Schumacher S G, Thangakunam B, Denkinger C M, Oliver A A, Shakti K B, Qin Z Z, Michael J S, Luo R, Pai M, Christopher D J
McGill University Department of Epidemiology & Biostatistics, Montreal, Canada; McGill International TB Centre, Montreal, Quebec, Canada.
Department of Pulmonary Medicine, Christian Medical College Vellore, India.
Int J Tuberc Lung Dis. 2015 Sep;19(9):1084-90. doi: 10.5588/ijtld.15.0120.
Both product innovation (e.g., more sensitive tests) and process innovation (e.g., a point-of-care [POC] testing programme) could improve patient outcomes.
To study the respective contributions of product and process innovation in improving patient outcomes.
We implemented a POC programme using Xpert(®) MTB/RIF in an out-patient clinic of a tertiary care hospital in India. We measured the impact of process innovation by comparing time to diagnosis with routine testing vs. POC testing. We measured the impact of product innovation by comparing accuracy and time to diagnosis using smear microscopy vs. POC Xpert.
We enrolled 1012 patients over a 15-month period. Xpert had high accuracy, but the incremental value of one Xpert over two smears was only 6% (95%CI 3-12). Implementing Xpert as a routine laboratory test did not reduce the time to diagnosis compared to smear-based diagnosis. In contrast, the POC programme reduced the time to diagnosis by 5.5 days (95%CI 4.3-6.7), but required dedicated staff and substantial adaptation of clinic workflow.
Process innovation by way of a POC Xpert programme had a greater impact on time to diagnosis than the product per se, and can yield important improvements in patient care that are complementary to those achieved by introducing innovative technologies.
产品创新（如更灵敏的检测方法）和流程创新（如即时检测[POC]项目）均可能改善患者预后。
研究产品创新和流程创新在改善患者预后方面各自的作用。
我们在印度一家三级护理医院的门诊实施了一项使用Xpert（®）MTB/RIF的即时检测项目。我们通过比较常规检测与即时检测的诊断时间来衡量流程创新的影响。我们通过比较涂片显微镜检查与即时检测Xpert的准确性和诊断时间来衡量产品创新的影响。
在15个月期间，我们纳入了1012例患者。Xpert具有较高的准确性，但与两张涂片相比，一次Xpert检测的增加值仅为6%（95%可信区间3-12）。与基于涂片的诊断相比，将Xpert作为常规实验室检测并未缩短诊断时间。相比之下，即时检测项目使诊断时间缩短了5.5天（95%可信区间4.3-6.7），但需要专门的工作人员并对门诊工作流程进行大幅调整。
通过即时检测Xpert项目进行的流程创新对诊断时间的影响比产品本身更大，并且可以在患者护理方面产生重要改善，这与引入创新技术所取得的改善相辅相成。
