Erratum to: Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.
Erratum to: Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.
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勘误表：评估停用双磷酸盐试验有效性的可行性：一项试点研究。
DOI：
10.1007/s00198-017-4105-1
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Saag,KG
中科院分区：
文献类型：
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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
中止双膦酸盐的有效性（EDGE）研究是一项有计划的实用性临床试验，以指导“药物假期”的临床决策。这项试点研究评估了这项研究的工作流程和可行性。虽然参与者招募和治疗依从性是次优的，行政程序一般是可行的，最低限度地破坏诊所flow.IntroductionThe持续或中断长期阿仑膦酸钠（ALN）骨折的比较效果是未知的。一个大的实用ALN停药研究有可能回答这个问题。MethodsWe进行了一项为期6个月的试点研究，计划在目前长期ALN使用者（年龄≥65岁，使用ALN ≥3年的女性）中进行EDGE研究，以确定研究工作流程和可行性，包括评估试验进行的行政方面（例如，签约时间、机构审查委员会（IRB）批准），评估研究中心和受试者招募率，并评估随机化后结局，包括依从性、双膦酸盐相关不良事件以及受试者和研究中心满意度。我们评估结果1和6个月后randomization.ResultsNine网站参加，包括7个社区为基础的医疗实践和两个学术医疗中心。平均而言，合同执行耗时3.4（2.3）个月，IRB批准耗时13.9（4.1）天。研究中心招募了27名受试者（13名继续ALN，14名停止ALN）。在随访中，22%的参与者没有遵守随机分配：继续治疗组为30.8%，停药组为14.3%，没有骨折或不良事件报告。网站报告没有关于工作流程的问题，和参与者非常满意的study.ConclusionsAdministrative程序的EDGE研究一般是可行的，以最小的中断诊所流程。在这个方便的样本中，参与者招募在大多数实践地点都是次优的。考虑到治疗组依从性较低，将需要一种全面的招募方法来有效实现EDGE研究的科学目标。
SummaryThe Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide “drug holiday” clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow.IntroductionThe 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.MethodsWe conducted a 6-month pilot study of the planned the 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, institutional review board (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.ResultsNine sites participated, including seven community-based medical practices and two 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.ConclusionsAdministrative 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.