Recruitment methods and yield rates for a multisite clinical trial exploring risk reduction for Alzheimer's disease (rrAD).

Recruitment methods and yield rates for a multisite clinical trial exploring risk reduction for Alzheimer's disease (rrAD).
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DOI:
10.1002/trc2.12422
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发表时间:
2023-10
影响因子:
4.8
通讯作者:
Binder, Ellen F
Binder, Ellen F
中科院分区:
其他
文献类型:
--
作者:
Szabo-Reed, Amanda N;Hall, Tristyn;Vidoni, Eric D;Van Sciver, Angela;Sewell, Monica;Burns, Jeffrey M;Cullum, C Munro;Gahan, William P;Hynan, Linda S;Kerwin, Diana R;Rossetti, Heidi;Stowe, Ann M;Vongpatanasin, Wanpen;Zhu, David C;Zhang, Rong;Keller, Jeffrey N;Binder, Ellen F

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阿尔茨海默病风险降低(rrAD)试验是一项多中心临床试验,旨在评估运动和强化血管药理学治疗对阿尔茨海默病风险增加的社区老年人认知功能的影响。比较了不同转诊来源的合格性、知情同意率和随机化率。研究完成后,对每个研究中心的项目团队进行了非正式访谈。最初,筛选了3290名受试者,其中28%有资格同意,805名同意参加(87.2%的合格者),513名(36.3%的同意者)被随机分配。从研究中心列表服务/数据库发送的电子邮件中筛选的个体数量最多(20.9%)。医生的专业转介产生了最大比例的同意个人(57.1%)。来自非专业联系人(即,朋友,家人; 75%)和来自研究中心的邮件/电话联系人(73.8%)的推荐具有最高的随机化率。专业推荐或电子邮件从listservs/注册是最有效的招募参与者。合格/随机化受试者的最大收益来自非专业人士和邮件/电话联系人。今后的试验应考虑针对这些招募方法作出特别努力。临床试验招募通常被认为是促进我们对认知健康干预措施理解的一个重大障碍。引用最多的转介来源是电子邮件,其次是电台、电视、当地报纸、通讯或杂志文章的采访/社论。联系人最多的推荐方法是电子邮件,但并没有产生最大的同意或合格参与者。获得知情同意的可能性最大的来源是专业推荐(即医生)、社交媒体和来自研究中心的邮件/电话联系。合格/随机化受试者的最大产出来自研究中心的非专业联系人和邮件/电话联系。调查结果表明,网站可能需要专注于更有选择性的推荐来源,如使用联系人邮件和电话列表,而不是更广泛的招聘来源,如社交媒体或电视/广播广告。
The risk reduction for Alzheimer's disease (rrAD) trial was a multisite clinical trial to assess exercise and intensive vascular pharmacological treatment on cognitive function in community‐dwelling older adults at increased risk for Alzheimer's disease. Eligibility, consent, and randomization rates across different referral sources were compared. Informal interviews conducted with each site's project team were conducted upon study completion. Initially, 3290 individuals were screened, of whom 28% were eligible to consent, 805 consented to participate (87.2% of those eligible), and 513 (36.3% of those consented) were randomized. Emails sent from study site listservs/databases yielded the highest amount (20.9%) of screened individuals. Professional referrals from physicians yielded the greatest percentage of consented individuals (57.1%). Referrals from non‐professional contacts (ie, friends, family; 75%) and mail/phone contact from a site (73.8%) had the highest yield of randomization. Professional referrals or email from listservs/registries were most effective for enrolling participants. The greatest yield of eligible/randomized participants came from non‐professional and mail/phone contacts. Future trials should consider special efforts targeting these recruitment approaches. Clinical trial recruitment is commonly cited as a significant barrier to advancing our understanding of cognitive health interventions. The most cited referral source was email, followed by interviews/editorials on the radio, television, local newspapers, newsletters, or magazine articles. The referral method that brought in the largest number of contacts was email but did not result in the greatest yield of consents or eligible participants. The sources that yielded the greatest likelihood of consent were professional referrals (ie, physician), social media, and mail/phone contact from study site. The greatest yield of eligible/randomized participants came from non‐professional contacts and mail/phone contact from a site. Findings suggest that sites may need to focus on more selective referral sources, such as using contact mailing and phone lists, rather than more widely viewed recruitment sources, such as social media or TV/radio advertisements.
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DOI: 10.1186/s12874-022-01535-7
发表时间: 2022-02-10
影响因子: 4
作者:
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影响因子: 11.7
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