Challenges in efficacy research: the case of feeding alternatives in patients with dementia.
Challenges in efficacy research: the case of feeding alternatives in patients with dementia.
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功效研究的挑战：痴呆症患者的喂养替代方案案例。
DOI：
10.1111/jan.12365
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发表时间：
2014
影响因子：
3.8
通讯作者：
Batchelor-Aselage,Melissa
中科院分区：
文献类型：
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作者：
Zapka,Jane;Amella,Elaine;Magwood,Gayenell;Madisetti,Mohan;Garrow,Donald;Batchelor-Aselage,Melissa
目的探讨在家庭照顾者和养老院管理层中可能影响参与临床试验的因素，以确定晚期痴呆患者采用手喂养和经皮胃造瘘管喂养的疗效。背景关于晚期痴呆患者使用管喂养还是手喂养的决策充满了实际、情感和伦理问题，并且没有得到大量证据。设计质量案例研究。方法回顾有家庭照顾者的焦点小组的笔录，以寻找行为理论指导的主题。对与养老院管理人员和工作人员接触的笔记的分析以组织准备模型为指导的主题进行了审查。数据收集于2009-2012年间。结果与照顾者参与意愿相关的因素包括对痴呆症预后的了解、对喂养需求的看法以及研究方案的清晰度。养老院参与的意愿受到公司批准、对法律和监管问题的担忧以及与调查人员的先前关系的影响。结论参与严格的试验需要长期了解复杂的公司要求并培训合格的研究人员。护理员的客观考虑将取决于适当的招募时机、招募材料的设计和对学习要求的了解。临床标准和政策环境以及那里的长期趋势与各级人民的反应有关。
AimsTo explore factors at the family caregiver and nursing home administrative levels that may affect participation in a clinical trial to determine the efficacy of hand feeding vs. percutaneous gastrostomy tube feeding in persons with late‐stage dementia.BackgroundDecision‐making regarding use of tube feeding vs. hand feeding for persons with late‐stage dementia is fraught with practical, emotional and ethical issues and is not informed by high levels of evidence.DesignQualitative case study.MethodsTranscripts of focus groups with family caregivers were reviewed for themes guided by behavioural theory. Analyses of notes from contacts with nursing home administrators and staff were reviewed for themes guided by an organizational readiness model. Data were collected between the years 2009–2012.ResultsFactors related to caregiver willingness to participate included understanding of the prognosis of dementia, perceptions of feeding needs and clarity about research protocols. Nursing home willingness to participate was influenced by corporate approval, concerns about legal and regulatory issues, and prior relationships with investigators.ConclusionParticipation in rigorous trials requires lengthy navigation of complex corporate requirements and training competent study staff. Objective deliberation by caregivers will depend on appropriate recruitment timing, design of recruitment materials and understanding of study requirements. The clinical standards and policy environment and the secular trends there‐in have relevance to the responses of people at all levels.