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Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials
The BMJ ( IF 93.6 ) Pub Date : 2022-12-08 , DOI: 10.1136/bmj-2022-072007
Miriam Santer 1 , Ingrid Muller 1 , Taeko Becque 1 , Beth Stuart 1, 2 , Julie Hooper 1 , Mary Steele 1 , Sylvia Wilczynska 3 , Tracey H Sach 4 , Matthew J Ridd 5 , Amanda Roberts 6 , Amina Ahmed 6 , Lucy Yardley 7, 8 , Paul Little 1 , Kate Greenwell 7 , Katy Sivyer 7 , Jacqui Nuttall 9 , Gareth Griffiths 9 , Sandra Lawton 10 , Sinéad M Langan 11 , Laura M Howells 6 , Paul Leighton 6 , Hywel C Williams 6 , Kim S Thomas 6
Affiliation  

Objective To determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management. Design Two independent, pragmatic, parallel group, unmasked, randomised controlled trials. Setting 98 general practices in England. Participants Parents and carers of children (0-12 years) with eczema (trial 1) and young people (13-25 years) with eczema (trial 2), excluding people with inactive or very mild eczema (≤5 on POEM, the Patient-Oriented Eczema Measure). Interventions Participants were randomised (1:1) using online software to receive usual eczema care or an online ([www.EczemaCareOnline.org.uk][1]) behavioural intervention for eczema plus usual care. Main outcome measures Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 being very severe) every four weeks over 24 weeks. Outcomes were reported by parents or carers for children and by self-report for young people. Secondary outcomes included POEM score every four weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, perceived barriers to treatment use, and intervention use. Analyses were carried out separately for the two trials and according to intention-to-treat principles. Results 340 parents or carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised. The mean baseline POEM score was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) for young people. Three young people withdrew from follow-up but did not withdraw their data. All randomised participants were included in the analyses. At 24 weeks, follow-up rates were 91.5% (311/340) for parents or carers and 90.2% (304/337) for young people. After controlling for baseline eczema severity and confounders, compared with usual care groups over 24 weeks, eczema severity improved in the intervention groups: mean difference in POEM score −1.5 (95% confidence interval −2.5 to −0.6; P=0.002) for parents or carers and −1.9 (−3.0 to −0.8; P<0.001) for young people. The number needed to treat to achieve a 2.5 difference in POEM score at 24 weeks was 6 in both trials. Improvements were sustained to 52 weeks in both trials. Enablement showed a statistically significant difference favouring the intervention group in both trials: adjusted mean difference at 24 weeks −0.7 (95% confidence interval −1.0 to −0.4) for parents or carers and −0.9 (−1.3 to −0.6) for young people. No harms were identified in either group. Conclusions Two online interventions for self-management of eczema aimed at parents or carers of children with eczema and at young people with eczema provide a useful, sustained benefit in managing eczema severity in children and young people when offered in addition to usual eczema care. Trial registration ISRCTN registry [ISRCTN79282252][2]. Consent was not obtained from participants for data sharing. Authors will consider reasonable request to make relevant anonymised participant level data available. [1]: http://www.EczemaCareOnline.org.uk [2]: /external-ref?link_type=ISRCTN&access_num=ISRCTN79282252

中文翻译:

湿疹护理 支持儿童和青少年自我护理的在线行为干预措施:两项独立、务实、随机对照试验

目的 确定两种在线行为干预措施(一种针对父母和照顾者,另一种针对年轻人)支持湿疹自我管理的有效性。设计 两项独立、务实、平行、未掩蔽、随机对照试验。在英格兰设立 98 项常规做法。参与者 患有湿疹的儿童(0-12 岁)(试验 1)和患有湿疹的年轻人(13-25 岁)(试验 2)的父母和照顾者,不包括患有非活动性或非常轻度湿疹的人(POEM ≤ 5,患者) -定向湿疹措施)。干预措施 参与者被随机 (1:1) 使用在线软件接受常规湿疹护理或在线 ([www.EczemaCareOnline.org.uk][1]) 湿疹行为干预加常规护理。主要结果指标 主要结果是在 24 周内每 4 周使用 POEM 评估一次湿疹症状(范围 0-28,其中 28 为非常严重)。结果由儿童的父母或照顾者报告,以及年轻人的自我报告。次要结局包括 52 周内每 4 周进行一次 POEM 评分、生活质量、湿疹控制、瘙痒强度(仅限年轻人)、患者支持、治疗使用、治疗使用的感知障碍和干预使用。这两项试验根据意向治疗原则分别进行了分析。结果 340 名儿童父母或照顾者(169 名常规护理;171 名干预)和 337 名年轻人(169 名常规护理;168 名干预)被随机分组​​。父母和照顾者的平均基线 POEM 分数为 12.8(标准差 5.3),年轻人为 15.2(5.4)。三名年轻人退出随访,但没有撤回数据。所有随机参与者均纳入分析。24 周时,父母或照顾者的随访率为 91.5% (311/340),年轻人的随访率为 90.2% (304/337)。在控制基线湿疹严重程度和混杂因素后,与 24 周内的常规护理组相比,干预组的湿疹严重程度有所改善:父母 POEM 评分的平均差异为 -1.5(95% 置信区间 -2.5 至 -0.6;P=0.002)或照顾者,年轻人则为-1.9(-3.0至-0.8;P<0.001)。在两项试验中,第 24 周时 POEM 评分相差 2.5 所需治疗的人数均为 6。两项试验的改善均持续至 52 周。在两项试验中,启用显示出有利于干预组的统计显着差异:父母或照顾者在 24 周时的调整平均差为 -0.7(95% 置信区间 -1.0 至 -0.4),年轻人为 -0.9(-1.3 至 -0.6) 。两组均未发现任何危害。结论 除了常规湿疹护理之外,针对湿疹儿童和青少年湿疹的父母或照顾者的两种湿疹自我管理在线干预措施,在管理儿童和青少年湿疹严重程度方面提供了有用的、持续的益处。试用注册 ISRCTN 注册表 [ISRCTN79282252][2]。数据共享未获得参与者的同意。作者将考虑合理的请求,以提供相关的匿名参与者级别数据。[1]:http://www.EczemaCareOnline.org.uk [2]:/external-ref?link_type=ISRCTN&access_num=ISRCTN79282252
更新日期:2022-12-08
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