Institute of Health and Society, Newcastle University, UK.
Health Technol Assess. 2010 Nov;14(52):1-251. doi: 10.3310/hta14520.
To investigate the clinical effectiveness and cost-effectiveness of laxatives versus dietary and lifestyle advice, and standardised versus personalised dietary and lifestyle advice.
A prospective, pragmatic, three-armed cluster randomised trial with an economic evaluation.
General practices in England and Scotland, UK.
People aged ≥ 55 years with chronic constipation, living in private households. Participants were identified as those who had been prescribed laxatives three or more times in the previous 12 months, or with a recorded diagnosis of chronic functional constipation.
Prescription of laxatives, with class of laxative and dose at the discretion of the GP and patient (standard care control arm); standardised, non-personalised dietary and lifestyle advice; and, personalised dietary and lifestyle advice, with reinforcement.
The primary outcome was the constipation-specific Patient Assessment of Constipation-Symptoms (PAC-SYM)/Patient Assessment of Constipation-Quality of Life (PAC-QOL).
The trial planned to recruit and retain 1425 patients from 57 practices (19 per arm); however, only 154 patients were recruited from 19 practices. Due to these low recruitment rates it was not possible to report the conventional trial findings. Baseline characteristics of the sample from data gathered from both postal self-completion questionnaires and face-to-face interviews suggest that our sample experienced very few symptoms of constipation (PAC-SYM) and that the condition itself did not have a major impact upon their quality of life (PAC-QOL). The low level of symptoms of constipation is most likely explained by 90% of the sample using a laxative in the previous week. Most participants in our sample were satisfied with the performance of their laxatives, and levels of anxiety and depression were low. Their fibre consumption was classified as 'moderate' but their average water consumption fell below the recommended guidelines. Daily diaries, completed each day for a period of 6 months, were analysed primarily in terms of overall response rate and item response rates, and the participants accepted this method of data collection. For the economic evaluation, all of the trial arms experienced a reduction in utility, as measured by EQ-5D. There was no statistical evidence to suggest that either the personalised intervention arm or the standardised intervention arm was associated with significant changes in utility at 3 months compared with the control arm. Data on related health-care costs show a cost saving of £13.34 for those in the personalised arm, compared with the control arm, and a smaller cost saving for the standardised arm. These savings primarily occurred because of reduced hospital costs. There was no significant change measured in utility, so the personalised arm appeared to be the preferred course, producing the greatest cost savings.
Due to the low number of participants in the trial, no firm conclusions could be drawn about the effectiveness of the interventions. However, a number of factors that contributed to the conduct and progress of the trial are highlighted, which may be relevant to others conducting research on a similar topic or population.
ISRCTN73881345.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 14, No. 52. See the HTA programme website for further project information.
研究泻药与饮食和生活方式建议、标准化与个性化饮食和生活方式建议相比的临床效果和成本效益。
前瞻性、实用、三臂集群随机试验，结合经济评估。
英国英格兰和苏格兰的普通诊所。
年龄≥55 岁、患有慢性便秘、居住在私人住宅中的人群。参与者被确定为在过去 12 个月内被开出处方 3 次或以上的人群，或有慢性功能性便秘记录诊断的人群。
开出泻药，由全科医生和患者自行决定泻药的类别和剂量（标准护理对照组）；提供标准化、非个性化的饮食和生活方式建议；以及提供个性化的饮食和生活方式建议，并进行强化。
主要结局指标为便秘特异性患者评估便秘症状（PAC-SYM）/患者评估便秘生活质量（PAC-QOL）。
该试验计划从 57 个诊所招募并保留 1425 名患者（每组 19 名）；然而，仅从 19 个诊所招募了 154 名患者。由于这些低招募率，无法报告常规试验结果。从邮寄自我完成问卷和面对面访谈收集的数据中，样本的基线特征表明，我们的样本经历的便秘症状非常少（PAC-SYM），并且该病症对他们的生活质量（PAC-QOL）没有重大影响。便秘症状水平低的最可能原因是 90%的样本在前一周使用了泻药。我们样本中的大多数参与者对泻药的疗效感到满意，焦虑和抑郁水平较低。他们的纤维摄入量被归类为“中等”，但他们的平均水摄入量低于推荐的指导方针。参与者每天填写的为期 6 个月的日常日记主要分析了总体反应率和项目反应率，参与者接受了这种数据收集方法。对于经济评估，所有试验组的效用均有所降低，这是通过 EQ-5D 测量的。没有统计学证据表明，个性化干预组或标准化干预组在 3 个月时与对照组相比，在效用方面有显著变化。与对照组相比，个性化组的相关医疗保健成本数据显示节省了 13.34 英镑，而标准化组的成本节省较小。这些节省主要是由于医院成本降低所致。效用没有显著变化，因此个性化组似乎是首选方案，可带来最大的成本节约。
由于试验参与者人数较少，无法对干预措施的有效性得出明确结论。然而，强调了一些导致试验进行和进展的因素，这些因素可能与其他在类似主题或人群中进行研究的人有关。
ISRCTN73881345。
本项目由英国国家卫生与保健优化研究所卫生技术评估计划资助，将在《卫生技术评估》杂志全文发表；第 14 卷，第 52 期。欲了解更多关于该项目的信息，请访问 HTA 计划网站。
