Risk Factors for Adverse Events in Patients With Breast, Colorectal, and Lung Cancer.

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.

Facts and Fears in Public Reporting: Patients' Information Needs and Priorities When Selecting a Hospital for Cancer Care.

Objective. Public reporting on the quality of provider care has the potential to empower patients to make evidence-based decisions. Yet patients seldom consult resources such as provider report cards in part because they perceive the information as irrelevant. To inform more effective public reporting, we investigated patients' information priorities when selecting a hospital for cancer treatment. We hypothesized that patients would be most interested in data on clinical outcomes. Methods. An experienced moderator led a series of focus groups using a semistructured discussion guide. Separate sessions were held with patients aged 18 to 54 years and those older than 54 years in Philadelphia, Pennsylvania; Phoenix, Arizona; and Indianapolis, Indiana, in 2017. All 38 participants had received treatment for cancer within the past 2 years and had a choice of hospitals. Results. In selecting hospitals for cancer treatment, many participants reported that they considered factors such as reputation, quality of the facilities, and experiences of other patients. For most, however, decisions were guided by trusted advisors, with the majority agreeing that a physician's opinion would sway them to disregard objective data about hospital quality. Nonetheless, nearly all expressed interest in having comparative data. Participants varied in selecting from a hypothetical list, "the top 3 things you would want to know when choosing a hospital for cancer care." The most commonly preferred items were overall care quality, timeliness, and patient satisfaction. Contrary to our hypothesis, many preferred to avoid viewing comparative clinical outcomes, particularly survival. Conclusions. Patients' information preferences are diverse. Fear or other emotional responses might deter patients from viewing outcomes data such as survival. Additional research should explore optimal ways to help patients incorporate comparative data on the components of quality they value into decision making.

Automating Treatment Summary Development Using Electronic Billing Information: A Pilot Study of Survivors of Head and Neck Cancer.

PURPOSE: Although the provision of a treatment summary (TS) is a quality indicator in oncology, routine delivery of TSs remains challenging. Automatic TS generation could facilitate use, but data on accuracy are lacking in complex cancers such as head and neck cancer (HNC). We developed and evaluated an electronic platform to automate TS generation for HNC. METHODS: The algorithms autopopulated TSs using data from billing records and an institutional cancer registry. A nurse practitioner used the medical record to verify the accuracy of the information and made corrections electronically. Inaccurate and missing data were considered errors. We described and investigated reasons for errors in the automatically generated TSs. RESULTS: We enrolled a heterogeneous population of 43 survivors of HNC. Using billing data, the information on primary site, lymph node status, radiation, and chemotherapy use was accurate in 93%, 95%, 93%, and 95% of patients, respectively. Billing data captured surgery accurately in 77% of patients; once an omitted billing code was identified, accuracy increased to 98%. Chemotherapies were captured in 90% of patients. Using the cancer registry, month and year of diagnosis were accurate in 91% of cases; stage was accurate in 28% of cases. Reprogramming the algorithm to ascertain clinical stage when pathologic stage was unavailable resulted in 100% accuracy. The algorithms inconsistently identified radiation receipt and treating physicians from billing data. CONCLUSION: It is feasible to automatically and accurately generate most components of TSs for HNC using billing and cancer registry data, although clinical review is necessary in some cases.

Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer.

PURPOSE: To improve the care of survivors of head and neck cancer, we developed the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR). HN-STAR is an electronic platform that incorporates patient-reported outcomes into a clinical decision support tool for use at a survivorship visit. Selections in the clinical decision support tool automatically populate a survivorship care plan (SCP). We aimed to refine HN-STAR by eliciting and incorporating feedback on its ease of use and usefulness. METHODS: Human-computer interaction (HCI) experts reviewed HN-STAR using think-aloud testing and the Nielsen Heuristic Checklist. Nurse practitioners (NPs) thought aloud while reviewing the clinical decision support tool and SCP and responded to an interview. Survivors used HN-STAR as part of a routine visit and were interviewed afterward. We analyzed themes from the feedback. We described how we addressed each theme to improve the usability of HN-STAR. RESULTS: Five HCI experts, 10 NPs, and 10 cancer survivors provided complementary usability insight that we categorized into themes of improvements. For ease of use, themes included technical design considerations to enhance user interface, ease of completion of a self-assessment, streamlining text, disruption of the clinic visit, and threshold for symptoms to appear on the SCP. The theme addressing usefulness was efficiency and comprehensiveness of the clinic visit. For each theme, we report revisions to HN-STAR in response to the feedback. CONCLUSION: HCI experts provided key technical design insights into HN-STAR, whereas NPs and survivors provided usability feedback and clinical perspectives. We incorporated the feedback into the preparation for additional testing of HN-STAR. This method can inform and improve the ease of use and usefulness of the survivorship applications.

Preventable and mitigable adverse events in cancer care: Measuring risk and harm across the continuum.

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.

Peers without fears? Barriers to effective communication among primary care physicians and oncologists about diagnostic delays in cancer.

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.

Performance of a Trigger Tool for Identifying Adverse Events in Oncology.

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.

A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study.

BACKGROUND: Head and neck cancer survivors commonly experience severe long-term toxicities, late-occurring symptoms, and significant risks of the second primary malignancy and comorbid illnesses. With multiple simultaneous health issues, these complex cancer survivors often do not receive comprehensive health care that addresses their needs. A tool is needed to streamline and standardize comprehensive care for this cohort. METHODS/DESIGN: We designed the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) to address health care challenges for head and neck cancer survivors. HN-STAR is an electronic platform that aims to simplify the provision of personalized care in cancer survivorship clinics. It uses an algorithmic approach to integrate patient-reported outcomes, clinical details, and evidence-based guidelines to standardize comprehensive care provided in routine survivorship visits. It has four integrated components: (1) a simplified treatment summary, which pulls treatment details from a clinical database or can be completed manually using a streamlined form; (2) an online self-assessment for patients to report their own symptoms; (3) an interactive discussion guide presenting all relevant information to the provider during the clinic visit; and (4) a survivorship care plan generated at the end of each visit that reflects decisions made during the visit. By using a modifiable electronic platform, HN-STAR provides a method for incorporating survivorship care plans into clinical practice and for disseminating evidence on symptom management and preventive care. This is a study to assess the feasibility of a future multi-site, randomized clinical trial of HN-STAR. We will enroll head and neck cancer survivors who are followed in one of two nurse practitioner-led survivorship clinics. We will implement HN-STAR for one routine survivorship visits. We will assess (1) usability and feasibility outcomes of HN-STAR from the perspective of key stakeholders and (2) the planned outcomes intended for the larger trial. We will collect usability and feasibility data from online surveys of survivors and their providers. Our findings will inform whether it is feasible to advance HN-STAR to trial. If so, we will adapt HN-STAR and the study design of the trial in response to feedback from survivors and providers. The long-term goal is to determine if such an intervention will lead to improved and simplified comprehensive survivorship care. DISCUSSION: This feasibility study will evaluate implementation of HN-STAR into clinical practice in terms of usability, practicality, and clinical flow in two distinct clinical settings. This study will also provide critical baseline data to characterize this vulnerable population. Findings from this study will inform a multicenter randomized trial of HN-STAR, aimed at standardizing and streamlining the delivery of evidence-guided comprehensive care for head and neck cancer survivors. Ultimately, if found effective, the modular structure of HN-STAR could permit its expansion to survivors of other complex cancers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02571673.

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records.

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.