Montgomery J E, Sneyd J R
Department of Anaesthesia, Derriford Hospital, Plymouth, UK.
Anaesthesia. 1998 Mar;53(3):227-30. doi: 10.1046/j.1365-2044.1998.00309.x.
In order to evaluate satisfaction with, and recollection of, the consent process, we sent a postal questionnaire to 204 patients who had taken part in one of six clinical trials. Three trials were multicentre commercial studies and three were 'in house'. The readability of the different patient information sheets was compared. Seventy-seven per cent of patients responded, of whom 82% remembered having an information sheet. Most (99%) thought this was easy to read and understand. Five patients claimed that they had felt pressurised to take part in the trials. Nearly all patients (97%) realised that participation was voluntary and that other treatment would not be affected; 83% knew they could have changed their minds. There were no differences in the response patterns between the patients taking part in the different trials although the patient information sheets produced by pharmaceutical companies were longer and more complex than the 'in hospital' variety. We conclude that increasing the amount and complexity of information does not alter patient satisfaction. Taken overall, patients were content with the way they were approached when asked for consent for clinical trials.
为了评估患者对同意程序的满意度及记忆情况，我们向参与六项临床试验之一的204名患者邮寄了问卷调查。其中三项试验是多中心商业研究，三项是“内部”试验。我们比较了不同患者信息表的易读性。77%的患者进行了回复，其中82%记得收到过信息表。大多数患者（99%）认为信息表易于阅读和理解。五名患者声称他们在参与试验时感到有压力。几乎所有患者（97%）都意识到参与是自愿的，且不会影响其他治疗；83%的患者知道他们可以改变主意。尽管制药公司制作的患者信息表比“院内”的更长、更复杂，但参与不同试验的患者的回复模式并无差异。我们得出结论，增加信息的数量和复杂性并不会改变患者的满意度。总体而言，患者对征求其参与临床试验同意的方式感到满意。
