What patients want - Consumer involvement in the design of a randomized controlled trial of routine oxygen supplementation after acute stroke
What patients want - Consumer involvement in the design of a randomized controlled trial of routine oxygen supplementation after acute stroke
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DOI：
10.1161/01.str.0000204053.36966.80
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发表时间：
2006-03-01
期刊：
影响因子：
8.3
通讯作者：
Crome, P
中科院分区：
文献类型：
--
作者：
Ali, K;Roffe, C;Crome, P
背景和目的-让中风患者和护理人员参与急性中风补充氧气研究的设计，并获取他们对研究重要性、同意问题、相关性和结局指标可接受性以及首选方法的看法随访。方法-本研究涉及定性和定量研究。与有斯托克个人经历的个人举行了三次焦点小组会议，主要是斯托克患者及其伴侣或护理者（一个年轻卒中患者协会和2个言语障碍支持小组，每个小组来自英国西米德兰兹郡的不同城镇）。研究人员解释了计划中的氧气补充研究，并鼓励参与者在半结构化访谈中发表评论和提出建议。然后，观众被要求完成一份问卷调查有关的study.Results -七十三人（67%的中风患者和33%的照顾者，平均年龄64;范围31至86岁;和47%的男性）参加了3次会议。对问卷的总体答复率为70%。大部分受访者认为研究是有价值的（97%），而计划的成果措施亦是相关的。此外，超过20%的受访者将语言、记忆、睡眠和认知功能的评估作为重要结果。75%的人会同意家庭成员代表不称职的患者同意，92%的人会同意医生招募不称职的患者参加研究，并在以后寻求同意/同意。大多数受访者（80%）的首选个人接触的研究人员或一个代表的问卷follow-up.Conclusions -参与中风患者和照顾者帮助我们确定结果的措施，是重要的中风人群，但不定期处理中风评估量表。高比例的受访者要求放弃同意，并同意代表不称职的病人家属的同意。虽然消费者的参与帮助我们使研究与公众更相关，但它也导致了方案设计中困难的科学和伦理冲突。
Background and Purpose - To involve stroke patients and carers in the design of a study of oxygen supplementation in acute stroke and to obtain their views on the importance of the study, consent issues, relevance, and acceptability of the outcome measures, and the preferred method of follow-up.Methods - This study involved qualitative and quantitative research. Three focus group meetings were held with individuals who have had personal experience of stoke, mostly stoke patients and their partners or carers (an association of young stroke sufferers and 2 dysphasia support groups each from a different town in the West Midlands, UK). The researchers explained the planned oxygen supplementation study and encouraged participants to comment and make suggestions in a semistructured interview. The audience was then asked to complete a questionnaire relating to the study.Results - Seventy-three people (67% stroke patients and 33% carers; mean age 64; range 31 to 86 years; and 47% males) attended the 3 meetings. The overall response rate to the questionnaires was 70%. Most of the respondents considered the study worthwhile (97%) and the planned outcome measures relevant. In addition, assessment of speech, memory, sleep, and cognitive function was raised by > 20% of respondents as important outcomes. Seventy-five percent would agree with assent from a family member on behalf of incompetent patients, and 92% would agree to a doctor recruiting incompetent patients to the study and seeking consent/assent later. The majority of respondents (80%) preferred personal contact with the researcher or a representative to a questionnaire for follow-up.Conclusions - Involvement of stroke patients and carers helped us identify outcome measures that are important to the stroke population but not routinely addressed in stroke assessment scales. A high proportion of respondents asked for waiver of consent and agreed to family's assent on behalf of incompetent patients. Although consumer involvement has helped us to make the study more relevant to the public, it has also led to difficult scientific and ethical conflicts in protocol design.