If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.

UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.

Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.

Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.

Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.

Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.

A pervasive theme of healthcare reform globally is greater candour about the imperfections of care quality, particularly for patients and family members when things go wrong. Numerous healthcare systems now have published policies around disclosure. However, as Moore and Mello document in their paper in this issue of BMJ Quality and Safety,1 details about how, what and when to disclose are scant, and based on minimal evidence about what works for patients, families, clinicians and organisations. Moore and Mello provide important insights from New Zealand, where a mandatory system for compensation following treatment injuries has been in place for over 40 years, on how to achieve reconciliation that satisfies the concerns of aggrieved patients and carers while being acceptable to clinicians and organisations.

Moore and Mello relate their findings in particular to the North American context. The traditional medical malpractice liability system in the USA has long...

Reducing 28-day or 30-day readmissions has become an important aim for healthcare services, spurred in part by the introduction of financial incentives for hospitals with high readmission rates in the USA, England, Denmark, Germany and elsewhere.1 Unfortunately, many of the most effective interventions are costly, since they are multimodal and involve several components and multiple healthcare practitioners.2 Therefore, some healthcare teams are turning to predictive models in order to identify patients at high risk for readmission and focus resource intensive readmission prevention strategies on such ‘at risk’ patients. Recent years have seen an explosion in these predictive models, which use patterns observed within large data sets to generate readmission risks for individual patients. In 2011, a systematic review found 26 models for readmissions,3 but an updated review that examined papers published up to 2015 found 68 more.4

While doubts remain about...

On 22 July 2011, a terrible attack by a lone shooter on the Norwegian island of Utøya cost 77 young lives, injured 78 and changed the lives of hundreds forever within 73 min. In the current international context of increased threat, sharing experience about disaster response is crucial. With some exceptions,1–3 many of these studies adopt a deficit-based analysis approach and focus on dysfunctions rather than positive lessons.

In contrast, Brandrud et al4 adopted an original approach. The group used the conclusions of two official and independent commissions as starting point, namely that the medical response to the incident was particularly well managed. This enabled a ‘positive deviance’5 6 analysis to draw important lessons from this incident.

The authors attempted to gather crucial insights with the help of detailed group interviews and expert review: How did a rural...

Background

Despite the investment in exploring patient-centred alternatives to medical malpractice in New Zealand (NZ), the UK and the USA, patients' experiences with these processes are not well understood. We sought to explore factors that facilitate and impede reconciliation following patient safety incidents and identify recommendations for strengthening institution-led alternatives to malpractice litigation.

Methods

We conducted semistructured interviews with 62 patients injured by healthcare in NZ, administrators of 12 public hospitals, 5 lawyers specialising in Accident Compensation Corporation (ACC) claims and 3 ACC staff. NZ was chosen as the research site because it has replaced medical malpractice litigation with a no-fault scheme. Thematic analysis was used to identify key themes from interview transcripts.

Results

Interview responses converged on five elements of the reconciliation process that were important: (1) ask, rather than assume, what patients and families need from the process and recognise that, for many patients, being heard is important and should occur early in the reconciliation process; (2) support timely, sincere, culturally appropriate and meaningful apologies, avoiding forced or tokenistic quasi-apologies; (3) choose words that promote reconciliation; (4) include the people who patients want involved in the reconciliation discussion, including practitioners involved in the harm event; and (5) engage the support of lawyers and patient relations staff as appropriate.

Discussion

Policymakers and healthcare institutions are keenly interested in non-litigation approaches to resolving malpractice incidents. Interviewing participants involved in patient safety incident reconciliation processes suggests that healthcare institutions should not view apology as a substitute for other remedial actions; use flexible guidelines that distil best-practice principles, ensuring that steps are not missed, while not prescribing a ‘one size fits all’ communication approach.

Objective

The HOSPITAL score has been widely validated and accurately identifies high-risk patients who may mostly benefit from transition care interventions. Although this score is easy to use, it has the potential to be simplified without impacting its performance. We aimed to validate a simplified version of the HOSPITAL score for predicting patients likely to be readmitted.

Design and setting

Retrospective study in 9 large hospitals across 4 countries, from January through December 2011.

Participants

We included all consecutively discharged medical patients. We excluded patients who died before discharge or were transferred to another acute care facility.

Measurements

The primary outcome was any 30-day potentially avoidable readmission. We simplified the score as follows: (1) ‘discharge from an oncology division’ was replaced by ‘cancer diagnosis or discharge from an oncology division’; (2) ‘any procedure’ was left out; (3) patients were categorised into two risk groups (unlikely and likely to be readmitted). The performance of the simplified HOSPITAL score was evaluated according to its overall accuracy, its discriminatory power and its calibration.

Results

Thirty-day potentially avoidable readmission rate was 9.7% (n=11 307/117 065 patients discharged). Median of the simplified HOSPITAL score was 3 points (IQR 2–5). Overall accuracy was very good with a Brier score of 0.08 and discriminatory power remained good with a C-statistic of 0.69 (95% CI 0.68 to 0.69). The calibration was excellent when comparing the expected with the observed risk in the two risk categories.

Conclusions

The simplified HOSPITAL score has good performance for predicting 30-day readmission. Prognostic accuracy was similar to the original version, while its use is even easier. This simplified score may provide a good alternative to the original score depending on the setting.

Introduction

On 22 July 2011, Norway suffered a devastating terrorist attack targeting a political youth camp on a remote island. Within a few hours, 35 injured terrorist victims were admitted to the local Ringerike community hospital. All victims survived. The local emergency medical service (EMS), despite limited resources, was evaluated by three external bodies as successful in handling this crisis. This study investigates the determinants for the success of that EMS as a model for quality improvement in healthcare.

Methods

We performed focus group interviews using the critical incident technique with 30 healthcare professionals involved in the care of the attack victims to establish determinants of the EMS’ success. Two independent teams of professional experts classified and validated the identified determinants.

Results

Our findings suggest a combination of four elements essential for the success of the EMS: (1) major emergency preparedness and competence based on continuous planning, training and learning; (2) crisis management based on knowledge, trust and data collection; (3) empowerment through multiprofessional networks; and (4) the ability to improvise based on acquired structure and competence. The informants reported the successful response was specifically based on multiprofessional trauma education, team training, and prehospital and in-hospital networking including mental healthcare. The powerful combination of preparedness, competence and crisis management built on empowerment enabled the healthcare workers to trust themselves and each other to make professional decisions and creative improvisations in an unpredictable situation.

Conclusion

The determinants for success derived from this qualitative study (preparedness, management, networking, ability to improvise) may be universally applicable to understanding the conditions for resilient and safe healthcare services, and of general interest for quality improvement in healthcare.

Background

Medication errors are frequent and may cause harm to patients and increase healthcare expenses.

Aim

To explore whether a new labelling influences time and errors when preparing medications in accordance with medication charts in an experimental setting.

Method

We carried out an uncontrolled before and after study with 3 months inbetween experiments. Phase I used original labelling and phase II used new generic labelling. We set up an experimental medicine room, simulating a real-life setting. Twenty-five nurses and ten pharmacy technicians participated in the study. We asked them to prepare medications in accordance with medication charts, place packages on a desk and document the package prepared. We timed the operation. Participants were asked to prepare medications in accordance with as many charts as possible within 30 min.

Results

Nurses prepared significantly more medication charts with the generic labelling compared with the original 3.3 versus 2.6 (p=0.009). Mean time per medication chart was significantly lower with the generic labelling 6.9 min/chart versus 8.5 min/chart (p<0.001). Pharmacy technicians were significantly faster than the nurses in both phase I (6.8 min/chart vs 9.5 min/chart; p<0.001) and phase II (6.1 min/chart vs 7.2 min/chart; p=0.013). The number of errors was low and not significantly different between the two labellings, with errors affecting 9.1% of charts in phase I versus 6.5% in phase II (p=0.5).

Conclusions

A new labelling of medication packages with prominent placement of the active substance(s) and strength(s) in the front of the medication package may reduce time for nurses when preparing medications, without increasing medication errors.

Background

Childbirth is a leading reason for hospital admission in the USA, and most labour care is provided by registered nurses under physician or midwife supervision in a nurse-managed care model. Yet, there are no validated nurse-sensitive quality measures for maternity care. We aimed to engage primary stakeholders of maternity care in identifying the aspects of nursing care during labour and birth they believe influence birth outcomes, and how these aspects of care might be measured.

Methods

This qualitative study used 15 focus groups to explore perceptions of 73 nurses, 23 new mothers and 9 physicians regarding important aspects of care. Transcripts were analysed thematically. Participants in the final six focus groups were also asked whether or not they thought each of five existing perinatal quality measures were nurse-sensitive.

Results

Nurses, new mothers and physicians identified nurses' support of and advocacy for women as important to birth outcomes. Support and advocacy actions included keeping women and their family members informed, being present with women, setting the emotional tone, knowing and advocating for women's wishes and avoiding caesarean birth. Mothers and nurses took technical aspects of care for granted, whereas physicians discussed this more explicitly, noting that nurses were their ‘eyes and ears’ during labour. Participants endorsed caesarean rates and breastfeeding rates as likely to be nurse-sensitive.

Conclusions

Stakeholder values support inclusion of maternity nursing care quality measures related to emotional support and providing information in addition to physical support and clinical aspects of care. Care models that ensure labour nurses have sufficient time and resources to engage in the supportive relationships that women value might contribute to better health outcomes and improved patient experience.

Background

Respiratory rate (RR) is an independent predictor of adverse outcomes and an integral component of many risk prediction scores for hospitalised adults. Yet, it is unclear if RR is recorded accurately. We sought to assess the potential accuracy of RR by analysing the distribution and variation as a proxy, since RR should be normally distributed if recorded accurately.

Methods

We conducted a descriptive observational study of electronic health record data from consecutive hospitalisations from 2009 to 2010 from six diverse hospitals. We assessed the distribution of the maximum RR on admission, using heart rate (HR) as a comparison since this is objectively measured. We assessed RR patterns among selected subgroups expected to have greater physiological variation using the coefficient of variation (CV=SD/mean).

Results

Among 36 966 hospitalisations, recorded RR was not normally distributed (p<0.001), but right skewed (skewness=3.99) with values clustered at 18 and 20 (kurtosis=23.9). In contrast, HR was relatively normally distributed. Patients with a cardiopulmonary diagnosis or hypoxia only had modestly greater variation (CV increase of 2%–6%). Among 1318 patients transferred from the ward to the intensive care unit (n=1318), RR variation the day preceding transfer was similar to that observed on admission (CV 0.24 vs 0.26), even for those transferred with respiratory failure (CV 0.25).

Conclusions

The observed patterns suggest that RR is inaccurately recorded, even among those with cardiopulmonary compromise, and represents a ‘spot’ estimate with values of 18 and 20 breaths per minute representing ‘normal.’ While spot estimates may potentially be adequate to indicate clinical stability, inaccurate RR may alternatively lead to misclassification of disease severity, potentially jeopardising patient safety. Thus, we recommend greater training for hospital personnel to accurately record RR.

Background

The WHO Surgical Safety Checklist (SSC) was developed in 2008 as part of the Safe Surgery Saves Lives campaign.1 Broadly mandated and put into practice in hospitals around the world, the SSC has been the focus of 8 years of extensive research. Initial studies reported positive outcomes on morbidity and mortality.2 3 Other studies have reported more limited impacts, for example,4 still others have reported no impact at all5 6 or questioned the effectiveness of SSC.7 Such results have prompted calls for the reconsideration of policies mandating the SSC as an organisational safety practice.8

Much is at stake here. The role of team communication in care quality is incontrovertible9 10; therefore, decisions to pursue or abandon the SSC are consequential and should be made by drawing from a robust...

Social media usage has become a cultural norm in the USA. Overall, 76% of online adults in the USA use social media.1 And it is not just a phenomenon embraced by the young—31% of all seniors are on Facebook.2 With growing engagement across demographics, social media networks offer new platforms of digital interaction at a scale that is hard to comprehend—313 million active Twitter users sending half a billion tweets and 1.9 billion Facebook accounts uploading 350 million photos every day. SnapChat has created some of the country's youngest billionaires. All these activities, driven by the public's desire to curate and share life experiences, provide new opportunities to observe and understand lived reality in greater detail and closer to real time than ever before.

Concurrently, the concept of patient centredness, whether through better understanding of the patient experience, or better engagement with the patient in...

The Smartest Person is a popular Dutch television quiz show in which three contestants receive a few seconds to answer trivia questions. In one of the rounds, to answer the question, contestants must hit certain key words, for example, ‘Apartheid’, ‘Prison’, ‘Nobel Peace Prize’ and ‘South Africa’ for the question ‘What do you know about Nelson Mandela?’ Contestants who mention one of these key words, regardless of context, hear a rewarding ‘ting!’ and receive 20 extra seconds. The most efficient strategy to win is to mention the four key words without a linking sentence; answering with a complete and cogent sentence costs precious seconds. In fact, contestants can win even when they get the context wrong, for example: ‘Nelson Mandela is an Italian actor starring in a film about the Apartheid (ting!). He recently spent a night in Prison (ting!) after he egged the house of a Nobel Peace Prize...

Perspective

Value in healthcare is the clinical outcome and patient experience relative to the costs of care. Traditionally, healthcare providers have primarily focused on improving the quality of care in order to increase value. In fact, change introduced with the primary intention of saving costs is viewed with suspicion, lest it negatively impact the quality of care. Modifying existing practices to primarily decrease costs can thus be quite challenging, even when these changes are evidence-based and have no adverse impact on the quality of care. Attempting to limit the use of intravenous proton pump inhibitors (PPIs) to appropriate indications falls under this category of changes. PPIs are one of the most overused medications, and the intravenous route is often used when oral administration would suffice, significantly increasing medication and administration costs.1–3 Studies have shown that oral PPIs have similar efficacy compared with...

Low-value healthcare has been defined as care that is inappropriate for a specific clinical indication, inappropriate for a clinical indication in a specific population or an excessive frequency of services relative to expected benefit.1 Quantifying the prevalence of low-value healthcare informs clinicians and health policy makers on the use and associations of unwarranted care.2 In this Viewpoint, we clarify the approaches used in the literature for measuring and reporting the level of low-value care in a given population. Categorising low-value service measures depends on the denominator used. Future analyses should consider using all types of measures when possible, or explain why it is not practical or desirable to do so, and at the very least describe for the reader which measure has been used, as this can dramatically impact interpretation of the results.

Low-value care: listed and (variably) measured

Defining, quantifying and reducing low-value...