Central and West Region, The Welsh Ambulance Services NHS Trust, Swansea, UK.
Swansea University Medical School, Swansea, UK.
Emerg Med J. 2018 Nov;35(11):708-710. doi: 10.1136/emermed-2018-207881. Epub 2018 Sep 12.
Rapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting.
Scratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient's study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area.
Nineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found.
Paramedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting.
ISRCTN60065373; Post-results.
髋关节脱位的快速镇痛是一项小型研究，旨在确定开展随机对照试验（RCT）以测试护理人员在髋关节骨折患者中早期进行股外侧肌间隔阻滞以作为院前疼痛缓解的临床和成本效益的可行性。目的是设计一种简单有效的随机分组隐藏方法，适合护理人员在紧急院前环境中使用。
使用刮擦银贴纸制作刮刮卡，隐藏试验组分配。每个护理人员都分配了一个独特的连续数字范围，用作刮刮卡号码和患者的研究 ID。卡片设计允许护理人员在事故编号、日期和签名上书写。为每位护理人员准备了一个装有卡片的小信封。该研究于 2016 年 6 月 28 日至 2017 年 7 月 31 日在斯旺西地区进行。
19 名试验护理人员在整个研究中使用了 71 张刮刮卡，报告在使用刮刮卡随机分配患者时没有问题。报告了与刮刮卡使用有关的 5 个方案偏差。在对刮刮卡进行审核时，找到了所有未使用的卡片，并且没有发现对银面板进行篡改的证据。
护理人员可以使用刮刮卡作为院前护理试验中随机分配患者的方法。在未来，应该使用仅允许选择顶卡和更具保护性的存储卡的方法。刮刮卡可以考虑在紧急院前环境中的 RCT 中更广泛地使用。
ISRCTN60065373；后结果。
