It has been 22 years since the introduction of ‘never event’ to the discourse surrounding patient safety. Originally coined by then-CEO of the National Quality Forum (NQF) Kenneth Kizer, MD,1 the term refers to errors so egregious that they are intolerable, and thus, should never happen.2 Although interventions and regulatory muscle have been directed at eliminating them, never events continue to occur. Against this backdrop, in this issue of BMJ Quality and Safety, Zaslow and colleagues3 argue that the power of the concept to improve patient safety is undercut because there is no standardised definition and because not all never events are preventable. They call for the development of a consensus-based universal definition and a common list of never events to promote standardisation and improve safety.

I am not optimistic that these changes will improve the usefulness of the concept of the never...

Background

Diagnostic errors have been attributed to reasoning flaws caused by cognitive biases. While experiments have shown bias to cause errors, physicians of similar expertise differed in susceptibility to bias. Resisting bias is often said to depend on engaging analytical reasoning, disregarding the influence of knowledge. We examined the role of knowledge and reasoning mode, indicated by diagnosis time and confidence, as predictors of susceptibility to anchoring bias. Anchoring bias occurs when physicians stick to an incorrect diagnosis triggered by early salient distracting features (SDF) despite subsequent conflicting information.

Methods

Sixty-eight internal medicine residents from two Dutch university hospitals participated in a two-phase experiment. Phase 1: assessment of knowledge of discriminating features (ie, clinical findings that discriminate between lookalike diseases) for six diseases. Phase 2 (1 week later): diagnosis of six cases of these diseases. Each case had two versions differing exclusively in the presence/absence of SDF. Each participant diagnosed three cases with SDF (SDF+) and three without (SDF–). Participants were randomly allocated to case versions. Based on phase 1 assessment, participants were split into higher knowledge or lower knowledge groups. Main outcome measurements: frequency of diagnoses associated with SDF; time to diagnose; and confidence in diagnosis.

Results

While both knowledge groups performed similarly on SDF- cases, higher knowledge physicians succumbed to anchoring bias less frequently than their lower knowledge counterparts on SDF+ cases (p=0.02). Overall, physicians spent more time (p<0.001) and had lower confidence (p=0.02) on SDF+ than SDF– cases (p<0.001). However, when diagnosing SDF+ cases, the groups did not differ in time (p=0.88) nor in confidence (p=0.96).

Conclusions

Physicians apparently adopted a more analytical reasoning approach when presented with distracting features, indicated by increased time and lower confidence, trying to combat bias. Yet, extended deliberation alone did not explain the observed performance differences between knowledge groups. Success in mitigating anchoring bias was primarily predicted by knowledge of discriminating features of diagnoses.

Background

Triage and clinical consultations increasingly occur remotely. We aimed to learn why safety incidents occur in remote encounters and how to prevent them.

Setting and sample

UK primary care. 95 safety incidents (complaints, settled indemnity claims and reports) involving remote interactions. Separately, 12 general practices followed 2021–2023.

Methods

Multimethod qualitative study. We explored causes of real safety incidents retrospectively (‘Safety I’ analysis). In a prospective longitudinal study, we used interviews and ethnographic observation to produce individual, organisational and system-level explanations for why safety and near-miss incidents (rarely) occurred and why they did not occur more often (‘Safety II’ analysis). Data were analysed thematically. An interpretive synthesis of why safety incidents occur, and why they do not occur more often, was refined following member checking with safety experts and lived experience experts.

Results

Safety incidents were characterised by inappropriate modality, poor rapport building, inadequate information gathering, limited clinical assessment, inappropriate pathway (eg, wrong algorithm) and inadequate attention to social circumstances. These resulted in missed, inaccurate or delayed diagnoses, underestimation of severity or urgency, delayed referral, incorrect or delayed treatment, poor safety netting and inadequate follow-up. Patients with complex pre-existing conditions, cardiac or abdominal emergencies, vague or generalised symptoms, safeguarding issues, failure to respond to previous treatment or difficulty communicating seemed especially vulnerable. General practices were facing resource constraints, understaffing and high demand. Triage and care pathways were complex, hard to navigate and involved multiple staff. In this context, patient safety often depended on individual staff taking initiative, speaking up or personalising solutions.

Conclusion

While safety incidents are extremely rare in remote primary care, deaths and serious harms have resulted. We offer suggestions for patient, staff and system-level mitigations.

Background

Temporal structuring is determined by practices and social norms and affects the quality and timing of care. In this case study of hyperacute stroke wards which provide initial stroke investigation, treatment and care, we explored temporal structuring patterns to explain how these may affect quality of care.

Methods

This paper presents a thematic analysis of qualitative interviews with hyperacute stroke staff (n=76), non-participant observations (n=41, ~102 hours) and documentary analysis of the relevant service standards guidance. We used an inductive coding process to generate thematic findings around the concept of temporal structuring, with graphically illustrated examples.

Results

Five temporal structures influence what-happens-when: (1) clinical priorities and quality assurance metrics motivate rapid activity for the initial life-prolonging assessments and interventions; (2) static features of ward organisation such as rotas and ward rounds impact consistency of care, determining timing and quality of care for patients; (3) some services experimented with staff rotas to try to meet peaks in demand, sometimes unsuccessfully; (4) implicit social norms or heuristics about perceived necessity affected staff motivation to make changes or improvements to consistency of care, particularly around weekend work; and (5) after-effects such as bottlenecks or backlogs affect quality of care, which are hard to measure effectively to drive service improvement.

Conclusions

Patients need temporally consistent high quality of care. Temporal consistency stems from the design of services, including staffing, targets and patient pathway design as well as cultural attitudes to working patterns. Improvements to consistency of care will be limited without changes to structures such as rotas and ward rounds, but also social norms around weekend work for certain professional groups.

Background

Accurate and timely diagnosis relies on sharing perspectives among team members and avoiding information asymmetries. Patients/Families hold unique diagnostic process (DxP) information, including knowledge of diagnostic safety blindspots—information that patients/families know, but may be invisible to clinicians. To improve information sharing, we co-developed with patients/families an online tool called ‘Our Diagnosis (OurDX)’. We aimed to characterise patient/family contributions in OurDX and how they differed between individuals with and without diagnostic concerns.

Method

We implemented OurDX in two academic organisations serving patients/families living with chronic conditions in three subspecialty clinics and one primary care clinic. Prior to each visit, patients/families were invited to contribute visit priorities, recent histories and potential diagnostic concerns. Responses were available in the electronic health record and could be incorporated by clinicians into visit notes. We randomly sampled OurDX reports with and without diagnostic concerns for chart review and used inductive and deductive qualitative analysis to assess patient/family contributions.

Results

7075 (39%) OurDX reports were submitted at 18 129 paediatric subspecialty clinic visits and 460 (65%) reports were submitted among 706 eligible adult primary care visits. Qualitative analysis of OurDX reports in the chart review sample (n=450) revealed that participants contributed DxP information across 10 categories, most commonly: clinical symptoms/medical history (82%), tests/referrals (54%) and diagnosis/next steps (51%). Participants with diagnostic concerns were more likely to contribute information on DxP risks including access barriers, recent visits for the same problem, problems with tests/referrals or care coordination and communication breakdowns, some of which may represent diagnostic blindspots.

Conclusion

Partnering with patients and families living with chronic conditions through OurDX may help clinicians gain a broader perspective of the DxP, including unique information to coproduce diagnostic safety.

Direct-to-onsumer telemedicine (DTCT) has become popular as an alternative to traditional care. However, uncertainties about the potential risks associated with the lack of comprehensive quality evaluation could influence its long-term development. This study aimed to assess the quality of care provided by DTCT platforms in China using unannounced standardised patients (USP) between July 2021 and January 2022. The study assessed consultation services on both hospital and enterprise-sponsored platforms using the Institute of Medicine quality framework. It employed 10 USP cases, covering conditions such as diabetes, asthma, common cold, gastritis, angina, low back pain, child diarrhoea, child dermatitis, stress urinary incontinence and postpartum depression. Descriptive and regression analyses were employed to examine platform characteristics and compare quality across platform types. The results showed that of 170 USP visits across 107 different telemedicine platforms, enterprise-sponsored platforms achieved a 100% success in access, while hospital-sponsored platforms had a success rate of only 47.5% (56/118). Analysis highlighted a low overall correct diagnosis rate of 45% and inadequate adherence to clinical guidelines across all platforms. Notably, enterprise-sponsored platforms outperformed in accessibility, response time and case management compared with hospital-sponsored platforms. This study highlights the suboptimal quality of DTCT platforms in China, particularly for hospital-sponsored platforms. To further enhance DTCT services, future studies should compare DTCT and in-person care, aiming to identify gaps and potential risks associated with using DTCT as alternatives or supplements to traditional care. The potential of future development in enhancing DTCT services may involve exploring the integration of hospital resources with the technology and market capabilities of enterprise-sponsored platforms.

‘The problem with...’ series covers controversial topics related to efforts to improve healthcare quality, including widely recommended, but deceptively difficult strategies for improvement and pervasive problems that seem to resist solution. The series is overseen by Ken Catchpole (Guest Editor) and Kaveh Shojania.

The concept of ‘never events’ (NEs), introduced in 2002, is used to classify patient safety incidents that should never happen. The term is typically reserved for severe events such as performing surgery on the wrong body part,1 discharging a baby from the hospital to the wrong parents,2 or stage 3 or 4 pressure ulcers.3 The terminology was introduced as a wake-up call for reducing their incidence, but they continue to occur.

Recent systematic reviews have highlighted variability among lists of NEs,4 or how serious patient safety events in general are defined.5 Our group recently...

Readers of this journal will be familiar with the power of data to inform healthcare decisions, processes, policies and investments, with the goal of better patient care. They may also know first-hand how these data are always limited, partial, political and context-dependent,1–3 yet useful and necessary nonetheless. This is one of the data paradoxes recounted in the book by the same name,4 by Professor Klaus Hoeyer, University of Copenhagen. The book examines the work that is required to produce and use data in healthcare, while also exploring the contradictions inherent in these data that make it challenging to inform improvements, practice and policy. It is based on research about the Danish healthcare system, although its arguments are applicable internationally. The paradoxes are universal, as is the data work involved.

The book is rich in conceptual insight, anecdotes and storytelling and questions...

Great diagnosticians are often portrayed as recognising rare diseases that evade the efforts of mere mortals. This makes for great TV and local legends, but does not reflect daily practice, where the most common diagnostic challenge is discriminating between common conditions like pneumonia and heart failure or appendicitis and gastroenteritis.

Questions about how to train the brain to make those distinctions are central to the efforts of many clinician educators. An unresolved issue is whether the structure of knowledge (about diseases and diagnostic pathways) in the physician’s long-term memory or the clinician’s mode of cognition (intuitive or analytical thinking) is more deterministic of diagnostic success. A study1 in this issue of BMJQS sheds light on this issue, but also invites a broader question: is physician cognition still essential for this task at all?

A test of lookalikes

In a two-phase experiment, Mamede et al1...

Telehealth has been in use for decades, yet prompted by the COVID-19 pandemic, its adoption rapidly expanded globally, including Australia, India, Europe and North America.1–4 Telehealth is a broad term for healthcare that can be delivered or supported remotely by a variety of clinicians and healthcare professionals. Through telehealth, patients and clinicians do not need to be colocated within the clinic or hospital. Delivered through various modalities, telehealth encompasses video visit encounters, telephone-based encounters, remote patient monitoring technology that transmits data to clinicians and e-visits conducted through secure messages.5 For example, a video visit consists of a real-time virtual interaction among clinicians, patients and potentially caregivers through a secure system, such as Zoom. Telehealth can include patient and provider education, public health and administrative services,5 but our focus is delivery and support of healthcare involving a patient...

Patients are increasingly seeking more accessible, simpler and more streamlined experiences across healthcare. These evolving expectations offer healthcare providers new opportunities to engage with service users, through a growing wave of direct-to-consumer care solutions. The advent of home diagnostics, online pharmacies and, importantly, telemedicine are some key examples of this emerging trend.1 2

By enhancing accessibility, enabling timely care and improving patient engagement, telemedicine holds the potential to significantly improve health outcomes and, potentially, the overall efficiency of healthcare delivery.3 In particular, direct-to-consumer telemedicine allows users to independently initiate medical services remotely. By bypassing traditional intermediaries such as referral clinicians or facilitators, users can establish a direct engagement with healthcare providers via text messaging, video or telephone calls. Despite the advancements in telemedicine adoption during the pandemic,4 its impacts on the various dimensions of quality, as defined by the Institute of...

Listing of Medical Device 2024 Safety Communications

2024 Medical Device Recalls

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shuttin

Abiomed Impella CP with SmartAssist provides short-term support to the heart’s ventricle. Nine pumps that failed inspections were mistakenly sent to customers.

On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions m

B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the resp

NIM Vital is used during surgery to find, monitor, and stimulate nerves. A software issue is causing issue false negatives even when in contact with a nerve.

Older software versions for CADD-Solis and CADD-Solis VIP may cause pump issues that can cause serious injury or death.

Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.