Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.
Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.
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DOI：
10.1007/s00198-017-4073-5
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发表时间：
2017-08
期刊：
影响因子：
--
通讯作者：
Saag KG
中科院分区：
文献类型：
--
作者：
Wright NC;Foster PJ;Mudano AS;Melnick JA;Lewiecki EM;Shergy WJ;Curtis JR;Cutter GR;Danila MI;Kilgore ML;Lewis EC;Morgan SL;Redden DT;Warriner AH;Saag KG
继续或停止长期阿仑膦酸钠 (ALN) 对骨折的比较效果尚不清楚。一项大型、务实的 ALN 停药研究有可能回答这个问题。我们对当前长期 ALN 使用者（年龄≥65 岁且使用 ALN ≥3 年的女性）进行了一项为期 6 个月的试点研究，以确定研究工作流程和可行性，包括： 评估试验实施的管理方面（例如签订合同的时间、IRB 批准）；评估场地和参与者招募率；评估随机化后的结果，包括依从性、双磷酸盐相关不良事件以及参与者和中心满意度。我们评估了随机分组后 1 个月和 6 个月的结果。 9 个地点参与其中，包括 7 个社区医疗机构和 2 个学术医疗中心。平均 (SD) 合同执行时间为 3.4 (2.3) 个月，IRB 批准时间为 13.9 (4.1) 天。站点招募了 27 名参与者（13 名继续 ALN，14 名停止 ALN）。在随访过程中，22% 的参与者没有遵守随机分配：继续治疗组中有 30.8% 的参与者，停药组中有 14.3% 的参与者没有遵守随机分配。没有骨折或不良事件的报告。站点报告没有有关工作流程的问题，参与者对研究非常满意。 EDGE 研究的管理程序总体上是可行的，对诊所流程的干扰最小。在这个便利样本中，大多数实践地点的参与者招募都不是最理想的。考虑到治疗组依从性较低，需要采取全面的招募方法才能有效实现 EDGE 研究的科学目标。
The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned The Effectiveness of DiscontinuinG bisphosphonatEs (EDGE) study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including: evaluating the administrative aspects of trial conduct (e.g. time to contract, IRB approval); assessing rates of site and participant recruitment; and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including 7 community-based medical practices, and 2 academic medical centers. On average (SD) contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN, and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.
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影响因子：
6.2
作者：
Leder, Benjamin Z.;Clarke, Bart L.;Kiel, Douglas P.
通讯作者：
Kiel, Douglas P.
影响因子：
4
作者：
Lenart, B. A.;Neviaser, A. S.;Lyman, S.;Chang, C. C.;Edobor-Osula, F.;Steele, B.;van der Meulen, M. C. H.;Lorich, D. G.;Lane, J. M.
通讯作者：
Lane, J. M.
DOI：
10.1016/j.ecl.2012.04.007
发表时间：
2012-09-01
影响因子：
4.5
作者：
Diab, Dima L.;Watts, Nelson B.
通讯作者：
Watts, Nelson B.
影响因子：
4.1
作者：
Miller, Paul D.;Bolognese, Michael A.;Martin, Javier San
通讯作者：
Martin, Javier San
影响因子：
6.2
作者：
Kendler, David L.;Roux, Christian;Bone, Henry G.
通讯作者：
Bone, Henry G.