Patients' and doctors' views and experiences of the patient safety trajectory of breast cancer care.

INTRODUCTION: Successful breast cancer outcomes can be jeopardised by adverse events. Understanding and integrating patients' and doctors' perspectives into care trajectories could improve patient safety. This study assessed their views on, and experiences of, medical error and patient safety. METHODS: A cross-sectional, quantitative 20-40 item questionnaire for patients attending Cork University Hospital Cancer Centre and breast cancer doctors in the Republic of Ireland was developed. Domains included demographics, medical error experience, patient safety opinions and concerns. RESULTS: 184 patients and 116 doctors completed the survey. Of the doctors, 41.4% felt patient safety had deteriorated over the previous five years and 54.3% felt patient safety measures were inadequate compared to 13.0% and 27.7% of patients respectively. Of the 30 patients who experienced medical errors/negligence claims, 18 reported permanent or long-term physical and emotional effects. Forty-two of 48 (87.5%) doctors who experienced medical errors/negligence claims reported emotional health impacts. Almost half of doctors involved in negligence claims considered early retirement. Forty-four patients and 154 doctors didn't experience errors but reported their patient safety concerns. Doctors were more concerned about communication and administrative errors, staffing and organisational factors compared to patients. Multiple barriers to error reporting were highlighted. CONCLUSION: This is the first study to assess patients' and doctors' patient safety views and medical error/negligence claims experiences in breast cancer care in Ireland. Experience of medical error/negligence claims had long-lasting implications for both groups. Doctors were concerned about a multitude of errors and causative factors. Failure to embed these findings is a missed opportunity to improve safety.

An International Perspective on Definitions and Terminology Used to Describe Serious Reportable Patient Safety Incidents: A Systematic Review.

OBJECTIVES: Patients are unintentionally, yet frequently, harmed in situations that are deemed preventable. Incident reporting systems help prevent harm, yet there is considerable variability in how patient safety incidents are reported. This may lead to inconsistent or unnecessary patterns of incident reporting and failures to identify serious patient safety incidents. This systematic review aims to describe international approaches in relation to defining serious reportable patient safety incidents. METHODS: Multiple electronic and gray literature databases were searched for articles published between 2009 and 2019. Empirical studies, reviews, national reports, and policies were included. A narrative synthesis was conducted because of study heterogeneity. RESULTS: A total of 50 articles were included. There was wide variation in the terminology used to represent serious reportable patient safety incidents. Several countries defined a specific subset of incidents, which are considered sufficiently serious, yet preventable if appropriate safety measures are taken. Terms such as "never events," "serious reportable events," or "always review and report" were used. The following dimensions were identified to define a serious reportable patient safety incident: (1) incidents being largely preventable; (2) having the potential for significant learning; (3) causing serious harm or have the potential to cause serious harm; (4) being identifiable, measurable, and feasible for inclusion in an incident reporting system; and (5) running the risk of recurrence. CONCLUSIONS: Variations in terminology and reporting systems between countries might contribute to missed opportunities for learning. International standardized definitions and blame-free reporting systems would enable comparison and international learning to enhance patient safety.

Ethical frameworks for quality improvement activities: an analysis of international practice.

PURPOSE: To examine international approaches to the ethical oversight and regulation of quality improvement and clinical audit in healthcare systems. DATA SOURCES: We searched grey literature including websites of national research and ethics regulatory bodies and health departments of selected countries. STUDY SELECTION: National guidance documents were included from six countries: Ireland, England, Australia, New Zealand, the United States of America and Canada. DATA EXTRACTION: Data were extracted from 19 documents using an a priori framework developed from the published literature. RESULTS: We organized data under five themes: ethical frameworks; guidance on ethical review; consent, vulnerable groups and personal health data. Quality improvement activity tended to be outside the scope of the ethics frameworks in most countries. Only New Zealand had integrated national ethics standards for both research and quality improvement. Across countries, there is consensus that this activity should not be automatically exempted from ethical review but requires proportionate review or organizational oversight for minimal risk projects. In the majority of countries, there is a lack of guidance on participant consent, use of personal health information and inclusion of vulnerable groups in routine quality improvement. CONCLUSION: Where countries fail to provide specific ethics frameworks for quality improvement, guidance is dispersed across several organizations which may lack legal certainty. Our review demonstrates a need for appropriate oversight and responsive infrastructure for quality improvement underpinned by ethical frameworks that build equivalence with research oversight. It outlines aspects of good practice, especially The New Zealand framework that integrates research and quality improvement ethics.

Why Do Medical Professional Regulators Dismiss Most Complaints From Members of the Public? Regulatory Illiteracy, Epistemic Injustice, and Symbolic Power.

Drawing on an analysis of complaint files that we conducted for the Irish Medical Council (Madden and O'Donovan 2015), this paper offers three possible explanations for the gap between the ubiquity of official commitments to taking patients' complaints seriously and medical professional regulators' dismissal-as not warranting an inquiry-of the vast majority of complaints submitted by members of the public. One explanation points to the "regulatory illiteracy" of many complainants, where the remit and threshold of seriousness of regulators is poorly understood by the general public. Another points to possible processes of "institutional epistemic injustice" (Fricker 2007; Anderson 2012) that unjustly undermine the credibility of certain complainants, such as those with low levels of formal education. A third explanation highlights the marginalization of the general public from "symbolic power" (Bourdieu 1989) to define what matters in medical professional regulation. The paper is offered in a spirit of ideas in progress and raising questions rather than definitive insights into the regulatory process.

Knowledge, confidence, skills and practices among midwives in the republic of Ireland in relation to perinatal mental health care: The mind mothers study.

OBJECTIVE: The study aimed to identify midwives' competency in perinatal mental health care in terms of their knowledge, confidence, skill and educational priorities, and to explore their clinical practices in relation to the assessment and management of perinatal mental health problems. RESEARCH DESIGN: An exploratory descriptive study design was used on a sample of 438 midwives in the Republic of Ireland. Data were collected over a two-month period in 2016 using an anonymous, self-completed survey designed by the research team. FINDINGS: The majority of midwives cared for women with perinatal mental health problems in their clinical practice; however, beyond depression and anxiety, their knowledge of perinatal mental health problems was quite limited. Similarly, midwives reported a lack of skill in opening a discussion with women on sensitive issues, such as sexual abuse, intimate partner violence and psychosis, and providing information to women's partners/families. The findings indicated that midwives adopted a selective approach to screening for perinatal mental health problems, with a tendency not to inquire about sensitive topics, or address them only with women deemed at-risk. CONCLUSIONS: Timely and appropriate care is required to ensure the best outcomes for women with perinatal mental health problems and their families. A greater understanding of perinatal mental health among midwives is required to enable them to provide support and information to women and their families, and to identify when specialist intervention is required. Education and other structural supports, such as care pathways and documentation, is required to train and support midwives in their key role of caring for, and collaborating with, women with perinatal mental health problems.

Using action research to develop midwives' skills to support women with perinatal mental health needs.

AIMS AND OBJECTIVES: The aim of the research was to identify and develop midwives' skills to support women with mental health needs during pregnancy, using an action research approach. BACKGROUND: A review of perinatal mental health services in a large Dublin maternity unit revealed a high number of referred women who 'did not attend' the perinatal mental health service with few guidelines in place to support midwives in identifying and referring women for specialist help. DESIGN: Action research using cooperative inquiry involved a mental health nurse specialist and a team of midwives, who were drawn to each other in mutual concern about an area of practice. METHODS: Data were gathered from three Cooperative Inquiry meetings, which incorporated one main Action Research Cycle of constructing, planning, taking and evaluating action. Data were analysed using a thematic content analysis framework. RESULTS: Participants experienced varying levels of uncertainty about how to support women with perinatal mental health needs. Cooperative inquiry supported participants in making sense of how they understood perinatal mental health and how they managed challenges experienced when caring for women with perinatal mental health issues. Participants developed a referral pathway, highlighted the significance of education to support women with perinatal mental health issues and identified the value of using open questions to promote conversation with pregnant women about mental health. CONCLUSIONS: Midwives value education and support to identify and refer women at risk of perinatal mental health issues. Cooperative inquiry, with a focus on action and shared reflection, facilitated the drawing together of two professional groups with diverse knowledge bases to work together to develop practice in an area of mutual concern. RELEVANCE TO CLINICAL PRACTICE: Perinatal mental health is a significant public health issue and midwives need support to make psychosocial assessments and to negotiate access to specialist services where available and when required.

The human side of cancer biobanking.

The future success of translational research is critically dependent on the procurement and availability of high-quality tissue specimens linked to accurate histopathologic and clinical information about the individual banked specimen. The international community has awakened to this critical need only recently. Three major roadblocks have hindered the success of previous biobank consortiums: (1) Ethical issues surrounding patient consent and ownership of intellectual property, (2) Failure to properly preserve the molecular content of the tissue, and failure to reliably document clinical data linked to the specimen, and (3) Management issues: inadequate funding, competition for use of the tissue, inadequate personnel and facilities, and absence of dedicated database software. This chapter reviews these critical roadblocks and discusses international efforts to provide strategies to implement high-quality biobanks.

Lessons learnt from the organ retention controversy.

This paper examines the lessons to be learnt from the organ retention controversy in the Republic of Ireland. The paper emphasises the importance of good communication between clinicians and families of deceased persons and a move away from a medical culture based on paternalism to a partnership approach between clinicians and patients based on mutual trust and understanding. A model of authorisation rather than consent is proposed as the way forward for dealing with the difficult and traumatic experience of asking families for permission to carry out a post mortem examination on their deceased child.