Abstract:
OBJECTIVES:Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. METHODS:Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network. Measures of prescriber compliance were designed using the original pazopanib label guidelines for liver monitoring. RESULTS:Results from the VA (n = 288) and oncology databases (n = 283) indicate that prescriber liver chemistry monitoring was less than 100%: 73% to 74% compliance with baseline testing and 37% to 39% compliance with testing every 4 weeks. Compliance was highest near drug initiation and decreased over time. Among patients who should have had weekly testing, the compliance was 56% in both databases. The more serious elevations examined, including combinations of liver enzyme elevations meeting the laboratory definition of Hy's law were infrequent but always led to appropriate discontinuation of pazopanib. Only 4 patients were identified for analysis in the Dutch database; none had recorded baseline testing. CONCLUSIONS:In this population-based study, prescriber compliance was reasonable near pazopanib initiation but low during subsequent weeks of treatment. This study provides information from real-world community practice settings and offers feedback to regulators on the effectiveness of label monitoring guidelines.
journal_name
J Patient Safjournal_title
Journal of patient safetyauthors
Shantakumar S,Nordstrom BL,Hall SA,Djousse L,van Herk-Sukel MPP,Fraeman KH,Gagnon DR,Chagin K,Nelson JJdoi
10.1097/PTS.0000000000000332subject
Has Abstractpub_date
2019-03-01 00:00:00pages
55-60issue
1eissn
1549-8417issn
1549-8425journal_volume
15pub_type
杂志文章abstract:OBJECTIVE:To evaluate medication boxed warning nonadherence in the inpatient setting. METHODS:This was a prospective cohort quality improvement project approved by our institution's Total Quality Council. General medicine and ICU patients 18 years and older were included if they were cared for by a prescriber-led mult...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000101
更新日期:2017-03-01 00:00:00
abstract:OBJECTIVES:In recent years, several instruments for measuring patient safety culture (PSC) have been developed and implemented. Correct interpretation of survey findings is crucial for understanding PSC locally, for comparisons across settings or time, as well as for planning effective interventions. We aimed to evalua...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000585
更新日期:2019-03-15 00:00:00
abstract:OBJECTIVE:The objective of this study was to explore medical oncology outpatients' perceived experiences of errors in their cancer care. METHODS:A cross-sectional survey was conducted. English-speaking medical oncology outpatients aged 18 years or older were recruited from 9 Australian cancer treatment centers. Partic...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000368
更新日期:2019-12-01 00:00:00
abstract:OBJECTIVES:This study aimed to explore nurses' perceptions regarding disclosure of patient safety incidents. METHODS:An anonymous online survey was conducted, and results were compared with those of the general public using the same questionnaire in a previous study. RESULTS:Among 689 nurses, 96.8% of nurses felt maj...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000781
更新日期:2020-09-08 00:00:00
abstract:INTRODUCTION:Apologizing to patients is an encouraged practice, yet little is known about how and why providers apologize and what insights apologies could provide in improving quality and safety. OBJECTIVE:The aim of the study was to determine whether provider apologies in the electronic health record could identify ...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000514
更新日期:2020-09-01 00:00:00
abstract:OBJECTIVES:Relatively little is known about rates of outpatient adverse drug events (ADEs), and most health systems do not routinely identify them. We developed a computerized ADE measurement process and used it to detect ADEs from electronic health records and then categorized them according to type, preventability, a...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3181dcae06
更新日期:2010-06-01 00:00:00
abstract:OBJECTIVES:Adverse drug events (ADEs) are common in ambulatory care and may result from poor patient-physician communication about medication-related symptoms. A module was developed within an electronic patient portal that was designed to enhance communication about medication symptoms and, in turn, reduce ADEs and he...
journal_title:Journal of patient safety
pub_type: 杂志文章,随机对照试验
doi:10.1097/PTS.0b013e31829e4b95
更新日期:2013-09-01 00:00:00
abstract:OBJECTIVES:We sought to synthesize data on systemic arthroprosthetic cobaltism, a recently described syndrome that results from wear or corrosion of chrome-cobalt hip components. METHODS:We conducted a systematic literature review to identify all reported cases of systemic arthroprosthetic cobaltism. To assess the epi...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000220
更新日期:2019-06-01 00:00:00
abstract:OBJECTIVES:Patients are a valuable, yet underutilized source of information for safety measurement and improvement in health care. The aim of this review was to identify patient-report safety climate (SC) measures described in the literature, analyze the included items to consider their alignment with previously establ...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000705
更新日期:2020-04-27 00:00:00
abstract:OBJECTIVES:Predictions estimate supplies of filtering facepiece respirators (FFRs) would be limited in the event of a severe influenza pandemic. Ultraviolet decontamination and reuse (UVDR) is a potential approach to mitigate an FFR shortage. A field study sought to understand healthcare workers' perspectives and poten...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000600
更新日期:2020-06-01 00:00:00
abstract:OBJECTIVE:: This study aimed to evaluate different shortcuts of Healthcare Failure Mode and Effects Analysis (HFMEA) in a radiotherapy setting. DESIGN:: A 2 × 2 study design was set up, in which 4 similar groups analyzed separately the possible risks of the same process by using different versions of HFMEA. SETTING::...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e31822b07ee
更新日期:2011-09-01 00:00:00
abstract:OBJECTIVES:There is evidence that most adverse events result from individual errors and that most malpractice suits with payouts reflect both patient injury and error. HYPOTHESIS:There are outlier physicians with regard to the frequency and total amount of malpractice payouts. METHODS:Using the public use file of the...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000326
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:Safety advocates have identified barcode verification technology as an important tool to improve health-care practices. METHODS:We evaluated the evidence for the role of barcode technology in improving a wide range of medication safety outcomes across a broad range of settings. Important implementation issue...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000049
更新日期:2015-06-01 00:00:00
abstract:OBJECTIVES:Documentation of allergies in a coded, non-free-text format in the electronic health record (EHR) triggers clinical decision support to prevent adverse events. Health system-wide patient safety initiatives to improve EHR allergy documentation by specifically decreasing free-text allergy entries have not been...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000711
更新日期:2020-06-01 00:00:00
abstract:INTRODUCTION:Significant resource is invested into investigation of adverse healthcare events. Outcomes of such investigations have varying degrees of effectiveness. The "hierarchy of effectiveness" model proposes system-focused changes have greater impact than person-focused actions. The traditional approach to invest...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000641
更新日期:2020-03-24 00:00:00
abstract::Implanted medical devices (IMDs) are extremely common, yet they are not systematically documented on hospital admission. Through structured patient interviews, we determined the prevalence of IMDs in hospital inpatients. Using medical record review, we evaluated the sensitivity of the medical record reporting of IMDs ...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000187
更新日期:2018-09-01 00:00:00
abstract:OBJECTIVES:After a simultaneously performed bilateral total knee arthroplasty, our institutional clinical experience suggested that there was an alarming incidence of severe postoperative hypotension and bradycardia. We therefore performed this study to define the incidence of postoperative hemodynamic instability and ...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/pts.0b013e3181fe255d
更新日期:2010-12-01 00:00:00
abstract:AIMS:This study measured the effect of aviation-style team training on 3 surgical teams from different specialties. It focused on team working and communication, particularly briefing, time-out, and debriefing, and sought to understand how improvements in team skills could be implemented in a broad range of naturalisti...
journal_title:Journal of patient safety
pub_type: 杂志文章,多中心研究
doi:10.1097/PTS.0b013e3181f100ea
更新日期:2010-09-01 00:00:00
abstract:BACKGROUND:Patient safety issues in medical institutions have received worldwide attention. Nurses play a pivotal role in providing health care at the bedside and the interception of adverse events (AEs). A knowledge of contributory factors for these AEs is vital to individuals, institutional procedures, and also natio...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000791
更新日期:2020-10-01 00:00:00
abstract:OBJECTIVES:To determine if there is a relationship between the risk of postoperative complications and the nonclinical hospital characteristics of bed size, ownership structure, relative urbanicity, regional location, teaching status, and area income status. METHODS:This study involved a secondary analysis of 2006 adm...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3182995e5b
更新日期:2013-12-01 00:00:00
abstract:OBJECTIVE:To develop an objective tool designed to standardize the identification of high-alert medications (HAMs) according to patient safety risk. METHODS:Medications were evaluated using the High-Alert Medication Stratification Tool (HAMST). Tool revision occurred through assessing medications on an organization-ap...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000445
更新日期:2017-12-12 00:00:00
abstract:OBJECTIVE:Pharmacists can play an important role as leaders to reduce patient safety risks, optimize the safe function of medication management systems, and align pharmacy services with national initiatives that measure and reward quality performance. The objective of this article is to determine the actions that pharm...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3181d108cb
更新日期:2010-03-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to assess whether bundled team training interventions for surgeons and office staff could effectively improve the accuracy of surgery scheduling, minimizing scheduling factors that may contribute to occurrence of wrong site surgery. METHODS:This quasiexperimental observational s...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000370
更新日期:2017-02-24 00:00:00
abstract:OBJECTIVES:The aim of this study was to identify physical design elements that contribute to potential falls in patient rooms. METHODS:An exploratory, physical simulation-based approach was adopted for the study. Twenty-seven subjects, older than 70 years (11 male and 16 female subjects), conducted scripted tasks in a...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000339
更新日期:2017-02-03 00:00:00
abstract:OBJECTIVES:This study assesses fall prevention measures and subsequent incident reporting of falls resulting in an "inpatient fracture neck of femur (FNOF)" within a single NHS Trust, with the aim of identifying potential areas of improvement and changing practice within a Trust. METHODS:Forty patients (mean age, 82.6...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000193
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:Despite increasing recognition that patients could play an important role in promoting the safety of their care, little is known on this issue regarding health-care professionals' (HCPs') attitudes toward patient involvement. OBJECTIVES:To investigate physicians' and nurses' attitudes toward patient involve...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e318267c4aa
更新日期:2012-12-01 00:00:00
abstract:OBJECTIVES:There is a pressing need to improve safety and efficiency in the operating room (OR). Postsurgical adverse events, such as surgical site infections and surgical flow disruption, occur at a significant rate in industrial countries where a considerable portion of such complications result in death. The aim of ...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000693
更新日期:2020-03-13 00:00:00
abstract:OBJECTIVE:To analyze the patterns of potentially avoidable readmissions due to adverse drug events (ADEs) to identify the most appropriate risk reduction interventions. METHODS:In this observational study, we analyzed a random sample of 534 potentially avoidable 30-day readmissions from 10,275 consecutive discharges f...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000346
更新日期:2017-03-17 00:00:00
abstract::Error disclosure is a high-stakes, emotionally charged interaction for patients and families as well as clinicians. A failed disclosure can result in emotional distress, reduced patient and family trust, litigation, and lost opportunities to learn from and prevent subsequent errors. However, many clinicians have littl...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000491
更新日期:2018-05-16 00:00:00
abstract:OBJECTIVE:The aim of the study was to explore experiences from the next of kin's perspective of a new involvement method in the regulatory investigation process of adverse events causing patient death. METHODS:The study design was a qualitative process evaluation of the new involvement method in two Norwegian counties...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000630
更新日期:2019-10-22 00:00:00