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IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance

FDA MedWatch -

Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting

I-PASS handover system: a decade of evidence demands action

Quality and Safety in Health Care Journal -

In this issue of BMJ Quality and Safety, Jorro-Barón and colleagues1 report the findings of a stepped-wedge cluster randomised trial (SW-CRT) to evaluate the implementation of the I-PASS handover system among six paediatric intensive care units (PICUs) at five Argentinian hospitals between July 2018 and May 2019. According to the authors, prior to the intervention there were complaints that handovers were ‘...lengthy, disorganized, ...participants experienced problems with interruptions, distractions, and ... senior professionals had problems accepting dissent’.

Adverse events were assessed by two independent reviewers using the Global Assessment of Pediatric Patient Safety instrument. Study results demonstrated significantly improved handover compliance in the intervention group, validating Kirkpatrick Level 3 (behavioural change)2 effectiveness of the training initiative. Notably, however, on the primary outcome there were no differences between control and intervention groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention...

Implementing automated prognostic models to inform palliative care: more than just the algorithm

Quality and Safety in Health Care Journal -

Palliative care is associated with improved patient-centred and caregiver-centred outcomes, higher-quality end-of-life care, and decreased healthcare use among patients with serious illness.1–3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or ‘triggers’), including a projected survival of less than 1 year,4 to help clinicians identify patients likely to benefit from palliative care. Nevertheless, referrals often occur within the last 3 months of life5 due in part to clinician overestimation of prognosis.6 A growing number of automated predictive models leverage vast data in the electronic medical record (EMR) to accurately predict short-term mortality risk in real time and can be paired with systems to prompt clinicians to refer to palliative care.7–12 These models hold great promise to overcome the many clinician-level...

No one left behind: a case for more inclusivity in authorship for quality improvement and implementation research

Quality and Safety in Health Care Journal -

Authorship has long been seen as the coin of the realm in academic medicine. Students seek publications on their resumes, faculty get promoted at least in part based on publication volume and impact and anyone who succeeds in authoring a publication points proudly to the external recognition that legitimises their work. So, what happens when a new type of science that involves rapid tests of change, diverse team members and the realities of shifting institutional priorities becomes a prevalent and acceptable form of scholarship in healthcare? Philips and colleagues in this issue of BMJ Quality & Safety, argue how authorship determination in quality improvement (QI) and implementation research warrants a unique approach compared with traditional human subjects research where authorship has been discussed extensively.1 Their Viewpoint highlights the International Committee of Medical Journal Editors (ICMJE) guidelines for authorship and notes the subjectivity of the guideline criteria that...

Handoff improvement and adverse event reduction programme implementation in paediatric intensive care units in Argentina: a stepped-wedge trial

Quality and Safety in Health Care Journal -

Background

There are only a few studies on handoff quality and adverse events (AEs) rigorously evaluating handoff improvement programmes’ effectiveness. None of them have been conducted in low and middle-income countries. We aimed to evaluate the effect of a handoff programme implementation in reducing AE frequency in paediatric intensive care units (PICUs).

Methods

Facility-based, cluster-randomised, stepped-wedge trial in six Argentine PICUs in five hospitals, with >20 admissions per month. The study was conducted from July 2018 to May 2019, and all units at least were involved for 3 months in the control period and 4 months in the intervention period. The intervention comprised a Spanish version of the I-PASS handoff bundle consisting of a written and verbal handoff using mnemonics, an introductory workshop with teamwork training, an advertising campaign, simulation exercises, observation and standardised feedback of handoffs. Medical records (MR) were reviewed using trigger tool methodology to identify AEs (primary outcome). Handoff compliance and duration were evaluated by direct observation.

Results

We reviewed 1465 MRs: 767 in the control period and 698 in the intervention period. We did not observe differences in the rates of preventable AE per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention 60.4 (33.2–109.9), p=0.99, risk ratio: 1.0 (0.74–1.34)), and no changes in the categories or AE types. We evaluated 841 handoffs: 396 in the control period and 445 in the intervention period. Compliance with all items in the verbal and written handoffs was significantly higher in the intervention group. We observed no difference in the handoff time in both periods (control 35.7 min (29.6–41.8) vs intervention 34.7 min (26.5–42.1); difference 1.43 min (95% CI –2.63 to 5.49, p=0.49)). The providers’ perception of improved communication did not change.

Conclusions

After the implementation of the I-PASS bundle, compliance with handoff items improved. Nevertheless, no differences were observed in the AEs’ frequency or the perception of enhanced communication.

Trial registration number

NCT03924570

Barriers and enablers to the implementation of multidisciplinary team meetings: a qualitative study using the theoretical domains framework

Quality and Safety in Health Care Journal -

Background

Evidence-based clinical practice guidelines recommend discussion by a multidisciplinary team (MDT) to review and plan the management of patients for a variety of cancers. However, not all patients diagnosed with cancer are presented at an MDT.

Objectives

(1) To identify the factors (barriers and enablers) influencing presentation of all patients to, and the perceived value of, MDT meetings in the management of patients with pancreatic cancer and; (2) to identify potential interventions that could overcome modifiable barriers and enhance enablers using the theoretical domains framework (TDF).

Methods

Semistructured interviews were conducted with radiologists, surgeons, medical and radiation oncologists, gastroenterologists, palliative care specialists and nurse specialists based in New South Wales and Victoria, Australia. Interviews were conducted either in person or via videoconferencing. All interviews were recorded, transcribed verbatim, deidentified and data were thematically coded according to the 12 domains explored within the TDF. Common belief statements were generated to compare the variation between participant responses.

Results

In total, 29 specialists were interviewed over a 4-month period. Twenty-two themes and 40 belief statements relevant to all the TDF domains were generated. Key enablers influencing MDT practices included a strong organisational focus (social/professional role and identity), beliefs about the benefits of an MDT discussion (beliefs about consequences), the use of technology, for example, videoconferencing (environmental context and resources), the motivation to provide good quality care (motivation and goals) and collegiality (social influences). Barriers included: absence of palliative care representation (skills), the number of MDT meetings (environmental context and resources), the cumulative cost of staff time (beliefs about consequences), the lack of capacity to discuss all patients within the allotted time (beliefs about capabilities) and reduced confidence to participate in discussions (social influences).

Conclusions

The internal and external organisational structures surrounding MDT meetings ideally need to be strengthened with the development of agreed evidence-based protocols and referral pathways, a focus on resource allocation and capabilities, and a culture that fosters widespread collaboration for all stages of pancreatic cancer.

Publication of inspection frameworks: a qualitative study exploring the impact on quality improvement and regulation in three healthcare settings

Quality and Safety in Health Care Journal -

Background

The Dutch healthcare inspectorate publishes its inspection frameworks to inform both the public and healthcare providers about regulatory procedures and in the hope that publication will motivate healthcare providers to improve quality and comply with standards. This study explores the consequences of publishing these frameworks for the regulation of quality and safety in healthcare.

Methods

We selected recently published inspection frameworks used in three healthcare settings: nursing home care, dental care and hospital care. We conducted 37 interviews with 39 respondents (healthcare professionals, managers, quality officers, policy advisers and inspectors) and explored their awareness of and experiences with these frameworks. We held a group interview with three inspectors to reflect on our findings. All data underwent thematic content analysis.

Results

We found that the institutional infrastructure of a sector plays an important role in how an inspection framework is used after publication; particularly the presence and maturity of quality improvement work in the sector and the inspectorate’s grip on a sector matter. Respondents mentioned differences in framework use in organisational contexts, particularly relating to scale. In some organisations, the framework served as an accountability mechanism to check if quality meets basic standards, while in other organisations professionals adopted it to stimulate discussion and learning across teams.

Conclusion

Publication of inspection frameworks might result in quality improvement work, and in particular contexts could be used as a regulatory strategy to target quality improvement in a healthcare sector. For this, it is important that regulators consider the capabilities and possibilities for learning and improving within a sector.

Visual mapping of team dynamics and communication patterns on surgical ward rounds: an ethnographic study

Quality and Safety in Health Care Journal -

Background

The effect of team dynamics on infection management and antimicrobial stewardship (AMS) behaviours is not well understood. Using innovative visual mapping, alongside traditional qualitative methods, we studied how surgical team dynamics and communication patterns influence infection-related decision making.

Materials/methods

Between May and November 2019, data were gathered through direct observations of ward rounds and face-to-face interviews with ward round participants in three high infection risk surgical specialties at a tertiary hospital in South Africa. Sociograms, a visual mapping method, mapped content and flow of communication and the social links between participants. Data were analysed using a grounded theory approach.

Results

Data were gathered from 70 hours of ward round observations, including 1024 individual patient discussions, 60 sociograms and face-to-face interviews with 61 healthcare professionals. AMS and infection-related discussions on ward rounds vary across specialties and are affected by the content and structure of the clinical update provided, consultant leadership styles and competing priorities at the bedside. Registrars and consultants dominate the discussions, limiting the input of other team members with recognised roles in AMS and infection management. Team hierarchies also manifest where staff position themselves, and this influences their contribution to active participation in patient care. Leadership styles affect ward-round dynamics, determining whether nurses and patients are actively engaged in discussions on infection management and antibiotic therapy and whether actions are assigned to identified persons.

Conclusions

The surgical bedside ward round remains a medium of communication between registrars and consultants, with little interaction with the patient or other healthcare professionals. A team-focused and inclusive approach could result in more effective decision making about infection management and AMS.

Effectiveness of a multifaceted intervention to improve emergency department care of low back pain: a stepped-wedge, cluster-randomised trial

Quality and Safety in Health Care Journal -

Background

Overuse of lumbar imaging is common in the emergency department (ED). Few trials have examined interventions to address this. We evaluated the effectiveness of a multifaceted intervention to implement guideline recommendations for low back pain in the emergency department.

Methods

We conducted a stepped-wedge, cluster-randomised trial in four EDs in New South Wales, Australia. After a 13-month control phase of usual care, the EDs received a multifaceted intervention to support guideline-endorsed care in a random order, based on a computer-generated random sequence, every 4 weeks over a 4-month period. All sites were followed up for at least 3 months. The primary outcome was the proportion of low back pain presentations receiving lumbar imaging. Secondary healthcare utilisation outcomes included prescriptions of opioid and non-opioid pain medicines, inpatient admissions, length of ED stay, specialist referrals and re-presentations. Clinician beliefs and knowledge about low back pain care were measured before and after the intervention. Patient-reported pain, disability, quality of life and satisfaction were measured at 1, 2 and 4 weeks post ED presentation.

Results

A total of 269 ED clinicians and 4625 episodes of care for low back pain (4491 patients) were included. The data did not provide clear evidence that the intervention reduced lumbar imaging (OR 0.77; 95% CI 0.47 to 1.26; p=0.29). It did reduce opioid use (OR 0.57; 95% CI 0.38 to 0.85; p=0.006) and improved clinicians’ beliefs (mean difference (MD), 2.85; 95% CI 1.85 to 3.85; p<0.001; on a scale from 9 to 45) and knowledge about low back pain care (MD, 0.48; 95% CI 0.13 to 0.83; p<0.01; on a scale from 0 to 11). There was no difference in pain scores at 1-week follow-up (MD, 0.04; 95% CI –1.00 to 1.08; p=0.94; on a scale from 0 to 10). A similar trend was observed for all other patient-reported outcomes and time points. This study found no effect on the other secondary healthcare utilisation outcomes.

Conclusion

It is uncertain if a multifaceted intervention to implement guideline recommendations for low back pain care decreased lumbar imaging in the ED; however, it did reduce opioid prescriptions without adversely affecting patient outcomes.

Trial registration number ACTRN12617001160325.

mHOMR: the acceptability of an automated mortality prediction model for timely identification of patients for palliative care

Quality and Safety in Health Care Journal -

Introduction

Patients with non-cancer serious illnesses are under-recognised and receive palliative care only in the final weeks of life, if at all.1 The modified Hospitalised-patient One-year Mortality Risk (mHOMR) tool is a computer-based mortality prediction tool that accurately identifies patients at risk of 1-year mortality and is a feasible alternative to healthcare provider (HCP)-dependent models.2 Briefly, the tool uses data from the electronic health record to calculate an mHOMR score for each new hospital admission. The alert only notifies the lead physician, suggesting they refer the patient topalliative care and does not provide the actual score.2 In this study, we sought the perspectives of patients, family members, and HCPs to identify acceptability of mHOMR as a mortality risk tool. Together, these two studies represent the feasibility and acceptability components of the implementation outcomes (IO) framework.3

Methods

Previously we...

Approach to authorship for quality improvement and implementation research

Quality and Safety in Health Care Journal -

In 1999, the Institute of Medicine (IOM) unveiled the dire need to make healthcare safer.1 In an effort to reduce harm, improve performance and minimise cost, quality improvement (QI) methodology was identified as an ideal approach to closing the quality gap.1–3 In the years that followed, the dissemination of publications using QI methods increased significantly.4 By 2008, the first edition of the Standards for Quality Improvement Reporting Excellence (SQUIRE) Guidelines was published in an effort to support the breadth, usability and rigour of scholarly healthcare improvement work.5 Seven years later, the modified SQUIRE 2.0 Guidelines bolstered the thorough, theory-driven reporting of interventions and improvement efforts to spread generalisable and actionable knowledge.6 Furthermore, the advent of learning health systems, defined by the IOM as a system ‘designed to generate and apply the best evidence for the...

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

FDA MedWatch -

Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer

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