50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated d
ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tab
A slow but significant change has occurred in how healthcare professionals and organisations are expected to respond when something has gone wrong in a patient’s care.1 In 2001, the US accreditation organisation The Joint Commission began to require that healthcare facilities disclose all outcomes of care, including ‘unanticipated outcomes’, to patients.2 Over time and across the world, the need to be transparent with patients and families when care has not gone well is now recognised as a key element of high-quality, safe and patient-centred healthcare. In 2020, the US National Steering Committee for Patient Safety released ‘Safer Together: A National Action Plan to Advance Patient Safety’.3 One recommendation was that organisations ‘implement and maintain programmes for providing appropriate ongoing support in the aftermath of harm’. The following year, the WHO’s ‘Global Patient Safety Action Plan 2021–2030’ emphasised the need to ‘Establish the principle...
Patients are vulnerable during emergency episodes outside the formal care sector, for example, care provided by paramedics responding to a stroke or heart attack at home. Yet much less is known about the safety of Emergency Medical Services (EMS) as compared with primary or secondary healthcare.1 This relative lack of information is important given there are aspects of EMS care that create unique patient safety challenges. EMS staff are not surrounded by the usual safety infrastructure one finds in hospitals or community facilities. The episodic nature of each interaction means EMS staff lack the information one finds in more predictable care contexts. Even in highly developed EMS systems, patient history will be unavailable. This results in an almost complete reliance on the patient, family/carer or bystander to describe pertinent clinical history such as ‘do not resuscitate’ plans for the patient, or how the current emergency...
Too often, seemingly simple interventions are implemented without fully considering how the intervention might achieve the desired results, whether it can cause harm, or whether a different intervention should be considered.1–3 The tendency to favour rapid cycle implementation over analysis and measurement represents a common pitfall in quality and safety studies.4 Quality improvement and patient safety (QIPS) studies often omit the critical details underlying the success (or lack thereof) of the intervention, in part due to the perception that simple interventions do not require rigorous measurement.3 4 Consequently, reported measures often solely focus on the outcomes rather than the mechanisms and processes that led to the outcomes.
For instance, suppose you are doing rounds at your healthcare setting. You notice a blue flower next to your patient’s name on the electronic whiteboard, but you are unsure what...
In 2008, the Sickle Cell Society of the UK published clinical standards for the care of adults with sickle cell disease (SCD).1 Over the subsequent decade, nations including France, Nigeria and the USA also published national guidelines for the management of SCD across the lifespan. However, studies have repeatedly demonstrated that patients are not consistently receiving this evidence-based care, and that up to a third of providers in the USA are unaware of the guidelines.2
The barriers to appropriate care of individuals with SCD are complex, given the wide range of manifestations of the disease,1 the scarcity of haematology and primary care providers and multidisciplinary team members,2 and complex sociopolitical factors including medical racism and the significant bias that individuals with SCD experience in healthcare settings and the community.3 In sub-Saharan Africa and India, where the vast majority of...
Extensive research has been conducted into the effects of feedback interventions within many areas of healthcare, but prehospital emergency care has been relatively neglected. Exploratory work suggests that enhancing feedback and follow-up to emergency medical service (EMS) staff might provide staff with closure and improve clinical performance. Our aim was to summarise the literature on the types of feedback received by EMS professionals and its effects on the quality and safety of patient care, staff well-being and professional development.Methods
A systematic review and meta-analysis, including primary research studies of any method published in peer-reviewed journals. Studies were included if they contained information on systematic feedback to emergency ambulance staff regarding their performance. Databases searched from inception were MEDLINE, Embase, AMED, PsycINFO, HMIC, CINAHL and Web of Science, with searches last updated on 2 August 2022. Study quality was appraised using the Mixed Methods Appraisal Tool. Data analysis followed a convergent integrated design involving simultaneous narrative synthesis and random effects multilevel meta-analyses.Results
The search strategy yielded 3183 articles, with 48 studies meeting inclusion criteria after title/abstract screening and full-text review. Interventions were categorised as audit and feedback (n=31), peer-to-peer feedback (n=3), postevent debriefing (n=2), incident-prompted feedback (n=1), patient outcome feedback (n=1) or a combination thereof (n=4). Feedback was found to have a moderate positive effect on quality of care and professional development with a pooled effect of d=0.50 (95% CI 0.34, 0.67). Feedback to EMS professionals had large effects in improving documentation (d=0.73 (0.00, 1.45)) and protocol adherence (d=0.68 (0.12, 1.24)), as well as small effects in enhancing cardiac arrest performance (d=0.46 (0.06, 0.86)), clinical decision-making (d=0.47 (0.23, 0.72)), ambulance times (d=0.43 (0.12, 0.74)) and survival rates (d=0.22 (0.11, 0.33)). The between-study heterogeneity variance was estimated at 2=0.32 (95% CI 0.22, 0.50), with an I2 value of 99% (95% CI 98%, 99%), indicating substantial statistical heterogeneity.Conclusion
This review demonstrated that the evidence base currently does not support a clear single point estimate of the pooled effect of feedback to EMS staff as a single intervention type due to study heterogeneity. Further research is needed to provide guidance and frameworks supporting better design and evaluation of feedback interventions within EMS.PROSPERO registration number
Surveys based on hypothetical situations suggest that health-care providers agree that disclosure of errors and adverse events to patients and families is a professional obligation but do not always disclose them. Disclosure rates and reasons for the choice have not previously been studied.Objective
To measure the proportion of errors disclosed by neonatal intensive care unit (NICU) professionals to parents and identify motives for and barriers to disclosure.Design
Prospective, observational study nested in a randomised controlled trial (Study on Preventing Adverse Events in Neonates (SEPREVEN); ClinicalTrials.gov). Event disclosure was not intended to be related to the intervention tested.Setting
10 NICUs in France with a 20-month follow-up, starting November 2015.Participants
n=1019 patients with NICU stay ≥2 days with ≥1 error.Exposure
Characteristics of errors (type, severity, timing of discovery), patients and professionals, self-reported motives for disclosure and non-disclosure.Main outcome and measures
Rate of error disclosure reported anonymously and voluntarily by physicians and nurses; perceived parental reaction to disclosure.Results
Among 1822 errors concerning 1019 patients (mean gestational age: 30.8±4.5 weeks), 752 (41.3%) were disclosed. Independent risk factors for non-disclosure were nighttime discovery of error (OR 2.40; 95% CI 1.75 to 3.30), milder consequence (for moderate consequence: OR 1.85; 95% CI 0.89 to 3.86; no consequence: OR 6.49; 95% CI 2.99 to 14.11), a shorter interval between admission and error, error type and fewer beds. The most frequent reported reasons for non-disclosure were parental absence at its discovery and a perceived lack of serious consequence.Conclusion and relevance
In the particular context of the SEPREVEN randomised controlled trial of NICUs, staff did not disclose the majority of errors to parents, especially in the absence of moderate consequence for the infant.Trial registration number
Hospitalised people with dementia (PwD) experience worse care and more patient safety incidents than non-dementia patients. Visual identifiers are commonly used to identify patients who have a diagnosis of dementia, with the aim of promoting more personalised care. However, little is known about how they work in practice, nor about the potential unintended consequences that might arise from their use. We aim to identify the mechanisms through which visual identifiers could support good care for PwD, how and why their use may have negative consequences and the conditions for their effective use.Methods
We conducted interviews with 21 dementia leads and healthcare professionals, 19 carers and two PwD, and produced case studies of visual identification systems in four UK acute hospital trusts between 2019 and 2021. Analysis drew on the concept of classification to identify and explore mechanisms of action.Results
We identified four mechanisms through which visual identifiers could help towards providing good care for PwD: enabling coordination of care at organisational level; signalling eligibility for dementia-specific interventions; informing prioritisation of resources on wards; and acting as a quick reference cue for staff. But identifier effectiveness could be undermined by: lack of standardisation and consistency; a lack of closely coupled information about individual needs; and stigma associated with a dementia diagnosis. Identifier effectiveness was dependent on their implementation being supported through staff training, resources directed and efforts to develop a supportive culture for caring for this patient group.Conclusion
Our research highlights the potential mechanisms of action of visual identifiers and their possible negative consequences. Optimising the use of identifiers requires consensus on the rules of classification and the symbols used, and closely coupled patient information. Organisations need to provide support, offer the right resources and training and engage meaningfully with carers and patients about the use of identifiers.
Hydroxyurea (HU) is an effective but underused disease-modifying therapy for patients with sickle cell anaemia (SCA). EMBRACE SCD, a sickle cell disease treatment demonstration project, aimed to improve access to HU by increasing prescription (Rx) rates by at least 10% from baseline in children with SCA.
The Model for Improvement was used as the quality improvement framework. HU Rx was assessed from clinical databases in three paediatric haematology centres. Children aged 9 months–18 years with SCA not on chronic transfusions were eligible for HU treatment. The health belief model was the conceptual framework to discuss with patients and promote HU acceptance. A visual aid showing erythrocytes under the effect of HU and the American Society of Hematology HU brochure were used as educational tools. At least 6 months after offering HU, a Barrier Assessment Questionnaire was given to assess reasons for HU acceptance and refusals. If HU was declined, the providers discussed with family again. We conducted chart audits to find missed opportunities to prescribe HU as one plan–do–study–act cycle.
At initial measurement, 50.2% of 524 eligible patients had HU prescribed. During the testing and initial implementation phase, the mean performance after 10 data points was 53%. After 2 years, the mean performance was 59%, achieving an 11% increase in mean performance and a 29% increase from initial to the last measurement (64.8% HU Rx). During a 15-month period, 32.1% (N=168) of the eligible patients who were offered HU completed the barrier questionnaire with 19% (N=32) refusing HU, mostly based on not perceiving enough severity of their children’s SCA or fearing side effects.
Reviewing patient charts for missed opportunity of offering HU with feedback and evaluating the reasons of declining HU via a questionnaire were key components in increasing HU Rx in our population.