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Clinical prediction models (CPMs) are tools that compute the risk of an outcome given a set of patient characteristics and are routinely used to inform patients, guide treatment decision-making, and resource allocation. Although much hope has been placed on CPMs to mitigate human biases, CPMs may potentially contribute to racial disparities in decision-making and resource allocation. While some policymakers, professional organizations, and scholars have called for eliminating race as a variable from CPMs, others raise concerns that excluding race may exacerbate healthcare disparities and this controversy remains unresolved. The Guidance for Unbiased predictive Information for healthcare Decision-making and Equity (GUIDE) provides expert guidelines for model developers and health system administrators on the transparent use of race in CPMs and mitigation of algorithmic bias across contexts developed through a 5-round, modified Delphi process from a diverse 14-person technical expert panel (TEP). Deliberations affirmed that race is a social construct and that the goals of prediction are distinct from those of causal inference, and emphasized: the importance of decisional context (e.g., shared decision-making versus healthcare rationing); the conflicting nature of different anti-discrimination principles (e.g., anticlassification versus antisubordination principles); and the importance of identifying and balancing trade-offs in achieving equity-related goals with race-aware versus race-unaware CPMs for conditions where racial identity is prognostically informative. The GUIDE, comprising 31 key items in the development and use of CPMs in healthcare, outlines foundational principles, distinguishes between bias and fairness, and offers guidance for examining subgroup invalidity and using race as a variable in CPMs. This GUIDE presents a living document that supports appraisal and reporting of bias in CPMs to support best practice in CPM development and use., (© 2024. The Author(s).)

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.

Introduction: We developed an enhancement to a chemotherapy order-entry system that alerted prescribers to potential drug interactions between patients' usual outpatient medications and those prescribed for onsite cancer treatment. This report summarizes the interactions and analyzes the impact of alerts on clinician behavior., Methods: We studied electronic orders created from November 2010 to December 2011 by oncology clinicians at two comprehensive cancer centers who shared a chemotherapy order-entry system and an ambulatory electronic medical record. The enhancement generated an alert if a new chemotherapy system order for an antineoplastic agent or supportive care medication interacted with an existing medication in the ambulatory record, and tracked prescribers' responses., Results: New chemotherapy system orders triggered 29,592 drug interaction alerts. New orders for antineoplastic agents accounted for 495 (32.6%) of 1518 high- and medium-severity alerts. Interactions with antibiotics accounted for the majority of these alerts. New chemotherapy system orders for antiemetics triggered 352 (23.2%) alerts and more than two-thirds were attributed to interactions with analgesic opioids. High- and medium-severity alerts changed prescriber behavior in 224 (14.8%) occurrences, including potentially fatal interactions between meperidine and monoamine oxidase inhibitors. Clinicians who overrode alerts indicated that they would monitor the patient (54.6%), the patient already tolerated the combination (24.5%), and they would adjust the dose (15.1%)., Conclusion: Cancer patients are at risk of serious interactions between medications ordered for cancer care and those provided for general medical care. Organizations and order-entry applications should develop countermeasures to identify and prevent potentially serious drug interactions.

Objective: To understand how patient-reported quality is related to adverse events (AEs)., Design: Random sample telephone survey., Setting: Sixteen acute care Massachusetts hospitals., Participants: Two thousand and five hundred and eight-two of 4163 (62% response rate) eligible adult patients., Main Outcome Measures: Patients hospitalized from 1 April 2003 to 1 October 2003 provided global quality ratings and whether they experienced AEs. Service recovery, defined as efforts by a service provider to return customers to a state of satisfaction after a lapse in service, was operationalized as high participation in one's care, timely discharge and disclosure of the circumstances of an AE., Results: Of respondents, 82% rated the quality as high and 23% reported one or more AEs. Patients with no AEs gave higher quality ratings (85 vs. 77 or 62% for patients with 1 or 2+ AEs, respectively, P < 0.001). Patients were more likely to rate the quality high if they reported high participation (86 vs. 53%), or felt discharge timing was just right (85 vs. 64%); for those with AEs, ratings were higher among those reporting disclosure (82 vs. 66%) (all P < 0.01). In adjusted analyses, patients with AEs experiencing all three service recovery components rated their quality higher (86 vs. 68%, P < 0.01)., Conclusions: Patients with AEs rate the quality of care lower than others. However, patients with AEs who experienced 'service recovery' as we defined it rated their quality of care at levels similar to those who did not experience AEs. Hospitals seeking to improve quality ratings might consider efforts to ensure patient safety and to address AEs in a transparent and responsive way.

Background & Aims: Rectal bleeding is associated with colorectal cancer. We characterized the evaluation of patients aged 40 years and older with rectal bleeding and identified characteristics associated with inadequate evaluation., Methods: We conducted a retrospective review of records of outpatient visits that contained reports of rectal bleeding for patients aged 40 years and older (N = 480). We studied whether patient characteristics affected whether or not they received a colonoscopy examination within 90 days of presentation with rectal bleeding. Patient characteristics included demographics; family history of colon cancer and polyps; and histories of screening colonoscopies, physical examinations, referrals to specialists at the index visit, and communication of laboratory results. Data were collected from medical records, and patient income levels were estimated based on Zip codes., Results: Nearly half of the patients presenting with rectal bleeding received colonoscopies (48.1%); 81.7% received the procedure within 90 days. A history of a colonoscopy examination was more likely to be reported in white patients compared with Hispanic or Asian patients (P = .012 and P = .006, respectively), and in high-income compared with low-income patients (P = .022). A family history was more likely to be documented among patients with private insurance than those with Medicaid or Medicare (P = .004). A rectal examination was performed more often for patients who were white or Asian, male, and with high or middle incomes, compared with those who were black, Hispanic, female, or with low incomes (P = .027). White patients were more likely to have their laboratory results communicated to them than black patients (P = .001)., Conclusions: Sex, race, ethnicity, patient income, and insurance status were associated with disparities in evaluation of rectal bleeding. There is a need to standardize the evaluation of patients with rectal bleeding., (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objective: Contact precautions decrease healthcare worker-patient contact and may impact patient satisfaction. To determine the association between contact precautions and patient satisfaction, we used a standardized interview for perceived issues with care., Design: Prospective cohort study of inpatients, evaluated at admission and on hospital days 3, 7, and 14 (until discharged). At each point, patients underwent a standardized interview to identify perceived problems with care. After discharge, the standardized interview and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey were administered by telephone. Responses were recorded, transcribed, and coded by 2 physician reviewers., Participants: A total of 528 medical or surgical patients not admitted to the intensive care unit., Results: A total of 528 patients were included in the primary analysis, of whom 104 (20%) perceived some issue with their care. On multivariable logistic regression, contact precautions were independently associated with a greater number of perceived concerns with care (odds ratio, 2.05 [95% confidence interval, 1.31-3.21]; P < .01), including poor coordination of care (P = .02) and a lack of respect for patient needs and preferences (P = .001). Eighty-eight patients were included in the secondary analysis of HCAHPS. Patients under contact precautions did not have different HCAHPS scores than those not under contact precautions (odds ratio, 1.79 [95% confidence interval, 0.64-5.00]; P = .27)., Conclusions: Patients under contact precautions were more likely to perceive problems with their care, especially poor coordination of care and a lack of respect for patient preferences.

Purpose: There is no consensus in the oncology community about the optimal model for anticoagulation management of ambulatory cancer patients. To understand oncologists' preferences regarding anticoagulation management, we compared the characteristics of patients referred to an oncology-oriented anticoagulation management service with "usual care" patients managed by the patient's primary oncologist., Methods: We performed a retrospective medical record review of ambulatory oncology patients' anticoagulation care at a comprehensive cancer center. We examined the characteristics of 33 patients anticoagulated before implementation of a dedicated oncology anticoagulation management service. We compared this group with 33 patients managed by the anticoagulation management service and with 39 usual care patients managed by the primary oncologist after the anticoagulation management service was created. We also examined differences in laboratory test utilization, time in the therapeutic range (for patients anticoagulated with warfarin), and anticoagulation-related adverse events during a 3-month assessment period., Results: Anticoagulation management service patients were more likely to be treated for hematologic malignancies, use erythropoietin stimulating agents, and require warfarin management for previous venous thromboembolic disease compared to usual care patients. In contrast, oncologists were more likely to manage anticoagulation care of patients with advanced solid tumors undergoing active chemotherapy. Anticoagulation management service and usual care patients on warfarin therapy had comparable time in the therapeutic range and complication rates., Conclusion: Oncologists selectively referred patients to the anticoagulation management service. Anticoagulation management service patients' warfarin control and complication rates were comparable to care provided by the primary oncologist, suggesting that an oncology-specific anticoagulation management service may be a feasible and effective option for anticoagulation management of ambulatory oncology patients.

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 health-care utilization., Methods: The researchers conducted a randomized, controlled clinical trial of MedCheck, an automated electronic message generated in a patient Internet portal. MedCheck asked intervention patients if they had filled a recent prescription and if they had experienced any problems with the medication. Patients' responses were forwarded automatically to primary care physicians. The study enrolled 375 intervention patients and 363 controls. After 3 months, the investigators reviewed patients' medical records and conducted telephone interviews to identify ADEs and to assess health-care utilization., Results: Among the 375 intervention patients, 184 (49%) responded to at least 1 MedCheck message. Patients reported 52 unfilled prescriptions and 56 medication problems. Patients responded to 72% of messages within 1 day. There was no statistically significant difference between intervention and control groups in the rate of ADEs, preventable or ameliorable ADEs, serious ADEs, or in subjects' health-care utilization., Conclusions: Internet portals have the potential to enhance patient-physician communication. However, additional development is required to demonstrate that such interventions can improve medication safety or health-care utilization.

Background: Oncology care is delivered largely in ambulatory settings by interdisciplinary teams. Treatments are often complex, extended in time, dispersed geographically and vulnerable to teamwork failures. To address this risk, we developed and piloted a team training initiative in the breast cancer programme at a comprehensive cancer centre., Methods: Based on clinic observations, interviews with key staff and analyses of incident reports, we developed interventions to address four high-risk areas: (1) miscommunication of chemotherapy order changes on the day of treatment; (2) missing orders on treatment days without concurrent physician appointments; (3) poor follow-up with team members about active patient issues; and (4) conflict between providers and staff. The project team developed protocols and agreements to address team members' roles, responsibilities and behaviours., Results: Using a train-the-trainer model, 92% of breast cancer staff completed training. The incidence of missing orders for unlinked visits decreased from 30% to 2% (p<0.001). Patient satisfaction scores regarding coordination of care improved from 93 to 97 (p=0.026). Providers, infusion nurses and support staff reported improvement in efficiency (75%, 86%, 90%), quality (82%, 93%, 93%) and safety (92%, 92%, 90%) of care, and more respectful behaviour (92%, 79%, 83%) and improved relationships among team members (91%, 85%, 92%). Although most clinicians reported a decrease in non-communicated changes, there was insufficient statistical power to detect a difference., Conclusions: Team training improved communication, task coordination and perceptions of efficiency, quality, safety and interactions among team members as well as patient perception of care coordination.

Objective: As home medication use increases, medications previously managed by nurses are now managed by patients and their families. Our objective was to describe the types of errors occurring in the home medication management of children with cancer., Methods: In a prospective observational study at 3 pediatric oncology clinics in the northeastern and southeastern United States, patients undergoing chemotherapy and their parents were recruited from November 2007 through April 2011. We reviewed medical records and checked prescription doses. A trained nurse visited the home, reviewed medication bottles, and observed administration. Two physicians independently made judgments regarding whether an error occurred and its severity. Overall rates of errors were weighted to account for clustering within sites., Results: We reviewed 963 medications and observed 242 medication administrations in the homes of 92 patients. We found 72 medication errors. Four errors led to significant patient injury. An additional 40 errors had potential for injury: 2 were life-threatening, 13 were serious, and 25 were significant. Error rates varied between study sites (40-121 errors per 100 patients); the weighted overall rate was 70.2 errors per 100 patients (95% confidence interval [CI]: 58.9-81.6). The weighted rate of errors with injury was 3.6 (95% CI: 1.7-5.5) per 100 patients and with potential to injure the patient was 36.3 (95% CI: 29.3-43.3) per 100 patients. Nonchemotherapy medications were more often involved in an error than chemotherapy., Conclusions: Medication errors were common in this multisite study of outpatient pediatric cancer care. Rates of preventable medication-related injuries in this outpatient population were comparable or higher than those found in studies of hospitalized patients.

Purpose: Observational studies describe high rates of errors in home oral chemotherapy use in children. In hospitals, proactive risk assessment methods help front-line health care workers develop error prevention strategies. Our objective was to engage parents of children with cancer in a multisite study using proactive risk assessment methods to identify how errors occur at home and propose risk reduction strategies., Methods: We recruited parents from three outpatient pediatric oncology clinics in the northeast and southeast United States to participate in failure mode and effects analyses (FMEA). An FMEA is a systematic team-based proactive risk assessment approach in understanding ways a process can fail and develop prevention strategies. Steps included diagram the process, brainstorm and prioritize failure modes (places where things go wrong), and propose risk reduction strategies. We focused on home oral chemotherapy administration after a change in dose because prior studies identified this area as high risk., Results: Parent teams consisted of four parents at two of the sites and 10 at the third. Parents developed a 13-step process map, with two to 19 failure modes per step. The highest priority failure modes included miscommunication when receiving instructions from the clinician (caused by conflicting instructions or parent lapses) and unsafe chemotherapy handling at home. Recommended risk assessment strategies included novel uses of technology to improve parent access to information, clinicians, and other parents while at home., Conclusion: Parents of pediatric oncology patients readily participated in a proactive risk assessment method, identifying processes that pose a risk for medication errors involving home oral chemotherapy.

Background: Although pain is common among patients with advanced cancer, little is known about longitudinal variability in pain intensity. For this report, the authors examined variability in pain intensity over 24 months among ambulatory patients with advanced stage cancers, associations between patient characteristics and within-patient pain variability, and the relation of pain variability to overall survival., Methods: The sample comprised 949 patients with solid tumors who received care and reported pain scores in at least 3 different months within 24 months of their initial stage IV diagnosis during the period from 2004 to 2006. Pain intensity was measured using a scale ranging from 0 (no pain) to 10 (worst pain). Pain variability was defined as the standard deviation of the maximum monthly pain scores and was dichotomized at the 50th percentile into high and low variability groups., Results: Considerable between-patient differences in pain variability (range, 0-5.77) were observed. Nonwhites, patients with a stage IV cancer diagnosed within the previous 3 months, and those with moderate or severe pain at baseline were more likely to experience high pain variability. Although patients with head and neck cancer generally had the highest pain variability, the intensity of their pain typically decreased over the disease course. High pain variability with worsening pain trajectory was associated with increased risk of death., Conclusions: Longitudinally, pain intensity was highly variable among patients with stage IV cancer. Minority patients, newly diagnosed patients, patients with head and neck cancer, and patients with moderate or severe pain at baseline were at higher risk of large fluctuations in pain intensity., (Copyright © 2012 American Cancer Society.)

Introduction: To prevent oral chemotherapy prescription errors, we enhanced a prescription-writing module in an ambulatory electronic medical record. We sought to describe the enhancement, examine its performance to date, and identify opportunities for improvement., Methods: Enhancements to the oral chemotherapy writing module included weight- and body surface area-based dosing, fields for cancer diagnosis and intent of therapy (curative v palliative), and dose-limit warnings. We studied all prescriptions for 18 oral chemotherapies generated by oncology clinicians during the first 17 months after the safe prescribing enhancements were introduced, from May 1, 2010, to October 1, 2011. We examined the frequency with which clinicians used the new features, the number and type of alerts generated, and clinician actions in response to alerts., Results: Six hundred clinicians generated 6,673 prescriptions for 2,043 patients. Six drugs-temozolomide, capecitabine, lenalidomide, hydroxyurea, imatinib, and erlotinib-accounted for 5,512 of all oral chemotherapy prescriptions (83%). Prescribers indicated the intent of therapy 13% of the time and listed the patient's cancer diagnosis 46% of the time. Prescribers customized their instructions using a free-text field in 64% of prescriptions. Clinicians' 6,673 prescription attempts triggered 395 dose-limit warnings (5%), mostly for temozolomide. Clinicians ignored most (96%) warnings, because current dosing recommendations exceeded the dose-limit warnings for the alerted medications., Conclusion: Oncology clinicians readily accepted features designed to enhance oral chemotherapy safety. Additional enhancements are needed to facilitate prescriptions with complex dosing regimens and to provide dose-limit warnings that reflect current clinical practice.

Background: Pain is common among cancer patients., Objective: To characterize the incidence of severe pain among newly diagnosed patients with stage IV cancer in ambulatory care., Methods: A retrospective cohort of 505 ambulatory oncology patients with newly diagnosed stage IV solid tumours at a comprehensive cancer centre (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) was followed from January 1, 2004, to December 31, 2006. Pain intensity scores were extracted from electronic medical records. The incidence of severe pain was calculated using the maximum monthly pain scores reported at outpatient visits., Results: Of the 505 patients included in the present study, 340 (67.3%) were pain-free at the initial visit, 90 (17.8%) experienced mild pain, 48 (9.5%) experienced moderate pain and 27 (5.4%) experienced severe pain. At least one episode of severe pain within one year of diagnosis was reported by 29.1% of patients. Patients with head and neck, gastrointestinal and thoracic malignancies were more likely to experience severe pain compared with patients with other types of cancer (52.6%, 33.9% and 30.5%, respectively). In the multivariable model, patients whose primary language was not English (OR 2.90 [95% CI 1.08 to 7.80]), patients who reported severe pain at the initial visit (OR 9.30 [95% CI 3.72 to 23.23]) and patients with head and neck (OR 10.17 [95% CI 2.87 to 36.00]) or gastrointestinal (OR 4.05 [95% CI 1.23 to 13.35]) cancers were more likely to report severe pain in the following year., Conclusions: The incidence of severe pain was high in ambulatory patients with newly diagnosed stage IV cancer.

Purpose: The prevalence and severity of pain have not been well described among oncology patients in ambulatory care. To better understand the burden of pain among patients with advanced cancer, we examined the prevalence of pain reported during office and treatment visits., Methods: A retrospective study of 4,014 patients with advanced disease (stage 4 at diagnosis or metastatic progression) who completed an ambulatory visit between 2004 and 2006 was conducted at a comprehensive cancer center in Boston, Massachusetts., Results: At their first visit during the study period, 74% of patients reported no pain (0 score); 12%, low pain (1 to 3 score); 9%, moderate pain (4 to 6 score); and 5%, severe pain (7 to 10 score). The prevalence of pain was highest among patients who were younger than 60 years of age, were nonwhite, did not speak English as their primary language, or were covered by Medicaid, received free care, or paid their own health care costs. Patients with thoracic, breast, and head and neck cancers had higher pain scores than those with other diseases. Pain was reported more frequently among patients whose diagnosis or metastatic progression occurred less than 3 months before the reported pain score. In multivariable regression analysis, age, race, cancer type, and time since diagnosis/progression were identified as important factors associated with severe pain., Conclusion: Younger age, minority race, and recent onset of advanced disease are associated with severe pain among patients with cancer. Recognizing these high-risk groups could inform targeted interventions to address pain care in ambulatory patients with advanced cancer.

Context: Pain is common among patients with advanced cancer despite the dissemination of clinical pain care guidelines., Objectives: We sought to assess the quality of pain care among patients with advanced disease., Methods: We reviewed the records of 85 adult ambulatory patients with advanced breast, lung, and gastrointestinal cancer treated in 2004-2006. Patients' screening pain intensity scores were at least 7 of 10. Nurse reviewers completed medical record reviews of care rendered at the index visit and over the subsequent 30 days based on the 2004 National Comprehensive Cancer Network pain guideline. An expert panel then rated the quality of the evaluation, treatment, and overall pain care. We used a multivariable model to analyze guideline compliance and resolution of severe pain., Results: Among advanced cancer patients with severe pain, clinicians adjusted pain medications only half the time and made few timely referrals for pain-related consultations. By 30 days after the index visit, 34% of patients continued to report severe pain. The expert panel judged the overall quality of pain care as "fair" or "poor" in about two-thirds of cases because more timely and effective intervention could have reduced the severity and duration of pain. Resolution of severe pain was associated with adjustment of pain medications at the index visit (adjusted odds ratio 3.8, 95% CI 1.3-10.6)., Conclusion: There is room for improvement in the pain care of patients with advanced cancer. Additional research is needed to understand the reasons for poor performance., (Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)