Department of Obstetrics and Gynaecology, Research Institute GROW, Maastricht University Medical Centre, Maastricht, The Netherlands
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, CAPHRI School of Public Health and Primary Care, Maastricht, The Netherlands.
Hum Reprod. 2015 Jun;30(6):1331-41. doi: 10.1093/humrep/dev084. Epub 2015 Apr 23.
To what extent are outcome measures in endometriosis-related quality of life studies influenced by the setting in which patient recruitment is performed?
Quality of life outcomes in women with endometriosis are highly influenced by recruitment strategies.
Most studies on quality of life in women with endometriosis are conducted in tertiary care centres or patient associations. It is conceivable that the setting in which patient recruitment is performed influences the quality of life results. This has not been investigated before.
STUDY DESIGN, SIZE, DURATION: Retrospective questionnaire based cohort study (part of the World Endometriosis Research Foundation (WERF) EndoCost study). The investigated women were recruited in three settings: a tertiary care centre for endometriosis (n = 135); five secondary care centres (n = 63); an endometriosis patient association (n = 291).
PARTICIPANTS/MATERIALS, SETTING, METHODS: The secondary and tertiary care population included women with a laparoscopic and/or histological diagnosis of endometriosis. The patient association population consisted of women with a self-reported diagnosis of surgically confirmed endometriosis.
The populations did not differ in terms of age, co-morbidities and education level. Delay of diagnosis was the longest in the patient association (median 7 years) (tertiary care 2 years; secondary care 1.5 years) (P < 0.001). The tertiary care population reported more laparotomies (64%) than the other populations (secondary care 43%; patient association 47%) (P = 0.002). Affected job was least prevalent in the secondary care setting (35%) (patient association 64%; tertiary care 56%) (P < 0.001). Affected relationships were most prevalent in the patient association setting (52%) (tertiary care 38%; secondary care 22%) (P < 0.001). Chronic pain was least prevalent in patients in secondary care (44%) (tertiary care 65%; patient association 61%) (P = 0.009). Substantial differences in quality of life were detected between secondary care (median physical component 50.4, mental component 49.6); tertiary care (physical component 46.2, mental component 46.2) and the patient association (physical component 45.0, mental component 44.6) (P < 0.001, P = 0.018).
LIMITATIONS, REASONS FOR CAUTION: The response rate was relatively low (35%). Analysis of the hospital populations revealed that non-responders and responders did not differ with respect to age or revised American Fertility Society classification, indicating that the non-responder bias is limited. However, other factors, such as social and marital status or symptomatology, might be different for non-responders. Missing values were analysed as if the symptom was not present. Missing values never exceeded 10%, except for one value. Therefore, it can be expected that the effect of missing data on the outcome is negligible. Twenty-five patients belonged to more than one category. A sensitivity analysis showed that the influence of assigning patients to another category was limited.
Outcomes regarding quality of life are highly influenced by recruitment strategy. None of the groups appeared to be a representative selection of the total population of women with endometriosis. An alternative strategy for creating a representative population for cost and quality of life studies is probably to recruit women who live in a specific geographic area rather than women that visit a specific hospital or are a member of a patient association.
STUDY FUNDING/COMPETING INTERESTS: The WERF EndoCost study was funded by the World Endometriosis Research Foundation. The sponsors did not have a role in the design and conduct of this study: collection, management, analysis, interpretation of the data; preparation, review, approval of the manuscript. L.H. is the chief executive and T.M.D. was a board member of WERF at the time of funding. T.M.D holds the Merck-Serono Chair and the Ferring Chair in Reproductive Medicine in Leuven, Belgium and has served as consultant for Merck-Serono, Schering-Plough, Astellas, and Arresto.
Not applicable.
招募患者的环境在多大程度上影响子宫内膜异位症相关生活质量研究的结果测量？
子宫内膜异位症患者的生活质量结果受招募策略的影响很大。
大多数关于子宫内膜异位症患者生活质量的研究都是在三级保健中心或患者协会进行的。可以想象，招募患者的环境会影响生活质量结果。这一点尚未被调查过。
研究设计、规模、持续时间：回顾性问卷调查队列研究（世界子宫内膜异位症研究基金会（WERF）EndoCost 研究的一部分）。调查的女性分别在三个环境中招募：一家子宫内膜异位症三级保健中心（n=135）；五家二级保健中心（n=63）；一个子宫内膜异位症患者协会（n=291）。
参与者/材料、设置、方法：二级和三级保健人群包括腹腔镜和/或组织学诊断为子宫内膜异位症的女性。患者协会人群由自我报告手术证实的子宫内膜异位症诊断的女性组成。
人群在年龄、合并症和教育水平方面没有差异。协会人群的诊断延迟时间最长（中位数为 7 年）（三级保健为 2 年；二级保健为 1.5 年）（P<0.001）。三级保健人群报告的剖腹手术（64%）多于其他人群（二级保健为 43%；患者协会为 47%）（P=0.002）。二级保健环境中受影响的工作比例最低（35%）（患者协会为 64%；三级保健为 56%）（P<0.001）。患者协会环境中受影响的关系最普遍（52%）（三级保健为 38%；二级保健为 22%）（P<0.001）。慢性疼痛在二级保健人群中发生率最低（44%）（三级保健为 65%；患者协会为 61%）（P=0.009）。在二级保健（身体成分 50.4，心理成分 49.6）、三级保健（身体成分 46.2，心理成分 46.2）和患者协会（身体成分 45.0，心理成分 44.6）之间检测到生活质量的显著差异（P<0.001，P=0.018）。
局限性、谨慎的原因：响应率相对较低（35%）。对医院人群的分析表明，未响应者和响应者在年龄或修订后的美国生育协会分类方面没有差异，表明未响应者的偏差是有限的。然而，其他因素，如社会和婚姻状况或症状，可能对未响应者有所不同。缺失值的分析方法是假设该症状不存在。缺失值从未超过 10%，除了一个值。因此，可以预期缺失数据对结果的影响可以忽略不计。有 25 名患者属于多个类别。敏感性分析表明，将患者分配到另一个类别的影响是有限的。
生活质量方面的结果受招募策略的影响很大。没有一个组似乎是子宫内膜异位症患者总人群的代表性选择。为成本和生活质量研究创建代表性人群的替代策略可能是招募居住在特定地理区域的女性，而不是访问特定医院或是患者协会成员的女性。
研究资金/利益冲突：WERF EndoCost 研究由世界子宫内膜异位症研究基金会资助。赞助商在研究的设计和实施过程中没有作用：数据的收集、管理、分析、解释；准备、审查、批准手稿。L.H. 是 WERF 的首席执行官，T.M.D. 在资助时是 WERF 的董事会成员。T.M.D. 担任 Merck-Serono、Schering-Plough、Astellas 和 Arresto 的顾问。
不适用。
