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Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets

FDA MedWatch -

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identif

Retrospective validation study of a large language model approach to screening for intraabdominal surgical site infections for quality and safety reporting

Quality and Safety in Health Care Journal -

Surgical site infections (SSIs), particularly intra-abdominal (IAB) infections, are challenging to identify and remain a resource-intensive focus of infection prevention programmes. Current automated screening measures rely on discrete data from the electronic health record (EHR), such as microbiology results, diagnosis codes and/or return to the operating room. This approach has poor specificity, and therefore surveillance methods depend heavily on additional manual chart review by trained infection preventionists. Large language models (LLMs) offer an opportunity to improve surveillance by synthesising complex clinical documentation alongside structured data elements.

We evaluated the performance of a locally hosted LLM (gpt-35-turbo-16k) to improve IAB SSI screening using perioperative clinical notes and microbiology results. The model analysed documentation across the perioperative period (3 days before through 30 days after surgery) to generate case-level SSI summaries and likelihood assessments. We compared the performance of this tool against the current EHR-based screening workflow.

Among 1977 abdominal surgical cases, including 56 with confirmed IAB SSIs, the LLM screened 104 cases as high risk, identifying all infections (negative predictive value (NPV) 100%) and achieving a positive predictive value (PPV) of 53.8%. In contrast, the EHR-based workflow identified 288 cases for further review, with a PPV of only 19.4% and the same NPV of 100%. Analysis of 57 224 notes required ~107 million tokens, translating to approximately USD 0.05 per case.

An LLM-based approach to SSI surveillance has the potential to substantially improve efficiency while remaining highly accurate and cost-effective. By reducing reliance on manual chart review, this strategy could allow infection preventionists to shift their attention from surveillance toward quality improvement and patient safety initiatives.

Tailoring improvement to the evidence-practice relationship

Quality and Safety in Health Care Journal -

Introduction

The relationship between scientific evidence and clinical practice is almost universally described as a gap—a disconnect between the evidence that tells us what to do and what we actually do in practice. An oft-cited statistic is that it takes 17 years for evidence to change practice and entire fields like implementation science have emerged to address this gap.1

However, this is only one of the ways in which evidence and practice relate. In other situations, the problem is not a failure to integrate known evidence, but the absence of evidence altogether. Additionally, practice itself can be highly variable or highly uniform, whether guided by evidence or not. Each of these scenarios represents a distinct relationship between evidence and practice. As such, each requires a different approach to effectively improve care.

This Viewpoint argues that recognising the specific association between the conduct of clinical practice and...

Lucian Leapes legacy for patient safety

Quality and Safety in Health Care Journal -

"Errors must be accepted as evidence of systems flaws, not character flaws."—Lucian Leape1

In losing Lucian Leape to heart failure last 30 June, at the age of 94 years, we lost a rare physician whose insights fundamentally changed how clinicians and the public understand the practice of medicine. His contributions helped transform medicine’s moral self-conception from one that prized perfection and regarded error as a character failure to one that prizes humility and understanding failure. Medical mistakes were his laboratory. They were both his subject and his inspiration. And his career was a study in audacity and late blooming.

He was born on 7 November 1930, in Bellevue, Pennsylvania. His father worked for a steel company. His mother was a schoolteacher. He studied chemistry at Cornell, where he met his wife, Marty. He served in the US Navy, then went to Harvard Medical School, graduating in 1959....

Are we careless about continuity of care?

Quality and Safety in Health Care Journal -

At the Alma-Ata conference in 1978, multiple influential organisations gathered to define the core values of primary care.1 At this meeting, it was decided to adopt continuity of care as one of the core values. Continuity of care has several components: relational continuity, which stresses the personal patient–practitioner relationship over time; management continuity, which is about coordination of care across different healthcare professionals (HCPs); and informational continuity, which relates to appropriate transfer of patient data between different HCPs and between primary and secondary care.2

Numerous studies have shown beneficial effects of aiming for continuity of care. It is associated with reductions in emergency department use, hospital admissions and mortality.3–5 Importantly, it is also associated with improvements in patient satisfaction.6 7 Inversely, a reduction in continuity of care is associated with reduced patient satisfaction and higher...

From measurement to improvement: new evidence towards reducing emergency diagnosis of cancer

Quality and Safety in Health Care Journal -

Many patients with cancer are diagnosed in an emergency care context (often also termed ‘emergency presentation’ (EP)), and these patients have markedly worse prognosis and poorer patient experience even after adjustment for stage at diagnosis.1 2 Therefore, reducing the frequency of diagnosis of cancer as an emergency is an important public health and healthcare quality improvement target. Yet the extent to which preventing diagnosis as an emergency leads to improved survival remains unclear, and we do not know whether effective strategies to reduce the frequency of emergency diagnosis exist. Khalaf et al provide important new evidence to help address these critical questions.3

In 2012, Elliss-Brookes et al linked English cancer registration with National Health Service hospital administration and screening programme data to produce the first population-wide study examining the ‘routes to diagnosis’ of cancer.4 The findings were revealing. Across 15 common...

Less continuity with more complaints: a repeated cross-sectional study of the association between relational continuity of care and patient complaints in English general practice

Quality and Safety in Health Care Journal -

Objective

Relational continuity of care is associated with better patient experience and health outcomes. In England, relational continuity of primary care has been declining over a decade, coinciding with an increase in patient complaints. This study investigates the relationship between relational continuity of care and patient complaints.

Methods

Cross-sectional analysis of linked practice-level data in the English National Health Service (NHS) (2016/2017–2022/2023) obtained from NHS Digital and General Practice Patient Survey (GPPS). A negative binomial model was used to investigate the association between the proportion of patients never or almost never seeing their preferred general practitioner (GP) and new written complaints per 10 000 patients, with adjustment for patient demographics, socioeconomic status, care experiences, practice care capacity and care quality. Mediation analysis was further conducted to examine patients’ lost trust and unmet clinical needs as potential mechanisms.

Results

A 10 percentage point increase in the proportion of patients reporting low continuity was associated with 1.34 more new complaints per 10 000 patients (95% CI 1.23 to 1.46). The association may be stronger after than before the pandemic, among general practices with historically better continuity, and in more deprived areas. The findings were robust in using different measures of relational continuity, adjusting for primary case demand–supply mismatches, implementing a Poisson model with practice fixed effects and excluding ethnicity from the model specification. Mediation analysis showed that neither lost trust nor unmet care needs were important mediators of the effects of low continuity.

Conclusion

Self-reported low continuity of primary care is associated with more patient complaints in England. Future research should explore potential underlying mechanisms and establish whether the same relationship exists between objectively measured relational continuity and patient complaints.

Digital quality measure of potentially avoidable emergency presentations among patients with colorectal cancer

Quality and Safety in Health Care Journal -

Background

We previously developed a digital quality measure (dQM) of emergency presentations (EPs) in colorectal cancer (CRC) and found it to be associated with worse outcomes. Potentially avoidable EPs were common in this cohort, but identifying them required time-intensive chart reviews. We aimed to enhance the existing dQM to automate the detection of potentially avoidable EPs.

Materials and methods

We defined potentially avoidable EPs as those preceded by a CRC red flag (iron-deficiency anaemia or haematochezia ≥60 days prior, or positive stool-based screening test ≥180 days prior). The enhanced dQM was applied to a national cohort of incident CRC cases diagnosed in the Veterans Affairs healthcare system from 2017 to 2021. We examined associations with cancer stage, treatment and mortality.

Results

The enhanced dQM had a positive predictive value of 92% (95% CI 85.5% to 95.7%) for identifying potentially avoidable EPs. Among 9096 CRC cases, 28.1% were identified as EPs. Of these, 31.6% were classified as potentially avoidable. These patients were more likely to have advanced-stage disease (adjusted OR 1.50; 95% CI 1.27 to 1.78), less likely to receive treatment (adjusted OR 0.58; 95% CI 0.48 to 0.70) and had higher mortality (adjusted HR 1.58; 95% CI 1.40 to 1.79) compared with other patients with CRC.

Conclusions

The enhanced dQM accurately identified potentially avoidable EPs, which were associated with worse outcomes. This measure is unique in its focus on cases of preventable care delays, which can help guide future efforts to improve diagnostic timeliness and reduce EPs among patients with CRC.

Regulating voluntary assisted dying at the clinical coalface: a qualitative interview study in Victoria, Australia

Quality and Safety in Health Care Journal -

Background

Voluntary assisted dying (VAD) in Victoria, Australia, is governed by a stringent legislative framework, designed and enforced by the state, as well as other forms of regulation. However, there remains limited understanding about how these various forms of regulation operate at the frontline or how clinicians themselves can influence regulation.

Objectives

This article explores how clinicians working at the frontline (clinical coalface) may influence the regulation of VAD in Victoria, and how this contributes to the safe and effective delivery of VAD.

Methods

Reflexive thematic analysis of 30 semistructured interviews with 37 ‘regulators’ (defined as those capable of steering and guiding behaviour with respect to VAD).

Results

Data analysis resulted in the generation of three main themes: (1) coalface regulation extends regulations at the clinical level, ensuring adherence to laws while developing new standards and systems for safe and effective practice; (2) coalface regulation guides day-to-day VAD practice; and (3) coalface regulation plays a critical role in quality monitoring and improvement.

Conclusions

Clinicians play a significant role in VAD regulation in Victoria and fulfil what we define as a ‘coalface regulator’ role. These coalface regulators are influential in ensuring the safe and effective delivery of VAD. Understanding how coalface regulation intersects with other forms of VAD regulation and how this regulatory influence can be harnessed is critical for optimising VAD regulation, safety and improving service delivery at a local and system level.

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