Albers-Heitner Pytha, Berghmans Bary, Joore Manuela, Lagro-Janssen Toine, Severens Johan, Nieman Fred, Winkens Ron
Integrated Care Unit, University Hospital Maastricht, Maastricht, The Netherlands.
BMC Health Serv Res. 2008 Apr 15;8:84. doi: 10.1186/1472-6963-8-84.
Urinary incontinence affects approximately 5% (800.000) of the Dutch population. Guidelines recommend pelvic floor muscle/bladder training for most patients. Unfortunately, general practitioners use this training only incidentally, but prescribe incontinence pads. Over 50% of patients get such pads, costing 160 million euros each year. Due to ageing of the population a further increase of expenses is expected. Several national reports recommend to involve nurse specialists to support general practitioners and improve patient care. The main objective of our study is to investigate the effectiveness and cost-effectiveness of involving nurse specialists in primary care for urinary incontinence. This paper describes the study protocol.
METHODS/DESIGN: In a pragmatic prospective multi centre two-armed randomized controlled trial in the Netherlands the availability and involvement for the general practitioners of a nurse specialist will be compared with usual care. All consecutive patients consulting their general practitioner within 1 year for urinary incontinence and patients already diagnosed with urinary incontinence are eligible. Included patients will be followed for 12 months. Primary outcome is severity of urinary incontinence (measured with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF)). Based on ICIQ-UI SF outcome data the number of patients needed to include is 350. For the economic evaluation quality of life and costs will be measured alongside the clinical trial. For the longer term extrapolation of the economic evaluation a Markov modelling approach will be used.
DISCUSSION/CONCLUSION: This is, to our knowledge, the first trial on care for patients with urinary incontinence in primary care that includes a full economic evaluation and cost-effectiveness modelling exercise from the societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.
Current Controlled Trials ISRCTN62722772.
尿失禁影响了约5%（80万）的荷兰人口。指南建议对大多数患者进行盆底肌肉/膀胱训练。遗憾的是，全科医生只是偶尔采用这种训练方法，却常常开具失禁护理垫。超过50%的患者使用此类护理垫，每年花费达1.6亿欧元。由于人口老龄化，预计费用还会进一步增加。几份国家报告建议让专科护士参与其中，以协助全科医生并改善患者护理。我们研究的主要目的是调查在初级护理中让专科护士参与尿失禁治疗的有效性和成本效益。本文描述了该研究方案。
方法/设计：在荷兰进行一项务实的前瞻性多中心双臂随机对照试验，将专科护士为全科医生提供的服务及参与情况与常规护理进行比较。所有在1年内因尿失禁咨询全科医生的连续患者以及已被诊断为尿失禁的患者均符合条件。纳入的患者将被随访12个月。主要结局指标是尿失禁的严重程度（采用国际尿失禁咨询问卷简表（ICIQ-UI SF）进行测量）。根据ICIQ-UI SF结局数据，所需纳入的患者数量为350名。在临床试验过程中，将同时测量生活质量和成本以进行经济学评估。对于经济学评估的长期推断，将采用马尔可夫模型方法。
讨论/结论：据我们所知，这是第一项针对初级护理中尿失禁患者护理的试验，该试验从社会角度进行了全面的经济学评估和成本效益建模分析。如果该干预措施被证明是有效且具有成本效益的，那么将考虑并预期实施该干预措施。
当前受控试验ISRCTN62722772。
