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Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA MedWatch -

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

From incident reporting to the analysis of the patient journey

Quality and Safety in Health Care Journal -

Patricia Trbovich and Charles Vincent

Incident reporting has been a mainstay of patient safety initiatives throughout the world, but its purpose and potential for stimulating safety improvements are still much debated. Record review studies of adverse events revealed the nature and scale of harm to patients, and it was initially hoped that incident reporting systems would capture these adverse events on an ongoing basis.1 2 This epidemiological dream was never realised; studies showed that incident reporting was actually very poor at identifying adverse events.3 Furthermore, incident reporting, record review and other systems such as pharmacy reports capture very different types of problems, which means that combining information sources can provide a more complete picture of safety issues.4 5

In this issue, de Vos and colleagues6 extend this argument to suggest that we should draw on a...

Every patient should be enabled to stop the line

Quality and Safety in Health Care Journal -

When Taiichi Ohno introduced ‘Stop the Line’ manufacturing, people were sceptical.1 2 Each assembly line worker was entrusted with the responsibility to push a red button to stop the line if she/he noticed something wrong. The idea was to catch problems early, before they got out of control. But the approach seemed at odds with production goals, namely keeping assembly lines running at full speed. Why not have managers, more trained in production, oversee the line and make fewer stops? Ohno’s idea seemed too risky to some managers, who resisted. Indeed, managers who implemented Stop the Line experienced a productivity drop. Investigating and fixing problems took time. But soon, things flipped. The teams using Stop the Line were faster and more reliable than those that did not and Stop the Line manufacturing became a standard Toyota approach.

When patients enter the hospital, they entrust clinicians...

Engaging with theory: from theoretically informed to theoretically informative improvement research

Quality and Safety in Health Care Journal -

Repeated calls have been made for the increased use of theory in designing and evaluating improvement and implementation interventions.1–4 The benefits are argued to include identifying contextual influences on quality improvement (QI), supporting the generalisability of findings and anticipating how future phenomena might unfold.2 5 Most importantly, the ability of theories to provide robust explanations is invaluable for understanding how, why and in what circumstances interventions work (or do not work),6 thus addressing crucial questions relating, for example, to variation in improvement outcomes.4 7

Although the use of theory in improvement and implementation research appears to be increasing over time,8 the emphasis largely remains on adopting a theoretically informed approach, that is, applying theory to design an intervention or to systematise and explain evaluation findings. Despite the recognised need...

Connecting perspectives on quality and safety: patient-level linkage of incident, adverse event and complaint data

Quality and Safety in Health Care Journal -

Background and objective

Incident, adverse event (AE) and complaint data are typically used separately, but may be related at the patient level with one event triggering a cascade of events, ultimately resulting in a complaint. This study examined relations between incidents, AEs and complaints that co-occurred in admissions.


Independently and routinely collected incident, AE and complaint data were retrospectively linked for surgical admissions in an academic centre (2008–2014). Two investigators reviewed whether incidents/AEs in admissions were clinically related and in what sequence (incident preceding vs following AE). Likelihood of occurrence of AEs and AE cascades (ie, ≥3 AEs) was studied using logistic regression analyses.


Complaints were filed for 33 (0.1%) of 26 383 admissions. Complaints filed by patients with incidents and/or AEs (n=13) mostly addressed quality/safety problems, whereas other complaints mostly addressed relationship problems. Incidents and AEs co-occurred in 730 (2.8%) admissions, which seemed clinically related in 34% of these cases. Incidents with related AEs preceded as well as followed AEs (56.6%/44.4%). Patients with incidents were at greater risk of AEs than patients without incidents, even for seemingly unrelated AEs (OR 1.4; 95% CI 1.3 to 1.6). Risk of AE cascades was greater when patients with AEs also had incidents, regardless of whether these seemed related (unrelated: OR 2.0; 95% CI 1.6 to 2.5; related: OR 5.7; 95% CI 4.3 to 7.4) or whether incidents preceded or followed AEs in these admissions (53% vs 52%, P>0.05).


Patient-level linkage of incident, AE and complaint data can reveal relations between events that otherwise remain obscured, such as incidents that trigger as well as follow AEs, introducing event cascades, regardless of whether clinical relations seem present.

We want to know: patient comfort speaking up about breakdowns in care and patient experience

Quality and Safety in Health Care Journal -


To assess patient comfort speaking up about problems during hospitalisation and to identify patients at increased risk of having a problem and not feeling comfortable speaking up.


Cross-sectional study.


Eight hospitals in Maryland and Washington, District of Columbia.


Patients hospitalised at any one of eight hospitals who completed the Hospital Consumer Assessment of Healthcare Providers and Systems survey postdischarge.

Main outcome measures

Response to the question ‘How often did you feel comfortable speaking up if you had any problems in your care?’ grouped as: (1) no problems during hospitalisation, (2) always felt comfortable speaking up and (3) usually/sometimes/never felt comfortable speaking up.


Of 10 212 patients who provided valid responses, 4958 (48.6%) indicated they had experienced a problem during hospitalisation. Of these, 1514 (30.5%) did not always feel comfortable speaking up. Predictors of having a problem during hospitalisation included age, health status and education level. Patients who were older, reported worse overall and mental health, were admitted via the Emergency Department and did not speak English at home were less likely to always feel comfortable speaking up. Patients who were not always comfortable speaking up provided lower ratings of nurse communication (47.8 vs 80.4; p<0.01), physician communication (57.2 vs 82.6; p<0.01) and overall hospital ratings (7.1 vs 8.7; p<0.01). They were significantly less likely to definitely recommend the hospital (36.7% vs 71.7 %; p<0.01) than patients who were always comfortable speaking up.


Patients frequently experience problems in care during hospitalisation and many do not feel comfortable speaking up. Creating conditions for patients to be comfortable speaking up may result in service recovery opportunities and improved patient experience. Such efforts should consider the impact of health literacy and mental health on patient engagement in patient-safety activities.

Explaining organisational responses to a board-level quality improvement intervention: findings from an evaluation in six providers in the English National Health Service

Quality and Safety in Health Care Journal -


Healthcare systems worldwide are concerned with strengthening board-level governance of quality. We applied Lozeau, Langley and Denis’ typology (transformation, customisation, loose coupling and corruption) to describe and explain the organisational response to an improvement intervention in six hospital boards in England.


We conducted fieldwork over a 30-month period as part of an evaluation in six healthcare provider organisations in England. Our data comprised board member interviews (n=54), board meeting observations (24 hours) and relevant documents.


Two organisations transformed their processes in a way that was consistent with the objectives of the intervention, and one customised the intervention with positive effects. In two further organisations, the intervention was only loosely coupled with organisational processes, and participation in the intervention stopped when it competed with other initiatives. In the final case, the intervention was corrupted to reinforce existing organisational processes (a focus on external regulatory requirements). The organisational response was contingent on the availability of ‘slack’—expressed by participants as the ‘space to think’ and ‘someone to do the doing’—and the presence of a functioning board.


Underperforming organisations, under pressure to improve, have little time or resources to devote to organisation-wide quality improvement initiatives. Our research highlights the need for policy-makers and regulators to extend their focus beyond the choice of intervention, to consider how the chosen intervention will be implemented in public sector hospitals, how this will vary between contexts and with what effects. We provide useful information on the necessary conditions for a board-level quality improvement intervention to have positive effects.


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