Can clinical trials requiring frequent participant contact be conducted over the Internet? Results from an online randomized controlled trial evaluating a topical ointment for herpes labialis.
Can clinical trials requiring frequent participant contact be conducted over the Internet? Results from an online randomized controlled trial evaluating a topical ointment for herpes labialis.
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DOI：
10.2196/jmir.6.1.e6
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发表时间：
2004-02-17
影响因子：
7.4
通讯作者：
McAlindon T
中科院分区：
文献类型：
--
作者：
Formica M;Kabbara K;Clark R;McAlindon T
互联网对进行随机临床试验具有巨大的吸引力，可能特别适用于需要经常与参与者接触的试验。例如，唇疱疹疗法的试验通常需要在疫情爆发期间每天到诊所就诊，这给参与者带来了沉重的负担。基于互联网的随机临床试验设计可以减轻这一负担，使频繁的症状报告大大减少了工作量。为了评估一项需要频繁参与者互动的基于网络的随机临床试验的可行性，采用一项为期6个月、双盲、随机、安慰剂对照的试验性试验，使用一种含有双辛烷基磺基琥珀酸钠（DSS）的外用软膏（Zilex; Meditech Pharmaceuticals, Inc ., Scottsdale, Arizona， USA），用于治疗复发性唇疱疹。次要目标是获得有效性结果的初步数据，以协助规划DSS的全面试验。患有医生确诊的唇疱疹的成年人被招募来申请参加这项试验。符合条件的申请人被随机分配到DSS或安慰剂组，并在报名时邮寄给他们，说明在每次唇疱疹爆发期间每2小时局部使用一次。参与者被要求每两周完成一次在线问卷，在感冒疮开始时，每天完成一次“爆发问卷”，直到爆发结束。可行性结局指标包括试验参与者特征、唇疱疹频率、参与者保留和依从性（研究药物）以及数据完整性。治疗效果指标包括爆发持续时间、结痂形成天数和疼痛。在292名申请者中，182人符合条件；32名确诊为唇疱疹的参与者参加了这项试验。16名随机分为verum组，16名随机分为安慰剂组。29名（91%）参与者完成了试验。在试验期间，在23名（72%）参与者中报告了34次暴发，导致每100人月观察的冷疮发病率为19.8。有32次疫情的在线数据；由于没有解决日期，因此无法准确计算12次（38%）爆发的持续时间。虽然DSS治疗组的平均爆发持续时间较短（6.6 vs 7.7天，P= 0.2），平均结皮天数较短（3.5 vs 4.9， P= 0.1），但这些差异没有达到统计学意义。DSS组的平均疼痛评分有统计学意义（3.1比7.6，P=. 04），但该组的参与者也比安慰剂组服用更多的对乙酰氨基酚片（1.1比0.5，P=.55）。两组对药物的依从性相似：verum组中有7人（50%）报告按照指示使用乳膏，而安慰剂组中有6人（46.2%）；（p = .8）。我们有效地招募了参与者，并取得了很高的总体保留率。然而，参与者对每日爆发访问时间表的依从性很低，只有7名（50%）参与者按照指示使用了乳霜。这些限制可以在未来基于互联网的研究中通过使用个人数字助理（pda）、使用提醒设备和提供激励来解决。通过提高参与者的依从性，需要频繁与参与者联系的临床试验可能在互联网上是可行的。
The Internet has tremendous appeal for conducting randomized clinical trials and may be especially applicable to trials requiring frequent participant contact. Trials of cold sore remedies, for example, often require daily clinic visits during outbreaks, imposing substantial burden on participants. An Internet-based randomized clinical trial design may reduce this burden, permitting frequent symptom reports with considerably less effort. To evaluate the feasibility of a Web-based randomized clinical trial requiring frequent participant interaction, using a 6-month, double-blind, randomized, placebo-controlled pilot trial of a topical ointment containing dioctyl sodium sulfosuccinate (DSS) (Zilex; Meditech Pharmaceuticals, Inc, Scottsdale, Arizona, USA) intended for treatment of recurrent herpes labialis. A secondary objective was to obtain preliminary data on effectiveness outcomes, to assist in planning a fully-powered trial of DSS. Adults with physician-confirmed herpes labialis were recruited to apply to the trial. Eligible applicants were randomized to DSS or placebo, mailed to them upon enrolment with instructions to apply topically every 2 hours for the duration of every cold sore outbreak. Participants were instructed to complete online questionnaires at 2-week intervals and, at the initiation of a cold sore, daily "outbreak questionnaires" until outbreak termination. Feasibility outcome measures included trial participant characteristics, frequency of cold sores, participant retention and adherence (to study medication), and data completeness. Treatment effectiveness outcome measures included outbreak duration, days to crust formation, and pain. Of the 292 individuals applying, 182 screened eligible; 32 participants with confirmed herpes labialis enrolled in the trial. 16 were randomized into the verum group and 16 into the placebo group. 29 (91%) participants completed the trial. During the trial, 34 outbreaks were reported among 23 (72%) participants, resulting in a cold sore incidence rate of 19.8 per 100 person-months of observation. Online data were available for 32 outbreaks; the absence of a resolution date made it impossible to accurately calculate the duration of 12 (38%) outbreaks. Although the DSS treatment group had a shorter mean outbreak duration (6.6 vs 7.7 days, P= .2) and fewer mean days to crust formation (3.5 vs 4.9, P= .1), these differences did not reach statistical significance. The DSS group has statistically significant lower mean pain scores (3.1 vs 7.6, P= .04), but participants in this group also consumed more acetaminophen tablets than the placebo group (1.1 versus 0.5, P=.55). Adherence to medication was similar in both groups: 7 (50%) of the verum group reported using the cream as directed compared to 6 (46.2%) in the placebo group; ( P= .8). We efficiently recruited participants and achieved high overall retention rates. However, participant adherence to the daily outbreak visit schedules was low and only 7 (50%) participants used the cream as directed. These limitations could be addressed in future Internet-based studies by using Personal Digital Assistants (PDAs), using reminder devices, and providing incentives. By enhancing participant adherence, clinical trials requiring frequent participant contact may be feasible over the Internet.
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DOI：
10.1089/109065701753617435
发表时间：
2001-12-01
期刊：
GENETIC TESTING
影响因子：
--
作者：
Salkowski, A;Tromp, G;Kuivaniemi, H
通讯作者：
Kuivaniemi, H
影响因子：
120.7
作者：
Spruance, SL;Rea, TL;Boon, R
通讯作者：
Boon, R
影响因子：
7.6
作者：
Gong, YH;Wen, AM;Sacks, SL
通讯作者：
Sacks, SL
影响因子：
5
作者：
Lenert, LA;Looman, T;Jackson, CM
通讯作者：
Jackson, CM
影响因子：
105.7
作者：
McAlindon, T;Formica, M;Lehmer, M
通讯作者：
Lehmer, M