Feed aggregator

American Health Packaging on Behalf of BluePoint Laboratories Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution

FDA MedWatch -

American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.Risk Statement: The failed dissolution of pot

Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution

FDA MedWatch -

Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Risk Statement: The failed dissolution of potassium chlor

Can virtual reality simulations improve macrocognition?

Quality and Safety in Health Care Journal -

Simulation studies provide a unique opportunity to develop a deeper understanding of how healthcare workers manage risk in everyday care. In this issue of the journal, Mumma and colleagues1 use a simulation design to analyse how nurses think during infection prevention and control practices and identify the cognitive skills that are associated with high performance.

Most nurse educators are familiar with the low-fidelity glow germ simulation intended to make nursing students and other health care providers aware of cross-contamination and the ubiquitous nature of microorganisms. Mumma et al have taken this exercise to another level by using actual microorganisms, thereby increasing the stakes of the simulated experience. The study has considerable methodological rigour and is an exciting way to highlight a unique use of simulation. Several important ideas and insights stem from reading this article.

The study looked at how 42 nurses provided care for two simulated...

Variation in quality of care between hospitals: how to identify learning opportunities

Quality and Safety in Health Care Journal -

In healthcare, as in life, the adage ‘variety is the spice of life’ often holds true. Variation can represent individual patient preferences, but when it comes to the quality of healthcare, variation can also be unwanted and harmful. Analysis of variation in a quality-of-care indicator assumes that finding only limited variation is a good thing, suggesting consistently high compliance with evidence-based guidelines and providing evidence of equity. In this editorial, we consider how variation is and should be quantified, comment on the findings of a review1 in this issue of BMJ Quality and Safety, and explore whether measurement at the hospital level is best for learning. We conclude by reflecting on the assumption that only limited variation is good.

How is variation analysed? Take CT scanning for suspected stroke as an example. This should be done soon after the patient arrives in the emergency department. The scan...

Understanding linguistic inequities in healthcare: moving from the technical to the social

Quality and Safety in Health Care Journal -

When patients and clinicians do not speak the same language, the quality and safety concerns that can arise seem evident. However, the literature on the association between language and a host of health outcomes is vast and varied. In this issue of BMJQS, Chu et al share the results of their well-conducted systematic review and meta-analysis of the relationship between a patient’s spoken language and hospital readmissions and emergency department (ED) revisits.1 They report that adult inpatients who prefer a non-dominant language are more likely to experience an unplanned hospital readmission or ED revisit after discharge. Moreover, they found that children whose parents spoke a non-dominant language had more ED revisits. The authors’ work is a thoughtful synthesis of a somewhat disparate literature and offers a starting point to consider key challenges in the broader area of research on linguistic inequities in healthcare.

Language as a...

Connecting pathogen transmission and healthcare worker cognition: a cognitive task analysis of infection prevention and control practices during simulated patient care

Quality and Safety in Health Care Journal -

Background

Relatively little is known about the cognitive processes of healthcare workers that mediate between performance-shaping factors (eg, workload, time pressure) and adherence to infection prevention and control (IPC) practices. We taxonomised the cognitive work involved in IPC practices and assessed its role in how pathogens spread.

Methods

Forty-two registered nurses performed patient care tasks in a standardised high-fidelity simulation. Afterwards, participants watched a video of their simulation and described what they were thinking, which we analysed to obtain frequencies of macrocognitive functions (MCFs) in the context of different IPC practices. Performance in the simulation was the frequency at which participants spread harmless surrogates for pathogens (bacteriophages). Using a tertiary split, participants were categorised into a performance group: high, medium or low. To identify associations between the three variables—performance groups, MCFs and IPC practices—we used multiblock discriminant correspondence analysis (MUDICA).

Results

MUDICA extracted two factors discriminating between performance groups. Factor 1 captured differences between high and medium performers. High performers monitored the situation for contamination events and mitigated risks by applying formal and informal rules or managing their uncertainty, particularly for sterile technique and cleaning. Medium performers engaged more in future-oriented cognition, anticipating contamination events and planning their workflow, across many IPC practices. Factor 2 distinguished the low performers from the medium and high performers who mitigated risks with informal rules and sacrificed IPC practices when managing tradeoffs, all in the context of minimising cross-contamination from physical touch.

Conclusions

To reduce pathogen transmission, new approaches to training IPC (eg, cognitive skills training) and system design are needed. Interventions should help nurses apply their knowledge of IPC fluidly during patient care, prioritising and monitoring situations for risks and deciding how to mitigate risks. Planning IPC into one’s workflow is beneficial but may not account for the unpredictability of patient care.

"Its probably an STI because youre gay": a qualitative study of diagnostic error experiences in sexual and gender minority individuals

Quality and Safety in Health Care Journal -

Background

There is a critical need to identify specific causes of and tailored solutions to diagnostic error in sexual and gender minority (SGM) populations.

Purpose

To identify challenges to diagnosis in SGM adults, understand the impacts of patient-reported diagnostic errors on patients’ lives and elicit solutions.

Methods

Qualitative study using in-depth semistructured interviews. Participants were recruited using convenience and snowball sampling. Recruitment efforts targeted 22 SGM-focused organisations, academic centres and clinics across the USA. Participants were encouraged to share study details with personal contacts. Interviews were analysed using codebook thematic analysis.

Results

Interviewees (n=20) ranged from 20 to 60 years of age with diverse mental and physical health symptoms. All participants identified as sexual minorities, gender minorities or both. Thematic analysis revealed challenges to diagnosis. Provider-level challenges included pathologisation of SGM identity; dismissal of symptoms due to anti-SGM bias; communication failures due to providers being distracted by SGM identity and enforcement of cis-heteronormative assumptions. Patient-level challenges included internalised shame and stigma. Intersectional challenges included biases around factors like race and age. Patient-reported diagnostic error led to worsening relationships with providers, worsened mental and physical health and increased self-advocacy and community-activism. Solutions to reduce diagnostic disparities included SGM-specific medical education and provider training, using inclusive language, asking questions, avoiding assumptions, encouraging diagnostic coproduction, upholding high care standards and ethics, involving SGM individuals in healthcare improvement and increasing research on SGM health.

Conclusions

Anti-SGM bias, queerphobia, lack of provider training and heteronormative attitudes hinder diagnostic decision-making and communication. As a result, SGM patients report significant harms. Solutions to mitigate diagnostic disparities require an intersectional approach that considers patients’ gender identity, sexual orientation, race, age, economic status and system-level changes.

Between-hospital variation in indicators of quality of care: a systematic review

Quality and Safety in Health Care Journal -

Background

Efforts to mitigate unwarranted variation in the quality of care require insight into the ‘level’ (eg, patient, physician, ward, hospital) at which observed variation exists. This systematic literature review aims to synthesise the results of studies that quantify the extent to which hospitals contribute to variation in quality indicator scores.

Methods

Embase, Medline, Web of Science, Cochrane and Google Scholar were systematically searched from 2010 to November 2023. We included studies that reported a measure of between-hospital variation in quality indicator scores relative to total variation, typically expressed as a variance partition coefficient (VPC). The results were analysed by disease category and quality indicator type.

Results

In total, 8373 studies were reviewed, of which 44 met the inclusion criteria. Casemix adjusted variation was studied for multiple disease categories using 144 indicators, divided over 5 types: intermediate clinical outcomes (n=81), final clinical outcomes (n=35), processes (n=10), patient-reported experiences (n=15) and patient-reported outcomes (n=3). In addition to an analysis of between-hospital variation, eight studies also reported physician-level variation (n=54 estimates). In general, variation that could be attributed to hospitals was limited (median VPC=3%, IQR=1%–9%). Between-hospital variation was highest for process indicators (17.4%, 10.8%–33.5%) and lowest for final clinical outcomes (1.4%, 0.6%–4.2%) and patient-reported outcomes (1.0%, 0.9%–1.5%). No clear pattern could be identified in the degree of between-hospital variation by disease category. Furthermore, the studies exhibited limited attention to the reliability of observed differences in indicator scores.

Conclusion

Hospital-level variation in quality indicator scores is generally small relative to residual variation. However, meaningful variation between hospitals does exist for multiple indicators, especially for care processes which can be directly influenced by hospital policy. Quality improvement strategies are likely to generate more impact if preceded by level-specific and indicator-specific analyses of variation, and when absolute variation is also considered.

PROSPERO registration number

CRD42022315850.

Association between language discordance and unplanned hospital readmissions or emergency department revisits: a systematic review and meta-analysis

Quality and Safety in Health Care Journal -

Background and objective

Studies conflict about whether language discordance increases rates of hospital readmissions or emergency department (ED) revisits for adult and paediatric patients. The literature was systematically reviewed to investigate the association between language discordance and hospital readmission and ED revisit rates.

Data sources

Searches were performed in PubMed, Embase and Google Scholar on 21 January 2021, and updated on 27 October 2022. No date or language limits were used.

Study selection

Articles that (1) were peer-reviewed publications; (2) contained data about patient or parental language skills and (3) included either unplanned hospital readmission or ED revisit as one of the outcomes, were screened for inclusion. Articles were excluded if: unavailable in English; contained no primary data or inaccessible in a full-text form (eg, abstract only).

Data extraction and synthesis

Two reviewers independently extracted data using Preferred Reporting Items for Systematic Reviews and Meta-Analyses-extension for scoping reviews guidelines. We used the Newcastle-Ottawa Scale to assess data quality. Data were pooled using DerSimonian and Laird random-effects models. We performed a meta-analysis of 18 adult studies for 28-day or 30-day hospital readmission; 7 adult studies of 30-day ED revisits and 5 paediatric studies of 72-hour or 7-day ED revisits. We also conducted a stratified analysis by whether access to interpretation services was verified/provided for the adult readmission analysis.

Main outcome(s) and measure(s)

Odds of hospital readmissions within a 28-day or 30-day period and ED revisits within a 7-day period.

Results

We generated 4830 citations from all data sources, of which 49 (12 paediatric; 36 adult; 1 with both adult and paediatric) were included. In our meta-analysis, language discordant adult patients had increased odds of hospital readmissions (OR 1.11, 95% CI 1.04 to 1.18). Among the 4 studies that verified interpretation services for language discordant patient-clinician interactions, there was no difference in readmission (OR 0.90, 95% CI 0.77 to 1.05), while studies that did not specify interpretation service access/use found higher odds of readmission (OR 1.14, 95% CI 1.06 to 1.22). Adult patients with a non-dominant language preference had higher odds of ED revisits (OR 1.07, 95% CI 1.004 to 1.152) compared with adults with a dominant language preference. In 5 paediatric studies, children of parents language discordant with providers had higher odds of ED revisits at 72 hours (OR 1.12, 95% CI 1.05 to 1.19) and 7 days (OR 1.02, 95% CI 1.01 to 1.03) compared with patients whose parents had language concordant communications.

Discussion

Adult patients with a non-dominant language preference have more hospital readmissions and ED revisits, and children with parents who have a non-dominant language preference have more ED revisits. Providing interpretation services may mitigate the impact of language discordance and reduce hospital readmissions among adult patients.

PROSPERO registration number

CRD42022302871.

Grand rounds in methodology: designing for integration in mixed methods research

Quality and Safety in Health Care Journal -

Mixed methods research is a popular approach used to understand persistent and complex problems related to quality and safety, such as reasons why interventions are not implemented as intended or explaining differential outcomes. However, the quality and rigour of mixed methods research proposals and publications often miss opportunities for integration, which is the core of mixed methods. Achieving integration remains challenging, and failing to integrate reduces the benefits of a mixed methods approach. Therefore, the purpose of this article is to guide quality and safety researchers in planning and designing a mixed methods study that facilitates integration. We highlight how meaningful integration in mixed methods research can be achieved by centring integration at the following levels: research question, design, methods, results and reporting and interpretation levels. A holistic view of integration through all these levels will enable researchers to provide better answers to complex problems and thereby contribute to improvement of safety and quality of care.

Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination

FDA MedWatch -

Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 1

Male Enhancement Supplements Recalled

FDA MedWatch -

Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment o

Pages

Subscribe to Medication Safety Officers Society- MSOS aggregator