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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: 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.)

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: 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.

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.

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.

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.)

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.)

Although many patients prefer orally administered cancer therapy (including oral chemotherapy) because of its convenience, the shift from hospital to home-based administration creates concerns. This article explores the perceptions and experiences of oral chemotherapy users and their caregivers to assess vulnerabilities and improvement opportunities at each stage of the medication process: choosing oral chemotherapy, prescribing, dispensing, administering, and monitoring. The authors recruited 15 current and former oral chemotherapy users, as well as caregivers who administered the medications to children, to participate in one of two focus group sessions at a comprehensive cancer center. Participants largely were satisfied with oral cancer therapy but raised concerns regarding their lack of preparedness for side effects and their unfamiliarity with the possible techniques to mitigate drug toxicity. Participants also described difficulties obtaining medications through retail pharmacies. Parents of pediatric patients with cancer indicated concerns regarding their children's emotional health and correct medication administration. Participants believed that the initial prescribing encounter should have included more education, and they also wanted more frequent follow-up by healthcare practitioners. As oral cancer therapy is used more widely, oncology healthcare providers will need to create robust mechanisms to support their safe use.

Background: Health care organizations have begun to adapt high-performance teamwork training techniques from aviation to clinical environments. Oncology care is often delivered in multispecialty teams and with the patient's and family's active involvement. To examine the potential value of a patient-oriented teamwork intervention, a teamwork training initiative for oncology patients and their families was developed at the Dana-Farber Cancer Institute., Developing the Campaign: The content and format of the initiative evolved iteratively on the basis of several core team-training concepts derived from the research literature in health care and aviation. Initially a targeted intervention, the program evolved into a multifaceted campaign that included internal marketing, staff training, and one-on-one patient outreach by a group of volunteers. The You CAN campaign sought to convey a positive and empowering message that encouraged patients to (1) check for hazards in the environment, (2) ask questions of clinicians, and (3) notify staff of safety concerns., Implementing the Campaign: The You CAN campaignwas conducted from July through September 2007. To assess its progress, patients were surveyed at baseline and during the campaign. On the basis of the survey results, 32% (95% confidence interval [CI]: 25%-38%) of the ambulatory clinic population, or 1,145 patients, were exposed to the campaign. Although patients rated the quality of teamwork and communication favorably at both baseline and followup, there was no significant change in the self-reported use of teamwork techniques on a written survey. However, 39% (95% CI: 27%-51%) of those who were exposed to the campaign said that it changed their behavior., Discussion: A training program for patients and their families is feasible in ambulatory oncology and may be applicable to other clinical settings.

Oral chemotherapy is emerging as a new option for well-selected patients who can manage potentially complex oral regimens and self-monitor for potential complications. If a choice between oral and parenteral therapy is available, patients may opt for oral chemotherapy because it is more convenient to administer, allows them to avoid multiple office visits, and gives them a sense of control over their own cancer care. Whether these potential advantages are maintained in regimens that combine oral and parenteral drugs is less clear. The use of oral chemotherapeutic agents profoundly affects all aspects of oncology, including creating significant safety and adherence issues, shifting some traditional roles and responsibilities of oncologists, nurses, and pharmacists to patients and caregivers. The financing of chemotherapy is also affected. To address these issues, the NCCN convened a multidisciplinary task force consisting of oncologists, nurses, pharmacists, and payor representatives to discuss the impact of the increasing use of oral chemotherapy.

Objective: To characterise current safety practices for the use of oral chemotherapy., Design: Written questionnaire survey of pharmacy directors of cancer centres., Setting: Comprehensive cancer centres in the United States., Results: Respondents from 42 (78%) of 54 eligible centres completed the survey, after consulting with 89 colleagues. Clinicians at 29 centres used handwritten prescriptions, two used preprinted paper prescriptions, and six used electronic systems for most oral chemotherapy prescribing. For six commonly used oral chemotherapies, on average 10 centres required a diagnosis on the prescription, 11 required the protocol number, four required the cycle number, nine required double checking by a second clinician, 14 required a calculation of body surface area, and 14 required a calculation of dose per square metre of body surface area. Only a third of centres requested patients' written informed consent when oral chemotherapy was given off protocol. Nearly a quarter (10) of centres had no formal process for monitoring patients' adherence. In the past year respondents at 10 centres reported at least one serious adverse drug event related to oral chemotherapy, and respondents at 13 centres reported a serious near miss., Conclusion: Few of the safeguards routinely used for infusion chemotherapy have been adopted for oral chemotherapy at US cancer centres. There is currently no consensus at these centres about safe medication practices for oral chemotherapy.

Background: Although patients suffer the effects of medical errors and iatrogenic injuries, little is known about their ability to recognize these events in ambulatory specialty care., Methods: At a Boston cancer center in 2004, 193 adult oncology patients treated on a chemotherapy infusion unit were interviewed by four patient safety liaisons--volunteers recruited from the organization's Adult Patient and Family Advisory Council., Results: Among 193 patients, 83 reported 121 incidents. Investigators classified 2 (1%) adverse events, 4 (2%) close calls, 14 (7%) errors without risk of harm, and 101 (52%) service quality incidents. Respondents reported high staff compliance with safe practices such as identity checking (95%). Examining the most serious described by each of 42 (22%) respondents who reported a recent unsafe experience, investigators classified only one adverse event, 3 close calls, 9 harmless errors, and 27 service quality incidents., Discussion: Patients' perception of unsafe care was surprising, given the same patients' recognition of consistent application of safe practices, such as the use of two forms of identification before performing tests and administering treatments. Many ambulatory oncology patients also reported poor service quality. The relationship between patient perception of safe care, medical injury, and service quality merits further study.