Do Patient Safety Events Account for Adverse Outcomes in CKD?

患者安全事件会导致 CKD 的不良后果吗？

• 批准号: 8184497
• 负责人: JEFFREY C FINK
• 金额: $ 51.67万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8184497
• 关键词: Accounting; Acute Renal Failure with Renal Papillary Necrosis; Adverse event; Allopurinol; Ancillary Study; Atenolol; Cardiovascular system; Caring; Categories; Cessation of life; Chronic Kidney Failure; Chronic Kidney Insufficiency; Code; Cohort Studies; Critiques; Data; Disease; Disease Outcome; Disease Progression; Dose; Electrolytes; End stage renal failure; Event; Exposure to; Face; Frequencies; Funding; Glomerular Filtration Rate; Glyburide-metformin; Health Services Research; Hospitalization; Hospitals; Hypoglycemia; ICD-9; Impaired Renal Function; Incidence; Intoxication; Kidney; Kidney Diseases; Laboratories; Link; Measurement; Measures; Medical; Medication Errors; Metabolic; Methods; National Institute of Diabetes and Digestive and Kidney Diseases; Nomenclature; Non-Steroidal Anti-Inflammatory Agents; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Population; Population Study; Positioning Attribute; Prevalence; Protein Structure Initiative; Published Comment; Records; Renal function; Research; Research Design; Risk Factors; Role; Safety; Subgroup; Surveys; Telephone; Time; United States Agency for Healthcare Research and Quality; Visit; Walking; Work; adverse outcome; base; cohort; health care quality; high risk; hyperkalemia; meetings; mortality; patient safety; pill

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. PUBLIC HEALTH RELEVANCE: This study will be an ancillary to the NIDDK-funded Chronic Renal Insufficiency Cohort (CRIC) study. The research plan is to retrospectively analyze stored CRIC data to determine the frequency of study-defined events related to medical care (safety incidents) and determine to what extent such events contribute to adverse outcomes in chronic kidney disease. NOTE: The criteria scores and the critiques given below were provided by the reviewers assigned to this application. These do not necessarily reflect the positions of the reviewers at the close of the group discussion or the final majority opinion of the group, although the reviewers were asked to amend their criteria scores and critiques if their positions changed during the discussion. Please note that the criteria scores are not averaged in arriving at the final overall impact scores. If the reviewers have not changed their criteria scores after the discussion, those shown in the critiques may reflect the opinion of the reviewers before the meeting. The Resume and other initial sections of the summary statement are the authoritative representations of the final outcome of the group discussion. If there is any discrepancy between the reviewers' commentaries and the priority/impact score on the face page of this summary statement, the priority/impact score should be considered the most accurate representation of the final outcome of the group discussion.

描述（由申请人提供）：慢性肾脏病（CKD）患者易发生一系列与其护理相关的潜在有害事件（安全性事件）。然而，[建立CKD相关安全性事件的命名法]、检查这些安全性事件的患病率或确定安全性事件在CKD不良结局发生率中的作用的工作很少。假设：CKD患者的一般（PSI）和疾病特异性患者安全事件（CKD-PSI）发生频率较高，在导致疾病结局不良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导致CKD预后不良的不良事件。具体目标：1a）确定CKD队列中用药错误的频率（一组CKD-PSI）。1b）比较具有（1a）中定义的一个或多个药物相关CKD-PSI的受试者与未具有此类事件的对应者之间的不良事件率。2a）确定CKD组群中电解质/代谢紊乱的发生率，包括高钾血症和低血糖（第二组CKD-PSI）。2b）比较具有（2a）中定义的一种或多种电解质紊乱的受试者与没有这种事件的对应者的不良事件发生率。3a）检查CKD组群中的人住院期间AHRQ定义的PSI和第三组CKD-PSI（两者都是ICD-9代码衍生的）的发生率。3c）比较具有住院治疗和如（3a）中定义的PSI的受试者与具有住院治疗但没有此类事件的受试者的不良事件率。研究设计：现有队列的回顾性（辅助）研究。研究人群：NIDDK申办的慢性肾功能不全队列（CRIC）研究的参与者（n = 3939）。研究测量：用药记录（30天召回），包括非处方药，在i）基线、ii）首次半年期中电话访视和iii）每年重复时确定。将使用肾脏药物参考交叉游走和肾小球滤过率（GFR）的CRIC估计值确定用药错误。将记录基线和年度实验室检查值的电解质紊乱（主要但不限于高钾血症和低血糖）。此外，还将审查CRIC观察期间住院期间的ICD-9代码中的AHRQ-PSI和CKD-PSI。结局：将跟踪受试者的不良事件，包括住院治疗、肾功能丧失、ESRD和CVD事件以及死亡率。分析计划：将采用纵向和重复测量方法来估计指定CKD-PSI（作为复合亚组和相关亚组）与不良事件之间的关系，重点关注安全性事件发生一年内发生的事件。相关性：本研究将确定医疗护理的有害后果（安全性事件）在多大程度上导致CKD的特征性不良结局。 公共卫生相关性：本研究将作为NIDDK资助的慢性肾功能不全队列（CRIC）研究的辅助研究。本研究计划回顾性分析储存的CRIC数据，以确定研究定义的与医疗护理相关的事件（安全性事件）的频率，并确定此类事件在多大程度上导致慢性肾脏疾病的不良结局。 注：下面给出的标准评分和评论由分配给此应用程序的评审员提供。这些不一定反映小组讨论结束时评审员的立场或小组的最终多数意见，尽管评审员被要求修改他们的标准评分和评论，如果他们的立场在讨论期间发生变化。请注意，在得出最终的总体影响分数时，标准分数并不是平均值。如果评审员在讨论后没有改变他们的标准分数，则评论中显示的分数可能反映了评审员在会议前的意见。简历和简要说明的其他开头部分是小组讨论最终结果的权威表述。如果评审员的评论与本摘要页上的优先级/影响力评分之间存在任何差异，则优先级/影响力评分应被视为最准确地反映小组讨论的最终结果。