女性。对许多人来说,保留生育能力的手术是一种有吸引力的选择。然而,由于缺乏大规模的数据,以及相关研究中报告的结果存在显著差异,这可能会破坏未来进行一致性证据综合的努力。

目的

系统回顾包括接受宫颈癌保留生育能力手术的女性的研究中报告的结果,并确定是否存在差异。

检索策略

我们从建库至 2019 年 2 月检索了 MEDLINE、EMBASE 和 CENTRAL。

选择标准

1990 年 1 月至目前的随机对照试验、队列和观察性研究以及超过 10 名参与者的病例研究。

数据收集与分析

研究特征和所有报告的治疗结果。

主要结果

共确定了 104 项研究,共有 9535 名参与者。大多数研究报告了肿瘤学结果(97/104),其次是生育和妊娠(86/104)、术后并发症(74/104)、术中并发症(72/104)和生活质量(5/104)。报告的结果存在巨大差异和异质性,只有 12%的结果质量良好,87%的结果质量较差。

结论

报告的结果存在显著的异质性。对于未来的研究,需要达成一个有共识的核心结局集,以有效地协调可测量和与患者、临床医生和研究人员相关的报告结果。本系统综述为制定宫颈癌保留生育能力手术的核心结局集奠定了基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/98ae/10108142/440369658daa/BJO-130-163-g002.jpg

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