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A systematic approach to evaluate practice-based process- and outcome data applied to the treatment of neovascular age-related macular degeneration.
BMC Ophthalmology ( IF 2 ) Pub Date : 2020-01-09 , DOI: 10.1186/s12886-020-1303-y
Margriet I van der Reis 1 , M Elshout 1 , Tos T J M Berendschot 1 , Yvonne de Jong-Hesse 2 , Carroll A B Webers 1 , Jan S A G Schouten 1, 3
Affiliation  

BACKGROUND Following the principles of value-based health care, outcomes and processes of daily-practice eye care need to be systematically evaluated. We illustrate an approach that can be used to support data-driven quality improvements. We used patient data regarding the treatment of neovascular age-related macular degeneration (nAMD). METHODS In a cohort study, we reviewed medical records of patients with nAMD confirmed on fluorescein angiography (FA). Patients were treated with intravitreal injections with bevacizumab; ranibizumab; or photodynamic therapy (PDT). Visual acuity (VA), ophthalmic exam results and treatments were recorded. VA was compared between treatments by linear mixed model. Diagnosis was re-evaluated on the original FAs. Outcome analysis was performed by 1) selecting VA as the relevant outcome parameter; 2) Preventing selection by comparing treatments with historical untreated cohort and cohorts from the literature, 3) correcting for confounding due to lesion type, and 4) identifying relevant process variables that affect the outcome. These were severity of disease at presentation, and doctor- and patient dependent process variables. RESULTS In total, 473 eyes were included. At 12 months, change in VA was 0.54, 0.48, 0.09, and 0.07 LogMAR in the no-treatment, photodynamic therapy (PDT), bevacizumab, and ranibizumab groups, respectively. Lesion type on FA differed between groups. Diagnosis of nAMD could not be confirmed in 104 patients. Patient delay, inaccurate diagnosis and treatment intervals may have impacted outcomes. CONCLUSIONS The effect of PDT was small to absent. Anti-VEGFs were effective and appeared as effective as in RCTs. Correct selection of a comparator cohort and addressing confounding, including confounding by indication and effect modification, are needed to achieve valid results and interpretation. Patient delay, diagnosis accuracy, indication for and application of treatment can potentially be improved to improve treatment outcomes. In a value-based care perspective, systematic evaluation of diagnostic accuracy, treatment indication, protocols, and outcomes of new interventions is needed at an early stage to improve outcomes.

中文翻译:

一种用于评估基于实践的过程和结果数据的系统方法,该方法可用于治疗新血管性年龄相关性黄斑变性。

背景技术遵循基于价值的医疗保健原则,需要系统评估日常眼保健的结果和过程。我们说明了一种可用于支持数据驱动的质量改进的方法。我们使用有关新血管性年龄相关性黄斑变性(nAMD)治疗的患者数据。方法在一项队列研究中,我们回顾了经荧光素血管造影(FA)确诊的nAMD患者的病历。患者接受贝伐单抗玻璃体内注射治疗;雷尼单抗 或光动力疗法(PDT)。记录视力(VA),眼科检查结果和治疗。通过线性混合模型比较治疗之间的VA。对原始FA的诊断进行了重新评估。通过1)选择VA作为相关结果参数进行结果分析;2)通过将治疗方法与历史未治疗的队列和文献中的队列进行比较来防止选择,3)纠正因病变类型而引起的混淆,以及4)识别影响结果的相关过程变量。这些是就诊时的疾病严重程度,以及医生和患者所依赖的过程变量。结果总共包括473只眼。在12个月时,未经治疗,光动力疗法(PDT),贝伐单抗和兰尼单抗组的VA变化分别为0.54、0.48、0.09和0.07 LogMAR。两组间FA的病变类型不同。104例患者无法确定nAMD的诊断。患者延迟,错误的诊断和治疗间隔可能会影响预后。结论PDT的影响很小甚至没有。抗VEGF是有效的,并且显示出与RCT中一样有效。为了获得有效的结果和解释,需要正确选择比较者队列并解决混淆,包括通过指示和效果修改造成的混淆。患者延迟,诊断准确性,适应症和治疗应用可能会得到改善,以改善治疗效果。从基于价值的护理角度来看,早期需要对诊断准确性,治疗适应症,方案和新干预措施的结果进行系统评估,以改善结果。
更新日期:2020-01-11
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