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From SMART aims to systems thinking: expanding the scope of quality improvement and patient safety education

Quality and Safety in Health Care Journal -

Since the Institute of Medicine released its landmark report in 19991 highlighting serious concerns about patient safety (PS) and the quality of healthcare in the USA, training programmes around the world have made quality improvement (QI) and PS key components of resident education and experience. In recognising that physicians must learn to interact with and adapt to a constantly changing healthcare environment, the Accreditation Council for Graduate Medical Education (ACGME) and ACGME International (ACGME-I) identified QI and PS as two of the six ‘Pathways of Excellence’ expected in an optimal clinical learning environment.2 In this journal, Molina et al present an exemplary effort to train the next generation of healthcare professionals in improvement science.3 This 13-year QI initiative in a large paediatric residency programme demonstrated how applying QI methodology to the educational programme itself can strengthen resident training. Through phased interventions—including structured didactics,...

More alerts, less harm? Rethinking medication safety with AI

Quality and Safety in Health Care Journal -

Medication-related problems remain one of the leading causes of patient harm.1 Studies show that advances in electronic health records (EHR) and computerised prescribing systems with clinical decision support (CDS) have reduced prescription errors, improved physician performance and patient outcomes. However, these effects are not universally experienced and are influenced by usability, perceived usefulness, relevance and efficiency.2 3

Medication-related CDS can be classified as basic (eg, drug-drug interaction (DDI) or drug-allergy checks) or advanced, whereby patient-specific information in the EHR is used (eg, drug-disease contraindication or drug-laboratory test checks).4 However, a key persistent issue with CDS is alert fatigue, where clinically important alerts are ignored alongside alerts that are not clinically important or relevant. This is exacerbated when healthcare providers are presented with excessive and unimportant alerts, resulting in high alert override rates.5 Indeed, DDI software is often associated with...

Effectiveness of computerised alerts to reduce drug-drug interactions (DDIs) and DDI-related harm in hospitalised patients: a quasi-experimental controlled pre-post study

Quality and Safety in Health Care Journal -

Background

Drug–drug interaction (DDI) alerts target the co-prescription of two potentially interacting medications and are a frequent feature of electronic medical records (EMRs). There have been few controlled studies evaluating the effectiveness of DDI alerts. This study aimed to determine the impact of DDI alerts on rates of DDIs and on associated patient harms.

Methods

Quasi-experimental controlled pre–post study in five Australian hospitals. Three hospitals acted as control hospitals (EMR with no DDI alerts) and two as intervention (EMR with DDI alerts). Only DDI alerts at the highest severity level (defined as ‘major contraindicated’) were switched on at intervention hospitals. These alerts were not tailored to clinical context (ie, patient, drug). A total of 2078 patients were randomly selected from all patients (adult and paediatric) admitted to hospitals 6 months before and 6 months after EMR implementation. A retrospective chart review was performed by study pharmacists. The primary outcome was the proportion of admissions with a clinically relevant DDI. Secondary outcomes included the proportions of admissions with a potential DDI and with DDI-related harm.

Results

Potential DDIs were identified in the majority of admissions (n=1574, 74.7%) and clinically relevant DDIs identified in half (n=1026, 48.7%). DDI alerts were associated with a reduction in the proportion of admissions with potential DDIs (adjusted OR (AOR)=0.38 (0.19, 0.78)) but no change in clinically relevant DDIs (AOR=1.12 (0.68, 1.84)) or in DDI-related harm (AOR=2.42 (0.47,12.31)). 199 DDIs (76 at control and 123 at intervention hospitals) for 35 patient admissions were associated with patient harm, and 2 patients experienced severe DDI-related harm pre-EMR implementation.

Discussion

Implementation of DDI alerts, without tailoring alerts to clinical context, is unlikely to reduce patient harms from DDIs. Organisations should reconsider implementation of DDI alerts in EMRs where significant tailoring of alerts is not possible. Future research should focus on identifying safe, efficient and cost-effective ways of refining DDI alerts, so expected clinical benefits are achieved, and negative consequences of excessive alerting are minimised.

Contextual factors that influence adoption and sustainment of self-management support in cancer survivorship care: a practical application of theory with qualitative interviews

Quality and Safety in Health Care Journal -

Background

Self-management support (SMS) is a recommended component of cancer survivorship care that improves health-related quality of life and reduces healthcare utilisation. However, widespread implementation has been difficult to achieve, with a gap in the literature on system-wide implementation efforts. This study examines contextual factors perceived to influence SMS adoption and sustainment in cancer centres in the Republic of Ireland.

Method

Semistructured interviews were conducted with 47 key informants from 20 cancer organisations across community and hospital settings. Participants were asked to report the level of adoption and sustainment of SMS at their organisation. This information was used to categorise organisations as low, medium or high implementers. We conducted cross-case analysis following the principles of Framework Analysis. Using the Consolidated Framework for Implementation Research as a menu of constructs, we examined factors influencing adoption and sustainment and variation in levels of implementation.

Results

National policy, external accreditation, external financing opportunities and the presence of champions in organisations are influential early in the implementation process driving adoption. Healthcare provider-led programmes and evidence of SMS improving patient outcomes and aligning with an organisation’s priorities are necessary to secure buy-in, particularly among senior leadership. An organisational culture of entrepreneurship enables adoption and sustainment, with resources and a culture supporting staff well-being enabling sustainment.

Conclusion

While national policy is a driver, additional factors related to programme attributes and local contextual features such as the presence of champions, organisational readiness and culture influence implementation. The results may be used for future evaluations of SMS implementation in cancer survivorship care and to inform the development of tailored implementation strategies.

Socioeconomic inequalities in adherence to clinical practice guidelines and breast cancer survival: a multicentre population-based study in Spain

Quality and Safety in Health Care Journal -

Introduction and aims

Women residing in lower socioeconomic status (SES) areas have lower breast cancer survival but it is not clear how differences in the quality of care received contribute to these disparities. We compared adherence to clinical practice guidelines (CPG) for the diagnosis and treatment of breast cancer and subsequent breast cancer survival between women residing in lower versus higher SES areas.

Methods

We conducted a multicentre population-based study of all new cases of invasive breast cancer in women diagnosed 2010–2014 in six Spanish provinces with population-based cancer registries (n=3206). Clinical data were extracted in the framework of the European Cancer High Resolution studies and vital status follow-up covered a minimum of 5 years. SES of the patient’s residence was measured with the 2011 Spanish Deprivation Index. Adherence to CPG was measured with 16 indicators based on European and Spanish guidelines. Relative survival was modelled using flexible parametric models.

Results

There were no differences in the type of treatment received but women living in the lowest SES areas were less likely to undergo a sentinel lymph node biopsy, reconstruction after mastectomy, surgery within 30 days after pathological diagnosis and adjuvant treatment within 6 weeks after surgery. After accounting for demographic and clinical factors, women residing in lower SES areas had higher risk of death, HR=1.57 (95% CI 1.04, 2.36). Further accounting for adherence to CPG in the model, in particular having undergone a sentinel lymph node biopsy, eliminated the significant effect of SES.

Conclusions

Despite the overall coverage of the Spanish health system, women living in more deprived areas were less likely to receive care in line with CPG and had shorter survival.

QIing your QI: a 13-year experience of a paediatric residency QI programme

Quality and Safety in Health Care Journal -

Introduction

QI education is essential for resident physicians with established requirements from the Accreditation Council for Graduate Medical Education outlining the necessary components. Literature supports the inclusion of both didactic and experiential learning, however, most studies review knowledge and attitude based assessments of residency QI programs. In 2012, our pediatric residency program identified a gap in resident engagement in QI, which led to the formalization of a QI education program grounded in the Institute for Healthcare Improvement (IHI) Model for improvement with objective measures of QI projects.

Methods

Over 13 years, our program implemented interative interventions across three phases to enchance QI training. Initial core interventions involved the structure of didactics to teach core principles of QI and with time focusing on more individualized mentorship. Our efforts were guided through a residency QI committee. Our aim was to (1) increase the percentage of resident QI projects with SMART aims, and (2) increase the use of QI graphs (run charts and SPC charts) of resident QI projects. We tracked graduating resident exit survey satisfaction with the QI program as a balancing measure.

Results

From 2012 through 2025, over 300 resident completed 390 QI projects that were reviewed. The percentage of of projects with SMART aims and QI graphs increased over time. The percentage of projects applying for American Board of Pediatrics Part IV applications and presenting at conferences also increased. Resident satisfaction remained with with an average "Poor" rating of only 2.6%.

Conclusions

Using the model for improvement to assess objective measures in a residency QI program is both feasible and effective. This 13-year intiative demonstrates how systematic, iterative improvement can improve the rigor of resident QI projects. Future goals including leveraging informatics to further support residents with their projects and track downstream patient outcomes.

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

FDA MedWatch -

FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

FDA MedWatch -

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product

Better bottom lines: patient satisfaction associated with addressing sexual and gender minority health

Quality and Safety in Health Care Journal -

The quality of care anyone receives in the USA is highly dependent on where they receive care. Prior research has found that on average, risk-adjusted mortality differences between top-decile and bottom-decile hospitals can be over twofold. When looking specifically at patient safety, the difference is over 10-fold between top-decile and bottom-decile hospitals. Even after adjusting for population factors (eg, demographics, lifestyle and socioeconomics), co-morbidities and health system factors, these geographic differences in outcomes persist.1 Anyone entering a hospital should be alarmed by the high variability in the quality and outcome of the care they receive simply based on location.

The variability in care and outcomes is even more concerning for people who have faced,2 and continue to face,3 stigma and discrimination in seeking health care. For sexual and gender minority (SGM) populations, including lesbian, gay, bisexual, transgender and queer (LGBTQ+) people, entering a...

Addressing the risk of look-alike, sound-alike medication errors: bending metal or twisting arms?

Quality and Safety in Health Care Journal -

What should we do in order to improve quality and safety in medicines management? How beneficial is it to design the medicines management system—for example, the tasks, tools and physical environment—to support effective working versus making people adapt to the systems in which they find themselves? As Sanders and McCormick1 put the question: is it better (more convenient, more cost-effective, more appealing) to bend metal or to twist arms?

This question arises when considering, among other problems in healthcare delivery, that of confusing look-alike, sound-alike (LASA) medicine names, which persists as a threat to medication safety despite much discussion and examination.2 Various measures have been suggested to minimise the risk of LASA medication errors in the pharmacy setting, including education of pharmacy staff, procedural controls and medicines labelling,3 4 although with no silver bullet identified so far.5 6

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