Errington Julie, Malik Ghada, Evans Julie, Baston Jenny, Parry Annie, Price Lisa, Johnstone Hina, Peters Selena, Oram Victoria, Howe Karen, Whiteley Emma, Tunnacliffe Jane, Veal Gareth J
Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.
Pediatric Oncology and Haematology, Leeds General Infirmary, Leeds, UK.
Pediatr Blood Cancer. 2016 Jul;63(7):1193-7. doi: 10.1002/pbc.25960. Epub 2016 Mar 1.
While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible.
A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation.
A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8-15 years. Ninety-seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy-four percent of parents participated in research studies in order to "do something important", while 74% of patients participated "to help medical staff". Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety-six percent of parents and 87% of patients would participate in future studies.
The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience.
虽然大多数儿童癌症临床试验与治疗相关，但也可能会开展一些不直接影响治疗的额外可选研究调查。至关重要的是，这些研究要符合伦理道德进行，并且让参与这些研究的家庭尽可能有积极的体验。
开展了一项问卷调查研究，以调查影响家庭选择参与可选非治疗性研究的关键因素、对所涉试验的理解程度以及参与体验。
对来自英国六个中心的100名参与者进行了研究；其中77名家长、10名16岁以上患者和13名8至15岁患者。97%的家长和90%的患者认为研究同意前提供的信息长度合适，52%的家长和65%的患者完全理解所提供的信息。74%的家长参与研究是为了“做一些重要的事”，而74%的患者参与是为了“帮助医护人员”。令人鼓舞的是，不到5%的参与者认为如果不参与，他们的临床护理会受到负面影响。参与的积极方面包括感觉受到医护人员更多关注。消极方面包括在医院停留时间更长以及需要额外采集血样。96%的家长和87%的患者表示未来会参与研究。
该研究深入了解了参与非治疗性临床研究的儿童癌症患者及其家长的观点。绝大多数研究结果表明，参与被视为一种积极的体验。
