Incorporating parent, former patient and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition.
Incorporating parent, former patient and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition.
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DOI：
10.1136/bmjpo-2021-001112
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发表时间：
2021
影响因子：
2.6
通讯作者：
Modi N
中科院分区：
文献类型：
--
作者：
Lammons W;Moss B;Battersby C;Cornelius V;Babalis D;Modi N
比较有效性随机对照试验是解决现有治疗和护理过程中不确定性的有力工具。为了解决早产儿营养中两个长期存在的不确定性，我们寻求了一项计划中的全国性双聚群随机对照试验（协作）设计的家长和患者的观点。我们采用了定性焦点小组，并与家长、前患者和临床医生进行了访谈。我们遵循报告定性研究核对表的综合标准，并进行了框架分析，这是专题分析中的一种具体方法。我们确定了对试验方法和愿景的支持，并引出了与临床研究相关的父母情感需求的主题。它们是：减轻母亲母乳喂养的压力；选择退出同意以减轻家长压力；希望研究成为临床医生、家长和研究人员之间的伙伴关系；以协作的语气呈现试验信息的价值；并且以一种允许父母按照自己的节奏同化的形式。我们在一些临床医生中发现了焦虑和认知失调，他们认识到试验的不确定性，但由于他们强烈的观点而感到无法参与。父母和前患者的早期参与确定了父母情感需求在比较有效性研究设计中的中心地位。这些见解已被纳入试验注册流程和提供给参与者的信息。具体产出是一份双面传单，提供非常简短和更详细的信息，并使用家长认为具有包容性和参与性的语言。需要进一步的工作来支持临床医生解决阻碍试验参与的个人偏见。
Comparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition. We used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis. We identified support for the trial’s methodology and vision, and elicited themes illustrating parents’ emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views. The early involvement of parents and former patients identified the centrality of parents’ emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation.
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影响因子：
4.6
作者：
Greenbury SF;Ougham K;Wu J;Battersby C;Gale C;Modi N;Angelini ED
通讯作者：
Angelini ED
影响因子：
2.7
作者：
Berry, Jesia G.;Ryan, Philip;Gold, Michael S.
通讯作者：
Gold, Michael S.
DOI：
10.1136/archdischild-2016-310935
发表时间：
2017-07-01
影响因子：
4.4
作者：
Gale, C.;Hyde, M. J.;Modi, N.
通讯作者：
Modi, N.
影响因子：
3
作者：
Fiori, Martina;Endacott, Ruth;Latour, Jos M.
通讯作者：
Latour, Jos M.
影响因子：
2.5
作者：
Janvier, Annie;Bourque, Claude Julie;Turmel, Steve
通讯作者：
Turmel, Steve