Patient and clinician collaboration in the design of a national randomized breast cancer trial
Patient and clinician collaboration in the design of a national randomized breast cancer trial
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DOI：
10.1111/j.1369-7625.2004.00232.x
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发表时间：
2004-03-01
影响因子：
3.2
通讯作者：
Bradburn, J
中科院分区：
文献类型：
--
作者：
Marsden, J;Bradburn, J
目的研究乳腺癌患者参与激素替代疗法（HRT）临床试验的临床效果，以提高临床试验的成功率。（3）临床医生负责一个试点随机HRT研究乳腺癌患者]开发了这个合作研究。方法（1）进行了九个焦点小组讨论，以确定有关乳腺癌患者HRT和国家试验的问题：六名来自全国乳腺癌支持团体的妇女和三名先前参加过先导性随机HRT研究的患者。(2)研究利益相关者和焦点小组代表在为期1天的会议上讨论了焦点小组的建议（通过扎根理论分析），并就纳入国家HRT试验设计的相互优先事项达成共识（使用投票系统）。(3)从CAG-CT和焦点小组的代表参加了随后的国家HRT指导委员会会议，以确保这些优先事项被占，并由此产生的试验设计摘要分发给CAG-CT和所有焦点小组的代表征求意见。结果焦点小组表明，有关试验参与的因素的复杂性不仅限于研究主题的问题。患者-临床医生互动为协商试验设计和结局的潜在冲突提供了平台。患者的反馈表明，在试验设计中考虑了双方同意的优先事项。解释临床研究计划应在一开始就涉及所有研究利益相关者。考虑到患者参与试验的动机的复杂性，量化患者参与试验的影响可能过于简单。(C)Blackwell Publishing Ltd 2004 Health Expectations，7，pp.6-17.
Objective To show breast cancer patient involvement in the design of a national randomized trial of hormone replacement therapy (HRT) in symptomatic patients will increase accrual.Setting and participants Three stakeholder groups [(1) researchers from the Lynda Jackson Macmillan Centre, (2) the Consumers' Advisory Group for Clinical Trials (CAG-CT), (3) clinicians responsible for a pilot randomized HRT study in breast cancer patients] developed this collaborative study.Methods (1) Nine focus group discussions were conducted to identify issues relevant to breast cancer patients about HRT and a national trial: six involved women from breast cancer support groups nationwide and three patients who had previously participated in the pilot randomized HRT study. (2) Recommendations from the focus groups (analysed by Grounded Theory) were debated by the research stakeholders and focus group representatives at a 1-day meeting and consensus reached (using a voting system) on mutual priorities for incorporation into the design of a national HRT trial. (3) Representatives from the CAG-CT and focus groups participated in subsequent national HRT steering committee meetings to ensure that these priorities were accounted for and the resulting trial design summary was circulated to the CAG-CT and all focus group representatives for comment.Results Focus groups demonstrated that the complexity of factors relating to trial participation was not just restricted to the research topic in question. Patient-clinician interaction provided a platform for negotiating potential conflicts over trial design and outcomes. Patient feedback suggested that mutually agreed priorities were accounted for in the trial design.Interpretation Clinical research planning should involve all research stakeholders at the outset. Quantifying the impact of patient involvement in terms of trial accrual may be too simple given the complexity of their motivations for participating in trials.(C) Blackwell Publishing Ltd 2004 Health Expectations, 7, pp.6-17.