Abstract：
UNASSIGNED: The current study compared preparation time, errors, satisfaction, and preference for a prefilled syringe (PFS) versus two RSV vaccines requiring reconstitution (VRR1 and VRR2) in a randomized, single-blinded time and motion study.
UNASSIGNED: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare the number of preparation errors and satisfaction scores, respectively.
UNASSIGNED: Sixty-three pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the United States. The least squares mean preparation time per dose for PFS was 141.8 s (95% CI = 156.8-126.7; p <.0001) faster than for VRR1, 103.6 s (95% CI = 118.7-88.5; p <.0001) faster than for VRR2, and 122.7 s (95% CI = 134.2-111.2; p <.0001) faster than the pooled VRRs. Overall satisfaction (combined \"Very\" and \"Extremely\") was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine.
UNASSIGNED: The study is limited by the inability to completely blind observers. To minimize the effects of order, we utilized a 3-sequence block design; however, the order in which the vaccines were prepared may have affected outcomes. Participants were assessed once, whereas if repeated preparations were performed there may have been trained efficiencies gained for each vaccine.
UNASSIGNED: PFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.
UNASSIGNED: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare the number of preparation errors and satisfaction scores, respectively.
UNASSIGNED: Sixty-three pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the United States. The least squares mean preparation time per dose for PFS was 141.8 s (95% CI = 156.8-126.7; p <.0001) faster than for VRR1, 103.6 s (95% CI = 118.7-88.5; p <.0001) faster than for VRR2, and 122.7 s (95% CI = 134.2-111.2; p <.0001) faster than the pooled VRRs. Overall satisfaction (combined \"Very\" and \"Extremely\") was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine.
UNASSIGNED: The study is limited by the inability to completely blind observers. To minimize the effects of order, we utilized a 3-sequence block design; however, the order in which the vaccines were prepared may have affected outcomes. Participants were assessed once, whereas if repeated preparations were performed there may have been trained efficiencies gained for each vaccine.
UNASSIGNED: PFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.
摘要：
目的：本研究比较了准备时间，错误,满意,在一项随机研究中，与两种需要重建的RSV疫苗（VRR1和VRR2）相比，单盲时间和运动研究。方法：药剂师，护士,和药学技术人员被随机分配到三种疫苗的制备顺序。参与者阅读说明，然后连续制备三种疫苗，其间有3至5分钟的洗脱期。由训练有素的药剂师对准备时间和错误进行视频记录和审查，使用预定义，疫苗特异性检查表。参与者的人口统计，对疫苗制备的满意度，并记录疫苗偏好。受试者内方差分析用于比较准备时间。混合效应泊松和有序逻辑回归模型用于比较准备错误的数量和满意度得分，分别。结果：63名药师（60％），护士（35%）和药学技术人员(5%)参加了美国四个地点的活动。PFS的每个剂量的最小二乘平均准备时间比VRR1快141.8秒（95％CI：156.8，126.7；p<0.0001），比VRR2快103.6秒（118.7，88.5；p<0.0001），比合并的VRR快122.7秒（95％CI：134.2，111.2；p<0.0001）。PFS的总体满意度(“非常”和“非常”)为87.3%，VRR1为28.6%，VRR2为47.6%。大多数参与者(81.0%)更喜欢PFS疫苗。局限性：这项研究由于无法完全失明的观察者而受到限制。为了尽量减少秩序的影响，我们使用了3序列块设计，然而,疫苗的制备顺序可能影响结局.参与者被评估一次，而如果进行重复制备，则每种疫苗的训练效率可能会提高。结论:PFS疫苗可以大大简化疫苗制备过程,允许管理员每小时准备的剂量几乎是小瓶和注射器系统的四倍。
