Offering a randomized trial of intensive therapy for IDDM to adolescents - Reasons for refusal, patient characteristics, and recruiter effects
Offering a randomized trial of intensive therapy for IDDM to adolescents - Reasons for refusal, patient characteristics, and recruiter effects
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DOI：
10.2337/diacare.21.2.213
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发表时间：
1998-02-01
期刊：
影响因子：
16.2
通讯作者：
Silverstein, JH
中科院分区：
文献类型：
--
作者：
Tercyak, KP Jr;Johnson, SB;Silverstein, JH
目的：确定青少年拒绝参加IDDM强化治疗（IT）随机试验的原因，描述同意和拒绝参加的患者特征，并检查招募者对试验参与率的影响。研究设计和方法：共有99名年龄在11-18岁的青少年被提供了糖尿病控制和并发症试验的结果，并由两名护士招聘人员接触可能参与研究的人。拒绝试验的青少年接受了半结构化访谈，以描述拒绝研究的原因；回答被记录下来，然后被编码成不同的类别。收集同意者和拒绝者的患者特征并进行比较。比较两种护士招聘人员的差异入学率。结果：共有56名患者（57%）同意参与；43拒绝了。拒绝研究的四个最常见原因是：1)就诊次数增加（42%），2)胰岛素注射增加（30%），3)自我血糖监测频率增加（28%），4)交通困难（19%）。很少有人提到对随机分配到不想要的治疗条件的担忧以及对低血糖或体重增加的担忧。同意者和拒绝者在人口统计学特征、疾病状况或家庭组成方面没有差异。在两个护士招聘人员之间发现了很大的差异。其中一个的拒绝率为60%，而另一个的拒绝率为27%。结论：便利性问题（就诊次数增加、交通困难）和对IT需求的担忧（注射量增加和SMBG）是拒绝试验的主要原因。患者特征不能区分同意者和拒绝者。然而，招聘人员在研究拒绝率上差异很大，这表明提供者行为可能是青少年接受随机试验的一个重要但尚未得到充分研究的方面，特别是IT。
OBJECTIVE - To identify reasons adolescents refuse to participate in a randomized trial of intensive therapy (IT) for IDDM, to describe the patient characteristics of those who consent and those who refuse to participate, and to examine recruiter effects on trial participation rates.RESEARCH DESIGN AND METHODS - A total of 99 adolescents, age 11-18 years, were provided with the results of the Diabetes Control and Complications Trial and approached for possible study participation by two nurse recruiters. Adolescents refusing the trial were administered a semi-structured interview to describe reasons for study refusal; responses were recorded and later coded into categories. Patient characteristics of consenters and refusers were collected and compared. The differential enrollment rates of the two nurse recruiters were also compared.RESULTS - A total of 56 patients (similar to 57%) agreed to participate; 43 refused. The four most common reasons for study refusal were 1) increased clinic visits (42%), 2) increased insulin injections (30%), 3) increased frequency of self-monitoring of blood glucose (SMBG) (28%), and 4) transportation difficulties (19%). Concerns about randomization to an unwanted treatment condition and fears of hypoglycemia or weight gain were rarely cited. Consenters and refusers did not differ in demographic characteristics, disease status, or family composition. Large differences were found between the two nurse recruiters. one experienced a 60% refusal rate, while the other experienced a 27% refusal rate.CONCLUSIONS - Issues of convenience (increased clinic visits, transportation difficulties) and concerns about the demands of IT (increased injections and SMBG) were the predominant reasons for trial refusal. Patient characteristics did not differentiate consenters from refusers. However, recruiters differed greatly in study refusal rates, suggesting that provider behavior may be an important but understudied aspect of adolescent acceptance of randomized trials in general and IT in particular.