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Background: Computerized physician order entry systems are known to improve patient safety in acute-care hospitals. However, as clinicians frequently override drug interaction and allergy alerts, their value in ambulatory care remains uncertain.Objective: The purpose of the study was to examine whether ambulatory care clinicians were more likely to accept drug-drug interaction alerts that an expert panel judged to be of high clinical value.Study Design: We convened an expert panel to examine drug-drug interaction alerts generated by 2872 clinicians in Massachusetts, Pennsylvania and New Jersey who used a common electronic prescribing system between 1 January 2006 and 30 September 2006. We selected 120 representative drug interaction alerts from the most commonly encountered class-class interactions.Measurements: The expert panel rated each alert based on the following categories: (i) strength of the scientific evidence; (ii) probability that the interaction would result in an adverse drug event (ADE); (iii) severity of typical and most serious ADEs; (iv) the likelihood that a clinician could act on the information; and (v) the overall value of the alert to the average primary care clinician. We then used multivariate regression techniques to examine the relationship between the alert acceptance rate and the expert panel's mean rating of each category.Results: The decision of clinicians to accept drug interaction alerts increased (relative to a baseline alert acceptance rate of 8.8%) by 2.7% (95% CI 0.4, 5.1) for interactions that panelists judged would result in an ADE, by 2.3% (95% CI 0.9, 3.7) when primary care providers (PCPs) lacked prior knowledge about the information presented in the alert, and by 3.3% (95% CI 0.9, 5.8) when the PCP could readily act on the information provided in the alert.Conclusion: The value of electronic drug interaction alerts is influenced heavily by clinicians' judgements about the clinical value of the alert. Expert judgement should be taken into account when developing electronic decision support. [ABSTRACT FROM AUTHOR]

Objective: To understand the extent to which hospitalized patients participate in their care, and the association of patient participation with quality of care and patient safety.Design: Random sample telephone survey and medical record review.Setting: US acute care hospitals in 2003.Participants: A total of 2025 recently hospitalized adults.Main Outcome Measures: Hospitalized patients reported participation in their own care, assessments of overall quality of care and the presence of adverse events (AEs) in telephone interviews. Physician reviewers rated the severity and preventability of AEs identified by interview and chart review among 788 surveyed patients who also consented to medical record review.Results: Of the 2025 patients surveyed, 99.9% of patients reported positive responses to at least one of seven measures of participation. High participation (use of >4 activities) was strongly associated with patients' favorable ratings of the hospital quality of care (adjusted OR: 5.46, 95% CI: 4.15-7.19). Among the 788 patients with both patient survey and chart review data, there was an inverse relationship between participation and adverse events. In multivariable logistic regression analyses, patients with high participation were half as likely to have at least one adverse event during the admission (adjusted OR = 0.49, 0.31-0.78).Conclusions: Most hospitalized patients participated in some aspects of their care. Participation was strongly associated with favorable judgments about hospital quality and reduced the risk of experiencing an adverse event. [ABSTRACT FROM AUTHOR]

This article examines whether a patient safety 'champion' on an ambulatory chemotherapy infusion unit can increase reporting of adverse events and close calls. Reporting rates increased substantially on both intervention and control units. It was accompanied by more reports of medical errors and conditions that worried staff and fewer reports of service quality incidents. The facilitated reporting method described here is a novel approach to incident reporting, complements the spontaneous reporting systems used in hospitals and some ambulatory care settings, and may help to build a safety culture. By identifying errors and worrisome conditions, it may help managers identify problems before they lead to harm. [ABSTRACT FROM AUTHOR]

Objective: Although the patient Internet portal is a potentially transformative technology, there is little scientific information about the demographic and clinical characteristics of portal enrollees and the features that they access.Design: We describe two pilot studies of a comprehensive Internet portal called PatientSite. These pilots include a prospective one-year cohort study of all patients who enrolled in April 2003 and a case-control study in 2004 of enrollees and nonenrollees at two hospital-based primary care practices.Measurements: The cohort study tracked patient enrollment and features in PatientSite that enrollees accessed, such as laboratory and radiology results, prescription renewals, appointment requests, managed care referrals, and clinical messaging. The case-control study used medical record review to compare the demographic and clinical characteristics of 100 randomly selected PatientSite enrollees and 100 nonenrollees.Results: PatientSite use grew steadily after its introduction. New enrollees logged in most frequently in the first month, but 26% to 77% of the cohort continued to access the portal at least monthly. They most often examined laboratory and radiology results and sent clinical messages to their providers. PatientSite enrollees were younger and more affluent and had fewer medical problems than nonenrollees.Conclusion: Expanding the use of patient portals will require an understanding of obstacles that prevent access for those who might benefit most from this technology. [ABSTRACT FROM AUTHOR]

Few data exist about the impact of computerized prescribing systems on outpatient medication errors (MEs) and adverse drug events (ADEs). We compared the rates of MEs and ADEs in handwritten sites versus sites with basic computerized prescribing. These systems reduced ME rates but did not significantly reduce ADE rates. Failure to monitor accounted for a large percentage of preventable ADEs. More advanced computerized prescribing systems with decision support and monitoring functions may be necessary to reduce outpatient ADE rates. [ABSTRACT FROM AUTHOR]

Objective: Missed or cancelled imaging tests may be invisible to the ordering clinician and result in diagnostic delay. We developed an outpatient results notification tool (ORNT) to alert physicians of patients' missed radiology studies., Design: Randomised controlled evaluation of a quality improvement intervention., Setting: 23 primary care and subspecialty ambulatory clinics at an urban academic medical centre., Participants: 276 physicians randomised to intervention or usual care., Main Outcome Measure: 90-day test completion of missed imaging tests., Results: We included 3675 radiology tests in our analysis: 1769 ordered in the intervention group and 1906 in the usual care group. A higher per cent of studies were completed for intervention compared with usual care groups in CT (20.7% vs 15.3%, p=0.06), general radiology (19.6% vs 12.0%, p=0.02) and, in aggregate, across all modalities (18.1% vs 16.1%, p=0.03). In the multivariable regression model adjusting for sex, age and insurance type and accounting for clustering with random effects at the level of the physician, the intervention group had a 36% greater odds of test completion than the usual care group (OR: 1.36 (1.097-1.682), p=0.005). In the Cox regression model, patients in the intervention group were 1.32 times more likely to complete their test in a timely fashion (HR: 1.32 (1.10-1.58), p=0.003)., Conclusions: An electronic alert that notified the responsible clinician of a missed imaging test ordered in an ambulatory clinic reduced the number of incomplete tests at 90 days. Further study of the obstacles to completing recommended diagnostic testing may allow for the development of better tools to support busy clinicians and their patients and reduce the risk of diagnostic delays., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: The authors declare no conflicts of interest.

Objective: The aim of the study was to identify risk factors associated with medical errors and iatrogenic injuries during an initial course of cancer-directed treatment., Methods: In this retrospective cohort study of 400 patients 18 years or older undergoing an initial course of treatment for breast, colorectal, or lung cancer at a comprehensive cancer center, we abstracted patient, disease, and treatment-related variables from the electronic medical record. We examined adverse events (AEs) and preventable AEs by risk factor using the χ2 or Fisher exact tests. We estimated the association between risk factors and the relative risk of an additional AE or preventable AE in multivariable negative binomial regression models with backwards selection (P < 0.1)., Results: There were 304 AEs affecting 136 patients (34%) and 97 preventable AEs affecting 53 patients (13%). In multivariable analyses, AEs were overrepresented in those with lung cancer compared with patients with breast cancer (incident rate ratio = 1.9, 95% confidence interval = 1.1-3.2). Nonwhite race (1.6, 1.0-2.6), Hispanic or Latino ethnicity (2.0, 0.9-4.1), advanced disease (1.7, 1.1-2.6), use of each additional class of high-risk nonchemotherapy medication (1.6, 1.3-1.9), and chemotherapy (2.1, 1.3-3.3) were all associated with risk of an additional AE. Preventable AEs were associated with lung cancer (7.4, 2.4-23.2), Hispanic or Latino ethnicity (5.5, 1.7-17.9), and high-risk nonchemotherapy medications (1.5, 1.2-2.0)., Conclusions: Risk factors for AEs among patients with cancer reflected patients' underlying disease, cancer-directed therapy, and high-risk noncancer medications. The association of AEs with ethnicity merits further research. Risk factor models could be used prospectively to identify patients with cancer at increased risk of harm., Competing Interests: D.C. reports employment and stock or other ownership with Pascal Metrics, consulting for Mentice Inc, Phillips Inc, and Health Catalyst Inc, and travel, accommodations, and expenses from all three listed. D.P. reports consultancy for Boehringer Ingelheim and research funding from Boehringer Ingelheim, AstraZeneca, Exelixis, Genentech, Novartis, Merck, Lilly, GlaxoSmithKline, Bayer, and MedImmune. A.K. reports employment with AIG. S.N.W. reports honoraria from UpToDate. A.L.S., C.L.A., E.F., A.S.E., and C.A. disclose no conflict of interest., (Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Inpatient healthcare delivery to people who use drugs is an opportunity to provide acute medical stabilization and offer treatment for underlying substance use disorder (SUD). The process of delivering quality healthcare to people with SUD can present challenges., Methods: We convened a group of stakeholders to discuss challenges and opportunities for improving healthcare safety and employee satisfaction when providing inpatient care to people with SUD., Results: We developed, implemented, and evaluated a "Pain and Addiction Agreement" tool, a document to guide discussions between providers and patients about expectations and policies for inpatient care., Conclusions: In this article, we share our experience of working closely with stakeholders. We hope that our project can serve as a blueprint motivating other centers to pursue quality improvement initiatives to improve healthcare for people with SUD and support the people who take care of them in the hospital., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Teamwork is integral to effective health care but difficult to evaluate. Few tools have been tested outside of classroom or medical simulation settings. Accordingly, we aimed to develop and pilot test an easy-to-use direct observation instrument for measuring teamwork among medical house staff., Methods: We performed direct observations of 18 inpatient medicine house staff teams at a teaching hospital using an instrument constructed from existing teamwork tools, expert panel review, and pilot testing. We examined differences across teams using the Kruskal-Wallis statistic. We examined interrater reliability with the κ statistic, domain scales using Cronbach α, and construct validity using correlation and multivariable regression analyses of quality and utilization metrics. Observers rated team performance before and after providing feedback to 12 of the 18 team leaders and assessed changes in team performance using paired two-tailed t tests., Results: We found variation in team performance in the situation monitoring, mutual support, and communication domains. The instrument evidenced good interrater reliability among concurrent, independent observers (κ = 0.7, P < 0.001). It had satisfactory face validity based on expert panel review and the assessments of resident team leaders. Construct validity was supported by a positive correlation between team performance and the Hospital Consumer Assessment of Healthcare Providers and Systems physician communication score (r = 0.6, P = 0.03). Providing resident physicians with information about their teams' performance was associated with improved mean performance in follow-up observations (3.6-3.8/4.0, P = 0.001)., Conclusions: Direct observation of teamwork behaviors by medicine house staff on ward rounds is feasible and feedback may improve performance., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.)

Background: How openly healthcare providers communicate after a medical error may influence long-term impacts. We sought to understand whether greater open communication is associated with fewer persisting emotional impacts, healthcare avoidance and loss of trust., Methods: Cross-sectional 2018 recontact survey assessing experience with medical error in a 2017 random digit dial survey of Massachusetts residents. Two hundred and fifty-three respondents self-reported medical error. Respondents were similar to non-respondents in sociodemographics confirming minimal response bias. Time since error was categorised as <1, 1-2 or 3-6 years before interview. Open communication was measured with six questions assessing different communication elements. Persistent impacts included emotional (eg, sadness, anger), healthcare avoidance (specific providers or all medical care) and loss of trust in healthcare. Logistic regressions examined the association between open communication and long-term impacts., Results: Of respondents self-reporting a medical error 3-6 years ago, 51% reported at least one current emotional impact; 57% reported avoiding doctor/facilities involved in error; 67% reported loss of trust. Open communication varied: 34% reported no communication and 24% reported ≥5 elements. Controlling for error severity, respondents reporting the most open communication had significantly lower odds of persisting sadness (OR=0.17, 95% CI 0.05 to 0.60, p=0.006), depression (OR=0.16, 95% CI 0.03 to 0.77, p=0.022) or feeling abandoned/betrayed (OR=0.10, 95% CI 0.02 to 0.48, p=0.004) compared with respondents reporting no communication. Open communication significantly predicted less doctor/facility avoidance, but was not associated with medical care avoidance or healthcare trust., Conclusions: Negative emotional impacts from medical error can persist for years. Open communication is associated with reduced emotional impacts and decreased avoidance of doctors/facilities involved in the error. Communication and resolution programmes could facilitate transparent conversations and reduce some of the negative impacts of medical error., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: As there are few validated measures of patient safety in clinical oncology, creating an efficient measurement instrument would create significant value. Accordingly, we sought to assess the validity of a novel patient safety measure by examining the association of oncology-specific triggers and mortality using administrative claims data., Methods: We examined a retrospective cohort of 322 887 adult cancer patients enrolled in commercial or Medicare Advantage products for one year after an initial diagnosis of breast, colorectal, lung, or prostate cancer in 2008-2014. We used diagnosis and procedure codes to calculate the prevalence of 16 cancer-specific "triggers"-events that signify a potential adverse event. We compared one-year mortality rates among patients with and without triggers by cancer type and metastatic status using logistic regression models., Results: Trigger events affected 19% of patients and were most common among patients with metastatic colorectal (41%) and lung (50%) cancers. There was increased one-year mortality among patients with triggers compared to patients without triggers across all cancer types in unadjusted and multivariate analyses. The increased mortality rate among patients with trigger events was particularly striking for nonmetastatic prostate cancer (1.3% vs 7.5%, adjusted odds ratio 1.96 [95% CI 1.49-2.57]) and nonmetastatic colorectal cancer (4.1% vs 11.7%, 1.44 [1.19-1.75])., Conclusions: The association between adverse event triggers and poor survival among a cohort of cancer patients supports the validity of a cancer-specific, administrative claims-based trigger tool., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: Failure to complete recommended diagnostic tests may increase the risk of diagnostic errors., Objectives: The aim of this study is to develop and evaluate an electronic monitoring tool that notifies the responsible clinician of incomplete imaging tests for their ambulatory patients., Methods: A results notification workflow engine was created at an academic medical center. It identified future appointments for imaging studies and notified the ordering physician of incomplete tests by secure email. To assess the impact of the intervention, the project team surveyed participating physicians and measured test completion rates within 90 days of the scheduled appointment. Analyses compared test completion rates among patients of intervention and usual care clinicians at baseline and follow-up. A multivariate logistic regression model was used to control for secular trends and differences between cohorts., Results: A total of 725 patients of 16 intervention physicians had 1,016 delayed imaging studies; 2,023 patients of 42 usual care clinicians had 2,697 delayed studies. In the first month, physicians indicated in 23/30 cases that they were unaware of the missed test prior to notification. The 90-day test completion rate was lower in the usual care than intervention group in the 6-month baseline period (18.8 vs. 22.1%, p  = 0.119). During the 12-month follow-up period, there was a significant improvement favoring the intervention group (20.9 vs. 25.5%, p  = 0.027). The change was driven by improved completion rates among patients referred for mammography (21.0 vs. 30.1%, p  = 0.003). Multivariate analyses showed no significant impact of the intervention., Conclusion: There was a temporal association between email alerts to physicians about missed imaging tests and improved test completion at 90 days, although baseline differences in intervention and usual care groups limited the ability to draw definitive conclusions. Research is needed to understand the potential benefits and limitations of missed test notifications to reduce the risk of delayed diagnoses, particularly in vulnerable patient populations., Competing Interests: None declared., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: As there are few validated tools to identify treatment-related adverse events across cancer care settings, we sought to develop oncology-specific "triggers" to flag potential adverse events among cancer patients using claims data., Methods: 322 887 adult patients undergoing an initial course of cancer-directed therapy for breast, colorectal, lung, or prostate cancer from 2008 to 2014 were drawn from a large commercial claims database. We defined 16 oncology-specific triggers using diagnosis and procedure codes. To distinguish treatment-related complications from comorbidities, we required a logical and temporal relationship between a treatment and the associated trigger. We tabulated the prevalence of triggers by cancer type and metastatic status during 1-year of follow-up, and examined cancer trigger risk factors., Results: Cancer-specific trigger events affected 19% of patients over the initial treatment year. The trigger burden varied by disease and metastatic status, from 6% of patients with nonmetastatic prostate cancer to 41% and 50% of those with metastatic colorectal and lung cancers, respectively. The most prevalent triggers were abnormal serum bicarbonate, blood transfusion, non-contrast chest CT scan following radiation therapy, and hypoxemia. Among patients with metastatic disease, 10% had one trigger event and 29% had two or more. Triggers were more common among older patients, women, non-whites, patients with low family incomes, and those without a college education., Conclusions: Oncology-specific triggers offer a promising method for identifying potential patient safety events among patients across cancer care settings., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Massachusetts has one of the highest rates of 30-day readmissions in the country. To identify patient-reported factors that may contribute to readmissions, we conducted semi-structured interviews with patients with unplanned readmissions within 30 days of inpatient discharge from the medicine services at an urban medical center between June and August 2016. Interviews with patients and/or proxies were conducted in English, Spanish, Mandarin, or Cantonese, then translated to English if necessary, transcribed verbatim, and deidentified. A team of four coders conducted the thematic analysis. Most patients did not identify factors associated with readmission beyond their underlying illness; however, a mismatch between the patient's clinical care needs and services available at postacute facilities, as well as poor communication between providers, facilities, and patients/proxies, were identified as contributing factors to readmissions. Non-English speaking patients and their families reported confusion with written discharge instructions, even if an interpreter provided verbal instructions. Patients will benefit from future interventions that aim to improve transfers to postacute care facilities, develop written materials in languages prevalent in the local population, and improve communication among providers, facilities, and patients and their families.

Background: Computerized physician order entry (CPOE) has grown since the early 1990s. While many systems serve adult patients, systems for pediatric and neonatal populations have lagged. Adapting adult CPOE systems for pediatric use may require significant modifications to address complexities associated with pediatric care such as daily weight changes and small medication doses., Objective: This article aims to review the neonatal intensive care unit (NICU) CPOE literature to characterize trends in the introduction of this technology and to identify potential areas for further research., Methods: Articles pertaining to NICU CPOE were identified in MEDLINE using MeSH terms "medical order entry systems," "drug therapy," "intensive care unit, neonatal," "infant, newborn," etc. Two physician reviewers evaluated each article for inclusion and exclusion criteria. Consensus judgments were used to classify the articles into five categories: medication safety, usability/alerts, clinical practice, clinical decision Support (CDS), and implementation. Articles addressing pediatric (nonneonatal) CPOE were included if they were applicable to the NICU setting., Results: Sixty-nine articles were identified using MeSH search criteria. Twenty-two additional articles were identified by hand-searching bibliographies and 6 articles were added after the review process. Fifty-five articles met exclusion criteria, for a final set of 42 articles. Medication safety was the focus of 22 articles, followed by clinical practice (10), CDS (10), implementation (11), and usability/alerts (4). Several addressed more than one category. No study showed a decrease in medication safety post-CPOE implementation. Within clinical practice articles, CPOE implementation showed no effect on blood glucose levels or time to antibiotic administration but showed conflicting results on mortality rates. Implementation studies were largely descriptive of single-hospital experiences., Conclusion: CPOE implementation within the NICU has demonstrated improvement in medication safety, with the most consistent benefit involving a reduction in medication errors and wrong-time administration errors. Additional research is needed to understand the potential limitations of CPOE systems in neonatal intensive care and how CPOE affects mortality., Competing Interests: None declared., (Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: To examine the composition and concordance of existing instruments used to assess medical teams' performance., Method: A trained observer joined 20 internal medicine housestaff teams for morning work rounds at Tufts Medical Center, a 415-bed Boston teaching hospital, from October through December 2015. The observer rated each team's performance using nine teamwork observation instruments that examined domains including team structure, leadership, situation monitoring, mutual support, and communication. Observations recorded on paper forms were stored electronically. Scores were normalized from 1 (low) to 5 (high) to account for different rating scales. Overall mean scores were calculated and graphed; weighted scores adjusted for the number of items in each teamwork domain. Teamwork scores were analyzed using t tests, pairwise correlations, and the Kruskal-Wallis statistic, and team performance was compared across instruments by domain., Results: The nine tools incorporated five major domains, with 5 to 35 items per instrument, for a total of 161 items per observation session. In weighted and unweighted analyses, the overall teamwork performance score for a given team on a given day varied by instrument. While all of the tools identified the same low outlier, high performers on some instruments were low performers on others. Inconsistent scores for a given team across instruments persisted in domain-level analyses., Conclusions: There was substantial variation in the rating of individual teams assessed concurrently by a single observer using multiple instruments. Because existing teamwork observation tools do not yield concordant assessments, researchers should create better tools for measuring teamwork performance.

Background: There are few published studies of the use of portable or handheld computers in health care, but these devices have the potential to transform multiple aspects of clinical teaching and practice., Objective: This article assesses resident physicians' perceptions and experiences with tablet computers before and after the introduction of these devices., Methods: We surveyed 49 resident physicians from 8 neurology, surgery, and internal medicine clinical services before and after the introduction of tablet computers at a 415-bed Boston teaching hospital. The surveys queried respondents about their assessment of tablet computers, including the perceived impact of tablets on clinical tasks, job satisfaction, time spent at work, and quality of patient care., Results: Respondents reported that it was easier (73%) and faster (70%) to use a tablet computer than to search for an available desktop. Tablets were useful for reviewing data, writing notes, and entering orders. Respondents indicated that tablet computers increased their job satisfaction (84%), reduced the amount of time spent in the hospital (51%), and improved the quality of care (65%)., Conclusion: The introduction of tablet computers enhanced resident physicians' perceptions of efficiency, effectiveness, and job satisfaction. Investments in this technology are warranted., Competing Interests: None., (Georg Thieme Verlag KG Stuttgart · New York.)

Although chemotherapy is a well established treatment modality, chemotherapy errors represent a potentially serious risk of patient harm. We reviewed published research from 1980 to 2017 to understand the extent and nature of medication errors in cancer chemotherapy, and to identify effective interventions to help prevent mistakes. Chemotherapy errors occur at a rate of about one to four per 1000 orders, affect at least 1-3% of adult and paediatric oncology patients, and occur at all stages of the medication use process. Oral chemotherapy use is a particular area of growing risk. Our knowledge of chemotherapy errors is drawn primarily from single-institution studies at university hospitals and referral centres, with a particular focus on prescription orders and pharmacy practices. Although the heterogeneity of research methods and measures used in these studies limits our understanding of this issue, the rate of chemotherapy error-related injuries is generally lower than those seen in comparable studies of general medical patients. Although many interventions show promise in reducing chemotherapy errors, most have little empirical support. Additional research is needed to understand and to mitigate the risk of chemotherapy medication errors., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings., Methods: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012. Candidate AEs, or injuries due to medical care, were identified by trained nurse reviewers over the course of 1 year from medical records and safety-reporting databases. Physicians determined the AE harm severity and the likelihood of preventability and harm mitigation., Results: The 400-patient sample represented 133,358 days of follow-up. Three hundred four AEs were identified for an overall rate of 2.3 events per 1000 patient days (91.2 per 1000 inpatient days and 0.9 per 1000 outpatient days). Thirty-four percent of the patients had 1 or more AEs (95% confidence interval, 29%-39%), and 16% of the patients had 1 or more preventable or mitigable AEs (95% confidence interval, 13%-20%). The AE rate for patients with breast cancer was lower than the rate for patients with colorectal or lung cancer (P ≤ .001). The preventable or mitigable AE rate was 0.9 per 1000 patient days. Six percent of AEs and 4% of preventable AEs resulted in serious harm. Examples included lymphedema, abscess, and renal failure., Conclusions: A heavy burden of AEs, including preventable or mitigable events, has been identified. Future research should examine risk factors and improvement strategies for reducing their burden. Cancer 2017;123:4728-4736. © 2017 American Cancer Society., (© 2017 American Cancer Society.)

Objective: Relatively little attention has been devoted to the role of communication between physicians as a mechanism for individual and organisational learning about diagnostic delays. This study's objective was to elicit physicians' perceptions about and experiences with communication among physicians regarding diagnostic delays in cancer., Design, Setting, Participants: Qualitative analysis based on seven focus groups. Fifty-one physicians affiliated with three New York-based academic medical centres participated, with six to nine subjects per group. We used content analysis to identify commonalities among primary care physicians and specialists (ie, medical and surgical oncologists)., Primary Outcome Measure: Perceptions and experiences with physician-to-physician communication about delays in cancer diagnosis., Results: Our analysis identified five major themes: openness to communication, benefits of communication, fears about giving and receiving feedback, infrastructure barriers to communication and overcoming barriers to communication. Subjects valued communication about cancer diagnostic delays, but they had many concerns and fears about providing and receiving feedback in practice. Subjects expressed reluctance to communicate if there was insufficient information to attribute responsibility, if it would have no direct benefit or if it would jeopardise their existing relationships. They supported sensitive approaches to conveying information, as they feared eliciting or being subject to feelings of incompetence or shame. Subjects also cited organisational barriers. They offered suggestions that might facilitate communication about delays., Conclusions: Addressing the barriers to communication among physicians about diagnostic delays is needed to promote a culture of learning across specialties and institutions. Supporting open and honest discussions about diagnostic delays may help build safer health systems., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Current risk-stratification models insufficiently identify readmission risk., Setting: Academic medical center in Boston, MA., Patients: One hundred seventy-seven medicine inpatients., Methods: We prospectively interviewed clinicians about whether they would be surprised if patients scheduled for discharge were readmitted within 30 days and to identify one patient at the highest risk. Multivariate models examined the impact of clinicians' judgment on readmission., Results: The 30-day same-hospital readmission rate was 10.7%. The number of hospitalizations (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.04-1.30), emergency department visits (1.10, 1.02-1.19), and discharge medications (1.07, 1.00-1.14) were associated with readmission in bivariate models. The negative-predictive value when clinicians would be surprised about a readmission was high (95%)., Conclusion: Clinicians are better at predicting those not readmitted than those who are.

Objective: No methodologically robust system exists for capturing consumer-generated patient safety reports. To address this challenge, we developed and pilot-tested a prototype consumer reporting system for patient safety, the Health Care Safety Hotline., Design: Mixed methods evaluation., Setting: The Hotline was implemented in two US healthcare systems from 1 February 2014 through 30 June 2015., Participants: Patients, family members and caregivers associated with two US healthcare systems., Intervention: A consumer-oriented incident reporting system for telephone or web-based administration was developed to elicit medical mistakes and care-related injuries., Main Outcomes Measures: Key informant interviews, measurement of website traffic and analysis of completed reports., Results: Key informants indicated that Hotline participation was motivated by senior leaders' support and alignment with existing quality and safety initiatives. During the measurement period from 1 October 2014 through 30 June 2015, the home page had 1530 visitors with a unique IP address. During its 17 months of operation, the Hotline received 37 completed reports including 20 mistakes without harm and 15 mistakes with injury. The largest category of mistake concerned problems with diagnosis or advice from a health practitioner. Hotline reports prompted quality reviews, an education intervention, and patient follow-ups., Conclusion: While generating fewer reports than its capacity to manage, the Health Care Safety Hotline demonstrated the feasibility of consumer-oriented patient safety reporting. Further research is needed to understand how to increase consumers' use of these systems., (© The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

Background: Computerized provider order entry (CPOE) is a technology with potential to transform care delivery. While CPOE systems have been studied in adult populations, less is known about the implementation of CPOE in the neonatal intensive care unit (NICU) and perceptions of nurses and physicians using the system., Objective: To examine perceptions of clinicians before and after CPOE implementation in the NICU of a pediatric hospital., Methods: A cross-sectional survey of clinicians working in a Level III NICU was conducted. The survey was distributed before and after CPOE implementation. Participants were asked about their perception of CPOE on patient care delivery, implementation of the system, and effect on job satisfaction. A qualitative section inquired about additional concerns surrounding implementation. Responses were tabulated and analyzed using the Chi-square test., Results: The survey was distributed to 158 clinicians with a 47% response rate for pre-implementation and 45% for post-implementation. Clinicians understood why CPOE was implemented, but felt there was incomplete technical training. The expectation for increased job satisfaction and ability to recruit high-quality staff was high. However, there was concern about the ability to deliver appropriate treatments before and after implementation. Physicians were more optimistic about CPOE implementation than nurses who remained concerned that workflow may be altered., Conclusions: Introducing CPOE is a potentially risky endeavor and must be done carefully to mitigate harm. Although high expectations of the system can be met, it is important to attend to differing expectations among clinicians with varied levels of comfort with technology. Interdisciplinary collaboration is critical in planning a functioning CPOE to ensure that efficient workflow is maintained and appropriate supports for individuals with a lower degree of technical literacy is available.

Rationale, Aims and Objectives: Variation in the workup of rectal bleeding may result in guideline-discordant care and delayed diagnosis of colorectal cancer. Accordingly, we undertook this study to characterize primary care clinicians' initial rectal bleeding evaluation., Methods: We studied 438 patients at 10 adult primary care practices affiliated with three Boston, Massachusetts, academic medical centres and a multispecialty group practice, performing medical record reviews of subjects with visit codes for rectal bleeding, haemorrhoids or bloody stool. Nurse reviewers abstracted patients' sociodemographic characteristics, rectal bleeding-related symptoms and components of the rectal bleeding workup. Bivariate and multivariable logistic regression models examined factors associated with guideline-discordant workups., Results: Clinicians documented a family history of colorectal cancer or polyps at the index visit in 27% of cases and failed to document an abdominal or rectal examination in 21% and 29%. Failure to order imaging or a diagnostic procedure occurred in 32% of cases and was the only component of the workup associated with guideline-discordant care, which occurred in 27% of cases. Compared with patients at hospital-based teaching sites, patients at urban clinics or community health centres had 2.9 (95% confidence interval 1.3-6.3) times the odds of having had an incomplete workup. Network affiliation was also associated with guideline concordance., Conclusion: Workup of rectal bleeding was inconsistent, incomplete and discordant with guidelines in one-quarter of cases. Research and improvements strategies are needed to understand and manage practice and provider variation., (© 2016 John Wiley & Sons, Ltd.)

Purpose: Although patient safety is a priority in oncology, few tools measure adverse events (AEs) beyond treatment-related toxicities. The study objective was to assemble a set of clinical triggers in the medical record and assess the extent to which triggered events identified AEs., Methods: We performed a retrospective cohort study to assess the performance of an oncology medical record screening tool at a comprehensive cancer center. The study cohort included 400 patients age 18 years or older diagnosed with breast (n = 128), colorectal (n = 136), or lung cancer (n = 136), observed as in- and outpatients for up to 1 year., Results: We identified 790 triggers, or 1.98 triggers per patient (range, zero to 18 triggers). Three hundred four unique AEs were identified from medical record reviews and existing AE databases. The overall positive predictive value (PPV) of the original tool was 0.40 for total AEs and 0.15 for preventable or mitigable AEs. Examples of high-performing triggers included return to the operating room or interventional radiology within 30 days of surgery (PPV, 0.88 and 0.38 for total and preventable or mitigable AEs, respectively) and elevated blood glucose (> 250 mg/dL; PPV, 0.47 and 0.40 for total and preventable or mitigable AEs, respectively). The final modified tool included 49 triggers, with an overall PPV of 0.48 for total AEs and 0.18 for preventable or mitigable AEs., Conclusion: A valid medical record screening tool for AEs in oncology could offer a powerful new method for measuring and improving cancer care quality. Future improvements could optimize the tool's efficiency and create automated electronic triggers for use in real-time AE detection and mitigation algorithms.

Background: Although delayed colorectal cancer diagnoses figure prominently in medical malpractice claims, little is known about the quality of primary care clinicians' workup of rectal bleeding., Methods: In this study, 438 patients were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for rectal bleeding, hemorrhoids, and blood in the stool at 10 Boston adult primary care practices. Following nurse chart abstraction, physician reviewers assessed the overall quality of care and key care processes. Subjects' characteristics and physician reviewers' processes-of-care assessments were tabulated, and logistic regression models were used to examine the association of process failures with overall quality and guideline concordance., Results: Although reviewers judged the overall quality of care to be good or excellent in 337 (77%) of 438 cases, 312 (71%) patients experienced at least one process-of-care failure in the workup of rectal bleeding. Clinicians failed to obtain an adequate family history in 38% of cases, complete a pertinent physical exam in 23%, and order laboratory tests in 16%. Failure to order or perform tests, or to make follow-up plans were associated with increased odds of poor or fair care. Guideline concordance bore little relationship with quality judgments. Reviewers judged that 128 delays could have been reduced or prevented., Conclusion: Process-of-care failures among adult primary care patients with rectal bleeding were frequent and associated with fair or poor quality. Educating practitioners and creating systems to ensure adequate history taking, physical examination, and processes for ordering, performing, and interpreting diagnostic tests may improve performance., (Copyright © 2016 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Purpose: Widespread consensus exists about the importance of addressing patient safety issues in oncology, yet our understanding of the frequency, spectrum, and preventability of adverse events (AEs) across cancer care is limited., Methods: We developed a screening tool to detect AEs across cancer care settings through medical record review. Members of the study team reviewed the scientific literature and obtained structured input from an external multidisciplinary panel of clinicians by using a modified Delphi process., Results: The screening tool comprises 76 triggers-readily identifiable findings to screen for possible AEs that occur during cancer care. Categories of triggers are general care, vital signs, medication related, laboratory tests, other orders, and consultations., Conclusion: Although additional testing is required to assess its performance characteristics, this tool may offer an efficient mechanism for identifying possibly preventable AEs in oncology and serve as an instrument for quality improvement., (Copyright © 2016 by American Society of Clinical Oncology.)

The Harvard Fellowship in Patient Safety and Quality is a 2-year physician-oriented training program with a strong operational orientation, embedding trainees in the quality departments of participating hospitals. It also integrates didactic and experiential learning and offers the option of obtaining a master's degree in public health. The program focuses on methodologically rigorous improvement and measurement, with an emphasis on the development and implementation of innovative practice. The operational orientation is intended to foster the professional development of future quality and safety leaders. The purpose of this article is to describe the design and development of the fellowship., (© The Author(s) 2014.)

The authors sought to create a curriculum suitable for a newly created clinical fellowship curriculum across Harvard Medical School-affiliated teaching hospitals as part of a newly created 2-year quality and safety fellowship program described in the companion article "Design and Implementation of the Harvard Fellowship in Patient Safety and Quality." The aim of the curriculum development process was to define, coordinate, design, and implement a set of essential skills for future physician-scholars of any specialty to lead operational quality and patient safety efforts. The process of curriculum development and the ultimate content are described in this article., (© The Author(s) 2014.)

Background: An important aspect of medical care is clear and effective communication, which can be particularly challenging for individuals based on race/ethnicity. Quality of communication is measured systematically in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, and analyzed frequently such as in the National Healthcare Disparities Report. Caution is needed to discern differences in communication quality from racial/ethnic differences in perceptions about concepts or expectations about their fulfillment., Objectives: To examine assumptions about the degree of commonality across racial/ethnic groups in their perceptions and expectations, and to investigate the validity of conclusions regarding racial/ethnic differences in communication quality., Methods: We used 2007 HCAHPS data from the National CAHPS Benchmarking Database to construct racial/ethnic samples that controlled for other patient characteristics (828 per group). Using multiple-groups confirmatory factor analyses, we tested whether the factor structure and model parameters (ie, factor loadings, intercepts) differed across groups., Results: We identified support for basic tests of equivalence across 7 racial/ethnic groups in terms of equivalent factor structure and loadings. Even stronger support was found for Communication with Doctors and Nurses. However, potentially important nonequivalence was found for Communication about Medicines, including instances of statistically significant differences between non-Hispanic whites and non-Hispanic blacks, Asians, and Native Hawaiian/other Pacific Islanders., Conclusions: Our results provide strongest support for racial/ethnic comparisons on Communication with Nurses and Doctors, and reason to caution against comparisons on Communication about Medicines due to significant differences in model parameters across groups; that is, a lack of invariance in the intercept.

Objective: To analyze the print news media's coverage of sentinel events involving cancer patients., Methods: Using LexisNexis, we identified English-language newspaper articles covering medical errors in cancer care between January 1, 2000, and December 31, 2010. Articles were coded for 3 major themes using a standardized abstraction instrument: narrative statements and point of view most prominently represented, attribution of blame, and orientation toward patient safety. We also abstracted country where the newspaper was published, type of error event, and extent of patient harm., Results: We analyzed 64 articles from 37 print newspaper syndications that circulated in 6 countries/regions. Reports of medical errors rarely were framed from the point of view of a safety expert or the responsible clinician (13% and 3%, respectively) compared with the patient and legal points of view (both 30%). Articles held individual clinicians (41%) and hospital systems (28%) responsible for most errors. Four in 10 articles failed to present medical errors as "systems" problems. Article perspective varied considerably by country, with 53% of articles from the UK and 63% from Australia and New Zealand judged as negatively slanted compared with 14% in the United States and Canada., Conclusions: In reports of medical errors involving cancer patients, the news media regularly blame individual clinicians for mistakes and fail to present a systems-based understanding of these events.

Few studies have examined care processes within providers' and institutions' control that expedite or delay care. The authors investigated the timeliness of breast cancer care at a comprehensive cancer center, focusing on factors influencing the time from initial consultation to first definitive surgery (FDS). The care of 1,461 women with breast cancer who underwent surgery at Dana-Farber/Brigham and Women's Cancer Center from 2011 to 2013 was studied. The interval between consultation and FDS was calculated to identify variation in timeliness of care based on procedure, provider, and patients' sociodemographic characteristics. Targets of 14 days for lumpectomy and mastectomy and 28 days from mastectomy with immediate reconstruction were set and used to define delay. Mean days between consultation and FDS was 21.6 (range 1-175, sd 15.8) for lumpectomy, 36.7 (5-230, 29.1) for mastectomy, and 37.5 (7-111, 16) for mastectomy with reconstruction. Patients under 40 were less likely to be delayed (OR = 0.56, 95 % CI = 0.33-0.94, p = 0.03). Patients undergoing mastectomy alone (OR = 2.64, 95 % CI = 1.80-3.89, p < 0.0001) and mastectomy with immediate reconstruction (OR = 1.34 95 % CI = 1.00-1.79, p = 0.05) were more likely to be delayed when compared to lumpectomy. Substantial variation in surgical timeliness was identified. This study provides insight into targets for improvement including better coordination with plastic surgery and streamlining pre-operative testing. Cancer centers may consider investing in efforts to measure and improve the timeliness of cancer care.

Background: Existing patient safety climate instruments, most of which have been developed in the USA, may not accurately reflect the conditions in the healthcare systems of other countries., Objectives: To develop and evaluate a patient safety climate instrument for healthcare workers in Chinese hospitals., Methods: Based on a review of existing instruments, expert panel review, focus groups and cognitive interviews, we developed items relevant to patient safety climate in Chinese hospitals. The draft instrument was distributed to 1700 hospital workers from 54 units in six hospitals in five Chinese cities between July and October 2011, and 1464 completed surveys were received. We performed exploratory and confirmatory factor analyses and estimated internal consistency reliability, within-unit agreement, between-unit variation, unit-mean reliability, correlation between multi-item composites, and association between the composites and two single items of perceived safety., Results: The final instrument included 34 items organised into nine composites: institutional commitment to safety, unit management support for safety, organisational learning, safety system, adequacy of safety arrangements, error reporting, communication and peer support, teamwork and staffing. All composites had acceptable unit-mean reliabilities (≥0.74) and within-unit agreement (Rwg ≥0.71), and exhibited significant between-unit variation with intraclass correlation coefficients ranging from 9% to 21%. Internal consistency reliabilities ranged from 0.59 to 0.88 and were ≥0.70 for eight of the nine composites. Correlations between composites ranged from 0.27 to 0.73. All composites were positively and significantly associated with the two perceived safety items., Conclusions: The Chinese Hospital Survey on Patient Safety Climate demonstrates adequate dimensionality, reliability and validity. The integration of qualitative and quantitative methods is essential to produce an instrument that is culturally appropriate for Chinese hospitals., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Implementation of practice guidelines is a beguilingly complex activity that requires attention to the task of clinicians, the constraints they face, and the social practice of medicine. Local clinical opinion leaders can accelerate the pace of change by encouraging early adoption and modeling new practices. "Tough love" approaches to guideline adoption have a role in raising the salience of the safe practice. However, successful implementation requires a healthy respect for the challenge of enlisting frontline practitioners in integrating changes into the practice of active clinicians. The implementation of guideline-based practices for aseptic technique in neuraxial analgesia at four Israeli hospitals illustrates the challenges and opportunities associated with changing physician practice.

To understand the vulnerability of patients with cancer to central line-associated bloodstream infections related to tunneled central venous catheters (CVCs), patients were asked to describe their line care at home and in clinic and to characterize their knowledge and experience managing CVCs. Forty-five adult patients with cancer were recruited to participate. Patients were interviewed about the type of line, duration of use, and observations of variations in line care. They also were asked about differences between line care at home and in the clinic, precautions taken when bathing, and their education regarding line care. Demographic information and primary cancer diagnosis were taken from the patients' medical records. Patients with hematologic and gastrointestinal malignancies were heavily represented. The majority had tunneled catheters with subcutaneous implanted ports. Participants identified variations in practice among nurses who cared for them. Although many participants expressed confidence in their knowledge of line care, some were uncertain about what to do if the dressing became loose or wet, or how to recognize an infection. Patients seemed to be astute observers of their own care and offered insights into practice variation. Their observations show that CVC care practices should be standardized, and educational interventions should be created to address patients' knowledge deficits.