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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

FDA MedWatch -

Huntsville, Texas — StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dys

Eliminating hospital nurse understaffing is a cost-effective patient safety intervention

Quality and Safety in Health Care Journal -

More than 20 years since a landmark study1 documented hospitalised patients were more likely to die when their nurse cared for too many patients at a time, hundreds of rigorously conducted studies in over 30 countries have documented a relationship between nurse understaffing and poorer outcomes of all kinds, including preventable patient deaths and avoidable burnout of nurses.2–4 Despite the empirical evidence, chronic hospital nurse understaffing persists.

Why has the research evidence not substantively transformed hospital staffing practices? One possible explanation is that the benefits of eliminating nurse understaffing accrue to patients and nurses, while the costs of staffing more nurses accrue to hospitals.

Hospitals are the most expensive healthcare setting, largely because of the intensive nursing care that hospitalised patients require. Indeed, if patients can have procedures and treatments administered outside of hospitals (eg, outpatient offices, home care), they do,...

Expression of concern: Reducing opioid use for chronic non-cancer pain in primary care using an evidence-based, theory-informed, multistrategic, multistakeholder approach: a single-arm time series with segmented regression

Quality and Safety in Health Care Journal -

BMJ is concerned about the consent obtained from veterans to use their personal information in this research paper1 and broader Veterans' Medicines Advice and Therapeutics Education Services (MATES) program. BMJ was contacted by veterans who asked the journal to retract the content on this basis.

 The MATES program was operated by the Department for Veterans Affairs (DVA), and the research was conducted by the University of South Australia (UniSA).2 DVA was responsible for obtaining consent from the veterans to use their personal information in the MATES program; they were also responsible for managing opt-out requests.

 In 2018, a veteran lodged a complaint with the Australian Information and Privacy Commissioner about the validity of consent for DVA’s collection and use of their personal information in the MATES programme. In 2023, the Privacy Commissioner determined that DVA had breached an Australian privacy principle by using and disclosing...

Checklist conundrum: are we checking the right boxes?

Quality and Safety in Health Care Journal -

Since the 18th century, bedside rounds have been a fundamental component of clinical care, serving as a setting where clinical information is gathered, processed and shared.1 This tradition highlights the importance of maintaining a high level of structure during clinical encounters. Over time, structured tools to guide care have been widely adopted across multiple specialties.2–6 Systematic checklists, in particular, have become the most used form of structured intervention in bedside wards to enhance patient care and safety.7–9 This intervention has been associated with improved non-clinical outcomes, such as communication and adherence to standard protocols.7–9 However, their impact on clinical outcomes remains a matter of debate.10

A 2014 systematic review found that safety checklists improved team communication, improved adherence to standards and reduced adverse...

Cost-effectiveness of eliminating hospital understaffing by nursing staff: a retrospective longitudinal study and economic evaluation

Quality and Safety in Health Care Journal -

Background

Understaffing by nursing staff in hospitals is linked to patients coming to harm and dying unnecessarily. There is a vicious cycle whereby poor work conditions, including understaffing, can lead to nursing vacancies, which in turn leads to further understaffing. Is hospital investment in nursing staff, to eliminate understaffing on wards, cost-effective?

Methods

This longitudinal observational study analysed data on 185 adult acute units in four hospital Trusts in England over a 5-year period. We modelled the association between a patient’s exposure to ward nurse understaffing (days where staffing was below the ward mean) over the first 5 days of stay and risk of death, risk of readmission and length of stay, using survival analysis and linear mixed models. We estimated the incremental cost-effectiveness of eliminating understaffing by registered nurses (RN) and nursing support (NS) staff, estimating net costs per quality-adjusted life year (QALY). We took a hospital cost perspective.

Findings

Exposure to RN understaffing is associated with increased hazard of death (adjusted HR (aHR) 1.079, 95% CI 1.070 to 1.089), increased chance of readmission (aHR 1.010, 95% CI 1.005 to 1.016) and increased length of stay (ratio 1.687, 95% CI 1.666 to 1.707), while exposure to NS understaffing is associated with smaller increases in hazard of death (aHR 1.072, 95% CI 1.062 to 1.081) and length of stay (ratio 1.608, 95% CI 1.589 to 1.627) but reduced readmissions (aHR 0.994, 95% CI 0.988 to 0.999). Eliminating both RN and NS understaffing is estimated to cost £2778 per QALY (staff costs only), £2685 (including benefits of reduced staff sickness and readmissions) or save £4728 (including benefits of reduced lengths of stay). Using agency staff to eliminate understaffing is less cost-effective and would save fewer lives than using permanent members of staff. Targeting specific patient groups with improved staffing would save fewer lives and, in the scenarios tested, cost more per QALY than eliminating all understaffing.

Interpretation

Rectifying understaffing on inpatient wards is crucial to reduce length of stay, readmissions and deaths. According to the National Institute for Health and Care Excellence £10 000 per QALY threshold, it is cost-effective to eliminate understaffing by nursing staff. This research points towards investing in RNs over NS staff and permanent over temporary workers. Targeting particular patient groups would benefit fewer patients and is less cost-effective.

Duration of antibiotic therapy in the intensive care unit: factors influencing decision-making during multidisciplinary meetings

Quality and Safety in Health Care Journal -

Objectives

In the intensive care unit (ICU), antibiotics are often given longer than recommended in guidelines. A better understanding of the factors influencing antibiotic therapy duration is needed to develop improvement strategies to effectively address these drivers of excessive duration. This study aimed to explore the determinants of adherence to recommended antibiotic therapy durations among healthcare professionals involved in antibiotic decision-making within the ICU, focusing on multidisciplinary meetings (MDMs).

Methods

Semistructured interviews were held with healthcare professionals involved in antibiotic decision-making during MDMs in four Dutch ICUs. Participants included intensivists, clinical microbiologists and ICU residents. Transcripts were analysed using deductive and inductive content analysis methods.

Results

A total of 20 participants were interviewed. The interviews revealed that decision-making regarding antibiotic therapy duration is a complex process, primarily centred around professional interactions during MDMs and involving a broad range of determinants. These determinants were categorised into the following four steps: (1) the introduction of duration as a topic for discussion in the MDM (eg, lack of priority to discuss antibiotic therapy duration); (2) the discussion of antibiotic therapy duration itself (eg, lack of core members during MDM); (3) the establishment of a concrete decision (eg, lack of documentation of the decisions made); (4) the execution of the decision (eg, forgetting to stop antibiotics).

Conclusions

Our study identified numerous factors that influence decisions about the duration of antibiotic therapy during MDMs in the ICU. By describing these factors throughout the decision-making process, we provided valuable insights into barriers that commonly arise in specific steps, highlighting critical areas for improvement. Daily MDMs were deemed essential for informed decision-making regarding antibiotic therapy duration by the interviewees. Strategies to improve appropriate duration in the ICU should prioritise strengthening interdisciplinary communication between healthcare professionals and adding structure to these meetings.

Patient-reported harm from NHS treatment or care, or the lack of access to care: a cross-sectional survey of general population prevalence, impact and responses

Quality and Safety in Health Care Journal -

Objectives

The aim of this article is to provide an estimate of the proportion of the general public reporting healthcare-related harm in Great Britain, its location, impact, responses post-harm and desired reactions from healthcare providers.

Design

We used a cross-sectional survey, using quota sampling.

Setting

This research was conducted in Great Britain.

Participants

The survey had 10 064 participants (weighted analysis).

Results

In our survey 9.7% participants reported harm caused by the National Health Service (NHS) in the last 3 years through treatment or care (6.2%) or the lack of access to care (3.5%). The main location where the harm first occurred was hospitals. A total of 37.6% of participants reported a moderate impact and 44.8% a severe impact of harm. The most common response to harm was to share their experience with others (67.1%). Almost 60% sought professional advice and support, with 11.6% contacting the Patient Advice and Liaison Service (PALS). Only 17% submitted a formal complaint, and 2.1% made a claim for financial compensation. People wanted treatment or care to redress the harm (44.4%) and an explanation (34.8%). Two-thirds of those making a complaint felt it was not handled well and approximately half were satisfied with PALS. Experiences and responses differed according to sex and age (eg, women reported more harm). People with long-term illness or disability, those in lower social grades, and people in other disadvantaged groups reported higher rates and more severe impact of harm.

Conclusions

We found that 9.7% of the British general population reported harm by the NHS, a higher rate than reported in two previous surveys. Our study used a broader and more inclusive definition of harm and was conducted during the COVID-19 pandemic, making comparison to previous surveys challenging. People responded to harm in different ways, such as sharing experiences with others and seeking professional advice and support. Mostly, people who were harmed wanted help to redress the harm or to gain access to the care needed. Low satisfaction with PALS and complaints services may reflect that these services do not always deliver the required support. There is a need to better understand the patient perspective following harm and for further consideration of what a person-centred approach to resolution and recovery might look like.

Randomised controlled trial of audit-and-feedback strategies to reduce imaging overutilisation in the emergency department

Quality and Safety in Health Care Journal -

Background

Evaluation of neck trauma is a common reason for emergency department (ED) visits. There are several validated clinical decision rules, such as the National Emergency X-Radiography Utilization Study (NEXUS) Cervical Spine (C-spine) Rule, that can be used to risk stratify these patients and identify low-risk patients who do not require CT imaging. Overutilisation of CT imaging exposes patients to unnecessary radiation, impairs hospital throughput and increases healthcare costs. Various audit-and-feedback strategies have been described in other settings, but it is not known whether these strategies are effective for reducing imaging overutilisation in the ED. Additionally, the effectiveness of face-to-face feedback strategies as compared with digital feedback strategies for addressing this problem has not been previously evaluated. The aim of this study was to compare audit-and-feedback strategies to reduce CT overutilisation in the ED.

Methods

This was a prospective randomised controlled trial, in which emergency medicine clinicians were randomised into three arms to receive digital feedback, hybrid face-to-face/digital feedback or no feedback. Each clinician received three rounds of feedback on patient encounters in which they ordered a CT of the C-spine. Patient encounters were retrospectively reviewed to determine each clinician’s overutilisation rate, defined as the percentage of patients who underwent CT of the C-spine despite being classified as low risk by NEXUS criteria.

Results

A total of 78 emergency medicine clinicians were randomised into three arms. Baseline overutilisation rates for each group were 46%–47% of CT of the C-spine studies. After three rounds of audit-and-feedback strategy, the clinicians in the digital feedback group had an overutilisation rate of 33%, compared with 44% in the control group (p=0.020). The hybrid feedback group had an overutilisation rate of 36% (p=0.055 vs control; p=0.577 vs digital feedback). Over the study period, the digital group saw a reduction of 1.26 CT of the C-spine studies per provider per month (p=0.049), and the hybrid feedback group saw a reduction of 1.43 CTs per provider per month (p=0.044).

Conclusion

A digital audit-and-feedback strategy is effective for reducing overutilisation of CT imaging of the C-spine in the ED, while the effectiveness of a hybrid strategy requires further investigation.

Does the use of structured interventions to guide ward rounds affect patient outcomes? A systematic review

Quality and Safety in Health Care Journal -

Background

Ward rounds are an essential activity occurring in hospital settings. Despite their fundamental role in guiding patient care, they have no standardised approach. Implementation of structured interventions during ward rounds was shown to improve outcomes such as efficiency, documentation and communication. Whether these improvements have an impact on clinical outcomes is unclear. Our systematic review assessed whether structured interventions to guide ward rounds affect patient outcomes.

Methods

A systematic search was carried out in May 2023 on Embase, Medline, CINAHL, ERIC, Web of Science Core Collection, the Cochrane Library (Wiley) and Google Scholar, and a backward and forward citation search in January 2024. We included peer-reviewed, original studies assessing the use of structured interventions during bedside ward rounds (BWRs) on clinical outcomes. All inpatient hospital settings where BWRs are performed were included. We excluded papers looking at board, teaching or medication rounds.

Results

Our search strategy yielded 29 studies. Two were randomised controlled trials (RCTs) and 27 were quasi-experimental interventional studies. The majority (79%) were conducted in intensive care units. The main clinical outcomes reported were mortality, infectious complications, length of stay (LOS) and duration of mechanical ventilation (DoMV). Mortality, LOS and rates of urinary tract and central-line associated bloodstream infections did not seem to be affected, positively or negatively, by interventions structuring BWRs, while evidence was conflicting regarding their effects on rates of ventilator-associated pneumonia and DoMV, with a signal towards improved outcomes. Studies were generally of low-to-moderate quality.

Conclusion

The impact of structured interventions during BWRs on clinical outcomes remains inconclusive. Higher quality research focusing on multicentric RCTs or on prospective pre–post trials with concurrent cohorts, matched for key characteristics, is needed.

PROSPERO registration number

CRD42023412637.

Integrating equity into incident reporting and patient concerns systems: a critical interpretive synthesis

Quality and Safety in Health Care Journal -

Background

Hospital incident reporting and patient concerns systems are widely used to detect and respond to patient harm. Despite increasing recognition of the link between equity and safety, equity remains poorly integrated into the design and function of these systems. Consequently, these systems risk obscuring or reproducing inequities rather than revealing and attending to them.

Objective

To examine how issues of equity are currently considered in research about hospital incident reporting and patient concerns systems and identify opportunities to more systematically include equity in how patient safety is addressed.

Methods

A critical interpretive synthesis was conducted to develop a theoretical understanding of the topic through inductive analysis and interpretation. The databases CINAHL, EMBASE, MEDLINE and PsycINFO were searched from database inception to 6 February 2024. Select social science, patient safety and health services literature supported the interpretive process.

Results

After screening 6508 abstracts and conducting hand searches, we included 30 articles in our review. Our analysis identified four equity-related themes. The first theme describes how knowledge injustices in ‘what counts as a safety event or contributor’ shape what patient issues are recognised, recorded and addressed. The second theme examines how individual bias and systemic discrimination affect which safety events and concerns get reported. The third theme explores both opportunities and limitations of stratifying data to uncover equity-related patterns of harm. The fourth theme presents alternate frameworks, including restorative and human rights approaches, as ways to address inequities and humanise harm.

Conclusion

The findings provide direction for changes within incident reporting and patient concerns practices (eg, expanding definitions of harms; creating accessible and culturally safe patient concerns systems). They also affirm the opportunity to learn from, and build on, initiatives such as taking a restorative approach that moves beyond a customer service and risk management framing.

Pages

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