SAUL N. WEINGART, MARIA TOTH, JONATHAN ENEMAN, MARK D. ARONSON, DANIEL Z. SANDS, AMY N. SHIP, ROGER B. DAVIS, RUSSELL S. PHILLIPS, Lessons from a patient partnership intervention to prevent adverse drug events, International Journal for Quality in Health Care, Vol. 16, No. 6 (December 2004), pp. 499-507

Background: Identifying adverse events and near misses is essential to improving safety in the health care system. Patients are capable of reliably identifying and reporting adverse events. The effect of a patient safety reporting system used by families of pediatric inpatients on reporting of adverse events by health care providers has not previously been investigated. Methods: Between Nov. 1, 2008, and Nov. 30, 2009, families of children discharged from a single ward of British Columbia’s Children’s Hospital were asked to respond to a questionnaire about adverse events and near misses during the hospital stay. Rates of reporting by health care providers for this period were compared with rates for the previous year. Family reports for specific incidents were matched with reports by health care providers to determine overlap. Results: A total of 544 familes responded to the questionnaire. The estimated absolute increase in reports by health care providers per 100 admissions was 0.5% (95% confidence interval −1.8% to 2.7%). A total of 321 events were identified in 201 of the 544 family reports. Of these, 153 (48%) were determined to represent legitimate patient safety concerns. Only 8 (2.5%) of the adverse events reported by families were also reported by health care providers. Interpretation: The introduction of a family-based system for reporting adverse events involving pediatric inpatients, administered at the time of discharge, did not change rates of reporting of adverse events and near misses by health care providers. Most reports submitted by families were not duplicated in the reporting system for health care providers, which suggests that families and staff members view safety-related events differently. However, almost half of the family reports represented legitimate patient safety concerns. Families appeared capable of providing valuable information for improving the safety of pediatric inpatients. See related commentary by Vincent and Davis on page [15][1] and at [www.cmaj.ca/lookup/doi/10.1503/cmaj.111311][2] [1]: /lookup/volpage/184/15 [2]: http://www.cmaj.ca/lookup/doi/10.1503/cmaj.111311

Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.

You are a Registered Nurse working in a busy oncology unit. While assessing one of your patients, you notice that the bag of morphine used in his patient-controlled analgesia (PCA) system is running low.

Governments, payers, and other stakeholders are promoting or even demanding expanded access to care, greater coordination of care, use of health information technology--and maximization of the value, efficiency, reliability, quality, and safety of care, often without increased revenue. An all-new edition of a bestseller, this book provides detailed strategies to help leaders and their organizations address these critical challenges in a changing health care environment. Top experts, including David Bates (Brigham and Women's Hospital), Paul Convery (Baylor Health Care System), and Peter Pronovost and colleagues (Johns Hopkins University), survey current knowledge, describe case studies, and provide invaluable advice on the following urgent topics: * Balancing systems-based solutions and accountability in a safety culture * Identifying and responding to patient safety problems * Training physician and nursing leaders for performance improvement * Engaging patients in patient safety * Ensuring safe, effective, and efficient use of health information technology * Improving management of chronic disease * Implementing, sustaining, and spreading improvement Special Features: * Foreword by world-quality and safety expert Ross Wilson, M.D. * Key messages for a leaders--a global audience of chief executive officers, chief medical officers, chief operations officers, and other health care executives; quality and safety officers; and other clinical leaders--in hospitals, health systems, and other health care settings * Authoritative tutorials on current literature and experience and what's next on the horizon * Detailed case studies of best practices

Medical Interns’ Perceptions about Disclosing Medical Errors

The objective of this study was to find out the barriers of sentinel events reporting at tertiary hospital and then formulate recommendations to ameliorate based the findings of this study. The study was carried out in 2015 and conducted as two parts; the first part is a retrospective data, review of Occurrence Variance Reports forms according to the reporter. The second part was through self-administered questionnaires, which was randomly distributed to the hospital staff. A total of 120 completed questionnaires out of 135 were received.  In this study, we found that the commonest reasons that prevent the hospital staff from reporting the sentinel events are poor communication of policy and procedure of sentinel events reporting, lack of motivation among the staff to report sentinel events in 28 % and 26 % respectively. Staff fear of punitive actions from the hospital administration was rated as the first and second priority reason in preventing employee reporting sentinel events in about half of the cases. No feedback from reporting sentinel events was the reason for underreporting in about one fifth. Sentinel events definition was not clear and sentinel cases reporting form was not available in 14 % and 15 % respectively. This study highlights the common factors that may contribute to under-reporting of sentinel events in tertiary hospital. The findings may be useful in formulating beneficial strategies to improve reporting which will have great value on quality of care and patient safety.

Nature Medicine - The phase 3 CAPRI clinical trial evaluating the impact of a digital nurse navigator-led system in patients receiving oral anticancer treatment shows that remote monitoring using a...

Among all types of medical errors, cases in which the wrong patient undergoes an invasive procedure are sufficiently distressing to warrant special attention. Nevertheless, institutions underreport such procedures, and the medical literature contains no discussions about them. This article examines the case of a patient who was mistakenly taken for another patient's invasive electrophysiology procedure. After reviewing the case and the results of the institution's “root-cause analysis,” the discussants discovered at least 17 distinct errors, no single one of which could have caused this adverse event by itself. The discussants illustrate how these specific “active” errors interacted with a few underlying “latent conditions” (system weaknesses) to cause harm. The most remediable of these were absent or misused protocols for patient identification and informed consent, systematically faulty exchange of information among caregivers, and poorly functioning teams.

Self-monitoring comprises an “awareness of bodily symptoms, sensations, daily activities, and cognitive processes” and “measurements, recordings, or observations that inform cognition and provide information for independent action or consultation with care providers” (Wilde & Garvin, 2007, p. 344). This definition reveals key dimensions of self-awareness, observation, recording, knowledge, and reporting. Self-monitoringis proposed to contribute to self-management through improved symptom recognition and disease regulation (Wilde & Garvin, 2007).

Background: Low back pain (LBP) affects nearly 4 out of 5 individuals during their lifetime and is the leading cause of disability globally. Digital therapeutics are emerging as effective treatment options for individuals experiencing LBP. Despite the growth of evidence demonstrating the benefits of these therapeutics in reducing LBP and improving functional outcomes, little data has been systematically collected on their safety profiles. Objective: This study aims to evaluate the safety profile of a multidisciplinary digital therapeutic for LBP, the Kaia App, by performing a comprehensive assessment of reported adverse events (AEs) by users as captured by a standardized process for postmarket surveillance. Methods: All users of a multidisciplinary digital app that includes physiotherapy, mindfulness techniques, and education for LBP (Kaia App) from 2018 to 2019 were included. Relevant messages sent by users via the app were collected according to a standard operating procedure regulating postmarket surveillance of the device. These messages were then analyzed to determine if they described an adverse event (AE). Messages describing an AE were then categorized based on the type of AE, its seriousness, and its relatedness to the app, and they were described by numerical counts. User demographics, including age and gender, and data on app use were collected and evaluated to determine if they were risk factors for increased AE reporting. Results: Of the 138,337 active users of the Kaia App, 125 (0.09%) reported at least one AE. Users reported 0.00014 AEs per active day on the app. The most common nonserious AE reported was increased pain. Other nonserious AEs reported included muscle issues, unpleasant sensations, headache, dizziness, and sleep disturbances. One serious AE, a surgery, was reported. Details of the event and its connection to the intervention were not obtainable, as the user did not provide more information when asked to do so; therefore, it was considered to be possibly related to the intervention. There was no relationship between gender and AE reporting (P>.99). Users aged 25 to 34 years had reduced odds (odds ratio [OR] 0.31, 95% CI 0.08-0.95; P=.03) of reporting AEs, while users aged 55 to 65 years (OR 2.53, 95% CI 1.36-4.84, P=.002) and ≥75 years (OR 4.36, 95% CI 1.07-13.26; P=.02) had increased odds. AEs were most frequently reported by users who had 0 to 99 active days on the app, and less frequently reported by users with more active days on the app. Conclusions: This study on the Kaia App provides the first comprehensive assessment of reported AEs associated with real-world use of digital therapeutics for lower back pain. The overall rate of reported AEs was very low, but significant reporting bias is likely to be present. The AEs reported were generally consistent with those described for in-person therapies for LBP.