Do Patient Safety Events Account for Adverse Outcomes in CKD?

描述（由申请人提供）：慢性肾脏疾病（CKD）患者易受一系列与其护理相关的潜在有害事件（安全事件）的影响。然而，[建立CKD相关安全事件的术语]，检查这些安全事件的发生率，或确定安全事件在不良CKD结局发生率中的作用的工作很少。假设：CKD患者有高频率的一般（PSI）和疾病特异性患者安全事件（CKD-PSI），这在导致不良疾病结局的不良事件中占很大比例。总体目标：检查CKD人群中疾病特异性CKD-PSI[指定为触发因素]和一般PSI的患病率，并确定这些PSI的发生率是否会导致不良事件，从而导致不良的CKD结局。具体目的：1a)确定CKD队列中用药错误的频率（一组CKD- psi）。1b)比较（1a）中定义的有一种或多种药物相关CKD-PSI的受试者与没有此类事件的受试者的不良事件发生率。2a)确定CKD队列中电解质/代谢紊乱的发生率，包括高钾血症和低血糖（第二组CKD- psis）。2b)比较（2a）中定义的有一种或多种电解质紊乱的受试者与没有这种事件的受试者的不良事件发生率。3a)检查CKD队列患者住院期间ahrq定义的PSI和第三组CKD-PSI（均源自ICD-9代码）的发生率。3c)比较（3a）中定义的住院和PSI受试者的不良事件发生率与住院但没有此类事件的对照者的不良事件发生率。研究设计：对现有队列进行回顾性（辅助）研究。研究人群：NIDDK赞助的慢性肾功能不全队列（CRIC）研究的参与者（n = 3939）。研究测量：药物记录（30天召回），包括非处方药，在i)基线，ii)第一次半年度中期电话访问，iii)每年重复。用药错误将使用肾脏药物参考交叉行走和肾小球滤过率（GFR）的CRIC估计来确定。电解质紊乱（主要但不限于高钾血症和低血糖）将从基线和年度实验室值记录。此外，将审查在CRIC观察期间住院的ICD-9代码，以确定AHRQ- PSI和CKD-PSI。结果：将追踪参与者的不良事件，包括住院、肾功能丧失、ESRD和CVD事件以及死亡率。分析方案：采用纵向和重复测量方法评估指定CKD-PSI（包括复合组和相关亚组）与不良事件之间的关系，重点关注安全事件一年内发生的事件。相关性：本研究将确定医疗保健的有害后果（安全事件）对CKD特征性不良结局的影响程度。

DESCRIPTION (provided by applicant): Persons with chronic kidney disease (CKD) are susceptible to an array of potentially harmful events related to their care (safety events). However, [there has been little work to establish a nomenclature for CKD-relevant safety events], to examine the prevalence of these safety events, or to determine the role of safety events in the incidence of poor CKD outcomes. Hypothesis: Patients with CKD have a high frequency of both general (PSI) and disease-specific patient safety incidents (CKD-PSI) that account for a significant proportion of adverse events leading to poor disease outcomes. Overall aims: Examine the prevalence of disease-specific CKD-PSI [designated as triggers] and general PSI in the CKD population, and determine whether the incidence of these PSIs cause adverse events which account for poor CKD outcomes. Specific aims: 1a) Determine the frequency of medication errors (one set of CKD-PSI) in a CKD cohort. 1b) Compare the rate of adverse events among subjects who have had one or more medication-related CKD-PSI as defined in (1a) to that of their counterparts who have not had such an event. 2a) Determine the incidence of electrolyte/metabolic disturbances including hyperkalemia and hypoglycemia (2nd set of CKD-PSIs) in a CKD cohort. 2b) Compare rate of adverse events in subjects who have had one or more electrolyte disturbance as defined in (2a) to that of their counterparts who have not had such an event. 3a) Examine the incidence of both AHRQ-defined PSI and a 3rd set of CKD-PSI (both ICD-9 code-derived) during hospitalizations of persons in CKD cohort. 3c) Compare the rate of adverse events in subjects who had a hospitalization and a PSI as defined in (3a) to that of their counterparts with a hospitalization and no such event. Study design: Retrospective (ancillary) study of an existing cohort. Study population: Participants (n = 3939) in the NIDDK- sponsored Chronic Renal Insufficiency Cohort (CRIC) study. Study Measurements: Medication records (30 day recall), including over-the-counter pills, determined at i) baseline, ii) the first semiannual interim phone visit, and iii) repeated annually. Medication errors will be determined using a renal drug reference cross-walk and CRIC estimates of glomerular filtration rate (GFR). Electrolyte disturbances (principally, but not exclusively, hyperkalemia and hypoglycemia) will be recorded from baseline and annual laboratory values. Additionally, ICD-9 codes from hospitalization over the course of CRIC observation will be reviewed for AHRQ- PSI and CKD-PSI. Outcomes: Participants will be tracked for adverse events including hospitalization, loss of renal function, ESRD and CVD events, and mortality. Analytic plans: Longitudinal and repeated measures methods will be employed to estimate the relationship between designated CKD-PSI (both as composite and relevant subgroups) and adverse events with focus on events occurring within one year of safety incidents. Relevance: This study will determine the extent to which harmful consequences of medical care (safety events) contribute to the characteristically poor outcomes of CKD.