George Donae Elizabeth, Dholakia Saumil, Tharyan Prathap
Assistant Professor of Psychiatry, Department of Psychiatry, Psychiatry Unit II, Christian Medical College, Vellore, Tamil Nadu, India.,
Associate Professor of Psychiatry, Department of Psychiatry, Psychiatry Unit II, Christian Medical College, Vellore, Tamil Nadu, India.,
Indian J Med Ethics. 2018 Jan-Mar;3(1):9-15. doi: 10.20529/IJME.2017.072. Epub 2017 Aug 1.
This study assessed the perspectives of adults who had acute nonorganic psychiatric disorders and were admitted in a private, not for- profit medical college hospital, and also of their key relatives, on randomised controlled trials (RCTs). Structured questionnaires and audio-recorded interviews were used for the purpose. We explored their willingness and motivation to participate in two hypothetical RCTs with different risks and burdens. The transcripts of the interviews were analysed using the principles of grounded theory and framework analysis. Of the 24 consenting participants (12 patient and key-relative dyads), the 20 who completed the interviews had largely positive attitudes towards research and RCTs. However, 50% of those interviewed declined to participate in either of the hypothetical RCTs. The refusal to participate seemed to be influenced by a lack of education; forgetfulness, which impeded the process of making informed decisions; unfavourable benefit-risk-burden ratios; practical difficulties; dependence on treating doctors and relatives for decision-making; and the wish to exercise one's choice regarding treatment options. The factors that motivated the patients and relatives were trust in doctors and organisations, altruism, expectation of personal benefits and favourable risk-benefit ratios. These observations indicate that while the respondents in this study valued research, they were discerning about whether or not to participate in the trials; their decision-making was influenced by individualised assessments of risks and burdens and pragmatic considerations, rather than only by the benefits they would obtain.
本研究评估了患有急性非器质性精神障碍并入住一家私立非营利性医学院附属医院的成年人及其主要亲属对随机对照试验（RCTs）的看法。为此使用了结构化问卷和录音访谈。我们探究了他们参与两项具有不同风险和负担的假设性随机对照试验的意愿和动机。访谈记录采用扎根理论和框架分析原则进行分析。在24名同意参与的参与者（12对患者及其主要亲属）中，完成访谈的20人对研究和随机对照试验大多持积极态度。然而，50%的受访者拒绝参与任何一项假设性随机对照试验。拒绝参与似乎受到以下因素影响：缺乏教育；健忘，这妨碍了做出明智决策的过程；不利的效益-风险-负担比；实际困难；在决策时依赖主治医生和亲属；以及希望对治疗方案行使个人选择权。促使患者及其亲属参与的因素包括对医生和机构的信任、利他主义、对个人利益的期望以及有利的风险效益比。这些观察结果表明，虽然本研究中的受访者重视研究，但他们在是否参与试验方面很有辨别力；他们的决策受到对风险和负担的个体化评估以及实际考虑因素的影响，而不仅仅取决于他们将获得的益处。
