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Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

FDA MedWatch -

FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis with advanced cirrhosis of the liver because some patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure

Safe care on maternity units: a multidimensional balancing act

Quality and Safety in Health Care Journal -

What are the key features of hospitals that consistently deliver safe care on labour and delivery? This is the primary question posed by Liberati and colleagues in this issue of BMJ Quality & Safety.1 The authors propose a framework distilled from observations on a group of high-performing units in the UK participating in a training activity to improve patient safety. This study combined ethnography with individual interviews and focus groups and involved over 400 hours of total observations at six different maternity care sites. The seven features in their resulting For Us framework correspond well to existing theoretical as well as applied quality improvement strategies. While we agree that their framework describes features that every labour and delivery unit should strive to include, this approach has some limitations in terms of generalisability. Specifically, Liberati and colleagues studied maternity units that are high performing, but their sample included...

Healthcare-associated infections: where we came from and where we are headed

Quality and Safety in Health Care Journal -

Healthcare-associated infections (HCAIs) are those infections acquired by an individual who is seeking medical care in any healthcare facility, including acute care hospitals, long-term care facilities (including nursing homes), outpatient surgical centres, dialysis centres or ambulatory care clinics.1 They are further defined as occurring at least 48 hours after hospitalisation or within 30 days of receiving medical care.2 HCAIs have plagued hospitals, physicians and patients for centuries and likely played a role in the reputation that hospitals historically had as dangerous places.3 In the mid-19th century, Ignaz Semmelweis observed that labouring mothers in an obstetrics unit had a high incidence of Puerperal (Childbed) fever, which he thought was related to direct contact with medical students. After working with cadavers, students often moved directly from the anatomy lab to the hospital, leading Semmelweis to postulate that students were contaminated and bringing a pathogen into...

Seven features of safety in maternity units: a framework based on multisite ethnography and stakeholder consultation

Quality and Safety in Health Care Journal -

Background

Reducing avoidable harm in maternity services is a priority globally. As well as learning from mistakes, it is important to produce rigorous descriptions of ‘what good looks like’.

Objective

We aimed to characterise features of safety in maternity units and to generate a plain language framework that could be used to guide learning and improvement.

Methods

We conducted a multisite ethnography involving 401 hours of non-participant observations 33 semistructured interviews with staff across six maternity units, and a stakeholder consultation involving 65 semistructured telephone interviews and one focus group.

Results

We identified seven features of safety in maternity units and summarised them into a framework, named For Us (For Unit Safety). The features include: (1) commitment to safety and improvement at all levels, with everyone involved; (2) technical competence, supported by formal training and informal learning; (3) teamwork, cooperation and positive working relationships; (4) constant reinforcing of safe, ethical and respectful behaviours; (5) multiple problem-sensing systems, used as basis of action; (6) systems and processes designed for safety, and regularly reviewed and optimised; (7) effective coordination and ability to mobilise quickly. These features appear to have a synergistic character, such that each feature is necessary but not sufficient on its own: the features operate in concert through multiple forms of feedback and amplification.

Conclusions

This large qualitative study has enabled the generation of a new plain language framework—For Us—that identifies the behaviours and practices that appear to be features of safe care in hospital-based maternity units.

Association between intrahospital transfer and hospital-acquired infection in the elderly: a retrospective case-control study in a UK hospital network

Quality and Safety in Health Care Journal -

Background

Intrahospital transfers have become more common as hospital staff balance patient needs with bed availability. However, this may leave patients more vulnerable to potential pathogen transmission routes via increased exposure to contaminated surfaces and contacts with individuals.

Objective

This study aimed to quantify the association between the number of intrahospital transfers undergone during a hospital spell and the development of a hospital-acquired infection (HAI).

Methods

A retrospective case–control study was conducted using data extracted from electronic health records and microbiology cultures of non-elective, medical admissions to a large urban hospital network which consists of three hospital sites between 2015 and 2018 (n=24 240). As elderly patients comprise a large proportion of hospital users and are a high-risk population for HAIs, the analysis focused on those aged 65 years or over. Logistic regression was conducted to obtain the OR for developing an HAI as a function of intrahospital transfers until onset of HAI for cases, or hospital discharge for controls, while controlling for age, gender, time at risk, Elixhauser comorbidities, hospital site of admission, specialty of the dominant healthcare professional providing care, intensive care admission, total number of procedures and discharge destination.

Results

Of the 24 240 spells, 2877 cases were included in the analysis. 72.2% of spells contained at least one intrahospital transfer. On multivariable analysis, each additional intrahospital transfer increased the odds of acquiring an HAI by 9% (OR=1.09; 95% CI 1.05 to 1.13).

Conclusion

Intrahospital transfers are associated with increased odds of developing an HAI. Strategies for minimising intrahospital transfers should be considered, and further research is needed to identify unnecessary transfers. Their reduction may diminish spread of contagious pathogens in the hospital environment.

Removing hospital-based triage from suspected colorectal cancer pathways: the impact and learning from a primary care-led electronic straight-to-test pathway

Quality and Safety in Health Care Journal -

Background

The 2-week wait referral pathway for suspected colorectal cancer was introduced in England to improve time from referral from a general practitioner (GP) to diagnosis and treatment. Patients are required to be seen by a hospital clinician within 2 weeks if their symptoms meet the criteria set by the National Institute for Health and Care Excellence (NICE) and to start cancer treatment within 62 days. To achieve this, many hospitals have introduced a straight-to-test (STT) strategy requiring hospital-based triage of referrals. We describe the impact and learning from a new pathway which has removed triage and moved the process of requesting tests from hospital to GPs in primary care.

Method

An electronic STT pathway was introduced allowing GPs to book tests supported by a decision aid based on NICE guidance eliminating the need for a standard referral form or triage process. The hospital identified referrals as being on a cancer pathway and dealt with all ongoing management. Routinely collected cancer data were used to identify time to cancer diagnosis compared with national data

Results

11357 patients were referred via the new pathway over 3 years. Time from referral to diagnosis reduced from 39 to 21 days and led to a dramatic improvement in patients starting treatment within 62 days. Challenges included adapting to a change in referral criteria and developing a robust hospital system to monitor the pathway.

Conclusion

We have changed the way patients with suspected colorectal cancer are managed within the National Health Service by giving GPs the ability to order tests electronically within a monitored cancer pathway halving time from referral to diagnosis

Changing hospital organisational culture for improved patient outcomes: developing and implementing the leadership saves lives intervention

Quality and Safety in Health Care Journal -

Background

Leadership Saves Lives (LSL) was a prospective, mixed methods intervention to promote positive change in organisational culture across 10 diverse hospitals in the USA and reduce mortality for patients with acute myocardial infarction (AMI). Despite the potential impact of complex interventions such as LSL, descriptions in the peer-reviewed literature often lack the detail required to allow adoption and adaptation of interventions or synthesis of evidence across studies. Accordingly, here we present the underlying design principles, overall approach to intervention design and core content of the intervention.

Methods of intervention development

Hospitals were selected for participation from the membership of the Mayo Clinic Care Network using random sampling with a purposeful component. The intervention was designed based on the Assess, Innovate, Develop, Engage, Devolve model for diffusion of innovation, with attention to pressure testing of the intervention with user groups, creation of a think tank to develop a comprehensive assessment of the landscape, and early and continued engagement with strategically identified stakeholders in multiple arenas.

Results

We provide in-depth descriptions of the design and delivery of the three intervention components (three annual meetings of all hospitals, four rounds of in-hospital workshops and an online community), designed to equip a guiding coalition within each site to identify and address root causes of AMI mortality and improve organisational culture.

Conclusions

This detailed practical description of the intervention may be useful for healthcare practitioners seeking to promote organisational culture change in their own contexts, researchers seeking to compare the results of the intervention with other leadership development and organisational culture change efforts, and healthcare professionals committed to understanding complex interventions across healthcare settings.

Identifying and encouraging high-quality healthcare: an analysis of the content and aims of patient letters of compliment

Quality and Safety in Health Care Journal -

Background

Although healthcare institutions receive many unsolicited compliment letters, these are not systematically conceptualised or analysed. We conceptualise compliment letters as simultaneously identifying and encouraging high-quality healthcare. We sought to identify the practices being complimented and the aims of writing these letters, and we test whether the aims vary when addressing front-line staff compared with senior management.

Methods

A national sample of 1267 compliment letters was obtained from 54 English hospitals. Manual classification examined the practices reported as praiseworthy, the aims being pursued and who the letter was addressed to.

Results

The practices being complimented were in the relationship (77% of letters), clinical (50%) and management (30%) domains. Across these domains, 39% of compliments focused on voluntary non-routine extra-role behaviours (eg, extra-emotional support, staying late to run an extra test). The aims of expressing gratitude were to acknowledge (80%), reward (44%) and promote (59%) the desired behaviour. Front-line staff tended to receive compliments acknowledging behaviour, while senior management received compliments asking them to reward individual staff and promoting the importance of relationship behaviours.

Conclusions

Compliment letters reveal that patients value extra-role behaviour in clinical, management and especially relationship domains. However, compliment letters do more than merely identify desirable healthcare practices. By acknowledging, rewarding and promoting these practices, compliment letters can potentially contribute to healthcare services through promoting desirable behaviours and giving staff social recognition.

Observational study assessing changes in timing of readmissions around postdischarge day 30 associated with the introduction of the Hospital Readmissions Reduction Program

Quality and Safety in Health Care Journal -

Background

The Hospital Readmissions Reduction Program (HRRP) initially penalised hospitals for excess readmission within 30 days of discharge for acute myocardial infarction (AMI), congestive heart failure (CHF) or pneumonia (PNA) and was expanded in subsequent years to include readmissions for chronic obstructive pulmonary disease, elective total hip arthroplasty, total knee arthroplasty and coronary artery bypass graft surgery. We assessed whether HRRP was associated with delays in readmissions from immediately before the 30-day penalty threshold to just after it.

Methods

We included Medicare fee-for-service beneficiaries discharged between 1 January 2007 and 31 October 2015. Readmissions were assessed until December 31, 2015. The study period was divided into three phases: January 2007 to March 2009 (pre-HRRP), April 2009 to September 2012 (implementation) and October 2012 to December 2015 (penalty). We estimated additional readmissions between postdischarge days 31–35 compared with days 26–30 using a negative binomial difference-in-differences model, comparing target HRRP versus non-HRRP conditions at the same hospital in the same month in the pre-HRRP and penalty phases.

Results

HRRP was not associated with a significant difference in AMI readmissions between postdischarge days 31–35 versus postdischarge days 26–30 for each hospital in the penalty phase, as compared with non-HRRP conditions and the pre-HRRP phase (p=0.19). There were statistically significant increases in readmissions CHF (0.040%, 95% CI 0.024% to 0.056%, p<0.01), PNA (0.022%, 95% CI 0.002% to 0.042%, p=0.03) and stroke (0.035%, 95% CI 0.010% to 0.060%, p<0.01); however, these readmissions represent <0.01% of readmissions during this time period.

Conclusion

We did not identify consistently significant associations between HRRP and delayed readmissions, and importantly, any findings suggesting delayed readmissions were extremely small and unlikely to be clinically relevant.

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