The Value-of-Information and Value-of-Implementation from Clinical Trials of Diagnostic Tests for HIV-Associated Tuberculosis: A Modeling Analysis.
The Value-of-Information and Value-of-Implementation from Clinical Trials of Diagnostic Tests for HIV-Associated Tuberculosis: A Modeling Analysis.
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DOI：
10.1177/23814683231198873
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发表时间：
2023-07
影响因子：
--
通讯作者：
Reddy, Krishna P.
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文献类型：
--
作者：
Pei, Pamela P.;Fitzmaurice, Kieran P.;Le, Mylinh H.;Panella, Christopher;Jones, Michelle L.;Pandya, Ankur;Horsburgh, C. Robert;Freedberg, Kenneth A.;Weinstein, Milton C.;Paltiel, A. David;Reddy, Krishna P.
目标.传统的信息价值（VOI）分析假设完全吸收的最佳决策。我们采用了一个扩展的框架，其中包括价值的实施（VOM）-鼓励采用最佳策略的好处，并估计如何未来的试验诊断测试艾滋病毒相关的结核病可以改善公共卫生决策和临床和经济成果。方法.根据目前的信息，我们评估了南非住院艾滋病毒感染者中3种结核病筛查策略的临床结果和成本：痰液Xpert（Xpert）、痰液Xpert加尿液AlereLAM（Xpert+AlereLAM）以及痰液Xpert加更新、更敏感、更昂贵的尿液FujiLAM（Xpert+FujiLAM）。我们预测的增量净货币效益（INMB）的决策的基础上，一项试验的结果比较死亡率与每一个战略，而不是决策的基础上，仅根据目前的知识，富士的诊断性能的改善。我们使用一个有效的微观模拟来估计VOI（在决策前减少参数不确定性的INMB）和VOM（鼓励采用最佳策略的INMB）。结果根据目前的信息，采用Xpert+FujiLAM比目前的做法（假设50% Xpert和50% Xpert+AlereLAM）多产生0.4个生命年/人。虽然采用这种最佳策略的决定不受临床试验信息的影响（VOI = 0美元，3，000美元/年的生命挽救支付意愿阈值），但扩大Xpert+FujiLAM的实施是有价值的，这导致5年的INMB（代表VOM）为6.5亿美元。结论.传统的VOI方法考虑了基于试验数据切换到新的最佳策略的价值，但未能考虑试验在增加最佳策略的摄取方面的说服价值。对试验的评价应包括侧重于其在减少执行障碍方面的价值。在传统的VOI分析中，假设即使没有试验，也总是采用最佳决策。这可能会导致在采用需要新的临床试验证据时低估试验的价值。为了捕捉试验可能对决策者采用最优决策的意愿产生的影响，我们还考虑了实施价值（VOM），这是一种量化新研究信息在促进更广泛采用最优策略方面的益处的度量。试验总价值（VOT）包括VOI和VOM。我们基于模型的分析表明，从南非HIV相关结核病筛查策略试验中获得的信息，在使用传统的VOI评估方法进行测量时，没有价值。一种新的策略，其中包括尿液FujiLAM测试，从健康经济的角度来看是最佳的，但未得到充分利用。试验将减少下游健康结果的不确定性，但可能不会改变最佳决策。高VOT（近7亿美元超过5年）完全在于促进FujiLAM的吸收，以VOM为代表。我们的研究结果强调了采用更全面的方法来评估前瞻性试验的重要性，因为传统的VOI方法可能会大大低估其价值。在考虑试验设计和成本时，试验者和资助者可以也应该评估VOT指标。如果VOI较低，则可以将试验的VOM和成本与其他外展计划的收益和成本进行比较，以确定提高吸收率的最具成本效益的方法。
Objectives. Conventional value-of-information (VOI) analysis assumes complete uptake of an optimal decision. We employed an extended framework that includes value-of-implementation (VOM)—the benefit of encouraging adoption of an optimal strategy—and estimated how future trials of diagnostic tests for HIV-associated tuberculosis could improve public health decision making and clinical and economic outcomes. Methods. We evaluated the clinical outcomes and costs, given current information, of 3 tuberculosis screening strategies among hospitalized people with HIV in South Africa: sputum Xpert (Xpert), sputum Xpert plus urine AlereLAM (Xpert+AlereLAM), and sputum Xpert plus the newer, more sensitive, and costlier urine FujiLAM (Xpert+FujiLAM). We projected the incremental net monetary benefit (INMB) of decision making based on results of a trial comparing mortality with each strategy, rather than decision making based solely on current knowledge of FujiLAM’s improved diagnostic performance. We used a validated microsimulation to estimate VOI (the INMB of reducing parameter uncertainty before decision making) and VOM (the INMB of encouraging adoption of an optimal strategy). Results. With current information, adopting Xpert+FujiLAM yields 0.4 additional life-years/person compared with current practices (assumed 50% Xpert and 50% Xpert+AlereLAM). While the decision to adopt this optimal strategy is unaffected by information from the clinical trial (VOI = $ 0 at $3,000/year-of-life saved willingness-to-pay threshold), there is value in scaling up implementation of Xpert+FujiLAM, which results in an INMB (representing VOM) of $650 million over 5 y. Conclusions. Conventional VOI methods account for the value of switching to a new optimal strategy based on trial data but fail to account for the persuasive value of trials in increasing uptake of the optimal strategy. Evaluation of trials should include a focus on their value in reducing barriers to implementation. In conventional VOI analysis, it is assumed that the optimal decision will always be adopted even without a trial. This can potentially lead to an underestimation of the value of trials when adoption requires new clinical trial evidence. To capture the influence that a trial may have on decision makers’ willingness to adopt the optimal decision, we also consider value-of-implementation (VOM), a metric quantifying the benefit of new study information in promoting wider adoption of the optimal strategy. The overall value-of-a-trial (VOT) includes both VOI and VOM. Our model-based analysis suggests that the information obtained from a trial of screening strategies for HIV-associated tuberculosis in South Africa would have no value, when measured using traditional methods of VOI assessment. A novel strategy, which includes the urine FujiLAM test, is optimal from a health economic standpoint but is underutilized. A trial would reduce uncertainties around downstream health outcomes but likely would not change the optimal decision. The high VOT (nearly $700 million over 5 y) lies solely in promoting uptake of FujiLAM, represented as VOM. Our results highlight the importance of employing a more comprehensive approach for evaluating prospective trials, as conventional VOI methods can vastly underestimate their value. Trialists and funders can and should assess the VOT metric instead when considering trial designs and costs. If VOI is low, the VOM and cost of a trial can be compared with the benefits and costs of other outreach programs to determine the most cost-effective way to improve uptake.
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DOI：
10.1016/s0140-6736(18)31267-4
发表时间：
2018-07-28
期刊：
Lancet (London, England)
影响因子：
--
作者：
Gupta-Wright A;Corbett EL;van Oosterhout JJ;Wilson D;Grint D;Alufandika-Moyo M;Peters JA;Chiume L;Flach C;Lawn SD;Fielding K
通讯作者：
Fielding K
DOI：
10.1097/01.qai.0000225729.79610.b7
发表时间：
2006-08-01
影响因子：
3.6
作者：
Holmes, Charles B.;Wood, Robin;Losina, Elena
通讯作者：
Losina, Elena
影响因子：
2.1
作者：
Chapman, RH;Berger, M;Neumann, PJ
通讯作者：
Neumann, PJ
影响因子：
4.6
作者：
Kerkhoff, Andrew D.;Barr, David A.;Meintjes, Graeme
通讯作者：
Meintjes, Graeme
影响因子：
3.2
作者：
Edoka, Ijeoma P.;Stacey, Nicholas K.
通讯作者：
Stacey, Nicholas K.