■盆腔器官脱垂很常见,会引起不愉快的症状,并对女性的生活质量产生负面影响。在英国,大多数盆腔器官脱垂的女性都会去诊所接受子宫托护理。
为了确定与临床护理相比,阴道子宫托自我管理对脱垂女性脱垂特定生活质量的临床效果和成本效益;并评估干预可接受性和对有效性的情境影响,坚持和忠诚。
■多中心,平行组,采用混合方法过程评估的优势随机对照试验。
■参加英国NHS门诊子宫托服务的妇女,年龄≥18岁,使用任何类型/材料的子宫托(架子除外,Gellhorn或Cube)至少2周。排除:手动灵活性有限的女性,认知缺陷(禁止同意或自我管理),怀孕或不讲英语。
■自我管理干预涉及30分钟的教学预约,一份信息传单,2周随访电话和当地诊所电话求助热线号码。基于诊所的护理涉及由中心的常规实践确定的常规预约。
■基于Web的远程应用程序;最小化是按年龄计算的,阴道栓型用户类型和中心。
■参与者,实施干预措施的人员和研究人员对小组分配没有盲化.
■患者报告的主要结局(使用盆底影响问卷-7进行测量)是脱垂特异性生活质量,成本-效果结局是随机化后18个月时每质量调整生命年的增量成本(使用专门制定的健康资源使用问卷).次要结果指标包括自我效能感和并发症。过程评估数据通过访谈收集,录音和检查表。分析是有意治疗。
■将三百四十名妇女随机分组(自我管理,n=169;诊所护理,n=171)。随机化后18个月,有291份具有有效主要结果数据的问卷(自我管理,n=139;诊所护理,n=152)。基线经济分析基于264名参与者(自我管理,n=125;诊所护理,n=139),具有有效的生活质量和资源使用数据。自我管理是一种可接受的干预措施。在18个月时,脱垂特异性生活质量没有组差异(校正平均差-0.03,95%置信区间-9.32至9.25)。干预交付是忠诚的。自我管理具有成本效益,每获得质量调整后的生命年的支付意愿门槛为20,000英镑,估计增量净收益为564.32英镑,成本效益概率为80.81%。18个月时,在以临床为基础的护理组中报告了更多的子宫托并发症(校正平均差3.83,95%置信区间0.81~6.86).一般自我效能感没有组间差异,但是自我管理的女性对子宫托自我管理活动更有信心。在这两组中,环境因素对依从性和有效性的影响。没有报告严重的意外严重不良反应。有32起严重不良事件(自我管理,n=17;诊所护理,n=14),都与干预无关。骨盆底影响问卷-7的基线数据出现偏差,全球COVID-19大流行的影响,在招募的样本中,交叉的潜在影响和缺乏种族多样性是可能的局限性.
■自我管理是可以接受且具有成本效益的,与临床治疗相比,脱垂女性的并发症较少,且未改善或恶化其生活质量.未来的研究需要开发一种对女性治疗欲望变化敏感的生活质量衡量标准。
■本研究注册为ISRCTN62510577。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:16/82/01)资助,并在《卫生技术评估》中全文发布。28号23.有关更多奖项信息,请参阅NIHR资助和奖励网站。
盆腔器官脱垂是大量女性所经历的一种常见且令人痛苦的疾病。脱垂是指通常在骨盆中的器官落入阴道。女人会有一种进入阴道的感觉,随着肠,膀胱和性问题。一种可能的治疗方法是阴道子宫托。子宫托是一种插入阴道并将盆腔器官保持在通常位置的装置。使用阴道子宫托的女性通常每6个月回到诊所,取出并更换子宫托;这被称为基于诊所的护理。然而,女人可以自己照顾子宫托;这叫做自我管理。本研究比较了自我管理和临床护理。240名脱垂妇女参加了会议;171人接受了诊所护理,169人进行了自我管理。每个女人在任何一组中都有平等的机会。自我管理小组中的妇女接受了30分钟的教学任命,一份信息传单,为期2周的后续电话和当地中心的电话号码。根据治疗医疗保健专业人员的建议,诊所护理组中的妇女返回诊所。自我管理被认为是可以接受的。妇女以适合自己生活方式的方式自我管理子宫托。18个月后,两组妇女的生活质量没有差异。与接受诊所护理的女性相比,自我管理组的女性经历的子宫托并发症较少。自我管理的成本低于诊所护理。总之,自我管理没有比诊所护理更能改善妇女的生活质量,但这确实导致女性经历更少的并发症,并且在NHS中交付的成本更低。研究结果支持将自我管理作为使用子宫托治疗脱垂的女性的治疗途径。
UNASSIGNED: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women\'s quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care.
UNASSIGNED: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity.
UNASSIGNED: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation.
UNASSIGNED: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking.
UNASSIGNED: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres\' usual practice.
UNASSIGNED: Remote web-based application; minimisation was by age, pessary user type and centre.
UNASSIGNED: Participants, those delivering the intervention and researchers were not blinded to group allocation.
UNASSIGNED: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat.
UNASSIGNED: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations.
UNASSIGNED: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment.
UNASSIGNED: This study is registered as ISRCTN62510577.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.
Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women’s quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women’s quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.