Abstract：
BACKGROUND: The Helicobacter Eradication Aspirin Trial (HEAT) is a multicentre, double blind, randomised controlled trial investigating whether Helicobacter (H.) pylori eradication reduces hospitalisation for peptic ulcer bleeding. Recruited participants were aged 60 and over and taking aspirin (≤325 mg daily) for at least four months prior to consent. Based on results of a pilot study, a sample size calculation predicted 6600 H. pylori-positive randomised participants would be required, from 33,000 volunteers, recruited from 170,000 invited patients. Methodology was therefore designed for recruitment of large numbers of patients from primary care using a novel electronic search tool, automated mail-out and electronic follow-up. Recruitment started in 2012 and completed in 2017.
METHODS: All participants were recruited from GP practices, with assistance from the UK Clinical Research Network (UKCRN). H. pylori-positive participants were randomised to one week of eradication treatment or placebo. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. The primary endpoint is hospitalisation due to peptic ulcer bleeding. The trial will end when 87 adjudicated events have occurred, identified from searches of GP databases, review of secondary care admission data and mortality data, and reported events from randomised participants and GPs.
RESULTS: HEAT has recruited participants from 1208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 returned expressions of interest. Of these, 30,166 patients were consented to the trial, of whom 5355 H. pylori-positive participants (17.8% of those consented) were randomised. Mean age at consent was 73.1 ± 6.9 (SD) years and 72.2% of participants were male. Of the randomised (H. pylori-positive) participants, 531 have died (as of 17 Sep 2020); none of the deaths was due to trial treatment.
CONCLUSIONS: The HEAT trial methodology has demonstrated that recruitment of large numbers of patients from primary care is attainable, with the assistance of the UKCRN, and could be applied to other clinical outcomes studies.
BACKGROUND: ClinicalTrials.gov ; registration number NCT01506986 . Registered on 10 Jan 2012.
METHODS: All participants were recruited from GP practices, with assistance from the UK Clinical Research Network (UKCRN). H. pylori-positive participants were randomised to one week of eradication treatment or placebo. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. The primary endpoint is hospitalisation due to peptic ulcer bleeding. The trial will end when 87 adjudicated events have occurred, identified from searches of GP databases, review of secondary care admission data and mortality data, and reported events from randomised participants and GPs.
RESULTS: HEAT has recruited participants from 1208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 returned expressions of interest. Of these, 30,166 patients were consented to the trial, of whom 5355 H. pylori-positive participants (17.8% of those consented) were randomised. Mean age at consent was 73.1 ± 6.9 (SD) years and 72.2% of participants were male. Of the randomised (H. pylori-positive) participants, 531 have died (as of 17 Sep 2020); none of the deaths was due to trial treatment.
CONCLUSIONS: The HEAT trial methodology has demonstrated that recruitment of large numbers of patients from primary care is attainable, with the assistance of the UKCRN, and could be applied to other clinical outcomes studies.
BACKGROUND: ClinicalTrials.gov ; registration number NCT01506986 . Registered on 10 Jan 2012.
摘要：
背景：根除螺杆菌阿司匹林试验（HEAT）是一个多中心，双盲,调查幽门螺杆菌(H.)根除幽门螺杆菌可减少消化性溃疡出血的住院治疗。招募的参与者年龄在60岁及以上，并在同意前服用阿司匹林（每天≤325mg）至少四个月。根据一项试点研究的结果，样本量计算预测将需要6600名幽门螺杆菌阳性随机参与者，来自33,000名志愿者，从17万名受邀患者中招募。因此，方法学设计用于使用新颖的电子搜索工具从初级保健中招募大量患者，自动邮寄和电子跟进。招聘始于2012年，并于2017年完成。
方法：所有参与者都是从GP实践中招募的，在英国临床研究网络（UKCRN）的协助下。幽门螺杆菌阳性参与者被随机分配至根除治疗或安慰剂治疗一周。招聘是使用定制的基于网络的数据库进行管理的，该数据库直接与在参与实践中下载的编程搜索工具进行通信。主要终点是消化性溃疡出血导致的住院治疗。审判将在87起判决事件发生后结束，从GP数据库的搜索中确定，二级护理入院数据和死亡率数据的审查，并报告来自随机参与者和全科医生的事件。
结果：HEAT招募了来自英国1208个GP实践的参与者。在发出的188,875封邀请函中，38,771份归还的意向书。其中,30,166名患者同意该试验，其中5355名幽门螺杆菌阳性参与者(占同意者的17.8%)被随机分组.同意时的平均年龄为73.1±6.9（SD）岁，72.2％的参与者为男性。随机化的(H.幽门螺杆菌阳性)参与者，531人死亡（截至2020年9月17日）；没有一个死亡是由于试验治疗。
结论：HEAT试验方法表明，从初级保健中招募大量患者是可以实现的，在UKCRN的协助下,并可应用于其他临床结局研究。
背景：ClinicalTrials.gov；注册号NCT01506986。2012年1月10日注册。
方法：所有参与者都是从GP实践中招募的，在英国临床研究网络（UKCRN）的协助下。幽门螺杆菌阳性参与者被随机分配至根除治疗或安慰剂治疗一周。招聘是使用定制的基于网络的数据库进行管理的，该数据库直接与在参与实践中下载的编程搜索工具进行通信。主要终点是消化性溃疡出血导致的住院治疗。审判将在87起判决事件发生后结束，从GP数据库的搜索中确定，二级护理入院数据和死亡率数据的审查，并报告来自随机参与者和全科医生的事件。
结果：HEAT招募了来自英国1208个GP实践的参与者。在发出的188,875封邀请函中，38,771份归还的意向书。其中,30,166名患者同意该试验，其中5355名幽门螺杆菌阳性参与者(占同意者的17.8%)被随机分组.同意时的平均年龄为73.1±6.9（SD）岁，72.2％的参与者为男性。随机化的(H.幽门螺杆菌阳性)参与者，531人死亡（截至2020年9月17日）；没有一个死亡是由于试验治疗。
结论：HEAT试验方法表明，从初级保健中招募大量患者是可以实现的，在UKCRN的协助下,并可应用于其他临床结局研究。
背景：ClinicalTrials.gov；注册号NCT01506986。2012年1月10日注册。
