Subject retention and adherence in a randomized placebo-controlled trial of a disease-modifying osteoarthritis drug.
Subject retention and adherence in a randomized placebo-controlled trial of a disease-modifying osteoarthritis drug.
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DOI：
10.1002/art.20831
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发表时间：
2004-12
影响因子：
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通讯作者：
S. Mazzuca;K. Brandt;B. Katz;K. Lane;J. Bradley;L. Heck;S. Hugenberg;S. Manzi;L. Moreland
中科院分区：
文献类型：
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作者：
S. Mazzuca;K. Brandt;B. Katz;K. Lane;J. Bradley;L. Heck;S. Hugenberg;S. Manzi;L. Moreland
目的描述一种缓解疾病的骨关节炎药物（DMOAD）的30个月多中心随机安慰剂对照试验（RCT）中达到显著受试者保留和依从性水平的方法。研究对象为45-64岁患有单侧膝关节骨关节炎的肥胖女性。在随机化之前，每位志愿者完成了为期4周的“心脏无力”（FOH）测试，在此期间，她被要求证明可靠的预约保持和≥ 80%的给药方案依从性。通过FOH测试的受试者被随机分配接受多西环素或安慰剂治疗30个月。双盲期需要15次双月随访访视;从给药监测器下载访视间依从性数据，并用于估计治疗覆盖率和识别可纠正的不依从性模式。受试者在每次随访时都会获得象征性的奖励和小额现金支付。免费提供预防或治疗强力霉素副作用的措施。研究协调员通过访视间电话监测安全性并加强参与。结果在463名合格志愿者中，32名（7%）未通过FOH试验，被排除在双盲阶段之外。在随机分配至治疗组的431例受试者中，307例（71%）完成了30个月RCT，124例提前停用研究药物。近一半的脱落者返回进行16个月和30个月的X线片检查，导致14.8%的随机化受试者失访。两个治疗组在停药率或保留率方面无显著差异。两组中超过30个月的治疗覆盖率都很高。结论：本30个月随机对照试验的停药率（29%）低于迄今为止发表的任何持续时间≥ 2年的DMOAD试验。30个月X线片可用的受试者比例（85%）和对给药方案的依从性（平均>80%）也非常高。
OBJECTIVE To describe the methods by which remarkable levels of subject retention and adherence were achieved in a 30-month multicenter randomized placebo-controlled trial (RCT) of a disease-modifying osteoarthritis drug (DMOAD). METHODS Subjects were obese 45-64-year-old women with unilateral knee osteoarthritis. Before randomization, each volunteer completed a 4-week "faintness-of-heart" (FOH) test, during which she was required to demonstrate reliable appointment keeping and > or =80% adherence to the dosing regimen. Subjects who passed the FOH test were randomized to treatment with doxycycline or placebo for 30 months. The double-blind phase entailed 15 bimonthly followup visits; intervisit adherence data were downloaded from the dosing monitor and used to estimate therapeutic coverage and to identify correctable patterns of nonadherence. Subjects received token incentives and a small cash payment at each followup visit. Measures to prevent or treat side effects of doxycycline were dispensed free of charge. Study coordinators monitored safety and reinforced participation through between-visit telephone calls. RESULTS Of 463 eligible volunteers, 32 (7%) failed the FOH test and were excluded from the double-blind phase. Among the 431 subjects randomized to treatment groups, 307 (71%) completed the 30-month RCT and 124 discontinued the study drug prematurely. Nearly half of the dropouts returned for their 16- and 30-month radiographs, resulting in loss to followup of 14.8% of randomized subjects. The 2 treatment groups did not differ significantly with respect to rates of discontinuation or retention. Therapeutic coverage over 30 months was very high in both groups. CONCLUSION The rate of discontinuation in this 30-month RCT (29%) was lower than that of any DMOAD trial of > or =2 years duration published to date. The proportion of subjects for whom 30-month radiographs were available (85%) and adherence to the dosing regimen (mean >80%) also were remarkably high.