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Data carve out in the midst of the COVID-19 pandemic
American Journal of Transplantation ( IF 8.8 ) Pub Date : 2022-06-29 , DOI: 10.1111/ajt.17132
Roslyn B Mannon 1 , Kiran K Khush 2 , Sumit Mohan 3 , David M Vock 4 , Richard Knight 5 , James Pittman 6 , Christopher Zinner 7 , Jeffrey P Orlowski 8
Affiliation  

In the viewpoint of Subramanian et al.,1 the authors suggest that the Scientific Registry of Transplant Recipients (SRTR) decision to implement a data “carve out” from March 13, 2020 to June 12, 2020, due to the COVID-19 pandemic, could potentially result in systematic geographic bias, particularly as viral prevalence has varied geographically. While the authors indicate that this particular statistical approach is “unfair,” it is unclear which particular metric they are referring to, thus making their claims of “potential” biases difficult to assess.

As members of the SRTR Review Committee (SRC), we disagree with the authors' interpretation of the “carve out” and the suggested solutions they provide. We have extensively reviewed incoming data throughout the pandemic and have advised the SRTR to take steps to avoid inequity against specific sites or regions.

First, the carve out period was selected due to the national disruption in transplant operations, not because of the high rate of infections and mortality (largely concentrated in urban centers, as noted by the authors). We believed that the near-total disruption of normal operations at transplant centers and organ procurement organizations, even outside regions of high prevalence, supported” carving out” data during a period when there was an incomplete understanding of the level of risk or the appropriate management of our patients.2 Over the ensuing months, we observed a return of transplant operations, which eventually surpassed previous activity, regardless of region.

Secondly, the carve out, as implemented, excludes follow-up for any patient transplanted prior to March 13, 2020, on March 12, 2020. In effect, this acknowledges that patients transplanted prior to the onset of the pandemic would not be evaluated beyond this point. In addition, patients transplanted during the first few weeks of the pandemic are not included in subsequent evaluations. Patients transplanted after the carve out, once transplant operations mostly resumed to pre-pandemic levels, are followed per normal methods. While we acknowledge potential variation at the center level, our choices are reflective of the observed effect of the pandemic systemwide.

Finally, the authors provide two potential solutions which are not implementable. Eliminating data reporting completely during a pandemic of over 2 years duration runs counter to the SRTR mission “to provide timely and accurate information on the performance of Organ Procurement Organizations (OPOs) and transplant programs.”3 While we agree that there were additional waves, these occurred in the setting of better understanding of non-pharmaceutical interventions, widespread vaccination, and a therapeutic armamentarium that mitigated the associated rates of graft failure and death in our patient populations.4 Additionally, it is unclear how we would define “significant” COVID-19 waves in order to implement the authors' suggestion to censor data during such waves, particularly if the waves vary regionally and do not appear to have adversely impacted outcomes on a regional level. The SRC noted that, given the 2.5-year cohorts included in the evaluations, waves have now affected all areas of the country. To this end, in January 2021, changes to the SRTR website address the impact of the pandemic on transplant operations throughout the US. Lastly, as noted by the authors, social determinants of health vary widely across centers within a particular geographic region and the impact of “significant” COVID-19 waves is not uniform across centers even within a small geographic area.

As noted by Subramanian et al.,1 it is critical that the SRTR continue its important functions. We believe, as a multidisciplinary review committee, that this remains our focus. We will continue to monitor the data carefully and closely, with the goal of supporting transplant activities for the benefit of our patients.



中文翻译:

在 COVID-19 大流行期间挖掘数据

在 Subramanian 等人的观点中,1作者建议,由于 COVID-19 大流行,移植接受者科学登记处 (SRTR) 决定实施从 2020 年 3 月 13 日到 2020 年 6 月 12 日的数据“划分” ,可能会导致系统性地理偏差,特别是当病毒流行率在地理上有所不同时。虽然作者指出这种特定的统计方法是“不公平的”,但尚不清楚他们指的是哪个特定指标,因此很难评估他们声称的“潜在”偏见。

作为 SRTR 审查委员会 (SRC) 的成员,我们不同意作者对“排除”的解释以及他们提供的建议解决方案。我们在整个大流行期间广泛审查了传入的数据,并建议 SRTR 采取措施避免针对特定地点或地区的不公平现象。

首先,之所以选择排除期是因为全国移植手术中断,而不是因为感染率和死亡率高(正如作者所指出的,主要集中在城市中心)。我们认为,移植中心和器官获取组织的正常运营几乎完全中断,即使在高流行地区之外,也支持在对风险水平或适当管理不完全了解的时期内“分割”数据我们的病人。2在接下来的几个月里,我们观察到移植手术的恢复,最终超过了之前的活动,无论在哪个地区。

其次,实施的分拆排除了对 2020 年 3 月 13 日之前移植的任何患者的随访,即 2020 年 3 月 12 日。实际上,这承认在大流行开始之前移植的患者不会在超过这点。此外,在大流行的最初几周内移植的患者不包括在随后的评估中。一旦移植手术大部分恢复到大流行前的水平,在分娩后移植的患者将按照正常方法进行随访。虽然我们承认中央层面存在潜在差异,但我们的选择反映了在整个系统范围内观察到的大流行病影响。

最后,作者提供了两个无法实施的潜在解决方案。在持续时间超过 2 年的大流行期间完全取消数据报告与 SRTR 的使命背道而驰,即“及时提供有关器官采购组织 (OPO) 和移植计划绩效的准确信息。” 3虽然我们同意存在额外的浪潮,但这些浪潮发生在对非药物干预、广泛疫苗接种和治疗性医疗设备的更好理解的背景下,这些设备减轻了我们患者人群中相关的移植失败率和死亡率。4个此外,尚不清楚我们将如何定义“重大”COVID-19 浪潮,以实施作者在此类浪潮中审查数据的建议,特别是如果浪潮因区域而异并且似乎没有对区域层面的结果产生不利影响. SRC 指出,鉴于评估中包括 2.5 年的队列,浪潮现在已经影响到该国的所有地区。为此,SRTR 网站于 2021 年 1 月进行了更改,以解决大流行病对全美移植手术的影响。最后,正如作者所指出的,健康的社会决定因素在特定地理区域内的各个中心之间差异很大,即使在一个小地理区域内,“重大”COVID-19 浪潮的影响在各个中心之间也不统一。

正如 Subramanian 等人所指出的,1 SRTR 继续其重要职能至关重要。我们相信,作为一个多学科审查委员会,这仍然是我们的重点。我们将继续仔细、密切地监测数据,目标是支持移植活动,造福我们的患者。

更新日期:2022-06-29
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