Nursing, Midwifery and Allied Health Professions (NMAHP) Research Unit, Glasgow Caledonian University, Glasgow, UK.
ERIC, The Children's Bowel and Bladder Charity, Bristol, UK.
Health Technol Assess. 2024 Jan;28(5):1-266. doi: 10.3310/PLTR9622.
BACKGROUND: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. OBJECTIVE: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. METHODS: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. RESULTS: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. SCOPING REVIEW: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. EFFECTIVENESS SYSTEMATIC REVIEWS: studies explored service delivery models ( = 15); interventions delivered by families/carers ( = 32), wider children's workforce ( = 21), continence teams ( = 31) and specialist consultant-led teams ( = 42); complementary therapies ( = 15); and psychosocial interventions ( = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. CONCLUSIONS: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. STUDY REGISTRATION: This study is registered as PROSPERO CRD42019159008. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in ; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.
背景:多达 30%的儿童在其生命的某个阶段会出现便秘。尽管这种情况通常是短暂的,但三分之一的儿童会发展为慢性功能性便秘,可能伴有溢出性失禁。最佳管理策略仍不清楚。 目的:确定治疗儿童慢性功能性便秘最有效的干预措施,以及这些干预措施的组合和顺序,并了解如何最好地实施这些干预措施。 方法:关键利益相关者,包括两名患有慢性功能性便秘的儿童的家长、两名经历过儿童慢性功能性便秘的成年人和四名健康专业人士/控尿专家,在整个研究过程中都提供了意见。我们进行了务实的混合方法综述。对于所有的综述,纳入的研究都集中在任何干预/策略上,这些干预/策略是在任何环境中实施的,旨在改善患有临床诊断为慢性功能性便秘(不包括诊断/评估研究)的儿童(0-18 岁)的任何结局。两名评审员应用纳入标准并评估偏倚风险。一名评审员提取数据,由另一名评审员核对。我们系统地检索了电子数据库(包括医学文献分析和检索系统在线、医学文摘数据库、护理与联合卫生文献累积索引)(2011 年 1 月至 2020 年 3 月)和灰色文献,包括报告任何干预/策略的研究(任何设计)。对数据进行编码、制表和映射。研究质量未进行评估。对于每种不同的干预措施,我们纳入了被认为是低偏倚风险的现有系统评价(使用系统评价的偏倚风险评估工具),并对新的随机对照试验进行了任何荟萃分析更新。如果没有低偏倚风险的系统评价,我们纳入了随机对照试验和其他原始研究。使用特定设计的工具来判断偏倚风险。证据以叙述的方式进行综合,并通过深思熟虑的判断过程来判断证据的确定性为高、中、低、极低或证据不足。纳入的研究(任何设计,英语)详细说明了与干预相关的成本。研究被归类为成本-后果、成本-效果、成本-效用或成本-效益,并使用共识健康经济标准检查表评估报告质量。纳入的研究报告了与实施障碍或促进因素相关的数据。使用最佳拟合框架综合方法,围绕综合实施研究领域框架对因素进行综合。 结果:利益相关者优先考虑了结局,制定了一个模型,为证据综合提供了信息,并确定了证据空白。 范围综述:651 项研究,包括 190 项随机对照试验和 236 项原始研究,保守地报告了 48 项干预措施/干预措施组合。 有效性系统评价:研究探讨了服务提供模式(15 项);由家庭/照顾者(32 项)、更广泛的儿童劳动力(21 项)、控尿团队(31 项)和专科顾问领导的团队(42 项)实施的干预措施;补充疗法(15 项);和心理社会干预(4 项)。一种干预措施(益生菌)具有中等质量的证据;其他所有证据的质量都较低或极低。31 项研究报告了与成本或资源使用有关的证据;数据不足以支持普遍的结论。106 项研究描述了实施的障碍和促进因素。 结论:儿童慢性功能性便秘的管理很复杂。现有证据仍然有限,研究规模小,设计和报告质量差。确定了许多证据空白。当前临床指南中的治疗建议基本保持不变,但需要研究从考虑单一干预措施的有效性转变。临床护理和未来的研究必须考虑儿童的个体特征。 研究注册:本研究已在 PROSPERO 注册,注册号为 CRD42019159008。 资金来源:本研究由英国国家卫生与保健研究所(NIHR)卫生技术评估计划(NIHR 拨款号:128470)资助,并全文发表在;第 28 卷,第 5 期。有关该奖项的更多信息,请参见 NIHR 资助和奖项网站。
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