Shinkins Bethany, Yang Yaling, Abel Lucy, Fanshawe Thomas R
Test Evaluation Group, Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Worsely Building, Clarendon Way, Leeds, LS2 9LJ, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.
BMC Med Res Methodol. 2017 Apr 14;17(1):56. doi: 10.1186/s12874-017-0331-7.
Evaluations of diagnostic tests are challenging because of the indirect nature of their impact on patient outcomes. Model-based health economic evaluations of tests allow different types of evidence from various sources to be incorporated and enable cost-effectiveness estimates to be made beyond the duration of available study data. To parameterize a health-economic model fully, all the ways a test impacts on patient health must be quantified, including but not limited to diagnostic test accuracy.
We assessed all UK NIHR HTA reports published May 2009-July 2015. Reports were included if they evaluated a diagnostic test, included a model-based health economic evaluation and included a systematic review and meta-analysis of test accuracy. From each eligible report we extracted information on the following topics: 1) what evidence aside from test accuracy was searched for and synthesised, 2) which methods were used to synthesise test accuracy evidence and how did the results inform the economic model, 3) how/whether threshold effects were explored, 4) how the potential dependency between multiple tests in a pathway was accounted for, and 5) for evaluations of tests targeted at the primary care setting, how evidence from differing healthcare settings was incorporated.
The bivariate or HSROC model was implemented in 20/22 reports that met all inclusion criteria. Test accuracy data for health economic modelling was obtained from meta-analyses completely in four reports, partially in fourteen reports and not at all in four reports. Only 2/7 reports that used a quantitative test gave clear threshold recommendations. All 22 reports explored the effect of uncertainty in accuracy parameters but most of those that used multiple tests did not allow for dependence between test results. 7/22 tests were potentially suitable for primary care but the majority found limited evidence on test accuracy in primary care settings.
The uptake of appropriate meta-analysis methods for synthesising evidence on diagnostic test accuracy in UK NIHR HTAs has improved in recent years. Future research should focus on other evidence requirements for cost-effectiveness assessment, threshold effects for quantitative tests and the impact of multiple diagnostic tests.
诊断试验的评估具有挑战性,因为其对患者预后的影响具有间接性。基于模型的试验卫生经济评估能够整合来自不同来源的各类证据,并能在现有研究数据的期限之外进行成本效益估计。为了全面地对卫生经济模型进行参数化,必须对试验影响患者健康的所有方式进行量化,包括但不限于诊断试验的准确性。
我们评估了2009年5月至2015年7月发布的所有英国国家卫生研究院卫生技术评估(NIHR HTA)报告。如果报告评估了一项诊断试验、包含基于模型的卫生经济评估以及包含对试验准确性的系统评价和荟萃分析,则纳入该报告。从每份符合条件的报告中,我们提取了以下主题的信息:1)除试验准确性之外还搜索和综合了哪些证据,2)使用了哪些方法来综合试验准确性证据以及结果如何为经济模型提供信息,3)如何/是否探讨了阈值效应,4)如何考虑路径中多个试验之间的潜在依赖性,以及5)对于针对初级保健环境的试验评估,如何纳入来自不同医疗环境的证据。
在符合所有纳入标准的22份报告中,有20份实施了双变量或HSROC模型。用于卫生经济建模的试验准确性数据在4份报告中完全来自荟萃分析,在14份报告中部分来自荟萃分析,在4份报告中完全未来自荟萃分析。在使用定量试验的7份报告中,只有2份给出了明确的阈值建议。所有22份报告都探讨了准确性参数不确定性的影响,但大多数使用多个试验的报告没有考虑试验结果之间的依赖性。22项试验中有7项可能适用于初级保健,但大多数在初级保健环境中发现的试验准确性证据有限。
近年来,英国国家卫生研究院卫生技术评估中采用适当的荟萃分析方法来综合诊断试验准确性证据的情况有所改善。未来的研究应关注成本效益评估的其他证据要求、定量试验的阈值效应以及多项诊断试验的影响。