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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., In a retrospective longitudinal cohort of 322 887 newly diagnosed patients with breast, colorectal, lung, or prostate cancer, there was increased one‐year mortality among patients who experienced oncology‐specific claims‐based triggers compared to patients without triggers. Increased mortality was observed across all cancer types, stratified by metastatic status, in unadjusted and multivariate analyses.

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., A claims‐based trigger tool was developed to identify potential adverse events and medical errors among 320 000 patients with breast, colorectal, lung, and prostate cancers. During an initial year of therapy, cancer‐specific trigger events affected 19% of patients and 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.

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.

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.

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.

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.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.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.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.

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

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.

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.

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.

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.

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]; PP = .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: 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.

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.

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.

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 wereyoungerthan60yearsofage,werenonwhite,didnotspeak 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.

Objective To develop a patient safety culture instrument for use in Chinese hospitals, we assessed the appropriateness of existing safety culture questionnaires used in the USA and Japan for Chinese respondents and identified new items and domains suitable to Chinese hospitals. Design Focus group study. Setting and participants Twenty-four physicians, nurses and other health-care workers from 11 hospitals in three Chinese cities. Methods Three focus groups were conducted in 2010 to elicit information from hospital workers about their perceptions of the appropriateness and importance of each of 97 questionnaire items, derived from a literature review and an expert panel, characterizing hospital safety culture. Results Participants understood the concepts of patient safety and safety culture and identified features associated with safe care. They judged that numerous questions from existing surveys were inappropriate, including 39 items that were dropped because they were judged unimportant, semantically redundant, confusing, ambiguous or inapplicable in Chinese settings. Participants endorsed eight new items and three additional dimensions addressing staff training, mentoring of new hires, compliance with rules and procedures, equipment availability and leadership walk-rounds they judged appropriate to assessing safety culture in Chinese hospitals. This process resulted in a 66-item instrument for testing in cognitive interviews, the next stage of survey development. Conclusions Focus group participants provided important insights into the refinement of existing items and the construction of new items for measuring patient safety culture in Chinese hospitals. This is a necessary first step in producing a culturally appropriate instrument applicable to specific local contexts.

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.

Item does not contain fulltext OBJECTIVE: To understand the extent to which hospitalized patients participate in their care, and the association of patient participation with quality of care and patient safety. DESIGN: Random sample telephone survey and medical record review. SETTING: US acute care hospitals in 2003. PARTICIPANTS: A total of 2025 recently hospitalized adults. MAIN OUTCOME MEASURES: Hospitalized patients reported participation in their own care, assessments of overall quality of care and the presence of adverse events (AEs) in telephone interviews. Physician reviewers rated the severity and preventability of AEs identified by interview and chart review among 788 surveyed patients who also consented to medical record review. RESULTS: Of the 2025 patients surveyed, 99.9% of patients reported positive responses to at least one of seven measures of participation. High participation (use of >4 activities) was strongly associated with patients' favorable ratings of the hospital quality of care (adjusted OR: 5.46, 95% CI: 4.15-7.19). Among the 788 patients with both patient survey and chart review data, there was an inverse relationship between participation and adverse events. In multivariable logistic regression analyses, patients with high participation were half as likely to have at least one adverse event during the admission (adjusted OR = 0.49, 0.31-0.78). CONCLUSIONS: Most hospitalized patients participated in some aspects of their care. Participation was strongly associated with favorable judgments about hospital quality and reduced the risk of experiencing an adverse event. 01 juni 2011

OBJECTIVES Missed and delayed breast cancer diagnoses are major sources of potential harm to patients and medical malpractice liability in the United States. Follow-up of abnormal mammogram results is an essential but challenging component of safe breast care. To explore the value of an inexpensive method to follow up abnormal test results, we examined a paper-based fail-safe system. METHODS We examined a fail-safe system used to follow up abnormal mammograms at a primary care practice at an urban teaching hospital. We analyzed all abnormal mammogram reports and clinicians' responses to follow-up reminders. We characterized potential lapses identified in this system and used regression models to identify patient, provider, and test result characteristics associated with such lapses. RESULTS Clinicians responded to fail-safe reminders for 92% of 948 abnormal mammograms. Clinicians reported that they were unaware of the abnormal result in 8% of cases and that there was no follow-up plan in place for 3% of cases. Clinicians with more years of experience were more likely to be aware of the abnormal result (odds of being unaware per incremental year in practice, 0.92; 95% confidence interval, 0.88-0.97) and were more likely to have a follow-up plan. CONCLUSIONS A paper-based fail-safe system for abnormal mammograms is feasible in a primary care practice. However, special care is warranted to ensure full clinician adherence and address staff transitions and trainee-related issues.

Process of care failures may contribute to diagnostic errors in breast cancer care.To identify patient- and provider-related process of care failures in breast cancer screening and follow-up in a non-claims-based cohort.Retrospective chart review of a cohort of patients referred to two Boston cancer centers with new breast cancer diagnoses between January 1, 1999 and December 31, 2004.We identified 2,275 women who reportedor =90 days between symptom onset and breast cancer diagnosis or presentation with at least stage II disease. We then selected the 340 (14.9%) whose physicians shared an electronic medical record. We excluded 238 subjects whose records were insufficient for review, yielding a final cohort of 102 patients.NoneWe tabulated the number and types of process of care failures and examined risk factors using bivariate analyses and multivariable Poisson regression.Twenty-six of 102 patients experiencedor =1 process of care failure. The most common failures occurred when physicians failed to perform an adequate physical examination, when patients failed to seek care, and when diagnostic or laboratory tests were ordered but patients failed to complete them. Failures were attributed in similar numbers to provider- and patient-related factors (n = 30 vs. n = 25, respectively). Process of care failures were more likely when the patient's primary care physician was male (IRR 2.8, 95% CI 1.2 to 6.5) and when the patient was non-white (IRR 2.8, 95% CI 1.4 to 5.7).Process failures were common in this patient cohort, with both clinicians and patients contributing to breakdowns in the diagnostic process.

Article-at-a-Glance 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 campaign was 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 follow-up, 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.

Background: Efforts to enhance patient-physician communication may improve management of underdiagnosed chronic conditions. Patient internet portals offer an efficient venue for coaching patients to discuss chronic conditions with their primary care physicians (PCP). Objectives: We sought to test the effectiveness of an internet portal-based coaching intervention to promote patient-PCP discussion about chronic conditions. Research Design: We conducted a randomized trial of a nurse coach intervention conducted entirely through a patient internet portal. Subjects: Two hundred forty-one patients who were registered portal users with scheduled PCP appointments were screened through the portal for 3 target conditions, depression, chronic pain, mobility difficulty, and randomized to intervention and control groups. Measures: One-week and 3-month patient surveys assessed visit experiences, target conditions, and quality of life; chart abstractions assessed diagnosis and management during PCP visit. Results: Similar high percentages of intervention (85%) and control (80%) participants reported discussing their screened condition during their PCP visit. More intervention than control patients reported their PCP gave them specific advice about their health (94% vs. 84%; P = 0.03) and referred them to a specialist (51% vs. 28%; P + 0.002). Intervention participants reported somewhat higher satisfaction than controls (P = 0.07). Results showed no differences in detection or management of screened conditions, symptom ratings, and quality of life between groups. Conclusions: Internet portal-based coaching produced some possible benefits in care for chronic conditions but without significantly changing patient outcomes. Limited sample sizes may have contributed to insignificant findings. Further research should explore ways internet portals may improve patient outcomes in primary care.

Article-at-a-Glance Background A two-stage probability sample of patients recently discharged from 16 general acute care hospitals in Massachusetts were interviewed to determine the rates at which patients experience what they considered to be adverse events, to describe the kinds of events they reported, and to identify the correlates of those reports. Methods Eligible respondents were adults, 18 years of age or older, who were medical or surgical patients overnight or longer between April 1 and October 1, 2003, and who were discharged to their homes in Massachusetts. Questions covered perceptions of adverse events during hospitalizations and possible correlates of those events. Telephone interviews were carried out an average of nine months after discharge with 2,582 patients (response rate, 53%–60%). Results Twenty-nine percent of respondents reported at least one unexpected "negative" event during their hospitalization. After physician review, the revised estimate was that 25% perceived that they had experienced at least one event that met our definition for an adverse event. The most common reported events were reactions to newly prescribed drugs (40%) and the effects of surgery (34%). Physician reviewers coded 57% of the adverse events as "significant" and 18% as "serious" or "life-threatening." The physician reviewers also rated 31% of the reported adverse events as likely to be preventable. Discussion The estimate that one in four hospital patients experienced an adverse event is considerably higher than the published rates based on hospital record review, indicating the potential value of surveys for studies of patient safety. Because of nonresponse among older patients, that estimate is probably an underestimate. Designs that would reduce lags between discharge and interviews and decrease hospital nonresponses would reduce two key threats to confidence in the survey results.

Background Patient Internet portals have created new opportunities for assessment and management of chronic conditions. Objective To conduct an online screening survey for a study recruitment using a secure patient Internet portal to identify primary care patients with untreated depression, chronic pain, or mobility difficulty before nonurgent office visits. Design Internet-based screening survey for a randomized trial. Participants Patients who were registered portal users who had scheduled primary care appointments. Approach Electronic study invitations via the portal were sent to 4,047 patients with scheduled visits to 34 primary care physicians participating in the study. After clicking on a link in the study invitation, patients were consecutively shown the study description, consent form, and lastly, the screening survey to determine final eligibility for study participation. Results Of the 2,113 (52%) patients who opened the study invitation, 1,001 consented online to join the study and 981 (98%) of these completed the screening survey. Of the respondents, 319 (33%) screened positive for 1 or more of the 3 conditions. Conclusions The online screening survey conducted through the patient portal was effective in identifying patients with chronic conditions in advance of scheduled primary care visits for participation in an intervention study.

Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies.We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two.Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28 percent) were ameliorable, and 20 (11 percent) were preventable. Of the 51 ameliorable events, 32 (63 percent) were attributed to the physician's failure to respond to medication-related symptoms and 19 (37 percent) to the patient's failure to inform the physician of the symptoms. The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting-enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events.Adverse events related to drugs are common in primary care, and many are preventable or ameliorable. Monitoring for and acting on symptoms are important. Improving communication between outpatients and providers may help prevent adverse events related to drugs.

Although there is extensive evidence on disparities in the process and outcomes of health care, data on racial and ethnic disparities in patient safety remain inconclusive in the United States.The aims of this study were to (1) explore differences in reporting race/ethnicity in studies on disparities in patient safety; (2) assess adjustment for socioeconomic status, comorbidity, and disease severity; and (3) make recommendations on the inclusion of race/ethnicity for future studies on adverse events.We searched PubMed database (for articles published from 1991 to May 1, 2013) using a predetermined criteria for studies on racial and ethnic disparities in patient safety. Only quantitative studies that used chart review or administrative data for the detection of adverse events were considered for eligibility. Two reviewers independently extracted data on inclusion of race/ethnicity in baseline characteristics and in stratification of outcomes.A total of 174 studies were initially obtained from the search. Of these, 24 met inclusion criteria and received full-text review. Meta-analysis was not performed because of the methodological and statistical heterogeneity between studies. Eight studies included race/ethnicity in baseline characteristics and adjusted for confounders. Hospital-level variations such teaching status and percentage of minorities served were infrequently analyzed.To our knowledge, this is the first methodological review of racial/ethnic disparities in patient safety in the United States. The evidence on the existence of disparities in adverse events was mixed. Poor stratification of outcomes by race/ethnicity and consideration of geographic and hospital-level variations explain the inconclusive evidence; variations in the quality of care at hospitals should be considered in studies using national databases.

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.

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.

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.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.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.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.

Item does not contain fulltext BACKGROUND: Evidence suggests that patients can report a variety of adverse events (AEs) not captured by traditional methods such as a chart review. Little is known, however, about whether patient reports are useful for measuring patient safety. OBJECTIVES: To examine the degree to which physician reviewers agreed that patient reports of "negative effects" constituted AEs, and to identify questionnaire items that affected reviewers' judgments. METHODS: We surveyed patients discharged from Massachusetts hospitals in 2003 to elicit information about negative effects associated with hospitalization. Physician reviewers judged whether patient-reported negative effects represented AEs, and classified the severity of the event. Likelihood ratios were calculated to assess whether patient responses to questionnaire items affected reviewers' judgments. RESULTS: Of the 2582 patients surveyed, 753 patients reported 1170 negative effects, and 71.2% of these effects were classified as AEs by physician reviewers. Negative effects most likely to be classified as AEs involved newly prescribed medications and changes to previously prescribed medications. Additional information elicited from follow-up survey questions modestly affected reviewers' classification of serious AEs. Negative effects reported by women, younger patients, those reporting better health status, and those not admitted through the emergency department were more likely to be classified as AEs. CONCLUSIONS: Many patients were able to identify care-related AEs. Patient responses to questions about the sequelae of the events provided limited additional information for physicians to use in gauging the presence and severity of the event. Patient reports complement other incident-detection methods by providing information that is credible and unavailable from other sources. 01 oktober 2011

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 Little is known about how the characteristics of adverse events (AEs) affect the likelihood of disclosure or how the disclosure of an AE relates to patients' perception of quality of care. Methods The study included a random sample of medical and surgical acute care adult patients in Massachusetts hospitals between April 1 and October 1, 2003. The unit of analysis was the AE, and multivariable regression analyses accounted for clustering at the patient level. Results Overall, 603 patients reported 845 AEs, and 40% of AEs were disclosed. The AEs that required additional treatment (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.16-2.32) or affected patients who reported good health (OR, 2.04; 95% CI, 1.29-3.24) were more likely to be disclosed. Disclosure was less likely if the events were preventable (OR, 0.58; 95% CI, 0.41-0.83) or if the patients were still affected by the AE at the time of survey (OR, 0.49; 95% CI, 0.31-0.78). Higher-quality ratings were associated with disclosure (OR, 2.04; 95% CI, 1.39-2.99) of preventable and nonpreventable events and with patients who felt that they were able to protect themselves from AEs (OR, 1.98; 95% CI, 1.21-3.24). Lower-quality ratings were associated with events that were preventable (OR, 0.55; 95% CI, 0.40-0.76), with events that caused increased discomfort (OR, 0.62; 95% CI, 0.46-0.86), or with events that still adversely affected the patient at the time of the survey (OR, 0.68; 95% CI, 0.46-0.98). Conclusions Rates of disclosure of AEs by medical personnel remain low in hospitalized patients. Disclosure of some of these events is associated with higher ratings of quality by patients.

Electronic prescribing systems with decision support may improve patient safety in ambulatory care by offering drug allergy and drug interaction alerts. However, preliminary studies show that clinicians override most of these alerts.We performed a retrospective analysis of 233 537 medication safety alerts generated by 2872 clinicians in Massachusetts, New Jersey, and Pennsylvania who used a common electronic prescribing system from January 1, 2006, through September 30, 2006. We used multivariate techniques to examine factors associated with alert acceptance.A total of 6.6% of electronic prescription attempts generated alerts. Clinicians accepted 9.2% of drug interaction alerts and 23.0% of allergy alerts. High-severity interactions accounted for most alerts (61.6%); clinicians accepted high-severity alerts slightly more often than moderate- or low-severity interaction alerts (10.4%, 7.3%, and 7.1%, respectively; P.001). Clinicians accepted 2.2% to 43.1% of high-severity interaction alerts, depending on the classes of interacting medications. In multivariable analyses, we found no difference in alert acceptance among clinicians of different specialties (P = .16). Clinicians were less likely to accept a drug interaction alert if the patient had previously received the alerted medication (odds ratio, 0.03; 95% confidence interval, 0.03-0.03).Clinicians override most medication alerts, suggesting that current medication safety alerts may be inadequate to protect patient safety.

Hospitals routinely survey patients about the quality of care they receive, but little is known about whether patient interviews can detect adverse events that medical record reviews do not.To compare adverse events reported in postdischarge patient interviews with adverse events detected by medical record review.Random sample survey.Massachusetts, 2003.Recently hospitalized adults.By using parallel methods, physicians reviewed postdischarge interviews and medical records to classify hospital adverse events.Among 998 study patients, 23% had at least 1 adverse event detected by an interview and 11% had at least 1 adverse event identified by record review. The kappa statistic showed relatively poor agreement between interviews and medical records for occurrence of any type of adverse event (kappa = 0.20 [95% CI, 0.03 to 0.27]) and somewhat better agreement between interviews and medical records for life-threatening or serious events (kappa = 0.33 [CI, 0.20 to 0.45]). Record review identified 11 serious, preventable events (1.1% of patients). Interviews identified an additional 21 serious and preventable events that were not documented in the medical record, including 12 predischarge events and 9 postdischarge events, in which symptoms occurred after the patient left the hospital.Patients had to be healthy enough to be interviewed. Delay in reaching patients (6 to 12 months after discharge) may have resulted in poor recall of events during the hospital stay.Patients report many events that are not documented in the medical record; some are serious and preventable. Hospitals should consider monitoring patient safety by adding questions about adverse events to postdischarge interviews.

Service quality deficiencies are common in health care. However, little is known about the relationship between service quality and the occurrence of adverse events and medical errors. We hypothesized that patients who reported poor service quality were at increased risk of experiencing adverse events and medical errors.Patients were interviewed during and after their admissions regarding problems experienced during the hospitalizations. We used this information to identify service quality deficiencies. We then performed a blinded, retrospective chart review to independently identify adverse events and errors. We used multivariable methods to analyze whether patients who reported service quality deficiencies (obtained by patient report) experienced any adverse event, close call, or low risk error (ascertained by chart review).The 228 participants (mean age 63 years, 37% male) reported 183 service quality deficiencies. Of the 52 incidents identified on chart review, patients experienced 34 adverse events, 11 close calls, and 7 low risk errors. The presence of any service quality deficiency more than doubled the odds of any adverse event, close call, or low risk error (adjusted odds ratio = 2.5; 95% confidence interval = 1.2-5.4). Service quality deficiencies involving poor coordination of care (adjusted odds ratio = 4.4; 95% confidence interval = 1.4-14.0) were associated with the occurrence of adverse events and medical errors.Patient-reported service quality deficiencies were associated with adverse events and medical errors. Patients who report service quality incidents may help to identify patient safety hazards.

Objective Communication failures account for many adverse drug events (ADEs) in adult primary care. Improving patient–physician communication may improve medication safety. Accordingly, the goal of this study was to learn whether electronic medication safety messages directed to patients can improve communication about medications and identify ADEs. Design We studied adult patients enrolled in a patient Internet portal at three primary care practices affiliated with a teaching hospital. MedCheck, a medication safety application, sent patients a secure electronic message 10 days after they received a new or changed prescription. MedCheck asked if the patient had filled the prescription or experienced medication-related problems, and then forwarded the patient's response to their primary care physician. Measurements We selected a stratified random sample of 267 subjects from 1821 patients who received and opened a MedCheck message from April 2001 to June 2002. We reviewed subjects’ medical records for three months following their first MedCheck message. We analyzed patient and clinician response rates and times, examined patient–clinician communication about medications, and identified ADEs. Results Patients opened 79% of MedCheck messages and responded to 12%; 77% responded within 1 day. Patients often identified problems filling their prescriptions (48%), problems with drug effectiveness (12%), and medication symptoms (10%). Clinicians responded to 68% of patients’ messages; 93% answered within 1 week. Clinicians often supplied or requested information (19%), or made multiple recommendations (15%). Patients experienced 21 total ADEs; they reported 17 electronically. Conclusion Patients and physicians responded promptly to patient-directed electronic medication messages, identifying and addressing medication-related problems including ADEs.

Purpose. Service quality, defined as patients’ self-reported experience of care, is used as a metric for evaluating quality. Most studies rely on retrospective consumer surveys rather then more intensive data collection methods, possibly underestimating the incidence of service quality incidents. Subjects and Methods. The objective of the study was to characterize patient-reported service quality deficiencies on a general medicine unit. We studied a cohort of 228 adult inpatients at a Boston teaching hospital. Investigators reviewed medical records and interviewed patients during the hospitalization and by telephone after discharge. Physician investigators classified patients’ incident reports. We calculated the rate of service incidents, characterized incident types, and used multivariable Poisson and logistic regression models to examine factors associated with patient reporting and overall rating of the hospitalization. Results. Eighty-eight (38.6%) of 228 patients experienced 157 service quality incidents during the admission, for a rate of 68.9 incidents per 100 admissions. The most common service quality problems involved waits and delays (n = 45), problems with communication between staff and patients (n = 36), and environmental issues and amenities (n = 35). In the multivariable analysis, men (IRR 1.6, 95% CI 1.1–2.2), patients covered by hospitalists (1.5, 1.1–2.2), and patients with more medication allergies (1.1 per allergy, 1.1–1.2) reported more service incidents; patients with Medicaid or free care reported fewer (0.5, 0.3–0.9). Patients with service quality incidents were more likely to describe the hospitalization as other than excellent (adjusted OR 1.8 per incident, 95% CI 1.3–2.5). Conclusion. Service quality deficiencies are common among medical inpatients, and are strongly associated with patients’ dissatisfaction with the hospitalization

Little is known about how well hospitalized patients can identify errors or injuries in their care. Accordingly, the purpose of this study was to elicit incident reports from hospital inpatients in order to identify and characterize adverse events and near-miss errors.We conducted a prospective cohort study of 228 adult inpatients on a medicine unit of a Boston teaching hospital.Investigators reviewed medical records and interviewed patients during the hospitalization and by telephone 10 days after discharge about "problems,""mistakes," and "injuries" that occurred. Physician investigators classified patients' reports. We calculated event rates and used multivariable Poisson regression models to examine the factors associated with patient-reported events.Of 264 eligible patients, 228 (86%) agreed to participate and completed 528 interviews. Seventeen patients (8%) experienced 20 adverse events; 1 was serious. Eight patients (4%) experienced 13 near misses; 5 were serious or life threatening. Eleven (55%) of 20 adverse events and 4 (31%) of 13 near misses were documented in the medical record, but none were found in the hospital incident reporting system. Patients with 3 or more drug allergies were more likely to report errors compared with patients without drug allergies (incidence rate ratio 4.7, 95% CI 1.7, 13.4).Inpatients can identify adverse events affecting their care. Many patient-identified events are not captured by the hospital incident reporting system or recorded in the medical record. Engaging hospitalized patients as partners in identifying medical errors and injuries is a potentially promising approach for enhancing patient safety.

Medication errors are common among inpatients and many are preventable with computerized prescribing. Relatively little is known about outpatient prescribing errors or the impact of computerized prescribing in this setting.To assess the rates, types, and severity of outpatient prescribing errors and understand the potential impact of computerized prescribing.Prospective cohort study in 4 adult primary care practices in Boston using prescription review, patient survey, and chart review to identify medication errors, potential adverse drug events (ADEs) and preventable ADEs.Outpatients over age 18 who received a prescription from 24 participating physicians.We screened 1879 prescriptions from 1202 patients, and completed 661 surveys (response rate 55%). Of the prescriptions, 143 (7.6%; 95% confidence interval (CI) 6.4% to 8.8%) contained a prescribing error. Three errors led to preventable ADEs and 62 (43%; 3% of all prescriptions) had potential for patient injury (potential ADEs); 1 was potentially life-threatening (2%) and 15 were serious (24%). Errors in frequency (n=77, 54%) and dose (n=26, 18%) were common. The rates of medication errors and potential ADEs were not significantly different at basic computerized prescribing sites (4.3% vs 11.0%, P=.31; 2.6% vs 4.0%, P=.16) compared to handwritten sites. Advanced checks (including dose and frequency checking) could have prevented 95% of potential ADEs.Prescribing errors occurred in 7.6% of outpatient prescriptions and many could have harmed patients. Basic computerized prescribing systems may not be adequate to reduce errors. More advanced systems with dose and frequency checking are likely needed to prevent potentially harmful errors.

Purpose Resident physicians learn to perform inpatient bedside procedures in a manner that is neither standardized nor rigorous. As a result, residents may be unskilled and uncomfortable performing procedures. This study characterizes residents' comfort performing medical procedures and identifies factors associated with lack of comfort. Subjects Study subjects were internal medicine resident physicians who performed one of four medical procedures (central line, lumbar puncture, paracentesis, or thoracentesis) on adult medical inpatients between July 1, 2003, and June 30, 2004. Methods This prospective cohort study was conducted at a 556-bed Boston teaching hospital. Resident physicians evaluated their comfort with 9 aspects of 4 medical procedures, recording this information in an electronic log. We also abstracted operator characteristics and patient demographic data. We analyzed residents' comfort with each aspect of the procedure and defined "overall comfort" as comfort with each of the 9 aspects. Results A majority of resident physicians reported lack of comfort with at least one aspect of the procedure. Residents reported lack of comfort with 37% of unsupervised procedures. They also reported lack of comfort with the prospect of managing complications in 35% of procedures. In the multivariable analysis, overall comfort was associated with the use of a dedicated medical procedure service (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.1-3.4) and inversely associated with postgraduate year 1 status (OR 0.3, CI 0.1-0.5), first time performing the procedure (OR 0.4, CI 0.2-0.8), thoracenteses (OR 0.4, CI 0.2-0.8), and emergent procedures (OR 0.6, CI 0.3-1.0). Conclusions Many resident physicians are uncomfortable performing common bedside procedures. Experience and supervision mitigate some, but not all, discomfort.

PURPOSE: Patients' knowledge of the indications of their prescription medications was studied and those medications that were most likely to be taken without patients understanding the correct indication were identified. METHODS: Adult patients who received care at four primary care practices were surveyed. Patients were eligible to participate if they were over 18 years old and had received a prescription from a participating physician at a clinic visit. Patients were telephoned and asked to retrieve the bottles of all medications they were currently taking, identify their medications, and state the reason they took each medicine. The primary outcome was absent or incorrect knowledge of a drug's indication. RESULTS: A total of 2340 prescription medications were used by the 616 patients whose data were analyzed. Eighty-three patients (13.5%) lacked knowledge of the indication for at least one of their prescription medications. They did not know the indication for 148 medications (6.3%). After multivariable adjustment, lack of knowledge was more common for cardiovascular drugs (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.03-2.19) and less common for diabetes medications (OR, 0.37; 95% CI, 0.16-0.84) and analgesics (OR, 0.23; 95% CI, 0.05-1.01) compared with all other medications, and more common if the patient taking these medications was older, black, or had a high school education or less. CONCLUSION: More than 13% of patients in primary care practices did not know the indication of at least one of their prescription medications. Lack of knowledge was most prevalent for cardiovascular medications.

Background. Patient safety ‘best practices’ that call for patient participation to prevent adverse drug events have not been rigorously evaluated. Objective. To consider lessons learned from a patient partnership intervention to prevent adverse drug events among medical in-patients. Design. Prospective randomized, controlled pilot trial. Setting. Boston teaching hospital. Patients. Two hundred and nine adult in-patients on a general medicine unit. Intervention. Intervention patients ( n = 107) received drug safety information and their medication list; controls ( n = 102) received drug safety information only. Measurements. Adverse drug events and close-call drug errors were identified using chart review and incident reports from nurses, pharmacists, and physicians. Patients and clinicians were surveyed about the intervention. Results. In 1053 patient-days at risk, 11 patients experienced 12 adverse drug events and 16 patients experienced 18 close calls. There was a non-significant difference between intervention patients and controls in survey responses and in the adverse drug event rate (8.4% versus 2.9%, P = 0.12) and close-call rate (7.5% versus 9.8%, P = 0.57). Eleven percent of patients were aware of drug-related mistakes during the hospitalization. Among nurse respondents, 29% indicated that at least one medication error was prevented when a patient or family member identified a problem. Conclusion. Partnering with in-patients to prevent adverse drug events is a promising strategy but requires further study to document its efficacy.

Little is known about the prevalence and character of medication-related symptoms in primary care and their relationship to adverse drug events (ADEs) or about factors that affect patient-physician communication regarding medication symptoms.The study included 661 patients who received prescriptions from physicians at 4 adult primary care practices. We interviewed patients 2 weeks and 3 months after the index visit, reviewed patients' medical records, and surveyed physicians whose patients identified medication-related symptoms. Physician reviewers determined whether medication symptoms constituted true ADEs. We used multivariable regression to examine factors associated with patients' decision to discuss symptoms with a physician and with physicians' decision to alter therapy.A total of 179 patients identified 286 medication-related symptoms but discussed only 196 (69%) with their physicians. Physicians changed therapy in response to 76% of reported symptoms. Patients' failure to discuss 90 medication symptoms resulted in 19 (21%) ameliorable and 2 (2%) preventable ADEs. Physicians' failure to change therapy in 48 cases resulted in 31 (65%) ameliorable ADEs. In multivariable analyses, patients who took more medications (odds ratio [OR] = 1.06; 95% confidence interval [CI] = 1.04-1.08; P.001) and had multiple medication allergies (OR = 1.07; 95% CI = 1.03-1.11; P = .001) were more likely to discuss symptoms. Male physicians (OR = 1.20, 95% CI = 1.09-1.26; P = .002) and physicians at 2 practices were more likely to change therapy (OR = 1.24; 95% CI = 1.17-1.28; P.001; and OR = 1.17; 95% CI = 1.08-1.24; P = .002).Primary care physicians may be able to reduce the duration and/or the severity of many ADEs by eliciting and addressing patients' medication symptoms.

Background Although computerized physician order entry reduces medication errors among inpatients, little is known about the use of this system in primary care. Methods We calculated the override rate among 3481 consecutive alerts generated at 5 adult primary care practices that use a common computerized physician order entry system for prescription writing. For detailed review, we selected a random sample of 67 alerts in which physicians did not prescribe an alerted medication and 122 alerts that resulted in a written prescription. We identified factors associated with the physicians' decisions to override a medication alert, and determined whether an adverse drug event (ADE) occurred. Results Physicians overrode 91.2% of drug allergy and 89.4% of high-severity drug interaction alerts. In the multivariable analysis using the medical chart review sample (n = 189), physicians were less likely to prescribe an alerted medication if the prescriber was a house officer (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.08-0.84) and if the patient had many drug allergies (OR, 0.70; 95% CI, 0.53-0.93). They were more likely to override alerts for renewals compared with new prescriptions (OR, 17.74; 95% CI, 5.60-56.18). We found no ADEs in cases where physicians observed the alert and 3 ADEs among patients with alert overrides, a nonsignificant difference (P= .55). Physician reviewers judged that 36.5% of the alerts were inappropriate. Conclusions Few physicians changed their prescription in response to a drug allergy or interaction alert, and there were few ADEs, suggesting that the threshold for alerting was set too low. Computerized physician order entry systems should suppress alerts for renewals of medication combinations that patients currently tolerate.