STAR (Simple Trials for Academic Research) Unit, Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK.
Division of Primary Care, University of Nottingham, Nottingham, UK.
Trials. 2022 Feb 14;23(1):140. doi: 10.1186/s13063-022-06054-w.
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.
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.
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.
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.
ClinicalTrials.gov ; registration number NCT01506986 . Registered on 10 Jan 2012.
幽门螺杆菌根除阿司匹林试验（HEAT）是一项多中心、双盲、随机对照试验，旨在研究幽门螺杆菌（H. pylori）根除是否可减少消化性溃疡出血的住院治疗。入组的参与者年龄在 60 岁及以上，在同意入组前至少连续服用阿司匹林（≤325mg/天）4 个月。根据一项试点研究的结果，预测需要从 17 万受邀患者中招募 3.3 万名志愿者，纳入 6600 名 H. pylori 阳性随机参与者，以进行研究。因此，方法学设计旨在通过一种新的电子搜索工具、自动邮件发送和电子随访，从初级保健中招募大量患者。该研究于 2012 年开始招募，并于 2017 年完成。
所有参与者均通过英国临床研究网络（UKCRN）从全科医生诊所招募。H. pylori 阳性参与者被随机分配接受一周的根除治疗或安慰剂治疗。通过专门的基于网络的数据库进行招募管理，该数据库直接与参与实践中下载的编程搜索工具进行通信。主要终点是因消化性溃疡出血而住院治疗。当通过全科医生数据库搜索、二级保健入院数据和死亡率数据以及随机参与者和全科医生报告的事件确定发生 87 例经裁定的事件时，试验将结束。
HEAT 已从英国的 1208 家全科医生诊所招募了参与者。在发出的 188875 封邀请信中，有 38771 封表示有兴趣。其中，有 30166 名患者同意参加试验，其中 5355 名 H. pylori 阳性患者（同意参加试验者的 17.8%）被随机分配。同意时的平均年龄为 73.1±6.9（SD）岁，72.2%的参与者为男性。在随机（H. pylori 阳性）参与者中，截至 2020 年 9 月 17 日，有 531 人死亡（无死亡归因于试验治疗）。
HEAT 试验方法学表明，在英国临床研究网络的协助下，从初级保健中招募大量患者是可行的，并且可以应用于其他临床结局研究。
ClinicalTrials.gov；注册号 NCT01506986。于 2012 年 1 月 10 日注册。
