电子风险评估在一般实践中用于癌症患者的临床有效性和成本效益的实用集群随机对照试验研究方案（ERICA）。

Protocol for a pragmatic cluster randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of Electronic RIsk-assessment for CAncer for patients in general practice (ERICA).

机构信息

Primary Care Diagnostics, University of Exeter, EXETER, GB, UK

Institute of Health Research, University of Exeter, Exeter, UK.

出版信息

BMJ Open. 2023 Mar 20;13(3):e065232. doi: 10.1136/bmjopen-2022-065232.

DOI:10.1136/bmjopen-2022-065232

PMID:36940950

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10030284/

Abstract

INTRODUCTION

The UK has worse cancer outcomes than most comparable countries, with a large contribution attributed to diagnostic delay. Electronic risk assessment tools (eRATs) have been developed to identify primary care patients with a ≥2% risk of cancer using features recorded in the electronic record.

METHODS AND ANALYSIS

This is a pragmatic cluster randomised controlled trial in English primary care. Individual general practices will be randomised in a 1:1 ratio to intervention (provision of eRATs for six common cancer sites) or to usual care. The primary outcome is cancer stage at diagnosis, dichotomised to stage 1 or 2 (early) or stage 3 or 4 (advanced) for these six cancers, assessed from National Cancer Registry data. Secondary outcomes include stage at diagnosis for a further six cancers without eRATs, use of urgent referral cancer pathways, total practice cancer diagnoses, routes to cancer diagnosis and 30-day and 1-year cancer survival. Economic and process evaluations will be performed along with service delivery modelling. The primary analysis explores the proportion of patients with early-stage cancer at diagnosis. The sample size calculation used an OR of 0.8 for a cancer being diagnosed at an advanced stage in the intervention arm compared with the control arm, equating to an absolute reduction of 4.8% as an incidence-weighted figure across the six cancers. This requires 530 practices overall, with the intervention active from April 2022 for 2 years.

ETHICS AND DISSEMINATION

The trial has approval from London City and East Research Ethics Committee, reference number 19/LO/0615; protocol version 5.0, 9 May 2022. It is sponsored by the University of Exeter. Dissemination will be by journal publication, conferences, use of appropriate social media and direct sharing with cancer policymakers.

TRIAL REGISTRATION NUMBER

ISRCTN22560297.

摘要

简介

英国的癌症预后比大多数可比国家差，其中很大一部分原因可归因于诊断延误。电子风险评估工具（eRAT）已被开发出来，用于使用电子记录中记录的特征来识别初级保健患者中癌症风险≥2%的患者。

方法和分析

这是一项在英国初级保健中进行的实用集群随机对照试验。将个体全科医生以 1:1 的比例随机分为干预组（提供六种常见癌症部位的 eRAT）或常规护理组。主要结局是诊断时的癌症分期，对于这六种癌症，将其分为 1 期或 2 期（早期）或 3 期或 4 期（晚期），通过国家癌症登记数据评估。次要结局包括没有 eRAT 的另外六种癌症的诊断分期、使用紧急转诊癌症途径、全科医生诊断的总癌症病例数、癌症诊断途径以及 30 天和 1 年的癌症生存率。还将进行经济和过程评估以及服务提供建模。主要分析探讨了诊断时早期癌症患者的比例。样本量计算使用干预组中晚期癌症诊断的 OR 为 0.8，相当于在六年癌症中加权发病率为 4.8%的绝对减少。这需要总共 530 个实践，干预措施从 2022 年 4 月开始，为期 2 年。