Blanch Danielle C, Rudd Rima E, Wright Elizabeth, Gall Victoria, Katz Jeffrey N
Department of Psychology, Northeastern University, 125 Nightingale Hall, 360 Huntington Avenue, Boston, MA 02115, USA.
Patient Educ Couns. 2008 Nov;73(2):280-5. doi: 10.1016/j.pec.2008.06.017.
Randomized controlled trials in patient education often have difficulty enrolling vulnerable populations-specifically, older, poorer, and less educated individuals. We undertook a randomized controlled trial (RCT) of an educational intervention for arthritis management, which included strategies to remove literacy-related barriers to participation. This paper reports on the multi-stage recruitment process and assesses whether refusal to participate was related to education, age, gender, working status, or insurance status.
The recruitment protocol was designed to eliminate literacy-related barriers to participation. Patients were never asked to read or fill out forms. Interactions were oral, using everyday terms and short, clear sentences. Patients who declined during a screening call were considered Stage 1 Refusers. Patients who initially expressed interest but neither completed a baseline questionnaire nor provided consent were considered Stage 2 Refusers. Patients who consented were considered Enrollees. Age, gender, and insurance status were compared between Stage 1 Refusers and Enrollees. A second analysis compared these variables, plus educational attainment and working status, between Stage 2 Refusers, and Enrollees.
Of 408 eligible patients, there were 193 (47.3%) Stage 1 Refusers, 81 (19.9%) Stage 2 Refusers and 134 (32.8%) Enrollees. A higher proportion of Stage 1 Refusers than Enrollees were > or = 65 years old (58% vs. 37%, p = .0003). Multivariate analysis, adjusting for gender and insurance status, confirmed the effect of older age on refusal (OR = 2.3 (1.4, 3.6)). There were no significant differences between Stage 2 Refusers and Enrollees.
We found no evidence of refusal to participate due to educational attainment, working status, insurance status, or gender. Older patients were more likely to refuse participation at the first stage of recruitment.
Researchers should continue efforts to increase participation among older patients, particularly when studies are designed to be generalized to an elderly population as is the case with arthritis research. Strategies used in this recruitment protocol designed to remove literacy-related barriers to recruitment may be responsible for the observation that subjects with lower education did not have a higher rate of refusal. Such strategies deserve further study.
患者教育方面的随机对照试验在招募弱势群体（特别是老年人、贫困者和受教育程度较低者）时往往存在困难。我们开展了一项关于关节炎管理教育干预的随机对照试验（RCT），其中包括消除与识字能力相关的参与障碍的策略。本文报告了多阶段招募过程，并评估拒绝参与是否与教育程度、年龄、性别、工作状态或保险状态有关。
招募方案旨在消除与识字能力相关的参与障碍。从不要求患者阅读或填写表格。互动采用口头形式，使用日常用语和简短、清晰的句子。在筛查电话中拒绝的患者被视为第1阶段拒绝者。最初表示有兴趣但既未完成基线问卷也未提供同意的患者被视为第2阶段拒绝者。同意参与的患者被视为入选者。比较第1阶段拒绝者和入选者的年龄、性别和保险状态。第二项分析比较了第2阶段拒绝者和入选者之间的这些变量，以及教育程度和工作状态。
在408名符合条件的患者中，有193名（47.3%）第1阶段拒绝者，81名（19.9%）第2阶段拒绝者和134名（32.8%）入选者。第1阶段拒绝者中年龄≥65岁的比例高于入选者（58%对37%，p = .0003）。在对性别和保险状态进行调整的多变量分析中，证实了年龄较大对拒绝的影响（比值比 = 2.3（1.4，3.6））。第2阶段拒绝者和入选者之间没有显著差异。
我们没有发现因教育程度、工作状态、保险状态或性别而拒绝参与的证据。老年患者在招募的第一阶段更有可能拒绝参与。
研究人员应继续努力提高老年患者的参与度，特别是当研究设计如关节炎研究那样旨在推广到老年人群体时。本招募方案中用于消除与识字能力相关的招募障碍的策略可能是观察到教育程度较低的受试者拒绝率没有更高的原因。此类策略值得进一步研究。
